rational use of drugs: an overview

Rational use of drugs:an overview

Kathleen HollowayTechnical Briefing Seminar

November 2008

Department of Essential Medicines and Pharmaceutical Policy TBS 2008

Department of Essential Medicines and Pharmaceutical PolicyTBS 2008

Objectives

• Define rational use of medicines and identify the magnitude of the problem

• Understand the reasons underlying irrational use

• Discuss strategies and interventions to promote rational use of medicines

• Discuss the role of government, NGOs, donors and WHO in solving drug use problems


The rational use of drugs requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, and at the lowest cost to them and their community.

WHO conference of experts Nairobi 1985

• correct drug

• appropriate indication

• appropriate drug considering efficacy, safety, suitability for the patient, and cost

• appropriate dosage, administration, duration

• no contraindications

• correct dispensing, including appropriate information for patients

• patient adherence to treatment


Adequacy of diagnostic processSource: Thaver et al SSM 1998, Guyon et al WHO Bull 1994, Krause et al TMIH 1998, Bitran HPP 1995, Bjork et al HPP 1992, Kanji et al HPP 1995.

0 10 20 30 40 50 60

Tanzania

Angola

Senegal

Burkino Faso

Bangladesh

Pakistan

% observed consultations where the diagnostic process was adequate


5-55% of PHC patients receive injections - 90% may be medically unnecessary

0% 10% 20% 30% 40% 50% 60%

Eastern Caribean

J amaica

El Salvador

Guatemala

Ecuador

L.AMER. & CAR.

Nepal

Indonesia

Yemen

ASIA

Zimbabwe

Tanzania

Sudan

Nigeria

Cameroon

Ghana

AFRICA

% of primary care patients receiving injections

Source: Quick et al, 1997, Managing Drug Supply

15 billion injections per year globally half are with unsterilized needle/syringe2.3-4.7 million infections of hepatitis B/C

and up to 160,000 infections of HIV per year associated with injections


0

5

10

15

20

25

30

35

FR GR LU PT IT BE SK HR PL IS IE ES FI BG CZ SI SE HU NO UK DK DE LV AT EE NL

DD

D p

er

1000 in

h. p

er

day

Variation in outpatient antibiotic use in 26 European countries in 2002

Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.


% compliance with clinical guidelines over time by region

0

10

20

30

40

50

60

70

<1992 1992-5 1996-9 2000-3 2004-7

Africa (n=125) Asia/Pacific (n=61)

Central Asia/Mediterranean (n=22) Latin America (n=31)


Treatment of diarrhoea in private and public sectors

0

10

20

30

40

50

60

70

ORS use Antibiotic use Antidiarrhoealuse

STG compliance

% d

iarr

ho

ea c

ases

tre

ated

Private-for-profit (n=43,33,35,4) Public (n=119, 100, 67, 80)


Treatment of ARI by prescriber type

0

10

20

30

40

50

60

70

80

Cough syrup use Approp.ABs inpneumonia

Inapprop.ABs inviral URTI

STG compliance

% A

RI c

ases

tre

ated

Doctor (n=20,18,40,12) Paramedic/nurse (n=13,94,69,61)


Overuse and misuse of antimicrobials contributes to antimicrobial resistance

• Malaria– choroquine resistance in 81/92 countries

• Tuberculosis– 0-17 % primary multi-drug resistance

• HIV/AIDS– 0-25 % primary resistance to at least one anti-retroviral

• Gonorrhoea – 5-98 % penicillin resistance in N. gonorrhoeae

• Pneumonia and bacterial meningitis – 0-70 % penicillin resistance in S. pneumoniae

• Diarrhoea: shigellosis– 10-90% ampicillin resistance, 5-95% cotrimoxazole resistance

• Hospital infections– 0-70% S. Aureus resistance to all penicillins & cephalosporins

Source: WHO country data 2000-3


Adverse drug events

• 4-6th leading cause of death in the USA

• estimated costs from drug-related morbidity & mortality 30 million-130 billion US$ in the USA

• 4-6% of hospitalisations in the USA & Australia

• commonest, costliest events include bleeding, cardiac arrhythmia, confusion, diarrhoea, fever, hypotension, itching, vomiting, rash, renal failure

Source: Review by White et al, Pharmacoeconomics, 1999, 15(5):445-458


Changing a Drug Use Problem:An Overview of the Process

1. EXAMINEMeasure Existing

Practices(Descriptive

Quantitative Studies)

2. DIAGNOSEIdentify Specific

Problems and Causes(In-depth Quantitative and Qualitative Studies)

3. TREATDesign and Implement

Interventions (Collect Data to

Measure Outcomes)

