policy change and regulation of primary care prescribing...

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PolicyChangeandRegulationofPrimaryCarePrescribingandDispensinginMacedonia–AQualitativeStudy

By:

NedaMilevskaKostova,MSc,MPPMAthesissubmittedinpartialfulfilmentoftherequirementsforthedegreeof

DoctorofPhilosophy

TheUniversityofSheffieldSchoolofHealthandRelatedResearch(ScHARR)

November2017

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Abstract

Background. Former socialist countries’ transitions to market economies have had

significant implications for health service policy and delivery. This study uses the

transitioninMacedoniaasacasestudysettingtoexplorehowsuchchangesandrelated

policies have been perceived to impact upon an important area, the prescribing and

supply of medicines. This study focuses on the key primary care policies relating to

limitationstoprescribingvolumeanddispensingpolicyenforcement.

Study aims were to explore experiences and perceptions of how privatisation and

regulation policies influenced the prescribing and dispensing of medicines from the

perspectives of primary care physicians, pharmacists, patients and elite group

stakeholders.

Methods. A qualitative design was used utilising semi-structured interviews with a

purposiveandsnowballsampleof17doctors,12pharmacists,14patientsand13elites.

Interviews were conducted face-to-face and fully recorded and transcribed and then

analysedusingathematicanalysisapproach.

Findings.Differingbutoftennegativeperspectivesemerged,withprimarycareprovider

physicians and pharmacists feeling pressure from both regulatory and governmental

bodies and patients qua their expectations and medicines demands. Physicians and

pharmacists felt detached from policies and that guidance was lacking.

Disempowerment and threats to professional autonomy resulted, with unethical

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implications for irrational prescribing and supplying medicines without prescriptions.

Elites considered recent policy changes as necessary although they, and other

participants, made comparisons to the previous system which was viewed with

nostalgia, as being fairer. Mandatory prescription enforcement appeared ineffective

withpatientsbeingabletoobtainmedicines,althoughpatientsreportednewpressures

innegotiatingmedicinesupplyandjustifyingself-medicationpractices.Lackofcoherent

policyimplementationwasarecurringtheme.

Discussion and Conclusions. Increasing regulation, marginalised professionals and

patientsledtonumerousnegativeexperiences.UsingaHabermasianperspective,policy

changeswithinMacedonia reflect a system that threatens individuals' lifeworlds; new

policies represent juridification and professionals’ perception of being isolated,

uninvolved and unsupported, reflecting disruption of communicative acts and justice.

Thisstudysuggeststheneedtoimprovecommunicationbetweendifferentstakeholders

and involve practitioners and patients to ensure policy changeis sensitive, and not a

threat,toindividuals'autonomy.

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Acknowledgements

Iwould like to thankmy supervisors,DrRichardCooper andDrKatyCooper, and the

staffoftheUniversityofSheffield,especiallyProfPetraMeierandDrAllanWailooforall

their advice and assistance during this research, which was an exceptional academic

experience.Iwouldalsoliketothankalltheparticipantsintheinterviewsconductedfor

theirsincereengagementandopenness.

I extendmy utmost gratitude tomy family for their immeasurable andwholehearted

support,andtomymotherVioletaandmydearestfriendSnezhanafortheirbeliefand

constantencouragement.

IdedicatethisworktoZoran,VedaandBodan.

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Publications

Journalarticles:

Müller-NordhornJ.,HolmbergC.,DokovaK.G.,Milevska-KostovaN.,ChicinG.,UlrichsT.,RechelB.,WillichS.N.,PowlesJ.,TinnemannP.(2012).PerceivedchallengestopublichealthinCentralandEasternEurope:aqualitativeanalysis.BMCPublicHealth,12:311.

Milevska-KostovaN.(2010).Reformsinhealthcare–privatizationofprimaryhealthcareandothermodelsforimprovementofeffectivenessandefficiencyofuseofhealthcareresources.Revijazasocijalnapolitika,no.5:409-22.

Milevska-KostovaN.,DunnW.N.,ChichevalievF.(2009).PatientSafetyintheRepublicofMacedonia:Legislativeandpolicyaspects,JournalforEuropeanIssues‘Evrodijalog’11:87-106

Bookcontributionsandchapters:

MilevskaKostovaN,ChichevalievaS.,PonceNA.,vanGinnekenE.,WinkelmannJ.(2017).TheformerYugoslavRepublicofMacedonia:Healthsystemreview.HealthSystemsinTransition,2016;18(7):1–160.

MilevskaKostovaN.(2013).EquityinHealthinMacedonia:Socio-EconomicandFinancialAspectsandEffectsofPolicyChangesonAccesstoPrescriptionMedicinesinPrimaryHealthcare.In:Gordon,C.,Kmezic,M.Opardija,J.(eds).StagnationandDriftintheWesternBalkans:TheChallengesofPolitical,EconomicandSocialChange.PeterLang:Germany.

MilevskaKostovaN.,E.Stikova,D.Donev(2013).Healthpolicyanalysisanddevelopment,in:BurazeriGandZaletel-Kragelj(eds):Health:Systems–Lifestyle–Policies,Vol.1(2nded).Lage:JacobsVerlag.

MilevskaKostovaN.,DunnW.(2010).DelphiAnalysis.In:KovacicL.Zaletel-KrageljL.(eds).Methodsandtoolsinpublichealth,Lage,Germany:HansJacobs.

DonevD.,MilevskaKostovaN.,GalanA.(2010).Strategicplanninginhealthcare–Generalapproach.In:KovacicL.Zaletel-KrageljL.(eds).Methodsandtoolsinpublichealth,Lage,Germany:HansJacobs.

MilevskaKostovaN.,DonevD.(2008).Socio-medicalandethicaldimensionsofthehealthpractice,inKovacicL.Zaletel-KrageljL.(eds).ManagementofHealthcarepractice:AHandbookforTeachers,ResearchersandHealthProfessionals,Lage,Germany:HansJacobs.

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TableofContents

Abstract........................................................................................................................2

Acknowledgements......................................................................................................4

Publications..................................................................................................................5

TableofContents.........................................................................................................6

ListofTables..............................................................................................................11

ListofFigures.............................................................................................................11

Abbreviations.............................................................................................................12

GlossaryofTerms.......................................................................................................13

CHAPTER1:Introduction.....................................................................................191.1. Overview..........................................................................................................19

1.2. Rationaleforstudyingprescribinganddispensingofmedicinesintransition

economies..................................................................................................................20

1.3. Mybackgroundandresearchinterests.............................................................21

1.4. Thesisoutline...................................................................................................22

CHAPTER2: Healthsystemreforms,prescribinganddispensingmedicinesinMacedonia 25

2.1. Overviewofhealthreformandprivatizationintransitioncountries.................25

2.2. HealthreformandprimarycareprivatizationinMacedonia.............................27

2.2.1HealthreforminMacedonia...........................................................................27

2.2.2PrivatizationofprimaryhealthcareinMacedonia..........................................28

2.2.3CapitationpaymentinprimaryhealthcareinMacedonia..............................29

2.3. PrescribinganddispensinginprimaryhealthcareinMacedonia.......................31

2.3.1Overviewofprescribinganddispensingpolicies............................................31

2.3.2Prescribingpolicychanges..............................................................................33

2.3.3Dispensingpolicychanges...............................................................................36

2.3.4Prescribinganddispensinglevelsinprivatizedprimaryhealthcare...............38

2.4. Summaryofchapter.........................................................................................41

CHAPTER3:Literaturereview.............................................................................433.1. Introduction.....................................................................................................43

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3.2. Literaturesearchstrategy.................................................................................43

3.2.1Searchmethods...............................................................................................44

3.2.2Databasesearchstrategy................................................................................44

3.2.3Inclusionandexclusioncriteria.......................................................................46

3.2.4Resultsofliteraturesearch.............................................................................47

3.3. Medicines:Anoverview...................................................................................48

3.4. Regulatingmedicinessupplyanddemand........................................................51

3.4.1Regulatingmedicinessupply...........................................................................52

3.4.2Regulatingmedicinesdemand........................................................................53

3.5. Prescribingofmedicines...................................................................................54

3.5.1Rationalprescribing........................................................................................54

3.5.2Autonomyandprescribing..............................................................................573.5.3Rationalprescribingandrelationshiptochangesinbehaviour......................59

3.6. Overviewoffactorsinfluencingprescribinginprimaryhealthcare....................62

3.6.1.Providers’experiencefactors.........................................................................63

3.6.2.Regulatoryfactorsandsystem’sinfluenceonprescribing.............................65

3.6.3.Patients’influenceandphysician-patientrelationship..................................66

3.7. Rationaldispensingandchallengestolegalsupply...........................................68

3.8. MedicinesupplyandHabermas’SystemandLifeworld.....................................71

3.8.1Habermas’theoryofcommunicativeactionandhealthcare..........................72

3.8.2TheLifeworld:patients’roleinprescribinganddispensing............................76

3.9. Prescribinganddispensingintransitioncountries............................................78

3.9.1Primarycareandsystem/lifeworldinteractions.............................................78

3.9.2Primarycareintransitioncountries................................................................80

3.9.3Privatisationofprimarycareintransitioncountries.......................................823.9.4Prescribinganddispensinginprimarycareintransitioncountries:systemand

lifeworldperspective................................................................................................84

3.10. Researchquestions...........................................................................................88

3.11. Summaryofchapter.........................................................................................88

CHAPTER4:Methodology...................................................................................924.1. Introduction.....................................................................................................92

4.2. Choiceofqualitativemethodology...................................................................93

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4.2.1Epistemologicalposition.................................................................................94

4.2.2Rationaleforchoiceofsemi-structuredinterviewmethod............................97

4.3. Datacollection...............................................................................................100

4.3.1Sampling........................................................................................................100

4.3.2Samplesize....................................................................................................103

4.3.3Researchinstruments....................................................................................105

4.3.4Incentivesforparticipants.............................................................................106

4.3.5Interviewing..................................................................................................107

4.3.6Reflectingoninterviewinganddatacollectionprocess................................110

4.3.7Recording,transcribingandtranslation........................................................112

4.4. Dataanalysis..................................................................................................114

4.4.1Descriptionofthematicanalysis...................................................................1144.4.2Datafamiliarization.......................................................................................115

4.4.3.Generatinginitialcodes...............................................................................117

4.4.4.Developmentofthemes...............................................................................119

4.4.5.Reviewingandrefiningofthemes................................................................120

4.4.6Presentingthedatafindingsandwrite-up....................................................121

4.5. Qualityandcredibilityofthisresearch...........................................................122

4.6. Researchethicsandconfidentiality................................................................124

4.7. Disseminationoffindings...............................................................................127

4.8. Summaryofchapter.......................................................................................128

CHAPTER5:Findings.........................................................................................1305.1. Introduction...................................................................................................130

5.1.1Overviewofchapter......................................................................................130

5.1.2.Approachestodatapresentation................................................................131

5.1.3.Summaryofkeythemes...............................................................................1325.2. Reflectionsonpastandpresentpolicies.........................................................136

5.2.1Nostalgiaforthepastsystem........................................................................1375.2.1.1Reflectionsonthepastsystem...........................................................................1375.2.1.2Autonomyinprescribingandobtainingmedicineswithinthepastsystem.......141

5.2.2Reflectionsonrecentpolicies:necessityforchangeandqualifiedacceptance

...............................................................................................................................148

5.2.3Summaryofpolicyperceptions.....................................................................159

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5.3. Policyimplementationproblems:lackofinvolvementandsupport................160

5.3.1Lackofinvolvementinpolicymaking...........................................................162

5.3.2Providers’lackofsupportanddetachment..................................................167

5.3.3Unwillingnesstoshareresponsibility............................................................178

5.3.4Summaryofthemefindings..........................................................................184

5.4. Pressuresinpractice.......................................................................................185

5.4.1Providers’professionaldisempowerment....................................................186

5.4.2Patients’negotiationofmedicinesupply......................................................193

5.4.3Summaryofpressuresinpractice.................................................................200


CHAPTER6:Discussion......................................................................................2056.1. Introduction...................................................................................................205

6.1.1Overviewofchapter......................................................................................2056.1.2Observations.................................................................................................206

6.2. Thesignificanceoffindingsinthisresearch....................................................208

6.2.1Reflectionsonpastandrecentpolicies:nostalgiaforthepast.....................209

6.2.2Reflectionsonprofessionalautonomy..........................................................214

6.2.3Involvementinpolicymaking.......................................................................216

6.2.4Lackofsupportinpolicyimplementationanddetachment.........................219

6.2.5Perceivedreasonsforinadequatepolicyimplementationandaccepting

responsibility..........................................................................................................221

6.2.6Non-prudentdispensingandillegalmedicinesupply...................................224

6.2.7Providers’perceivedpressuresinpracticefromthesystem........................226

6.2.8Providers’perceivedpressuresinpracticefrompatients.............................227

6.2.9Patients’perceivedpressures:Negotiatingmedicinesupply.......................229

6.3. Medicinesupplypolicychanges-aHabermasianperspective.........................2306.3.1ConsideringparticipantgroupsthroughaHabermasianperspective...........231

6.3.2Systemandlifeworldperspectives................................................................233

6.4. Methodologicalchallengesandlimitationsofthestudy.................................236

6.4.1Methodologicalchallenges...........................................................................236

6.4.2Limitationsofthisstudy................................................................................238

6.5. Futureresearchquestions..............................................................................239

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CHAPTER7:Conclusionsandrecommendations................................................2447.1. Conclusions....................................................................................................244

7.2. Currentpolicyinsights....................................................................................246

7.3. Policyrecommendations................................................................................247

7.3.1Involvementofstakeholdersinpolicymaking...............................................248

7.3.2Provisionofinformationonpolicychanges..................................................249

7.3.3Involvementinpolicyimplementation.........................................................249

7.3.4Guidelinesandcommunicationtrainingforproviders.................................250

7.3.5Patients’literacyandawarenessraisingcampaigns.....................................251

7.4. Finalreflections..............................................................................................252

APPENDICES......................................................................................................253AppendixA:ETHICSAPPROVALS..............................................................................253

AppendixB:INFOSHEETFORPARTICIPANTS............................................................255

AppendixC:CONSENTFORM....................................................................................258AppendixD:INTERVIEWSCHEDULEQUESTIONSFORELITES.....................................259

AppendixE:INTERVIEWSCHEDULEQUESTIONSFORPHYSICIANS.............................261

AppendixF:INTERVIEWSCHEDULEQUESTIONSFORPHARMACISTS.........................263

AppendixG:INTERVIEWSCHEDULEQUESTIONSFORPATIENTS................................265

REFERENCES......................................................................................................267

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ListofTables

Table1.PreventivegoalsinprimaryhealthcareinMacedonia(2009and2014)............30

Table2.SummaryofpolicychangesinprescribinganddispensinginprimarycareinMacedonia...............................................................................................................32

Table3.PrescribedanddispensedmedicinescoveredbytheHealthInsuranceFund,2008-2014................................................................................................................39

Table4.Keywordsusedinelectronicdatabasessearch.................................................45

Table5.ThefourtypesofengagedinteractionbetweensystemandlifeworldandtheoutcomessummarizedbyBarryetal(2001)...........................................................75

Table6.Samplingrationaleforinterviewees–Elitestakeholders................................104

Table7.Interviewees’characteristics–Elites(educationalbackground).....................104

Table8.Interviewees’characteristics–Primarycarephysicians..................................105

Table9.Interviewees’characteristics–Pharmacists.....................................................105

Table10.Interviewees’characteristics–Patients.........................................................105

Table11.Thesixphasesofthematicanalysis................................................................115

Table12.Anexampleofanalysisconductedonasectionoftranscript,togetherwiththeresolvedinterpretationinthefinalcolumn...........................................................118

Table13.Summaryofkeythemesandsub-themesandrelationshiptoparticipants...133

Table14.Summaryofkeyrecommendations...............................................................247

ListofFigures

Figure1.DevelopmentofprimaryhealthcareinMacedonia..........................................29

Figure2.PolicychangesforrationalprescribinginprimaryhealthcareinMacedonia...32

Figure3.SimplifiedflowchartofprescribinganddispensinginMacedonia....................37

Figure4.PrescribedanddispensedmedicinesbyATCgroupscoveredbytheHealthInsuranceFund.........................................................................................................39

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Abbreviations

ATC AnatomicalTherapeuticChemicalclassificationsystem

DRG Diagnosis-relatedgroups

EI Eliteinterviewee

EML EssentialMedicinesList

GP Generalpractitioner

HIF HealthInsuranceFund

MALMED MacedonianAgencyforMedicinesandMedicalDevices

MoH MinistryofHealth

OTC Over-the-counter(medicines)

Pat Patient

PCP Primarycarephysician

Ph Pharmacist

PML PositiveMedicinesList

PC Policychange

PHC Primaryhealthcare

RTP Researchtrainingprogramme

WHO WorldHealthOrganisation

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GlossaryofTerms

The Glossary of terms was prepared based on thematerials used in this thesis, with

intentiontoclarifymeaningsandusesofparticulartermsinthecontextofthisresearch.

Anatomical Therapeutic Chemical (ATC) Classification System - system used for the

classificationofmedicines.Firstpublishedin1976,thesystemdividesmedicinesinto

different groups according to the organ or system onwhich they act and/or their

therapeuticandchemicalcharacteristics.

Appropriate prescribing - defined with various terms referring to the result or what

shouldresultasoutcomeofprescribedmedicineortreatment(Buetowetal1997).

Althoughsuggestedbysomescholarsthatforspecificpurposescanbesynonymized

with ‘rational prescribing’, the term ‘appropriate prescribing’ refers to a different

conceptexplainingwhatresults,orshouldresultastheoutcomeoftheprescribing,

for which purpose ‘rational prescribing’ is not always ‘appropriate’ (Buetow et al

1997). As will be explained later in this thesis, the ‘rational prescribing’ and

‘appropriateprescribing’aredistinguished,butmainly for thepurposeofproviding

theoretical understanding of the two concepts; otherwise, the thesis is not

concerned with doing particular research on their distinctions, and therefore,

commonlyusedintheresearchistheterm‘rationalprescribing’.

Culture - Culture in its wider definition presents ‘that complex whole which includes

knowledge, belief, art, morals, law, custom and any other capabilities and habits

acquired byman as amember of society’ (Taylor 1871). Culture is also defined as

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cultivated behaviour representing the totality of a person's learned, accumulated

experience,whichissociallytransmittedthroughcommunication.

EssentialMedicines List (EML) - also called ‘list of essentialmedicines’ and ‘essential

drug list’, as defined by theWorld Health Organisation consists of medicines that

‘satisfy the health care needs of the majority of the population; they should

thereforebeavailableat all times inadequateamountsand inappropriatedosage

forms,atapricethecommunitycanafford.’(WHO2016).

Fee-for-service - model of payment in the health systems, used both in primary or

hospitalcare inwhichservicesareunbundledandpaidforseparately.Themodel is

based on payment dependent on the quantity of care, rather than quality of care

(BerensonandRich2010).

Medicine (drug) - also referred to as drug, pharmaceutical drug, pharmaceutical,

medication or medicament, is commonly defined as any chemical substance

intendedforuseinthemedicaldiagnosis,cure,treatment,orpreventionofdisease.

For the purposes of this research, the terms the above terms will be used

interchangeablyassynonyms.

Patient-basedcapitationmodel–amodelforhealthcareservicespayment,inwhicha

physicianreceivesapaymentthatisdependentonthenumberandtypeofpatients

registeredwiththephysician’spractice(Chaix-Couturieretal2000).

Positivemedicineslist(PML)–Listofmedicinesthatarerecognizedbythegovernment

as reimbursableunderhealth insurance.Someof themedicineson thepositive list

can be obtainedwith certain co-payment, defined based on separate criteria. The

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positivemedicineslistisbasedontheEssentialMedicinesList(EML).Inthispaper,it

isusedsynonymouslywiththeterm‘positivelist’.

Prescribing – term referring to recommending substance or action as something

beneficial.Inmedicalterms,prescribing(ofahealthpractitioner)referstoadviceand

authorizationforuseofamedicineortreatmentforsomeone,especiallyprovidedto

thepatientinwriting.Forthepurposesofthisresearch,theterm‘prescribing’willbe

generallyusedforprescribingofmedicines.

Prescribing culture – literature defines this term as decision making, including

prescribing based on different influences (Maddox 2011; Hall et al 2003) from the

society, including others’ prescribing behaviour and patients, guided by informal

rules (Bishop et al 2011; Cavazos et al 2008), and not necessarily evidence based

(Ljungberg et al. 2007), and sometimes stretching beyond clinical appropriateness

(e.g.Fontanaetal2000;Woodetal2007).

Prescribing of medicines - one of the most frequent therapeutic decisions made by

general practitioners (Bakker et al 2007), representing a focal point of contact

between physicians and patients and being used as one of the indicators of the

qualityofmedicalcare(Hardingetal1985).

Primaryhealthcare -oftenusedfordescribinganarrowconceptoffamilydoctor-type

servicesdeliveredtoindividualpatientsorfirstpointofcontactwiththehealthcare

system. Primary Health Care is otherwise a broader concept, which in addition to

primary care services includes health promotion and disease prevention, and also

population-levelpublichealthfunctions,reflectingtheapproachtoserviceprovision

foracommunityproposedintheWHO1978AlmaAtaDeclaration(WHO1979).For

thepurposesofthisresearch,theterm‘primaryhealthcare’willmostlybeusedinits

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narrowdefinition of provision of services by primary healthcare providers (general

practitioners,familyphysicians,pharmacists)topatients.

Privatization -aprocessoftransferringownershipofabusiness,enterprise,agencyor

public service fromthepublic sector (government) to theprivate sector (business).

Privatization has different forms, one of which is concession, i.e. an exclusivity

contractbetweenprivateandpublicsectorforoperationofpublicutilityordelivery

ofpublicserviceforanagreednumberofyears.InthecaseofMacedonia,although

calledprivatization,thereformofprimaryhealthcarebyallcharacteristicsismorea

concessiontypeoftransformation.

Publicpolicy-principledguidetoactiontakenbytheadministrativeexecutivebranches

of the state with regard to a class of issues in a manner consistent with law and

institutional customs. The foundation of public policy is composed of national

constitutionallawsandregulations.Publicpolicyisconsideredstrongwhenitsolves

problems efficiently and effectively, serves justice, supports governmental

institutions and policies, and encourages active citizenship (Norwich University

2016).

Publicpolicyanalysis-problem-solvingdisciplinethatdrawsontheories,methodsand

substantive findings of the behavioural and social sciences, social professions and

socialandpoliticalphilosophy.Process-wise,publicpolicyanalysisismultidisciplinary

inquiry designed to create, critically assess and communicate information that is

usefulinunderstandingandimprovingpublicpolicies(Dunn2004).Forthepurposes

ofthisresearch,publicpolicyanalysisisusedtodefinethedisciplineandtheprocess

referringtopublicpoliciesrelatingtohealth,healthsystemsandhealthpolicies.

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Rational prescribing - described in various terms referring to the process whereby

prescribing decisions are made, based on the medical indication, necessity and

knowneffectivenessoftheprescribedmedicineortreatment.Althoughsuggestedby

some scholars that for specific purposes can be synonymized with ‘appropriate

prescribing’, the term ‘appropriate prescribing’ refers to a different concept

explainingwhatresults,orshouldresultastheoutcomeoftheprescribing,forwhich

purpose‘rationalprescribing’isnotalways‘appropriate’(Buetowetal1997).Aswill

be explained later in this thesis, ‘rational prescribing’ and ‘appropriate prescribing’

aredistinguished,butmainlyforthepurposeofprovidingtheoreticalunderstanding

of the two concepts; otherwise, the thesis is not concerned with doing particular

researchontheirdistinctions,andtherefore,commonlyused in theresearch is the

term‘rationalprescribing’.

Transitioncountries(transitioneconomies)–countries(andtheireconomies)changing

from a centrally planned command economy to a market economy. Transition

economiesundergoasetofstructuraltransformationsintendedtodevelopmarket-

based institutions (Leave 2010; Kornai and Eggleston 2001). According to the

literature, the transition countries comprise 29 economies of Central and Eastern

Europe and the Former Soviet Union, divided into three groups: i) Central Eastern

EuropeandBalticStates:Croatia,Estonia,Hungary,Latvia,Lithuania,Poland,Slovak

Republic and Slovenia; ii) South-Eastern Europe: Albania, Bosnia and Herzegovina,

Bulgaria,Macedonia,Montenegro, Serbia, andRomania; and iii) Commonwealthof

IndependentStates:Armenia,Azerbaijan,Belarus,Georgia,Kazakhstan,Kyrgyzstan,

Moldova,Russia,Tajikistan,Turkmenistan,UkraineandUzbekistan. Inaddition, the

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EuropeanBankofReconstructionandDevelopment (EBRD)also categorisesTurkey

andMongoliainthisgroup(Carvalhoetal2013).

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CHAPTER1:Introduction

1.1. OverviewThisfirstchaptersetsoutthereasonsforstudyingprescribinganddispensingpractices

and attitudes during a period of significant changes within a healthcare system, my

relationshiptothetopicandanoverviewofthestructureofthethesis.

This research explores the subjective effects of healthcare reforms in transition

countries, namely those that have experienced a shift from command to market

economy.Throughtheuseofqualitativeresearchitprovidesagreaterunderstandingof

the effect of this transition onhealthcare services provision, and especiallymedicines

supplyatthelevelofprescribinganddispensing,asviewedbyarangeofstakeholders.

Specifically, this researchexplores theeffectsofpolicy changes relating toprescribing

anddispensingofmedicinesinprimarycareinMacedoniaonthepracticesandattitudes

ofpolicymakers,physicians,pharmacistsandpatients intermsofmedicinesprovision.

Particular focus is chosen for two reasons: i) as a country,Macedonia has undergone

major privatization reform, explained in detail further in this thesis, and ii) as a sub-

setting, a significant proportion of prescribing and dispensing happens at the primary

healthcare level. I have undertaken the research using semi-structured interviews. I

hopethatthisknowledgewillinformbetterdesignandimplementationoffuturepolicy

changesinMacedoniaaswellasinothercountriesundergoinghealthcarereform.

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1.2. Rationaleforstudyingprescribinganddispensingofmedicinesintransitioneconomies

Healthcare reforms and privatization in transition economies have been the focus of

previous research (Kornai and McHale 2000; Leive 2010). These have been analysed

mostlyfromafinancialperspectiveor inrelationtohealthoutcomes(Janssenandvan

derMade 1990;Querciolli et al 2013). However, there is little published evidence on

effects of privatisation on social and behavioural aspects such as the attitudes of

primarycareproviders(i.e.physiciansandpharmacists)andpatients(Butleretal1998;

Ong et al 1995; Emanuel and Emanuel 1992). This research seeks to address this

omissionanddoessousingafurtherspecificfocus,whichisarguedtohavebeenabsent

intransitioncountrypolicychangeresearch,namelythesupplyofmedicines.Medicines

represent an important, tangible aspect of all health systems and several aspects of

their control and supply have been argued to have considerable significance for

differentstakeholders(Whyte,vanderGeestandHardon2002;Britten2008).Involving

prescribing doctors, dispensing pharmacists and consuming patients, the supply of

medicineswillbearguedtobeanimportanttrajectoryforframingtheimpactofpolicy

reformandisworthyofempiricalinvestigation.

Undertakingsuch research, is innovativeandcandirectly informtheon-goingdebates

aboutthesignificantchangestohealthcaresystemsaimedatimprovingeffectivenessof

the use of limited resources to address increasing demands for healthcare (Maarse

2006;HiggsandJones2001,p.144).Suchissueshavebeenrarelysubjecttoqualitative

research in transition economies, resulting in very limited existing literature exploring

transitioneconomies.Furtherresearchusingqualitativemethodsallowsforanin-depth

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cultural and sociological exploration of the policies and policy responses within the

uniquecontextualcircumstancesofthesecountries.

1.3. MybackgroundandresearchinterestsMyinterestinstudyingprescriptionpracticeswithinprimaryhealthcarestemsfrommy

background as a pharmacist andmy experience in researching healthcare reforms in

Macedonia since its independence. In the past years of my work, I have explored a

numberofcaseswhenpolicieswereadoptedbasedonothercountries’bestpracticesor

on international experts’ advice, without prior thorough assessment of their likely

effects on society or on the individual. Most often the response was either partial

compliance or continuation of previous practices, leading to recurrent failure of

implementation.Theprescribinganddispensingpoliciesareonesuchexample,where

sequentialchangesmadetoaddressfailurehavenotproducedthedesiredresults,with

continuing high levels of antibiotic use (Radoshevic et al 2009; Ivanovska et al 2013).

This is particularly observable within prescribing and dispensing of antibiotics, for

example, which in Macedonia continues to be an issue; the extremely high levels of

antibiotic prescribing and self-medication are contributing to the global concern of

increasingantimicrobialresistance(Angelovskaetal2016).

In trying to understand these failures of policy implementation in general, and the

effects of primary care reform in particular, my research interest is focused on

understandingthepracticesandattitudesofpolicymakers,physicians,pharmacistsand

patientsrelatingtopolicychangescoveringprescribinganddispensingofmedicines.In

addition, I would like to explore whether taking these practices and attitudes into

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considerationcouldcontributepositively towardspolicydesignand implementation in

Macedoniaandothersimilarcountries.

1.4. ThesisoutlineBeyond this introductory chapter, the thesis is logically structured and divided into

severalparts.Thefollowingsectionprovidesanoverviewofthethesis.

Thesecondchapterprovidesanoverviewofthehealthreformsintransitioncountries,

followed by a description of the reforms, and particularly prescribing and dispensing

policychanges,inMacedonia.

The third chapter, Literature Review, outlines the existing body of literature on

prescribing and dispensing ofmedicines,models of prescribing and issues concerning

prescribing and dispensing in primary healthcare. An overview of the literature on

prescribing and dispensing in the specific context of transition countries is then

provided.

Thefourthchapter,Methodology,givesacriticaloverviewofexistingmethodologyand

providesjustificationforchoosingaqualitativeresearchmethodologyandalsotheuse

ofsemi-structured interviewmethods in this research.Thischapterprovidesdetailsof

all stages of the research process, including the rationale for choosing the groups of

interest,sampling, interviewing,transcribingandtranslation. Itdescribeshowthedata

were interpretedandanalysedusingthematicanalysis, followedbyacriticalreflection

ofqualityandcredibilityinrelationtothisstudyandaconsiderationofresearchethics

issuesthataroseaspartofthisresearch.

23

The fifth chapter, Findings, provides an account of the discerned themes from the

research, which were summarized as: i) reflections on past and present policies; ii)

issues arising from implementation; and iii) pressures in prescribing and dispensing

practice. As will be shown in this chapter, there is general understanding of the

necessityforchange,butdifferentopinionsandperceptionsregardingthedevelopment

andimplementationofpoliciesforprescribinganddispensinginprimarycare;nostalgia

forthepastsystemplaysakeyroleinshapingtheseperceptionsandthepractice.There

isalsoacknowledgementoflackofeffectivepolicyimplementation,butreluctancefrom

various groups to accept responsibility. Perceived disempowerment and reduced

autonomywasarticulatedbyprovidersasdetachment fromthesystemand increased

pressures in practice, whereas for patients it provided justification for negotiating

medicinesupplyandcontinuingself-medicationpractices.

Chapter Six,Discussion, contextualises the findings. Firstly, it compares and contrasts

thefindingswiththeliteratureidentifiedinchapterthreeanditisarguedthatthereare

similarities to themes previously identified in other research and health systems. A

second aim is to argue that an existing theory, namely Habermas’s social theory of

systemandlifeworld,isanimportantwayinwhichthefindingscanbeinterpreted.The

chapter then goes on to consider the implications of the findings, not only for

Macedonia,butothertransitioncountriestoo.

The seventh and final chapter, Conclusions and Recommendations, summarises the

researchandoffersseveralrecommendationsbasedontheemergingresearchfindings

ofthisstudy,atbothpolicymakingandimplementationlevels.Intermsofpolicymaking

process, a recommendation is made to consider better involvement of providers in

policymakingandprovidingthemwithmoreinformationonpolicychanges.Intermsof

24

implementation, the key recommendations relate to: encouraging feedback about

practiceexperiences frombothprovidersandpatientsthatwould informfuturepolicy

formulation, providing additional education of providers in communication with

patients, alongside continuing efforts for awareness raising and improving health

literacyofpatients.

Followingthemainbodyofthethesis,varioussupportingmaterialsandinformationare

provided in theAppendices A to G, including ethical approvals, research instruments,

and information sheets provided to participants, aswell as the consent form used to

provide their participation under the principles of research ethics and guaranteed

confidentiality.

25

CHAPTER2: Healthsystemreforms,prescribinganddispensingmedicinesinMacedonia

2.1. Overviewofhealthreformandprivatizationintransitioncountries

Transitionfromplannedtomarketeconomyhasinevitablybroughtanewparadigmof

systemstructure,operation,functions,reallocationofresourcesandthinkingwithinthe

post-socialist societies (Krelle 2000). Countries deciding to make this shift have

embarkedonaprocessofmassive reforms in theeconomyandvirtuallyall sectorsof

the society. For some sectors, this transition was blueprinted with a relatively well-

designedroadmapfortherequiredreformstowardsthedesireddeliberativedemocracy

with equality and equity as main values. For example, market economy principles

dictated liberalisation of production and markets, enabling competition and

engagementofprivatecapital(KornaiandMcHale2000).Accordingly,withmoreorless

success, the transition countries have completed this process, at least from its

regulatoryandnormativestandpoint.

The health and social sectors, as dominant accomplishments of a welfare state in

developed democracies, exhibit a variety of approaches in reaching the same goals,

partlyduetothenuancesofeconomicandsocialcontextsandpartlyasaresultofthe

specificculturalfabricofparticularstates.Whilebasedonthesameprinciplesofequity

andequality,individualsocietiesvaluehealthdifferently,asillustratedbythefractionof

resources they allocate for healthcare (Leive 2010). For example, in the EU average

healthexpenditurein2015accountedfornearly10%ofGDP,butrangesbetween7%of

GDP in Luxembourg to around 11% in Germany, Sweden and France (OECD 2016).

26

Therefore, the advice and guidance on restructuring the healthcare systems was far

more ambiguous and much less determined in terms of how these transformations

should proceed (Kornai and McHale 2000). In transition countries, in 2014 the

investmentinhealthrangedfromlittleover5%ofGDPinAlbania,LatviaandRomania

toover10%inSerbia; inthesameyear,Macedoniawasdedicating6.5%of itsGDPto

healthexpenditures(WHO2017).

Priorto1990,systemsinmostofthesecountrieswerefinancedfromgeneralrevenues,

usinghistoricallydeterminedline-budgetsforhospitalsandfixedsalariesforphysicians.

Healthcare was virtually free to the population and was largely accessible through

unnecessarily extensive health infrastructure. With the reforms, healthcare financing

was channelled through newly introduced social insurance schemes and its execution

transformedtoamoreperformance-basedsystem,mostlyasacombinationofsomeof

the well-established paymentmechanisms of fee-for-service, capitation (payment per

patient) and pharmaceutical price regulation (Leive 2010). At the same time, the

economicrestructuringanddeclineoftheproductionsectorsnowballedareductionin

government expenditures for health. This affected access to healthcare, especially in

terms of: lapses in availability of care, reductions in supplies of medicines and other

materials,lowersalariesforhealthcareprovidersanddecreaseintheirmotivation,and

loweringofpatients’confidenceandtrustinthequalityofcare(Shkolnikov,2001;Atun

et al 2005; Kunitz 2004; Bartlett et al 2012, pg.4-5). The first in line for reformswas

primary care, as the gatekeeper of the system authorising access to specialist and

hospitalcare(Franksetal1992).

Thegoals for reformingprimarycarewere relativelysimilar inall countries: improving

efficiency and introducing a stronger gatekeeping role,while ensuring availability and

27

accessibility as an entry point to the health system (Cernis-Istenic 1998;Nordyke and

Peabody2002).Toimprovetheefficiencyofprimarycare,somecountries,asaresultof

donor-driven initiatives and examples from developed countries (Anell 2011), have

opened the market to private initiative (Nordyke and Peabody 2002; Cernic-Istenic

1998) and implemented the privatization model, for example Croatia (Hebrang et al

2003; Dzakula et al 2014), Slovenia (Albrecht and Klazinga 2009; Albrecht 2009) and

Macedonia(Nordyke2000;MilevskaKostovaetal2017).

2.2. HealthreformandprimarycareprivatizationinMacedonia

2.2.1HealthreforminMacedonia

Prior to gaining independence in 1991,Macedonia had a centrally planned command

economy and a well-distributed health care system, free to all at all levels of care

(IvanovskaandLjuma1999).Similartoothertransitioneconomies,Macedoniainitiated

economicandpoliticalchangestriggeringmarket-orientedreformsinall(Carvalhoetal

2013),includingthehealthsector(Lazareviketal2012).Thereformshavechangedthe

whole economic and societal fabric,with implications for the health andwellbeing of

thepopulation(IvanovskaandLjuma1999).

Under the pressure of decreasing resources, the government initiated health sector

reforms (Menon 2006). The first decade of reforms was marked with health market

liberalizationenablingprivateserviceprovisionduringthe1990s(NordykeandPeabody

2002),followedbyestablishmentofathird-partypayersystem,throughestablishment

ofaHealthInsuranceFundin2000andreintroductionofasocialinsurancemodelbased

onmandatorysalarycontributionsforhealthinsurance(Gjorgevetal2006;Leive2010).

28

Incontinuationofthesereforms,governmentconsideredimprovementofresourceuse

efficiency, part of which was primary healthcare privatization, initiated in 2005

(Milevska-Kostova2010).

2.2.2PrivatizationofprimaryhealthcareinMacedonia

In2005,theMacedoniangovernmentcommencedaprocessofprivatizationofprimary

healthcare (PHC), seeking to improve its efficiency and quality, and to strengthen its

gatekeeperrole in thesystem(Figure1) (NordykeandPeabody2002).Theattemptto

capitalizeonprivateinvestmentinthepublicdomainbeganwiththetransferofprimary

healthcare providers from public to private sector; they then needed to open private

practice and set up contracts with the Health Insurance Fund (HIF) for provision of

primary care services. This privatisation involved general practitioners, paediatricians,

gynaecologistsandpharmacists(Gjorgjevetal2006;MilevskaKostovaetal2017).

Variousmodelsofprimarycarefundingwereassessed, includingfee-for-service,salary

and mixed systems (Nordyke 2002). For general practitioners, paediatricians and

gynaecologists, the model applied was the blended capitation model, consisting of:

paymentofa fixedamount foreachpatient registered in thephysician’s roster,anda

variableamountfordeliveryofpreventivecare,i.e.fulfilmentofpre-definedpreventive

goals (Chaix-Couturier et al 2000; Tulevska and Dimkovski 2015), elaborated in more

detailinthefollowingparagraphs.

By the end of 2008, a total of 2176 primary care providers were contracted by the

Health Insurance Fund (HIF 2009), constituting 95% of all licensed primary care

providers (LKM 2009). Within the taxonomy of privatization models, the process of

transformationofprimaryhealthcareinMacedoniaisclosesttothemodeloffranchising

29

(Savas 1989), as it ismainly concernedwith provisionof services by private providers

throughpublic funding,anddoesnot involveany transferofassets fromthepublic to

theprivatedomain(PooleJr.2008).

Figure1.DevelopmentofprimaryhealthcareinMacedonia

(Adaptedfrom:NordykeandPeabody2002)

2.2.3CapitationpaymentinprimaryhealthcareinMacedonia

The introduced payment model in primary healthcare is a patient-based blended

capitationmodel;contractedphysiciansreceiveadefinedamountperregisteredpatient

(Chaix-Couturier et al 2000; Glazier et al 2009), as well as incentives for rational

prescribing and preventive services delivery. In practice, the contract consists of two

major payment categories: 70% fixed amount, and 30% conditional amount based on

fulfilmentoftheso-calledpreventivegoalsofthePHC(Table1),whicharerevisedeach

trimester by the Health Insurance Fund. When the system was introduced, the

preventivegoalsandweightedpercentagefortheirfulfilmentwere:rationalprescribing

by limiting the number of prescriptions per registered patient (7% of capitation fee),

Yugoslaviato1991State-runsystem

Macedonia1991-present

Macedonianpublicsystem

Reformedsystem2001+

Capitation-basedPrimaryhealthcare

Independence

1991

Reforms

1999-2001

Privatesectorprovision

Legalisation

1991

30

rational referrals and sick-leaves (4%), and preventive services for early detection of

malignancies inadultsandhealthconditions inchildren(combined19%)(HIF2010). In

2009,rationalprescribingwasdefinedthroughabudgetceilingforprescribing.

Table1.PreventivegoalsinprimaryhealthcareinMacedonia(2009and2014)

2009 2014Goal Descriptionof

activities%ofcapitation

feeDescriptionof

activities%of

capitationfee

Prescriptions Rationalprescribingbasedonnumberofprescriptionsper

patient

7% RationalprescribingPrescribingwithinbudgetceiling

6%

ContinuousMedicalEducation

- - Undertakingtraining 2%

SickleavesandReferrals

Rationalreferraltohigherlevelsofhealthcare

2% Rationalandjustifiedsickleavesandreferrals

(max.15dayssickleave)

2%

Rationalandjustifiedreferralforsickleave

2%

Preventiveservices

Adults:Preventiveactivitiesforearly

detectionofcancersandcardiovascular

diseasesChildren:Preventiveactivitiesforvariousconditions,including

deformities

19%total Adults:Preventiveactivitiesfor

cardiovasculardiseases,diabetesmellitusand

kidneydiseases

20%

(Source:adaptedfromPreventiveGoalsinPHC(2010)andTulevskaandDimkovski(2015))

The initial preventive goals were later adjusted in accordance with the increasing

understanding of population needs and the accumulated experience of purchasing

health services from private providers. As shown in Table 1, in 2014, the preventive

goalswerereformulatedto: rationalprescribingbasedondefinedbudgetceiling (6%),

rational referralsandsick leaves (2%),undertaking training (2%),andotherpreventive

31

servicesnowalsoincludingpreventionofmajornon-communicablediseasesintheage

group14-65anddeformitiesinchildren(20%)(TulevskaandDimkovski2015).Basedon

experience, insteadofnumberofissuedprescriptions,rationalprescribingwasdefined

and monitored through prescribing budget ceilings. The newly introduced budget

ceilingsforprescribingweredefinedforeachphysicianweightedonthecharacteristics

oftheirpatients,inparticularageandgender(HIF2014).

2.3. PrescribinganddispensinginprimaryhealthcareinMacedonia

2.3.1Overviewofprescribinganddispensingpolicies

Prescribing and dispensing policies in primary healthcarewere gradually changed and

adapted to address the main issues of: i) rational prescribing and dispensing, i.e.

prescribing and dispensing based on medical indication, necessity and known

effectiveness of the prescribed medicine or treatment; and ii) cost containment, i.e.

reducingcostsincurredasaresultofexcessiveandunnecessaryprescribing.Thissection

is intended to provide a structured overview of these changes. Table 2 and Figure 2

below summarize the policy changes relating to rational prescribing and dispensing

reflectedthroughthefollowingpolicychanges(PCs):

- PC1: Limiting prescriptions per patient per trimester (part of the preventivegoalsdefinedforprimarycarephysicians);

- PC2: Budget ceiling for prescribing (part of the preventive goals defined forprimarycarephysicians);

- PC3: Dispensing only upon presentation of valid prescription, and withinmedicinequotas(partoftheenforcementofdispensinginpharmacies).

32

Table2.SummaryofpolicychangesinprescribinganddispensinginprimarycareinMacedonia

Policychange Year Mechanism Indicator Incentive/PenaltyPrescribingpolicychangesPC1 2005

(Uponinitiationofprivatisation)

Partofpreventivegoalsforphysicians,measuredasnumberofprescriptions

2prescriptionsperpatientpertrimester

7%ofvariablecapitationlost/gained

PC2 2009 Partofpreventivegoalsforphysicians,measuredasnumberofprescriptionsPartofpreventivegoalsforphysicians,measuredasbudgetspentonprescriptions

Budgetceiling,adjustedtonumberandage/genderofregisteredpatients


2014


DispensingpolicychangesPC3 2009

Enforcementofdispensingpolicyinpharmacies

Dispensingonlyuponpresentationofvalidprescription

Finesinaccordancewithpenalstipulationsinthelaw

2011

Budgetceilings(quotas)fordispensingunderhealthinsurance

Ceilingdefinedperpopulationcoverageandhistoricalrecords

None

Legend:PC=policychange

Figure2.PolicychangesforrationalprescribinginprimaryhealthcareinMacedonia

(Source:owncompilation)

1991-2005

PublicandprivatePHC

Capitation-basedPrimaryhealthcare

PrivatePHConly:

1.PHCproviders

Reforms

Privatization

PC1:2005PrivatePHConly:

1.PHCproviders

Prescribingregulation

PC2:20092014

Prescribingregulation:

-Rationalprescribing:7%ofcapitation-Mechanism:no.ofprescriptions

Prescribingregulation:

-Rationalprescribing:6%ofcapitation-Budgetceilingsforprescribing

PrivatePHConly:

2.Pharmacists

PrivatePHConly:

2.Pharmacists

Dispensingregulation

PC3:20092011

Dispensingregulation:

-Enforcementofdispensingpolicy

Dispensingregulation:

-Budgetceilings(quotas)forpharmacies

Contractingofpharmacies

33

As can be seen from the above, prescribing and dispensing were among the areas

reformedaspartoftheprimaryhealthcarereform,andthus,thenextsectionsprovide

anoverviewofpoliciespertainingtothisprocessandrelevanttothisresearch.

2.3.2Prescribingpolicychanges

With the health system reforms and the aforementioned liberalisation of service

deliveryandmedicinesupplymarkets,akeypriority for thegovernmentsof transition

economieswas the regulation of private providers (Petrova 2001; Bartlett et al 2012,

p.3). Under the pressure of decreasing resources and with the international

community’s guidance, the government of Macedonia continued the reform of

increasingefficiency,asinothertransitioneconomies.Theresourcesdidnotmatchthe

needs and the demand for healthcare (Nordyke 2001); this was particularly true for

pharmaceutical expenditures, as the pre-independence policies enabled health

insurancecoverageofallmedicinesandmedicalpreparations,includingvitamin/mineral

supplements. Thus, citizenswereused toobtaining theirmedical supply atno charge,

and providers were not bound by any limitation in their prescribing decision-making.

Also,therewerenopoliciesregulatingrationalprescribing(Petrova2002),suchas, for

exampleclinicalguidelines.

Oneofthefirstchangesintheearly1990swasremovalofover-the-countermedicines

from the health insurance package. The next policy action was development of the

Positive Medicines List (PML), encompassing essential medicines covered by health

insurance. However, there was still no regulation on the quantity of medicines that

providers could prescribe or dispense. The overall pharmaceutical expenditure was

34

controlled throughcentralizeddecisionson theprocuredanddistributedquantitiesof

medicines.

Itwasnotuntil2005thatthefirsttangiblepolicychangesforefficiencyimprovementin

prescribinganddispensingwereconceptualizedandimplemented(Lazareviketal2012).

As explained earlier in this chapter, a transfer of primary care providers (physicians,

dentists and pharmacists) from the public to the private domain occurred between

2005-2009 (LKM 2009). Primary care providers were paid for their services via a

combined capitation model, where 70% of the capitation amount was fixed (fee per

patient) and the remaining 30% was conditioned by implementation and delivery on

pre-definedpreventivegoals,including‘rationalprescribing’(HIF2007;HIF2014).

The first policy on ‘rational prescribing’ (Policy Change PC1) involved measuring the

appropriatenessofprescribingasadherencetoanassignednumberofprescriptionsper

patient, unadjusted by any parameter. Physicians were allowed to prescribe a total

numberofprescriptionscalculatedas2prescriptionsperpatientquarterly.Atthisstage,

eachprescriptioncouldbeusedforanymedicineonthePML, irrespectiveofthecost.

Thus, thispolicychangeregulatedthehabitofprescribingandnotthepharmaceutical

expenditure. As such, it could not have been expected to contribute much to cost-

containment, as it was based on counting (prescriptions) and not on accounting (for

their value). It was rather intended to introduce ‘discipline’ and awareness that

medicinesarealimitedcommodityandcancomewitha‘pricetag’(Ernstetal2000).

Furtherevolvingfromthis,in2009,thepolicywaschanged(toPC2)tointroducebudget

ceiling for prescribing (this time irrespective of the number of prescriptions), with

amounts adjusted to reflect the demographic structure of the registered population

35

with thephysician’s practice (i.e. age, gender and rural/urban location) (HIF 2010).At

first,thisstillconstituted7%ofthevariablecapitationamount,andwasreducedto6%

in2014(seeTable2above).Lateron,withtheintroductionofinformationtechnologyin

the health sector, an e-prescription system was introduced in 2015, as an additional

control over pharmaceutical spending in real time (Milevska Kostova et al 2017). This

latestpolicychange ismentionedto illustratetheever-changingcontextofprescribing

inMacedonia,butitwasnotanalysedwithinthisresearch,sinceitwasintroducedafter

thedatacollectionforthisresearchwasalreadycompleted.

While themain focus of the research is on analysing the demand sidemeasures, the

interconnectednesswith the supply sidemeasures imposes theneed tobriefly review

these, as they potentially correlatewith prescribing behaviour and patients’ influence

on thisbehaviour.Within the cost-containment strategies, supply sidemeasureswere

also introduced, such as reference pricing, through capping of medicines’ prices to a

maximum level of reimbursement by health insurance (Mossialos et al 2004) and

promotion of generic substitution, through measures encouraging use of generic

medicines (Godman et al 2014; Dauti et al 2015). This triggered expansion of the

PositiveMedicinesListespeciallyformedicineswithminimumornoco-payments,which

were introduced earlier (in 2003) as a demand sidemeasure for containing costs on

medicines covered by health insurance. According to the Health Insurance Fund, by

2013,76.5%ofthemedicinesonthepositive listcouldbeobtainedwithnoadditional

chargetopatients,amajorchangecomparedto2009whenthissharewasonlyaround

20%(Dautietal2015).Theeffectsofthischangecanbeviewedfromtheperspectives

of the twomain stakeholderswithin this research:physicians andpatients. Physicians

stillneededtocomplywiththeprescribingbudgetceilings;thusitappearsunlikelythat

36

this policy intervention would influence physicians’ decision to prescribe more than

before or more than they would consider necessary. To patients, the removal of co-

payments for a larger share of medicines might resemble the conditions of the past

system,andthusencourageincreasedpressureonphysiciansforprescriptionmedicines

(Leive2010).

2.3.3Dispensingpolicychanges

Withregardstomedicinedispensing,thesituationwasslightlydifferent,butconsistent

with the rational prescribing efforts of the government. Privatization of public

pharmacies was completed by 2005 and constituted complete transfer to private

ownership,includingpremises.Thiswasaccompaniedbyanobligationforbothprivate

andnewlyprivatizedpharmaciestosignacontractwiththeHealthInsuranceFundfor

dispensingmedicineunder thehealth insurance scheme.Basedon thisobligation, the

pharmacies were only allowed to dispense medicines upon receipt of a valid

prescription(HIF2004).However, thisrulewasoftennotadheredto,withpharmacies

regularly selling prescription-onlymedicines in the absence of a prescription (Rietveld

2006).Startingin2009,withthethirdimportantpolicychange(PC3),arequirementfor

avalidprescriptionwasenforcedmorerigorously(MoH2008),withon-siteinspections

andcontrolsoverthedispensingofprescription-onlymedicines.

Further to the above, in 2011 the Health Insurance Fund introduced budget ceilings

(quotas) to pharmacies for prescription medicines covered by health insurance. The

budget ceilingsweredeterminedbasedonpopulation coverage andhistorical data of

dispensingofparticularmedicines.Thispolicywasintendedtocontributetotherational

37

prescribingandcontainmentofcostsonpharmaceuticalsunderhealthinsurance.Thisis

categorisedwithinthisthesisaspartofPolicyChange3(PC3).

