rational use of drugs: an overview kathleen holloway technical briefing seminar 2003 essential drugs...

Rational use of drugs:an overview

Kathleen HollowayTechnical Briefing Seminar 2003Essential Drugs and Medicines Policy

WHO Geneva

WHO, Dept. Essential Drugs and Medicines Policy 2

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

3

% PHC patients treated according to guidelines

0

10

20

30

40

50

60

70

1990/1 1992/3 1994/5 1996/7 1998/9 2000/1

Africa Asia

Africa/Asia 1990/1 1992/3 1994/5 1996/7 1998/9 2000/1no.countries 5/5 3/3 10/3 12/5 12/5 3/2no.surveys 9/7 4/6 16/6 15/6 14/7 3/4

Source: WHO database on drug use 2003


% drugs that are prescribed unnecessarilyestimated by a comparison of expected versus actual prescription

Chalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000

0

10

20

30

40

50

60

70

80

Nepal Yemen Nigeria

% antibiotics % injections % drugs % cost


Adequacy of diagnostic process 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

6

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 injectionsSource: 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

7

30 to 60 % of PHC patients receive antibiotics -

perhaps twice what is clinically needed

0% 10% 20% 30% 40% 50% 60% 70%

Guatemala

Jamaica

El Salvador

Eastern Caribean

L.AMER. & CAR.

Bangladesh

Nepal

Indonesia

ASIA

Zimbabwe

Tanzania

Ghana

Cameroon

Swaziland

Sudan

AFRICA

% of PHC patients receiving antibioticsSource: Quick et al, 1997, Managing Drug Supply


Overuse and misuse of antimicrobials contributes to antimicrobial resistance

• Malaria

– choroquine resistance in 81/92 countries

• Tuberculosis

– 2 - 40 % primary multi-drug resistance

• Gonorrhoea

– 5 - 98 % penicillin resistance in N. gonorrhoeae

• Pneumonia and bacterial meningitis

– 12 - 55 % penicillin resistance in S. pneumoniae

• Diarrhoea: shigellosis

– 10-90+ % amp, 5-95% TMP/SMZ resistance

Source: DAP, EMC, GTB, CHD (1997)


Adverse drug eventsReview by White et al, Pharmacoeconomics, 1999, 15(5):445-458

• 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


Drug Purchases through the Private Sector

• 50-90% of all drug purchases are private– 25% to 75% illness episodes self-medicated

– 1/2 consumers buy 1-day supply at a time

– 50% of people worldwide fail to take drugs correctly

• Results not always therapeutic– over-treatment of mild illness

– inadequate treatment of serious illness

– mis-use of anti-infective drugs

– over-use of injections


Prescribing by dispensing and non-dispensing doctors in Zimbabwe Trap et al 2000

2.31

28.4

58

8.65

1.67

9.5

48

13

0 10 20 30 40 50 60 70

no.drug items/Px

% Px with injections

% Px with antibiotics

consultation time (mins)

dispensing doctors non-dispensing doctors


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


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

Strategies to Improve Use of Drugs


Educational StrategiesGoal: to inform or persuade

• Training for Providers– Undergraduate education– Continuing in-service medical education e.g. 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


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

17

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

Hadiyono et al, SSM, 1996, 42:1185

Intervention Control0

20

40

60

80

% Prescribing Injections

PrePre

PostPost


Effects of Opinion Leader on Choice Antibiotic for Prophylaxis in a Teaching Hospital

Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct84 85 86

0

0.1.1

0.2

0.3

0.4

0.5

0.6

0.7

% of all C-sections Discuss-ion withObstetricChief

Cefazolinrecommend-ed

Cefoxitinnot recommended


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

• Avoidance of perverse financial incentives – prescribers’ salaries from drug sales, flat prescription fees,

– insurance policies that reimburse non-essential drugs or incorrect doses


Review of 59 evaluations of clinical guidelinesGrimshaw & Russell, Lancet, Nov.27 1993, 342:1317-1322

• Significant improvement found in:– 55/59 studies concerning the process of care

– 9/11 studies concerning patient outcome

• Size of the improvement varied 5-60% and was higher if there was:– involvement of users in guideline development

– a specific educational intervention

– a patient-specific reminder at consultation e.g. a decision by a funding body not to reimburse prescriptions not meeting guidelines


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

Kafuko et al, UNICEF, 1996.

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%


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

Holloway, Gautam & Reeves, HPP, 2001

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)

23

0

1

2

3

4

5

1994

1995

1996

1997

1998

1999

0

10

20

30

40

Sources: Danish Medicines Agency & H. Westh, Hvidovre Hosp, 2000.Monnet DL., 40th ICAAC, Toronto, Canada, 527 [abstr. 628].

Change in subsidization: from 50 to 0% (01/1996)

Tet

racy

clin

e-R

E.

coli

Ho

spit

alIs

ola

tes

(%,

5-m

onth

mov

ing

aver

age)

Tetracycline prescription rate & tetracycline-resistant E.Coli in hospital isolates, 2 municipalities in Denmark, 01/1994-12/1999

T

etra

cycl

ine

Use

(#

pre

scrip

tions

per

1,0

00 in

habi

tant

s)


Regulatory strategies

Goal: 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


Choosing an Intervention• A single educational strategy is often not effective and

does not have a sustainable impact

• Printed materials alone are not effective

• Combination of strategies, particularly of different types (e.g. educational + managerial) always produces better results than a single strategy

• Focused small groups and face to face interactive workshops have been shown to the effective

• Audit and feedback, peer review, are very effective

• Economic strategies are very powerful strategies to change drug use but may be difficult to introduce

26

Review of 30 studies in developing countries size of drug use improvements with various interventions

0

Improvement in outcome measure (%)

10 20 30 40 50 60

Large group training Small group training

Diarr. community case mgt

ARI community case mgt

Info/guidelines

Group process

Supervision/audit

EDP/Drug supply

Economic strategies

Minor Moderate Large

Source: Ross-Degnan et al, Plenary presentation, Conference on Improving the Use of Medicines, 1997, Chiang Mai, Thailand.