4. FOLLOW UPMeasure Changes

in Outcomes (Quantitative and Qualitative

Evaluation)

improveintervention

improvediagnosis


Treatment Choices

Prior Knowledge

HabitsScientific Information

RelationshipsWith Peers

Influenceof DrugIndustry

Workload & Staffing

Infra-structure

Authority & Supervision

Societal

Information

Intrinsic

Workplace

Workgroup

Social &CulturalFactors

Economic &Legal Factors

Many Factors Influence Use of Medicines


Strategies to Improve Use of Drugs

Economic: Offer incentives

– Institutions– Providers and patients

Managerial: Guide clinical practice

– Information systems/STGs– Drug supply / lab capacity

Regulatory: Restrict choices

– Market or practice controls– Enforcement

Educational: Inform or persuade

– Health providers– Consumers

Use of Medicines


Educational StrategiesGoal: to inform or persuade

• Training for Providers– Undergraduate education– Continuing in-service medical education (seminars, workshops)– Face-to-face persuasive outreach e.g. academic detailing– Clinical supervision or consultation

• Printed Materials– Clinical literature and newsletters– Formularies or therapeutics manuals– Persuasive print materials

• Media-Based Approaches– Posters– Audio tapes, plays– Radio, television


Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC Facilities

Intervention Control0

20

40

60

80

% Prescribing Injections

PrePre

PostPost

Source: Hadiyono et al, SSM, 1996, 42:1185


Training for prescribersThe Guide to Good Prescribing

• WHO has produced a Guide for Good Prescribing - a problem-based method

• Developed by Groningen University in collaboration with 15 WHO offices and professionals from 30 countries

• Field tested in 7 sites

• Suitable for medical students, post grads, and nurses

• widely translated and available on the WHO medicines website


Managerial strategies Goal: to structure or guide decisions

• Changes in selection, procurement, distribution to ensure availability of essential drugs– Essential Drug Lists, morbidity-based quantification, kit systems

• Strategies aimed at prescribers– targeted face-to-face supervision with audit, peer group

monitoring, structured order forms, evidence-based standard treatment guidelines

• Dispensing strategies – course of treatment packaging, labelling, generic substitution


RCT in Uganda of the effects of STGs, training and supervision on % of Px conforming to guidelines

Randomisedgroup

No. healthfacilities

Pre-intervention

Post-intervention

Change

Control group 42 24.8% 29.9% +5.1%

Dissemination ofguidelines

42 24.8% 32.3% +7.5%

Guidelines + on-site training

29 24.0% 52.0% +28.0%

Guidelines + on-site training + 4supervisory visits

14 21.4% 55.2% +33.8%

Source: Kafuko et al, UNICEF, 1996.


Economic strategies:Goal: to offer incentives to providers an consumers

• Avoid perverse financial incentives – prescribers’ salaries from drug sales– insurance policies that reimburse non-essential

drugs or incorrect doses – flat prescription fees that encourage polypharmacy

by charging the same amount irrespective of number of drug items or quantity of each item


Pre-post with control study of an economic intervention (user fees) on prescribing quality in Nepal

Fees (completedrug courses)

control fee / Pxn=12

1-band item feen=10

2-band item feen=11

Av. no. itemsper prescription

2.9 2.9(+/- 0)

2.9 2.0(-0.9)

2.8 2.2(-0.6)

% prescriptionsconforming toSTGs

23.5 26.3(+2.7%)

31.5 45.0(+13.5%)

31.2 47.7(+16.5%)

Av.cost (NRs)per prescription

24.3 33.0(+8.7)

27.7 28.0(+0.3)

25.6 24.0(-1.6)

Source: Holloway, Gautam & Reeves, HPP, 2001


PHC prescribing with and without Bamako initiative in Nigeria

5.3

72.8

64.7

93

35.4

2.1

38

25.6

21

15.3

0 20 40 60 80 100

no.drug items/Px

% Px with injections

% Px with antibiotics

% pres EDL drugs

no.EDL drugs avail

21 Bamako PHCs 12 non-Bamako PHCs

Source: Scuzochukwu et al, HPP, 2002


Regulatory strategiesGoal: to restrict or limit decisions

• Drug registration• Banning unsafe drugs - but beware unexpected results

– substitution of a second inappropriate drug after banning a first inappropriate or unsafe drug

• Regulating the use of different drugs to different levels of the health sector e.g.– licensing prescribers and drug outlets– scheduling drugs into prescription-only & over-the-counter

• Regulating pharmaceutical promotional activities

Only work if the regulations are enforced


Impact of multiple interventions on injection use in Indonesia

Source: Long-term impact of small group interventions, Santoso et al., 1996

0%

20%

40%

60%

80%

100%

1 3 5 7 9 11 13 15 17 19 21 23 25

Months

Pro

po

rtio

n o

f vi

sits

wit

h i

nje

ctio

n

Comparison group Interactive group discussion

Interactive group discussion (IGC group only)

Seminar (both groups)

District-wide monitoring(both groups)


Varying intervention impact in developing countriesSource: WHO database 2007

Intervention type No.studies Median impact Range

Printed materials 5 6% +1% to +8%

Community education 3 13% 0% to +26%

Provider education 24 10% -2% to +31%

Provider+Comm.educ 14 11% -4% to +32%

Provider supervision 23 14% +1% to +39%

Community case mgt 6 19% +3% to +29%

Provider group process 9 20% +4% to +41%

Essential drug program 2 21% +16% to +25%

Provider & Community education + supervision

7 21% +11% to +49%


What are countries doing to promote the rational use of medicines? national policies