The policy changes described in Table 2 and Figure 2 (section 2.3.1 above) have

influenced the regulation of the pharmaceutical market in Macedonia, particularly

prescribing and dispensing (shown in Figure 3 below); namely, the primary care

providers, representedbyphysicians andpharmacists,wereputundermore stringent

regulatorycontrolatboththepointofprescribingandofdispensing.

Figure3.SimplifiedflowchartofprescribinganddispensinginMacedonia

*Legend:solidline=referral;dottedline=back-referral:prescribing;dashedline=reporting

(Source:owncompilation)

Thisnewpolicysettinginevitablyinfluencedandcontinuestoinfluencetheprescribing

anddispensingofmedicinesasthesystemofincentiveshaschangedforbothphysicians

andpharmacists inprimarycare.Thenextsectionprovidesanoverviewofprescribing

anddispensinglevelsinprivatizedprimaryhealthcareinMacedonia.

38

2.3.4Prescribinganddispensinglevelsinprivatizedprimaryhealthcare

In theory, the above elaborated policy changes were expected to have the following

effects:

1) MovefromPC1(limitationofnumberofprescriptions)toPC2(budgetceilingfor

prescribing)from2009:

a. Physiciansinprimaryhealthcarehaveto:(1)monitorthebudgetceiling

insteadofnumberofprescriptions;(2)negotiatewithpatientsifthereis

no obvious need for the prescriptionmedicine; (3) negotiatewith the

policymakersfortheincreaseofbudgetceilings;

b. Patients need to: negotiate with the physician the necessity of the

prescriptionmedicine,ifthereisnoobviousmedicalindicationforit;

2) Amending PC2 (budget ceiling for prescribing)with PC3 (dispensing only upon

presentation of valid prescription from 2009, within definedmedicine quotas

from2014):

a. Pharmacists have to: (1) expect reducedprofits from theprescription-

onlymedicinesthataredispensedwithoutprescription;(2)engagewith

patients in explainingwhy themedicine cannot be dispensedwithout

prescription;(3)handlethedispensingwithinthedefinedquotas.

b. Patients need to: (1) visit a primary healthcare physician to obtain a

valid prescription in order to obtain prescription-only medicines; (2)

obtainmedicinesfromthepharmacieswherethequotaisavailable.

Whilemost of the above theories require testing via a qualitative approach, it is also

useful to examine quantitative data from this time period. Table 3 and Figure 4

represent the trends inprescribing inprimaryhealthcare,both in termsof amountof

funding and number of prescriptions during the period for which data was available

(2008to2014).

39

Table3.PrescribedanddispensedmedicinescoveredbytheHealthInsuranceFund,2008-2014

YearNumberofprescriptions

%increasecomparedtopreviousyear

Amountspentonprescribedmedicines

(millionMKD)

%increasecomparedtopreviousyear

2008 10,283,273 - 1,318.9 -

2009 14,959,878 45.5% 1,828.7 38.7%

2010 15,277,792 2.1% 1,778.0 -2.8%

2011 16,332,551 6.9% 1,902.8 7.0%

2012 17,485,146 7.1% 1,993.2 4.8%

2013 17,822,132 1.9% 2,124.0 6.6%

2014 19,385,458 8.8% 2,235.8 5.3%

(Source:owncompilationfromHIFAnnualreports2008to2014)

Figure4.PrescribedanddispensedmedicinesbyATCgroupscoveredbytheHealthInsuranceFund

AnatomicalTherapeuticChemicalclassification(ATC)codeslegend:A-alimentarytractandmetabolism;B-bloodandbloodformingorgans;C-cardiovascularsystem;D-dermatologicals;G-genito-urinarysystemand sex hormones; H - systemic hormonal preparations, excluding sex hormones and insulins; J -antiinfectives for systemic use; L - antineoplastic and immunomodulating agents; M - musculo-skeletalsystem;N-nervoussystem;P-antiparasiticproducts,insecticidesandrepellents;R-respiratorysystem;S-sensoryorgans;V-various

(Source:owncompilationfromHIFAnnualreports2010to2014)

40

Fromtheabovedata,itcanbeconcludedthatmedicineprescribinganddispensinghave

generally showed an upward trend, despite the introduced policy changes. Itmay be

argued tobea resultofotherpolicy changes,whichmightactas confounding factors

(e.g. the reductionofmedicines’prices in2013).However, these trends inprescribing

anddispensingcallforadditionalresearch,intermsofattitudes,opinionsandpractices

inprimarycare,whichisthemainaimofthisthesis.

It is noteworthy, that the above data does not represent the totality of medicines

consumption in the country. Namely, within the current system, there are two key

agencies responsible forpharmaceuticalpoliciesandmaintaining recordsofmedicines

on thepharmaceuticalmarket.The firstone is theHealth InsuranceFund, responsible

forpurchasinghealthservices(e.g.physicians,pharmacies)underthehealth insurance

scheme,includinginsurance-coveredmedicines.ThesecondistheAgencyforMedicines

andMedicalDevices, responsible for registrationofmedicines and issuingpermits for

puttingmedicines into use, and thus responsible for keeping records of allmedicines

placedonthemarket,i.e.includingtheshareofmedicinesdispensedwithprescription

issued outside of health insurance or medicines dispensed without prescription.

However, no data could be retrieved from the Agency for Medicines and Medical

Devices. At the time of data collection for this research, this agency had non-

systematizeddataonlyinpaperformat,andwasnotequippedtoanalysethedataorto

provideanydataforthisanalysis.

In addition, only partial records could be gathered from the Health Insurance Fund,

presented above. Due to changes in themethodology of data collection and analysis,

detailed informationon thenumberofprescriptionsandpharmaceuticalexpenditures

41

wasalsonotavailablefromtheHIFrecordspriorto2008.Thus,thepictureofmedicine

consumptionaspresentedisincomplete.

Although incomplete, as mentioned above, the presented data shows a steadily

increasing trend in prescribing between the analysed policy changes described in the

earliersections.ThedatapresentedinTable3andFigure4showthatthepolicychange

fromlimitationsofprescriptions(PC1,2005until2009)tobudgetceiling(PC2,2009until

present time) did not produce the desired results of reducing prescribing levels,

althoughitspredominantaimwastoreducepharmaceuticalexpenditure(HIF2009;HIF

2010;HIF2011).

Ithastobenotedaswell,thattheincreasednumberofprescriptionsmight inpartbe

due to enforcement of the policy for dispensing of prescription-only medicines with

prescriptiononly,towardstheendof2009.Sincetherearenocomprehensiveanalyses

andrecordsoftheactualenforcementofthispolicy,thisisonlyahypothesis.

Due to the limited quantitative data available, a qualitative method was chosen to

further explore the impact of policy changes relating to prescribing and dispensing in

primaryhealthcareinMacedonia.

2.4. SummaryofchapterDuring the 1990s, transition economies including Macedonia initiated economic and

politicaltransformations,includingthehealthsector,primarilyforcostcontainmentand

increasing resource use efficiency. In Macedonia, prior to the primary healthcare

reform,prescriptionpolicieswereratherliberalandnotcost-efficientandnewpolicies

wereintroducedtoregulatemedicinesupplyanddemand,throughrationalprescribing

42

and dispensing in primary care in particular. In prescribing, measures included firstly

limitation on number of prescriptions, followed by prescribing budget ceilings. In

dispensing,theseincludedreinforcementoftheexistingpoliciesofdispensingwithvalid

prescription,alongsidenewpolicyondispensingquotas.

Both the reinforcement of the existing and the introduction of the new policieswere

expectedtohaverelevantinfluenceonprescribinganddispensing,andwillbeexplored

inthisresearch.Thenextchapterprovidesareviewofrelevantliterature,identifyingthe

gapsinknowledgetobeaddressedwiththisresearch.

43

CHAPTER3:Literaturereview

3.1. IntroductionThischapterprovidesanoverviewoftheexistingknowledgeonprescribingmedicines,

regulationofprescribinganddispensing, and factors influencing them, inparticular at

primarycarelevel.Further,theliteraturereviewtouchesuponthetheoriesofbehaviour

that may explain the attitudes and practices and potentially behaviour changes of

primary healthcare providerswith respect to prescribing and dispensing. This chapter

also provides an introduction to the main theoretical framework for the research,

drawinguponHabermas’ theoryof social life, and inparticular the interactionsof the

system and the lifeworld pertaining to decision-making around prescribing. Further in

the chapter, the literature on prescribing and dispensing in transition countries is

reviewed,withtheaimofprovidingunderstandingtothereaderofthecontextinwhich

prescribinganddispensingisresearched–namelytheprimaryhealthcarereformsand

changes in the pharmaceutical policies inMacedonia,which belongs to this cluster of

countries.Thechapterconcludesbysummarisingthegapsintheliteratureandtheaims

ofthisresearchincontributingtotheexistingbodyofknowledge.

3.2. LiteraturesearchstrategyTheaimoftheliteraturereviewwastoidentifyrelevantandup-to-dateliteratureonthe

followingkeytopicareas:

• Regulationof prescribing anddispensing, challenges to regulation, and factorsinfluencingprescribinganddispensing;

• Theoriesofbehaviourwhichmayaffectprescribinganddispensing,particularlyHabermas’theory;

• Prescribing and dispensing in transition countries, particularly followingprivatisationandreformofprimaryhealthcare.

44

3.2.1Searchmethods

Within the literature search, systematic principles were used to identify relevant

literatureon the topicareasabove, thoughnotasa full systematic reviewona single

topic. The initial literature search was conducted between July-December 2014 and

updatedfornewreferencesinMarch-April2017.Intheprocess,thefollowingelectronic

databases were used: PubMed, PubMed Central, Medline, Google Scholar and the

CochraneDatabaseofSystematicReviews(CDSR).

Theliteraturesearchusedacombinationofthefollowingmethods:

• Searchingofbibliographicdatabases–aslistedabove;

• Expertknowledgeofthesubjectarea–myexpertiseandthatofmysupervisors

indifferentareasoftheabovetopicswasusedasasourceofkeyarticles;

• Referencetrackingfromkeyarticles–relevantarticlestothe literaturereview

andresearchquestionscitedinthekeyarticles;and

• Iterativesearching–furthersearchesoftheliteraturefollowingdevelopmentof

understandingofthewidertopic.

3.2.2Databasesearchstrategy

Duetothebroadnatureofthetopicandthedifferentthemescoveredbytheliterature

review, thedatabases listedaboveweresearchedusingcombinationsof the following

terms, which were adapted in further iterative searches as additional useful articles

wereidentified:

• Topic area 1 (regulation of prescribing and dispensing): Terms around the

followingwereused:prescribing,dispensing,regulation,challenges, influences,

factors,combinedwithtermsforprimaryhealthcare.

45

• Topicarea2 (theoriesofbehaviourandHabermas’ theory): Termsaround the

followingwereused:theory/theories+behavio(u)r+prescribing,or“Habermas’

theory”

• Topicarea3(prescribinganddispensing intransitioncountries):Termsaround

the following were used: prescribing, dispensing, regulation, transition

country/ies,transitioneconomy/ies,privatis(z)ation.

ThespecifictermsandtheircombinationusedinthesearchstrategyareshowninTable

4below.Freetext terminologywasbasedonthemainconceptsandthekey issuesof

researchinteresttothisthesis.

Table4.Keywordsusedinelectronicdatabasessearch

Topicareaandtopics Searchterms

Topicarea1:PrescribinganddispensingPrescribing prescr*;prescriptionmedicines;prescribers;

prescribingANDpractices;attitudes;behaviour;challenges;influences;factors;ANDreviewANDprimaryhealthcare;primarycare

Dispensing dispens*;dispensingofprescriptionmedicinesANDpractices;attitudes;behaviour;challenges;influences;factors;ANDreviewANDprimaryhealthcare;primarycare

Regulation regulationANDprescriptionmedicines;prescribing;pharmaceuticalpolicies;pharmaceuticalmarket;challenges;influences;factors;ANDreviewANDprimaryhealthcare;primarycare

Topicarea2:TheoriesofbehaviourandHabermas’theoryTheoriesofbehaviour BehaviourAND

medicineuse;prescribing;dispensingANDreview

Habermas’theory Habermas’theoryHabermas’theoryANDmedic*;medicines;physician-patientrelationship;prescribing;healthdecisionmaking

46

Topicareaandtopics Searchterms

Topicsarea3:PrescribinganddispensingintransitioncountriesPrescribingintransitioncountries

Transitioncountry/ies;Transitioneconomy/iesANDprescribingANDprivatis(z)ation;policies;practices;attitudes;qualitative;influences;factors;ANDreviewANDprimaryhealthcare;primarycare

Dispensingintransitioncountries

Transitioncountry/ies;Transitioneconomy/iesANDdispensingANDpolicies;pharmaceuticalpolicies;practices;attitudes;qualitative;challenges;influences;factors;ANDreviewANDprimaryhealthcare;primarycare

3.2.3Inclusionandexclusioncriteria

Inclusioncriteria

Thefollowingtypesofarticleswereincluded:

• Key theory articles outlining the main topic areas, including theories around

regulationofprescribingandtheoriesofbehavioursuchasHabermas’theory;

• Reviewarticlesonprescribinganddispensing;

• Key empirical studies reportingon themain topic areas, such as regulationof

prescribing,challengestoregulation,andfactorsinfluencingprescribing,bothin

primaryhealthcaregenerallyandwithintransitioncountries;

• Keyqualitativestudiesonattitudesandpracticesinprescribinganddispensing,

includingphysician-patientrelationshipandpatients’expectations;

• Articles published in English, or any of the Slavic languages spoken in the

countries in South-Eastern Europe (Bosnian, Bulgarian, Croatian,Macedonian,

Montenegrin,andSerbian).

47

Exclusioncriteria

Articlesrelatedtothefollowingtopicswereexcluded:

• Prescribing in inpatient facilities (secondary and tertiary care, surgery practice

andemergencywards);

• Prescribing associatedwith specific population groups, such as elderly in care

homes,prisonersinprisonsandsoforth;

• Developingcountriesthatwerenotclassifiedastransitioncountries.

3.2.4Resultsofliteraturesearch

Sincetheliteraturesearchconsistedofaseriesofiterativesearchesondifferenttopics,

plus references identified via expert knowledge and reference tracking from relevant

articles,itwasnotpossibletoprovideaprecisefigureforthetotalnumberofincluded

articles. For the search in the first topic area on prescribing and dispensing, large

number of articles were retrieved, which were filtered using the [AND] function for

different combinations of two or three searchwords. The search in the second topic

areaalsoretrievedanumberofarticlesandbookchaptersontheoriesofbehaviourand

Habermas’ theory in relation to medicine supply. The situation was different with

regards to the third topic area, relating to prescribing and dispensing in transition

countries.Namely,thesearchonprescribingordispensinginprimarycareintransition

countries generated very few articles; the results were similar for the search on

privatisationandprescribingordispensing,andfortheuseofqualitativemethodologies

for researchingprescribing anddispensing in transition countries.After assessmentof

their relevance, thesearticleswereanalysedandwhereappropriatewereused in the

literaturereview.

48

3.3. Medicines:AnoverviewMedicinesplayasignificantroleinthecuring,managementandpreventionofdiseases

(Britten, 2008, p.4) and represent a core element of many healthcare treatments

(Hardingetal1985).Itisarguedthatmillionsofliveshavebeensavedduetotheuseof

medicines(WHO2002;WHO2009;Podolsky2010),andthatlongerlifeexpectancycan

inpartbeattributedtomedicineuse(VanRaay2011).

However,foraslongastherehavebeenmedicines,alongsidebenefits,therehasbeena

threatof theirharmful andevendeadlyeffects. In the16th century,Paracelsus (1538)

formulatedthisobservationas:“thedosagemakesit[themedicine]eitherapoisonora

remedy”, explaining the need for knowledge-founded and experience-drivenmedicine

administration,understandingandcontrolof thepositiveand theadverseeffects, the

appropriate time to begin and discontinue the administration, the type of

administration route and the appropriate dosages. In a broader sense, Paracelsus’

observation can be seen as a precursor of measured and monitored medicine use.

Therefore, prescribing was introduced in an attempt to balance the need to provide

medicinesfor improvingqualityof lifewhileworkingtopreventthediversionofthose

substancestotheiroveruse,misuseandabuse(GreeneandWatkins2012,p.5).

Asmedicinesrepresentasignificantelementoftreatmentpathwaysformanydiseases,

their common availability and the potential absence of professional supervision raise

concerns regarding potential inappropriate use (Oster et al., 1990; Barber, 1993;

BlenkinsoppandBradley,1996;O’Mahonyetal2015).Thishasbeenarguedtoresultin

potential iatrogenic harm, misdiagnosis, the masking of more serious conditions and

harmful interactions with other medicines taken concurrently (Bissell et al 2001;

O’Connor et al 2012; Patterson et al 2012). Thus, providing professional support and

49

expertknowledgeintherapeuticdecisionsonmedicinesbecomesanintrinsicpartofthe

healthcaresystem.Prescribing representsoneof thecoreactivities formeasuringand

monitoringthetreatmentsofmanymedical interventions (Bradley1991;Britten2008,

p.5).Withthisinmind,theinvestigatedliteratureshowsthatprescribingwasofinterest

to research frommany aspects, including clinical, economic and social (Mosiallos and

Mrazek2002).Inparticular,suchinterestarisesfromthecomplexsettingsofprescribing

itself,takingplaceatdifferentlevels(CribbandBarber1997;Opondoetal2012;Davey

et al 2017), and making a decision that involves or is influenced by a wide array of

stakeholders, including health professionals, patients (Ryan et al 2014), professional

groups, industry and suppliers (Lieb and Scheurich 2014) and the regulatory and

paymentauthorities(Caroneetal2012).Inaddition,asaresultofwhatisarguedtobe

theasymmetryofinformationbetweenproviders(suchasdoctorsandpharmacists)and

patients (Carone et al 2012) additional processes are needed to prevent harm and

manage these different perspectives. The regulation of prescribing and dispensing

representkeyexamplesofsuchprocessesandwillbefurtherelaboratedinsubsequent

sectionsofthisthesis.

In most countries, access to and supply of medicines is governed by regulatory

frameworksandclinicalevidencebasedonknowledgeofbenefitsandrisksofmedicines

to thepopulation (Barber1993;Bond2008;Caroneetal2012).Basedon the levelof

deregulation,literaturesuggeststhataccesstomedicinesingeneralcanbedividedinto

three submarkets: over-the-counter (OTC), hospital submarket and prescription

submarket (Britten,2008,p.3).Eachof thesehasbeensubject to research in termsof

effectiveness,risksandsoforth(Barber1993,Bisselletal2001).WhileOTCmedicines

(also referred to as non-prescription medicines or pharmacy medicines) are more

50

loosely regulated and can be obtained and administered by the general population

without physician’s prescription, the other two submarkets exhibit different levels of

control and management mechanisms, for a number of reasons, including cost

containment, but also appropriateness of administration, dosage and duration of

treatment (Buetowetal1997,Spinewineetal2007,Daveyetal2013,Rashidianetal

2015). In most developed and transition countries medicines at both hospital and

primary care level are subject to administration and dispensing based on clinical

indication,embeddedinevidence-basedclinicalpracticeguidelines(GrolandGrimshaw

2003;Carlsenetal2007;Franckeetal2008;Tonkin-Crine2012).

Whilst thehospital submarket shares someof the sameconcernsandchallengeswith

the prescriptionmarket (also referred to as primary care level prescribing), the latter

involves an additional layer of direct involvement of patients in consultation and

therapeutic decision-making, and their knowledge, attitude, and demand in particular

influencesprescribingpractices (Chretienetal1975;Bauchneretal1999;Palmerand

Bauchner 1997; Vanden Eng et al 2003; Ryan et al 2014; Ofori-Asenso and Agyeman

2016). As will be reviewed later in this chapter, there is an ample body of literature

suggesting that diverse factors influence providers’ prescribing behaviour (Butler et al

1998;Macfarlaneetal1997;Mangione-Smithetal1999;Tonkin-Crane2012).

In addition to the above, and bearing in mind that the prescription market in most

developedcountriesrepresents75-85%oftotalpharmaceuticalsexpenditures(Teleand

Groot2009),prescribingatprimarycarelevelisofparticularinteresttothisthesis,and

is elaborated in detail in further sections, from the aspect of regulation and factors

influencingdecision-makinginprescribing.Towardstheendofthechapter,prescribing

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anddispensingintransitioncountriesisreviewed,withtheaimofframingtheresearch

questionswithinthewideravailableliterature.

3.4. RegulatingmedicinessupplyanddemandPharmaceuticalsareoneoftheareasenjoyinggreatattentionofgovernmentsandtheir

political agendas, in an attempt to secure health policy objectives: protecting public

health; guaranteeing patient access to safe and effective medicines; improving the

quality of care; and ensuring that pharmaceutical expenditure does not overrun and

underminetheseandothergovernmentobjectives(Mossialosetal2004).Assuch,one

ofgovernments’rolesinpharmaceuticalpolicyistoprovidethefundingandframework

thatallowsthehighestattainablequalityofcarewithintheavailable limitedresources

(Mossialosetal2004;Caroneetal2012).

Regulationofthepharmaceuticalmarketisacomplexprocess,involvingmultipleactors,

such as government and third-party payers (insurance), prescribing physicians,

dispensing pharmacists, patients and patient advocacy groups, manufacturers and

wholesale suppliers, and research-based industries (Mossialos et al 2004). And, while

themainaimsofsomegroupssuchas industryandwholesalersaretomaximisesales

and profits, conversely, the interests of providers and patients are mostly aimed at

achievingthebestattainablecarewithlittleifanyconsiderationofcostsandeconomic

efficiency.Intryingtobalancetheseinterestsandachieveeffectiveandefficientuseof

resources, governments apply different mechanisms in regulating pharmaceutical

spending adjusted to their context and circumstances (Permanand et al 2004). In

general, these can be divided into regulating the two sides: the supply side and the

demandside.

52

3.4.1Regulatingmedicinessupply

Governments tend to focus on regulatory measures on the supply side, namely the

pharmaceutical industry and wholesale providers. The supply-side strategies for

optimising pharmaceutical expenditure are often implemented through regulating

pharmaceutical prices and reimbursement levels (Mrazek et al 2004). These so-called

cost-containmentpoliciesonthesupplysideareusuallyimplementedthroughmeasures

suchas:directfixedpricecontrols,profitcontrolsandreferencepricing(Mossialosetal

2004). Fixed pricing is aimed at securing pharmaceutical prices that are considered

reasonable for a givenhealth system (Mrazeket al 2004),or asdefinedby theWorld

HealthOrganisation ‘ataprice thecommunitycanafford.’ (WHO2016).Profit control

(currentlyuniquetotheUK)isaimedatensuringthatpharmaceuticalproducersarenot

making excessive profits on patent-protected products (Department of Health UK,

1999).Referencepricingisasystemofsettingmaximummedicinereimbursementlevels

perdrug thatwillbepaidby thegovernmentorhealth insurance,basedongroupsof

drugs with a similar function (Mrazek et al 2004; Kanavos and Taylor 2007). Yet, the

success–orfailure–ofthesepolicies isdiscussedintheliteratureasbeingdifficultto

measure as societies are faced with continuing trends of increase in pharmaceutical

expenditures (Mossialos et al 2004). The literature notes that in part, this increase in

pharmaceuticalexpenditureisduetogrowingdemand,whichisincreasinglyaddressed

through demand side measures (Mrazek 2002; Mossialos et al 2004). The following

section gives a brief overview of demand-side instruments for regulating the

pharmaceuticalmarket.

53

3.4.2Regulatingmedicinesdemand

Another method of controlling pharmaceutical spending and consumption is through

influencing behaviour of groups that generate the demand, namely physicians,

pharmacists and patients (Hutton et al 1994). According to the literature, no single

strategy could be identified as a ‘magic bullet’ (Oxman 1995; Tonkin-Crine 2012) and

differentpolicyapproacheshavebeendesignedandimplementedtoaddressthisissue.

Demandsidemeasuresareusuallyaimedat influencingmedicineconsumption.This is

frequently done through monitoring and influencing physician decision-making and

changing thephysician-patient relationship (Mossialoset al 2004;Godmanetal 2010;

Godman et al 2014). One of the most common approaches is standardization of

physiciandecision-making,throughenforcementofclinicalguidelines.Clinicalguidelines

havebecomea common tool forpromotingquality andequityof services, andat the

same time controlling costs (Carlsen, Glenton and Pope 2007). These evidence-based

protocolsareintendedtoimprovethestandardandconsistencyofhealthcare(Tonkin-

Crine2012,p.8),andtoensureavailabilityofstate-of-artknowledgeindecision-making.

In addition to guidelines, physicians are exposed to the latest scientific developments

and practice through their continuous professional development, which in many

countriesisobligatory.Bothofthesemechanismsforensuringstandardisationinhealth

care are then monitored by relevant authorities, either from health outcome or

expenditureperspectives(Goossensetal2005;WHO2009;Zwaretal1999;Mossialos

etal2004;Godmanetal2014).

Clinicalguidelinesarealsousedtostandardizedecision-makinginprescribing,especially

since there is a documented trend of overmedicalisation of healthcare (e.g. Chand

2014), stemming from, among other things, inadequate management of diagnostic

54

uncertainty (Whaley et al 2013), lack of commitment of physicians and patients in

shared decision-making (Arnold and Strauss 2005), expressed or perceived patients’

expectations(Littleetal2004;BrittenandUkoumunne1997)andpermanentexpansion

of treatments (Hanslik and Flahault 2016). The next section elaborates more on the

literaturerelatedtorationalprescribingingeneral,andattheprimarylevelinparticular,

sinceasexplainedearlier, thedominantproportionofprescribinghappensatprimary

carelevelasinmosthealthcaresystemsprimarycareprovidersaregatekeepers(Willcox

etal2011)andthefirstcontactofpatientswiththehealthcaresystem(Shi2012).

3.5. PrescribingofmedicinesAlthough it has been recognized for some time that prescribing should be necessary,

safe and effective (Parish 1973), prescribing approaches are not always standardized

(Batemanetal1996;Buusmanetal2007)oradherenttotherelevantclinicalguidelines

(Metgeetal2004;Carlsenetal2007;Tonkin-Crine2012).Insupportofthisstatement

are studies showing an overall increase in prescribing and antibiotic prescribing in

primary care in particular (Butler et al 1998; Holloway et al 2013), despite the global

trend of gradual epidemiological shift from communicable to noncommunicable

diseases in the past forty years (Omran 2005). The following section provides an

overviewofwhatconstitutesgoodandthereforerationalprescribing.

3.5.1Rationalprescribing

In order to discuss the factors influencingprescribing and themechanismsof rational

prescribinginthesubsequentsections,itisnecessarytoexaminetheliteratureonwhat

constitutesrationalprescribing.

55

Rational prescribing is widely described in the literature as cost-effective prescribing

basedon clinical indication, forwhich evidence shows that theprescribedmedication

will produce benefit or prevent further complications of patients’ health conditions.

According to the World Health Organisation (WHO), rational use of medicines is a

process in which ‘patients receive medications appropriate to their clinical needs, in

dosesthatmeettheirownindividualrequirements,foranadequateperiodoftime,and

atthelowestcosttothemandtheircommunity’(WHO1985;WHO2016).A2011report

commissionedbytheKing’sFund,statesthatwithintheUK,rationalprescribingiscost-

efficient therapy proven to bemost effective according to evidence-based guidelines

(Kings Fund 2011). Clinical guidelines often describe the treatment in full, including

medicinestobeadministered,andanyprescribingthatdoesnotfitintotheseguidelines

or recommendations is considered inappropriate, irrational or unnecessary (Tonkin-

Crine 2012, p.7). This unnecessary prescribing has been extensively researched (e.g.

Gallagher et al 2007; Garfield et al 2009; Holloway et al 2013; Ofori-Asenso and

Agyeman2016),identifyingforexample,widepracticeofprescribingantibioticsforviral

and self-limiting conditionswhere antibioticswould contribute either nothing or very

littleintermsofalleviatingthesymptomsorimprovingthehealthcondition(Littleetal

2005;LlorandBjerrum2014).Inasimilarway,literatureshowsthattrendsintreatment

of depression in primary healthcare shifted from under-treatment due to lack of

recognition of depressive conditions (Davidson andMeltzer-Brody 1999; Moore et al

2009), towardaconcernwithover-treatmentandover-prescriptionofantidepressants

(Heath1999;Sirdifieldetal2015)andmedicalizationofpatientswithproblemsofliving

(Hyde et al 2005, NICE 2004); this resulted in dramatic increase of antidepressants’

prescribing over the last three decades although the number of clinical cases of

56

depressiondidnotfollowsucharisingtrend(Middletonetal2001).TheWHOestimated

that globally more than 50% of all medicines are prescribed, dispensed, or sold

inappropriately(WHO2002).

Theresearch interestonprescribingandprescribingbehavioursdates fromthe1950s,

whenDunlopetal (1952)conductedasurveyofprescribingofgeneralpractitioners in

England(Dunlopetal1952).Oneofthemajorfindingsofmoststudiesconductedsince

suggests tremendous variations in volume and cost of prescribing between countries

(Goossensetal2005;Ferechetal2006)andbetweenindividualprescribers(Denigetal

1988;Bradley1991;McGuireetal1994;Carlsenetal2007;Buusmanetal2007;Glinzet

al 2017). Variations in prescribing have been analysed against both clinical and non-

clinical variables (Wilkin 1987; Webb and Lloyd 1994; Bradley 1992; Lewis and Tully

2011) and results show that non-clinical variables, such as the physician’s personal

characteristics/experience and patients’ expectations also play an important role in

prescription behaviour (Bradley 1992;Webb and Lloyd 1994;Wilson, 1996; Cockburn

and Pit 1997; Lewis and Tully 2011). These will be considered in more detail in

subsequentsections.

According to Aronson (2006), good prescribing is one that ‘recommends a medicine

appropriate to the patient’s condition andminimizes the risk of undue harm from it’

(Aronson 2006). In his discussion on good prescribing, Barber (1993) argued that the

olderdefinitionof rational prescribingdefinedbyParish (1973) as ‘appropriate’ instils

ambiguityandthereforeneedstoberevisitedtoreflectthesafetyandeffectivenessof

medicinetreatment.Barber(1993)arguedthatratherthandefiningtheoutcomeofthe

prescribing, it isworthwhile toconsider theprocesselements that lead to thedesired

outcome,i.e.definingwhatprescribersshouldconsiderintheirprescribingdecision.In

57

his view, prescribers’ decisions should be based on the key aspects of safety,

effectiveness,economicconsiderationand respect forpatients’ choices (Barber1993).

Accordingtothis, thecomplexityof theprescribingdecisionshouldallowforacertain

level of autonomy of the providers in order to be able to address what constitutes

rationalprescribing.

In this sense,over thepast twodecades, irrationalprescribingasa resultof failure to

prescribe in accordance with clinical guidelines has been challenged by the ‘patient-

centred’approach inwhichanalternativeautonomyofdoctors for individualizationof

prescribing therapy emerges (Armstrong 2002). The following section reviews the

literature dealing with prescribing from the perspective of professional autonomy of

providers.

3.5.2Autonomyandprescribing

Autonomy of the medical profession has been subject to research from different

perspectives, including economic, political and clinical (Elston 1991). While economic

andpoliticalautonomyareconcernedwithdoctors’rightstoparticipateinpolicymaking

and defining their remuneration, clinical autonomy addresses the professionals’

discretioninmedicalandtreatmentdecision-making(Armstrong2002).

Prescribing has been of particular interest to clinical autonomy, given that, as

mentioned earlier, it represents one of the key elements of treatment pathways

(O’Mahonyetal2015)andmostfrequentdecisionstakenbyphysiciansatprimarycare

level (Bakker et al 2007). According to Davis (1997), the right to prescribe is a key

componentof clinical freedom, representingoneof thecoreactivities thatdemarcate

the medical profession from other groups (Britten 2001). In the 1990s, the share of

58

patients attending primary care who received prescriptions was estimated at 68% in

Germany (Himmel et al 1997) and 50% in Australia (Cockburn and Pit 1997), with

growing trends in recentyears (Cadieuxetal2007). Literature links suchoutcomes to

the considerable autonomy of the medical profession over prescribing (Ensor and

Duran-Moreno 2004) citing it as an opportunity for increasing the consumption of

medicinesbeyondtheir‘appropriateuse’(ScottandShiell1997)orlevelsofdemandofa

well-informedconsumer (McGuireetal1994).Thus,beginning in the1990s,extensive

literature emerged on clinical autonomy and prescribing, reviewed briefly in the

subsequentparagraphs.

Accordingtotheliterature,sincethe1990s,autonomyofprescribinghasbeenafocusof

governments’ attempts to regulate overprescribing and excessive associated costs.

Beyond the standardization of decision-making discussed earlier, many governments

deregulatedtheclassesofmedicinesnotassociatedwithabuse(Britten2001),withthe

aimof reducing the power of doctors and increasing choice for patients (Blenkinsopp

andBradley1996;Branstadetal.1994).

Clinical autonomy in prescribing was examined by Freidson (1985) and Elston (1991)

from the perspective of the two dominant theses of proletarianisation and

deprofessionalisation. The proleterianisation thesis argues that economic forces are

increasingly influencing clinical pathways, allowing for dominance of bureaucratic

criteriaoverautonomy(Armstrong2002;McKinlayadArches1985;McKinlay&Stoeckle

1988).Thedeprofessionalisationthesis,ontheotherhand,considersthediminishingof

dominance of health professionals through changing relations between doctors and

patients,emergenceofwell-informedpatientsandriseofconsumerism(Scamblerand

Britten 2001). These and other authors (Gabe et al 1994) concluded that both theses

59

werenotparticularlyapplicabletoclinicalautonomy,giventheincreasingformalisation

through which professions control their own members (Freidson 1985), such as via

clinicalguidelinesdiscussedearlier.

In the context of transition economies, clinical autonomy has been affected by both

bureaucratic criteria and changing relationships between providers and patients.

Britten’s (2001) arguments on clinical freedom in prescribingbeingunder threat from

bothregulatoryandpatientpressuresarevalidandapplicableinthetransitioncontext,

andwillbereviewedunderappropriatesectionslaterinthischapter.

Irrationaldispensingalsooccurs as aphenomenon (Ofori-AsensoandAgyeman2016),

mostly as a practice of non-compliance with the policies regulating dispensing of

prescriptionmedicines.The following section reviews the literature related to rational

dispensing.

3.5.3Rationalprescribingandrelationshiptochangesinbehaviour

As discussed earlier, trends for increasing pharmaceutical expenditure are largely

relatedtoprescribinglevels,whichmightnotalwaysbedirectlyassociatedwithclinical

conditions and necessity for therapy. As already mentioned, the main approach in

promoting rational prescribing on the demand side is through influencing medicine

consumption.Inthisrespect,andofparticularinteresttothisthesis,istheinfluenceof

policychangesonchangeofbehaviourinprescribinganddispensing.

Policiesandmechanismsforpromotingrationalprescribingattheleastassumechange

of behaviour, which has been described also in the literature as the most difficult

intervention especially at the level of individual interaction (Butler et al 1998; Arnold

60

andStrauss2005).So, tobeable to influencebehaviour it is important tounderstand

thebehaviouranditstheoreticalunderpinnings.

Theories of human behaviour emanate from all disciplines of social sciences,

conceptualising behaviour in several ways. The largest number of theories comes

primarily fromwithin thepsychology field,and these focuseitheron the individualas

the locus of behaviour or on behaviour itself, relationships between behaviour,

individualsandthesocialandphysicalenvironments inwhichtheyoccur(Tonkin-Crine

2012).

Physicians’ behaviour in decision-making, and in particular in prescribing, has been

analysedfromtheperspectiveofdifferenttheories(Groletal2007;Tonkin-Crine2012),

including:socialcognitivetheory(Bandura1998);theoryofreasonedactionandtheory

of planned behaviour (Ajzen 1991; Ajzen 1998); self-determination theory (Ryan and

Deci2000);operant learningtheory(Blackman1974);self-regulationtheory(Leventhal

et al 1998) and so forth. The aim of such analysis was to understand physicians’

behavioursandidentifyattitudesandbeliefsthathaveaneffectontheirmotivationto

prescribe,whichwouldpotentiallybeusedforformulatingpoliciesandinterventionsto

changethesebehaviours(Walkeretal2001).Conclusionsemergingfromthesestudies

show that, empirical evidence of the effectiveness and feasibility of most theoretical

approachespromotingbehaviour change is limited (Grol et al 2007). This implies that

drawing conclusions and proposing specific interventions needs to be based on the

specificitiesofthedifferenteconomic,political,andorganizationalcontexts(Godinetal

2008;Goodwin2012),bearinginmindtheircomplexitiesandthebehaviourintendedto

bechanged(Walkeretal2007;Goossensetal2005;Ferechetal2006).Anillustrative

example is an international comparative study in 13 countries showing major

61

differences between physicians in the decision of whether or not to prescribe, from

twiceaslikelytofourtimeslesslikely,comparedtotheoverallmean(Butleretal2009).

Bearing in mind the above, policies have been designed to embed different

contextualizedmechanisms to addressprescribingbehaviour amongphysicians. These

mechanisms inmedicolegal terms can be divided into preventive and curative,where

preventive impliesthatphysiciansareeducated intheoryandadvised intheirplaceof

practiceongoodprescribingbasedonclinicalguidelinesandprescribingprotocols,and

curativeisbasedonincentiveandpunishmentsystems.Inmostcases,acombinationof

thetwotypesofmechanisms isused. IntheUKandmostEUcountriesthereareboth

interventionsforprovidinginformationthroughguidelinesandcontinuousprofessional

development, as well as through audit and feedback - based on the monitoring of

prescribing at the primary care practice level over a certain period of time, and

providing feedback that potentially would initiate behaviour change (Tonkin-Crine

2012).Inadditiontothesepreventivemechanisms,asmentionedabove,countrieshave

also established curative actions; most EU countries are monitoring physicians'

prescriptionpatterns,andincasesoflargedivergencefromthepredefinedbenchmark,

thephysiciansareadvised,askedtoexplainandmaybefinedorundergo legalaction,

includingwaivingoftheirprescribingright ifnoexplanationisprovided(Carone2012).

These interventions have been shown to have positive effect on changing behaviour

towardsreducingunnecessaryprescribingandonhigheradherencetoclinicalguidelines

(Zwaretal1999;Muncketal1999;Daveyetal2013).Anelaboratereviewofallstudies

published during 1990-2006, produced by the World Health Organisation (WHO),

showed trends of some improvement in rational prescribing over the 25-year period

based on the interventions assessed in these studies. The review concludes that the

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mostfrequenttypesofinterventionsusedforimprovingappropriatenessofprescribing

havebeeneducationalprogrammes forhealthprovidersaloneor in combinationwith

educational programmes and health information for patients (WHO 2009); however,

increasing numbers of interventions consisting of enhanced supervision and routine

monitoring of prescribing have also been observed. The review concludes thatmulti-

faceted interventionsdirectedatbothprovidersandpatientshavetendedtobemore

effectivethanthosethatemployonestrategyonly(WHO2009).

Thus, interventions aimed at change in behaviour can have significant influence on

appropriate prescribing and rational useofmedicines.However, at the same time, as

argued by Britten (2001), ‘the acts of prescribing and dispensing define social

relationshipsbetweenpatients,doctors,nurses,pharmacistsandothers’(Britten2001),

and behaviour is determined by these interactions,which are in turn influenced by a

number of factors. The next section provides an overview of factors influencing

prescribing with a focus on primary healthcare, representing a focal point of contact

betweenphysiciansandpatients.

3.6. OverviewoffactorsinfluencingprescribinginprimaryhealthcareAs already described, prescribing medicines is one of the most frequent therapeutic

decisions made in primary healthcare (Bakker et al 2007) and is used as one of the

indicatorsofqualityof care (Glinzetal2017).Aselaboratedearlier,oneof themajor

findings of most studies on factors influencing prescribing suggests considerable

variations,identifyingbothclinicalandnon-clinicalreasons(Goossensetal2005;Ferech

et al 2006; Denig et al 1988; Bradley 1991; McGuire et al 1994; Carlsen et al 2007;

Buusman et al 2007; Teixeira et al 2013; Glinz et al 2017). In this sense, there is a

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continuous research interest in factors influencing prescribing. A recent review of

qualitative studies on physician prescribing behaviour divided the influencing factors

intotwomaingroups:intrinsicandextrinsic(Rodriguesetal2013).Amongtheintrinsic

factorsconclusiveevidenceisdrawnonthephysicians’experience(Paredesetal1996;

Schoutenetal2007;Palucketal2001;Kumaretal2003;DenigandHaaijer-Ruskamp

1995) and level of education (Liabsuetrakul et al 2003;Palucket al 2001;Kumaret al

2003).Amongtheextrinsic factors foundto influenceprescribing, themostprominent

arethosepertainingtotheregulatorymechanismsandpatients(Björnsdóttiretal2010;

Kotwanietal2010;Rodriguesetal2013).

Alloftheabovereflectthecomplexityoftheprescribingprocessandhighlighttheneed

tounderstandthe influenceof these factors (Rodriguesetal2013)onprescribingand

dispensing. These are elaborated indetail in the following sections, reviewed through

three perspectives: providers’ experience, regulatory mechanisms, and social factors

pertainingtothepatientsandphysician-patientinteraction.

3.6.1.Providers’experiencefactors

With regards to providers’ experience, several dimensions have been explored in the

literature. The majority of studies highlight professional and personal experience of

physicians as the most influential factor that dictates prescribing decisions (Wood-

Mitchell et al 2008; Schwartz et al. 1989; Tichelaar et al. 2010; Vallano 2004). The

predominance of this factor is reported to even influence prescribing when scientific

evidencecontradictstheprofessionalexperienceofthephysicians(Schwartzetal1989).

The influence of others’ prescribing on the physician’s decision-making has been

assessed in the literature, and there is evidence that such influence is recognizedand

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acknowledged in the physicians’ perceptions. Research on the attitudes of physicians

regardingtheinfluenceofotherphysiciansshowsthatfurthertotheirownexperience,

physicians value the experience of colleagues and peers, even though this is more

widelyresearchedandestablishedasafindingamongcliniciansathospitallevel.Afew

studies have found physicians’ decisions on prescribing in primary healthcare to be

influenced by specialists or the physicians in higher levels of care, i.e. hospitals

(Buusmanet al 2007; Eccles et al 1996). For example, several studies have concluded

thatphysiciansatprimarycarelevelfeelreluctanttodiscontinuetheprescriptionfroma

higher level of care, i.e. specialist or hospital clinicians (Armstrong and Ogden 2006;

Buusmanetal.2007;Cantrilletal.2000).

Theresearchonattitudesofphysicianstowardsinfluenceofpeersontheirprescribing

shows that physicians in primary care also value the experience and opinion of their

peers,butduetolackofpossibilitiestointeract(physicallyperse)onadailybasis,they

exchangetheirexpertisemainly inscientificmeetings(Prosseretal.2003;Woodetal.

2007).Yet,otherstudiesdepictthatsuch interaction isnotvaluedorpracticedamong

general practitioners, due to confidence in their own prescribing ability and fear of

criticism(Carthyetal2000).

Relatedtotheconfidenceintheirownprescribing,physiciansdiscloseditassometimes

beingsubjecttotheinfluenceofinformalrules(Bishopetal2011;Cavazosetal2008),

whicharenotalwaysevidence-based(Ljungbergetal.2007;Fontanaetal2000;Wood

et al 2007). Kumar et al (2003) found that physicians sometimes prescribed without

medical indication to prevent complications, and felt comfortablewith such decisions

(Kumaretal2003).Further literaturesuggeststhatdoctors’decisionmaking isaltered

by patient, time and workload pressures (Petursson 2005; Greenhalgh and Gill 1997;

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Milleretal1999;Welschenetal2004)-allinfluencedbythepoliciesregulatinghealth

systems.Theregulatoryfactorsinfluencingprescribingareelaboratedinfurtherdetailin

thenextsection.

3.6.2.Regulatoryfactorsandsystem’sinfluenceonprescribing

There is a long list of regulatory factors influencing prescribing that have been

researched in the literature. This review provides insights into those that are of

relevancetotheresearchquestions,andtothesituationintheanalysedcontext.

Costasafactorfordecision-makinginprescribinghasnotbeenextensivelyresearched,

although it was considered in part in several studies. The examined literature

distinguishesthecostsasthosearisingforthesystem,andthecoststhatarebornbythe

patient.When itcomestocostsofprescribing,physiciansarerarelyaware(Ernstetal

2000;Coenenetal2006)orconcerned (Coenenetal2006),although in somestudies

coststothesystemwereconsideredindecisionmaking(Greenfieldetal.2005;Jacoby

et al 2003; Little andWilliamson 1995), as well as costs to the patients (Hassel et al

2003). However, other factors are sometimes viewed as more important than costs

(Ljungbergetal2007;ProsserandWilley2006;Coenenetal2006),andwhiletakeninto

consideration, physicians are not ready to accept or make entirely cost-oriented

decisionsinprescribing(Maddox2011).

One of themost researched topics on regulatory factors is the relationship between

prescribing and attitudes and practices related to clinical guideline existence and

adherence (e.g. Sun et al 2015; Grol andGrimshaw 2003). It can be argued from the

literature that guidelines have significant influence on the prescribing decisions of

physiciansatbothprimary(Woodetal2005)andotherlevelsofcare(HigginsandTully

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2005; Ljungberget al 2007). Furthermore, targetededucational efforts at thepractice

level (Coenen et al 2005) and monitoring of prescribing (Tonkin-Crine 2013) have

significant influence in changing prescribing behaviour. However, there are studies

showing that guidelinesmight not always have predominance in influencing decision-

making(WathenandDean2004;Butleretal1998;Coenenetal2006),andthatother

factorscanoverridethe‘writtenrules’whentheydifferfromtheexperience(Schwartz

etal1989),fromotherguidelines(WathenandDean2004)orfromthebestinterestof

thepatient (Woodetal.2007).Theseother factors includeprofessionalexperienceas

mentionedearlier(Wood-Mitchelletal2008;Schwartzetal.1989;Tichelaaretal.2010;

Vallano 2004), maintaining a good relationship with the patient (Butler et al 1998;

Coenenetal2006),patientsatisfaction(Himmeletal1997)andsoforth.

Inthisrespect,influencingfactorsrelatedtopatientsandpatient-physicianrelationship

areelaboratedfurtherinthenextsection.

3.6.3.Patients’influenceandphysician-patientrelationship

The third type of influence on prescribing considered in this research is the group of

factorspertainingtopatientsandthephysician-patientrelationship.

Prescribing is inevitably influenced by patients and the physician-patient relationship,

consideredbyphysiciansasoneofthemainelementsindecision-makingforprescribing

(Mossialosetal2004),alongsidethesymptomsandconditionofthepatient(Butleretal

1998;Rodriguesetal2013).

Thepast twodecadeshave seencontinuousattentionwithin the researchcommunity

on the role of patients in shaping prescribing behaviour and practices of healthcare

providers (Cockburn and Pit 1997; Davey 2002; Vanden Eng 2003; Ashworth 2016). A

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numberofstudieshavefoundthatphysicianstendtoprescribeunderpatientpressure,

despite the imbalance of professional expertise and information between the two

parties.WiththeexpansionoftheInternetandeasieraccesstoinformationoutletsand

educational resources, this pressure is likely to become even greater in the future

(Gardiner 2008). Literature shows that patients come to the physician with certain

expectations, stemming from their somatic symptoms, previous experience, perceived

vulnerability, and so forth (Kravitz et al 1996); but also that physicians are to some

extent aware of the patients’ expectations (Rao et al 2000; Butler et al 1998). The

literature review by Rao et al (2000) on the visit-specific expectations of patients

underlines that, while there are studies showing no significant influence or that are

inconclusiveonsuchinfluences,therearestudiesconcludingthatunmetexpectationsof

patients – for prescription in particular - led to either repeated visits for the same

symptoms (Mcfarlane et al 1997) or obtaining the medicine without prescription

(Rapoport1979).Theseexpectations,fromatheoreticalperspective,playanimportant

roleinphysician-patientinteractions,aswillbereviewedinmoredetailinthefollowing

paragraphs.

There isampleevidence in the literature that thephysician-patient interactionplaysa

significantrole indecision-making(Britten2008,Ch.3)andhasa largecontributionto

excessiveandunnecessaryprescribing(CribbandBarber1997;Butleretal1998;Arnold

and Strauss 2005; Rodrigues 2013). While describing it as the most uncomfortable

decision about prescribing that they make (Bradley 1991; Bradley 1992), physicians

often inclinetowardsclinically inappropriateprescribingforreasons involvingpatients’

expectationsorperceivedexpectationstohavemedicinesprescribed(ArnoldandStraus

2005;Kotwanietal2010;Hornbergeretal1997;Himmeletal1997).

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As described by Butler et al (1998), for example, ‘general practitioners attempted to

sensepatients’flexibilityandprescribeantibioticsassoonastheyperceivedresistance

toanon-antibioticapproach’(Butleretal1998).Whenpatientsexpectantibioticsthey

aremore likely to be prescribed (Vinson and Lutz 1993; Kravitz et al 2002) andwhen

physiciansperceivethatpatientsexpectantibioticstheyare10timesmorelikelytobe

prescribed(CockburnandPit1997;Littleetal2004;Toiviainenetal2005).Inthissense,

irrespectiveof thepotentialnon-adherence to theclinical guidelinesor rationalization

policies, studies have shown that physicians’ decisions on prescribing can often be

drivenbythemotivationofpreservingagoodphysician-patientrelationship(Carlsenet

al2007)evenif itmeansfulfillingpatients’wisheswithoutevidence-basedjustification

(Miller et al 1999). Maintaining a good physician-patient relationship (Coenen et al

2006)andimpactonthetherapeuticpowerofthephysician-patientrelationship(Butler

etal1998)wereseenbysomephysiciansasmoreimportantthanprescribingbasedon

medicalindication.Itcanthusbeconcludedthatthephysician-patientrelationshipand

interactionduringapatient’svisitcontributetotheprescribingdecision.

3.7. RationaldispensingandchallengestolegalsupplyTheprevioussectionsprovidedanoverviewofprescribingandassociatedinfluencesand

also how policy has been used to regulate the supply of medicines but there is an

emerging literature that indicatessuchregulation isnotalwayseffective. Inparticular,

there have been several studies - drawing on ethnographic methods in transition

countries - that have explored the supply of prescriptionmedicines through practices

and settings that are not considered either legal or authorised. These have been

helpfullysummarisedbyWhyte,VanderGeestandHardon(2002)whohaveidentifieda

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phenomenon of ‘pharmacists as doctors’ wherein pharmacists provided an extensive

range of medicines without the need for patients to consult a physician. Although

stressing the socio-cultural significance of such research, they identified studies

particularly in Latin America where pharmacists were engaged in ‘quasi-legal and

shadowypractices’ (Whyte,VanderGeestandHardon,2002).Forsomecommunities,

this has been argued to arise due to logistical problems in seeking medical advice

(Ferguson 1988). In others, however, there appeared to be amore overt intention to

subvertrecognisedlawsand, indeed,somehealthprofessionalsappearedtorecognise

theproblematicnatureofsuchsupplies (Wolffers1987).VanderGeest (1982) framed

this phenomenon in termsof two keyquestions: howare suchpracticespossible and

whydopatientsusesuchsourcesofmedicines.Hearguedthatthereareeconomicand

commercialdriverswhichcaninfluencepharmaciststomakesuchsuppliesandfurther

questioned if this is a consequence of laisse fair capitalist economies andwhether it

wouldhappeninsocialistcountries(VanderGeest1982p.211).Thedesireforpatients

tomakesuchpurchasesisarguedtoariseforcomplexreasonsrelatingnotonlytomore

obviouseconomicfactors,butalsocomplexsocialfactors.