Combined Intervention StrategyPrescribing for Acute Diarrhea in Mexico City

0

20

40

60

80

100

% cases treated in line with algorithm

Study PhysiciansControl Physicians

37/5279/115

20/84

BaselineStage (n = 20)

After Workshop

AfterPeer Review (n = 20)

18-months Follow-up

11/46

31/110

16/7025/102

42/82


Impact of Training on Use of Diarrhea Treatment Algorithm in Three Mexico Settings

Source: Munoz, et al, unpub. (1993); Guiscafre, et al, Arch. Med. Res. (1995)

Intervention given by:

"Experts" in 2 clinics(San Jeronimo)

"Leaders" in 18 clinics (Coyoacan)

"Coordinators" in 124

Prescribers

31

65

157

Baseline %

24.5

17.7

24.7

Post%

71.2

43.4

31.2

Change %

+46.7

+ 25.6

+ 6.5 clinics (Tlaxcala)


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)


Drug & Therapeutic Committee Activitiesvery little data on drug use impact

0

20

40

60

80

100

Australia 1996 USA 2001 Netherlands1999

Germany 1995

% hospitals with a DTC Drug use monitoring / DUEStrategies to improve drug use


10 national strategies to promote RUDneeds sufficient govt. investment for medicines & staff !

1. Evidence-based standard treatment guidelines

2. Essential Drug Lists based on treatments of choice

3. Drug & Therapeutic Committees in hospitals

4. Problem-based training in pharmacotherapy in UG training

5. Continuing medical education as a licensure requirement

6. Independent drug information e.g bulletins, formularies

7. Supervision, audit and feedback

8. Public education about drugs

9. Avoidance of perverse financial incentives

10. Appropriate and enforced drug regulation


Why does irrational use continue?

Very few countries regularly monitor drug use & 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?


WHO future priorities

• Developing a model formulary process, the WHO Essential Drugs Library

• Training programmes

• Pilot projects to contain antimicrobial resistance

• Promoting drug & therapeutic committees

• Intervention research to promote RUD

– cost-effectiveness of interventions, policies

• Advocacy for the rational use of drugs (RUD)

– Essential Drug Monitor, effective drug information

– ICIUM2004


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/WHO: Promoting rational

use of drugs in the community• Newcastle, Australia/WHO : Pharmaco-economics• Boston University, USA/WHO: Drug Policy Issues


Local pilot projects to contain AMR

• Objectives– develop, implement & evaluate interventions to contain AMR

using surveillance data in local sites

– to develop a new method for the integrated surveillance, at community level, of antimicrobial use and resistance that can be used in many different countries

– to build local capacity in developing a multi-disciplinary approach to the containment of AMR

• 3 phases– (1) set up surveillance,

– (2) develop, implement & evaluate interventions

– (3) expand to other sites


Promoting DTCs : impact of magt., training & planning though hospital DTCs in Laos

0%

20%

40%

60%

80%

100%

1 2 3 4 5 6 7 8Months

% Px with Abs/Inj.

0

1

2

3

4

5

Av.no.drugs / Px

Injections

Antibiotics

No.drugs


Identifying effective strategies to promote

more rational use of drugs • Joint research initiative between

WHO/EDM, MSH and ARCH– over 20 intervention research projects in

developing countries

• WHO database on drug use– quantitative data on drug use and interventions

to improve drug use over the last decade


ICIUM20042nd International conference for improving use of medicines

• Next milestone in assessing progress on global medicines agenda

• Chiang Mai, Thailand, Mar 30-Apr 2, 2004• Objective: Examine state of the art in improving

medicines use in focus areas:– Intl. policy & systems - Natl. policy &

systems– Hospitals - Primary care– Private pharmacies - Community use


ICIUM2004: topic tracks

• “Meetings Within a Meeting”– Key constituencies and interest groups working on

pharmaceutical issues– Summarize topical lessons and research needs

• Preliminary topic tracks include– Child health - Malaria– TB - HIV/Aids, STIs– Chronic diseases - Antimicrobial

resistance– Impact of access on use


ICIUM2004: who should attend?

• Researchers– Leading drug use researchers & methodologists

– Fertilization across interest areas

• Policymakers– Learn cutting edge behavior change approaches

– Assessment of pharmaceutical policy impacts

• NGOs and Donors– Add value to existing programs

– Coordinate with global medicines initiative


ActivityDiscuss in groups the following questions

• Choose a major drug use problem in your country or project

• Identify the causes underlying the problem

• What are the main 1-2 strategies being undertaken to address this problem?

• Are these 1-2 strategies being evaluated? If so, how?

• What should be the roles of government, NGOs, donors, and WHO be in filling the gap in strategies/policies to address this problem?

rational use of drugs: an overview kathleen holloway technical briefing seminar 2003 essential drugs...

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