Promoting the rational use of medicines Hans V. Hogerzeil, MD, PhD, FRCP Edin WHO Essential Drugs and Medicines Policy October 2002.

Promoting the rational use Promoting the rational use of medicinesof medicines

Hans V. Hogerzeil, MD, PhD, FRCP EdinWHO Essential Drugs and Medicines Policy

October 2002

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Overview of the presentation

Access framework Examples of irrational use of medicines Measuring drug use (indicators) How to promote rational prescribing

Proven effective interventions Probably effective interventions Probably ineffective interventions

Promoting rational prescribing in the private sector

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Practical implications of the access framework

1. Rational

selection

4. Reliable

systems

2. Affordable

prices

3. Sustainable

financing

ACCESS TO

ESSENTIAL MEDICINES

Access framework

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Example irrational use

Irrational use of medicinesis a widespread hazard to health

Only half of 102 countries surveyed regulate drug promotion

In some areas, by age 2 children have had more than 20 injections

15 billion injections aregiven per year - and half of them are unsterile

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Published examples of irrational prescribing in teaching hospitals in developing countries

Yemen 1990: 68% of hypertensive patients receive diazepam; 80% of UTI receive furosemide, 80% of osteoarthritis receive vitamins

Ilorin 1991: 33% of inpatients are on tranquillizers Kathmandu 1992: Only 70% of medicines prescribed are from

the national list of essential medicines Thailand 1991: 79% of surgical antibiotic prophylaxis is

inappropriate (choice, dose and/or duration) South Africa 1991: 54% of antibiotic treatment in gynaecology

inpatients is inappropriate

Example irrational use

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Examples of irrational prescribing from 4800 general practices in the UK (1995)

Ulcer healing medication used “presumptively” In 0-90% of patients,SSRIs have replaced tricyclic

antidepressants In 0-56% of patients, buspirone has replaced diazepam

(300x as expensive) 0-97% of patients on beta-blockers receive long-acting

betablockers (16-25x as expensive) Other inhalors prescribed instead of salbutamol: (cost 8x) Combination medicines (cost up to 16x)

Example irrational use

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How to measure irrational drug use?WHO/INRUD indicators (1)

Prescribing indicators Average number of drugs per encounter (<2) Percentage of drugs prescribed by generic name

(close to 100%) Percentage of encounters with an antibiotic prescribed

(<30%) Percentage of encounters with an injection prescribed

(<10%) Percentage of drugs prescribed from EDL or formulary

(close to 100%)

Measuring drug use

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How to measure irrational drug use?WHO/INRUD indicators (2)

Patient care indicators Average consultation time Average dispensing time Percentage of drugs actually dispensed (100%) Percentage of drugs adequately labelled (100%) Patients’ knowledge of correct dosage (100%)

Facility indicators Availability of copy of EDL or formulary (100%) Availability of key drugs (100%)

Measuring drug use

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Promoting rational prescribing: Proven effective interventions

Standard treatment guidelines, when evidence-based, developed with end-users, with active dissemination and follow-up

Essential Medicines lists, when linked to treatment guidelines and used for training and supply

Hospital Drugs and Therapeutic Committees Undergraduate training Comprehensive approach, with all components

Interventions

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The Essential Medicines Target

S S

All the drugsin the world

Registered medicines

National list ofessential medicines

Levels of use

Supplementaryspecialistmedicines

CHWdispensary

Health center

Hospital

Referral hospital

Private sector

Selection

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Clinical guidelines and a list of essential medicines lead to better prevention and care

Health Technology and Pharmaceuticals

List of common diseases and complaints

Training andSupervision

Financing and Supply of drugs

Treatment guidelines

Treatment choice

Preventionand care

Essential medicines list / National formulary

Selection

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Example of challenge:New essential drugs are expensive

Antibiotics for gonorrhoea: 50-90x price of penicillins

Antimalarial drugs: chloroquine $0.10 per treatment artemether-lumefantrine $2.50/pp (25x)atovaquone-proguanil $40/pp (400x)

Antituberculosis: $15 for DOTS vs $300 for MDR (20x)

Antiretrovirals: $300-600/year; but 38 countries with a drug budget <$2 pp/year

Challenges

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WHO Model List of Essential Drugs

1977 First Model list published, ± 200 active substances List is revised every two years by WHO Expert Committee Last revision (April 2002) contains 325 active substances 2002 Revised procedures approved by WHO

The first list was a major breakthrough in the historyof medicine, pharmacy and public health

Médecins sans Frontières, 2000

Selection

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The WHO Model List of Essential Medicines is amodel product, model process and public health tool

Model product: list of essential drugs with information

Core list: minimum drug needs for a basic health care system, listing the most cost-effective drugs for priority conditions (selected on the basis of public health relevance and potential for safe and cost-effective treatment).