SuchissuesarenotrestrictedonlytoLatinAmericaandSmith(2009)providedareview

ofpharmacy servicesandhighlightedmany suchpractices in settings suchasVietnam

(Duongetal1997),Nepal(Wachteretal1999),Nigeria(OladipoandLamikanra2002),

Brazil(Volpatoetal2005),Zimbabwe(Nyazemaetal2007),Thailand(Apisarnthanarak

etal2008), andZambia (Kalungiaetal2016).Mostof these studiespointed to socio-

cultural factors dominating the decision to dispense and obtain medicines without

prescription,justifiedaslackofaccesstophysicians’prescription,butalsoasperceived

sufficientprofessionalknowledgeofpharmaciststoprescribe.

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Literature shows that such practices are present in Europe aswell; studies describing

self-medicationandhomekeepingofmedicines-antimicrobialmedicinesinparticular-

inSpain(Oreroetal1997;GonzalezNunezetal1998),Greece(Contopoulos-Ioannidiset

al2001;Mitsietal2005),Russia(Stratchounskietal2003),andMalta(BorgandScicluna

2002) also suggested considerable use of these medicines without consulting a

physician.Obtainingmedicines frompharmacieswithoutprescription isalsodescribed

in the literature as a frequent practice in eastern European countries (Grigoryan et al

2006; Versporten et al 2014). Recent research findings regarding the association

between inappropriate use ofmedicines and antimicrobial resistance (Goossens et al

2005)continuetokeeprationalprescribing(Aronson2004;Aronson2006;Wallerstedt

et al 2014; Reeve et al 2015) and legalmedicine supply high on the research agenda

(Goffetal2002,Irukaetal2005).

Other studies found that not only antimicrobials, but other classes of medicines are

dispensedwithoutprescription.AstudyinnorthwestSpainfoundthatnearlytwothirds

of pharmacist respondents admitted to dispensing medicines without prescription,

including angiotensin-converting enzyme inhibitors, benzodiazepines and oral

contraceptives(Caamanoetal2005);Guinovartetal(2015)confirmedthisfindingand

discoveredthatthepracticecontinuedwithupwardtrendforantibiotics.Severalstudies

were looking into determinants of quality of dispensing, indicating a wide range of

influences, such as social and demographic factors, educational background and

workload (Caamano et al 2004), as well as pharmacists’ opinions about their role,

especiallypertainingtounderestimationofphysiciansqualificationsandoverestimation

oftheirownqualificationstoprescribe(Caamanoetal2005;Beneyetal2000).

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This section provided a brief overview of a relatively neglected aspect of medicine

supply (Van der Geest 1982). Lack of existing literature and scarce emphasis put on

dispensingandrationaldispensingbyscholarswhohaveresearchedmedicinesupplyin

extenso,furtherconfirmsthenecessityforadditionalresearchinthearea.Forexample,

Britten in her book Medicines and Society (2008) looks into dispensing but is not

dedicatingsubstantiveattentionaspartofthemedicinesupply.

Sofar,theliteraturesurroundingthesupplyofmedicineshasbeenpresentedinterms

of mainly empirical research relating to various influences upon prescribing and

dispensingandassociatedrationalityandautonomy.Intheremainderofthischapter,a

theoretical approach to consideringnotonly the supplyofmedicineswill beprovided

(Britten2008),butalsohowthisrelatesuniquelytotransitioncountries.

3.8. MedicinesupplyandHabermas’SystemandLifeworldSeveral attempts have been made to offer a more sociological account of medicine

supply. Whyte, Van der Geest and Hardon (2002) argued that there was a socially

groundednatureofmedicinesandwhat they termed the ‘social livesofmedicines’ as

evidenced through numerous ethnographic accounts. In addition, Britten (2001) has

argued that ‘theactsofprescribinganddispensingdefine social relationshipsbetween

patients, doctors, nurses, pharmacists and others’ (Britten 2001). Britten went on to

exploretheconceptualizationofmedicinesandtheirroleandfunctioninsocietyfroma

morespecifictheoreticalperspective.Todoso,shearguedthatHabermas’socialtheory

of system and lifeworld could be applied to different aspects ofmedicines – in their

development, prescribing and consumption – and that this theory offered an

explanation for trends within medicine supply. In the following sections, Habermas’

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theoryofsystemandlifeworldwillbedescribedandparticularlyinrelationtomedicine

supplyandtherespectiverolesofprescribersandpatients.

3.8.1Habermas’theoryofcommunicativeactionandhealthcare

Beforeconsideringmedicinesupplyspecifically inthistheoreticalsense, it isnecessary

to describe the basic concepts of Habermas’ theory of social life and communicative

action (Habermas 1987). In his theory, and of particular relevance to this thesis,

Habermasprovidedargumentsforthetwodistinctspheresofsociallife:thesystemand

thelifeworld(Barryetal,2001;Finlayson,2005;Britten,2008),witheachofthesetwo

spheres governed by different rationality; the system being largely a subject of

instrumental rationality–orientatedtowardsstructure,systematisationandsuccessful

outputs; whilst the lifeworld is the depiction of the communicative rationality –

orientated towards reasoning, interpretation, exchange and achieving mutual

understanding (Stanford Encyclopaedia of Philosophy, 2015). System and lifeworld

representjustoneaspect,however,ofamorecomplexandbroadersocialtheory,which

focuses on the significance of communicative acts and rationality, and through

importantmechanismssuchasdiscourseethics.Althoughamoredetaileddiscussionof

theseconcepts isbeyond thescopeof this thesis–particularly in termsofHabermas’

political and philosophical aims – the enduring normativity of his work in relation to

system and lifeworld are argued to be highly relevant to this thesis, and as will be

shown, have been used by several writers to contextualise and understand different

aspectsofhealth (Mischler1984;Barryetal2001;ScamblerandBritten2001;Britten

2008;Thompson2009).Thesehaveoffered important insights into topicsasvariedas

doctorandpatientinteractions,theroleofmedicinesinsocietyandtheinvolvementof

patientsinresearchnetworks.

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Essentially,thelifeworldasexplainedbyHabermasreferstothesphereofsociallifeand

throughits‘communicativeaction’playsanessentialroleasoneofthebasicinterestsof

modern society (Habermas 1987), as central to human relationships (Cuff et al 2006,

p.292), and through which all cultural, experiential and knowledge exchanges occur

(Britten, 2008; Habermas, 1987).Within the lifeworld, communication and exchanges

haveintrinsicvalueandaimtoachievecommonunderstandingwithoutanydominance

orpowerimbalancebetweenindividuals(Barryetal2001).Inotherwords:

‘If communicativeaction is takenas themostbasic formofhumanaction,then, it opens up the possibility of a society in which social relations areconducted on the basis ofmutual recognition of one another as free andindependentbeings.’Cuffetal(2006,p.292)

Habermas’system-worldstemsfromMarx’sinterpretationsofsocietyandtheParsonian

conceptionofthesocialsystem(Cuffetal2006,p.323).Itisconcernedpredominantly

with the material exchanges of the society and structuralism, whereby all means,

includinghumanbeingsareutilizedforthesuccessfulproductionofactionsandoutputs

(Finlayson, 2005, Cuff et al 2006, p. 293). This uses rationality again, but instead of

communicative rationality, it values scientific rationality and objective measurements

(Britten2008,p.18). In thecontextofhealthcareandprescribing,Britten (2008,p.19)

explainingthisdivergenceas:

‘…the lifeworld/system distinction points out the tension between theexperiences,needsandconcernsof laypeople,patientsandcarersononehand and, on the other, the need to make profit in a capitalist society(pharmaceutical companies) and the role in enacting government policies(healthprofessionals)…Individualswhobecome ill notonly find themselvesas members of the familiar lifeworld but also members of an unfamiliarhealthcare system with different rules and modes of behaviour’ (Britten2008,p.19)

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Afurther importantaspectofHabermas’theory iswhathetermedthecolonisationof

the lifeworldby thesystem.This isarguedtoarise inmodernsocietiesand it involves

increasingsystematisationofparticularareasofthelifeworld,leadingtodeviationfrom

or stagnation of the original purpose of the lifeworld and its communicative action

(Barry et al 2001). In terms of the physician-patient encounter exemplifying the

system/lifeworld interaction such systematisation and superimposition could be

illustrated through, forexample,pressureof the systemon thephysician to seemore

patients, manifest as increasingly limited times for consultation and thorough

examination(Butleretal1998).Physicians,orhealthprovidersingeneralareexpected

to maximise their output in minimum time, as a prerequisite for being part of the

system and its presupposed efficiency (Cuff et al 2006). In turn, this leads to limited

space for communicative rationality, producing patient dissatisfaction and unmet

expectations (Kravitzetal1996;Raoetal2000) that representsa failure to reach the

commonunderstanding.

But however different the system and lifeworld rationalities are, they remain

interdependentandincontinuousinteraction(Habermas1987;Cuffetal2006,p.296).

Theactual typeof interactionbetween the twospheres– in this case thepatientand

the physician – iswhat determines the product and the outcomeof such interaction.

Barry et al (2001) in their research identify four types of interaction, summarized in

Table5below.

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Table5.ThefourtypesofengagedinteractionbetweensystemandlifeworldandtheoutcomessummarizedbyBarryetal(2001)

Interactionbetweensystemandlifeworld Outcome

Whendoctorandpatientbothusedthevoiceofmedicineexclusively(acutephysicalcomplaints)thisworkedforsimpleunitaryproblems

StrictlyMedicine

Whenbothdoctorandpatientengagedwiththelifeworld,moreoftheagendawasvoicedandpatientswererecognisedasuniquehumanbeings

MutualLifeworld

Patientsusethevoiceofthelifeworldbutwereignoredasphysiciansusethevoiceofmedicine

LifeworldIgnored

Patientsusethevoiceoflifeworldbutareblockedasphysiciansuseofthevoiceofmedicine

LifeworldBlocked

Their analysis supports the premise that prioritising the lifeworldwould contribute to

better outcomes and more humane treatment of patients as unique human beings

(Barry et al 2001), but would also contribute to higher compliance with the

recommendationsandmedicaladvicegiventothem(Roter1977;Kaplanetal1989).At

thesametime,andasBritten(2008)noted,thisemphasisontheindividualisedchoice

resonateswiththeworkofGiddens (1991)andtheworkon ‘individualisation’ofBeck

(2002)who postulated that contemporary society can be characterised by theway in

which individuals choose the kind of life theywant to live,with a reflexivity to every

aspectoftheirlivessoastoincreasethepossibilityofmaking‘theright’choices.

FollowingtheabovetheoreticalexplanationsofHabermas’theory, itcanbeconcluded

that the lifeworld has a significant role to play in prescribing, reviewed in the next

section.

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3.8.2TheLifeworld:patients’roleinprescribinganddispensing

The role of patients in medical decision making, and in particular in prescribing and

dispensing, is not to be neglected and needs to be viewed through its perspective of

complex, contextualizedandmeaningful interactionwith thephysicianand thehealth

systemingeneral.AsScamblerandBritten(2001)argue,analysingthephysician-patient

relationshipas‘anautonomousandself-containedunitofanalysis’raisestheconcernof

neglecting the broader sociological circumstances that influence it. The theoretical

underpinning of this role has initially been reviewed by Mishler (1984) through

Habermas’ theory of communicative action applied to medical encounters, later

researched and elaborated by other scholars (Frank 1997, p.143; Barry et al 2001;

Britten2008).

Patients’influenceondecision-makingwasexplainedbyMishler(1984)throughmedical

encounters: ‘the voice of the lifeworld refers to the patient’s contextually-grounded

experiences of events and problems in her life.’ (Mishler 1984, p.104). Stewart et al

(2003) consider that the patient’s contribution to the healing process includes ‘the

patient’s personal and subjective experience of sickness; the feelings, thoughts and

altered behaviour of someone who feels sick’ (Stewart et al 2003, p.35). Therefore,

behaviour and thus the influence of patients and their relationship with providers is

inevitablybound to the ‘complexwholewhich includesknowledge,belief,art,morals,

law, custom and any other capabilities and habits acquired by man as a member of

society’(Taylor1871).Patients’behaviourrepresentsthetotalityofaperson'slearned,

accumulated experience,which is socially transmitted through communication. In this

sense,thepersonalidentityasconceivedbyMead(1972)andDurkheim(1984)arisesas

a structure that results from taking over socially generalized expectations, and ‘an

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organizedsetofattitudesthatonetakesoverfromone’sreferencepersons’(Habermas

1989, p.58). Habermas refers to culture, society and personality as structural

componentsof the lifeworld,where individuality is expressed through theheightened

claims to autonomy and self-realization (Habermas 1989, p.107). Thus, beyond the

specialised knowledge and system realities, individuality plays a significant role in

shaping the communicative action and outcomes of a medical encounter, including

modifyingprescribingbehaviour(Britten2008,p.50).Habermas’scommunicativeaction

inmedicalencounterswasdescribedbyLazareetal(1975)asaprocessofnegotiation

betweenthephysicianandthepatient:

‘Patientsareconceivedofasappearingwithoneormorerequests...Itistheclinician's task to elicit the request, collect the relevant clinical data, andenterintoanegotiationthatshouldfosterarelationshipofmutualinfluencebetweenpatientandclinician.’(Lazareetal1975)

Increasing access to information, reducing the knowledge gap between providers and

patients and deprofessionalisation of medicine (Scambler and Britten 2001) become

enablersfortheempoweredpatient’snegotiationandinfluenceondecision-making,as

partoftheresistancetothecolonizationofthelifeworldbyeitherthestateormarket

forces (Williams and Popay 2002). Such influence is additionally induced by doctors’

attempts to ‘balance between the task of understanding the disease (the 'science of

medicine')andthatofunderstandingthepatient (the 'artofmedicine')’ (Butalid2014,

p.8). Physicians have a dual role to play, representing the system in the physician-

patientinteraction,andatthesametimebeingthemselvespartofthelifeworld;thusit

is arguable that their behaviour is affected by the exchanges made through this

interaction.And,indeed,thereisextensiveliteraturenotonlyonsuchinteractions,but

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also on their impact on prescribing outcomes, describing a shift from the traditional

supply-inducedcareintoamoredemand-inducedcare(Brink-Muinenetal2006).

However, as already mentioned, these interactions do not happen in a vacuum, and

have to be analysed also vis-à-vis the influences of a wider societal and economic

context.CribbandBarber(1997)talkaboutthecontextofchoiceofprescribingasbeing

oneof thekey factors shapingprescribingdecisions (CribbandBarber1997).Britten’s

(2008) further analysis confirmed that prescribing and dispensing is more than a

technical issue, and is influenced by a range of social and contextual factors (Britten

2008, p.115). As they are of particular interest to this thesis, the following sections

reviewtheliteratureonprescribinganddispensingintransitioncountries.

3.9. PrescribinganddispensingintransitioncountriesSinceprimarycareiscontinuouslyevolving,thedoctor-patientinteractionisinfluenced

by theprevailing context of a particular point in time (Butalid 2014, p.8). It is thusof

immense importance to provide an overview of primary care and its changes in the

transitioncountries,asthecontextinwhichprescribinganddispensingisofinterestto

thisthesis.

3.9.1Primarycareandsystem/lifeworldinteractions

Asexplainedearlier,primarycarerepresentsthefirstpointofcontactwithpatients,and

thephysician-patientrelationshiphasbeenwidelyresearchedwithregardstoit(Bakker

et al 1997; Bradley 1992). As the focus of this thesis is prescribing and dispensing at

primary care level, in order to understand the transition economy context in which

theseareresearched,itisnecessarytoprovidebackgroundinformationonthecontext

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inwhichprimarycareisset,functioningandevolving.Thissectionprovidesanoverview

of the different engagement mechanisms of providers in primary care through the

perspectiveoftheHabermas’theory.

Salaried primary healthcare is closest to and most resembles financing in the health

system under the socialist system of command economy (Mandel 1986). Salaries in

healthcare incentivise provision of care at the discretion of the provider that is not

basedonanyperformanceindicatorsandencouragesreferralsandprescribing,asthese

are often not financially confined. If viewing this through the perspective of the

system/lifeworld, in the salaried model, physicians have more time and space for

interactionwiththeirpatients,andacommonunderstandingismuchmorelikelytobe

reached.Suchacommonunderstanding is likelytobeunfavourablefromthesystem’s

perspective, as a result of disguised dissociation of doctors from the system, through

lack of performance indicators (characteristic of purposive rationality) and enormous

clinicalautonomy(supportiveofvaluerationality).

Thefee-for-service(FFS)model,ontheotherhand,isbasedontheconceptofefficient

useof allocated resources, incentivisingphysicians toprovide fewerunnecessary (and

sometimesnecessary)services.Itcanbearguedthatwiththefee-for-servicemodel,the

time for the consultation, i.e. communicative rationality and reaching a common

understanding are severely affected, as the system usually sets strict efficiency

requirementsoverthephysicianforobtainingtherewardfortheworkdelivered.Thus,

in this model, the system instrumentalizes providers in fulfilling its goals, explicitly

superimposingitselfontothelifeworld.

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The thirdmajor reimbursementmethod used in primary care, the capitationmodel –

and its modified alternatives, as already described in previous sections - is based on

paymentofasetamountex-ante foreachregisteredpatient,addingaproportionality

dimensiontotheincomerelativetothenumberofpatients.Inaddition,thecapitation

modelalsoaddressessomeoftheissuesofthefinancingofadditionalservices,suchas

medicines. The capitation model thus encourages the communicative rationality

between the system and the lifeworld, but still can arguably somewhat limit the

possibilities for reaching a common understanding, especially with regards to the

limitationssetforprescribingorreferrals.

Following this review of the main features of different models of primary care, the

followingsectionreviewsprimarycareinthecontextofthetransitioncountries.

3.9.2Primarycareintransitioncountries

Althoughthereweresomeexperimentationswithmodels,bythemid-2000stransition

economies have almost all introduced capitationmodels for payment among primary

caredoctors(e.g.Albania,Bulgaria,CzechRepublic,Hungary,Macedonia),orcapitation

combinedwith fee-for-service (Croatia, Poland, Romania) (Ciumas andVaidean 2008),

whilesomeintroducedmodifiedversionsofpartialorfullreimbursementthroughfee-

for-service forpreventivecareorminorsurgery (Leive2010).Policiesandmechanisms

of capitation are similar in the broadest sense; capitation amount per patient is set

basedonvariedcriteria,generallyaccountingforspecificadjustmentsfortheregistered

patientsintermsoftheirexpectedhealthneeds,dependentonage,gender,rural/urban

locationandsoforth(Leive2010).Mostofthecountriesadoptingthecapitationmodel

have a policy of limitation on the number of patients that can be registered under a

singleprovider (Kornai andEggleston2001); however in some systems the limit set is

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only to represent the cut-off point beyondwhich, for additionally registered patients,

physicianswouldreceivealowercapitationamount(Milevska-Kostovaetal2017,p.24).

This is aimed at dis-incentivising physicians to register more patients than optimally

possible to interact with, and thus ensuring equality of access, through, for example,

timededicatedtoeachpatient.Inotherwords,suchalimitationwasaimingatsecuring

timeandresourcesforcommunicativeactionandreachingmutualunderstanding,given

that medical consultations are central to health care and primary care in particular

(Butalid2014,p.9).Fromtheperspectiveofthesystem/lifeworld,thiscanbearguedas

somewhatparadoxical,sinceitmeansthatthesystemisdivergingitselftothelifeworld,

by attempting to enable sufficient time for communicative rationality, as opposed to

confiningitselftoefficiencyandobjectivemeasurementsoftheoutputs;inotherwords

stimulatingmoreservicesforlesstimeandresources.

Asdescribedatthebeginningofthissection, thepreviousdominantmodel insocialist

transitioncountrieswasthesalary-basedone(Mandel1986).Thus,primarycarereform

wasamajorchangeinthehealthsystemsoftransitioncountries,whichhavepreviously

focused their resource allocation and system development at the hospital level and

secondary and tertiary care provision (Leive 2010). Further to the change of

reimbursementmodel, somecountrieshavealsoemployedmore radicalmeasures for

improvingefficiencyandeffectivenessofresourceuse,throughprivatisationofprimary

care (Hebrang 2003; Menon 2006; Albrecht and Klazinga 2009), mirroring the

experience of some developed countries (Pollock 2004; Anell 2011). The following

subsectionreviewstherelevantliteratureonprivatisationofprimarycare.

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3.9.3Privatisationofprimarycareintransitioncountries

FollowingtheprinciplesoftheAlmaAtaDeclaration(AlmaAta1978)whereanemphasis

is put on prevention and basic care as an affordable andmuch needed approach for

developingcountries,asexplainedearlier,thetransitioneconomieshaveembracedthe

idea of having a stronger role of primary healthcare. This, in conjunction with the

already notorious perception of unresponsiveness and demotivated providers in the

publicdomainthatdeliverpoorqualityofcare(Lewisetal2004),ledtoprivatisationof

primary healthcare in many transition countries. Alongside democratization and

decentralisation,itwasconsideredoneofthemainoutcomesoftheoverallsocietaland

economic reform (Baillie et al 1998). The expectations were a better line of

responsibility and coordination, more effective use of resources and stronger

accountability forpublic spendingonhealth (Golinowska2007;WagstaffandMoreno-

Serra 2009). As a result, many of the transition countries, gaining confidence from

privatisationintheothereconomicandproductionsectors(Trupiano1993;Tirole1991),

haveembarkedontheprocessofprivatisationofprimarycare.Themodel,withvarious

differences,generallyconsistsoftransferofprimarycareproviderstotheprivatesector,

while retaining their function of providing services for public funding, through

contractingeitherwiththelocalandregionalself-governmentorwithmandatoryhealth

insurance institutions (Golinowska 2007). This reform applied to all physicians,

pharmacistsanddentistsatprimarycarelevel(KornaiandEggleston2001).Themodel

envisagedestablishmentoftheirownpracticesbydoctorsthroughself-employmentor

workingasagroupofpracticesofseveralphysicians(Croatia,Macedonia).Pharmacists

opened private pharmacies that could operate freely on the market, but were

contractedby the respective insurance institutions for theshareofmedicinescovered

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bythemandatoryhealthinsuranceschemeinthecountry.By2005,thetransformation

andtransferofprimarycaretotheprivatesectorwascompletedornearcompletionin

mostcountries;Slovakiareported94%ofprimaryhealthcare‘privatized’(Hlavackaetal

2004; Szalay et al 2011), the Czech Republic 95% (Rokosova et al 2005), and Poland,

Hungary and the Baltic States around 80% (Golinowska 2007). In Croatia, the process

began in 1997 when half of primary care was privatised and was completed several

yearslater(Hebrangetal2003).Withaslightdelaytotheabove,Macedoniaembarked

ontheprocessin2005,andby2009hadcompletedtheprivatisationof95%,with2010

being theyearof complete transferofprimary care intoprivateownership (Milevska-

Kostovaetal2017,p.24).Insomecountries,likeRussia,however,privatisationwasnot

consideredanoptionfortransformationofprimarycare(Sheiman1991).

Towhat extent this transformation of primary care has achieved the desired goals of

strengtheningitsgatekeeperroleandimprovingefficiencyofresourceusehasbeenthe

subject of a number of studies (e.g. Kornai and Eggleston 2001; Hebrang et al 2003;

Golinowska 2007). Existing literature points to, for example, increased levels of

fragmentationofservicesfollowingthereform(e.g.ChernichovskyandPotapchik1997)

and changes in the number of referrals to higher levels of care (Leive 2010).

Responsivenessandadaptabilityofphysicianstothenewconditionswasalsoassessed

(Hebrang et al 2003), showing improved accountability and competition for ensuring

improvedqualityofcare(Leive2010).

However, a common theme concluded by all the studies reviewed is the apparent

change of behaviour in one way or another, of both providers and patients. For

example,physicianswere triggeredby these reforms to further specialise (Golinowska

2007),orprovideawiderrangeofservices,including,forexamplesomeminorsurgeries

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andtelephonecounsellingafterworkinghours(KornaiandEggleston2001;Hebranget

al2003).Ontheotherhand,findingsalsoshowthatinmanycases,patientscontinued

tovisitprimarycarephysiciandominantlyforobtainingreferraltohigherlevelsofcare,

bringingintoquestiontheactualimplementationofthereformwithregardstoprimary

care’s gatekeeping role (Golinowska 2007). In addition, these and other literature

sources(WHO2009;Kaaeetal2016)notethelackofqualitativeresearchinthisarea,in

particular pertaining to the changes in beliefs, attitudes and practices as a result of

primarycare reform.Furthermore,nostudieswere identifiedwhichspecificallyassess

prescribinganddispensingintransitioncountriesusingqualitativemethodology,despite

the wide behavioural research literature available for developed countries. The next

sectionprovidesanoverviewofprescribinganddispensingintransitioneconomies,with

the intention of explaining the social, economic and cultural contexts in which the

researchquestionsarebased.

3.9.4Prescribinganddispensinginprimarycareintransitioncountries:systemandlifeworldperspective

The overall health reform and primary care transformation also affected medicine

supply. Before the reform period, most transition countries had expanded limit-free

pharmaceutical policies, without any limitations on prescribing or dispensing, which

were available free of charge to all patients. The pharmaceutical list was one of a

utopian health system, where everything, including vitamins and supplements, was

prescribedanddispensedfreeofchargeatthepointofdelivery,withinthepossibilities

oftheratherconfinedrealityofcommandeconomies(JoncheereandPaal2002).

Healthreformalsochangedtheservicesprovisionlandscape,includingmedicinesupply

throughprivatisationofdomesticandpenetrationofforeignpharmaceuticalproduction

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and distribution companies. Countries liberalised markets for provision of services,

including medicines (Nordyke and Peabody 2002), as a complementary reform to

privatisation(Goodhueetal1998).Theliberalisationwasquicklyembracedbyboththe

public and private sectors; for the former it was seen as a possibility to encourage

competitionand lowerpriceswhileexpandingmedicinesavailability for thebenefitof

thecitizens.The lattersaw itasanopportunity forexpandingmarketsandgenerating

welfare (GranvilleandLeonard2003). In itsownright, thisenabledcompetition in the

supplyside,bringingindeedwideravailabilityofmedicines,whichconsequentlyaffected

thedemandsideinwhichtheconsumers,i.e.patientsbecameempoweredtorecognize

thevariationsinthescopeandqualityofservicesandmedicinesprovided(Hebrangetal

2003). The changes had drawbacks too; a study on access to medicines in Russia by

Perlman andBalabanova (2011) showed that between the early 1990s and 2000s the

availabilityofprescriptionmedicinesinpharmaciesimproved,butatthesametimethe

percentage of patients unable to obtain prescriptions rose sharply. Similar situations

were reported in Armenia, Moldova, Ukraine and Kyrgyzstan (Falkingam et al 2010;

Jakab and Kutzin 2009; Balabanova et al 2012) where still in 2010 over half of the

respondentsreportedlackofaccesstomedicines(Footmanetal2014).

Returning to the issue of interest, models in which the transition economies have

regulated the pharmaceuticalmarket did not differmuch from themodels explained

earlier inthisthesis;countries introducedbothsupplysideanddemandsidemeasures

adapted to the given health system. Without reiterating the details of the

pharmaceuticalmarketregulationexplainedearlier inthischapter, Iwillbrieflyexplain

thedemandsidemeasuresintroduced,astheseareofparticularinteresttotheresearch

questions.

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Regulationofthepharmaceuticalmarketdidnotnecessarilycomewiththeexpertiseof

thepublicsectortodealwiththenewpublic-private interaction. Inthefirstyears,the

public sector, still under the old paradigm of health being ‘the most valuable public

good’thatneedstobeundisputedlyfunded,wasproducingpoliciesthatwerenottoo

successfulinpharmaceuticalcostcontainment.Justasanillustration,inthelate1990s,

the transition economies still spent between 16-26% of health expenditures on

medicines,whereas intheEUcountriesthissharewasbetween7-11%(Joncheereand

Paal 2002). A further difficulty was posed by the necessity formind shift in terms of

explaining tovoters that thenew ‘better’ societywouldactuallyprovide ‘less’ofwhat

was available before. Thus, with predominantly political motivation, as well as to

maintain social stability (Markota et al 1999), governments considered introducing

incrementalchangesincostcontainmentpolicies.

Atfirst, intransitioncountriesadoptingthecapitationmodel(e.g.Croatia,Macedonia)

there was a limitation on the number of prescriptions (and referrals) that primary

healthcare physicians could prescribe for their pool of registered patients. This policy

intervention intended to ‘train’ physicians to plan and rationalize their decisions for

prescribing (Hebranget al 2003).At the same time, a health insurance-covered list of

medicineswasintroduced,asanothermeasuretoconfinethepreviouslysoaringuseof

medicinesandhighpharmaceuticalspending(JoncheereandPaal2002).Inparallelwith

these policy interventions,many transition countries have introduced evidence-based

clinical guidelines for the recommended pathways of treatment,most of them taking

andadaptingtheproceduresfromdevelopedcountries,mainlytheUK(Kanavos1999).

At this point, the policies still did not have a sufficient effect, keeping costs high and

quality of care at ‘there is room for improvement’ levels. Further policy changeswere

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considered, and countries introduced fixed prescribing budgets in primary care (e.g.

Croatia,Macedonia)or substitutionofbrand-namewithgenericmedicines (e.g.Czech

Republic, Romania, Slovakia). In addition, patients’ co-payments for prescription

medicineswith varying rates between 10 and 50%were introduced as ameasure for

preventing overprescribing and overdispensing (e.g. Croatia, Czech Republic,

Macedonia).Theappliedcombinationofchangesdependedonmanyfactors(Hlavacka

etal2004;Rokosovaetal2005;Golinowska2007;Gjorgjevetal2006),mainlydrivenby

overall higher levels of prescribing compared to western countries. At this point,

countriesalsointroducedreferencepricingandrelatedpolicies,butasthosearesupply

sidemechanisms,forclarityofthetextthesearenotelaboratedfurtherinthisthesis.

Yet, in some countries (e.g. Slovakia) even after pharmaceutical reform, the share of

medicines remained as high as 28% (in 2008) of the total health expenditures

(Golinowska 2007). InMacedonia, too, as already elaborated in the previous chapter,

the number of prescriptions and pharmaceutical expenditure show a steady increase

overtheyears,despitetheintroducedpolicychanges.

With the above in mind, it can be argued that other factors – stemming from and

relatedtothelifeworldanditsinteractionswiththesystem–areinfluencingprescribing

and dispensing levels. This is confirmed in the literature from the aspects already

discussedabove.However,althoughsomefindingsmightbeuniversaltothephysician-

patientrelationship,theircommunicationandoutcomesoftheircommunicativeaction,

still their specific effects within the context of transition countries requires further

attention.

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3.10. ResearchquestionsAs shown throughout the literature review, there is a lack of qualitative research on

prescribinganddispensingintransitioncountries,whichmightprovideinsightsintothe

possiblereasonsforincreasinglevelsofmedicineusedespitemeasurestocontainsuch

trends.

Theresearchpresentedinthisthesisisconcernedwithtwomajorissues:

- What impactdopolicy changes for regulatingprescribinganddispensinghave

on:(1)theprescribingpractices inprimarycaresettingsand(2)thedispensing

practicesinpharmacies?

- What are the experiences, attitudes and opinions of patients, primary care

physicians, pharmacists and other stakeholders (policy/decision makers,

professional associations/chambers, academia) regarding the policy changes,

relevanttotheirpracticeandbehaviourinthenewcircumstances?

Inexploringthesetwoquestions,furthersecondaryquestionsalsoarose,concerning:

a. Whataretheissuesofconcernwiththepolicychanges?

b. Whatarethebenefitsandbarriersarisingfromthepolicychanges?

c. Are thereethical issuesarising fromthepolicychangesor fromeffortstoovercomebarriers?

3.11. SummaryofchapterThe aim of this chapter was to review the available literature and identify gaps in

knowledge leading to development of research questions on the impact of policy

changes on attitudes and practices of prescribing and dispensing. In addition, its

intentionwastoprovideanoverviewoftheresearchcontextbysummarisingthepast

andongoingchangestoprimaryhealthcareorganisationintransitioncountries,soasto

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inform the reader of the societal context in which prescribing and dispensing of

medicinesisbeingconsideredandstudiedinthisthesis.

The literature review showed that prescribing and dispensing are not solely based on

clinical indicationandmedicalknowledge.Other factorsalso influenceprescribingand

dispensing – such as regulatory factors (related to the system) and societal factors

(related to patients and the lifeworld). Literature suggested that individual attitudes,

beliefsandbehaviourhavesignificant impactonprescribinganddispensing.Physicians

have a dual role to play, representing the system in the physician-patient interaction,

andatthesametimebeingaconduitbetweenthepatient’slifeworldandsystemworld.

The literatureadditionallyhighlightsthefactthatcontext-specificcircumstancesplaya

key role in physician-patient interactions, prescribing behaviour and prescribing and

dispensing outcomes. These findings have been confirmed across different contexts;

howeverthe literatureontransitioncountries is ratherscarce.Therefore, this thesis is

aimedatreducingthesegapsinknowledge.

Thischapteralsoprovidedanoverviewoftransitioncountries’intensivehealthreforms,

wherepharmaceuticalexpenditurecontrolwassignificantlyconsideredinanattemptto

increaseefficiencyandeffectivenessofhealthsystems,andprimarycare inparticular.

(Nordyke and Peabody 2002, Cernis-Istenic 1998). Some countries have seen great

improvements inefficiency (Francoetal2004),whileothershavenotbeensubject to

researchtoevaluatetheeconomicandsocialbenefitsofthereforms.

Despitethelargeinterest inanalysingtheimpactofhealthpoliciesandhealthreforms

in transition economies (Leive 2010), a very small body of evidence exists from these

countriesintermsofqualitativehealthresearch.TheWHOreviewofmedicines’usein

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primarycareindevelopingandtransitionalcountriesnotedthatinadditiontothesmall

numberofstudies, theresearchtopicsandapproacheswereratherfragmented(WHO

2009). The same review emphasised that many topics remain virtually unexplored,

especiallyusingqualitativeapproaches.

Thestatusofempiricalresearchhasalsobeenconsidered,asaninsightintothecurrent

bodyofknowledgeontheresearchedtopic.Whileextensivequalitative literaturewas

found relating to prescribing in general, very few studies have been identified on

transitioneconomies(e.g.Petrusevskaetal2015;Vucemiloetal2013).Oftheavailable

studies, some are concernedwith the attitudes and perceptions of particular groups,

suchasphysicians(Petrusevskaetal2015)orofpatientsandtheircarers(Ilievska2010).

A significant gap in the literaturewas identified regarding the perceptions, views and

experiencesrelatedtoprescribingordispensinginthesecountries.Furthermore,agap

wasalso identified in termsof theoreticalexplanations;neitherHabermas’ theorynor

anyothertheoriesofbehaviourchangewereusedastheoreticalunderpinningsinanyof

the identified empirical studies. Drawing in particular on Britten’s (2008) use of

Habermas’systemandlifeworldinthecontextofmedicinesinsocietymoregenerally,it

is proposed to study Macedonian policy changes and regulation of prescribing and

dispensinginprimarycareusingsuchasocialtheory.Aswillbeconsideredinthenext

chapter, theory did not explicitly inform the analysis, as an inductive approach was

sought,butthediscussionchapterwillseektolocatethefindingsofthisstudynotonly

intheextantempiricalliteraturedescribedinthischapter,butalsoHabermas’concepts

ofsystemandlifeworld.

Fromaresearchpointofview,itisintriguingtoexploretheeffectsofpolicychangesin

transition economies on the views and experiences of different actors involved in

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prescribinganddispensing,andif,whyandhowthese,inturnhaveaffectedprescribing

and dispensing practices in Macedonia, as a case study. Given the similarities of

transitionsocietieselaboratedearlier,hopefully this researchwouldalsocontributeto

understandingofprescribinganddispensinginthecontextofothersimilarcountries.

Thenextchapter,Methodology,elaboratesontheavailablemethods,theiradvantages

and disadvantages, and justifies the choice of themost appropriatemethods for this

research,alongsideinstrumentsused,samplingandothermethodologicalissues.

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CHAPTER4:Methodology

4.1. Introduction

The aim of this chapter is to present and describe the research strategy and specific

methods chosen to answer the questions that have emerged from the previous

chapters, namely: what are the effects of prescription policy changes in primary

healthcare on firstly, prescribing and dispensing practices and, secondly, the involved

stakeholders’ perceptions and attitudes towards changes in the prescribing and

dispensingpolicies.Aswillbeelaboratedlaterinthischapter,inthisthesis,theinvolved

stakeholdersthatwereinvitedtosharetheiropinionsandattitudeswereprimarycare

physicians and pharmacists, patients, and elites, including policy makers,

representativesofprofessionalassociationsandacademia.

Inaddition,thischapterwilldescribeindetailthedatacollectionmethodsandconsider

specific issues relating to sampling, data collection and analysis, as well as concerns

relatingtoresearchethics,andpracticalandlogisticalissuesofconductingtheresearch.

Areflexiveapproachtotheresearch ispresented,demonstratingalsoanon-goingand

activeunderstandingofmyroleintheresearchprocess.

Thenextsectionswillprovidetherationalefortheappropriatenessofthemethodology

and methods chosen for this research. Further, a description of the actual research,

including the above mentioned stages, as a common requirement of the scientific

researchmethodology(Silverman2005,Seale1999).

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4.2. Choiceofqualitativemethodology

As summarised in previous chapters, the relevant healthcare reforms and the effects

thesereformshavehadontheMacedonianhealthsystemhavebeenmainlyexplored

usingquantitativeresearch.Thesehavebeentypifiedbytheuseofdependentvariables

such as the number of outpatient visits, or the volume of prescribed and dispensed

medicines. These represent indicators of success as the most appropriate units of

comparison and are arguably appropriate for a hypothetico-deductive epistemological

perspectiveonpolicychangeanditsimpact.Thisisnotunexpectedanditisrecognised

thatcommonresearchapproachesforassessinghealthreformsandtheirimpactutilise

numerical andmeasurable data, relating to resources (inputs) (Fox-Rushby andCairns

2005, p.67), process and outputs (Olsen 2009, p. 18). Similarly, the policies are often

changedbasedonevidencethatprovidescausalrelationshipbetweenthepolicychange

andtheeffectsofthatchange(Dunn2004,p.34).Suchapproachesarepredicatedona

positivistic epistemology, privileging scientific knowledge about the socialworld to be

amenable to causal inference. The research questions argued to be relevant to this

study seek to explore policy change from a very different perspective and value the

subjective meaning attributed to such changes and their impact. Furthermore, they

encouragetheexplorationofthedepthandpotentialvarietyofexperienceandassuch,

itisarguedthatqualitativemethodologiesareappropriate.

Inaddition,aselaborated in theprevious chapter, theprescribinganddispensingacts

arecomplexendeavoursofsystemandlifeworld,largelyinfluencedbytheinterpersonal

interaction between physician and patient. In this sense, research dealing with the

underlyingcausalityofprescribinganddispensingshouldnotbestrictlyconfinedtothe

formalpropertiesoftheprocess,suchasexaminingthestatisticalorquantitativedatato

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identifytheimpactofpolicychangesontheoutcomes.Thismayneglectthemoresubtle

elementsof thedynamicsof theseprocesses, includinganunderstandingof themicro

levelinteractionsanddecision-makingtakingplaceonanindividuallevelthatinevitably

influenceoutcomesonthemacrolevel.

Qualitative researchmethodologies vary but are broadly associated with attempts to

gainsubjectiveandhighlysituatedemic(asopposedtoobjectiveetic)accountsofsocial

phenomena. In the context of these research questions, it is argued that such

methodologies will value the subjective and variable nature of the impact of policy

change for a range of stakeholders and, as will be shown, through specific methods

associated with a qualitative methodology, permit the solicitation of rich, in-depth

individualaccounts.

4.2.1Epistemologicalposition

Inthisresearch,aswillbeshowninlatersections,differentmethodologicalapproaches

were considered. For addressing the research questions posed in this thesis, I

considered the use of both quantitative and qualitative methodology. After doing

thoroughreadingonmethodologies, I reasonedthatquantitativemethodologiescould

provide responses to questions involving association of policy changes with policy

outcomes in terms of levels of prescribing and dispensing – which I covered as

descriptiveanalysisinchaptertwo.However,Ifurtherconsideredthattheresponsesto

questions such as ‘what happened’ would be beneficial in knowing the outcomes of

policy changes and to assess if those outcomes are desirable or sufficient. But, those

responses would not be sufficient to understand more in-depth ‘how’ and ‘why’ the

policychangesarrivedat suchoutcomes.Furthermethodological readings revealed to

me that qualitative methods are more suited to responding to my chosen research

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questions, which are substantially grounded in the social world and its interactions.

Therefore, choosing qualitative methodology was considered valuable from the

perspective of richness of data that it could provide, while bearing in mind that the

accounts themselves do not necessarily represent ‘the truth’ but rather the ‘subtle

realism’ of the respondents through their views, opinions, experience and attitudes.

Whiletheseshouldberegardedasrespondents’interpretationsofthereality,theyare

alsomyinterpretationsasaresearcher,ofwhattheirviews,experiencesandattitudes

are.

Thus,Ifurtherreasonedwhichepistemologicalapproachtotake.Basedonreadingand

my further understanding of the research methodologies, I rejected the positivist

approachasnotappropriate,giventhatthisapproachisgroundedonthepostulatesof

objectivity, which in qualitative research, as discussed in following paragraphs is not

possibletoachieve.

Theepistemological foundationof theresearch isbasedonassumptions that thedata

collected are subject to various possible interpretations and these are dependent on

myselfastheresearcher.Acknowledgingthatwebringtoresearchourselvescomplete

withwhatweknowor thinkhighlights the impossibilityof separatingmyself from the

research. I inevitably, throughmybackgroundaspharmacistand roleof researcherof

healthpolicies andhealth reform inMacedonia in thepast fifteen years (described in

moredetailinChapterOne,section1.3onpage20),broughtpre-understandingstothe

research process, asmy thoughts and ideaswere not something I considered I could

abstract from, or according to Husserlian phenomenology, ‘bracket’ (Gearing, 2004).

FreshwaterandAvis (2004)alsodisputed theconceptof findings just ‘emerging’ from

qualitative research. In a much earlier work, Gadamer (1976) considered pre-

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understandingsasprejudices,justifyingtheirexistenceandarguingthattheyshouldnot

beeliminated,butratherproperlyacknowledgedintheprocess(Gadamer1976,p.9).

Inotherwords,pre-understandingsarenotnecessarilymisperceptionsordistortionsof

truthbutshouldbeunderstoodandacceptedasconditionsbywhichweencounterthe

world as we experience something. We bring these pre-understandings into the

research process and they influence howwe understand things or phenomena. Thus,

pre-understandingsandevenbiasesaresomethingwecannotsimplyavoidor‘bracket’,

whichisreinforcedbyFinlay(2003):

“We should no longer work towards abolishing the presence of theresearcher;insteadsubjectivityinresearchistransformedfromaproblemtoanopportunity”(Finlay,2003p.5).

Itisthereforeunderstandablethattheepistemologicalpositiontakeninthisresearchis

one where the research process is inextricably bound up in the researcher and that

construction of knowledge occurs jointly with the participant (Freshwater and Avis

2004).

I also attempted to have a critical view of my professional background and previous

knowledgeofthecontext,alongsidethatoftherespondents.Aspartofthatprocess, I

attemptedtoreflectonmyroleintheinterviews,andtheinfluencemyownexperience

had on the collected data. Inevitably, I had influence on the respondents, at least on

those in theelite stakeholders’andproviders’groups,givenmyworkandexposure in

theprofessionalcommunity.Assuch,anduponadvicefromthesupervisors,Idecidedto

usethemethodofkeepingareflexivejournal(elaboratedindetailsundersection4.3.6

Reflecting on interviewing and data collection process) that helped me keep a

continuousreflectionprocess,intermsofbothmyfeelingsandexperiences,andhowI

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influenced the encounters in the interviews. As an important part of qualitative

research, this process of reflexivity is elaborated in further detail under the section

describingthedatacollectionprocess,laterinthischapter.

Havingarguedthataqualitativeapproachwouldbemostappropriateforansweringthe

researchquestionsposed,inthenextsectionIelaboratethemainqualitativemethods

availablefordoingsuchresearch,thechoiceofmethodandjustificationforsuchchoice.

4.2.2Rationaleforchoiceofsemi-structuredinterviewmethod

Avarietyofqualitativemethodsareavailable(Silverman2005;Mason2002), including

observationalapproaches,focusgroups,one-to-oneinterviewsofvaryingtypesandalso

documentaryorcontentanalysis.Inthissection,thejustificationfortheuseofasingle

methodofdatacollection–semi-structuredone-to-oneinterviews–willbepresented.

However,inordertodemonstrateatransparentandreflexiveapproach,thealternative

methodsconsideredaredescribed,togetherwithreasonswhytheywerenotregarded

asappropriatetoanswertheresearchquestions.

Focus group discussions were initially considered as a possible method as these

representanempiricallywell-establishedmethod(Kitzinger1995,Morgan1998;Hedges

1985)andhavebeenused inpolicy related research.These involveagroupofpeople

beingaskedabouttheirperceptions,opinions,beliefsandattitudestowardsaproduct,

service, concept or idea (Henderson and Naomi 2009). Focus groups are valuable for

obtainingdata thatemerges fromgroupdiscussionsanddebate, and this canbewith

similarordifferenttypesofparticipants.Idecided,however,thatfocusgroupswerenot

an appropriatemethod for several reasons: firstly, the aimwas to consider individual

experiencesindepthandtheuseoffocusgroupsislesssuitedtothisthan,forexample,

individual interviews; secondly, there was a concern that some participants such as

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primarycareprovidersmightfeelunabletospeakopenlyinagroupenvironmentabout

someethicalaspectsofthepolicychangesforthefearofrepercussions;finallyprimary

careprivatisationimposedcompetitionamongproviders,whichwasconsideredanother

factorthatcouldinfluencethecompletehonestyandopennessoftherespondents.

Alsoconsideredwereobservationalmethods,whichrepresentanothercommonlyused

approach in qualitative research (e.g. Smith 1998b). Such methods involve

systematically observing people and events to explore behaviours and interactions in

naturalsettings(Mays1995).Relatedtothisstudy,itwasconsideredwhetherobserving

different participantsmay be of value but aswith focus groups, thiswas rejected for

severalreasons.Thechoiceofresearchmethodortechniquemayvarydependingupon

thenatureof the social phenomenaunder investigationanduponwhatonewants to

understand about those phenomena (Cooper 2006). Observational methods would

arguably not provide insights into the second research question about the views and

perceptions of stakeholders but could have offered insights into the first research

questionconcerningtheimpactofpolicychange.However,akeyconcernwasthatthis

research related to social phenomena relating to policy changes that occurred over

sometimeandassuchobservationalmethodswouldnotbeabletocapturetheimpact

ofpastpolicy changeandevents.A final concernwas that somestakeholders suchas

primary care providers for example, may have not given consent to have their

professionalactivitiesobserved;aswillbecomeapparent in the followingchapter, the

identification of examples of un-professional practicemay have been easier to solicit

frominterviewsasretrospectiveaccounts,thantohavedirectlyobserved.

The chosenmethodof qualitativedata collection involved theuseof semi-structured

interviews. Interviews are considered a ‘conversationwith a purpose’ (Erlandson et al

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1993) allowing for reflection, introspection and in-depth discussion, and involving

reasoning processes thatmay not be apparent through observation (Bryman 2008, p.

329). Of the available approaches in interviewing, a semi-structured interview was

chosen, as it allows both participant and researcher to influence the direction of the

conversation,whilstpermittingtheformertheopportunitytoexpresstheirreasoningin

their own language and in a way that they find most appropriate. I considered this

methodthemostappropriatesinceitwouldallowmetoexploretheresearchquestions

indepth,encouragingdetailedresponsesandalsoenablingmetoprobeandchallenge

responseswhereappropriate.Further to that, thismethodallows for issuesand ideas

arisingoutofearlyinterviewstobeusedtoinformsubsequentinterviews.Byadopting

suchaninterpretativeapproach,interviewswouldalsoallowtherespondentstoreflect

uponissuesortoraisenewonesthemselvesthattheyencounteredintheirpractice,but

which I have not anticipated in the questionnaire guide, and so could be asked of

subsequentrespondents.Theuseofunstructuredornarrativeinterviews(Squire2008)

was also considered but given the aim of capturing accounts from a potentiallywide

rangeofstakeholders,itwasfeltthatabalancewasneeded-betweenthedepthofdata

and the need to capture diverse accounts. The free association narrative interviews

(Holloway and Jefferson 2000), based on free associations made by the interviewee,

were also considered but rejected for the same reasons. The next section provides a

moredetailedaccountofthedatacollectionandinparticularthechoiceandmethodsof

recruitingdifferentparticipantstakeholders.

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4.3. Datacollection

4.3.1Sampling

After choosing semi-structured interviews as themost suitablemethod to inform the

researchquestions,thenextstepinmyresearchapproachwastoidentifyrespondents

foreachofthegroupsofinterestasdescribedaboveandbegintherecruitmentprocess

forthefieldwork.Theaimwastousearangeofdifferentstakeholdersbasedontheir

relationship to the various policy changes: physicians (as prescribers of medicines),

pharmacists(assuppliersofmedicines),patients(asconsumersandusersofmedicines)

andvariouselitestakeholders(selectedduetotheirinvolvementinoranalysisofpolicy

itself). Although sampling for these groups was ultimately the same and involved

purposivesampling,theidentificationandrecruitmentprocessvaried.

Elitestakeholders

Thisparticipantgroupwasidentifiedbasedontheliteraturereviewandalsothroughmy

experiencesandnetworks.Asaresearcherinthehealthsectorforoveradecade,Ihad

attended differentmeetings and events, and participated in a number of studies and

research projects involving many professionals belonging to the groups of research

interest. Through these endeavours, I had the chance to hear their elaborations and

expertiseonavarietyof issuesrelatedtohealthandthehealthsysteminthecountry,

which I consideredappropriate touse for thepurposive samplingapproach that Ihad

chosentoapply.Firstly, for samplingwithin thegroupofelites,aswillbeshown later

on,Iconsideredthoseinvolvedinhealthpolicyformulation,includinghealthauthorities,

academiaandprofessionalassociationsandchamberstobeparticularlyrelevant.Given

thesizeofthecountry,alloftheseinstitutionsarerepresentedwithheadquartersinthe

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capital,andsome(notall)haveexecutivebranches,whicharenotinvolvedinthepolicy

planning or formulation happening at central level. Having identified these key

associations or bodies, the next stage was to identify individuals or representatives.

AlthoughIpersonallyknowsomeofthem,Iusedformalinvitationandintroductionfor

allrecruitedparticipantsinthisgroup.

PhysiciansandPharmacists

In the initial stages, I considered a sampling strategy to identify the participants for

these two professional subgroups, by using the list of registered physicians and

pharmacies publicly available onn the Health Insurance Fund’s official website. There

were a number of issues identifiedwith this approach; firstly, the list did not always

contain the contact data for the registered entries, and secondly the lists comprised

namesofregisteredoffices,inwhichoneormorephysiciansorpharmacistsworked.In

this context, given that qualitative research does not require for the sample to be

randomorquantitativelyrepresentativeof thepopulationbecause ‘representativeness

isnotaprimerequirementwhentheobjective istounderstandsocialprocesses’ (Mays

and Pope 1995), I have undertaken a purposive sampling approach with these two

groups,usingrelevantcategoriessuchasdifferentages,toallowdifferentgenerational

perspectivesonthepolicychanges;administrativelyandgeographicallydifferentplaces

were also used to inform the sample, as I anticipated there might be differences in

attitudes and practices between larger and smaller communities, i.e. between urban

and rural areas. Reflexively, this approach to identifying and sampling also required

considerationparticularlywithregardstomypriorknowledgeofthecontextandsome

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people fromboth groups; however, I felt that thebenefits such insights offeredwere

ultimatelyanadvantageforthesampling.