0 20 40 60 80 100

EML updated in last 2 years (n=78)

STGs updated in last 2 years (n=42)

EML in insurance reimbursement (n=90)

Drug Info Centre for prescribers (n=118)

DTCs in most referral hospitals (n=92)

Public education on antibiotic use (n=107)

Antibiotic OTC non-availability (n=60)

National strategy to contain AMR (n=102)

Drug use audit in last 2 years (n=87)

% countries implementing policies

Source: EMP pharmaceutical policy database


Basic training and obligatory continuing medical education (CME) available for health professionals

0 20 40 60 80 100

Essential Medicines(n=68-89)

Clinical Guidelines(n=68-80)

Prescribing concepts(n=63-76)

Pharmaco-therapy(n=60-73)

Obligatory CME(n=99-105)

% countries with basic training available

Doctors Nurses and paramedics

Source: EMP pharmaceutical policy database


Why does irrational use continue?

Very few countries regularly monitor drug use and implement effective nation-wide interventions - because…

• they have insufficient funds or personnel?• they lack of awareness about the funds wasted

through irrational use?• there is insufficient knowledge of concerning the cost-

effectiveness of interventions?


What are we spending to promote rational use of medicines ?

• Global sales of medicines 2002-3 (IMS): US$ 867 billion

• Drug promotion costs in USA 2002-3: US$ >30 billion

• Global WHO expenditure in 2002-3: US$ 2.3 billion

– Essential Medicines expenditure 2% (of 2.3 billion)

– Essential Medicines expenditure on promoting rational use of medicines 10% (of 2%)

– WHO expenditure on promoting rational use of medicines 0.2% (of 2.3 billion)


2nd International Conference for Improving Use of Medicines, Chiang Mai, Thailand, 2004472 participants from 70 countries

Recommendations for countries to:• Implement national medicines programmes to

improve medicines use• Scale up successful interventions • Implement interventions to address community

medicines use

http://www.icium.org


WHO priorities

• Resolution WHA60.16– Urges Member States " to consider establishing and/or

strengthening…a full national programme and/or multidisciplinary national body, involving civil society and professional bodies, to monitor and promote the rational use of medicines "

– WHO to support countries to implement resolution

• Continue to give technical advice to countries– Model EML and formulary– Training on promoting RUM in community, PHC, hospitals– Research to identify cost-effective interventions– Advocacy


Health systems with no national programs:•No coordinated action•No monitoring of use of medicines

Health systems with national programs:•Coordinated action•Regular monitoring of use of medicine

Develop national plans of action

Situational analysis

Modifying action plans

Implement & evaluate national action plans

WHO facilitating multi-stakeholder action in countries


WHO Goal: to support establishment of national programs coordinated by mandated, resourced, multi-disciplinary, national bodies

Specific Objectives

1. Develop and pilot a standardised tool to undertake situational analysis and then undertake it in selected countries

2. Support establishment of national programs in selected countries using a multi-stakeholder approach, involving civil society & professional bodies and based on situational analysis

3. Establish global mechanism for sharing info & lessons learnt– Global steering committee to guide global program– Meetings for stakeholders from participating countries

4. External evaluation of strategy after 5 years to review progress with recommendations next 6 years


Creating the WHO Essential Drugs Libraryto facilitate the work of national committees

WHOModel List

Summary of clinical guideline

Reasons for inclusionSystematic reviewsKey references

WHO Model Formulary

Cost:- per unit- per treatment- per month- per case prevented

Quality information:- Basic quality tests- Internat. Pharmacopoea- Reference standards

Evidence-based clinical

guideline


WHO-sponsored training programmes

• INRUD/MSH/WHO: Promoting the rational use of drugs

• MSH/WHO: Drug and therapeutic committees

• Groningen University, The Netherlands / WHO: Problem-based pharmacotherapy

• Amsterdam University, The Netherlands / WHO: Promoting rational use of drugs in the community

• Newcastle, Australia / WHO: Pharmaco-economics

• Boston University, USA / WHO: Drug Policy Issues


Identifying effective strategies to promote more rational use of drugs

• Joint research initiative between WHO/PSM, MSH, Harvard and Boston Universities, and ARCH– over 20 intervention research projects in

developing countries

• WHO/EMP databases on drug use and policy– quantitative data on drug use and interventions to

improve drug use over the last decade– data from MOHs on pharmaceutical policies


Conclusions

• Irrational use of medicines is a very serious global public health problem.

• Much is known about how to improve rational use of medicines but much more needs to be done– policy implementation at the national level– implementation and evaluation of more interventions,

particularly managerial, economic and regulatory interventions

• Rational use of medicines could be greatly improved if a fraction of the resources spent on medicines were spent on improving use.


ActivityDiscuss in groups the following questions

• What should be the roles of:• government, • NGOs and donors, • WHO,

in promoting the rational use of medicines?

rational use of drugs: an overview

Documents