Complementary list: essential drugs for which specialised diagnostic or treatment facilities may be needed

Selection

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WHO Essential Medicines LibraryCombining information from various partners

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- Intern. Pharmacopoea- Reference standards

Clinical guideline BNF

WHO clusters

MSHUNICEF

MSF

WHO/EDM

WHO/EDM

WHO/EC, Cochrane

Statistics:- ATC- DDD

WCCs Oslo/Uppsala

Selection

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The WHO Model List of Essential Medicines is amodel product, model process and public health tool

Model process: example for national committees

Independent Membership of the Committee, careful consideration of conflict of interest

Transparent process, standard application, web review Link to evidence-based clinical guidelines Systematic review of comparative efficacy, safety, cost-

effectiveness and public health relevance Rapid dissemination, electronic access Regular review

Selection

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National Essential Drugs List

< 5 years (127)> 5 years (29)No NEDL (19)Unknown (16)

By Dec.1999:

156 countries with EDLS

1/3 within 2 years

3/4 within 5 years

The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings

Countries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists.

Achievements

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135 countries have treatment guidelines, formularies

Achievements

Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice

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Training in rational prescribing has expanded in universities throughout the world

DAP’s role

Problem-based pharmacotherapy In 21 languages For medical students,

clinical officers Measurable improvement in

prescribing Now also: Teacher’s Guide to

Good Prescribing

Achievements

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Impact of problem-based pharmacotherapy teachingon examination scores (Argentina, 1999-2002)

25,2

40

41,5

52

42,7

36

37,6

36

24,4

16

15

9,5

5,9

2,4

6,9

8,4

0% 20% 40% 60% 80% 100%

2002(n=131)

2001(n=855)

2000(n=559)

1999(n=802)

3 4-5 6-7 > 8

Interventions

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Example of an indicator survey time series:Percent prescriptions by generics, from EDL, and actually dispensed (Delhi State, 1995-2000)

0

20

40

60

80

100

120

1995 1997 1999 2000

Availability

Generics

EDL

Perc

en

t

Year under review

Measuring drug use

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Trends in research: From drug utilisation to cost-effective intervention (1)

Drug utilisation studies tend to be descriptive, aggregated data : WHAT?

Indicator studies

more focused on rational drug use: WHAT? HOW MUCH?

Qualitative studies WHY?

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Trends in research:From drug utilisation to cost-effective intervention (2)

Intervention studies

HOW MUCH? WHY? (intervention) HOW MUCH NOW?

Conclusion DOES IT WORK? IS THE INTERVENTION

EFFECTIVE?

Management studies IS THE INTERVENTION REPRODUCABLE?

IS IT COST-EFFECTIVE?

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Trends in researchExample: Is it reproducable and cost-effective?

Mexico (1992-1994) Research District StateAdequate treatment Diarrhoea: % change 46.7 25.6 29.3ARI: % change 32.6 28.8 8.5

Cost-benefit ratioDiarrhoea: 3.3 3.9 4.4ARI: 16.2 18.4 21.6

Source: Guiscafre et al. Arch Med Res 1995; 26, Supp. S31-39

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Promoting rational prescribing: Interventions which need more testing

Probably effective: Drug sellers interventions Public education Changing fee structure

Probably ineffective: Drug information bulletins and other printed materials Banning ineffective/dangerous medicines Arbitrary prescription limitations, counter signatures Traditional stand-up lecturing

Interventions

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Promoting rational prescribing: Possible interventions in the private sector

Regulation: market approval, re-licensing, re-evaluation per therapeutic category, regulation of promotion

Training: basic training, national clinical guidelines, continuing medical education by universities and professional bodies, re-licensing of professionals on basis of education points, district DThCommittees, medical audit, patient information leaflets, public education

Financial incentives: separate prescribing from dispensing, dispensing fee (flat or tiered), price controls on generic/brand drugs, contracting out

Insurance: reimbursement limited to essential medicines, reference pricing

Interventions

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Where to start in countries with a strong private sector?

Regulation: market approval, re-licensing, re-evaluation per therapeutic category, regulation of promotion

Training: basic training, national clinical guidelines, continuing medical education by universities and professional bodies, re-licensing of professionals on basis of education points, district DThCommittees, medical audit, patient information leaflets, public education

Financial incentives: separate prescribing from dispensing, dispensing fee (flat or tiered), price controls on generic/brand drugs, contracting out

Insurance: reimbursement limited to essential medicines, reference pricing

Interventions

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Conclusion

Good experiences, policy advice, training tools and national expertise are available

Future of essential medicines lies with the public sector and insurance systems

There are many effective interventions possible for the private sector

Thank you

www.who.int / medicines