Patients

Forthefinalparticipantgroup–thepatients–Iundertookaslightlydifferentpurposive

sampling approach, by selecting from the patients who visited the office of the

interviewedphysicianorpharmacist.Thepurposefulnessofthissamplingapproachcan

bearguedinthesensethatpatientswhovisittheparticularphysicianorpharmacyare

more likely to have similar attitudes, as they are not assigned to the practice or

pharmacyby somespecific criteria,other than thechoiceof thepatient.Aconcern in

utilisingthiskindofsamplingwasseeninthepossibilitythatsomedimensionsoftheir

interactionmightnotbeavailabletocapture, forexample, radicallydifferentattitudes

withinthegroup.However,atthisstage,Ihopedthatwithinthesampledpatientsthere

wouldbesomewithexperienceofchangingtheirchosenphysician,andcertainlythose

thatobtainmedicinesindifferentpharmacies,thatwouldallowforexploringthisaspect

aswell.Apurposive approachwasused, however, in selectingpatientsbasedalsoon

factorssuchasdifferentgender,ageandgeographical location.This included,asmuch

as applicable in the given circumstances, choosing patients from both genders and

differentagesacrossallvisitedphysicians’officesandpharmacies.Once Ihaddecided

onthesamplingstrategy,thenextstageinvolveddefiningthesamplesize.

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4.3.2Samplesize

Sample size calculations are not very commonly used in qualitative research

(Sandelowski1995)anditcanoftenbedifficulttopredicthowmanyinterviewswillbe

undertaken. Theoretical saturation was used as a criterion to define the sample size

whichwasunderstoodasbeingwhen:“noadditionaldatabeingfoundwhereby[the…]

researcher becomes empirically confident that a category is saturated” (Glaser and

Straus1967).Although thiscriterionhasoriginallybeendevelopedandused in theory

development(GlaserandStraus1967),ithasbecomeanimportantapproachbywhich

purposivesamplesizesaredeterminedinhealthscienceresearch(Guestetal2006).So,

althoughadefinitivesamplesizewasnotpossible tocalculate initially, tomanage the

logistical aspects of the research, approximately fifteen participants in each of the

respondentgroupswereanticipated.Theactualsampleshaveshownthattheestimated

number of interviews, with the exception of the physicians’ group, was sufficient to

achievedatasaturationfordetailedanalysis,astheliteraturesuggeststhatuptotwelve

interviews are usually sufficient if the aim is to understand common perceptions and

experiencesamongagroupofrelativelyhomogeneousindividuals(Guestetal2006).

Thefinalsampleandassociatedcharacteristicsoftheparticipantsineachofthegroups

arepresentedinTables6-10below.

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Table6.Samplingrationaleforinterviewees–Elitestakeholders

N=12Representativearea RationaleforinclusionMinistryofHealth(2participants)

To learn about how the policies regulating prescription anddispensing have been designed, envisaged to be implementedandareimplemented;

HealthInsuranceFund(3participants)

To learn how Health Insurance Fund has transferred thesepolicies into their practice and what are the implications fromthesepolicychangesontheoverallpharmaceuticalsprescriptionandontheprescriptionreimbursements;

AgencyforDrugsandMedicalDevices(2participants)

To learn how the Agency for Drugs and Medical Devices hastransferred these policies into their practice and what are theimplications from these policy changes on the overallpharmaceuticalmarket;

Professionalassociationsandchambers(3participants)

To learn what is the professional standpoint of the medicalcommunity in regard to the medicine prescribing policies andhowitaffectsthepracticesandattitudesofhealthprofessionals;howtheprescriptionpoliciesoverallhaveaffectedtheworkandincomeofthepharmacists,iftherearecomplaintsorotherformsofdissatisfactionfromthechanges.Specificfocuswasputonthe:-MacedonianMedicalAssociation,asanumbrellaorganisationofallprofessionalassociations;and-Associationofprivatedoctorsinprimarycare.

Academicstaffworkinginthefieldsofeconomicsandsocialmedicine(2participants)

Tolearnhowtheselegislativeandpolicychangesareintendedtoinfluence the overall prescription regulation, and what are theforecastsoftheirlong-termeffectsintheMacedonianhealthcaresystem;toobtainacademicviewsonthepolicieswithregardtointernationalandEuropeanUnionpracticesinthefield.

Table7.Interviewees’characteristics–Elites(educationalbackground)

Elitestakeholders N=12Gender Female 6

Male 6Educationalbackground

Medicaldoctor 7Pharmacist 4Economist 1

Position Policymaker 7Professionalassociationrepresentative

3

Academiarepresentative 2

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Table8.Interviewees’characteristics–Primarycarephysicians

Physiciansinprimarycare N=17Gender Female 9

Male 8Geographicallocation

Capital 5Smalltownorcity 10Rural 2

Table9.Interviewees’characteristics–Pharmacists

Pharmacistsinprimarycare N=12Gender Female 9



Status Owner 2 Employee 10

Table10.Interviewees’characteristics–Patients

Patients N=14Gender Female 6



4.3.3Researchinstruments

Fourdifferenttopicguidesforsemi-structuredinterviewsweredeveloped,oneforeach

of thegroupsof interest toreflect thedifferentexperiences,perspectivesandrelative

knowledgeofeach.Whileallguidescomprisedcommonthemestoinformtheresearch

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question,theydifferedtoreflectthespecificpositionandroleofeachofthegroups.The

initial content of the topic guide was informed by the literature, identifying a broad

agendaof topics and themes to explore (Ritchie and Lewis 2003, p. 115). Thesewere

then discussed with the supervisors, who provided critical review and substantial

commentsthathelpedmestructuretheguideandreformulatequestions.Akeyaimwas

to maintain ‘neutrality’ in how questions were developed and to avoid leading the

respondents(RitchieandLewis2003,p.160).Followingthis,Iundertookpilotinterviews

with one representative from each group, to ensure questions were not only

understood,butalsocomprehensivesothattheypermittedsufficientscopeanddepth

ofdata tobeobtained (RitchieandLewis2003,p.135).Pilotingwasalsohelpfulas it

provided me with some experience of using the guides, mostly with regards to

maintainingneutralityduringtheconversations,whichcouldhavebeenjeopardizedasa

resultofmyknowledgeand involvement in thecontentandcontextof thecountryof

interest (Bryman 2008, p. 247). Following piloting,minor changeswere introduced to

the guides, so the data from the pilot interviews was used to inform the research

questions,as suggestedbyRitchieandLewis (2003,p.135).The research instruments

areprovidedinAppendicesDtoG.

4.3.4Incentivesforparticipants

Giventhenationaleconomicandsocietalcontextandthenecessitytorecruitphysicians

andpharmacistswhoarepartoftheprivatesector,itbecameapparentthattheremight

besomereluctancetoparticipateforthereasonsofinterviewsbeingatime-consuming

exercise. Itwasasa resultof theseassumptions that I decided tooffer some formof

remuneration to participants, as suggested by Seidman (2012 p.73) to ensure

uninterrupted time for getting an in-depth interview. The funds for this remuneration

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weretobesecured fromtheorganization inwhich Iwork in thecapacityofexecutive

director – Centre for Regional Policy Research and Cooperation “Studiorum”, a non-

governmentalresearchthink-tankthatdoesresearchonadailybasisandisfamiliarwith

suchconceptsascompensationforlossoftimeorearnings.Inpractice,thismeantthat

every invited and participating interviewee was offered a small monetary sum in

exchangeforthevalueofthetimetheywereaskedtospendintheinterview.However,

in practice, almost all participants declined the offered remuneration, with the

exception of four patient respondents. It could therefore, be concluded that the

participantsagreed to the interviewand shared theiropinions, viewsandexperiences

withoutexpectationofanydirectbenefit.

4.3.5Interviewing

This sectiondescribes theprocess of approaching and informing the respondents and

theinterviewitself,includingissuesrelatedtothelocation.

Firstly,prospectiveparticipantswereapproachedbytelephoneorinpersonwithabrief

explanationofthestudyinvitingthemtoparticipate.Oncetheyagreedandasrequired

bytheresearchethicsstandards,priortotheinterview,therespondentswereinformed

infurtherdetailofthepurposeofthestudyanditsoutcome,bothverballyandthrough

astudyinformationsheet(giveninAppendixB).Asignedconsentform(samplegivenin

AppendixC)wasarequirementfromallrespondentsforparticipating intheinterview.

The respondentwas given all relevant information, the right to voluntarily participate

and the right to withdraw at any given time without giving explanation about the

reasons.Theinformationsheetandtheconsentformwereprovidedtotheparticipants

inbothEnglishandMacedonianlanguages.Participantswereaskedtosigntheconsent

forminbothlanguages.

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Forsecuringanonymity, theconsentformcontainsa linewherethecodingnumberof

the interviewwaswritten. The audio recordings, aswill be described later, contained

only the codingnumber and thedateof the interview. Consent forms and audio files

werekeptseparatelyinlockedcabinets.

Themajorityofinterviewslastedbetween40minutesandanhour,butasmallnumber

weresignificantlylongerinduration.Theseincludedtwophysicians,onepharmacistand

two respondents in theelite stakeholders’ group.Regarding time the interviewswere

conducted, all respondents from physicians’ and pharmacists’ groups preferred to be

interviewed outside of their working hours, most of them requesting a time period

immediatelyafterworkinghours,whilethreephysiciansandtwopharmacistsagreedto

meetattheweekendwhentheywerefreefromprofessionalduties.Intheelitesgroup,

withtheexceptionofthreepersons,allrespondentsinsistedtheinterviewbeconducted

during their office hours. In the group of patients, interviews were scheduled on a

differentdaythanthedaywhentheywereinitiallyrecruitedfromthephysician’soffice

or pharmacy. Inmost cases – with exception to the retired persons – the interviews

werescheduledaftertheirownworkinghours.

Respondentswereencouragedtochoosealocationtheypreferred,toencouragetheir

engagement and participation in research (Mauthner 1997, Gallagher 2005) so they

could speak freely, comfortably and in confidence. Most of the interviews with

physicians and pharmacists took place at their office, or in the pharmacywhere they

worked(specifically,inthedispensary,sotobeuninterruptedbyincomingcustomers),

and some were conducted at the common room at their workplace (usually the tea

kitchen or similar place). Four interviews were conducted at the office where I work

(threewith theelites andonewithaphysician), as their preferredoptionof location,

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sincetheyfounditconvenientorconsidereditwouldallowforuninterruptedinterview

time.For thepatients severaloptionswereoffered, including theirhome,cafeteriaor

officewhereIwork.Withtheexceptionoftwo,whochosetobeinterviewedataquiet

cafeteria,allpatientsconsideredtheirhometobemostappropriatefortheinterview.

The participants were also given the choice of whether to conduct the interview in

either English orMacedonian language, as interviews conducted in a native language

may yieldmuch richerdata than if conducted in English as a second language (Wallin

andAhlstrom2006);allofthemchosetheirnativelanguage.Therearemanyadvantages

toconductinginterviewsinnativelanguage,suchastherearenolanguagebarriersand

it avoids theuseof interpreters,whichhasbeen shown to reduce validity (Kaaeet al

2016).

As the interview guide was exactly that – a guide that could provide structure for

systematically covering the relevant issues, while allowing flexibility to pursue details

salienttoeachindividualrespondent(RitchieandLewis2003,p.115)–itwasnotusedin

arigidmannerandadditionalquestionswereposedinresponsetoparticularresponses

and some questions were occasionally omitted. However, throughout the interview,

wherever possible, respondents were asked to reflect on their views of current or

potential problems, andwere encouraged to discuss ideas for overcoming any of the

obstaclesorissuestheyfoundtoberelevantandimportantintheirview.Forexample,

oneoftheparticipants,aswillbereviewedinthelaterchapters,openedadiscussionon

the ‘chosenpharmacy’ concept that at the timeof the interviewswasapolicyoption

considered by the government; another participant elaborated in extenso a policy

alternative that was considered prior to introducing the budget ceilings, but was not

adopted,yetitwasimportanttounderstandtheprocessfromtheperspectiveofpolicy

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formulation.Apharmacistfromaruralsettlementpickeduponatopicthatwasinthe

media during the period of the interviews, and related to the rural ‘pharmacies on

wheels’,whichwas consideredas issueof concern from thepharmacists’perspective.

Theintentionwas,asstatedearlierinthischapter,toidentifywhattherespondentsin

theirviewandfromtheirdailypracticeandexperienceconsideredtobeproblematic,if

any, and to gain new perspectives on why they perceived these to be problematic,

mostly in relation to their subsequentlydeclaredattitudesandbehaviour in thegiven

circumstances.Vignettequestionswereusedseveraltimes,toprobewithrespondents

whohavebeenextremelycategoricalaboutacertaintopic,however,notinthesenseof

controllingwhattherespondenthadtosayortodiverttheiropinionontheissue,but

rathertotestifthecategoricalattitudewasindeedintrinsicorwasusedasatheoretical

answer to the question posed. Such hypothetical situations were asked for example

regarding the prescribing ofmedicine withoutmedical indication to a close friend or

family member; dispensing medicine without prescription to a vulnerable patient

coming into the pharmacy, or what would be the policy response if physicians

prescribedsolittleastojeopardizetheaccesstomedicinestopreservetheirprescribing

budget.Promptingasatechniquewasnotused.

4.3.6Reflectingoninterviewinganddatacollectionprocess

As part of reflexive practice (Jupp 2006), what is also termed ‘benign introspection’

(Davies2002,p.7),keepingareflexivejournalofnoteshasbeenconsideredasanother

sourceof information,astheresearcherneedstofullyrecognizetheroleofreflexivity

with acceptance so that in social research ‘the specificity and individuality of �the

observer are ever present andmust therefore be acknowledged, explored and put to

creativeuse’ (Okely1996,p.28).Reflexivityencompasses thecontinuousevaluationof

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subjective responses and the research process itself and involves a shift in

understanding data as something objective to the active construction of knowledge

(Finlay2002).

ThroughoutmyresearchIhavebeenconsciousofmyrelationshipwiththecontextand

some of the respondents and thus decided to keep a reflexive journal, including

personalobservationsandprogressduringthecourseofthequalitativedatacollection

andanalysistofacilitatereflectiononeachaspectoftheresearch.Throughthisprocess,

I was able to identify ways in which my findings may have been shaped by the co-

construction of accounts and, where possible, I challenged myself as principal

researcher in relation to these co-constructions. As the interviewswere conducted in

the Macedonian language, the reflective journal was kept in the same language, for

uninterruptedreflexiveprocess.AsmentionedbyDavies(2002,p.8),thereareconcerns

of the interference from subjectivity of the interviewer’s observations, and these are

acknowledgedthroughoutthethesis,whererelevant.

In line with the above, throughout the data collection, analysis and interpretation

processes,Iwasreflectingalotonmyrelationshipwiththeresearchcontextandsome

oftherespondents.Withmybackgroundandpreviousexperience, itwas inevitableto

anticipate that some of the respondentswhowere familiarwithmy previouswork –

especially policymakers –would have pre-understanding ofmy knowledge, and thus

thiswasveryimportanttoacknowledgeintheinterviewingprocess.Thus,Idecidedto

undertakepilotingofresearchinstruments,whichwastoserveadualpurpose:toclarify

and further refine the questions, but as well to observe my interaction with the

respondentsintermsofkeepingneutralityasmuchaspossiblewhenaskingquestions.

Beyond the piloting phase, I kept this process of understanding the influence of my

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knowledge and relationship with some respondents throughout the entire data

collection, improving the approach to asking questions in each subsequent interview.

Theissueofknowingmypreviousworkwasnotsignificantfortheothertworespondent

groups–providersandpatients.However,with thesegroups I kept reflectingonhow

mypersonalpre-understandingswouldaffecttheinterviews,andcontinuedtoobserve

waysinwhichIcouldbeasneutralaspossiblewhenaskingthequestions.

Withalloftheabove,Ihavedescribedparticularinstancesofmyreflexivepracticeand

sensitivity about howmy experiences and relationshipwith the research context and

previousacquaintancewithsomeoftherespondentscouldinfluencethedatacollection

and analysis. The next section describes the process of recording, transcribing and

translationofdata.

4.3.7Recording,transcribingandtranslation

Themajority of interviewswere recorded using a digital audio recorder so that later

transcription could be undertaken. The recordings were made on a digital recording

device(Dictaphone),allowingconvenientandpromptdatatransferintoacomputerthat

was used for listening to the recordings while transcribing. As the interviews were

conductedinMacedonianasthenativelanguage(Kaaeetal2016),theuseofpersonal

computerdictationsoftwarewasnotconsidered,asnotechnicalpossibilitieswereyet

developedforthislanguageontherequiredprofessionallevelatthetimeofconducting

thedataanalysis.Eachrecordedfilewaslabelledwiththedateandthecodingnumber

assignedontotheconsentform,asareferencetoprotecttheanonymityofdata.After

eachinterview,briefnotesweremadeabouttheoverallimpressionfromtheinterview,

mainlyregardinghowmuchtherespondentfeltcomfortablewiththequestions,ifthere

were significant interruptions and so forth. These, as described under a separate

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section,werekeptinareflectivejournal.Onephysicianandfourpatientspreferrednot

toberecordedandinthesecases,extensivenotesweretakenduringtheinterviewand

follow-upnotesalsomadesummarisingkeypointsintheinterview.

I undertook transcription as soon as possible after each interview. This approachwas

chosenasthereisanadvantageofthisverytime-consumingprocess(Bryman2008,p.

456), over the professional transcription service, as it allows for closer familiarisation

withthedataandidentificationofkeythemesataveryearlystage,whichcontributed

to identifyingemerging issues thatwere incorporated into the subsequent interviews.

Through this process, itwasmuch easier forme to become aware of similarities and

differences between the accounts of different respondents, and to capture some

nuancesthatcouldbenotedonlyfromtherecordingandnotfromthewrittenaccount

itself. For example, a long pause of hesitation, a tone of voice or specific sound of

agreement or disapproval; these gave me valuable insights into the feelings of the

participantabouttheparticularissuethatwasnotverballyexpressed.

There are conflicting views in the literature about who should undertake translation.

Some literature suggests that combining the role of researcher and translator may

influencetheobjectivityoftheknowledgeclaims(Temple2005).Incontrast,ithasalso

been argued that a joint approachprovides thepossibility for checking the validity of

interpretations (Young and Ackerman, 2001), and offers the researcher significant

opportunities for close attention to cross-cultural meanings and interpretations and

potentially brings the researcher close to the problems of the equivalence of the

meaningwithin the research process (Temple and Young 2004). The latter arguments

coupledwithmyfamiliaritywiththe local language,andalsomyunderstandingof the

subjectitself,ledmetoundertakethetranslationprocessmyself.Theuseofthirdparty

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translation might not have enabled this, and the associated requirement to provide

contextual meaning in qualitative research (Esposito 2001). To address the threat to

validity posed in the literature by the subjective presentation of accounts from a

researcher’s own social position (Temple 2005) the technique of back translationwas

used (Pham and Harris 2001, Twinn 1998). Back translation was used on the pilot

interviewsandinvolvedmetranslatingthefullMacedonianlanguagetranscriptsofthe

pilot interview intoEnglish languagefirstly.ThentheseEnglishtranslationsweregiven

toaprofessionaltranslatorforbacktranslationintotheMacedonianlanguage.Thefinal

stage involved comparing the original Macedonian transcript with that produced

through the back translation and checking for any differences. No significant

discrepancieswerefoundintheuseofspecificterminologybetweenthetwodocument

types.Asaresult, Iwasconfidentthattheanalysisoftranscriptscouldbedone inthe

original language and that only the selected quotes relevant to the identified themes

wouldbetranslatedandusedinthedatainterpretationofthisthesis.

4.4. Dataanalysis

4.4.1Descriptionofthematicanalysis

Analysisofthedatainthisresearchwasundertakenusingthematicanalysis(Braunand

Clarke2006).Thisapproachtoanalysiswasselectedasitrepresentsawellrecognised,

transparent,andmethodicalapproachwhichcanbeappliedtothisresearchtopicandis

compatiblewith all qualitativemethods (Boyatzis 1998). This type of analysis enables

researchers to create the ‘big picture’ about experiences and events as participants

understandthemoractuponthem(ChamblissandSchutt2010,p.339).

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Althoughithasbeeninterpreteddifferently,thematicanalysis isusuallyunderstoodas

‘amethodforidentifying,analysingandreportingpatterns(themes)withindata’(Braun

andClarke,2006). Themost influential and thoroughapproach to thematicanalysis is

thatofBraunandClarke(2006)whoidentifysixphases(asillustratedinTable11).

Table11.Thesixphasesofthematicanalysis

Phaseofanalysis Descriptionoftheanalyticprocess

1.Familiarizingyourselfwiththedata

Transcribingdata(ifnecessary),readingandre-readingthedata,notingdowninitialideas.

2.GeneratinginitialcodesCodinginterestingfeaturesofthedatainasystematicfashionacrosstheentiredataset,collatingdatarelevanttoeachcode.

3.SearchingforthemesCollatingcodesintopotentialthemes,gatheringalldatarelevanttoeachpotentialtheme.

4.ReviewingthemesCheckingifthethemesworkinrelationtothecodedextracts(Level1)andtheentiredataset(Level2),generatingathematic‘map’oftheanalysis.

5.Definingandnamingthemes

Ongoinganalysistorefinethespecificsofeachtheme,andtheoverallstorytheanalysistells,generatingcleardefinitionsandnamesforeachtheme.

6.Producingthereport

Thefinalopportunityforanalysis.Selectionofvivid,compellingextractexamples,finalanalysisofselectedextracts,relatingbackfromtheanalysistotheresearchquestionandliterature,producingascholarlyreportoftheanalysis.

(ReproducedfromBraunandClarke,2006)

Thesectionsthatfollowofferamoresituatedaccountofthestagesastheyrelatedto

this research, giving relevant examples and insights that contribute to a transparent

approachtoresearch.

4.4.2Datafamiliarization

Thefirststepindataanalysis,assuggestedbyBraunandClarke(2006)istofamiliarize

oneselfwiththedata.This involvedreadingthetranscripts, listeningtoaudiofilesand

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beingimmersedineachrespondent’saccount.Inaddition,Iwentbacktothereflective

journal and tried to understand if my own pre-understandings emerged during the

interviewprocess, andhow theymighthaveaffected the respondents.Understanding

thatmypersonalhorizonswouldevolvethroughouttheresearch,Iundertookthisstep

as the firstattempttounderstandthetopic fromabroaderperspective. In thissense,

Gadamer (1996, p.360) helpedme through his emphasis on the essence of the right

questions, further stating that there is no understanding without the activity of

questioning.

Reflectinguponpotentialbasesofinterpretationoftherespondents’accounts,Iposed

myself several additional questions, which aimed to provide a greater context to the

fusingofhorizonsbetweenthetextsandtheresearcher:

• Whyisthepastsystemfrequentlymentionedandwhatisthesignificanceofits

influenceoncurrentpractices?

• Whatvaluedoprovidersandpatientsplaceonprescribinganddispensing?

• Whatvaluedoelitestakeholdersplaceonprescribinganddispensing?

• Howaredecisionsmadebyprovidersregardingprescribinganddispensing?

• Arethosedecisionsalwaysbasedonmedicalindicationandclinicalknowledge?

• What is the influenceofcommunicationbetweentheprovidersandthepolicy

makersonimplementation?

• What is the influence of communication between providers and patients on

prescribinganddispensing?

I personally transcribed the interviews as soon as possible after conducting each

interview, so as to maximise familiarity with the data. The transcribed and already

anonymisedtextwassetoutinMicrosoftWordasplaintextthatwaslaterreorganized

intotableformatwhilegeneratinginitialcodes,asdescribedinthenextsection.

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4.4.3.Generatinginitialcodes

Inqualitativeresearch,collecteddatacanbequitelargeevenifcollectedfromfewcases

orrespondents(ChamblissandSchutt2010,p.324).Itisthereforenecessarytoemploya

data management process, so to enable analysis of its meaningful parts that could

inform the research questions. I used coding, as this is the most often used data

management method in qualitative research, as conceived by Glaser and Strauss in

grounded theory (1967). Coding is a process inwhich the data are broken down into

theircomponentparts thatare related toasimilarconceptor issue,andareanalysed

based on their common characterisation (Braun and Clarke 2006). Coding is thus

essentialas it ‘providesthe linkbetweendataandtheconceptualization’ (Brymanand

Burgess2002,p.5).

Forcoding,softwarepackageshavebeendeveloped,suchasNVivoandsimilar. Ihave

familiarized myself with NVivo in one of the courses taken as part of the graduate

research requirements, but realized that it could not be used for the Macedonian

language.Thus, Ihadtotakeamanualratherthansoftware-assistedapproachtodata

analysis,inlinewithRitchieandLewis’s(2003)suggestionthatsoftwarepackagessuch

as theseshouldnotbea replacement for theresearcherand/orrigorousanalysis.The

nextstepofdataanalysisinvolvedmakingnotesofinitialideas,interestingfeaturesand

messagesfromrespondents’accounts.

Since thematic analysis is a flexible method, the size of data chunks identified for

analysiswasvariable.Insomecases,I identifiedabroadcodetoonecomponentofan

interviewandthenwithin it further identifiedseveralothers.As Igraduallycompleted

moretranscripts,theearlieridentifiedcodeswererevisitedandrefined.Forexample,I

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might have read an excerpt from an account and interpreted it as an example of a

specificphenomenon,when,ifIlookedatitwithinthecontextoftheaccountanddata

asawhole,Iwouldthenseeitasmorecomplex,andcontinuedtoanalyseintofurther

morespecificcodes.TheprocessofinitialcodingisillustratedinTable12below.

Table12.Anexampleofanalysisconductedonasectionoftranscript,togetherwiththeresolvedinterpretationinthefinalcolumn

Respondent

Transcribedtext Firstanalysisattempt

Secondanalysisattempt

Interpretation

PCP4 Thelistofmedicineswassatisfactory.Andtherewerenolimitations,wehadfreedomofprescribing.Let’ssay,IasapractitionerbelievethatcertainillnessshouldbetreatedwithcertainmedicationsandIwasfreetoprescribethem.Thingsaredifferenttoday.Nowadays,IcannotprescribecertainmedicationsalthoughIamanexperiencedpediatrician.IfacelimitationsandIamobligedtoaskfortheopinionofdifferentinstitutionfromaless-experiencedmedicalpractitioner.Itdoesn’tmakeanysensetome.

Emphasisputonfreedomtoprescribeandprofessionalknowledgeandexperiencevaluationinthepastsystemcomparedwiththecurrentpolicychanges

Previoussystemhadnolimitations

and

Professionalknowledgeandexperienceweremorevaluedinthepast

Thereisobviousattachmentandassociationwiththeprevioussystem

Professionalautonomyisaffectedbypolicychanges

Thecodingisnecessaryforcategorizingandsortingdata(Charmaz1984,p.111),andit

precedes the identification of themes (Bryman 2008, p.554), which are essentially

recurringmotifs in the interviews used at later stages to analyse the data against. In

following sections I describe the process of searching for themes, reviewing and

subsequentlyrefiningthem.

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4.4.4.Developmentofthemes

Asexplainedintheprevioussection,withinitialcodingIextractedthedatachunksfrom

thetranscriptsanddividedeachintocodes,i.e.unitsofmeaning,identifyinginteresting

featuresandchoosingcodestocapturethemeaningintheaccounts.

The next step of development of themeswas performedusing amanual approach of

identifyingthecommonpatternsinthedatachunkstoformpotentialthemesandsub-

themes, searching for the presence or absence of illustrative data extracts relating to

thesethemesfromeachparticipantineachofthegroups.Ihaverepeatedthisprocess

severaltimes;anapparent‘absence’ofdatafromaparticipantthatwashighlightedin

otherparticipants’accountstriggeredareviewoftheirtranscripttoensuretherelated

data had not been missed. A good example from my analysis relates to the theme

‘Nostalgiaforthepast’whichalthoughnotinitiallyplannedintheinterviewguides,has

strongly emerged in many accounts in all respondents’ groups. Although interview

guides included questions related to the past system, the strength of responses was

suchthatIfeltitshouldstandasathemeinitsownright.

At the same time, I was conscious of the issue of ‘importance’ of data that was not

dominant in all accounts, and therefore paid additional attention to data that was

raising interesting issuesbutwasonlypresent in someaccounts, considering theseas

deviant or negative cases. Frommy initial coding I started to get a sense for themes

existing within the transcripts, and continued to reflect on the identified themes,

reviewing and refining them into the finally defined themes and sub-themes. These

stepsareelaboratedinthenextsection.

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4.4.5.Reviewingandrefiningofthemes

Thenextstepinthematicanalysiswasreviewingandrefiningthethemes.Thisinvolved

reading and interpreting texts as a whole, and repeated coming back to the

supplementaryquestionsdevelopedatthestageoffamiliarizingmyselfwiththedatain

a process of deepening my understanding. As I was getting more immersed in the

transcripts and the extracted data, I continuously worked on refining the specifics of

eachtheme,theoverallstoryoftheanalysis,andfinallygeneratingcleardescriptorsfor

thethemes.

Indetail,firstlyIcheckedthethemesagainstthedataextractsandexploredwhetherthe

themesworkinrelationshiptothedata.Checkingifthethemes‘worked’inrelationto

theentiredatasetwasundertakenasaniterativeprocessusingthefollowingquestions

takenfromBraunandClarke(2006)toguidemydecisions:

• Isthisatheme?

• Whatisthequalityofthethemeanddoesittellussomethingusefulaboutmy

datasetandresearchquestions?

• Isthereenoughmeaningfuldatatosupportthistheme?

The main themes and sub-themes were further refined through continuation of the

iterative process, until I felt that optimal understanding of the transcripts had been

achieved. As an outcome of this process, I identified three themes eachwith several

sub-themes,elaboratedindetailinthenextchapteronfindings.

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4.4.6Presentingthedatafindingsandwrite-up

The final step of the thematic analysis, as suggested by Braun and Clarke (2006) is

writingupthefindingsandrelatingthembacktotheresearchaimsandliterature.This

sectiondescribesthisprocess infurtherdetailandparticularly inrelationtotheuseof

quotations.This involvedseveralaspectssuchasthelevelofdetail fromtheindividual

accounts to be presented and the presentation of deviant cases. It was considered

important to present not only quotations supporting the main themes, but also to

capture alternative and contrasting accounts, particularly from the perspective of

deviantcases(Emigh1997).AsnotedbyAnderson(2010):

‘It is also important to present outlying or negative/deviant cases that didnotfitwiththecentralinterpretation.’(Anderson2010)

However,asthedatawerecollectedinalanguagedifferentfromtheoneinwhichthis

thesis is written, additional attention was dedicated to the process of translation, as

alreadyelaboratedinthesectionondatacollection.

In summary, to present the findings of the present research, predominantly verbatim

fragments from personal interviewees’ accounts were used, and where necessary,

althoughtoaminimalextent,interpretationsofinterviewdatawereemployed,mainly

in an attempt to avoid duplicated presentation of very similar accounts, which

contribute toarrivingat a given findingor conclusion. In addition,deviant caseswere

treatedwithutmost sincerity andopenness, so toavoid reducing thedata richness in

theconvenienceoffittingthethemesintoexistingtheories.

The entire process of data collection and analysis should be subjected to scrutiny of

qualityandcredibilityissues,whichareelaboratedoninthenextsection.

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4.5. Qualityandcredibilityofthisresearch

The positivist approach in research utilises concepts of validity and reliability. Validity

refers to how well the research assesses what it is attempting to assess and if

generalisationoftheresultscouldbeinferred,whereasreliabilityisconcernedwiththe

degree to which the research process produces stable and consistent results (Bale

2011). These definitions are not entirely applicable to the qualitative interpretative

approach,asarguedbyRitchieandLewis(2003)dueto:

“the very different epistemological basis of qualitative research, there arereal concerns about whether the same concepts have any value indetermining the quality or sustainability of qualitative evidence.” (RitchieandLewis2003p.270)

Althoughtheneedforachievingrigourinqualitativehealthresearchiswellrecognised,

thereisnoagreementonspecificcriteriafordemonstratingtherobustnessofevidence

derived from qualitative inquiries into health practice issues (Bale 2011). However,

amongthemostcommonlyusedcriteriaforachievingtherequiredscientificrigourare

quality and credibility of the research. In the next paragraphs I address these in the

contextofmyresearch.

To evidence the quality of the research, I considered the categories of reflexivity and

reliability.Under the sectionondata collection, I have alreadydescribedmy reflexive

practiceandhowmyexperiencesandviewpointscouldinfluencethedatacollectionand

analysis,andhowIhaveaddressedthispotentialinfluenceintheprocess.

Assessmentof reliability of qualitative research is complicatedby a numberof issues,

relatedtothepossibilityforandtheextenttowhichthecurrentstudycanbereplicated

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intermsofdesignandsampling.Thepossibilitythatothersmaybeabletoreplicatethe

studywasconsideredfromtheperspectivetakenbyLeCompteandGoetz(1982),who

argued that the impossibility to ‘freeze’ the social setting has to be taken into

considerationwhenconsideringthereliabilityissueswithqualitativeresearch.Assuch,

the standpoints of Ritchie and Lewis (2003) and Mays and Pope (2000) mentioned

earlier become the main arguments for reliability, bearing in mind that the process

represents a mapping exercise of particular views, experiences and phenomena, and

that search for ‘subtle realism’ rather than ‘the truth’ is pursued. In this sense, and

relevant to this research, I applied a social constructivist approach, as explained by

Finlay(2002):

“Meanings are to be seen to be negotiated between researcher andresearchedwithinaparticularsocialcontextsothatanotherresearcherinadifferentrelationshipwillunfoldadifferentstory.“(Finlay2002p.53)

Fromthepointofviewthatthesocialsettingcannotbe ‘frozen’ (LeCompteandGoetz

1982),andthatmeaningsareboundtoa‘particularsocialcontext’(Finlay2002),Ihave

considered the credibility of the research as another technique to ensuring scientific

rigourofmywork.Evidencetothisendispresentationsandpapersproducedduringthe

courseofthisresearch.Aspresentedinthebeginningofthisthesis,Ihavewrittenand

published several publications related to the broader topic of health policy, primary

health care and policy changes in primary health care, which were written with or

consultedwithotheracademicsinthefield.Inaddition,asImyselfhaveconductedthe

researchwithin this thesis, this raised theconcernof lackofanadditionalperspective

fromanother researcher in termsof sampling, data gathering or data analysis. In this

sense, a general process of peer review (LeCompte and Goetz 1982) was pursued

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throughdiscussionswithmysupervisorsinrelationtothedata,interpretationsandthe

overallthesis,asdescribedunderrelevantsectionsearlierinthischapter.

Throughtheabove,IbelievethatIhavepaiddueattentiontotheissuesofqualityand

credibilitythroughoutthisresearchandthatthe identifiedthemesandsub-themes,as

wellasthediscussionandconclusionselaboratedinthefollowingchaptersarearesult

ofathoroughandappropriateapproachtotheresearchprocess.

4.6. Researchethicsandconfidentiality

In thecourseof the research, someof the issuesdiscussedduringdatacollectionand

analysisinvolveddisclosureofinformationthatmightincriminatetherespondents,such

asnon-complianceofPHCphysicianswith thepolicy for limitationofprescriptions,or

non-compliance of pharmacists with the existing dispensing policies. From an ethical

standpoint, during the interviews it was inferred that PHC physicians or pharmacists

were not always adhering to the prescribing and dispensing policies or in otherways

performed practices that were not in full compliance with ethical principles. As the

purposewas to researchattitudesandpractices, theanonymityandprotectionof the

datafrommisuseorabusebyathirdpartywasessential.

Asinanyotherresearchinvolvingpersonalandcorporatedata,thepersonalaccountsof

respondents or data collected and analysed in this study that may in any way

incriminate involved parties have been processed according to the principles of

protection of such data. As part of the research done under the regulations of the

University of Sheffield, the study was subject to University of Sheffield Ethics and

Research Governance conditions and approval, including proper information of

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respondents,obtaining informedconsentandmanagementandprotectionofpersonal

datagathered intheresearchprocess.1AnapplicationwaspreparedfortheUniversity

of Sheffield Ethics and Research Governance Committee, containing all necessary

information regarding the research, i.e. the project’s aim and objectives; the planned

methodology and research approach; types of respondents and sampling strategy;

means for ensuring confidentiality and anonymity; and use of a consent form. Ethics

approvalwasobtainedinMay2013(AppendixA).Theapplicationwasaccompaniedby

aninformationsheet,consentformandinterviewguidesforeachparticipantgroup.The

information sheet and consent form are given in Appendix B and Appendix C,

respectively.Theinterviewguidesaregiveninthesubsequentappendices,i.e.forelite

stakeholders(AppendixD),primarycareproviders(AppendixE),pharmacists(Appendix

F)andpatients(AppendixG).

Further to this, as the primary data collection was done in Macedonia, the research

proposalwas also submitted for review and approval to the Ethics Committee at the

StateMedical Faculty atUniversity “Ss. Cyril andMethodius” in Skopje, togetherwith

theobtainedEthicsapproval fromtheUniversityofSheffield.ThisEthicsCommittee is

authorized by the Ministry of Health to give approval for all medical and bioethical

researchdoneontheterritoryofthecountry.TheEthicsCommitteeconsideredthatthe

nature of the research, i.e. qualitative data collection, was not subject to ethical

approvalinthecountry,andprovidedawrittennoticethattheobtainedEthicsapproval

fromtheUniversityofSheffieldissufficienttocontinuetheresearch.

1DetailsofrulesandproceduresoftheUniversityofSheffieldEthicsandresearchGovernanceareavailableat:http://www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/routes;andregulatoryrequirementsforresearchdatamanagementareavailableat:https://www.sheffield.ac.uk/library/rdm/requirements(accessed:10September2017)

126

All research activities were conducted in line with relevant legal frameworks and

guidancerelatedtopersonaldataprotectionactsapplicableinboththecountryofstudy

(Law on Personal Data Protection, Official Gazette of the Republic ofMacedonia, no.

7/05and103/08),andcountryofsubmissionofthestudy(DataProtectionAct1998(c

29)).Furthertothis,thestudywasconductedandframedwithinUniversityofSheffield

Guidelinesonanonymity,confidentialityanddataprotection,asstatedintheUniversity

ofSheffield’sResearchEthicsPolicyNoteno.4:PrinciplesofAnonymity,Confidentiality,

andDataProtection.2

No personal data of respondents, such as date or place of birth, or personal

identification number were collected; respondents’ full names were stored securely:

information that identifies them was not stored on a computer. All forms from the

research, the interview recordings and transcripts were stored securely in a locked

cabinet, separately soas toensure thatno respondent couldbe identifiedbypersons

otherthanmyself.Allparticipantswereassignedacodingnumberthatwasusedinthis

thesis in order to protect their identity. However, given their specific role, the elite

stakeholderswereaskediftheywanttobeidentifiedinthestudy.Allofthemexpressed

awishtobeanonymous,sotheytoowereassignedacodingnumber.

Astherigidscientificrulesrequire,writtenconsent(AppendixC)wasobtainedfromall

respondents who agreed to participate. Respondents received an information sheet

(Appendix B), explaining their rights in relation to confidentiality and personal data

safeguardingpolicy.Theprotectionoftheidentityofparticipantsandtheiraccountswas

2ResearchEthicsPolicyNoteno.4:PrinciplesofAnonymity,Confidentiality,andDataProtection,availableat:http://www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/confidentiality-anonymity-data-protection

127

secured by providing a consent form signed by the participants with the following

content:

“Anyinformationyousupplywillbekeptconfidential.However,ifyoutellmesomethingthatmakesmethinkyouareindangerofbeingharmed,Iwilltellyousoandadviseyou toseekassistance fromappropriate institutionsandauthorities”.

Participants were made aware, in writing and in person that participation in the

researchwasentirely voluntary, that they couldwithdrawatany timewithout stating

thereasonandthattheywouldnotbeaffectedinanywaybywithdrawal.

4.7. Disseminationoffindings

Although the main purpose of my research was to prepare and defend this thesis, I

intend also to further elaborate and report the findings of the research to specific

audiences. Among these is the academic community in Macedonia, in particular the

teachingandresearchstaffattheStateMedicalFacultyattheUniversity“Ss.Cyriland

Methodius” in Skopje and the University American College Skopje where I am also

engagedasavisitingresearcher.Asmyintentionistocontinueworkinginthisfield,the

expandedresearchwillcontinuouslybepresentedinpapers,academicconferencesand

policymeetings.AsIalsoworkonformulationofnationalpoliciesinEurope,Ihopethat

the knowledge acquired through this research will have applied value for prescribing

and dispensing policies in my country and other transition countries with similar

economicandsocietalcontexts.

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4.8. Summaryofchapter

The primary aim of this chapter was to defend and describe the choice of the most

appropriate researchmethodology andmethods to answer the research questions of

thisresearch.Afurtheraimwastoreflectcriticallyupondifferentaspectsofthechosen

method and overall research process. Qualitative semi-structured interviews were

chosen, as theywould provide important insights into the perspectives, attitudes and

practices of diverse stakeholders regarding the changes of policy environment. The

stakeholders’ groups identified and interviewed in this research were: physicians,

pharmacists, patients and elite stakeholders. The researched changes in policy

environment were the primary care reform and accompanying prescribing and

dispensingpolicychanges,andtheirimpactonprescribinganddispensingpracticesand

behaviours.Thechapteralsodescribedthedatacollectionprocess, includingsampling,

researchinstruments,interviewprocessandreflexivepractice.Idescribedmyreflexive

practiceandelaboratedhowIviewedmyexperiencesandrelationshipwiththeresearch

context and how it might have influenced the data collection and analysis. I also

described the methods of recording, transcribing and translation, which I considered

particularlyimportantgiventheuseoflanguagedifferentfromtheoneinwhichIhave

writtenthisthesis.

Further, the chapter explained the data analysis. The chosen analytical method was

thematicanalysis,andIfollowedtheapproachproposedbyBraunandClarke(2006),as

this appearedmost appropriate to analyse similar concepts from different sources of

information–inthiscasedifferentgroupsofrespondentswhorepresentdifferentsides

in the prescribing process. Towards the end of the chapter, I addressed the issues of

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ensuringscientificrigour,throughconceptsofqualityandcredibilityofthisresearch,as

wellastheprocessforobservingethicsinresearch.

Thefollowingchaptersarededicatedtopresentationofthecollecteddatapertinentto

the research questions and its relevance to the wider body of knowledge from the

perspectiveof thechosentheoretical framework.Beyondthedatapresentation in the

next chapter, the subsequent chapters are dedicated to discussion of findings, and

linking them to the context and thewider social theory, leading into conclusions and

recommendationsintendedtofeedfuturepolicymakingprocesses.

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CHAPTER5:Findings

5.1. Introduction

5.1.1Overviewofchapter

This chapter describes the identified themes and associated attitudes andopinions of

physicians,pharmacists,patientsandelitestakeholdersinrelationtothevariouspolicy

changesdescribedinchapter2.Theaiminthischapteristoofferdescriptionsofthese

identifiedthemes,withillustrativeextractsfrominterviews.Itislefttothenextchapter,

to consider these findings in relation to the literature described in chapter 3 and in

particulartoHabermas’conceptionofsystemand lifeworld.Beforeelaboratingonthe

findings, it is important to offer a brief reminder of the rationale and context of the

study, and also explain the approach taken to the presentation of collected data and

emergingthemes.

Sinceitsindependence,Macedoniaembarkedonlargeeconomicandsocialreformsthat

affected the health system (Ivanovska and Ljuma1999; Lazarevik et al 2012). Prior to

reforms, the system provided universal health coverage, free to all at every point of

delivery, includinghealth services, rehabilitation treatment,prescriptionandover-the-

countermedicines.Alackofresourcesimposedaneedforrationalisationandincreased

efficiency of the use of such health services and medicines. Policy changes were

introduced to reduce pharmaceutical expenditures through rationalisation to a list of

essentialmedicines,andexistingpolicieswerereinforcedtodispensingofprescription

medicinesonlywithaprescriptionissuedbyaphysician.

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Theadoptionofnewandthereinforcementofexistingpolicieswereanticipatedtobring

a new period of rules and discipline in prescribing and dispensing. However, as

describedinthesecondchapter,bothpharmaceuticalcostsandnumberofprescriptions

havecontinuedtoincrease.Thischapterpresentsarangeofaccountsrelatingtothese

changes, from very different stakeholder perspectives based, as will be shown, on

differingvalues,beliefsandneeds.

5.1.2.Approachestodatapresentation

The complexity of policy changes of interest and the diversity of interviewed groups

raisedtheissueofthemostsuitableapproachtopresentationofcollecteddata.Oneof

the approaches consideredwas tohavea straightforwarddatapresentation, inwhich

the identified themes from each of the respondents’ groups would be presented in

separate sections. This approach would be beneficial in allowing for an in-depth

considerationoftheunderstanding,experiencesandpracticesofeachofthegroups in

relationtoallanalysedpolicychanges,andonlythentocomparativelyinterpretthemin

thesubsequentchapters.Thisapproach,though,whileseemingmoreappropriatefrom

the perspective of the different roles played by each group, was rejected as it was

consideredathreattoillustratingtherelevanceof,andrelationshipbetween,emerging

themes.Tryingtoofferdifferingperspectivessoovertlyasastructuremayalsoresultin

thedangerthatMasonterms‘mutivocality’,anditisimportant:

“[…]thatwegettogripswithdifferentandoftendivergingperspectivesinourarguments,andwithdifferentwaysofexpressing those […]but I thinkweshouldbecautious inassuming thatwecanabsentourselvesand in sodoingcreateagenuinelydemocraticmultivocality.”(Mason2002p.185)

132

As such, organising the findings in terms of identified themes, illustrated using

participantquotations,isarguedtobemostbeneficial.Suchanapproachwaschosenas

it best represented how analysis was undertaken but also as it would still allow the

varietyofopinionsandviewsoftheinterviewedstakeholderstoberepresented.Aswill

beshown, threemainoverarchingthemeswere identifiedbutwithinthesemanysub-

themeswere also apparent and these are considered in turn. It should also benoted

that whilst these represent summary themes and sub-themes, they did not reflect

consensus and it will be shownwhere contrasting orminority views and experiences

werealsoidentified.

Thischapterpresentsonly theemerging themesandsub-themesandquotations from

the interviewswithparticipants; it is left to the followingchapter toprovidea further

development of the findings, in terms of how they are related to the theoretical

framework – Habermas’ system and lifeworld – and how themes relate to existing

literature.

5.1.3.Summaryofkeythemes

Interviewsrevealeddifferingperspectivesbetweenstakeholdergroups.Usingthematic

analysis, key findingswereclustered into threekey themes,briefly summarized in the

following paragraphs, and elaborated inmore details in the subsequent sections (see

Table13below).

Table13.Summaryofkeythemesandsub-themesandrelationshiptoparticipants

Theme Sub-theme Group Sub-theme Sub-theme

Past and present policies

Nostalgia for the past system

Providers Autonomy in prescribing

Clinical experience & patient need

Elites

Better relationship

With the system With the patients – more patient-centred system

Some nostalgia for previous system but not sustainable

Patients Availability of medicines Freedom to obtain medicines (no need to negotiate)

Reflections on recent policies

Providers Qualified acknowledgement of need for policies’ cost containment Elites Necessity for change – efficiency, cost limitation, inappropriate prescribing

Patients Not aware of policies or what the changes are bringing

Lack of providers’ involvement in policy

Providers

Exclusion from policy making Pressure to implement policies Lack of support in implementation, detachment from system Reduced autonomy in prescribing due to policies Inability to prescribe where clinically appropriate due to budget ceilings

Elites

Acknowledgement

Lessened provider autonomy Poor enforcement of policies

Lack of willingness to share responsibility for implementation

Pressures in practice

Providers

Dis-empowerment

Pressure from patients – cannot get medicines they previously could Non-prudent prescribing and dispensing under patient pressure

Denial of irrational prescribing

Perception of patients playing an unenforced system

Elites

Acknowledgement

Increased power of patients qua rights Aware of prescribing under pressure and dispensing without prescription

Expectation

Perceived requirement for patient education on appropriate medications

Perceived requirement for better physician knowledge of clinical guidelines Lack of willingness to share responsibility for policy enforcement

Patients

New Demands

Reduced possibility for obtaining medicines (patients’ disempowerment)

Negotiating medicine supply

Response to system changes

Justification

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Oneof the key identified themes related to the stakeholders’ perceptionsof thepast

andpresentpolicies.Thenarrativesofprovidersrevealednostalgiaforthepastsystem,

whichbroughtcomparisonswithcurrentpractice,regardingprofessionalautonomyand

appreciationoftheirprofessioninthesociety.Similartoproviders,patientsalsofeltthe

past system to be more beneficial to their health needs, and the current one as

disempoweringwhenitcametonegotiatingthenecessitytoobtainmedicines.Manyof

therespondentsintheelitestakeholders’groupreferredtothebenefitsinthepast,and

conversely the lack of sustainability of such a system, justifying the need for policy

changes.

Thesecondkeythemethatemergedfromanalysisofthedatarelatedtopharmacistand

physicianproviders’ perceptions of a lack of their involvement in policymaking and a

lackofsupportfortheminimplementingnewpolicies.Theprovidersfeltdetachedfrom

thesystemforpolicydevelopmentandimplementation,whichforbothphysiciansand

pharmacistsmeant they had to find otherways of dealingwith the arising problems,

some of which were beyond their competences and authorisation. In a similar way,

patients, whilst not appearing very familiar with specific policies or their aims, were

explicitabouttheirowndisempowerment,whichintheirviewwasimposedbythenew

policycontext.Whileelitestakeholdersfully justifiedthenecessityforpolicychangein

terms of implementation, their opinions varied butwere generally in agreement that

implementationofpolicieswas lacking. Italsoemergedthatthiswasnoteffectiveand

patientswere still able to obtainmedicineswithout prescription, particularly cheaper

ones.Intheirviews,boththereasonsandtheresponsibilityforlackofimplementation

laidwiththepatientsandproviders.

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The third identified theme, closely linked to the other two above,was related to the

pressures in practice, experienced by both providers and patients. Physicians and

pharmacists perceived pressures from regulatory and governmental bodies to adopt

policies; policies,moreover, that they did not feel sufficiently involved inwhen being

developed.Theyalsoperceivedoranticipatedpressurefrompatients intermsoftheir

expectations and demands for medicines, with a related negative impact upon them

maintainingprofessionalautonomy.

Patientsalso feltpressures related to thenewpolicies, suchashaving tonegotiate to

obtainprescriptionsfromprimarycarephysicians,andfromthenowlimitedopportunity

to buy medicines without prescription. Accounts revealed that patients found their

autonomyandoptionsforself-medicationtobevery important.Mostofthemdidnot

consider out-of-pocket payments formedicines to be a problem asmuch as was the

limitationof their right topurchasemedicinesat theirowndiscretion.Their response,

however,tothisnewmedicinesupplysituationwasapragmaticone;intheirviews,the

reduced access tomedicines offered justification for subterfuge of regular prescribing

anddispensingprocedures.

Throughout all these accounts, it will be shown that there were diverse views and

differingopinions:

- For physicians and pharmacists, this was manifest in being caught between

patient demands and expectations and maintaining professional autonomy

within a more constraining system in which they felt unsupported and un-

consultedabout.

- Forelitestakeholders,thiswasarticulatedas justificationforpolicychangesto

contain costs and to reduce inappropriate prescribing, and an admission that

implementation was difficult for providers due to patient pressure and other

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issues; yet, they shifted the responsibility for implementation onto both

providersandpatients,suggestingbothgroupsneededabetterunderstanding

ofthepoliciesandassociateddrivers.

