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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
5.5. Summaryofchapter.......................................................................................201
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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6.6. Summaryofchapter.......................................................................................242
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
22
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
7%ofvariablecapitationlost/gained
2014
6%ofvariablecapitationlost/gained
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
51
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
63
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;
65
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
66
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
78
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
85
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
Male 3Geographicallocation
Capital 3Smalltownorcity 8Rural 1
Status Owner 2 Employee 10
Table10.Interviewees’characteristics–Patients
Patients N=14Gender Female 6
Male 8Geographicallocation
Capital 5Smalltownorcity 7Rural 2
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
PHCdoctors?Inwhatway?f. Howdoyouthinkthispolicyaffectedtheaccesstomedicines?
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?
a. Arethesegoalsaddressed?b. Arethesegoalsmet?Ifnot,why?
20. Whatarethemostimportantachievementsoftheprescribingpolicies?
[Policyof2005/7:limitationonnumberofprescriptions]21. 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]
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
PHCdoctors?Inwhatway?f. Howdoyouthinkthispolicyaffectedtheaccesstomedicines?
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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?
[General:Policiesondispensing]
25. 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?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?
a. Arethesegoalsaddressed?b. Arethesegoalsmet?Ifnot,why?
5. Whatarethemostimportantachievementsoftheprescribingpolicies?6. Inyouropinion,whatarethemaingoalsofthedispensingpolicies?
a. Arethesegoalsaddressed?b. Arethesegoalsmet?Ifnot,why?
7. Whatarethemostimportantachievementsofthedispensingpolicies?
[Policyof2005/7:limitationonnumberofprescriptions]8. 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. 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?
[General:Policiesondispensing]
12. 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?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?
[Policyof2009:budgetceilingforprescribing]
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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