- Forpatients, in termsof an awarenessof the consequencesof policy changes

that appeared to restrict their access to prescribed medicines yet having the

opportunity toactasnewhealthconsumersandobtainmedicinesbeyondthe

traditionalpathwayofaphysician.

The following sections describe in depth the identified themes emerging from the

interviewswithdifferentstakeholdergroups.Itrelationtotheorderingofthemes,this

adopts a temporal sequence, with the first to be presented relating to comparisons

between past and present policy, followed by reflections on the implementation and

finallythesubsequentimplicationsofthepolicychanges.

5.2. Reflectionsonpastandpresentpolicies

This theme is constructed from two sub-themes: ‘nostalgia for the past system’ and

‘recent policies: necessity for change and qualified acceptance’. The first sub-theme

focuses onwhat I interpreted as comparisons between the past and present policies,

andwhateffecttheexperiencefromthepasthadontheperceptionofthenewreality.

Thefirstsub-theme‘nostalgiaforthepastsystem’asitsuggests,isconcernedwiththe

reflectionsof participantson thepast system in general, andon the specific topics of

professionalautonomy,raisedbyprovidersandavailabilityofmedicines, raisedbythe

patients.Thesecondsub-theme‘reflectionsonrecentpolicies:necessityforchangeand

qualified acceptance’ focuses on what I interpreted as respondents’ perceptions and

acceptanceofpolicychanges.

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5.2.1Nostalgiaforthepastsystem

5.2.1.1Reflectionsonthepastsystem

In reflecting on their understanding of recent policy changes, all respondent groups

madeexplicitreferencetothepastsystemundersocialistcontroland,mosttellingly,its

benefits. The discourse of nostalgia was strongly present despite the apparent

understanding of the necessity for policy change. In most of the interviews, when

discussion was initiated on the actual system and respondents’ opinions on its

characteristics, the current situation was referred to as a compound of changes, and

significantemphasiswasplacedon thecomparisonwith theprevious socialist system.

Discussionsonspecificpolicies(describedinearlierchaptersasPC1,PC2andPC3)3only

came later in dialogues, upon explicit reference by the researcher. In the providers’

group, accounts varied according to whether they had experience of working in the

previoussystem,whileintheelitestakeholders’group,variationswerenotedaccording

towhethertheyhadexperienceasprovidersinprimarypracticeinthepast.

In many of the physicians’ accounts there appeared to be reminiscence and indeed

nostalgia for the past system. Itmainly projected through the professional autonomy

theyseemtohaveenjoyedwithprescribing.Suchdiscoursewasarticulatedinanalmost

uncriticalviewonthecircumstancesatthetimeandidealizationofthesystem,inwhich

prescribingwasthediscretionaryrightandresponsibilityofdoctors:

“Wecouldprescribeanythingwewanted.Therewerenopolicies…So,forany diagnosis the doctor could prescribe any medicine. I don’t know ifsomebody could have held him responsible for that… before 1990,what

3Thementionedpolicychangesare:PC1-prescribingpolicywithlimitationonnumberofprescriptionsperpatient;PC2–prescribingceilingpolicy;PC3-reinforcementofdispensingpolicyandintroductionofdispensingceilingpolicy.

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canIsay,youcouldgotothepharmacyandgooutcarryingfivebagsofmedicinesandyouwouldn’tspendapenny,therewasnoparticipationfeeoranything…”(PCP2)

“…wewerenotscrutinized,butweknewwhatwasappropriate,therewasnodoubtaboutit…”(PCP12)

What could be noted from the accounts was their perception of the professional

freedomtheyexperiencedinthepast.As illustratedinthequoteabove,suchfreedom

was associated with a perceived limitless amount of treatment and medicines. The

vocabulary physicians used suggested that this freedom and availability of care were

some of the features that, in their opinion, were significantly reduced in the current

system.

Besidesprofessionalautonomyandavailabilityofmedicines,elaboratedassub-themes

in the following sub-sections, the dialogues on previous policies did not reveal other

specific features of association to the past. Interestingly,when askedwhat the policy

wasatthetime,themajorityofphysicianscouldnotprovideasimpleresponse,asthey

wouldforthepolicychangesofthepresenttime.Rather,theyprovidedelaborationson

theoutcomesproducedbythepastpolicies.Theywerecertainthatthepolicy’saimwas

careforpatientandhigheststandardsofprofessionalpractice-evenattheexpenseof

theeconomy.Intheirview,thesystemwasresponsibleforprovidingthenecessarycare

atwhatevercost;atthecoreofhealthcarethenwerepatients,andeverythingelsewas

secondary. Within such a system, providers’ sole role was to provide health services

withoutanyfiscalresponsibility,andthustheywerenotconcernedwiththeeconomics

of care. In their opinion, this represented a good health system,where everyone got

whattheyneededandnoonetalkedaboutbudgets:

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“…weprescribedantibiotics,simply,withnobudgetlimitations,nodanger,I think that we used to have a very good health care system…it was abudget-free system…Beforeeverythingwasbudgeted,onecouldn’tknowwhereexactlythemoneycamefrom,themedicationswereproducedhere,theywerecheap,thefactorywasn’tmakinganyprofit…”(PCP13)

Theelitestakeholders,morenotablythosewhohadworkingexperienceinprimarycare

in the past system, shared similar opinions on the previous system’s benefits where

peoples’ welfare was put before profit. For most of them, it was an exceptional

achievement that medicines and even medical preparations without active

pharmaceuticalcomponents,includingsupplementsandvitamins,werepaidforthrough

healthinsurance.Oneofthemdescribeditasanideal,‘perfect’system:

“I'dhavetogobacktothesocialistsystem,whenallregistereddrugswereputonthepositive list,evenmultivitamins, supplements….Meaningthatthe system was perfect, the state provided complete coverage of thedrugs.”(EI4)

Thenotedaccesstomedicineswithoutanylimitationswasconfirmedthroughaccounts

of patients, who made similar recollections. Although patients constituted a mixed

group,manyofthemhadexperienceorcouldrecallprescribinganddispensingpractices

oftheprevioussystem.Withinthisgrouptoo,therewerereflectionsonthefairnessand

suitabilityofthepast,althoughnotaselaborateandeloquentasthoseofphysiciansand

pharmacists.

Whencomparingtotheprevioussystem,patientsmostlyreflectedonthefreeaccessof

medicines and the ease of obtaining them. In their recollections, at the time, while

medicines could only be obtained on prescription, getting the physician to prescribe,

evenwithoutmedical indication,was not seen as an obstacle. As illustratedwith the

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following quote, medicines - in this case antibiotics - were obtained withoutmedical

indication,yetwithphysician’sagreement:

“Ourchildrenweresmall, sowealwayshadantibioticswithuswhenwewentonholidays.Especiallyifyou’reabroad,youdon’tknowanydoctors,the language. In case the child got fever, you want to be prepared.Everyonehadahomepharmacy;nowyoucanhaveittoo,butyouhavetopayforit.”(Pat12)

Mostofthepatientsconsideredaccesstofreemedicinesasan importantbenefit. Ina

wider sense, this was articulated as a good physician-patient relationship and their

satisfactionwiththetreatmentfromthesystem.Oneofthepatients,however,pointed

tothefactthatalthougheverythingwasfree,therewerestillsomeobstaclestoaccess.

Asillustratedinthequotebelow,theseobstacleswerenotassociatedwithprescribing,

but with dispensing, and more specifically with the availability of medicines at

communitypharmacylevel:

“Everything was on prescription and it was free…it was not alwaysaccessible,pharmaciesweregettingmedicinesoncepermonth,butifyouhadafriendtheywouldstock itforyou... Itwasnotsohard,nowIthinkit’s more difficult to have your therapy…there are many more patientscomparedtothen,everybodyIknowisonsometherapy…”(Pat5)

Some disagreement with the idealisation of the system also emerged among elites,

questioningwhether such a situationwas realistic, in termsof the actual provisionof

servicesandmedicinestopatients:

“Imagine how all the needs of everyonewere covered (smiling)… it [theprevious socialist system] suffered from non-efficiency… [in the past] Ithink not everything was provided in real sense, people receivedprescriptions, but ifmedicineswere not available at the pharmacy, thatprescriptionwasworthless…”(EI7)

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Broadly, this respondent showed concern about the discrepancy of providers’ and

patients’perceptionsandtherealityofmedicinesupply.Inotherwords,itbroughtinto

question the roots of nostalgic feelings which might have been based on

(mis)perceptionsandidealisation,asalreadyillustratedwithearlierquotes.Inaddition,

thisquoteclearlyillustrateselitestakeholders’viewoninefficiencyofresourceuseasa

concern of sustainability, raising the issue of necessity for change, addressed as the

secondsub-themelaterinthissection,afterelaborationofthesub-themeonautonomy

inprescribingandavailabilityofmedicineswithinthepastsystem.

5.2.1.2Autonomyinprescribingandobtainingmedicineswithinthepastsystem

Within the reflections on past policies, participants mostly reminisced about aspects

they considered to have been negatively affected by the changes, in particular

pertaining to their professional role for providers, or personal benefits in medicine

supply for patients. Providers, and to some extent elite stakeholders reflected that

changesbrought reducedautonomy inprescribing. Interviewswithpatients resonated

on the same theme, but were expressed through their perspective of reduced

availability of medicines, due to reduced possibility to obtain prescriptions or be

dispensed a medicine without a prescription. As described in the previous section,

patients talked about their position to obtain medicines even without medical

indication, which confirmed their negotiating power and autonomy to take medicine

upontheirowndecision,once itwasputat theirdisposal.Withthisbeingsaid, Ihave

interpreted these two as interlinked, given that the expressed concern of reduced

availabilityofmedicines,inaway,couldalsobeinterpretedasreducedautonomyofthe

patientsinobtainingmedicines.

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Bothphysiciansandpharmacistsinprimarycarefeltalevelofthreattotheirprofession

inrelationtothecurtailingpolicychanges.Thiswasarticulatedbothinrelationtotheir

professional autonomyvis-à-vis the systemandprofessional appreciation in thewider

society,whichintheirview,werebothrelatedtothepolicychanges.

Physicians’ accounts revealed that for them themost important feature lostwith the

policychangeswasthe‘liberty’ofmakingdecisionsinprescribing:

“Back then we had the liberty of prescribing. So we could prescribemedicinewithnolimitsdependingontheknowledgeandtheexperienceofthe general practitioner, on what he [sic] gained in the process ofeducation.”(PCP6)

This so-called ‘liberty’ was not necessarily considered by all of them as an ultimate

freedom–althoughthewordingusedbysomeoftherespondentsmightimplicatesuch

perception. The above quote also illustrates physicians’ opinion of their knowledge

beingaveryimportantpartofthesystem.Thus,theirconcerncouldratherbelinkedto

theperceivedquestioningoftheirknowledgeandprofessionalism:

“Iamaphysicianforoverfifteenyears,andtheleastIknowiswhatisthebesttherapyforthepatients…”(PCP10)

“…professionalintegrityandethics’areinquestion…”(PCP12)

Elites,too,agreedthatpolicychangesaffectedtheautonomyofhealthcareproviders.

In the views of most elite respondents, the autonomy of physicians was somewhat

confinedtothelimitationsonprescribing.Thisreducedtheirabilitytoprovidethemost

optimalcare,describedbyonerespondent,asbeing‘creative’inprescribing:

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“When the doctors are prescribing, very often they are concerned withwhat is going to happen to them. The doctor has to be creative in theprescription of treatment, with untied hands … isn’t health the biggestnationaltreasure?”(EI3)

Defendingtheimportanceofautonomyinprescribingwasfoundmainlyintheaccounts

of theeliteswhowerepractisingmedicinebeforemoving into their currentpositions.

Thiswasunderstandable, given the influencepastexperiencesandmemorieshaveon

personal attitudes and perceptions. Conversely, among elite stakeholders without

experienceinprimarycarepractice,discussionshadamoreneutraltone.Therewasan

acknowledgementofreducedautonomy,buttheyhadadifferentviewonwhatitmeant

andwhyitwasimportanttoproviders:

“They [physicians] would prefer havingmore freedomwhen it comes totheir expertise, some of them even believe that there shouldn’t be anyprotocols,thattheyhavestudiedlongenoughtoknowit…”(EI8)

The abovequote also illustrates another issue raisedbymost elites, pertaining to the

existence of, and adherence to, evidence-based guidelines. For them, guidelineswere

inevitable, despite the desired ‘freedom’ and discretion in prescribing. Protocols, as

much as exerting rigidity of one’s behaviour, were considered to provide certainty in

decision-making.Intheiraccounts,therewasastronglyexpressedassociationbetween

autonomyasarightandprotocoladherenceasaresponsibility.Alongtheselines,when

asked,participantsdidnot feel competent todefine theboundariesofautonomy,but

werecertainitneededtobeconfinedtoevidence-basedmedicine,andconditionedbya

systematic,standardizedapproachinadvancingknowledgeandpractice:

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“Thephysicianshouldbeenabledtotreatthepatientsashe[sic]seesfit,by prescribing therapies that he [sic] thinks would give the bestresults…but, it [the system] should be upgraded with education of bothpatientsandphysicians…”(EI6)

In most elites’ accounts when talking about providers, there was an explicit

acknowledgement of a frustrating position regarding autonomy. But, the elites’ group

providedotherreasonsforreducedautonomy,whichintheirviewwasnotintendedto

undermineprimarycarephysicians’knowledgeorreputation.Rather,itwaspartofthe

cost-containment strategy, involving amongothers, a recommendation for prescribing

by a specialist for medicines usually prescribed at primary level. According to one

respondent, this resulted in a very cumbersome mechanism of referring patients

between levels of care for obtaining confirmation of therapy appropriateness –

particularlyandonlyforveryexpensivemedicines:

“Iunderstandthefrustration,sometimestheyneedtosendthepatienttoaspecialistforamedicinethatistypicalforprimarycare,becausethelawsaysithastoberecommendedbythespecialist…theserulesareimposedmainly formedicines thatareveryexpensive… inmostcases, theprice isthe reason for imposing limitations. So there might not be a medicaljustification,astherewasn’tforthe[…]butbecauseitwasexpensive,youcould readon the package that itmust be recommendedby a specialistalthoughithadnothingtodowiththat,themedicineistypicalforprimarycare, the samewas for […], itwas the same as itwas quite expensive…they have to ask permission, if youwish, to prescribe something that isalreadywithintheircompetences.”(EI7)

Physiciansfelttheirknowledgeandexperiencewerealsounderappreciatedbypatients.

They were particularly uncomfortable when they had to continue an already taken

prescribingdecisionwithwhichtheytendedtodisagreeprofessionally.Inseveralofthe

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accounts,providersnotedcasesofpatient’sdecisionforself-medicationorrequestsfor

medicinesforwhichpatientshaveheardfromanotherperson:

“I don’t like when the patient already started using antibiotic ‘at ownhand’ 4 or when ‘colleague’ who’s friend of the patient suggests theantibioticIshouldprescribe.”(PCP17)

Similartophysicians,pharmacistsexpressedthefeelingofthreattotheirprofession,but

moreintermsofitsappreciationinthesociety,andparticularlybypatients.Formanyof

them, one of their crucial roleswasmaking the final check on prescription regarding

medicineand itsdosage,andmakingsurethatpatientunderstood instructionsspoken

and hand-written by them on the box. But they felt patients, sometimes questioning

theirabilitytounderstandthedoctor’sinstructions,underminedthisrole:

“I dispensed the medicine based on the prescription, which said threetimesonepill perday…andhe [patient] startedquarrellingwithme thatthisishisregulartherapy,itshouldbehalfapillperday,notone;hesaidwhoamItoincreasethedosage,andtomakehimtakemore…Ithinkhesimplydidn’t rememberwhat thedoctor said,andheblamed it onme…wegetthateveryday,itisnotnice,butyougetusedtoit…”(Ph11)

The level of details provided by this respondent to describe the event illustrate the

apparentdiscontentofproviders–inthiscase,pharmacists–withthepatients’attitude

towardstheirprofession,manifestedasdistrustintheirknowledgeandqualifications.

Another pharmacist, expressed this discontent in even stronger language, clearly

exhibitingafrustrationfromtheattitudeofpatientswhocameinwithoutprescriptions,

sought medicines but would not listen to the professional advice provided. She

4Idiomdescribingmakingadecisionbasedonownjudgmentandresponsibility,notsupportedbyanyformalexpertiseorlegalmandate.

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explainedthatherfeelinginsuchmomentswasasifpharmacistswereperceivedtobe

simplydeliveringanorderedgood,likea‘grocerinagrocerystore’(Ph9):

“Iamnotagrocerinagrocerystore…itisthekindofattitudeof‘IpayforyoutogivemethemedicinesIwant’,likethey’rebuyingpearsorapples…‘giveme2capsulesofVibramycin’isnotrightwhenItellthemthatthefulltherapyisfivedays,buttheyinsist,eventhoughthemedicineissocheap,it isnotaboutthemoney, Ithinkit isabouttheirfeelingofbeingabletogetwhattheywant.”(Ph9)

Several of the elite stakeholders expressed similar views on lessened appreciation of

pharmacists, considering it to be largely due to poor enforcement of the dispensing

policy, which enables uncontrolled access to prescription medicines without a valid

prescription:

“Veryfrequentlypatientsarebuying[ontheirown]medicines...Only40%arecoveredbythestateandfor60%citizensarepaying…mostofthetimewithoutavalidprescription.”(EI4)

“Itisaratherannoyingfactthatpatientscancomeandgetanymedicinetheyaskfor.Firstthingtheyteachatpharmacyschoolisthateverydrugisa poison at the same time and has to be under control, under specificadministration…it’s irritating…people don’t draw blood themselves, sothey also shouldn’t buy or take medicines as they consider necessary.”(EI1)

Although most of policy makers’ accounts resonated in the tone of support and

understandingof the lessenedappreciationandprofession’s standing in society, there

werethosewhodisagreed.Oneofthem,criticalofhisownprofession,consideredthat

decreasedcognizancewasinparttheresponsibilityoftheprovidersandprofessionalism

theyexhibitedandpracticedattheirworkplace:

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“Iexpect thepharmacist tobemorepersistent inexplainingtotheclientthat taking medicines ‘at own hand’ is not appropriate. He can offeralternatives, herbal preparations, teas, supplements; he should advise avisittothedoctorattheveryleast.”(EI5)

This quote in a rather prescriptive tone, illustrates the standpoint of the majority of

elitesregardingthehealthproviders’ roles insociety,butalsotheir responsibilities.As

thisissuestronglyemergedandwasdiscussedatlengthwithallrespondentgroups,itis

elaborated inmoredetailsunder the second theme,aspartof the sub-themedealing

withthewillingnesstoshareresponsibilityforimplementation.

Providersheldviewsabouttheirownrolesandresponsibilities insociety.Accordingto

them, decreased appreciation of the profession in the society, was undoubtedly

associatedwiththepolicychangespertainingtoprescribinganddispensingbutalsowith

other circumstances, such as strengthening patients’ rights. Under these new

circumstances,patientswereperceivedtoexertpressureonprovidersintheprocessof

decision-making in prescribing. This raised the issue of pressure that pharmacists and

physiciansfelt fromactualandperceivedpatients’expectations,whichasanemerging

themeiselaboratedonlaterinthischapter.

Before going into the elaboration of the other two themes touched upon in the two

precedingparagraphs, it is importanttodescribethereflectionsofrespondentsonthe

recentpoliciesandtheirdifferingperspectivesonacceptanceofpolicychanges.

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5.2.2Reflectionsonrecentpolicies:necessityforchangeandqualifiedacceptance

Alongside the reminiscenceon thepastelaborated inprevioussections, reflectionson

recentpoliciesemergedverystronglythroughoutdialogueswithallrespondentgroups.

But,asmentionedearlier,whenreferring to thecurrentsituation,participantsdidnot

appear to differentiate between various recent policies and these appeared to be

considered together; specific policy changes were only discussed when prompted in

interviews.Asnoted inearlierchapters, interviewsspecificallysoughttoexploreviews

on limiting the number of prescriptions and prescribing budget ceilings, mandatory

dispensing only with prescription and introduction of dispensing budget ceilings.

Dialogueswere intended to investigate the understanding of current policies and the

necessity for theirenforcement,aswellasattitudes towards their implementation.As

will be elaborated upon further in this section, the findings showed diverse accounts

aroundacceptanceoftherecentpoliciesacrossrespondentgroups.Forexample,policy

makers were explicit about the necessity for change and drew uponwider economic

concerns, referring to issues such as ‘inefficiency’ and ‘lack of resources’ in their

accounts.Theirnarrativeswerealsocharacterisedbyameasuredandconsideredtone,

withobjectivityandfairnessbeingevidentintheiraccounts.Incontrast,theaccountsof

providers and patients were more emotional and rich with detailed descriptions of

particularevents,whichtheyusedtoillustratetheeffectsofpolicychanges.Theywere

lesskeentodiscussthenecessityforchange,butexhibitedtheirqualifiedacceptanceof

policyinterventions.

The majority of elite stakeholders were supportive of policy changes introduced in

primarycareinMacedonia.Intheirview,thechangesaddressedsomeofthekeyissues,

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oneofwhichwasthe inefficientresourceusepresentacrosstheentirehealthsystem.

To illustrate the effects of these changes, one of the respondents proudly used the

comparison with secondary and tertiary care, which in his view were far less-well

organizedandstillinefficient:

“Letmetellyou,ifsomethinggoodhashappenedinthiscountry,thebestthingistheprimaryhealthcare.It’sthemostorganizedsystem…unlikethesecondary or the tertiary care, where we invested far more and thesituationisstillnotasgood…”(EI2)

The efficiency of resource use, touched upon in the above quotewas pointed out by

several of the respondents as one of the keymotivations for changes. In their view,

therewasaneedtointroduceefficiencymeasures,forexamplethroughrationalization

oftheoversupplyofmedicalstaff,asillustratedbyoneparticipant:

“Therewasoversupplyofmedicalstaffinsomeplaces...Forexample,inatown of 10,000we had 17 doctors… In the pharmacieswe had in someplaces5[pharmaceutical]staffinoneshift…”(EI7)

Toimproveefficiency,accordingtoelitestakeholders,severalmodelswereconsidered.

While none of the respondents in this group discussed any of the other models

specifically,ingeneraltheywereinagreementthatthemodelofprivatisationofprimary

carechoseninMacedoniawasappropriateforthepurpose.Therewasalsoacommon

inference that change of the existing fixed salary system was inevitable, to reduce

inefficiencyandunfairtreatmentbetweenphysicians,asillustratedinthequotebelow:

“The reform in the primary care was inevitable…overemployment anddemotivation were the deciding factors. There were doctors who didnothingbutdrinkingcoffeeandchattingandgotthesamesalaryasthosewhowereexaminingfortytofiftypatientsaday.”(EI8)

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Improving efficiency was linked to the lack of resources, which also emerged in the

accounts.Asalreadyelaboratedabove,manyoftheelitesacknowledgedvarioustypes

ofbenefitsoftheoldsystem,butwhenelaboratingfurtheralsoraisedconcernsabout

the unsustainability of that system. One of the extensively discussed topics from this

point of view involved pharmaceutical expenditure, which, as elaborated before,

included both prescription and over-the-counter medicines and was used on a first-

come-first-servedbasis.Intheviewoftheelitestakeholders,changesandrestrictionsof

spendingonmedicineswereinevitable,andasoneparticipantnoted:

“[…] theneedsandtherequestsof thehealthsystemandthepatientsareone

thing,andwhatthestatecanaffordisadifferentthing…”(EI4).

Whilsttheconceptofequitywasnotexplicitlymentionedordiscussed,theabovequote

illustratestheimplicitviewamongstatleastsomeelitesthatafairandjustdistribution

ofthelimitedhealthresourceswasimportant.

Patientparticipantsdidnotappeartobeaswell-informedonthechangesandreasons

forthenewpolicies,astheothertwogroups,andtheirviewswereverymuchboundto

personal experiences with the system, and in some cases – second-hand knowledge

acquired through personal conversations with someone engaged as a provider. Only

threepatientsrecognizedtheinefficientresourceuse,exemplifiedthroughwidespread

stockpilingofmedicinesathome:

“It’snicetohaveallathand,butthat’snotright…Manypeople,metoo,werehavingboxesofmedicinesathome,mostofitfor‘Godforbid’casesandthenthrownthemawaywhenexpired.Iusedtodothesame,butnowIseethat itmakesnosensewhenyoucangotoyourdoctorandgettheprescriptionwhenyouneedit.”(Pat8)

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“My sister in law is a pharmacist, and she’s saying that earlier peoplewould leave [thepharmacy]withwholebagsofdrugs,especiallyaroundholidays.Andthen,somecomplainedtherewerenotenoughmedicinesinpharmacies; well, the medicines were available only they were in thewrongplace…”(Pat4)

Althoughdisclosed throughpersonalexamplesandwithout touchingupon the system

perspective, the above quotes suggest justification for the enactment of the policies,

from the perspective of the non-sustainability of earlier practices. Thus, through

recognising the importance of efficient resource use, these three patients implicitly

acknowledgedthenecessityforpolicychange.Furthermore,oneofthemillustratedthis

using theMacedonian idiomof ‘stretching your legs as longas your carpet is’5(Pat4),

referringtoitscommonmeaningthatonecanonlyspendasmuchastheyhaveandany

otherpracticerepresentsarouteintodebtsandpoorreputation.Theabovequotesalso

suggestthatsomepatientswereawareof,andknowledgeableabout,thecircumstances

and arising changes, from their personal involvement with the system or from

conversations with a person who had experience as a provider. However, and as

elaboratedinfollowingparagraphs,thiswasnotawidespreadunderstanding.

Such justification did not come forward so clearly in the other patients’ accounts,

althoughtherewasasenseofreluctantacceptanceofthechanges.Despitethelackof

understandingofthepolicies’aimsandfunctioning,patientsnonethelesswereawareof

the consequences of policy changes. The following quote is illustrative of the level of

awareness about more recent policy changes that characterised the majority of

interviewedpatients’accounts:

5Idiomwithameaningofgettingonlyasmuchasyoucanafford.

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“Itwasthewayitwas,nowit’sdifferent…Tome,themostimportantthingis to get the therapy I need, and I go to the doctor, she gives meprescriptions…when Igo to thepharmacy, for somemedicines they say Ihave to pay participation [co-payment] and for some there is noparticipation.IftheysayIhavetopay,Ipay…Idon’treallyknowhowtheydecidewhichonegoeswithparticipation[i.e.co-payment]andwhichonewithout.”(Pat11)

Ofnoteinthefinalsentenceofthisquoteandtypifyingmanypatients’experiences,was

alackofunderstandingastospecificdetailsaboutrecentpolicyandwiththeexception

of the three informed patients discussed earlier, ignorance of recent policy was also

boundupinaperceptionofpatientshavingnooptions:

“Your question is ridiculous to me, sounds like we have some otherchoice…weare patients,we have no other alternative but to do as theyhave decided; if I don’t like the procedures, I can always buy the drugsprivately,butwhyspendmoneywhenIcanfollowtheprocedureandgetitforalotless?”(Pat10)

Althoughaccordingtothisparticipant,theimplementationhadlittletodowithpatients’

choice,aswillbedescribedlaterinthechapter,therewerechoicesthatpatientsmade,

especiallywhen itcametonegotiatingmedicinesupplyandpracticingself-medication.

Their views on the impact of policies on their behaviour andpractices are elaborated

underthethirdthemeofpressuresinpractice.

Thus, I have to note that, specific policies were not deliberated at length with the

patients’group,giventheirlackofknowledgeonpolicies’rationaleandaim.Rather,the

discussions were directed towards opinions on the effects of policy implementation,

whichiselaboratedunderthesecondtheme,laterinthischapter.

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Among physicians there was some understanding of the necessity for change, and

qualified acceptance of the new circumstances. Very few of them expressed their

understanding inapositivetone,suchastheonewhousedtheanalogyofadomestic

budget:

“Budgetsarelimitedthing,itisnotabottomlesswell,andweallliveintherealworld…it’slikethebudgetyouhaveathome…”(PCP3)

When asked about privatisation, in a number of accounts there was a sense that

physicianswerenotquiteawarewhy thepolicychangehadbeen introduced.Mostof

themalreadyfeltusedtobeingprivateprovidersandrecalledthetransitionfrompublic

to private itself to have not been particularly difficult; they continued to perceive

themselvesaspartofthepublichealthserviceprovision,withoneparticipant(PCP10)

commentingthattheyfelttheybelongedtothe‘mostimportantandindispensablepart

of the healthcare system’. It was apparent, however, that many still questioned the

necessityofthistransformationoverall.However,theprevailingopinionwassomewhat

dismissiveofthepolicychange;tothem,privatisationdisruptedthecontinuityofcare,

andlinkstootherlevelsinthehealthsystem,asillustratedinthefollowingquote:

“They shouldn’t have privatized the primary care, we were ‘one’ in thehealth centres and working together with the hospitals, maternities,communitynurses…nowweareseparateworlds…”(PCP11)

Only one participating physician referred to the impact of policy change on the

efficiencyof resourceuseandserviceprovision,andeventhisparticipantappearedto

havegainedinsightsfromrathersuperficialinformationacquiredfromthebulletinsand

reportsreadoutofpersonalinterest:

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“It was introduced so as to limit the spending onmedicines. In general,practitioners prescribe medicines a lot, with their cap and fist6, and Ibelieve that this ministerial policy directly aims to limit that practice...”(PCP4)

Physicians continued to see privatisation as insufficiently thought-through policy with

lots of problems arising in its implementation. Their shared experiences hugely

contributedtotheirviewsthattheprevioussystemwasfarfairertobothpatientsand

providers. There was apparent justification of the policy changes, although mostly

hypothetical, further contrasted with statements of reluctant acceptance. The arising

dilemma as to whether the changes were a necessary, logical and inevitable step in

reforming the health system was mainly informed by individual examples of daily

practice,andthoseareelaboratedunderthesecondthemedealingwiththeaspectsof

policyimplementation,inthelaterpartsofthischapter.

Pharmacistswerealsonottoofamiliarwiththeoverallaimsofanyofthepoliciesthey

have been asked about. For them, privatisation was not a significant issue and they

readily accepted being part of the private sector. They were to a lesser extent

questioning the necessity for change compared to physicians. One of the underlying

reasons might be that liberalisation of the health market started with private

community pharmacy practice, as early as the beginning of the 1990s, whereas the

privatisationofprimarycarecameoveradecadelater.Severaloftherespondentswho

shared their opinion about the necessity for change considered it to be for ‘money

saving’(Ph7)andmonitoringtheuseofmedicines:

6CapandfistisalocalMacedonianidiomwhichapproximatestogivinginabundance

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“I think it was for the medicine usage, who was taking what and howmuch…in the previous system we had no control; of course we hadprescriptions, but no one was controlling who was taking howmuch ofwhat…”(Ph2)

However, far more important concerns for pharmacists were the other two policies

consideredinthisresearch,namelythedispensingceilingpolicy(referredtoasquotas)

andtheenforcementofthedispensingpolicy,whichareelaboratedlaterinthissection.

Although physicians and pharmacists shared their views on the overall policy

circumstancesandnecessityforchange,theyweremoreinterestedintalkingaboutthe

current system through recounting involvement with particular policies. They were

generally very opinionated about the budget ceilings or limits to prescribing and

dispensing, and they did not talk about privatisation specifically, as formost of them

thesepolicieswereseenaspartoftheprivatisationprocess.However,whilemostofthe

providersjustifiedpolicychanges,itwasapparentthatsuchjustificationwasacceptedin

theory qua policy change but in practice, views differed somewhat and were more

equivocal. Their accounts, reflecting quite an opposite opinion, were rich of detailed

narrationsofspecificeventssharedasexperiencewithimplementationofthesepolicies.

With regards to specific policies of interest to this research, understanding and

justification was amply offered by policy makers for the introduction of limitation to

prescribing. The major thread of arguments was namely around the expenditure on

medicines:

“Limitingtheprescribingwasaverynecessarystep,withthecountrybeingin transition and economically very weak…As you know, everything wascoveredbeforeandthatcreatedhugecosts,enormousdebtsofthehealthsystem…WeseparatedfromYugoslaviaandsomeofthecompanieswere

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in Slovenia, Croatia,wewere not part of the same country anymore, sothosedebtsbecamerealliabilities…”(EI1)

This respondent provided explanation for the necessity to introduce limitations to

prescribing,referringbacktotheoldsysteminwhicheverythingwascovered.Namely,

whatthisrespondentisexplainingisthehistoricalbackgroundofrisingdebts,generated

through unlimited medicine supply, despite the political and economic changes that

happenedinthecountry.DuringthetimesofSocialistFederativeRepublicofYugoslavia,

therewasonehealthmarketwithstate-ownedfactoriesforproducinganddistributing

medicinestostate-ownedhealthfacilities.AfterseparationfromYugoslavia,Macedonia

was still providing its supplies from some of these factories, whichwere now part of

othercountries,andwhich imposedmarketrulesformedicinesupply.Thus,underthe

new political circumstances, debts within the health system very quickly became

executableliabilities,demandingrestrictionsinmedicinesupply.

Furthertoimprovingefficiency,thepolicyforlimitationofnumberofprescriptionswas

justified as a measure for standardization of care at primary level. It was widely

acknowledged that unlimited medicine supply was encouraging overprescribing, and

several of the respondents talked about this as particularly apparent in prescribing of

antibiotics. One of the respondents pointed to research conducted in the early years

after independence (Spasovski 1996, PhD dissertation),which showed that antibiotics

wereprescribedwidely,to100%ofpatientswhocameinwithanysymptomthatcould

bemistakenforbacterialinfection,includingsorethroat,runningorcongestednose:

“…every patient who had some sort of infection was treated withantibiotics… so antibiotics were prescribed 100%... It was striking thatantibiotics were generously prescribed for respiratory infections,exclusivelyupperrespiratoryones,andtheresultswerecatastrophic.One

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could see that even children at the age of 6 were prescribed withaminoglycosides…”(EI9)

Thus, the policy of limitation on prescribing, in the policy makers’ view had dual

intended outcome: to ensure pharmaceutical costs containment and prudent

prescribing.Forseveralof themthepolicy,however,wasnotproducing theeconomic

saving anticipated, and for some initially it was not intended to. One participant

described it as ‘the first aid’ policy on dealing with overprescribing; the policy was

intendedtointroduceprescribingdisciplinewithprimarycarephysicians:

“Weexpectedsomeeffects,butnotdrastic…Andtherewassomeloweringof theexpenditures. The intentionwas for physicians tounderstand thatthereisalimit,andtomakethemadheretoit.This,asfirstaidpolicywasto limit the number of prescriptions per patient without any valueattachedtoit.So,thephysicianscouldwriteanymedicinefrom10to1000denarsanditwouldstillcountasoneprescription…Wehadnoexperiencewheretoputthethresholds…”(EI12)

Manyof the elite stakeholders shared the same viewabout the first policy changeof

limiting the number of prescriptions. Another policy maker respondent explained in

further detail, as illustrated through the quote below, how limiting the number of

prescriptions would potentially contribute to increased pharmaceutical expenditure,

sincetheprescriptionswerenotaccountedfortheirmonetaryvalue:

“Let’ssay,apackageofdiazepamcosts30denars,sothedoctorsasksthepatient togoandbuy thismedicine, thepatient stillneeds topay, ifnot30, then20, so that thesekindsofmedicineswouldn’tbecounted in thetotal number of prescriptions. The doctor doesn’t want the cheapmedicinestobecountedintheendsothathecouldprescribetoanyofhispatients or relatives a medicine that costs, let’s say, 3000 denars… It’sbecause the medicine that costs 30 and the other one that costs 3000denarswerecountedinthesameway.”(EI1)

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This participant was arguing for justification of subsequent budget ceiling policies for

prescribinganddispensing.Manyof theeliteshadonlygeneralunderstandingofhow

these policies were functioning in practice, and were interpreting them as an

advancement of the efficiency-improving agenda. The majority of them considered

budgetceilingspolicytobeabettersolutionthanthepreviouslimitationofnumberof

prescriptions, aimed at a real containment of pharmaceutical expenditure at primary

level:

“…Budget ceilingsonmedicineshad tobe introduced,aprescription is amonetary instrument and has to have a price tag to it. Over time, wefounddoctorsthatprescribedonlyseveralveryexpensivemedicinesallthetime,andthatwassymptomatic…”(EI1)

“…basedontheexperiencewiththelimits[onnumberofprescriptions]wewere able to define the [budget] ceilings…we are able to provide more[medicines]withthemoneywehave.”(EI12)

As elaborated earlier, providers did not consider budget ceilings to be an appropriate

measureforregulatingtheirrelationshipwiththesystem.Infact,themajorityofthem

considered this to be a measure of unnecessary control, again reinforcing that it

underminestheirprofessionalknowledgeandethicsinprescribingthemostappropriate

therapy:

“Idon’t think thereshouldbeabudgetbecauseweareawareenough…Idon’t think there should be a Fund, or a budget or anything. Nobody isthatfoolish,patientsaren’teither,nobodywouldtakeamedicationjusttohaveit;sopeoplereallyconsumethosemedications.”(PCP3)

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5.2.3Summaryofpolicyperceptions

Thedatapresentedabove illustrates thediversityof views regardingpastandcurrent

policies,andacceptanceofpolicychanges.

Across the accounts of all respondent groups, there was an explicit positive sense of

attachment to the policies of the past. In the narratives, the nostalgic notion was

dominantlylinkedtoautonomyinprescribinganddispensing(forproviders)andaccess

tomedicines(forpatients).Forproviders,theold‘perfect’and‘budget-free’systemwas

perceived as posing ‘no danger’ to the professional delivery of services. Stories from

their experiences were used to provide arguments that the previous system was far

fairerforbothprovidersandpatients,althoughthereweresomecontrastingviewsofits

unsustainability. Elites also perceived the previous system as fairer, but, were more

objectiveintheirunderstandingthatitwasunsustainable.Forpatients,thepastsystem

wasbetterasitrepresentedeasyandunlimitedaccesstomedicines.

On the current policies, respondent groups also had different opinions. These ranged

from justifying the inevitability of changes by the policy makers’ group to qualified

acceptance by the providers and patients. Policy makers advocated the necessity for

change, offering sustained and forthright arguments of justification that related to

improvingefficiencyofresourceuseandrationalprescribingbasedonprotocols.Among

providers, there was general lack of understanding of policy changes overall; the

accounts were deprived of serious contemplation on the aims of these policies at

conceptual level. The most apparent was the dilemma as to whether the changes -

privatisationinparticular-wereanecessary,logicalorinevitablestepinreformingthe

health system, which culminated in a reluctant acceptance of the policy changes.

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Overall,discussionswithregardstocurrentpoliciesweredrivenbyexamplesofpractice

anddifficultiesinimplementationandtheirconsequencesthatwillbeconsideredinthe

following sections of this chapter. Patients were aware that health reforms were

happening, but most of them were not aware of specific policy changes.

Understandably, their views were mostly informed by their own experiences, which

reflectedissuesofimplementation,andpatientslackedunderstandingofspecificpolicy

changes. Aminority of patientswere somewhatmore knowledgeable of the on-going

processes, mainly as a result of their own experience of working in the system or

knowing a provider. They, too, provided justification for policy changes, with

argumentationmainlyonresourceuseandavailabilityofmedicines.

Theabovesectionsdescribedthewiderunderstandingofthepolicycontextinwhichthe

present research is investigating the attitudes and practices of the primary care

physicians and pharmacists regarding prescribing and dispensing. In the following

sections, the other two main identified themes relating to implementation problems

andpressuresinpracticewillbepresented.

5.3. Policyimplementationproblems:lackofinvolvementandsupport

Thissectionexploresthesecondidentifiedkeytheme,whichrelatedmorespecificallyto

the implementationofpolicy changes,particularly from theperspectiveofpharmacist

and physician providers. Furthermore, this theme was broadly negative and revealed

perceptions amongst providers of a lack of being sufficiently included in any of the

processesrelatedtotheirlineofwork.Notably,theyexpressedalackofinvolvementin

policymaking, revealing the feelingofnotbeingconsultedsufficientlyaboutdecisions

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madeinprimarycare.Theyalsoexpresseddissatisfactionwiththesupportprovidedby

institutionsintheimplementationofimposedpolicies,andafeelingofbeingdetached

from the overall process. Elite stakeholders’ accountsmirrored to some extent these

perceptions of providers, but in contrast there was more concern about policy

implementationdeficienciesoverallandaperceivedfailuretoobservethefullpotential

of policies. However, they were unwilling to share the responsibility for the lack of

implementation,whichtheyconsideredtobemostlywithinthedomainoftheothertwo

groups – patients and providers. They believed that improving health literacy for

patients and education for providers could potentially be part of the solution.On the

same issue, providers also did not quite readily accept the responsibility; they

consideredpolicymakerstobeinapositiontoimproveimplementation,throughfixing

the identified flaws for implementation.Physiciansandpharmacistswerealso seeking

accountability fromtheothers in theprovidergroup(physicians frompharmacistsand

vice versa). Theirperceptionof responsibilitywasalwaysdescribedat individual level,

narrowing itdowntosporadicanddistantcasesof lackofadherencetopolicies.Also,

they were calling upon the interrelatedness of prescribing and dispensing but never

considered a shared responsibility as a possibility for improved implementation. In

addition, providers sought responsibility from patients, bringing to the attention

experiencedandperceivedpressures,whichareelaboratedunderthethirdthemelater

in this chapter. But, before arriving at the theme of pressures in practice, in

continuation, I elaborate the findings from the second theme of issues with

implementation, divided into three sub-themes: lack of involvement in policymaking,

lack of support to implementation, and willingness to share responsibility for lack of

implementation.

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5.3.1Lackofinvolvementinpolicymaking

An identified sub-theme concerned providers’ perceived lack of involvement in the

policydevelopmentprocess.Intheiraccountstheyemphasisedtheirfeelingofexclusion

from the processes that directly affected their daily work. Physicians were more

emotional about having a chance to participate in the policy making, whereas

pharmacists,werenot as concernedwith their involvement in consultationprocesses.

Several physicians admitted there might be some processes - consultations through

theirprofessionalassociationbodyforexample-butmostwerenotawareofwhenand

howtheseprocesseshadhappened,anddoubtediftheyactuallyexisted.Severalofthe

physiciansexpressedaveryscepticalview,withoneparticipantbelieving thatmostof

thepolicieshadbeen‘invented’bysomeone‘whowasneverapracticingdoctor’(PCP5).

Overall,therewasaperceivedlackofcommunication,whichexacerbatedthesenseofa

lackofinvolvementandadidacticapproach:

“I don’t think anyonewas ever invited to tell our problems…maybe theassociations…we are only invited when they [Ministry and HIF] want toinform us of the new rules. Sometimes not even that, they simply sendtheminane-mailasinstructions.”(PCP7)

Providersbelievedthatpoliciesshouldnotbedevelopedwithouttheirparticipation,and

were persuaded that officials and policy makers without practicing experience

particularlyinprimarycarecouldnotdevelopappropriatepolicies:

“Idon’tthinkanyoneworkingintheMinistryandnotintheprimaryhealthcare should create a policy; one should have experience in the field.”(PCP6)

“…weareforcedtosignthecontractbecauseifyoudon’t,you’dbeoutofwork, nobody asks if you want to sign it or not, all they [the HealthInsuranceFund]do isgiveus thepapers,wedon’t even read them,why

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shouldwe,evenifwereadanddon’tagreewitheverything,westillhavetosignthem.Otherwise,I’dbeoutofwork,andwhatpatientwouldcometomyprivatepractice?SoIaccepteverything.”(PCP3)

Althoughwanting to be part of the process, providerswere not very articulate about

howthisinvolvementcouldbeachieved.Onlytwoproviders,however,expressedtheir

ideasonhowtheycouldbeinvolved,mentioningonlineconsultationandsurveys:

“Well, maybe before sending out a plan of activities or measures, theycouldincludeusbymakingsurveysonwhetherweagreeonsomeissueornot….”(PCP6)

Among pharmacists, there were also several who did not feel they were consulted

enough.Onerespondentsharedanexampleofaninitiativeamongsmallpharmaciesto

becomearelevantvoiceatthenegotiatingtable,whichinherview,asdepictedinthe

first quote below (Ph6), was not adequately recognised. Instead, as illustrated in the

secondquote,theyfeltthattheysimplyhadtodeliveronthedecisions,withoutbeing

asked‘iftheycandoit’(Ph4):

“Largepharmacychainslike[…]and[…]areverystrong,Idon’thavesuchposition…We[smallpharmacies]gotorganizedintheJointPharmaciesofMacedonia, therewerebenefits for jointprocurement,havingonevoice,but still the HIF does how they think, we didn’t get to change much…”(Ph6)

“We get letters or e-mails with decisions, what, how to do…there is noquestion in thosemails ifwe can do it…I don’t evenwant to send replybackwithaquestion,astheywillseewhoissendingandmaybetheywillsendmeaninspection…”(Ph4)

Lackofinvolvementinthepolicymakingwasexpressedalsoasnotbeingconsultedon

thelistoftreatmentsmadeavailabletopatients.Asnotedintheearliersections,some

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ofthemedicinestypicallyprescribedatprimarylevelwereraisedathigherlevelofcare

and could be prescribed only upon specialist recommendation. The purpose of such

decisions was argued by policy makers to relate to controlling consumption of very

expensivemedicines (as exemplified in thequoteby EI7 earlier (page144), under the

sub-themeofautonomy),butwasinterpretedbyphysiciansasalackofinvolvement,as

theywerenotconsultedonsuchdecision.

“We are limited as [primary health] doctors to treat the patients inaccordancewith theknowledgewehaveacquired...if I knowapatient iswell off, Imight suggest to buy themedicine out-of-pocket, if it’s betterthantheoneontheinsurance”(PCP7)

“I want to be treated as a professional. I am not here to take anythingfromthem,I’mheretodomyjob,andIdeservetobepart[ofcreationofpolicies].”(PCP16)

Asreflectedinthisquote,andarticulatedbyotherphysiciansaswell,afterprivatisation,

there was a notion of divide - a sense of them and us - which was interpreted as

widening with the introduction of the subsequent policy changes. As a prevailing

perceptionamong theproviders, thisdetachment from the systemwas consideredan

important findingand interpretedunderaseparatesub-themeand isdescribed in the

nextsection.

Basedontheirexpressedperceptionoflackof involvementinpolicymaking,providers

wereaskedtoreflectonpossible ideastheymighthaveshared if theywere invitedto

participateinpolicycreationprocesses.Fromthesediscussionsandacrossotherpartsof

interviews, it was apparent that providers found it difficult to identify specific

suggestions.So,althoughhavingstrongfeelingsofbeingunrightfullydistancedfromthe

processes, providers did not appear to have specific proposals relating to their

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involvement. There was, however, a belief amongmost of the providers – especially

physicians–that,ifgiventhechancetoexertinfluence,theywouldeitherreverttothe

previous systemorwaive someof the restrictionsandadministrativeburden imposed

withthechanges.Thefirstofthesepropositionsisconsistentwiththeviewsexpressed

insection5.2.1.Thesecondsuggestedmoreofaconcernaroundpossiblebureaucracy

and process and did not appear to be related to the main concern about a lack of

involvement for providers. However, one respondent did express a view as to how

policiesshouldbechangedtoimproveproviders’position:

“…as there is a budget ceiling setting the limitwe cannot exceed, thereshould be a lower limit [threshold] thatwemustn’t go below aswell. Ifsomebodydoesn’tspendtheestimatedamountofmoney,he[sic]shouldberewarded.Thereshouldberewardsastherearesanctions.”(PCP3)

Itwasalsointerestingtoobservethatelites,inparticularpolicymakersdidnotconsider

itproblematicthatproviderswereonlyinformedaboutpolicydecisionsthattheywere

asked to conform to. Inpolicymakers’ accounts,providersweremostlymentionedas

part of the implementation process, and policymaking was seen as the work of

government institutions including themselves or institutions they represented. In this

way, they appeared to implicitly delineate the responsibilities: policy makers – for

policymaking,andproviders–for implementation.Overall,the issueof involvementof

diverse stakeholders in thepolicymakingprocesswas covered rather vaguely in their

accounts. Policy makers were unanimous in acknowledging the necessity for

involvement, but this appeared to bemanifestmore in a symbolic rather than actual

way; only a few policy makers advocated or actually gave examples of provider

involvementinpolicydevelopment,mostlythroughproviders’associations.

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Apartfromtheinvolvementinpolicy-making,participationofprovidersindevelopment

ofclinicalprotocolsandevidence-basedguidelineswasmentioned.Providers’opinions

werediversifiedandatoneextremewerethosewhohadnoopiniononwhoshouldbe

involvedinwritingsuchprotocols.Incontrast,othersconsideredtheirnon-involvement

tobeaproblematiclimittothemexpressingtheirprofessionalknowledgeandpotential

forprovidingbestcaretopatients.Inlinewiththelatter,onepolicymakerrespondent

raisedtheissue,confirminglackofproviders’involvement,despiteherviewthatitwas

criticaltoensuringownershipandadherencetosuchstandardizedprocedures:

“ThisisexactlywhatIwastalkingaboutearlier.Beforeit[theguideline]isacceptedandfinalizedbythe[HealthInsurance]FundandtheMinistry[ofHealth] asapublic document, tomake thedraft available for discussionandreviewtothedoctorsintheirAssociationorontheirwebsite,sotheycanprovidetheirinputandexpresstheirthoughtsabouttheguideline.Inthatcasetheguidelineswillbemoreacceptableforallofthem.”(EI6)

Other policy makers also considered evidence-based guidelines to be essential for

containing costs and providing better quality of care, but as mentioned earlier, they

have not made clear connection between guidelines development and providers’

involvement. Rather, in the view of the majority, this was the role of academia in

collaborationwiththeMinistryofHealthandHealthInsuranceFund.

Theissueof involvementofproviders inpolicymakinghasnotbeenexploredwiththe

patient group, for obvious reasons and theearlier discussed lackof knowledgewithin

thisgrouponpoliciesandpolicyprocessesinwhichtheyweredeveloped.

Insummary,therewasanexpresseddissatisfactionbyproviderswiththeirinvolvement

inpolicymaking,butalimitedknowledgeorideaastohowpoliciesshouldbechangedif

participation in theprocesseswasgranted.Policymakers shared theseviews to some

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extent,ultimatelyprovidingamixedmessageinarguingthatproviderinvolvementwas

important, but that delineation of responsibilities between policy making and

implementation was also necessary. Crucially, it was apparent that elite stakeholders

viewed providers as part of the latter in practice. The next section explores crucial

consequences related to implementation for providers, manifest as a lack of support

andaperceptionofdetachment.

5.3.2Providers’lackofsupportanddetachment

In addition to the lack of involvement in policy making, in their accounts, providers

expresseddissatisfactionabout thesupport theyhadobtained from institutions in the

implementation of the imposed policies. This emerged in relation to newly imposed

administrative work and lack of guidance with regards to problems arising in

implementation. It also led to increased curative actions (such as inspections) at the

expenseofpreventiveones(suchasadvice)bytherelevantinstitutions.

Theproviders’complaintsonthelackofsupportfromthesystemwere,amongothers,

relatedtotheadditionaladministrativeworkimposed.Asmentionedearlier,oneofthe

changes physicians would make if they could exert influence was reducing the

administrative burden. This lack of support from the system in relation to

implementation emerged from many provider accounts and was associated with the

viewthatprivatisationhadalsoimposedadditionaladministrativework,whichwasnot

their responsibility before, since they were part of large health centres that had

dedicated administrative units.With the subsequent policy changes, (i.e. limitation of

prescriptions and budget ceilings described earlier), the administrative workload

increased, comprising of record filling and frequent reporting to theHealth Insurance

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Fund.Intheirview,thisclericalworkimpactednegativelyonthemainworkoftreating

patientsasthefollowingthreequotesvariouslyillustrate:

“We are literally buried in admin stuff…paper forms, electronic forms,reports to the Fund, reports to theMinistry…andwithonlyonenurse… Ialsohavepatientstosee,so,weoftenstay[withthenurse]afterhourstofillthem[recordsandreports]”(PCP12)

“Lotofadministration…we’veevenbecomeaccountants…Iamalonewiththe nurse, and the capitation is not enough to hire an assistant; I givesomeextramoneytothenursetostayovertime,andmyself,Idoitwithinmysalary.”(PCP15)

“Let’s say that according to the Fund, we should give each patient 15minutes,thatthatwouldbethelengthoftheexaminationintheprimaryhealthcare,fiveminutesconsultation,andyouspendtherestofthetimewriting everything down, checking if it all corresponds with the healthbook,withthatinthecomputer,inthechart…”(PCP6)

Physiciansdidnot seemtohavewillinglyaccepted theamountofadministrativework

imposed,as in theiraccounts theydidnotexpressanyaddedvalue fromthe filesand

reportstheywerepreparingandsubmitting.Theyunderstoodtheepidemiologicalneed

for data collection, but nonetheless felt dissatisfaction from the lack of feedback

provided to them. Only one of the physician respondents was aware that the Health

InsuranceFundwasprovidingfeedbackthroughpublishingreportsonline:

“…thatinformationcanbefoundontheFund’swebsite,youcanlearnhowmany antibiotics we have spent, how many, to be more precise,antidepressants,howmanyantihypertensives,andsoon,sotheyprovideareportthatwehaveaccessto.Theinformationisalsodividedbycities.”(PCP8)

Regardless of the feelings of providers, this quote confirmed the existence of

transparency on the part of institutions, at least with regards to information sharing,

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and at the same time it raised the issue of providers’ wish to be informed,

understanding the policies and having meaningful participation in policy making, as

discussedearlier.

Another important manifestation of the isolation felt by providers was the lack of

support from the responsible authorities in dealing with arising issues during policy

implementation. Intheirview,theproblemsthatoccurredshouldbeaconcernofand

dealtwithbytheinstitutionsandnotmade‘theirownbusiness’(Ph3).Examplesshared

referred mainly to obtaining support for administrative issues, as these two quotes

illustrate:

“Ifyouknowsomeonethere [at theHIF]youcancallandask. Ifyoucallregularnumbersyou’realwaystransferredoraskedforyourmailtosendyouthesameunclearinformationyoualreadygot…”(PCP9)

“Clerks[attheFund]canbenice,buttheyarenotveryhelpful,theysimplydon’tget it [theproblem],they look intothe law,orsomebylawandtellyouwhatyoualreadyknow. I say, ‘Iknowthat,but this isdifferent’andthey simply smile or nod. They are not interested what is the problem.There are exceptions, for sure, but I have no such experience,unfortunately.”(PCP12)

Incontrasttothemajorityofproviderrespondentssharingthefeelingoflackofsupport,

several respondents expressed satisfaction from their relationship, with Health

Insurance Fund (HIF). In their opinions, HIF was responsive to questions and arising

issues,however,stillwithlimitedscope:

“IfIsende-mailtothe[HealthInsurance]Fund,theyrespondveryquickly,especiallyon[issuesof]reportingore-software…theyalwaysrefertotheirwebsite;allinstructionsareputthere”(PCP8)

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Elites held similar views with physicians in some aspects regarding policy

implementation.Asportrayedinthefollowingquote,elitesspokehighlyofpolicies,but

theywerewillingtoadmitthatsuitableimplementationwasnotalwaysinplace:

“Wearegoodatcreatingpoliciesandwritinglaws,wehaveaverygoodlegalandpolicybase,butitusuallystaysonpaper…”(EI6)

Eliteshaddiverseviewsonproviders’practices.Whilstthemajoritydisapprovedofnon-

compliance with the policies, some of them appeared to be sympathetic towards

providers’ perspectives,whichaspreviouslynoted,mayhavebeen related to the fact

thatsomeofthepolicymakerswerehavingproviderexperiencepreviously.Illustrating

this, several elites argued that there had been unrealistic setting of budget ceilings,

especiallyforthepharmacies:

“Nomatterhowmanyprescriptionsarebroughtin,theyshouldbeissued.Actually, the [Health Insurance] Fund issuesprescriptionsand I don't seewhythepharmacyshouldhavealimitedbudgetwhenthedoctorsalreadyhave set ceilingswith the Fund, right?All prescriptions from thedoctorshavetobedispensedbythepharmacies.Withthe limitedbudgetsthis isnot possible...it’s dishonest, you issue a prescription under the insuranceforamedicinethatcan’tgetcovered”(EI4)

This view was also shared by pharmacists, who felt that one of the difficulties of

implementation was the low threshold of the dispensing ceilings policy. This was

dramatically described by one pharmacist in terms of the need to then try and

communicatethistopatients:

“We had a lot of trouble at first to explain that they cannot get theirmedicine, that they have to come earlier in themonth...itwas like ‘firstcomefirstserved’…sometimeswepostedannouncementsonthewindowthatthemedicinesarefinishedforthatmonth…”(Ph2)

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However,therewerealsoopposingopinionsonthelevelsofprescribing.Intheviewof

some policy makers, both overprescribing and overdispensing still represented a

significantproblem,whichrequiredfurtherimprovement:

“Inthebeginningwehadhigherceilingsthanwewouldhaveexpectedtobeprescribed,andwenoticedthatourdoctorsarespendingalwayscloseto the upper limit;we lowered them and theywere again on the upperlimit. Tome thatmeans that still there is overprescribing, and probablymoreroomforcorrectionsofthebudgets.”(EI12)

Relatedtothis,physicians’accountsinvolvedadmissionsrelatingtooverprescribing,as

a resultofpreviouspracticesandperseveranceof somepatients,exemplified through

thequotebelow:

“Somepensionerswereveryusedtomakingstashesoftherapyforseveralmonths…Itwasnoteasytopersuadethemtogetaprescriptiononlyforamonth…somewerepersistentsayingitisdifficulttocomeeverymonth…”(PCP5)

This quote raises the issue of provider-patient relationship, and in particular the

pressuresprovidersexperienceorperceive frompatientsand representeda recurrent

themeinmanyprovideraccountsthatisdescribedinmoredetaillaterinthischapter.

Discussionsonpolicyimplementationelicitedanotherimportantfinding.Bothphysician

andpharmacistproviders,openlyandvigorouslyexpressedtheirfeelingofdetachment

from the system. Physicians felt that prior to the policy changes, within the health

systemtheyworkedincoordinationwithotherlevelsofcare,whereasunderthemore

recentpolicycircumstancestheyconsideredthemselvestobedistanced,especiallyasa

resultoftheprivatisation,asillustratedbythefollowingquote:

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“They shouldn’t have privatized the primary care, we were ‘one’ in thehealth centres and working together with the hospitals, maternities,communitynurses…nowweareseparateworlds…”(PCP11)

Echoing this theme, another physician expanded on the consequences of the policy

changesintermsofbeingmuchlessconnectedtoothers:

“Wegotalienatedfromeachother,fromthecolleagues,fromthe[HealthInsurance] Fund…in the beginning at leastwewould go there to submitthereports,nowwedon’tneedtogothereinpersonanymore,andIdon’tknowanybodythereanymore.”(PCP16)

“Providersarepartofthesystem,wearenotenemies…”(PCP11)

The participant in the first quote above further illustrated how these changes to

‘separateworlds’(PCP11)affectedtheverticallinksbetweentheprimaryandtheother

levelsofcare–asinthefollowingexamplewithpreventiveservices,whichinherview

shouldhavebeenre-established,toenabletheirfullpotentialasprofessionals:

“When Iworked at the health centre, if I had a child coming oftenwithrespiratory problems, I would send the community nurse to check theirhomeconditions,maybethekidlivesinadampplace,ortheydon’tcleanthedust;shewouldadvisethemtoairtheroomandsoforth.Now,Ican’tdothat,Ihavenoauthoritytosendthenurse.AllIcandoisaskthefamily,orvisitmyselfor,ifthenurseisagoodfriendshewillgoforme…”(PCP11)

Thesequotescapturedasenseofseparationanddifferenceandwerearecurrenttheme

in provider accounts. This perceptionof being isolatedwas not only felt to be due to

changes that had removed previous aspects of health care delivery but also due to a

perceptionthathealthprofessionalswereactivelybeingtreatedasiftheywerenotpart

ofthesystem;therewasanemergingfeelingofbeingunderunnecessarilystrictscrutiny

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andanassociateddislike forsuchtreatment. Invaryingaccounts, itwasapparentthat

health careprofessionals believed therewas intentionality to this consequenceof the

policychanges,andanassociatedlevelofdisquietfromparticipants:

“…They[MinistryandHIF]cannotsimplytreatusasifweareotherpeoplethanwewerebefore…theytakenowthatweareprivateandthatweworkforprofit,andthatwearedifferent,changed;wearethesameoldfolks,that treated patients the same way we were before, just now we havemorecontrolsandinspectionssnoopingaround…”(PCP4)

This participant highlights another dimension of this feeling – namely, this quote

insinuatessomethingthatwasinotheraccountsmoreopenlyoutspoken:thattheyhave

been subordinated to authorities and scrutinized in a rather negative way - with

numerouscontrolsandinspections,whichinsteadofbeingadvisoryinthefirstinstance

likethelegislationrecommends,inmostcasesendedupwithpenaltyforthephysician

orthepharmacy:

“Inspectioncame,theydocomealot…yes,sometimestheyinformyouandsometimesyoudon’tknowtheyarecoming…whenyouseetheinspector,you know already you will be fined, 500, 1000 euros, depends…usuallyyou’refined,notadvisedorwarned,liketheyaredoinginthepublichealth[settings]”.(PCP9)

“Itdidn'treallyhappentome,butacolleagueofminetoldmethatwhenthe inspector couldn’t findanythinghe simply finedher fornothavingaproper display of the nameplate [at the practice]. How insane is that…”(PCP4)

Oneexamplewasgivenofapenaltybeingimposedforaclericalerroronaprescription,

which the participant pharmacist considered to be completely unwarranted and

disproportionate. The participant felt that this undermined the relationship between

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providers and government and argued that such relationships were important but

neededtobebasedongoodwill,trustandconfidence.

In some other accounts, the dislike of the treatment was articulated as unreturned

commitment in the relationship – in which physicians feel they have invested

disproportionatelymore thanwhat theygot in return. Somehealth careprofessionals

havegivenextremeexamplesoftheirattemptstocopewiththechallengesofthedaily

workthattheyhavenotsignedupfor.And,yetintheirviewthesystemperceivesthem

asjustanothernumber:

“My replacement colleague broke her leg and I had to receive all herpatients for over a year, and Iwasusingmy stampand Iwent over theceilings every trimester…Igotpenalized for not stayingwithin the limits,but,whatcouldIdo…Who,youmeantheFund?Theyarenotinterested,forthemweareonlynumbers…”(PCP9)

Thisquiteclearlyillustratedhowthephysicians’feelingofbeingleftalonematerialized

in non-protection for unforeseen circumstances, forwhich they had nowhere to turn.

Similar,althoughhypothetical,examplesweregivenformaternityleave:

“Yousimplydonothavetheluxurytogetsick…ifIgoonamaternityleave,orlongersickleave,thereisnocoverageformypatients.Iamluckythatwe are two at the practice, so we can manage, but for those that arealone,Idon’tknowhowtheydeal…howcouldwemanage?Wewoulduseeachother’sstamps,wehaveagreementonthat”(PCP13)

Fromthequotesabove,andotherexamplesphysiciansclearlydepicttheirperceptionof

the response from the Health Insurance Fund per se, as turning a deaf ear for their

claimsorproblems.Another lessdramaticcasewaspenalisationfornotstayingwithin

thelimits,whichtriggeredtheissueofusingonlythestickwithoutthecarrot:

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“Igotfinedlastyearforgoingoverthelimitwiththeprescriptions,butitwassuchayear,manyofmypatientsweresick,theairpollutionwasveryhigh…Iwasneverrewardedforstayingwithinthebudget”(PCP16).

“If we spend under the ceiling, nothing happens (he smiles). On thecontrary,wefacesanctions.”(PCP9)

The pharmacists felt detachment in a similar way, but obviously in the context of

medicinedispensing. For them, thequotasonmedicines that canbedispensedunder

thehealthinsurancewerethekeystumblingblockintheirrelationshipwiththesystem.

Theirexamplesillustratedcircumstancesinwhichtheyweresurpassingthequotafora

certain medicine that was requested from them by a patient. They felt they had no

proper interaction with the responsible organisations to solve the issue through the

formalchannels:

“Weasked,butthey[HIF]saythatquotasareenough,buttherearetimeswhen we have no quotamedicines in stock…we don’t want to turn thepatient down, so what I do is I go to the neighbouring pharmacy to‘borrow’(showingquotationsign)fromtheirquotaiftheyhaveleft.ThenIreturnitthenextmonth…yes,Idothesameforthem…”(Ph3).

As explained above, they resorted to finding their own ways of solving such issues,

withinoroutsidethelegalframeworks.Althoughnotcapturedinthequote,theshrugof

shouldersofthepharmacistmadeitclearthatsuchbehaviourwasunlawfulandcould

be subject to penalty. However, she believes that providing medicines to a patient

shouldbethehighestpriority–asadedicationtotheprofession.

Onthesame issue,policymakershadanopposingopinion. In theiraccounts, someof

themprovidedexamplesofirregularitiestoillustratehowpharmacistsusedthepolicy’s

loopholesintheirpractice:

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“Itisnotforbiddentogetprescriptionmedicinewithaprivateprescriptionsolongasithasavalidstamp,butyoupayforitprivately[out-of-pocket].In some pharmacies inspectors found empty pink [private] prescriptionsunder the counter, stamped and ready to be used to cover for suchprivatelyboughtmedicines.”(EI12)

“Thecurrentsystemenablesustooverseeallactivitiesatprimarylevel;inpharmacies though,we can only see themedicines from the quota, andnot the other supplies they would have. But you can expect that if thequota is finished by the 10th of the month, the rest is soldprivately…whether all dispensed medicines are issued with a validprescriptioncanonlybedetectedbyinspectiononthespot.”(EI4)

Another example was shared by one of the pharmacist respondents, regarding the

disregardofthesystemfortheinvestments–bothmaterialandprofessional–madeby

theproviders.Namely,withprivatisation,providerswereexpectedto invest theirown

resources for opening a practice or pharmacy. At first, licensing of practices and

pharmacies was done in a non-systematic manner, with all applications that fulfilled

general technical conditions were approved. As the market reached saturation,

institutions, namely HIF, submitted to rationalisation of contracts, but without

consideration of the already invested resources. One respondent was agitatedly

explainingthefrustrationfromthesituationshewasput in,wheredespitediscussions

andnegotiationswiththeHIFtocontinuethecontract foravillagepharmacy,without

prior notice the HIF has not signed an extension, explaining that village didn’t have

enoughpatientsandthenearbytownwasclose:

“Theydidn'texplainanything, they simplydiscontinued thecollaborationwhen the contract expired…no prior notice, no nothing. I went severaltimestoask,butgotnoanswer,justthatIcanfileaclaim,that’sit…thereisnootherpharmacyinthevillage,thenearestoneisinthetownsome20kilometresaway.Ihadreallyinvestedalot,andit’snotacaroraTV[i.e.movableitem]tomoveittoadifferentplace…”(Ph6)

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Asnotedabove,policyimplementationanditsappropriatenesswerealsodiscussedwith

policymakers,astheywereseenasparticularlyknowledgeablethroughtheirpositionto

overview,monitorandcontroltheimplementation.Additionalissuesofconcernrelated

to implementation for them were the continuing trends of overprescribing and non-

compliancewiththedispensingpolicy.

Theissuewithoverprescribing,accordingtothepolicymakersisstillaseriousconcern

not only from a fiscal perspective, butmore so for its public health consequences. In

theirview, ithaditshighest levelsduringthepolicyof limitednumberofprescriptions

perpatient,forwhichreasonthefiscaldisciplinemeasuresofprescribingceilingswere

introduced:

“Doctors were prescribing generously, because the policy was that foreachpatient twoprescriptionswerecounted,withoutanyearmarkingoramount.Therewasacaseofonedoctorwhoprescribed200scatulastoasinglepatient inonemonth…itwassuspicioussowesent the inspection;he was fined but we never found out what actually happened… Hecould’ve sold those medicines or provided them to uninsured personsunderthenameofaregisteredpatient.”(EI4)

From the patients’ accounts, the issues evidently ofmost concernwere the access to

medicines and the impactnewpolicieshadonobtaining them; further and related to

the above, an important theme identified from their accounts was on the self-

medicationandproviding justification for it.Theyopenlyadmittednon-adherenceand

using loopholeswhenpossible,which they interpreted as a response to the curtailing

policy changes. Patients thought that information asymmetry is used for the interests

andmaterial gainsof theproviders,butalsoused it asanargument in justifying their

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self-medication practices; to them, self-medication and circumventing procedures for

legalmedicine supplywereaconsequenceof thepolicychanges.As this findingcame

strongly in patients’ accounts and was linked to the pressures felt by providers, it is

elaboratedundertheseparatethemeofpressuresinpractice,laterinthischapter.

Throughall of the above, the appropriatenessof policy implementationwas implicitly

linked to responsibility for policy implementation, analysed below as a separate sub-

theme.

5.3.3Unwillingnesstoshareresponsibility

Theexperiencesandopinionsdescribedabovesuggestedthatamongrespondentsthere

was a pronounced belief that policy implementation was lacking in certain aspects.

Policymakersconsideredoverprescribingandnon-adherencetodispensingpolicytobe

the most critical issues; for providers, lack of implementation was linked to lack of

support fromthesystemandpressures frompatients–the latterdescribedunderthe

thirdthemefurtherinthischapter.Patientsontheotherhand,consideredfailureofthe

policies to be mainly related to reduced access to medicines, and increased need to

negotiate their medicines’ supply. These findings triggered discussions regarding

responsibilityforimplementation.

Policymakerswerevery forthright in theiropinionsabout the responsibility forpolicy

implementation;intheirviewthesystemwasdoingasmuchasitcould,withthelimited

resources forcontroland inspectionbeingavailable,and itwasfelt thatgovernmental

effortsrelatedtoimplementationweresufficient.Theiraccountsveryclearlyplacedthe

responsibilitywithprovidersandpatients,andthepolicymakers’rolewasperceivedto

involve ensuring policies were in place rather than implementing them. Specific

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examplesweregivenonthedispensingpolicyenforcement,whichasdescribedearlier

wasconsideredbypolicymakersasoneoftheremainingimplementationissues:

“These[dispensingwithprescriptiononly]policiesarenotnew;theyhavebeenendorsedlongtimeago.ThemedicinethathasanRonit,evenifit’sanointment,mustn’tbedispensedbyapharmacist[withoutprescription].Buttheydoitregularly,theauthoritiesdidn’tfinethemnordidtheythinkofdoinganythinglikethat.Thiswasthepracticeupuntil2009whentheydecidedthateachmedicinemustbeprescribed[sotobedispensed].”(EI3)

This quote illustrates the opinion of policy makers that responsibility lay with

pharmacistsbutalso implicitlywithpatients too, since theunlawful act committedby

pharmacistswas initiatedbydemand from thepatients.Alsoofparticularnote in this

quotewasreferenceto‘prescribinganddispensingbyapharmacist’andwhilstthereis

no legal authority given to pharmacists to prescribe medicines in Macedonia, in the

accounts of several policy makers this practice was described. Namely, upon

enforcement of the dispensing policy in 2009, the pressure to dispense without

prescription was still felt to be considerable – both from patients to obtain their

medicines, aswell as fromownersofpharmacies interested inmaximizing their sales.

Accordingtoelites,subterfugewasusedtocreateaprocedurethatdeviatedfromthe

dispensingpolicy,inwhichpharmacieskeptblanknon-reimbursableprescriptionsunder

theirdeskandfilledthemwhenapatientwithoutaprescriptioncamein:

“They [prescriptions] could be from the [Health Insurance] Fund, emptylikethisone[showingaprescription],theonlydifferenceisthatthereisn’tanything in the upper corner, no name and surname, so they aren’tcountedbytheFundinthequota…Adoctorwould,let’ssay,leaveabunchofstampedprescriptions,andthey[pharmacists]wouldwritethemedicinedown,thepharmacistwouldwriteithimself.”(EI1)

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Thissoughttomakethesubsequentdispensinglegal,butalsoinvolvedobviousillegality

intheactualwritingoftheprescription.Furthermore,elitesarguedthatsuchpractices

encouraged self-medication through unprofessionalmeans. Hence,many of the elites

notonlyconsideredprovidersresponsibleforthelackofimplementation,buttheyalso

viewedthemtobeprimarilyresponsibleforthediminishedappreciationofthemedical

profession,elaboratedinmoredetailsundersection5.2.1.2.

It was not just in elite interviews that unprofessional practice emerged; some of the

pharmacistrespondentsdescribedsimilarexamplesofdispensingwithoutprescription.

However,theirinterpretationofsuchpracticeswasverydifferent,placingresponsibility

withpolicymakers,whoitwasargued,haveallowedvariableimplementationinprimary

care, andalsowerenot checkingonand recognising suchpractices.According toone

pharmacist, although such ambiguous enforcement was perceived to be common

knowledge,itwasregardedasa:

“[…] public secret that there are pharmacies issuing medicines withoutprescription. I know which those are; I don’t want to mentionnames…patients use it as an argument when they come withoutprescription.Itellthemtogothereiftheycangetitelsewhere”(Ph9)

Thepharmacistbelievedthattherewerefewornorepercussionsforthosewhodidnot

adhere to prudent policy implementation, and were alleged to be abused by those

‘havingconnections’(Ph9).

Itwasnot justpharmacistsbutphysicianswhoalsoengaged innon-standardpractices

thatdidnotfollowthenewpolicy:

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“IfIknowapatientiswelloff,Imightsuggesttobuythemedicineout-of-pocket,ifit’sbetterthantheoneoninsurance…Iissuetheprescription,butitisnotcountedinmymedicines’budget.”(PCP7)

As illustrated in theabovequote,mostprovidersperceivedtheirownbehaviourtobe

justified, anddistanced themselves fromany responsibilityorblame in relation to the

perceived problems of policy implementation. Rather, their opinions cast aspersions

towards other groups – namely policy makers or patients. According to them, their

responsibilitywasminimizedwiththeincreasedregulationthatmarginalisedthemand

their professional autonomy to make independent decisions about prescribing and

dispensing medicines. Among physicians, there was an apparent distancing from

responsibilitythatemergedintheiraccounts,illustratedthroughthequotesbelow:

“Doctors cannot be responsible if there are not enough medicines…Isometimesgooverthe limits,butcannotdo it toomuchandtoooften, Iget lessmoney,which is not patients’ business but I have to care aboutit…’don’tkillthemessenger’,youknow…Iamonlydoingastold,andthey[patients]cangoclaimitabove[totheauthorities]…”(PCP17)

“…youdoyour joband it isnotourfaultthattherearepatientswhogotused to consuming certain quantity of medications; the fault is withcompletelyotherfactor.”(PCP1)

“When theywerewriting them [lawsandbylaws] theyhopefully hadanideahowtheywouldworkinpractice.Idon’tknowiftheyarehappywiththis,butyouknowwhathurtsmost?IfIdon'tpasstheceilingIrisklosingpatients,andifIgoabove,Ilosethecapitation.It’slikethesnakeandthedonkeychoice7(laughs).I’mlike‘fromallsidesGorgisurrounded’8”(PCP6)

Again, similar narratives emerged between the two provider groups, and pharmacists

alsofeltthattheywerenotresponsibleandlevelledconcernsofpolicymakers:

7Idiomreferringtohavingtochoosebetweenoneoftwopooroptions.8FurtherMacedonianidiomthatimplieshavingnooptions.

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“Officials [i.e.policymakers] shouldbe responsible, theyprobablyhad inmind how to execute them when they were writing...And it’s theirresponsibilitytoenforce,toinspect,all…ifIgetavalidprescription,Idon’tthinkIhaveanyresponsibilitybuttodispenseit.Icannottelldoctorsthatantibioticsarenotforviralinfections,let’ssay,theylearntitinthemedicalschool”(Ph10)

Theabovequotessuggestthataswellaspolicymakers,providersalsoconsiderpatients

to bear a large share of the responsibility, based on perceptions of their demands in

relationtomedicines,asthefollowingquotesexplicate:

“…Imean self-treatment is theproblem.You come to thepharmacyandyoutakeantibiotics,youtaketuberculostatic,antiviralmedicine...”(Ph3)

“The other day, a patient came to ask for diazepam, he was obviouslydisturbed;he saidhisdaughterhadanaccidentat school, but, hedidn’tseemtomelikehehadadaughterofschoolage.Itriedtoexplainwhentouse,whennottouse,butIthinkheknewalready,heseemedlikeauser…”(Ph8)

The accountability of patientswas also referred to by policymakers,who considered

patients’behaviourofseekingwaystoperpetuateself-medicationpractices:

“Ipersonallythinkthatthedoctorsprescribedrugsrationally, there isnodilemma.Thepatientsspendirrationallywhentheydecidetobuydrugsontheirown.”(EI5)

“Unless we raise people’s awareness that they cannot simply go to thepharmacy andbuymedicines as if theywere in a grocery store, nothingwillchange.”(EI1)

However,ofnotewasthataminorityofprovidersadmittedthatsomeresponsibilitywas

withprovidersasalreadyillustratedinaquoteofonepharmacistwhoadmittedtothe

practiceofothercolleagues‘issuingmedicineswithoutprescription’(Ph9).Thisreflected

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a minority view, however, and most provider participants believed that the

responsibilityofprovidersrestedwiththeotherprovider.Physiciansreadilytransferred

theobligationforimprovingimplementationtopharmacists:

“Pharmacists shouldn’t dispense without prescription. If I didn’t think itwasnecessary,whyshouldtheythinkotherwise?Itisfortheirbenefitonly,notforthepatient’s…”(PCP10)

Pharmaciststoo,consideredthatphysicianscouldimprovetheirpracticestocontribute

tobetterimplementation:

“Sometimes patients do ask for antibiotics without prescription but Ialways suggest them to first consult a physician…I’m not competent forestablishingdiagnosiswhichiswhyIadvisethem[patients]togoandseeaphysician.Idothesamemyself.”(Ph5)

Patients’ narratives disclosed interesting views on responsibility for implementation.

Theyweremainlyconcernedwiththesatisfactionofprovidingfortheirrealorperceived

needs for medicines. Most patients were vaguely interested in the overall policy

implementationor responsibilitybut admitted tohavingmanaged toestablish regular

practicesofobtainingmedicines– sometimesoutside legalprocedures. Severalof the

respondents,acknowledgedthatdispensingwithoutaprescriptionwasnotappropriate

practice,butthiswasacceptedasanecessityduetoalackofotheropportunities:

“…ifyoucan’taffordtobuymedicinesprivately,youhavetofindaway…”(Pat2)

Although patients were aware that they are not always adhering to the regular

practices, they did not consider themselves directly responsible for lack of policy

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implementation. On the contrary, they used their feeling of subordination as a good

groundforjustifyingtheirpracticesandestablishedroutines,explainedatlengthinthe

thirdthemeofpressuresinpractice.

5.3.4Summaryofthemefindings

In summary, the views of policy makers on the policy changes reflected a forthright

justificationforthenecessityofchanges,althoughitwasadmittedthatimplementation

hadnotbeencompleteandthereforeasuccess.Theirunderstandingofthesometimes

unfavourable position of providers suggested a good degree of insight although,

ultimately,theyplacedtheresponsibilityforthelackofsuccessfulimplementationwith

providersandnotthemselves.Whiledistancingthemselvesfromresponsibilityforpolicy

implementation, they also found patients to be responsible for implementation

problems, throughperpetuatingpracticesof self-medicationand requestingmedicines

withoutprescription.

Patients’standpointdepictedafeelingof lackofcareandfocusontheirproblemsand

concerns when it came to medicines – quite contrary to the perceptions of policy

makers(asthelaterpartofthischapterwillshow)andprovidersaboutthesupremacy

of the patient, safeguarded by the system. To respond to this situation, they had

managedtodeveloptheirownwaysofhandlingthenewsituationoflimitedaccessand

need tonegotiatemedical supply.Theydiscloseda setof justifyingarguments for the

non-adherence and subterfuge of the regular prescribing and dispensing procedures,

anddidnotacceptanyresponsibilityforthat.

Providers considered the lack of implementation to be associated with additional

administrativeworkloadimposedintheirwork,aswellaswithlackofsupportfromthe

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system.Thisbroughtaboutthefeelingofisolationanddetachmentfromthesystem.In

theirview,lackofimplementationwasvaguelyassociatedwiththemselves,andmostly

with the providers outside of their own group. Still they placed the greatest share of

responsibilitywithpolicymakersandpatients.

Overall, it was apparent from all groups that there was lack of willingness to accept

responsibility for the failure of implementation. All groups, with exception of several

respondents, considered the responsibility to be with others, despite some of the

examples clearly pointing to shared responsibility for actions of all stakeholders and

finallyresulting inpolicyfailureofoverprescribing,subterfugeofdispensingpolicyand

encouragingself-medication.

5.4. PressuresinpracticeThis section presents the final group of findings, which are related to another

perspectiveof implementation,namelythediversepressuresexperiencedbyproviders

andpatientsinrelationtomedicinesupply.Presentingthemasaseparateoverarching

themerelating topressures inpracticewas justifiedgivenhow important these issues

wereforthetwogroups.Italsoemerged,althoughtoalesserextent,intheinterviews

withelitestakeholderswhoalsorecogniseditwasofimportance.Thisthirdmaintheme

is further divided into two sub-themes that are framed around the different insights

from providers and patients: one related to providers’ perceived pressures from the

systemand frompatients,and thesecondrelated topatients’perceivedpressures for

negotiatingmedicinesupply.

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5.4.1Providers’professionaldisempowerment

Many providers’ accounts revealed a key emerging theme related to pressures felt in

theirdailywork.Oneofthepressurespertainedtothesystem,andwaslargelylinkedto

the previously elaborated sub-theme of a lack of support in implementation and

detachment from the system. In addition, though, providers described a perceived

pressure from patients in relation to medicine supply, describing it as a lack of

understanding and empathy from patients about the circumstances imposed on the

providers. Inabroadersense,providers’ feelingscouldbesummarizedas loneliness in

handling the situation, in which they had to respond to requirements and deliver on

demandsofbothsidestheyinteractedwith–thesystemandthepatients.Or,asalready

illustrated in the previous section, they described their situation as unfavourable of

being‘fromallsidesGorgisurrounded’9(PCP6).Withthisandsimilarquotes,itappeared

thatprovidersconsideredpressuresfromthesystemandpatientstobeinterlinked–in

their view, the system was encouraging patients’ empowerment, while not equally

supporting providers, as part of the system. As the following quote illustrates, this

notioncame fromtheendorsementofpatients’ rights,at theexpenseof the rightsof

providers:

“Everyone talks about those patients’ rights, nobody says a thing aboutthe doctors’ rights, we haven’t read those anywhere, it hasn’t beenpromotedyet…patientsshouldknowthatwe,too,haverights…”(PCP6)

This quote captures providers’ perception of increased pressure from patients, but it

also suggests an implicit pressure from the system, by not taking actions to protect

9FurtherMacedonianidiomthatimplieshavingnooptions.

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providers’rightsandinterests.Theseperceptionswerearticulatedindifferentexamples

linked to all analysed policy changes. Namely, as described in the quote below, the

enforcementofprescribingceilingpolicyalsobroughttwotypesofpressure–onefrom

thesystemtochangeproviders’prescribingbehaviour,andtheotheronefrompatients,

whosebehaviourproviderswereexpectedtoinfluence,regardingmedicinedemand:

“PatientsarenotinterestedifIhavenobudgettoprescribe,theyfeeltheyhave the right to their medicines, they have paid for their healthinsurance…”(PCP3)

“Somepensionerswereveryusedtomakingstashesoftherapyforseveralmonths, because during the transition years, there were periods ofdeficiency of medicines. It was not easy to persuade them to get aprescriptiononlyforamonth…somewerepersistentsayingitisdifficulttocomeineverymonth…”(PCP5)

In their view, physicians’ position was pressurised from the current policies but also

frompast conduct. The secondquote above exemplifies thesepressures, arising from

theirdualroleofactingonbehalfofthesysteminsafeguarding it,andbeingpatients’

agentsindeliveringgoodqualitycareandprofessionaladvice.

Pharmacists felt similarly regarding pressures from the system and patients. In their

view, the system did not appropriately communicate the new circumstances of

dispensingceilingpolicy to thewiderpublic, causingmisperceptionanddistrust in the

profession:

“We had a lot of trouble at first to explain that they cannot get theirmedicine, that they have to come earlier in themonth...it was like ‘firstcomefirstserved’…sometimeswepostedannouncementsonthewindowthatthemedicinesarefinishedforthatmonth…”(Ph2)

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Related to this, the following short quote, illustrates pharmacists’ perception of

patients’negativityandsuspicionrelatedtothenewpoliciesandspecificallyquotas:

“Iknowthatsomepeoplethinkwearehidingthequotasotobeabletosellthemthemedicines…”(Ph8)

Providers expressed their reluctance to prescribe under pressure, but also admitted a

senseofdefeat,describingitas‘indulging’patientsintheirrequests:

“Itisdifficulttoexplaintoapatient,whenyoucanseeitintheireyes,theywouldnotgoawaywithoutantibiotic…Iwouldotherwisenotindulge,butIdecide to give those the antibiotic…I think it would do no good, but Iprescribeanyway”(PCP14)

“Itellyoungmothersthatantibioticsarenotalwaysneeded,but it isourmentality, an advice from other mothers, they even suggest what toprescribe…I really don’t like when the sentence starts with: ‘a friend ofminetoldme…’Ihaveadesiretosay‘gotoyourfriend’...”(PCP10)

Whilebeingdescriptiveofthepressuresfeltfrompatients,thislastquotealsoillustrates

the undermining of professional autonomy by providers themselves. When asked,

providers justified suchbehaviour again through the lackof support from the system,

describingitthroughexamplesof loosepolicyimplementationallowingpatientstostill

pursuetheirdesiredgoal:

“Our people get easily petty and they could say ‘OK, I don’t need thatprescriptionfromyou,I’llgetitfromanotherphysician’...Soyouprescribe,whatcanyoudo…”(PCP14)

In thepharmacists’accounts, this submission topressurewasalsoarticulated through

variable implementation and ambiguous enforcement of policy regulating dispensing

onlywithprescription.Manyofthepharmacistrespondentsarticulatedthepressurein

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terms of it being the persistence of patients obtaining medicines for their own self-

medicationplan.Inaddition,concernsemergedinrelationtohowtorespondtopatient

pressures when they ask that rules be not observed. Some of the pharmacist

respondents tried to justify the dispensing without prescription, through specific

situation,whichnotnecessarilycouldbeassociatedwiththediscussedpolicychanges:

“Sometimesapatientcomeswithoutaprescription,butweliveinasmalltown, everybody knows everybody. I ask him who is his doctor anddispensethemedicine.LaterIcallthedoctortoaskforaprescriptionandIgofetchitlater,sothatIhavethedispensedmedicinecovered.”(Ph7).

Such accounts reflected a duality and this pharmacist appeared to convey two

interpretations of such occurrences: firstly, that they reflected pressure and this

diminished theprofessional autonomyofproviders,but secondlyandmorepositively,

that this was perceived as an attempt to assist and serve the patient in need. The

majorityofpharmacistsheldtheopinionthatunevenimplementationofpolicieswasa

far more important factor enabling patients to exert pressures to obtain medicines

withoutprescription:

“…if I didn’t [give patient the medicine without prescription], he’d havegonetothepharmacynextdoor,wearethreeinarowifyoulookoutthewindow…”(Ph8)

TheabovequotesfromboththepharmacistandthephysicianrespondentPCP14earlier

(page188),suggestimportantlythattoproviders,simplykeepingthepatientasclientto

the pharmacy or as registered patient in the physician’s roster (and the associated

capitation)wassometimesmoreimportantthanprofessionalknowledgeandintegrity.

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Itwasnotonlyinprovideraccountsthatsuchpressureswereperceived,andasshown

in the following quote, it also emerged in the accounts of elite stakeholders. It was

apparent that they also understood and predicted some pressure and perceived

expectations frompatients,whichpossibly affectedproviders’ attitudes andpractices,

motivatedbymaintainingagoodphysician-patientrelationship:

“…theyprescribe,becausetheyareexpectedtoprescribe…itwouldmakethem look foolish if they don’t, the patient would go to see theneighbour[ingdoctor]ifhemust…”(EI10)

Elites also agreedwith providers that patientswere excessively demandingmedicines

and that such behaviour was one of the most challenging aspects of the policy

implementation.Elites’accountsrevealedthatthegreatestinfluenceonprescribingand

dispensingwasthatexertedbypatients,andthatthiscouldbetracedbacktothepast

whenmedicineswere fully accessible. This legacywas, in their view, additionally and

unintentionallyreinforcedbytherecentpoliciesonpatientempowerment:

“ThoseIcallthe‘informedpatients’(laughs).Theyreadofftheinternetortalk to friends and neighbours, and they all know what is wrong withthem,thenalsoknowthebesttherapy…ortheywouldnotlikethetherapythat thespecialistprescribed,before theyeventook it,because itwasn’twhat they’dexpected, so theyask for referral togo toanotherone…andthis is all covered with the insurance, the first opinion, the secondopinion…Weintroducedthis in2008 inthe lawonprotectionofpatients’rights but the intention was not to enable abuse, rather to give wideraccess…”(EI10)

In their view, such practices continued to exist, in a form of overprescribing and

dispensingwithoutprescription,bothofwhichwereviewedasunethical:

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“The electronic system has a real time information on the so-calledpatient pathways; thatmeanswhere and atwhat time the patients arewiththeirpapers…Weseea lotofantibioticsthere…individually Iamnotconvincedthatallthoseprescriptionswerereallynecessary.”(EI13)

Oneoftheelitesstakeholdersdescribedpatients’exertedpressureasonesupportedby

the ‘aura’ of supremacy of the patient, which was also reflected in their behaviour

towardsthesystemandresponsibleinstitutionsforhandlingtheclaims,asillustratedin

thenextquote:

“There is this aura that the system exists for the patients …in theirunderstanding there shouldn’t be any hesitation to giving them the bestavailable treatment, be it diagnostics, treatments, medicines, medicalaids…We get complaints from patients which are not always grounded,andwhenwerejectthemtheygotothesecondinstance[higherauthoritylevel]...”(EI1)

As noted above, elites considered such behaviour and a feeling of supremacy to be

reinforced by the recently endorsed policies that promoted patient empowerment.

Among other impacts, according to them, these policies enabled a high degree of

freedomofthepatienttomakechoicesthatcouldbesingle-handedlydecidedupon,but

hadimplicationsforphysician’spracticeandevenincome:

“Patients can change their physician as many times as they want, andtherewerelotofrequestsatfirst,sowelimitedittotwotimesperyear…inthebeginning, itwas required tostate the reason forchanging,nownotany more... They don’t even have to inform the doctor that they havechosenadifferentone,allthereistodoistogotothenewoneandsignin, the system automatically removes them from the doctor’s listing, noquestionsasked…thecapitationwillbedeductedfortheremovedpatient.”(EI13)

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This view was consistent with the providers’ concerns about the diminution of their

autonomyand respect for theirprofession,discussedearlier in this chapter.However,

policy makers perceived this reduction in autonomy and respect to also come from

providers themselves, and believed that more should be invested in the continuous

professional development and communication skills of providers in primary care. For

policy makers, the role of education and continuing professional development was

arguedtobekey;intheirview,thephysicianshadsufficientclinicalknowledge,butthey

lackedawarenessofclinicalguidelines. Inaddition,manyof themfelt that introducing

training on communicationwith patientswould be beneficial, for both physicians and

pharmacists,whichwasinawayconfirmedbytheprovidersthemselves:

“Many trainings we had [on rational prescribing] with foreignconsultants…weusedtoaskdoctorswhatwouldtheyprescribegiventhediagnosis.Wewouldgivethemtheexample,I’dask,thiswasthemedicineprescribed in one country, whatwould you have prescribed?…they saidthat it was easier to answer theoretical questions or to raise the color-coded card [with correct answers], rather than telling to the patient…”(EI9)

Insummary,thissectionhaspresentedavariedandcomplexaccountoftheexperiences

andviewsofphysiciansandpharmacistsinprimarycareinMacedoniainrelationtoone

particular aspect of implementation, articulated as pressures in practice. It has been

shown that they appear to be in a difficult position due to dual pressures – upwards

frompatients’pressureandexpectationsanddownwardsfromnewpolicyframeworks.

These, in their view, are exacerbated by a perceived lack of support or guidance in

relation to policy changes, elaborated in the previous sections. Similar accountswere

provided by policy makers, though their views also included proposed solutions for

reducing these pressures through continued professional development and providing

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training for communication with patients. The next section goes on to explore the

experiencesandviewsofpatients,with regards to theirperceivedpressures from the

newpolicycircumstances.

5.4.2Patients’negotiationofmedicinesupply

Thesecondsub-themerelatedtopressuresinpracticefollowingpolicychangeinvolves

patients’ felt pressures under the new policy circumstances. As elaborated earlier,

patientsrelatedcloselytothepastsystem,andsharedexperiencesofseveralnegative

consequencesrelatedtopolicychanges.Inthenewpolicysettingoflimitedprescribing

anddispensing,patientsnolongerhadunlimitedaccesstomedicinesandsupplements,

and in their view perceived themselves to be pressured into engaging in negotiation

overmedicinesupply.Aswillbecomeclear,thiswasmanifestintermsofpressurebeing

exercisedbypatientsoverphysicians inrelationtoprescribingdecisions,andalsoover

pharmacistsinrelationtodispensingmedicineswithoutprescription.

Althougharangeofpatientsandageswerepurposivelysampledinthisstudy,manyof

therespondentshadexperienceof,andcouldrecollect,theprescribinganddispensing

practices in theprevioussystem.Although therewasexplicitacknowledgementof the

necessityof limitationsandcost containment (asnoted in section5.2.2Reflectionson

recent policies: necessity for change and qualified acceptance), patients were critical

when considering the personal impact of such policy changes. Their understanding

appeared tobe informedby theirownpersonalneeds in relation tomedicines. There

was a sense that formany, they did not represent a burden to the system, and as a

result there was a certain entitlement or expectation in relation to medicines and

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therapies.Thiswasjustifiedintermsoftheviewthattheyhadcontributedsufficientlyto

healthinsurancethroughfringebenefits,asonepatientargued:

“…Iworkedfor35years,wasstrongasahorse,nevergotsick,soIthinkIamentitledtothehealthcaretoenablemetoenjoymyretirementforaslongas Iwouldbearound…Itakeaverycommontherapyforhighbloodpressure, I also take prevention for blood clotting… those are all regularstuff,halfofthenationistakingthem,Ithinktheyarenotasexpensiveascancertreatmentforexample…”(Pat12)

Intheirview,accesstomedicinesshouldbeguaranteed,andtheyfounditrathernovel

thatinsomeinstancestheyneededtonegotiateorarguewithphysiciansorpharmacists

toobtainthemedicaltherapy.Ofnotewasthatmostoftheexamplesgivenwereabout

anti-microbialtreatment,usuallyinsmallerchildren.Asthefollowingquoteillustrates:

“Severaltimesthepaediatriciansuggestedwetrywithoutantibiotics,butIknow my child, she is very weak on her throat, and if we don’t reactquicklyitgoesstraightdowntothelungs…Itriedonceanditdidn’twork,we ended up with pneumonia in Kozle [lung disease hospital forchildren]…I know my child and if I think antibiotics are needed, theyusually are…I am not in favour ofmedications, but when it’s needed, itcan’tbehelped…”(Pat9)

Tomanyoftheinterviewedpatientsthisneedtonegotiateformedicinesrepresenteda

newdimension of their relationshipwith the system, and thiswas not just related to

examples like the one above about controversial antibiotic prescribing, but also

medicines forwell-recognised long-termconditions.For thosewhowereon long-term

therapies,themainissueraisedwastheveryrealpossibilityofnotbeingabletoobtain

necessary therapies for longer periods in advance. One patient felt it was a futile

exercise that was not only an inefficient use of time, but was also undermining the

expertisebyaspecialist:

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“I’maheartpatientfor20years;Iknowallmedicines,I’vetakenthemall;I can even tell you which companies’ have better effect… enalapril, forexample,from[…]companyisnoteffective,at leastnotforme,soIstaywith[…]company…Igotothecardiologistonceayear,soItellmydoctor,if the cardiologist thinks that I can go with the therapy that long, whycan’tIgettheprescriptionsatonce?”(Pat12)

Whatthenemergesfromtheperspectiveofpatients,isathreattotheirpreviousability

toobtainanymedicinethroughprescribing,andacurrentprocesswherebyphysicians

appearedtoberestrictingpatients’accesstocertainmedicines.Although,asnoted,not

framedinanexplicitunderstandingorawarenessofthethreekeypoliciesthemselves,

patients nonethelesswere aware of the changes and the negative consequences and

needtonegotiatemore.

Two other patients, referring to the impact that new policies’ limited access to

medicines had on their routines, considered alternative solutions to obtaining the

requiredmedicines:

“IhaveaholidayapartmentinOhridandIgothereforthree-fourmonthsduring summer…so, I ask the doctor to give me the medicines for thewholeperiodbutitisnotpossible…uptothreemonths,yesbutafterthatIhavetocomebacktoSkopjetogettheprescription,becauseIcan’tgetitfrom a doctor in Ohrid…sometimes I decide to buy privately as it is lessbothering to pay than to go back in the heat just for theprescription…sometimes, I ask someone to go to my doctor for theprescription and then anyone traveling to Ohrid will bring it for me…”(Pat1)

“MydaughterlivesinSerbia,andIspendthewinterwithhertohelpwiththechildren…butitismostdifficultwiththemedicines,theyhavedifferentonesandalsoIdon’thaveinsurancethere.So,whenIhavetomakelargerstock, and it’s not easy…some of the medicines are the same as myhusband’s, so I takeprescriptions someonmynameand someonhis togetenoughofthemedicinesIneed.Ileavewithhimsome,andhecangetadditionalpackswhile I’maway…hedoesthesametogetthemedicines,

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someonmynameandsomeonhis…ifyoucan’taffordtobuymedicinesprivately,youhavetofindaway…”(Pat2)

Inthesecondquoteabove,thepatientisdescribingarathercomplexschemeoftrying

tocircumventcurrentpoliciesinordertobeabletocontinuetheestablishedpracticeof

providing sufficient medicine supply that was possible in the past. For the described

situationnotcoveredbythepolicies,thepatientneedsamedicinesupplyforaperiod

longerthantheallowedmaximum,soshecombinedprescriptionswithanotherpatient-

inthiscaseherpartner-tomakeanadvancesupplyinanothername,thatwilllaterbe

coveredbytheprescriptionsinhernameforthesupplyoftheotherpatient.

Thesequotes illustrate twoof thenon-standardalternative routes tomedicine supply

facedbypatientswithinthecurrentprescribinganddispensingpolicies, toeither fund

thesupplyofmedicinesthemselvesprivately,ortousesubterfugetoobtainsupplies.

Forsomeofthepatientsthewearyingnatureofsuchnegotiatedsupplies ledtoactive

attemptstoexerciseachoiceoverprescriber,andsotosearchforanotherdoctorwho

waswillingtoacquiescetopatients’requests:

“I have a very stressful job, Iwas tellingmy previous doctor that I havetrembles all day long if I don’t take Helex [anxiolytic], and that I don’tsleepwell,andItriedallalternativesheoffered,melatonin,valerian,butwithnoeffect.Healsosaidphysicalactivity,butI’mtootiredwhenIcomehome…HesaidHelexisaddictive,butIwasonlytakingoneinthemorningandoneintheevening,sometimesskipped…Heprescribedonceortwice,thensaidIshouldconsultaneurologist.Idecidedtochangethedoctor…”(Pat14)

Negotiating formedicineswas described aswell at the dispensing level. A few of the

patientsdescribedsituationswhentheycouldnotobtainthemedicinedespitehavinga

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validprescription,oftenasaresultoftheunavailabilityoftherequiredmedicineatthe

pharmacy,duetotheexhaustedquotasforthemonth:

“At the pharmacy they would sometimes have only two of the fourprescriptionsIneed,soIhavetogotoanotherpharmacy….itisfrustratingtodoiteverymonth…ImadearrangementwithourlocalpharmacythatIleave the prescriptions with them and they call me in when medicinescome…”(Pat6)

The negotiating at the pharmacy level also happened when there were no genuine

medical reasons. This patient had alreadymade the decision to obtain themedicines

andfoundawaytoeffectherdecisiondespitethecircumstances:

“Here in thevillagewehavenodoctor, therewasonebuthe closed theoffice…nowweonlyhaveadentist…WhenIneedantibioticIhavetogotothetown,andthenget it fromthepharmacyhere,butusually Ican’tgowhenI’msick,I’llgetevensicker…soIaskthepharmacistforthemedicineandIbringtheprescriptionlater…”(Pat14)

Further to this, in the patient group, such necessity to negotiatemedicine supply has

evolved into justification of ‘means’ towards the end goal of providing necessary or

desired therapy for their treatment and resulting sometimes in subterfuge of regular

mechanisms and unethical practices. The above quotes exemplify patients’ practices

alreadydescribedbyprovidersandconfirmedbyeliteswhoalsosharedtheseviews:

“Therearecaseswhenthepatienthasalreadyboughtandconsumedtheantibiotic … For example, the patient has bought himself Vibramycin[branded formof tetracyclineantibiotic] because thedose is onepill perday,itcosts40-50denars[lessthanoneGBpound],fivepills,hewilltakethem and will then come to me and I have no other choice than toprescribethesame…”(PCP14)

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As considered above, patients admitted to actively pressuring providers and

encouraging non-compliance with regular prescribing and dispensing procedures. For

them, this new realitywas a justificationof their practices - previous and current - of

obtaining medicines on their own, especially if they anticipated the physician would

considertheirchoiceofmedicinesnottobenecessary.Theyhaveveryopenlyspokenof

inclining towardsadecisionof takingmedicineswithoutpriorhealthcareprofessional

consultation. Examples were given mainly for antimicrobials and anxiolytics, mostly

amongyoungerrespondentsbuttheelderalike;somereferredtopreviousexperience

withthesamemedicalcondition:

“WhenIhaveasorethroatIknowthatIcan’tsolveitwithoutantibiotics.IusuallytakeVibramycin[abrandedformoftetracyclineantibiotic],ithelpsme every time, and it’s very affordable. I always have a dose at home,‘cause it’s best to take immediatelywhen you feel the scratching in thethroat”(Pat7)

“Idon’tmindpayingforthemedicines,andIdo…itisquickerandeasiertogo to a pharmacy and get what you need…some of the prescriptionmedicines should be without prescription [over-the-counter] if you askme…for example, my husband has a sleeping problem and he takesdiazepamfromtimetotime.Forthat,Idon’tthinkit’ssonecessarytogotoadoctor…Ithinkshouldnotbeonprescription,itseemslikeamatterofmarketing…”(Pat3)

Further,theseandotherrespondentsareseeminglyspeakingofavailabilityofmedicines

asamatterofmaterialpossibilitytoobtainthem;theaboveexamplesrevealdisregard

for the necessity of medical consultation, and provide another explanation for their

straightforward justification of self-medication practices. But, at the same time these

excerpts also disclose that medicines can be obtained without prescription, i.e. that

there are pharmacies enabling this practice. Here too, patients have inclined to

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developing a new skill for identifying such pharmacies where obtaining desired

medicineswasnotproblematic:

“…needed antibiotic for my girlfriend, she was burning with fever andParacetamol[brandedformofacetaminophen]didn’thelp…Theladysaidshecannotgivemeanydrugwithoutprescription,nomatterwhat…Ihadtogotothenextandthenext,andIbought it…Iwasscolded(laughing),butIgotit…”(Pat13)

“Somepharmacistsareverytough,theywouldn’tgiveanythingwithoutaprescription, they tell you that such are the rules, and there are strictinspections…theyareniceandapologizebutwillnotgivein…TherearefewthatIknowwhichsellyouthesamemedicineswithoutaprescription,andfor them there are no inspections... even, they will give you an advicewhichisbetterthantheother…”(Pat10)

Thesetwoquotesillustratethejustification,triggeringthecompensatorymechanismsof

finding their ownways of dealing with the arising issues while at the same time not

feeling the responsibility when those are outside of the normative, legal or ethical

frames.

For one patient the request for a medicine without prescription was justified if

supportedbytheprovider,and,asinthisquote,thiscouldbeforavarietyofmedicines

includingthosewithabusepotential:

“Mywife’smotherwasinterminalstageofcancerandshe[thewife]wasveryanxious,verynervous,Ibecameanxioustoo,Ididn’tknowwhattodo…Iwenttoapharmacyandaskedfordiazepamorsomethingsimilar…theydidn’thavediazepamand[thepharmacist]offeredmehelix[sic],Helex[abranded form of alprazolam, an anxiolytic] … explained the dosage…”(Pat11)

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Elites’ accounts confirmed the above practice of circumventing primary care for

obtaining a prescription, and going directly to a pharmacy with self-medication

intentions,exemplifiedthroughthefollowingquote:

“Still today patients don’t go to the doctor, they go straight to thepharmacy;ifthereareanyfamilytiestheywouldgetthemedicinewithoutany problem…those who want to get the medicines through the Fundregularlytakeprescriptions,butthereisonepart[ofthepopulation]thatdoesn’tbother,obviouslybecausetheycanaffordit.”(EI2)

The above quote also conveys the finding that despite policy changes restricting

unregulatedmedicine supply, obtaining a prescriptionmedicine was still viewed as a

matteroffinancialaffordabilityevenbyelitestakeholders.

5.4.3Summaryofpressuresinpractice

Thethemeofpressuresinpracticerevealedproviders’feltpressuresfrombothsystem

and patients, and patients’ felt pressures for obtaining medicines they deemed

necessary.

Inproviders’accountstherewasanobvioustensionbetweenthenecessitytorespond

tosystem’srequirementsanddeliveronpatients’demands.Thesystem’spressurewas

mainly articulated as an increased pressure to adhere to the new rules under the

conditions of perceived lack of involvement in policymaking and lack of support for

implementation.Thepressurefrompatientswasarticulatedasbothfeltandperceived,

forcingproviders to unwantedpractices of prescribingwithoutmedical indication and

illegaldispensingwithoutprescription.Althoughreluctanttoabide,providersadmitted

to accepting such demands under pressure, which contributed to their feeling of

isolationanddetachmentfromthesystem.

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Whatemerged inpatients’accountswasanewfoundneedtoseekoutandnegotiate

medicine supply both at prescriber level, but also through less regulated pharmacy

supplies.Atensionwasshowntoemergeinpatients’identity,wheretheyappearedto

besomewhatempoweredhealthconsumers,yetstilltreatedpaternalistically.Providers

had opposing views, as they found patients to be unjustifiably empowered andmore

supportedbythesystemthenthemselvesas itspart.Elitesagreedwithprovidersthat

patients’behaviour significantly influencesdecisions inprescribinganddispensing,but

werenegligentofthefactthatfailedpolicyimplementationwasoneofthekeyfactors

enablingsuchinfluence.

5.5. Summaryofchapter

Thischapterhasprovideddetaileddescriptionsoftheemergingthemesresultingfrom

the in-depth analysis of the interviews revealing several key findings related to the

effectsofpolicychangesontheprescribinganddispensingpracticesinprimarycarein

Macedonia.

Allgroupsexpressedapositivityandattachmenttotheprevioussystem,manifestasa

positive nostalgia. This nostalgiawas articulated by providers from the perspective of

professionalautonomyandbelongingtothesystem,andbypatientsaslessproblematic

and unlimited medicine supply in the past. Elite stakeholders also talked about the

benefitsof thepreviouspolicies, andagreed thatprofessionalautonomywas reduced

with the new policies, but also understood the lack of sustainability of that system,

justifyingthenecessityforchangeforimprovementofefficiencyofresourceuse.

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With regards to the policy implementation, all groups similarly believed that thiswas

lacking,howevereachgrouparguedthiswasso fordifferentreasons.Forproviders, it

was a consequence of the lack of their involvement in policy-making, ambiguity of

enforcementand lackof support from the system.Whileproviders largelyquestioned

the policy changes and patients were ambiguous, the views of the elites generally

describedthepolicychangesasbeingnecessary,althoughtheyalsomadecomparisons

to theprevioussystem,whichwasperceivedmorepositivelyasbeing fairerandmore

orientedtowardspatients,thoughnotsustainableintermsofcostefficiency.

Thepatientsontheotherhand,weremuchlessawareofthedetailsanddriversofthe

policy changes, beyond their experience in visiting a primary care physician or a

pharmacist.Whencomparedtothepastsystem,theytoo,felttheprevioussystemwas

muchmoreorientedtoaddresstheirneeds,andwerenotquitereadytojustifythecuts

onprescribinganddispensingunderthehealthinsurance;withtheexceptionofsome,

whohad knowledgeon policies through a personworking in primary care. The policy

makersheldamore forthrightviewthatresultantproblemsassociatedwith thepolicy

changes were attributable to the other groups. They identified perceived problems

amongst providers and patients related to a lack of professional development for the

formerandalackofhealthliteracyamongstthelatter.

Primary care physicians and pharmacists felt detached from the system, expressing

themselves as being left alone to cope with policy implementation. In line with the

feelingofdetachment,anotherimportantissuewasthelackofguidanceandsupportfor

thepolicyimplementation;tothephysiciansandpharmaciststhismeantthattheyhad

to find other ways of dealing with the arising problems, beyond the framework for

whichtheyhavebeenengaged.

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Inadditiontothis,providersfeltdisempoweredandtheirautonomythreatened.Intheir

view, this resulted in a deteriorated appreciation for their profession across society,

whichalsohadnegativeethical implications. Thiswasmanifest in termsof continuing

the practices of overprescribing and supplying medicines without prescriptions. The

elitesstakeholdersbroadlysharedasimilarstandpointtothatofproviderswithrespect

totheabove,butweremorecautiousinjustifyingthesepractices.Onthecontrary,they

distancedthemselves fromresponsibilityandconsidered improving implementation to

beinthedomainofprovidersandpatients.

Anotherimportantthemearisingfromtheinterviewsinvolvedpressuresinpractice.As

alreadynoted,theanalysisofinterviewsrevealeddifferingperspectives,withproviders

feeling pressure from both regulatory and governmental bodies to adopt the policy

changes but also from patients in relation to their expectations and demands for

medicines.Theirrepetitiveandampleexamplesofbeingpressureddepictedchangesin

their relationship with patients; they feel subordinated - to the system, through

privatisationandtothepatientsthroughtheperceivedpatients’supremacyasaresult

oftheirempowermentwiththepatients’rightspolicies.Whilepolicymakerstendedto

generally agreewith providers on the issueof patient pressure, patients’ felt strongly

that the situation was quite the opposite. They described being in an unfavourable

position in their interaction with the system, making the case for their access to

medicines,negotiatingmedicinesupplyandjustifyingself-medication.

Patients also did not consider their relationship with the physicians to have changed

dramatically,butexpresseda feelingofdisempowermentwhen itcametonegotiating

what they argued were necessary medicines. Their attitudes, in fact, appeared to

depend much on their ability to pay for the medicines out-of-pocket, and patients

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openly stated that they would circumvent going to the physician and getting the

prescription, iftheycouldfindapharmacistthatwoulddispensethemedicinewithout

it.Someextremeandnegativeopinionswereidentifiedinthisrespect,capturedinone

respondent’s view that all recentprescribing anddispensing rules andpolicieswere a

‘matterofmarketing’.

Thenextchapterfocusesontheinterpretationofthefindingspresentedinthischapter,

along with further reflection on the emerging themes in the context of relevant

literatureandalsoHabermas’theoryofcommunicativeaction.

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CHAPTER6:Discussion

6.1. Introduction

6.1.1Overviewofchapter

Social science approaches not only provide a means of describing particular socially

occurring phenomena but also offer a way of seeing them that might not be

immediatelyapparent(Cooper2006).Asevidentfromthepreviouschapter,thethemes

identified from the individual respondent’s accounts reflect the lived experiences of

individuals indifferentrolesandoftenatamicro-social level,butalways inrelationto

themacro-levelframingofdifferentpolicyinitiatives.Tothisend,theidentifiedthemes

wereanalysedfromtheperspectiveoftheircommonunderlyingconceptswhilelooking

into patterns of behaviour through individuals’ attitudes and practices, expressed

throughtheiraccounts.

The key task in this chapter is to provide additional context and reflection on these

emergingthemes,andcruciallytorelatethemnotonlytotheextantliteraturebutalso

to relevant theoretical concepts. Thus, beyond the attention to theexcerpts from the

respondents’ individual accounts, provided in the previous chapter, the interpretation

andcontextualisationofthesefindingsinthepresenttimeandmoreimportantlyinthe

theoretical framework chosen for this research is of equal importance and as such is

elaboratedinthischapter.

Thechapterwillreflectthefindings inthecontextoftheHabermasiansocialtheoryof

thesystemandthelifeworld,anditsnotionsof‘selectiverationalization’consequenton

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the growth and dominance of the capitalist economy and state bureaucracy (Brand,

1990), and ‘lifeworld colonization’ consequent on increasing systematisation of

particularareasofthelifeworld, leadingtodeviationfromorstagnationoftheoriginal

purposeofthelifeworldanditscommunicativeaction(Barryetal2001).Bothselective

rationalisation and lifeworld colonisation have direct relevance to understanding the

prescribing and dispensing practices as part of the provider–patient interaction

(Scambler 2001, p.21), and of decision-making in health care in general. Used as a

framework for critical analysis of prescribing and dispensing which are of particular

interest,Habermas’theoryprovidesthegroundsforunderstandingthebehavioursand

thereforepracticesonthepartofbothprovidersandpatients,whoarearguablyinclined

toresistanceoftheirrespectivelife-worldcolonisation.

6.1.2Observations

Before discussing the findings reported in the previous chapter, it is useful to share

some observations from the data collection and analysis processes. One of themost

discernible is that the clearest voices in this study were those of the primary care

providers. Such an observation is very natural since, compared to other stakeholders,

and the interviewed groups in particular, they have to managemultiple interactions,

processes and agents in their roles, described by Jones (2001) as being ‘ambivalent’

between decision making and mediation. In this sense, their engagement in the

interactionswithboththesystemandthe lifeworldneedtobeunderstoodaspolitical

rather than technical (Jones 2001) and this perspective will be used to frame the

discussionthatfollows.

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Thesecondimportantobservationfromtheinterviewswasthatprimarycareproviders

didnot appear tobe comfortableoffering criticismof the systemandpolicy changes;

there was an observable reservation together with disclaimers suggesting that their

experiencemight be only that of aminority. As the interviewswere progressing, the

unfolding stories of their ownandof their colleagues’ experiencesmade them realise

thatinfacttheywerenotsatisfied,butonthecontrary–theyfeltisolatedanddistanced

fromthesystemononesideandpressurizedfrompatientsontheother.However,they

quietly acknowledged an acceptance of policy changes, yetwere not ready to accept

responsibility for failure of implementation, but rather considered themselves to be

subjecttopressuresinpracticeresultingfromthepolicychanges.

Thethirdkeyobservationfromthedatacollectionwasrelatedtoethicalissuesarisingin

policy implementation. It was evident that all of the interviewed groups clearly

understood the unethical nature of some of their practices; however, these practices

wereinmostcasesspokenofinthethirdperson,orasiftheywerehappeningtoothers.

Most apparent were the examples in the providers’ accounts, describing with

condemnationthecasesofprescribingwithoutmedicalindicationordispensingwithout

valid prescription. This partial disapproval could be understood as a search for

justificationforpossiblytheirownpracticesthatwerenotopenlyarticulated,butatthe

sametimeasareflectionoftheapprehensionregardingpossiblesanctionsagainstsuch

practices. As noted in earlier chapters, this was an issue identified by Van der Geest

(1982) in relation to the supplyofmedicines to thepublic from inappropriateornon-

regularactivities. Ineithercase, it illustratesanunderstandingamongstproviders that

some acts were recognised as being unethical but arguably an inevitable means by

whichtodealwiththeambivalentroleearlierdescribed.

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6.2. Thesignificanceoffindingsinthisresearch

Thefollowingsectionfocusesonthesignificanceofstudyfindingsandtheirmeaningin

relationtothewiderliterature.Itbeginsbyelaboratingonthecomparisonsmadebythe

respondentswith regards to the previous system and the current policy context. This

study is argued to have offered a greater understanding of how new policies have

influencedandchangedprescribinganddispensing inMacedoniafromtheperspective

of different stakeholder groups, namely: primary care physicians and pharmacists,

patients and elite stakeholders. Analysis revealed three main themes that are briefly

summarized in the next paragraphs and discussed in more detail in the context of

existingliteraturelaterinthischapter.

In brief, analysis revealed considerable attachment to the previous system. This was

manifest as nostalgia and it will be shown that this is a recognised phenomenon in

transitioncountries,ingeneralandinthehealthsector(Bartlettetal2012;Kamat2008;

McDonald, Waring and Harrison 2006). Nostalgia may offer a way for individuals to

adapt to change and define their identity and given the impact of policy change for

providersandpatientsinparticular.

The findings also suggest a significant difference in the respective understanding of

policy changes from the perspective of providers and elite stakeholders and most

notably policymakers themselves. Part of the explanation for thismismatch could be

basedontherolesofeachrespondentgroup;however,itcouldalsobeinterpretedasa

resultofthelackofcommunicationandproviders’involvementinpolicymaking,which

wasalsoclearlynotedbythisrespondentgroup.Thefindingsfromthisresearchsuggest

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that the attitudes and practices of primary care providers and patients may be

significantfactorsinfluencingtheimplementationofprescribinganddispensingpolicies.

However,findingshavealsosuggestedthattheunevenpolicyenforcement,especiallyin

termsofdispensingwithoutprescriptionplaysakeyroleinpolicyoutcomes.

In this sense, the findings offer a more comprehensive understanding of the policy

implementationgaps andhow the responsibility forovercoming these is perceivedby

thedifferentstakeholders.Namely,theprovidersperceivedthesegapsintermsofalack

ofsupportandguidancefromthesystem,whichcontrastedwiththeaccountsofelites,

whodelineatedtheirroletobeonlythatofpolicymaking.Thefindingsalsosuggested

providers’ and elites’ perceived lack of understanding from patients, regarding the

necessityto implementthestringentrules inprescribinganddispensingbytheformer

and lack of health literacy by the latter. As will be shown later in this chapter, such

tensionshavebeendescribedintheliterature,usingHabermas’socialtheorytoexplain

them(Mishler1984;Britten2001).

A furtherkeyfinding–providers’dualpressurefromthesystemandpatients -willbe

shown to be similar to that previously identified in other research but in some cases

contrasting. A final theme to be considered further and related to the literature

concernedtheeffectsofpolicychangesonboththesystemandthelifeworld.Thiswill

bedonebyfocusingonprovidersandpatientsandtheirrespectiverolesandpositionsin

relationtothesystemandthelifeworld.

6.2.1Reflectionsonpastandrecentpolicies:nostalgiaforthepast

Aselaborated inthepreviouschapter,manyof theparticipants’accountsappearedto

involveareminiscenceandindeednostalgiafortheprevioussocialistsystem.Although

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participants(otherthanpolicymakers)didnotexhibitcomprehensiveunderstandingof

the discussed policies, either previously or at the time of interviews, most of them

articulated a preference for the previous system, viewed as more oriented towards

patients,evenattheexpenseoftheeconomy.Therewasanapparentinclinationofthe

stateinbecomingacoordinatingeconomicentityconsistingofinterdependentinclusive

associations rather than a mechanism of class and political control (Engels 1880).

Bartlett et al (2012) described that health systems in centrally planned economies, at

least formally,provideduniversalserviceandequalaccess.Suchaperception interms

of social theory can be interpreted as the lifeworld dominating the system with its

existence and experience (Habermas 1984). It can be also argued that the ‘voice of

lifeworld’, pertaining to contextual understanding of health subsumed the ‘voice of

medicine’, constructed of technical knowledge and instrumental efficiency (Mishler

1984).

Although it has be argued that the past communist systemwas typified by excessive

state involvement (Rechel 2008; Bartlet et al 2012), such involvement was oriented

towardsmaintainingcommunicativeactionwiththelifeworldandsupportingexchange

towardsmutual understanding betweenmembers of society (Braaten 1991, p.12). As

the findingsof this study indicate, it canbe argued that participants identifywith the

lifeworldratherthanwiththesystem,despitesomeofthem–namelypolicymakersand

providers–representingthelatter.Theexamplesgivenbytherespondentsrevealthat

thepastsystemwascolonizedbythelifeworld,totheextentofneglectingitsbasicaims

ofrationalisation,efficiencyandevencontrol.Andwhilethepastsystemaspartofthe

socialistparadigmcanbeconsideredasuitablefoundationfortheHabermasianconcept

of ‘regulatory ideals’, understood as the social forms to which society can aspire

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(Habermas 1989, p.115), at the same time rationalization of the lifeworld turns back

destructively upon the lifeworld itself (Habermas 1989, p.186). This in a way was

validated by the policy maker group who articulated that changes were not merely

necessary but inevitable, as a result of the perceived and experienced lack of

sustainabilityofthesystem.

Notwithstanding policy makers’ realisation of the inevitability of change, they, along

withprovidersandpatients, expressednostalgia for thepast system.Oneexplanation

for such attachment to thepastmaybe that, in the comparisonsof thepast and the

currentsystem,thedisadvantageofthecurrentisthelackofknowledgeandexperience

withthepastsysteminthecurrenttime.AsnotedbyGarroandMattingly(2000):

‘aspersonstalkabouttheirexperiences,pasteventsarereconstructedinamannercongruentwithcurrentunderstanding;thepresentisexplainedwithreference to the reconstructed past; and both are used to generateexpectationsaboutthefuture.’(GarroandMattingly2000,p.72)

Inotherwords, thetwoarecompared indifferent timeandcircumstances, raisingthe

emotionsofnostalgia, subsequently leading to idealisationofwhat isno longer there.

Conversely, the involvement in thecurrent system is real, and therefore very strongly

experienced as limited possibilities for communicative action in which the lifeworld

attenuates through what Scambler (2001, p.13) terms hyper-rationalized social

participation. Participants become part of interactions strongly confined to legal

exchangeandimmediatereturns,attheexpenseofthinkingandmutualunderstanding

(Crooketal1992,p.28).Andthus,thedistinctionbetweenthetwocomparedrealities

(pastandcurrent)becomessharper,causingtheparticipants–bothpartofthesystem

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andofthe lifeworld–tostrivetowards,andevenact in linewith,thepremisesofthe

pastsystem.

In contrast to theperceptionof thepast, theemerging realityunder thenewpolicies

wasanexperienceoflifeworldcolonisation,whichbecomes:

‘[…] increasingly state administered (“juridified”) with attenuatedpossibilities for communicative action as a result of thecommercializationand rationalization in terms of immediate returns.’(Scambler2001,p.13)

In the views of the respondents, this was particularly expressed as a perceived over-

imposition of the system forcing the participants to engage in their interaction ‘as

parties to contracts rather than as thinking and acting subjects’ (Crook et al., 1992,

p.28).

The notion of nostalgia in transition countries was also described by other authors.

Todorova and Gille (2010) have published a volume of essays on post-communist

nostalgia and its unexpected proliferation across the entire societal milieu, including

health,welfare,andevenmusicandarts(McCracken2015).Rechel(2008)describedthis

as a formofpathdependencyanda continued influenceof the legacyof thepaston

contemporary policy decisions. And indeed, as shown throughout this thesis, thepast

played a significant role in the policy processes, from their development to

implementationandfollowup.Thiswasevidentmainlyintheopinionsofprovidersand

patientswhodescribetheconditionsofthepastsystemalmostuncritically,despitethe

evidence from the wider literature of the socialist-time health systems describing

suffering from lack of patient rights, low quality of care, and little technological

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improvement (Kornai and Eggleston 2001). The effect of this nostalgic longing was

describedbyBoyer(2010),asthe:

‘…veryrealpropensityofEasternEuropetogovernanddirectitsownfutureis powerfully suppressed within a discourse environment where EasternEuropean citizens’ estrangement from the external steering of their socialtransformation is labelled (also autolabeled) nostalgic, where“modernizing”EasternEuropeanelitespersistentlyapologizefortheirfellowEasternEuropeancitizens...’(Boyer2010,p.26)

In health care writing and research, the concept of nostalgia has been utilised and

identifiedfromboth lay(Kamat2008)andhealthpractitionerperspectives(McDonald,

Waring and Harrison 2006) and has been argued to emerge particularly in times of

profound change and transition (Bissell 2005) and is therefore arguably a not

unexpectedtheme.Althoughnotexplicitlyarticulatedassuch in interviews,theuseof

nostalgia may represent a narrative device that helps secure a sense of identity for

participants.Assuch,itisimportantnottoconsidernostalgiasimplyasbeingboundup

in the past, but as a current and powerful psychological means of coping with and

adaptingtochangefor individuals (McDonald,WaringandHarrison2006).Gille (2010)

suggestedthatthisnostalgiainpost-socialistsocietiesis:

‘not “mere” nostalgia, but neither is it false consciousness— rather, it issocial critique,however confused,hidden, subtle, or cautious.’ (Gille2010,p.283)

The findings also suggest that such reminiscence can play a significant role in the

acceptanceandsuccessofpolicies.Thediscourseofnostalgia,the‘longingforthepast’

(Kumat2008)wasstronglypresentdespiteincrementalpolicychangeattemptsoveran

extendedperiodoftime,aswasthecaseinMacedonia.And,asGarro(2001)suggests,

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suchdiscourseof‘personalpasthastobeunderstoodasculturalpast’andbetakeninto

consideration in the processes of policy and decision-making for the present and the

future.Asalsoevidentfromthefindings,personalexperiencesofprovidersandpatients

drawingontheirpersonalpastandpresentcanbeinterpretedascollectiveexperiences

that have influenced prescribing and dispensing at an individual level, as well as the

policy implementationonamacro level.Drawingon the former, the following section

discusses influencesof theseexperiencesonperceptionson recentpolicies,beginning

withreflectionsonprofessionalautonomy.

6.2.2Reflectionsonprofessionalautonomy

Another important themediscerning fromthis research is theproviders’perceptionof

reducedprofessionalautonomy.Physiciansarticulatedthisaspressurefrompatientsto

prescribeevenwhenconsideredclinically inappropriate,and fromthesystemthrough

the imposition of budget ceilings. For pharmacists, professional autonomy was

jeopardized through uneven implementation of dispensing policies, which allowed

patientstoobtainmedicineswithoutprescription.Forbothgroups,thisresultedalsoin

aperceivedreduction inrespectfortheirrespectiveprofessionsfromwidersociety. In

theirviews,thepolicieswereatriggerforreconsideringprescribingpractices,butmore

sofromfinancialandadministrativeperspectivesratherthanfromthepointofviewof

professionalappropriatenessofdecision-makinginprescribing.Someauthorssuggested

that financial (dis)incentives can influence decision-makingmore in terms of changing

thequalitybutnotthequantityofprescribedmedicines(Mossialosetal2004),suchas

prescribing branded rather than generic medicines, or prescribingmedicines that are

noton thepositive-drug lists. The literature in this area is conflicting,however, and it

has been suggested that physicians can influence patient demand, both in terms of

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quantityandquality(Rochaix1993).However,thefindingsofthisstudysuggestthatthe

physicians were not confident in their ability to influence the demand, as a result of

theirreducedprofessionalautonomy.

Theconceptofprofessionalautonomyhasbeenof interest tomedical sociologists for

several decades (Freidson 1970) and although it has focused more on medical

dominance,otherprofessionssuchaspharmacyhavealsobeenexplored(Cooperetal

2012). Elston (1991) distinguishes clinical (or technical) autonomy as the right of the

physicians to set their own standards and devise clinical performance. It is in some

cases, brought into relationwith clinical freedom (Davis 1997), towhich, asdescribed

laterinthechapter,therespondentsalsorelate.Furthertothis,literaturesuggeststhat

prescribing exemplifies clinical autonomy (Davis 1997), predominantly as it represents

one of the core activities of physicians that differentiate them from other health

professionals (Britten 2001). For physicians in British general practice it has been

asserted that ‘prescribing isabattlegroundonwhich the causeof clinicalautonomy is

defended’(Britten2001).

Scambler and Britten (2001) continue the discussion of Haug (1975) to describe this

reduced professional autonomy as a ‘proletarianisation’ and ‘de-professionalization'

processes inwhich physicians are drawn into a factory-like systemof production that

imposes a loss of both autonomy and skills that also affect the physician-patient

relationship.This, in conjunctionwith further rationalisationof themedicalprofession

and increased layknowledgeonhealthhaveundermined the cultural authorityof the

medicalprofession(ScamblerandBritten2001);themoreinformedandcriticalpatients

arebecoming,themoreassertivetheyareindecision-makingrelatedtotheirhealthor

disease. Theproviders in this study felt suchassertivenessas increasedpressure from

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patients,whoweresupportedbythesystem–withtheseandotherpolicies,suchasthe

option to change their providerwithout any formal explanation – to act as agents of

socialcontrolofhealthprofessionals’workanddecision-making(Zola,1972).Providers

perceivedthisasashiftofpower,inwhichtheirpositionofknowledgesupremacyand

monopolywasmarginalized,bothatthelevelofdecision-makingforindividualpatients,

aswellasonamoresystemic levelofpolicyanddecision-making.Thismarginalisation

and the lack of support from the system in policy implementation, articulated rather

stronglyamongtheproviders,isdiscussedinthenextsections.

6.2.3Involvementinpolicymaking

Inadditiontothethemesofnostalgiaandprofessionalautonomy,thethirdkeytheme

discerned from the interviews concerned provider and patient relationships to policy.

This aroseboth in termsof policymaking and also implementation andwasperceived

negativelybyparticipants. In this section, itwill be argued that such findings contrast

withexistingliteratureandtheorybutthattheremaybeopportunitiestoinvolvesuch

groupsmoreactivelyinthefuture.

One of the experiences of the physicians and pharmacists arising from the policy

changeswastheirinvolvement–orrathernon-involvement–inthepolicyanddecision-

making processes. Findings suggest that the practice of involving providers in policy

making is not yet in place, with the exception of a few formal representatives of

professional associations. However, in the views of the respondents, such

representation is not sufficient, as this institutionalized form of ‘problem-solving

discourses on questions of general interest’ axiomatically has only limited scope of

action (Habermas 1996, p.372). They perceived their ideal involvement, in line with

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Habermas’ suggestions, as one enabled by a public sphere characterized by open

political discussion, informed by inputs of expert knowledge (Habermas 1996, p.169).

Theirnarrativesofmarginalisationandsegregationfromtheprocessesofpolicymaking

andpowertomakedecisionswerepointedatthesystem,whichintheirviewfailedto

ensure their participation in the process. In the wider literature, examples of non-

involvementhavebeendescribedmainlyforthenursingprofession(Richteretal2012;

Arabi et al 2014), and explore the possibilities for transforming nurses’ roles and

participation in health policy making, based on their professional experience and

effectivecommunication(InstituteofMedicine2011).

Theliteraturesuggeststhatinvolvementinthepolicymakingprocessofthosewhoplay

a part in implementation increases the possibility for interaction, familiarisation and

ultimately adherence in the process of policy implementation (Kingdon 2003, p. 160;

Dunn2004,p.64;Abood2007).Thus,alongtheselines,andincontrasttothefindingsof

this study of non-involvement of physicians and pharmacists at primary care level in

Macedonia, the wider literature suggests that providers, through their professional

bodies or at organizational level, havebeen verymuch and actively involved in policy

and decisionmaking (Garpenby 1989;Griesler 2012; Yariv 2015). Indeed, as noted by

Buse,Mays andWalt (2012) and drawing on the influential work of Alford (1975) in

relationtostructuralinterests,notinconsiderableinfluenceisexertedby:

‘professional monopolists – the doctors and to a lesser extent the otherhealth professionalswhose dominant interests are served by the existingeconomic,socialandpoliticalstructureofgovernmentandhealthsystems.’(Buse,MaysandWalt2012.p.113)

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Asnoted,itwasnotonlyprovidersbutpatients,too,whoperceivedthemselvesnotto

havebeeninvolvedinpolicyformationorhavingthepossibilityofdoingso.Recognition

of theroleof individualsor thepublicaskeyagents inhealthpolicymakinghavebeen

well documented (Buse, Mays and Walt 2012) and is associated with wider debates

aboutthedemocratisationofpolicymaking.Thereisaconsiderableliteraturedescribing

recent trendsofdemocratisationofpolicymakingprocesses throughexamples suchas

patientadvocacygroupsandpatientandpublicinvolvement(Smithetal2003,p.303).A

furtheraspectofHabermas’theoryofcommunicativerationality–discourseethics-has

been invoked in this area, drawing on his arguments that open dialogue enabling the

publicopinion tobeheardcan lead tomoredemocraticdecision-making (Godinetal,

2007; Habermas, 1987). The main rationale for and value of such involvement is

captured by Farrell (2004, p.41) as one of exploring the differences, in particular,

betweenprofessionalandlayperspectivesonhealthneedsanddemands.Thefindings

ofthisstudyinrelationtopatients,andparticularlytheirnegativeexperiencesandviews

about the system, raise questions as to the degree to which they could have been

includedinthepolicyprocess.Habermas’visionofamoreopensocietyoffersoneway

of achieving this. However, enduring barriers and power imbalances (Buse,Mays and

Walt(2012)maythreatensuchaims.Britten(2008,p.84-85)questionedhowthepublic

obtains information,providingarguments thatmuchof thepolicyprocess is conveyed

behindcloseddoors.Shearguesthatsystemimperativesneedtobechallengedbythe

lifeworld perspectives, including by means of greater patient involvement through

organizedformsofself-helpgroupsandvoluntaryorganisations(Britten2008,p.181),or

even througha system for individual reportingofexperiencedadverseeffects (Britten

2008, p.84). This is particularly relevant to Macedonia, where, as findings have

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suggested,involvementofpatients–andhealthprofessionals–inpolicymakingisstilla

declarative category. Illustrative of this is that in the Governing Board of the Health

InsuranceFundtheonemandatoryseat forpatients’ representative isalwaysgiven to

oneorganization,despitetherebeingover5000registeredcivilsocietyorganisationsin

the country (MCIC 2017). Thus, increasing patients’ involvement in the policymaking

process is advocated, especially in lightof the findings suggesting their influenceover

prescribinganddispensingandtheirself-medicationpractices.Aselaboratedinthefinal

chapter, this could be either through approaches suggested by Britten (2008), or

throughotherformsappropriatetotheresearchedcontext.

6.2.4Lackofsupportinpolicyimplementationanddetachment

Findings have also revealed a providers’ perceived lack of support in policy

implementation,articulatedasa feelingofdetachment fromthesystem.According to

them, policy changes resulted in a separation of primary care from the rest of the

system;althoughtheir rolecontinuedtobeservingpatientswithin thepublicdomain,

theirremovalfromthepublictotheprivatesectorimposedasenseofestrangement,a

notionof ‘themandus’. In thewider literature, this notion, described as professional

isolation,was researched for physicians, nurses (Magola,Willis and Schafheutle 2017)

andcommunitypharmacists(Cooper,BissellandWingfield2009).Professionalisolation

wasargued tostemfromdifferent factors, suchasheavyworkload, limited resources,

andhighexpectationsfrompatients(Szfran2017), leadingto increasedstressandfear

fromprofessionalerrors(Linzeretal2005;Lee,StewartandBrown2008).Cooperetal

(2009)havealsonotedthatitmightbeinimicaltoHabermas’communicativeaction,as

itnegatively influencestheprovider-patientrelationship (Cooper,BissellandWingfield

2009).

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Fromthefindings,itcanbearguedthattheoccurrenceofa‘themandus’notionwasa

resultofprivatisationandotherpolicy changes,but couldalsobeassociatedwith the

reminiscencesofthepast,elaboratedearlier.Namely,forproviderstheprevioussystem

supported communicative action through the ‘no limitation’ on prescribing and

dispensingpoliciesandallegeduniversalityofaccesstomedicines.Itprovidedforsocial

interaction inwhich reachingmutual understandingwas facilitated, at the expense of

materialsuccessandefficiency,whicharetheprimeaimsofthesystem’s instrumental

rationality (Scambler 2001). Thus, introducing limitations on medicines through

prescribing or dispensing – a manifestation of system’s natural inclination towards

instrumental rationality – was perceived by providers as reduced support in

implementationanddetachment.

It canbeargued that through the feelingsofdetachment,providersbecameawareof

theirdualrole–beinganagentforthesysteminachievingstrategicaction,orientedat

successandefficiency,whileat the same timeplayingapart in communicativeaction

towardsreachingunderstandingwithpatientsfortheirwellbeing(ScamblerandBritten

2001).Thedetachmentandprofessional isolationwere interpretedassuperimposition

ofthesystemoverthelifeworld.Thisunacceptedlifeworldcolonisationalsoraisedthe

issueofproviders’identificationwiththeirroleofsystem’sagency,asarguablythisrole

wasperformedbythesysteminthepast.

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6.2.5Perceivedreasonsforinadequatepolicyimplementationand

acceptingresponsibility

A key finding from all respondent groups was the perceived lack of successful policy

implementation.ThiswasalsoshownwithprescribingtrendsovertimeinChapterTwo,

suggestingthatpolicy interventionshavenot ledtotheintendedordesiredoutcomes.

Thereisasignificantbodyofliteratureonpolicyimplementationwhichrecognisesthat

policies do fail often for a variety of often context-specific reasons (Fotaki 2010;

McConnel 2015; Barreto 2011), including economic (Friedman 1982; Snower 1993; Le

Grand2006),political(Coleman1990)andsocial(McConnel2015)ornotachievewhat

wasintended,and:

“[…]itiscommontoobservea‘gap’betweenwhatwasplannedandwhatoccurredasaresultofapolicy.”(Buse,MaysandWalt2012,p.121)

In this research, understandably, each group perceived the lack of policy

implementation from their respective position and roles. For providers, their lack of

involvement in policy formulation was a very serious concern, and in line with the

literature,whichalsosuggeststhatstakeholderinvolvementisasanessentialpartofthe

policyprocessandisintendedtoproduceparticularoutcomesfromitsimplementation

(McConnell 2015). Policy implementation, as the step following policy formulation is

considereda ‘processofcarryingoutabasicpolicydecision’ (SabatierandMazmanian

1983,p.143),whichisactualised,appliedandutilizedintheworldofpractice(Ali2006;

Bhola2004).And,thus,providerstendedtovaluetheimportanceoftheirroleinpolicy

development, given their subsequent key role in implementation. Fotaki (2010)

consideredthatthefactthatpoliciesareoftendesignedas‘socialfantasies’oftheelites,

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and lack of involvement of multiple stakeholders, is a major reason for under-

achievementsinpolicyimplementation.

The under-achievement of policy implementation was perceived by patients through

theirreducedaccesstomedicines,whichisdiscussedinmoredetailinlatersections.For

policymakers,lackofimplementationwasconsideredtobelinkedtolackofproviders’

adherence to clinical guidelines and patients’ health illiteracy. Elite stakeholders

suggested ideas for addressing policy implementation through measures directed at

patients, in improving their health literacy, and providers, in additional training in

current clinical guidelines and improving their communication skills for negotiating

prescribingdecisionswithpatients.Theseareelaboratedfurtherlaterinthechapter.

Therecognitionofpolicyfailurehighlightstheneedtoidentifyandunderstandtheroot

causesorindependentinfluencesthathaveledtosuchfailure(Walsh2006;McConnell

2015; Howlett 2012). Changes of policies follow the initial failure when alternative

policiesareviableandfeasibletoimplement,aswellaswhenthereasonsforthefailure

itselfhavebeenunderstood(Walsh2006).Inthissense,thissectionwillnowattemptto

provideexplanations forpolicy failure, through theperceived responsibility forproper

policyimplementationandthepotentialethicalissuesthatmighthaveinterferedinthe

process.

As already described in the previous chapter, all groups interviewed in this research

provided their views about where the responsibility lay for lack of policy

implementation. Due to their different roles and positions, all groups had different

understandingandacceptanceof responsibility. In summary, forproviders, the largest

share of responsibility lay with the government and responsible authorities; this was

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justifiedbynotingtheirlackofinvolvementinpolicymaking.Tosomeextent,however,

the providers also considered some responsibility to rest with patients, and with

professionalsotherthanthemselves.Patientsweremoreinterestedindenouncingtheir

ownresponsibilitythanwithassigningittotheothergroups.Thepolicymakers,too,in

general distanced themselves from either direct or indirect responsibility for policy

implementation, arguing for their role as being one of policy setting not policy

implementation–astancethathasbeendescribedintheliteratureasdistancingofthe

theoristsbyrejectionofrealism(Llewellyn1996).

Whilemanyfactorsaretakenintoconsiderationinpolicymaking,thereislittlecertainty

into whether the chosen policy options would actually produce any of the desired

effects (Dunn 2004, p.24).When a policy is successful, there is little to be said about

responsibility,asmanywouldclaimtheirinvolvement,contributionorownershipforthe

success,andprobablyrightfullyso,aspolicy implementation indeeddependsonmany

stakeholders and their interests for such success (Howlett 2012; McConnel 2015).

However, it is farmorecomplexandsensitive, sometimesevenpainful, todiscuss the

issue of responsibility in the case of policy failure, or the lack of successful

implementation,as responsibility for failuremaybe linkedtomaterialandevenmoral

consequences (Clark and Wildavsky 1990). It would be easier to discuss this issue if

responsibility solely relates to defined policy implementation protocols. It becomes

more complex when responsibility is associated with discretionary right, such as

‘autonomy’forexample, inwhichprovidersassumeahigherlevelofresponsibilitydue

to their professional knowledge (Scambler and Britten 2001). Further complexity is

added in the context of health, where policy implementation relates to partially

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subjective judgements about a patient’s current health and whether prescribing or

dispensingisclinicallyindicated.

In prescribing and dispensing, several key milestones are important for defining the

responsibility of thedecision.As explainedearlier,multiple stakeholders are involved,

and the transferof responsibilitygoes fromone toanother,or involves severalat the

same time. Delineation of responsibility can be subdivided as follows: the act of

prescribing as a responsibility lies with the prescriber, although it is influenced by a

rangeoffactorsthatwerereviewedearlier;theactofdispensing,ontheotherhandis

with the pharmacist, and is again influenced by a number of factors that have been

discussed.Thepatient’s involvementoccurs throughout theprocess,bringingashared

responsibilitywiththeotheractors.Inthiscontext,itisdifficulttograspthenormative

and ethical aspects of the responsibility for policy implementation. As Britten argued

(2001)inherpaperonprescribingandclinicalautonomy,theresponsibilitycanbespilt

fromonetoanotherstepontheladder(Britten2001),wherethepatientusuallybears

thefinalconsequences.

6.2.6Non-prudentdispensingandillegalmedicinesupply

Datainthisstudyhassuggestedthat illegalpracticesintermsofmedicinesupplyhave

occurredfollowingpolicychange.Allrespondentgroupspointedtothelackofeffective

implementation and associated enforcement of the policy onmandatory prescription

dispensing.Policymakersattributedthistoalackofresponsibilityamongstpharmacists

andpatients.Whyte,VanderGeestandHardon(2002)summarizedthesepracticesat

community level, pointing to a phenomenon of ‘pharmacists as doctors’ wherein

pharmacistsprovideda rangeofmedicineswithout theneed forpatients to consult a

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physician.VanderGeest(1982)arguedthatthereareeconomicandcommercialdrivers,

whichcaninfluencepharmaciststomakesuchsupplies(VanderGeest1982p.211).This

was to some extent confirmed with the findings of this research, with pharmacists

articulatingthenewpolicycircumstancesandintroducingbudgetarylimitationstoplaya

role in making illegal dispensing decisions. But they also recognized the

inappropriateness of this practice and its effects on undermining of their profession.

They justified thepracticeasbeingaproductive tensionbetween the regulatory roles

thattheyplay,andpatient-focusedcare.

Thefindingsalsosuggestedthatpatientsplayasignificantroleinillegalmedicinesupply.

Self-medication practices were found regularly across the accounts justified by the

perceivedreducedpossibilityforobtainingmedicinesandimposedneedfornegotiating

medicine supply. Such practices of obtaining medicines from pharmacies without

prescription have been described in the literature as a global phenomenon, including

Europe(Oreroetal1997;GonzalezNunezetal1998;Contopoulos-Ioannidisetal2001;

Mitsietal2005;Stratchounskietal2003;BorgandScicluna2002),andEasternEurope

specifically(Grigoryanetal2006;Versportenetal2014).Mostofthesestudiespointto

thelackofenforcementofpoliciesasthemainenablerofpracticesinvolvingthesupply

of medicines without medical consultation. Some of them, however, suggested that

pharmacists’perceptionoftheirunderestimatedroleinconstructinghealthcouldbethe

driverfortakingadditionalprofessionalroles(Caamanoetal2005).

Thisstudyoffersasimilarexplanationand,asalreadydescribed,therewasanidentified

lackofpolicyenforcement.Inadditionfindingsinthisstudysuggestedthatpharmacists

recognizedunder-appreciationof theirprofessional role, implyingthatsuchmightalso

betheunderlyingreasonforpursuingillegalmedicinesupplypractices.Anotheraspect

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that should be taken into consideration is pharmacists’ felt pressures from patients.

Borg and Scicluna (2002) found that inMalta, pressuresoverpharmacists todispense

without prescription were higher than pressures on physicians to prescribe without

medicalindication(BordandScicluna2002).Allofthesepolicyimplementationaspects

werealsofoundinthisresearchtohavebeenneglectedbythesystem,feltbyproviders

alsoaspressuresfromthesystemandthesearediscussedinthenextsection.

6.2.7Providers’perceivedpressuresinpracticefromthesystem

Providers’perceivedsystempressuresweremainlyarticulatedasanincreasedpressure

to adhere to the new rules under the conditions of perceived lack of involvement in

policymaking and lack of support for implementation. There was an obvious tension

betweenthenecessitytorespondtothesystem’srequirementsanddeliveronpatients’

demands.Furtheraddingtothistensionwasproviders’perceivedlackofsupportfrom

the system in acting upon reducing the levels of medicine supply patients were

accustomedto. In this finebalancingact,providers feltprofessionaldisempowerment,

associatingitwithreducedclinicalautonomyinprescribing,re-enforcingBritten’s(2001)

notionofprescribing,alsomentionedearlierasa ‘battlegroundonwhich thecauseof

clinicalautonomyisdefended’.

Explanation of professional disempowerment could be offered using Mishler’s

operational concepts of ‘voice of medicine’, representing technical, decontextualized

scientific assumptions of medicine, and ‘voice of lifeworld’, pertaining to contextual

understandingofhealth issues (Leanzaetal2013),professionaldisempowermentwas

associatedmainlywiththesystem’srequirementforproviderstorepresentthe‘voiceof

medicine’ in exercising rationalization and lifeworld colonization (Habermas 1984),

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whereas in providers’ view the system itself was inclined to support the ‘voice of a

lifeworld’ – articulated through intensive promotion of patients’ rights and imposing

huge penalties on providers. Although reluctant to abide, providers accepted such

perceived distortion of roles, which contributed to their feeling of isolation and

detachmentfromthesystem,discussedinearliersectioninthischapter.

6.2.8Providers’perceivedpressuresinpracticefrompatients

The findings suggest that primary careproviders experiencedual pressures fromboth

the system and patients. The pressure and expectations from patients were not

necessarily related only to policy changes, although the findings suggest that the

changedpolicycontextexacerbatedthese,makingtheproviders’positionmoredifficult

in addressing them. There is ample literature on pressures and expectations from

patients during prescribing; these pressures are cited as a barrier to evidence-based

medicineandaperceivedcauseof irrationalprescribing (Butleretal1998:Youngand

Ward 2001; Lewis and Tully 2009). Lewis and Tully (2011) consider several causes of

increased pressures and expectations from patients; in particular, patients’ right to

involvementindecisionsabouttheircareandageneralriseinconsumerism,which‘may

have inadvertently facilitated a rise in public expectations of health care and, hence,

patientdemand’(LewisandTully2011).Thefindingsofmyresearcharelinkedtoextant

literature, inparticularstudiesconfirmingpatients’expectationsandtheir influenceon

prescribing (Cox et al 2007; Britten and Ukoumunne 1997; MacFarlane et al 1997;

Cockburn and Pit 1997), and physicians ceding to patients’ expectations (Little et al

2004; Kumar, Little and Britten 2003); both of which have been associated with

unnecessary prescribing and overtreatment (Stevenson et al 2000). The literature

suggeststhatpatientscometothephysicianwithcertainexpectations,andthepatients’

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influenceonprescribingisfarmoreevidentwhenpatientswanttheprescription,rather

thanwhentheydon’t(Britten2008,p.134).Patients’expectationsinthemselvesplaya

role(Kravitzetal1996),butsotoodoestheawarenessorperceptionofthephysician

aboutthoseexpectations(Raoetal2000;Butleretal1998).

ScamblerandBritten(2001)usedthe‘de-professionalization’thesis,whichisfocusedon

changes in physician-patient relationships, arguing that the increase in lay knowledge

andreducedtrust in theprofessions ledtorejectionof thepaternalisticapproachand

acceptance of consumerist behaviour in health care (Roter and Hall 1992). Habermas

speaks of ‘grammar of forms of life’ (1981, p.33, 36) in the sense of changing

relationshipsof knowledgeandpowerbetweenordinary citizensorpatientsand their

professionals, as a result of the increasing inclinationof professionals towardspolitics

andpower,andreducedtrustofpatientsintheirexpertjudgements.

Inthissensetheinfluenceofincreasedlayknowledgeandreducedtrustinprofessional

knowledge should not be underestimated (Scambler and Britten 2001; Curry 1996),

given that they play a part – through the patient – in individual decisionmaking and

negotiation for medicine supply, manifest as improper policy implementation at a

systemlevel.

In addition, findings suggested providers’ decision-making to be challenged by

empowered patients and their intention to actively participate in prescribing or

dispensingdecisions.Thiswasalsofoundinprimarycaresettings inCanada(O’Connor

et al 2003) and Australia (Davey et al 2002). InMacedonia, such empowerment was

negativelyassociatedwithprofessionalautonomy,discussedearlierinthischapter.

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It couldbeargued thatpatientempowermentalso comes from increased information

access through the Internet and further rationalisation of medical knowledge and

practice (Scambler and Britten 2001). Thus, the communicative action between

providersandpatients isbecomingmorecomplexandrequiresadditionalskills(Coxet

al 2007; Britten 2008). Elite stakeholders’ accounts suggested the need for providers’

improved skills in patient communication for conveying messages of professional

knowledge in lay language terms. Improvement of providers’ proficiency in

communicatingwithpatientsregardingprescribingdecisionsmightbeunderstoodasan

attempttoregainthebattleoverprofessionalautonomy(Bondetal2012;Elwynetal

2003;Weller2012;Stenneretal2011).

6.2.9Patients’perceivedpressures:Negotiatingmedicinesupply

Thefindingssuggestedthatpatientsalsofeltpressurisedbythenewreality.Likeother

participants, patients too felt nostalgia for the past, but appeared to have developed

strategies for managing the current situation, which for them was characterised by

limitedaccesstomedicines,andthereforethenecessity tonegotiatemedicinesupply.

Asapparentfromtheiraccounts,theyhaveusedloosepolicyimplementationasabasis

for establishing and maintaining such practices, including obtaining multiple

prescriptions and prescriptions on another patient’s name and self-medication. Thus,

despite the lack of patients’ knowledge of the overall policies and their expressed

dissatisfaction with the consequences of the reforms, it can be argued that they

acquiredskills tonegotiatefortheirmedicalsupply, throughpressureonphysiciansor

pharmacists.Throughthisprocess,theydevelopedasetofjustifyingargumentsfortheir

non-adherence and subterfuge of regular prescribing and dispensing procedures. As

notedearlier, forpatients,evocationsofnostalgiamayalso reflect identityclaimsand

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alsoattempts tomanage the scaleof such changes for individuals’ lives; changes that

may have led to new found responsibilities to obtain medicines that require

considerableunderstandingandinsight intosupplysources. Incurrent literature,there

are studies resonating with this finding (Ford et al 2003; Gattellari et al 2001). The

perceived necessity for over-involvement in prescribing decision making or self-

medicationmightbeduetoadocumentedphysicianunderestimationofpatients’desire

to participate (Cox et al 2007) or patients’ dissatisfaction from not achieving their

desired role in decisionmakingwhen consultingwith physicians (Ford et al 2003). To

overcome such challenges, Mishler (1984) suggested that: ‘achieving humane care is

dependent upon empowering patients’ (Mishler, 1984, p.193), which could be done

through increasingtheir involvementandactiveparticipation indecision-makingabout

theirownhealth(Mishler1984;ScamblerandBritten2001).

The following section discusses the influences of prescribing and dispensing policy

changesthroughtheHabermas’perspective,bearinginmindtherelationshipsbetween

andidentityofthedifferentparticipantgroups.

6.3. Medicinesupplypolicychanges-aHabermasianperspective

This thesis has provided a range of empirical insights into prescribing and dispensing

policychangeinMacedoniaandhasatseveralpointsmadereferencetotherelevance

of Habermas’ various theories. In this section, a more sustained attempt is made to

expand on such theory in the context of the findings with the aim of indicating how

many aspects of the identified themes can be viewed though Habermasian concepts.

More specifically, and given the inherent normativity in Habermas’ work, it will be

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argued that important aspects of his ideal construction of society and associated

mechanisms offer insights into howmedicine supply inMacedonia could not only be

conceptualisedbutimproved.

6.3.1ConsideringparticipantgroupsthroughaHabermasianperspective

Linkedtotheprecedingsectionshasbeenconsiderationoftherespectivepower(orlack

ofpower)ofdifferentgroups–whetherthisisproviderswhoareexcludedfrompolicy

change, or patients who are now empowered health consumers who must seek out

sources ofmedicines in contrast to previous systems. Although not anticipated in the

design of this study, involving these different participant groups in interviews may

perpetuate or reinforce the separate nature of their status and involvement in

prescribingandsupplyofmedicines.Withtheexceptionofpatients’perceivedpressure

uponprescribingfordoctors,itispossibletoviewtheseasquiteseparategroupsbutin

the literaturecloserconnectionshavebeen identified.ForBritten(2008), forexample,

physiciansmaybecapableofsupportingpatientsusingaHabermasianperspectiveand

simultaneouslybealsoable to sidewith the ‘state’ andgainmutualpower fromsuch

links.As a result, thedifferent groupsmayoperatewith additional links and resulting

powerdynamics:

“Even in private systems of heath care, there are common interestsbetween the state and health professionals if only in terms of statelegitimization of professionals’ claims and the social management of illhealthby legitimatingworkabsence forexample. […]Theymayalso seetheirroleinpartaspatientadvocatesandthereforerepresentativeofthelifeworld in thepublic sphere.However, these claims to act onbehalf ofpatientsmayalsoserveprofessionalinterests.”Britten(2008p.180)

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A further concern related to this and not captured in Britten’s quote above10is that

healthcareprofessionalsarealsoindividualsanditisarguablyincorrecttoviewthemas

beingonlyrepresentativeofthesystem.This isan importantconcernandthroughthe

datapresentedinthisstudy,ithashopefullybecomeapparentthathealthprofessionals

atthemicro-levelexperiencedifficultandpersonalsituationsandthreatstotheirwork

and identities. The significance of this need to distinguish between individual health

professionalexperienceandthehealthprofessioniscapturedbyGreenhalghandHeath

(2010),intheiruseofaHabermasianperspectivewhentryingtounderstandtherapeutic

relationships:

“The‘micro’ofinterpersonalrelationshipslinkwiththe‘macro’ofsocietyand state. In other words, any particular GP–patient encounter is aproductoftherolesof‘GP’and‘patient’inwidersociety,andisinfluencedbywiderpoliticalandeconomicforces.”GreenhalghandHeath(2010,p.1)

In this sense,Waitzkin (1991,p.83-92)makesan important contribution,arguing that

therapeutic relationships between doctors and patients can only be comprehensively

understoodiftheyareconsideredwithinthebroadersocialcontextsandstructures,so

as to understand whether they are based on communicative action oriented at

understandingoronstrategicactionorientedatsuccess(Habermas1984,p.289).

A final point in relation to this positionality of the participant groups concerns the

inclusion of a range of elite stakeholders (policy makers) and as noted earlier, it is

importantnottoover-statesomeoftheirclaimsaboutprovidersorpatientsbutinstead

toreflectmoreonwhytheyholdsuchviews.Thechoiceofelitesreflectedadesireto

includeperspectivesfromseveraldifferentareas–industry,government,andacademia

10SeeScamblerandBritten2001foramoredetaileddiscussionintermsofthedoctor-patientrelationship

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–andas such thesemustnotbeviewedasbeingeithermoreobjectiveornecessarily

moreinformed.

6.3.2Systemandlifeworldperspectives

Asalreadydiscussed inprevious sections, it canbeargued thatHabermas’ theoretical

constructionoftherelationshipbetweensystemandlifeworld‘justifiestheexploration

ofrationalitiesineverydaylife’(WilliamsandPopay2001,p.41).Assuch,itcanthenbe

used as a theoretical concept to understanding prescribing and dispensingwithin the

alreadyexplainedmedicinesupplypolicychanges.Inthisrespect,severalkeyissuesare

consideredaspartoftheexplorationofsuchrationalitieswithregardstothefindingsof

thisthesis:the influenceofpoliciesonthe interactionsbetweentheprovidersandthe

system,provider-patientrelationship,andchangesofattitudesandthereofpracticesas

aresultoftheimposedpolicychangesandconstructedrealities.

Asalreadyestablishedinthefindings,thereisevidentinfluenceofthepolicychangeson

the interactionsbetween theproviders and systemononehandand the lifeworldon

theother.Withinthesecomplexinteractions,theprovidersareactingasamediatorin

the dialogue between the lifeworld, represented by the communicative reason of

languageandculture,andthesystem,representedbyinstrumentalreasonofpowerand

resources(Habermas1987).

The system’s perspective on the policy changes has been one of necessity; increased

efficiency of resource use is central to the rationality process, and has been pursued

through further formalisation of relationships, in particular the juridification of

prescribing and dispensing. The findings suggest that there is an intention towards

further structuring and imposition of the system over the lifeworld. As described by

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Britten (2008, p.19), the ‘colonisation of the lifeworld’ (Habermas 1987) occurswhen

systemimperativesbegintodominateanddisruptthe lifeworld,gradually imposing its

systematisation.Cuffetal(2006)viewthisasaprocessofreshapingofthelifeworldin

systems’terms.Thesystemismoreinclinedtothestrategicratherthancommunicative

action,pursuingwhatcanbecalledanulteriormotive forachievementof itssetgoals

usingthenecessarymeans.

The lifeworld perspective of the policy changes has been one of reduced space for

communicative action and exchanges for mutual understanding. The new policy

environment was considered as one distancing the providers from the patients, by

settingbarrierstotheirmutualunderstanding.Thecurtailingpolicieshavedisabledthe

‘ideal speech’ described by Habermas (1987), which implies the non-existence of any

coerciononcommunicativeactionexceptthepowerofthebetterargument.Although

already established in the literature that such a situation is not entirely achievable in

practice (Barnes et al 2006; Hodge 2005), the reminiscence about the interactions of

providers andpatients in thepast suggested their belief in the existenceof the ‘ideal

speech’situation,inwhichbothprovidersandpatientshadtheirperspectiveonhowthe

mutualunderstandingwasachieved.

Providers’ belief that their relationship with patients had not changed arguably

suggestedsomedegreeofattachmenttothelifeworld.This isperhapsunderstandably

so, as the findings also suggested their distanced relationship with the system, with

which they are legally and normativelymore bound compared to patients.While this

situationofoccupyingamiddlegroundbetweenthepatientsandthesystemisevident

from the setup of the health systems in general, the feeling of ‘middleness’ of the

physiciansalsoappearsstronglyasconclusionfromtheliterature(ScamblerandBritten

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2001; Higgs and Jones 2001; Scambler 2001). The detachment from the system

identifiedinthisstudymightalsobeconsideredascontributortoenhancedproximityto

thelifeworld.

The above highlights the debate around the plausibility of the patients feeling

themselves to be informed enough to participate in decision-making (Cox et al 2007;

Britten2008).Theliteratureinthisareasuggeststhatinrecentyearsthetrendofsimply

followingtheinstructionsofthephysicianwhoisregardedastheonethatknowswhat

is in the best interest of the patient (Emanuel and Emanuel 1992; Street 2001), is

replacedbyapartnershipproducingcommunicativeactionbetweenthephysicianand

anempoweredwell-informedpatient in reachingunderstandingondefiningwhat that

bestinterestisandhowitcanbeoptimallyachieved(Waldetal2007;Streetetal2003).

But, as discussed earlier, although trends of decision-making ‘democracy’ are slowly

becomingarealityforpartofthepopulation,stillthepaternalisticrelationshipremains

widelypracticedacrosstheMacedonianhealthcaresystem.

In summary this section has suggested that the findings of this study reflect similar

situations in other countries and health systems and moreover that a Habermasian

perspectivecansimilarlybeconsideredofvalueinframingthevariousthemes.Several

issues related to the literature give suggestions as to how thingsmaybe improved in

Macedonia inthefutureandareconsidered later inthischapter.Beforedoingso, it is

necessary to reflect on the overall process and consider reflexively and transparently

strengthsandlimitationstothisstudy.

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6.4. Methodologicalchallengesandlimitationsofthestudy

6.4.1Methodologicalchallenges

Throughout this research I have encountered a number ofmethodological challenges

that have taught me that a pragmatic approach in doing research is very important,

whilemaintainingscientificrigourandobjectivity.InthissectionIbrieflyconsidersome

ofthese,astheymightprovideadditionalclarityregardingthemethodologicalchoices

madeduringtheresearch,whichinevitablybroughtsomelimitationstothestudy,also

discussedinthissection.

The first challenge that I encountered was regarding the access to certain forms of

proposed data. As explained in the methodology chapter, the initial proposal was to

conductamixed-methodsstudy,inwhichthefindingsfromthequantitativedataabout

trends in levels of medicines prescribed and dispended would complement the

qualitative part so as to be able to specifically understand and research in depth the

mostimportantfactorsinfluencingprescribinganddispensinginthecountryofinterest.

However, due to anumberof factors, suchasunavailabilityof reliableor comparable

dataforthestudyperiod,aswellas lackofresourcestoretrievethedatafromthe20

yearsofpaperarchives,thisinitialapproachwasreconsideredandadecisionwasmade

to focus on a qualitative study, in which the factors of influence would be first

researched theoretically and empirically from the existing literature, and the findings

wouldinformtheinterviewguidesfortheresearch.However,toillustratethesituation

intheresearchedcontext,Ihaveprovidedasummaryoftheavailable,butincomplete,

data on prescribing. These data, described in Chapter two, not only confirmed the

hypothesissetforthequantitativeanalysis-thatdespitepolicychangestheprescribing

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levels remained unchanged or showed a growing trend - but also raised questions,

whichIhopetobeabletoinformthroughotherresearchactivitiesinthefuture.

Thesecondmethodologicalchallengewasthelanguagebarrier.Whileit ismucheasier

todoquantitativeresearchindifferentcontextsduetotheuniversalityofthelanguage

ofnumbers,inqualitativeresearchitisfromthesubtlenessofthecommunicationofthe

languagethatsometimesthemostimportantfindingsemerge.Inthissense,whilewith

the full support frommy supervisors, it has been unavoidable that Iwould have sole

responsibilityfortheanalysisandinterpretationofthequalitativedata.Understanding

thatthefinessesareimportant,andthatthe‘devilisinthedetail’,Ihaveconsidered,as

explained in the methodology chapter, all possible strategies to avoid as much as

possibletheinfluenceImighthaveonthedata interpretationandtranslation,through

mypersonalbeliefsandattitudes,myknowledgeandexperience.

Another methodological challenge that I faced related to my knowledge of and

experienceinthecountryofinterest.Professionalandpersonalcontextsaffecttheway

research isundertaken. Inthe literature,aresearcherwithfamiliaritywiththecontext

and people being researched is defined as an insider-researcher, and due to their

specific knowledge and position, this issue requires due attention. The insider is

‘someonewhosebiography(gender,race,class,sexualorientationandsoon)givesher

[sic]a livedfamiliaritywiththegroupbeingresearched’(Griffith,1998,p.361),andas

suchhas a uniqueposition to study a particular issue in depth, froma perspective of

different knowledge, and easier access to people and information that can further

enhance that knowledge (Costley 2010, p.7). And, as a researcher works with the

participants and data to create an interpretation of their reality, an insider position

couldbeviewedaspotentiallyenhancing,asan insider’sknowledgecouldbevaluably

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used toobtain richerdata.With this inmind, I considered thebenefitsof the insider-

researcher position and the insights it offered were ultimately an advantage for this

research.However,ontheotherhand,theinsider’sknowledgecouldalsoinfluencethe

research in a negativeway, if the researcher’s pre-understandings guide or dominate

theresearchprocess(Finlay2003).Sinceinsiderknowledgecouldbebothabenefitand

athreat,asprincipalresearcherIfeltthatIneededtoconsidermypositionthroughout

the entire research process.Whilst being ‘insider-researcher’ has possible benefits in

terms of access to participants and rapport, it can lead to difficulties. Making

assumptionsand treating some topicsas tacitwaspossibleandmayhave led to their

under-representationandalsoinfluencedhowsomeparticipantsinteractedandoffered

accounts. In this respect, keeping the reflexive journal and immediate transcribing of

interviews helped me a lot, since I had a chance to observe these interactions and

reconsider the approach if I felt that the insider influence was interrupting the

interactive process with the respondents. Throughout this process, and as described

earlier, Gadamer (1996, p.360) was a useful resource through his emphasis on the

essenceof thecontinuingactivityofquestioningand reflectingonbothquestionsand

responses.

6.4.2Limitationsofthisstudy

Scientific rigour also requires to recognise and give due consideration to limitations

associatedwiththeresearchprocess.Thissectiondeliberatesonthelimitationsofthis

study.

One limitation relates to the time period over which this study was undertaken and

particularlythedatacollection.Thepolicychangesatthecentreofthisstudyoccurred

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during 2005 and 2011 and interviews were conducted between 2014-2015 and this

reflects twopossible limitations: one is that the interviewsmayhavebeen shapedby

somedegreeofrecallbiasandtheotheristhattheviewsandexperiencescapturedmay

notreflectthosecurrentatthetimeofwritingthisthesis.

Anotherlimitationtothisstudywasthesampling.Whiletheuseofpurposivesampling

wasconsideredanappropriatewidelyusedsamplingstrategyinqualitativeresearch,it

hastobepointedoutthatithasitsdisadvantages,inparticularrelatedtoeverpresent

concernofpossiblynotreachingsomeparticipantswhomaynotwanttheirpotentially

negativepracticetobemadeknown.

Afurtherlimitationofthisstudywasrelatedtovalidationofthefindings.Aselaborated

inearlierchapters,quantitativedatawasdifficult toobtainandthusamixedmethods

studycouldnotbeconducted.Inaddition,theobservationmethodwasalsoconsidered

at the initial stage, but due to legal limitations of privacy protection of patients, such

methodwasrejected.Asaresult,triangulationoffindingswasnotpossibletoperform,

and this study relies on self-report and researcher’s analysis and interpretations of

collected data. All of the above limitations open space for further and improved

researchinthisfield,towhichthenextsectionisdedicated.

6.5. FutureresearchquestionsIn this thesis I have explored the effects of recent policy changes on attitudes and

practicesrelatedtoprescribinganddispensingintransitioncountries,throughanalysing

thespecificcontextofMacedonia.Thisresearchwasbasedonqualitativeinterviewsand

interpretation of the findings using existing social theories, and in particular the

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Habermas’ social theory of system and lifeworld. In the process I have arrived at the

findingspresentedabove,whichgaverisetofurtherresearchquestions.Thepurposeof

this section is to summarise possible research questions around prescribing and

dispensingpoliciesandpracticesintransitioncountries.

Futureresearchbasedonthefindingsfromthisstudyarearguedtobepossible inthe

followingmethodologicalandtopicrelateddomains:

1. Expandinguseofqualitative research inhealthcare forunderstanding societal,

cultural and other factors influencing decision-making, and prescribing and

dispensing practices and behaviours in the transition countries, and in

particular:

a. Understanding the cultural influences of the past system and its effects on

presentpolicydevelopmentandimplementation;

b. Exploring the current power dynamics in policymaking, in particular involving

suppliers,providersandserviceusers;

c. Exploring the current and potential patient participation modalities for

democratisationofhealthpolicyanddecisionmaking;

d. Exploring the influencesof the supply side, inparticularof thepharmaceutical

industry,ondecision-makinginprescribinganddispensing;

e. Exploring the practices and attitudes in prescribing and dispensing at other

levelsofcare,especiallyhospitalsandotherin-patientfacilitiesandresearching

howpolicychangesinotherlevelsofcarehaveaffectedprescribingpractices.

2. Extending quantitative research in order to better estimate actual levels of

medicineconsumption,andinparticular:

a. Exploringmedicine consumptionatprimary care level,with a focusonout-of-

pocket medical supply, to assess the influence these policies have on the

economicandsocialwelfareofpatients;and

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b. Exploring non-prescription dispensing, to identify pockets of non-prescription

dispensing thatwill inform the policymaking process for addressing potential

policygaps.

Expandingonpoint1above,thebodyofknowledgerelatedtothehealthconsequences

ofpoliticalandeconomictransitioninpost-socialistsocietiesisgrowinginrecentyears

(PerlmanandBalabanova2011;McKeeandNolte2004;Aleshkinaetal2011;Jakaband

Kutzin 2009; Versporten et al 2014). As the literature review indicated, qualitative

methodology is not widely used to explore societal phenomena in post-socialist

economies.Thismayberelatedtothepriorityofanalysingtheimpactofchangesonthe

economic indicators traditionally used to measure the success of a democracy or

welfare state (Choe2011). Following thepresent study, I suggest that future research

mightmakegreateruseofqualitativemethods,astheymightprovideadditionalinsights

and more in depth understanding of why and how certain changes are perceived,

accepted and implemented in practice. There are, however, challenges to qualitative

research;domesticresearchersespeciallystilldonotfullyrecogniseitsabilitytoaddress

a wider range of questions through collection of richer and more authentic data

(O’Cathainetal2007;FossandEllefsen2002);whileforotherresearchersthelanguage

barriermaybe consideredaproblem.However, aswith this thesis, theseperceptions

arechanging(Kaaeetal2016),andinthefutureit isexpectedthatmorefocuswillbe

placed on qualitative research in these countries, which could potentially reveal new

knowledge on the perceptions, values and the meaning of health in transitional

contexts.And,asScambler(2001)encourages:

“Onegeneralramificationoftheprecedingdiscussionfor‘futureresearch’isperhapsworthreiterating.Thepositivistmethodsstilladoptedbymanymedical sociologists tackling health inequalities, especially but not

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exclusivelyinthequantitativevein,haveunsurprisinglyhadalimitedyield.What is required in their place, it has been contended, is a critical andpost-positivist mix of theoretical, conceptual and methodologicalinnovations.”(Scambler2001,p.110)

6.6. SummaryofchapterAsstatedearlier,therearemanystakeholdersinvolvedintheprocessofprescribingand

dispensing - government, prescribing physicians, dispensing pharmacists, patients and

the pharmaceutical and insurance industries. Yet, the link between them is the

prescribingphysiciansanddispensingpharmacists,whoarealsothekeydecisionmakers

on the demand-side of the pharmaceutical market. Thus, it is very important that

physiciansapproachprescribingasthe:

“appropriate choiceofmedicinenotonly from theperspectiveof thephysician

but also that of the patient, while at the same time aiming to maximize

effectivenessminimizeriskandminimizecost.”(Barber1995)

Thefocusofthisresearchhasbeenontheeffectsofpolicychangesonprescribingand

dispensingpracticesinprimaryhealthcareinthespecificcontextofatransitioncountry

thatisveryapplicabletosimilarcontexts.

PrescribingpolicychangesinMacedoniawereperceivednegativelyoverallcomparedto

theprevioussystem,andmanyidentifiedthemesreflectedthosefoundinotherhealth

systems,suchaspatientpressure, threats toautonomyanda lackof involvementand

consultation in the policy making process, as well as lack of support in policy

implementation from the system to primary care physicians and pharmacists. A key

aspectofthisstudyappearedtobethethreatposedbyincreasingregulationwhichboth

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marginalisedprofessionalsandpatientsinrelationtoconsultationandinvolvementand

threatened their autonomy and capacity to make independent decisions about

prescribing andobtainingmedicines.Habermas' conceptsof systemand lifeworld and

particularlytheencroachmentoftheformeronthe latterarearguedtoberelevant in

framing the themes in this study. The introduction of increasing waves of policy

representjuridification,andprofessionals’perceptionofbeingisolatedandun-involved

and unsupported reflect disruption of important forms of communicative acts and

justice.Using aHabermasian perspective, it is apparent that the policy changewithin

Macedoniaisbutoneexampleofmanysuchthreatstoindividuals'lifeworlds.Thisstudy

and theseassociated theoretical insights suggest theneed to improve communication

betweendifferentstakeholdersandtoensurethatpolicychangeisundertakeninaway

thatissensitiveto,andnotathreattoindividuals'autonomy-inprofessionalpractices

suchasprescribinganddispensing,andpublicaimsofobtainingappropriatemedicines.

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CHAPTER7:Conclusionsandrecommendations

7.1. ConclusionsThe market-driven policy changes that were introduced in Macedonia in relation to

regulating prescribing and dispensing are associated with various negative

consequences from the perspective of a range of stakeholders. For primary care

providers these changes meant detachment from the system, reduced professional

autonomyanddiminishedappreciationoftheirprofessioninthewidersociety.Thenew

policyenvironment createddualpressureson them– frompatientswishing toobtain

medicines,andfromthesystemthroughtheregulatoryandlegalmechanisms.Providers

alsoarticulatedlackofguidanceandsupportforpolicyimplementation;theirfeelingof

detachmentfromthesystemisamplifiedbylackofinvolvementinpolicymaking,andby

government support for patients’ empowerment through unlimited right to choice of

provider. While the elite stakeholders tend to generally agree with the healthcare

professionals on the issue of patient pressure, the patients’ group described their

position asunfavourable andmarginalized,making the case for unregulated access to

medicines,negotiatingmedicinesupplyandjustifyingself-medication.

However, providers and policy makers tend to agree on the persistence of irrational

prescribingandinappropriatedispensingbutonamoretheoreticallevel;mostproviders

considerit inappropriatetoprescribewithoutclinical indicationortodispensewithout

prescription,however, theyadmitadherencetosuchpracticeuponpatients’pressure.

This implies thatnotonlyprovidersbutalsoother interviewedgroups,asdescribed in

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thefindings,placedthemajorresponsibilityforthelackofpolicyimplementationwitha

groupotherthantheirown.

Patientswerenotconcernedwithirrationalprescribing,butforthemthemainconcern

was theaccess tomedicines,andnegotiatingmedicine supply.Theirattitudes, in fact,

dependedalotontheirabilitytopayforthemedicinesout-of-pocket,withmanyopenly

stating that theywouldcircumventgoing to thedoctorandgetting theprescription, if

theycouldfindapharmacistthatwoulddispensethemedicinewithoutit.

With regards to policy implementation, all groups similarly believed that this was

lacking, however due to different reasons. Providers considered it a consequence of

non-involvement, ambiguityof enforcementand lackof support from the system; the

elites held amore forthright view that resultant problems associated with the policy

changes were attributable to the other groups. For the patients the lack of

implementationwasnot consideredas such,butwas ratherusedasa justification for

circumventingtheregularproceduresofprescribinganddispensing.

Whileproviderslargelyquestionedthepolicychangesandpatientswereambiguous,the

views of the policymakers generally described policy changes as being necessary. All

groupsmadecomparisonstotheprevioussystem,whichwasperceivedmorepositively

asbeingfairerandpatient-centred,butnotsustainable.Tothisend,itcanbeconcluded

that future policy requires consultation and communication to ensure different

individualsarenotisolated,threatenedordeniedmedicines.

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7.2. CurrentpolicyinsightsThisresearchisarguedtobetimely,giventheevolvingpolicycontextandthefocuson

primary care reform in Macedonia. During the research, the number of interviews

conductedwithkeypolicymakersmighthavehadasmall–ifany–influenceonsomeof

theadditionalpolicychangesthatwereproposedandadoptedthereafter.Nonetheless,

eitheraspolicyreactivityorduetootherfactors,inthepastyeartheHealthInsurance

Fundproposedand theGovernmentadopted severalmeasuresaimedat reducing the

pressuresonproviders,including(HIF2015):

- Reducedfinesforproviders,especiallyforclericalerrorsinissuingprescriptionsanddispensingmedicines;

- Introducedmechanismsforcoveringthepatientsofaprovideronlonger-termsickleavewithoutaffectingbudgetceilingsofthedesignatedreplacementphysician;

- Expressedwillforrevisinglevelsofpreventivegoalsinthecomingperiod.

These changes are likely to increase the confidence of providers in their relationship

with the system, which might further promote their increased participation in

policymaking and adherence to policy implementation. Furthermore, the professional

associations of primary care providers have initiated wider outreach and increasing

visibilityactivitiesaimedattheirmembers,especiallyinrelationtotheirinteractionsand

negotiationswiththeHealthInsuranceFund.

It is therefore important to reiterate that policies need to be developed with

involvementofthosedirectlyresponsiblefortheir implementation,andthatstrategies

should be put in place to communicatewith the providers and support them in their

gatekeeping role at primary care level so they can be a successful part of an ever-

evolvinghealthcaresystem.

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7.3. PolicyrecommendationsThis section describes how the findings of this studymay inform the design of future

policies in prescribing and dispensing, as well as thewider agenda setting and policy

processinMacedonia,andinsimilarpoliticalandsocietalcontexts.Itwillexploreinturn

five key areas, relating to: increasing the involvement of provider and patient

stakeholders in policymaking and implementation, increasing awareness of policy

change through enhanced information, providing training for providers, and raising

publicawarenessandunderstandinginhealth-relatedmattersmoregenerally(seeTable

14forsummary).

Table14.Summaryofkeyrecommendations

Agenttargeted BroadRecommendation SpecificActionsPatientsandProviders

Increaseinvolvementinpolicymakingprocess

Throughrecognitionbygovernmentofthevaluetheycanaddtopolicyprocess.Importanceofworkingtowardscommunicativeactionandremovingpowerimbalance.Ensurepreviousfeedbackaboutpracticeexperienceisconsideredintheprocess.

Providers Increaseinformationaboutpolicychange

Ensurepropercommunicationofpolicychanges.Enableassistanceforpracticalquestionsfromprovidersonimplementationofthese.

ProvidersandPatients

Increaseinvolvementinfuturepolicyimplementation

Ensureadvisoryandconsultativesupportuponintroductionofpolicychanges.Encouragefeedbackaboutpracticeexperiences,andmakeitavailable(inanonymisedform)forotherproviders.Activelyinvolveagentsintheimplementationprocess.

Providers Trainingonguidelinesandcommunication

Introducerequirementformandatorycontinuousmedicaleducationtrainingtobelinkedtospecificguidelineswithpeer-to-peerexperienceexchange.Introducecommunicationwithpatients’moduleinsenioryearsofhealthsciencecurriculaatundergraduateandspecialisationlevels.

Patients Increaseawarenessofprescribinganddispensingpolicyandlaw

Continueandfortifyawareness-raisingeffortsforhealthliteracyusingexamplesandkeymessagesfrompracticeexperience.

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7.3.1Involvementofstakeholdersinpolicymaking

Therearethreekeypolicyimplicationsthatcanbeidentifiedthroughthefindingsofthis

thesis.Thefirstandmostobviousoneisthewiderconsiderationofallstakeholdersand

their interests in the process of policymaking and decision-making. As suggested in

Habermas’ theory on communicative rationality, democratisation of decision-making

means providing open dialogue that enables stakeholders to have their voice at the

decision-making table. In this case, it means involving patients but also health

professionalsthroughorganizedformsofprofessionalassociationsandviaothermeans,

astheir involvementmightprovidethepractice ‘street-level’perspectiveonthe issues

that are otherwise invisible to the desk policymaker. Government recognition of the

valuethesestakeholderscanaddtothepolicyprocessisessential,giventheimportance

ofworkingtowardscommunicativeactionandremovingpowerimbalances.Atthesame

time, failure to take into consideration the interests of all involved is very likely to

produce resistance to policy implementation, subterfuge of procedures and use of

loopholes to address the problems in implementation. In addition, ensuring

consideration of previous feedback about practice experience in the process can also

add value to learning from the implementation gaps, also raised as a concern in this

research. As illustrated in further paragraphs, such involvement might already be

underwayaspartofthecommunicationsanddiscussionsundertakenwithpolicymakers

duringthecourseofthisresearch.

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7.3.2Provisionofinformationonpolicychanges

Secondly,thisresearchhasdrawnupontheimportanceofarticulationandexchangeof

information related to policies if proper and successful implementation is desired.

Following on from the importance of stakeholder involvement, a pivotal factor is the

proper and timely exchangeof information and communicationon the envisaged and

introducedchanges.Thesenseofdetachmentperceivedbytheprovidersandtheself-

perceived disadvantaged position of patients can be largely attributed to a lack of

information and understanding. While no policy can be ensured full implementation

solely on the grounds of equality of information, proper articulation of its goals,

mechanismsand intendedoutcomes isacertainway tocontribute to it. In this sense,

some of the recommendations include ensuring establishment of regular and proper

communicationchannelsforsharinginformationonpolicychanges,butalsoforassisting

with practical questions providers might have for implementation. These channels

wouldcertainlyincludeprofessionalassociations’updatesandevents,butforexpanding

outreach, it is essential to consider other forms offered by new technologies, such as

Internetandsocialmedia.

7.3.3Involvementinpolicyimplementation

Pertinenttothefindingsonpolicyimplementation,andinparticularthelackofsupport

perceivedbyproviders, futurepoliciescouldbenefit fromencouraging feedbackabout

practice experiences from both providers and patients. This feedbackwould not only

inform policy making, but also practical aspects which might stand in the way of

successful policy implementation, as they were neglected in the desktop policy

development process. Such feedback could also assist other providers, and thus it is

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importantthatanappropriateanonymisedformofitismadepubliclyavailable.Also,as

one of the key aspects of lack of support in policy implementation was the newly

imposedadministrativeburdenandarisingpenaltiesforclericalerrors,itisadvisableto

considerintroductionofadvisoryandconsultativesupporttoproviders,asapriorstep

topenalisation.Theseconsultationsbypeersorpublicofficialscouldbealsousedasa

vehicletosharinginformationonpolicychangesandforeducationalpurposesonclinical

guidelines.

7.3.4Guidelinesandcommunicationtrainingforproviders

While admitting the problems with policy implementation, for which they did not

considerthemselvesresponsible,thepolicymakersprovidedideasforitsimprovement

throughactions targetingprovidersandpatients. Someof thekey issues in their view

were improvementofhealth literacyofpatients(elaborated inmoredetail inthenext

sub-section), along with further rationalisation and formalisation measures for

providers,throughreinforcementofexisting,andadoptionofnew,clinicalguidelinesfor

prescribing in primary care. In addition, they consider the improvement of

communication andnegotiation skills of providers in their interactionwithpatients to

significantly contribute to better policy implementation regarding prescribing and

dispensing. Mishler (1984) argued that if providers listened more and translated

technical language into the voice of the lifeworld, theywould becomemore effective

practitioners.Itisthusimperativetoconsiderwaysofimprovingcommunicationskillsof

providers throughout the educational process, starting fromundergraduate level, and

also during specialisation. This could be effectively done through introduction of a

specificmoduleoncommunicationwithpatients in the final yearsofeducation,when

students have requiredmedical expertise and couldmore practically understand and

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incorporate this knowledge into their future practice. In addition, practical aspects of

clinicalguidanceapplicationshouldbeintroducedasmandatorycomponentsofcurrent

continuedmedicaleducationsystem.Inthissense,peer-to-peerexperienceexchangeis

underutilizedbutcouldbeavaluableassettoimprovingguidanceadherence.

7.3.5Patients’literacyandawarenessraisingcampaigns

Despitearticulationofprudentprescribinganddispensing,accountsfromprovidersand

policymakerssuggestedacontinuingpracticeofirrationalprescribing.Whilstthisstudy

didnotsetouttoverifyormeasuresuchpractices,theemergenceofthesecontrasting

accountsdoessuggest someconcern.This researchalsounderlined the importanceof

thepatientinprescribinganddispensing.

Policy proposals for addressing irrational prescribing from the demand-side mention

parallel interventions of individual and collective health literacy improvement of the

population. These include patients’ education by providers – either physician or

pharmacist - during their consultation, and public campaigns. This section provides

elaborationonthelatter,astheformerwasaddressedaspartoftheprevioussectionon

communicationskillsforproviders.

Extensive efforts were made at national level and globally to address irrational

prescribing (Goossens et al 2006; Earnshaw et al 2014). On the demand side, these

efforts were directed at improving health literacy and information access through

awareness raising campaigns (Goossens et al 2006). In Macedonia, public awareness

raisingcampaigns for rationalantibioticusehavebeensystematicallyorganized in the

country since 2008, with endorsement of the European Antibiotic Awareness Day

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(EAAD)bytheEuropeanCentreforDiseasePreventionandControl(ECDC)(Earnshawet

al2014)andmorerecentlywiththeWorldAntibioticAwarenessWeek(WAAW).

Building on the above experience, further efforts should be made in continuing and

fortifying awareness raising efforts for prudent antibiotic use among patients. In

addition,themessagesconveyedtothepublicshouldberelatedtopracticeexperience

andqualitativeresearchonunderlyingreasonsfor irrationalprescribing.Theresultsof

thisresearchcouldbuilduponandinformfuturepubliccampaigns.

7.4. Finalreflections

Post-communist policy changes have been shown to exert considerable and often

unintended consequences upon key stakeholders in Macedonia, resulting in negative

experiences and inappropriate practices. These may be arguably linked to problems

relating to stakeholders not being involved in policymaking and implementation,

inadequate communication of policy changes and insufficient providers’ skills for

communicationwithpatients.Inaddition,suchnegativitymightbelinkedtoexperiences

from the past, which future policy formation should consider. Recognition of these

problems as identified in this research suggest important areas in which to consider

changeandinvolvephysicians,pharmacistsandpatientsmuchmore,andofferrespect

andprotectionoftheirthreatenedlifeworlds.

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APPENDICES

AppendixA:ETHICSAPPROVALS

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AppendixB:INFOSHEETFORPARTICIPANTS

ResearchProjectTitle:

EffectsofprescriptionpolicychangesonthepracticesandattitudestowardsprescribingintheprimaryhealthcareinMacedoniaResearchinginstitutions:SchoolofHealthandRelatedResearch(ScHARR),TheUniversityofSheffield,UKCentreforRegionalPolicyResearchandCooperation‘Studiorum’,MacedoniaResearcher:NEDAMILEVSKA-KOSTOVADearParticipant,Thankyouforacceptingtoreadthematerialsprovided.Youareinvitedtotakepart inthisresearchstudy,closelyrelatedtoyoureverydaylifeandwork.Before youdecidewhether to takepart in this research, it is important foryoutounderstandwhytheresearchisbeingdoneandwhatitwill involve.Pleasetaketimetoreadthefollowinginformationcarefully,anddonothesitatetoaskshouldyoufindanythingtobeunclearorifyouwanttohavemoreinformation.Giving of this information to you is by no means obliging you to participate - if youdecide to take part you will be asked to sign the attached Consent form, which youshouldalsoreadcarefullybeforesigning.BackgroundontheresearchTheaimofthisstudyistoinvestigatewhataretheeffectsofthepolicychangesaffectingtheregulationofprescriptionmedicinesandincentivesavailabletohealthcareprovidersandpharmacistsonproviders’experienceandperceptionofthepolicychanges.Theresearchwillconsistofqualitativedatagatheringandanalysis–performedthroughsemi-structured interviewswithdifferentstakeholdergroups, includingkey informants(policyanddecisionmakers,expertsandacademia,professionalassociationsandprivatesector),healthproviders (generalpractitionersandpharmacists involved inprescribinganddispensingofmedicines)andpatients.Whyhaveyoubeenchosen?Anumberofpersonswere invited in fourdifferentgroups toparticipate in this study,basedontheirexperiencesand/orexpertise.Youhavebeeninvitedaspartofthegroupofkeyinformants,constitutedofpolicyanddecisionmakers,expertsandacademia,professionalassociationsandprivatesector.

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Whatareyouexpectedtodo?TheprocedureYourinvolvementisexpectedaskeyinformanttothegroupofpolicyanddecisionmakers,expertsandacademia,professionalassociationsandprivatesector.Afterconsentingtoparticipate (bysigningtheconsent form),youwillbeaskedbytheresearcheranumberofopenquestions,thatallowyoutotalkaboutissuesforaslongasyouwantand toexpressyourself fullyand to thebestofyourknowledge.Pleasealsoconsiderthattherearenorightorwronganswers,andthatactuallyyourknowledgeandexperienceinthefieldisofgreatvalueforthestudy.Theinterviewwilltakenolongerthan40-60minutesofyourtime.Forthishowever,asuitable location is a prerequisite, and it can be chosen by you – it can be youroffice/working space, a space within the research institution mentioned above. Ifneitheroftheseissuitable,amutuallyacceptablevenuecanbeselected.Theinterviewwillbevoice-recordedunlessyourequestthatitnotbe.Therecordedinterviewwillthenbeanonymouslytranscribedintowrittenformtoallowfor better andmore accurate interpretation by the researcher. You can, if you wish,receivethefulltranscriptoftheinterviewtakenwithyou.Afterthat,allinterviewswillbeanalysedandusedintheresearchstudythatformspartofadoctoralthesisoftheresearchernamedabove.DecidingwhethertotakepartornotAccepting to read this Information Sheet is in noway obliging you to take part - it isentirelyuptoyoutodecidewhetherornottotakepart.Ifyoudodecidetotakepart,youwillbeaskedtosignaParticipantConsentForm,attachedherewith.As this isacademic research, therearenoenvisagedrisks to takingpart.ThemethodsandthesubjectchosenforthisresearchhavebeenapprovedbytheEthicsCommitteeofthe University of Sheffield, UK and the Ethics Committee of the University of Skopje,Macedonia.However, if you decide to take part you are still free to withdraw at any time andwithoutgivingareasonforsuchdecision.ConfidentialityandprivacyAll information that is collected about you and from you during the course of theresearchwillbekept insecuredatabaseandwithstrictconfidentiality. Ifyouexplicitlyrequire,anyinformation,whichwillbeusedfortheresearchstudy,willbeanonymous,meaningthatallpersonalinformationwillberemovedaccordingly.Theaudiorecordingsofyourinterviewduringthisresearchwillbeusedonlyforanalysisandforillustrationinconferencepresentationsandlectures.Nootherusewillbemadeof them without your written permission, and no one outside the research will beallowedaccesstotheoriginalrecordings.Researchoutcome:Whatwilltheresearchresultsbeusedfor?TheresultsofthisstudywillbeusedprimarilyaspartofaPhDthesisthatwillbewritten

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upandsubmittedbytheresearchernamedabove.Youarewelcometoreadandaccessthethesisonceithasbeendefendedandpublished.ContactforFurtherInformationIf you require clarification, further information or want to discuss any aspect of thisresearch,pleasedonothesitatetocontacttheresearcher,NEDAMILEVSKA-KOSTOVA:(mobile:+38971225446,e-mail:[email protected])Thankyou.

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AppendixC:CONSENTFORM

ParticipantConsentForm

TitleofResearchProject:EffectsofprescriptionpolicychangesonthepracticesandattitudestowardsprescribingintheprimaryhealthcareinMacedoniaNameofResearcher:NEDAMILEVSKAKOSTOVAParticipantIdentificationNumberforthisproject: Pleaseinitialbox1. IconfirmthatIhavereadandunderstandtheInformationsheet

dated________________explainingtheaboveresearchprojectandIhavehadtheopportunitytoaskquestionsabouttheproject.

2. IunderstandthatmyparticipationisvoluntaryandthatIamfreetowithdraw

atanytimewithoutgivinganyreasonandwithouttherebeinganynegativeconsequences.Inaddition,shouldInotwishtoansweranyparticularquestionorquestions,Iamfreetodecline.Insertcontactnumberhereofleadresearcher/memberofresearchteam(asappropriate).

3. Iunderstandthatmyresponses,ifIwishsowillbekeptstrictlyconfidential.Igivepermissionformembersoftheresearchteamtohaveaccesstomyanonymisedresponses.Iunderstandthatmynamewillnotbelinkedwiththeresearchmaterials,andIwillnotbeidentifiedoridentifiableinthereportorreportsthatresultfromtheresearch,ifIexpresssuchwish.

4.Iagreeforthedatacollectedfrommetobeusedinfutureresearch5. Iagreetotakepartintheaboveresearchproject.________________________ ____________________________________NameofParticipant Date Signature(orlegalrepresentative)_NEDAMILEVSKAKOSTOVA________ ____________________________________LeadResearcher Date SignatureTobesignedanddatedinpresenceoftheparticipantCopies:2Oncethishasbeensignedbyallpartiestheparticipantshouldreceiveacopyofthesignedanddated participant consent form, the letter/pre-written script/information sheet and any otherwritten informationprovided to theparticipants.A copyof the signedanddated consent formshould be placed in the project’smain record (e.g. a site file),whichmust be kept in a securelocation.

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AppendixD:INTERVIEWSCHEDULEQUESTIONSFORELITESElites:Policy/decisionmakers,experts/academia,professionalassociations/privatesector[Introductoryquestions]

1. Have you been (and how long) involvedwith the PHC reforms inMacedonia?How?

2. HaveyoubeeninvolvedwiththeprescribingpoliciesinMacedonia?How?3. Whoisresponsibleforpreparationandexecutionofprescribingpolicies?Who

shouldbeinvolved?4. Have/Do you participate/d in the preparation or execution of prescribing

policies?5. Inyouropinion,whatarethemaingoalsoftheprescribingpolicies?

a. Arethesegoalsaddressed?b. Arethesegoalsmet?Ifnot,why?

6. Whatarethemostimportantachievementsoftheprescribingpolicies?

[Policyof2005/7:limitationonnumberofprescriptions]7. In 2005/7, with the transformation (privatization) of the primary healthcare

(PHC), theprescribingpolicyhaschangedto involve limitationsonthenumberof prescriptions per patient, replacing the pre-2005 policy (of no-limitedprescribing).

a. Whatisyouropiniononitsdesignandeffectiveness?b. Isthispolicybetter/worsethantheonebefore2005(nolimitations,no

privatization)?Forwhomandinwhatway?c. Do you think this policy contributed to rational prescribing (of PHC

goals)?d. Wasthepolicyincentivising/dis-incentivisingforPHCdoctorsandhow?e. Had this policy any influence on the freedom/levels of prescribing for

PHCdoctors?Inwhatway?f. Howdoyouthinkthispolicyaffectedtheaccesstomedicines?

[Policyof2009:budgetceilingforprescribing]

8. In 2009, the prescribing policy in primary care was redefined using budgetceilings forPHCdoctors.How is thispolicy compared to thepolicyof2005/7?Comparedtothepre-2005policy?

a. Doyouthinkitiswelldesignedandfair?Ifnot,why?Towhomitisnotfair?

b. Whoisresponsibleforthis?

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c. Do you think this policy contributes to rational prescribing (of PHCgoals)?

d. Isthepolicyincentivising/dis-incentivisingforPHCdoctorsandhow?e. Has this policy any influence on the freedom/levels of prescribing for


9. Ofallpolicies(pre-2005,2005/7and2009),whichgavebestresultsin:a. Rationalprescribing?b. Accesstomedicines?c. Betteroffandworseoff?Whoandwhy?

[Overall:Policiesonprescribing]

10. Areprescribingpoliciesare(fullyorpartially)implemented?a. Ifnot,whatpartsarenotimplementedandwhy?b. Howcanthisbeovercome?c. Ifnot,whoisresponsibleforlackofimplementation?d. Howcanthisbeovercome?

[General:Policiesondispensing]

11. Although rather stringent policies exist on the dispensing of prescriptionmedicines, those arenotwell implemented. In your opinion (andexperience),wherethemainproblemlays?(enforcement,incentives,etc.)

a. Whoisresponsibleforsuchlowenforcement?b. Howcanthisbeovercome?c. Howisthelowenforcementreflectedontherationalprescribing?d. Whatcanbedonetoreducethenon-prescriptiondispensing?

[EXTRAS]

12. If you were a PHC provider, what would you say/do about the prescribingpolicies?Wouldyouthinkthepoliciesare:fair,incentivising,backward?

13. Ifyouwereapharmacist,whatwouldyousay/doaboutthedispensingpolicies?14. Ifyouwerethepatient,whatwouldyousay/doabouttheprescribingpolicies?15. Anyothercommentsoropinions?

Thankyou.

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AppendixE:INTERVIEWSCHEDULEQUESTIONSFORPHYSICIANS[Introductoryquestions]

16. HowlonghaveyoubeenworkinginthePHC?17. Whoisresponsibleforpreparationandexecutionofprescribingpolicies?Who

shouldbeinvolved?18. Have/Doyouparticipate/dinthepreparationofprescribingpolicies?19. Inyouropinion,whatarethemaingoalsoftheprescribingpolicies?


20. Whatarethemostimportantachievementsoftheprescribingpolicies?



a. Whatisyouropiniononitsdesignandeffectiveness?b. Isthispolicybetter/worsethantheonebefore2005(nolimitations,no

privatization)?Forwhomandinwhatway?c. Do you think this policy contributed to rational prescribing (of PHC

goals)?d. Wasthepolicyincentivising/dis-incentivisingforPHCdoctorsandhow?e. Had this policy any influence on the freedom/levels of prescribing for



22. In 2009, the prescribing policy in primary care was redefined using budgetceilings forPHCdoctors.How is thispolicy compared to thepolicyof2005/7?Comparedtothepre-2005policy?

a. Doyouthinkitiswelldesignedandfair?Ifnot,why?Towhomitisnotfair?

b. Whoisresponsibleforthis?c. Do you think this policy contributes to rational prescribing (of PHC

goals)?d. Isthepolicyincentivising/dis-incentivisingforPHCdoctorsandhow?e. Has this policy any influence on the freedom/levels of prescribing for


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[Overall:Comparingpolicies]23. Ifyoucompareallpolicies(pre-2005,2005/7and2009):

a. Do you have more/less patient visits now (after 2009) than before (pre-2009)?Pre-2005?

b. Doyouhavemore/lessprescriptions(inabsoluteterms)nowthanbefore?c. DoyouthinktheHIFspendingonmedicinesishigher/lowernow(post-2009)

thanwiththeprescription-limitpolicy(2005/7)?Whydoyouthinkso?

[Overall:Policiesonprescribing]24. Areprescribingpoliciesare(fullyorpartially)implemented?

a. Ifnot,whatpartsarenotimplementedandwhy?b. Howcanthisbeovercome?c. Ifnot,whoisresponsibleforlackofimplementation?d. Howcanthisbeovercome?



a. Whoisresponsibleforsuchlowenforcement?b. Howcanthisbeovercome?c. Howisthelowenforcementreflectedontherationalprescribing?d. Whatcanbedonetoreducethenon-prescriptiondispensing?e. Do you think a patient should be allowed to obtainmedicinewithout

prescription?Ifnot,why?f. Doyouthinkitisappropriatethatapatientcangetamedicinewithout

prescription?Ifnot,why?Howdoyoufeelaboutthissituation?g. Doyouthinkitisyourresponsibilitytopreventpatientsfromobtaining

medicineswithoutprescription?Ifnot,whoseresponsibilityitis?

[EXTRAS]26. Ifyouwerethepatient,whatwouldyousay/doabouttheprescribingpolicies?27. Anyothercommentsoropinions?

Thankyou.

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AppendixF:INTERVIEWSCHEDULEQUESTIONSFORPHARMACISTS[Introductoryquestions]

1. Howlonghaveyoubeenworkinginapharmacy?2. Whoisresponsibleforpreparationandexecutionofprescribingpolicies?Who

shouldbeinvolved?3. Have/Doyouparticipate/dinthepreparationofprescribingpolicies?4. Inyouropinion,whatarethemaingoalsoftheprescribingpolicies?


5. Whatarethemostimportantachievementsoftheprescribingpolicies?6. Inyouropinion,whatarethemaingoalsofthedispensingpolicies?


7. Whatarethemostimportantachievementsofthedispensingpolicies?



a. Do you think this policy contributed to rational prescribing (of PHCgoals)?

b. Had this policy any influence on the freedom/levels of prescribing forPHCdoctors?Inwhatway?

c. Howdoyouthinkthispolicyaffectedtheaccesstomedicines?

[Policyof2009:budgetceilingforprescribing]9. In 2009, the prescribing policy in primary care was redefined using budget

ceilings forPHCdoctors.How is thispolicy compared to thepolicyof2005/7?Comparedtothepre-2005policy?

a. Do you think this policy contributes to rational prescribing (of PHCgoals)?

b. Has this policy any influence on the freedom/levels of prescribing forPHCdoctors?Inwhatway?

c. Howdoyouthinkthispolicyaffectedtheaccesstomedicines?

[Overall:Comparingpolicies]10. Ifyoucompareallpolicies(pre-2005,2005/7and2009):

a. Doyoubelieve that thechange to2009policy forprescribingaffectedthelevelsofprivatepurchasedmedicinesbypatients?

b. Doyouhavemore/lesspatientsaskingmedicineswithoutprescriptions

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nowthanbefore?c. DoyouthinktheHIFspendingonmedicinesishigher/lowernow(post-

2009)than?Whydoyouthinkso?d. Do you think that patients now spend more/less on prescription

medicinesthanbefore?[Overall:Policiesonprescribing]

11. Areprescribingpoliciesare(fullyorpartially)implemented?a. Ifnot,whatisnotimplementedandwhy?Howcanthisbeovercome?b. Ifnot,whoisresponsible?Howcanthisbeovercome?



a. Whoisresponsibleforsuchlowenforcement?b. Howcanthisbeovercome?c. Howisthelowenforcementreflectedontherationalprescribing?d. Whatcanbedonetoreducethenon-prescriptiondispensing?e. Do you think a patient should be allowed to obtainmedicinewithout

prescription?Ifnot,why?f. Doyouthinkitisappropriatethatapatientcangetamedicinewithout

prescription?Ifnot,why?Howdoyoufeelaboutthissituation?g. Doyouthinkitisyourresponsibilitytopreventpatientsfromobtaining

medicineswithoutprescription?Ifnot,whoseresponsibilityitis?13. Haveyoueverdispensedaprescription-onlymedicinewithoutprescription?Do

youthinkitwasright?14. Howdoyoufeelaboutmedicinedispensingwithoutprescription?Doyouthink

thatitisrelatedtothecurrentsetupintheprescribingpolicy?Wasitdifferentinthepast?How?

15. Doyouthinkthatdispensing-on-prescriptionpolicyshouldbestrictlyenforced?Whateffectwouldthathaveonthepharmacies?Onthepatients?

16. Ifdispensing-on-prescriptionpolicyisfullyenforced,howdoyouthinkthatwillaffect your business (e.g. relationship with pharmaceutical companies wouldchange,lesspatientswoulduseyourservices,etc.)?

[EXTRAS]

17. Ifyouwerethepatient,whatwouldyousay/doabouttheprescribingpolicies?18. Anyothercommentsoropinions?

Thankyou.

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AppendixG:INTERVIEWSCHEDULEQUESTIONSFORPATIENTS[Introductoryquestions]

1. Areyoutakinganylong-termtherapy?Forhowlong?2. Whoisresponsibleforpreparationandexecutionofprescribingpolicies?Who

shouldbeinvolved?3. Have/Doyouparticipate/dinthepreparationofprescribingpolicies?4. Inyouropinion,whatarethemaingoalsofrulesformedicineprescribing?5. Inyouropinion,whatarethemaingoalsofrulesformedicinedispensing?6. Do you agree that a doctor and pharmacist should make a decision on your

therapy?

[Policyof2005/7:privatizationofPHC–limitationofprescriptions]In 2005/7, with the transformation (privatization) of the primary healthcare(PHC),theprescribingpolicyhaschanged,replacingthepre-2005policy(ofno-limitedprescribing).

7. Ifyouremember,howdidyoufeelaboutthechangeinPHC?Didyouhaveanyproblemswithyourtherapy?Ifyes,wasitrelatedto:

a. ObtainingprescriptionfromPHC?How?b. Obtainingmedicineatpharmacy?How?Orboth?


In 2009, the prescribing policy in PHCwas redefined using budget ceilings forPHCdoctors.

8. Did you have experience of changes in attitude or practice of your doctorrelatedtoyourprescriptionmedicines?

a. Ifyes,inwhatway?9. Did you have experience of changes in attitude or practice of the pharmacist

relatedtoyourprescriptionmedicines?a. Ifyes,inwhatway?

[Overall:Comparingpolicies]

Ifyoucompareyourexperiencewithmedicinesoverthepastdecade,from2004untiltoday(ifapplicable):

10. AccesstoyourmedicinesatyourPHCdoctor:a. Haveyouexperiencedanychangesinaccesstoyourdoctor?b. Tohis/herreadinesstoprescribethemedicinestoyou?c. Ifyes,inwhatwayhasthischanged?

11. Accesstomedicinesatthepharmacy:a. Have you experienced any changes in access to medicines at the

pharmacy?b. HaveyouexperiencedanychangestoobtainingHIF-coveredmedicines?

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c. Ifyes,inwhatwayhasthischanged?d. Doyouthinkthatthelevelsofyourspendingonprescriptionmedicines

havechangedcomparedtobefore?Ifyes,inwhatway?e. Haveyoueveraskedprescriptionmedicinewithoutprescription?Why?

Doyouthinkitwasright?f. Haveyouevergotaprescriptionmedicinewithoutprescription?Why?

Doyouthinkitwasright?

[Overall:Policiesonprescribing]12. Do you think it is right that a patient should always get a prescription for a

prescriptionmedicine?Ifnot,why?Howcanthisbeovercome?

[General:Policiesondispensing]13. Doyouthink it isrightthatapatientshouldalwayspresentaprescriptiontoa

pharmacisttoobtainaprescriptionmedicine?Ifnot,why?a. Do you think a patient should be allowed to obtainmedicinewithout

prescription?Ifyes,why?Ifnot,why?b. Doyouthinkitisappropriatethatapatientcangetamedicinewithout

prescription?Ifyes,why?Ifnot,why?14. Ifdispensing-on-prescriptionpolicyisfullyenforced,howdoyouthinkthatwill

affectyourhealthandaccesstomedicines?(notbeabletogetallmedicines,nofreedomofchoice,etc.)

[EXTRAS]

15. Anyothercommentsoropinions?Thankyou.

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