Promoting the rational use

of medicines

Hans V. Hogerzeil, MD, PhD, FRCP Edin

WHO Essential Drugs and Medicines Policy
October 2002
 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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 Access framework

Practical implications of the access framework

1. Rational 3. Sustainable
selection financing

ACCESS TO
ESSENTIAL MEDICINES

2. Affordable 4. Reliable
prices systems

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 Example irrational use

Irrational use of medicines

is 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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 Example irrational use

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

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 Example irrational use

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)

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 Measuring drug use

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%)

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 Measuring drug use

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%)

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 Interventions

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

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 Selection
The Essential Medicines Target
National list of
Registered medicines essential medicines
All the drugs
in the world
Levels of use

S CHW S
dispensary

Health center Supplementary

Hospital specialist
Referral hospital medicines

Private sector

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 Selection

Clinical guidelines and a list of essential medicines

lead to better prevention and care
List of common diseases and complaints

Treatment choice

Essential medicines list /

Treatment guidelines
National formulary

Training and Financing and

Supervision Supply of drugs

Prevention
and care

Health Technology and Pharmaceuticals

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Example of challenge:
New essential drugs are expensive
Antibiotics for gonorrhoea:
Antimalarial drugs:
Antituberculosis:
Antiretrovirals:
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Challenges
50-90x price of penicillins
chloroquine $0.10 per treatment
artemether-lumefantrine $2.50/pp (25x)
atovaquone-proguanil $40/pp (400x)
$15 for DOTS vs $300 for MDR (20x)
$300-600/year; but 38 countries with
a drug budget <$2 pp/year
 Selection

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 history

of medicine, pharmacy and public health
Médecins sans Frontières, 2000

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 Selection

The WHO Model List of Essential Medicines is a

model 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

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 Selection
WHO Essential Medicines Library
Combining information from various partners

WHO clusters WHO/EDM

Clinical
Summary of clinical guideline
guideline BNF

WHO/EC, Cochrane WHO Model

Reasons for inclusion Formulary
Systematic reviews WHO
Key references Model List

WHO/EDM
MSH Cost: Statistics: Quality information:
UNICEF - per unit - ATC - Basic quality tests
MSF - per treatment
- per month - DDD - Intern. Pharmacopoea
- per case prevented WCCs - Reference standards
Oslo/Uppsala

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 Selection

The WHO Model List of Essential Medicines is a

model 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

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

By Dec.1999:
156 countries with EDLS National Essential Drugs List

< 5 years (127)

1/3 within 2 years > 5 years (29)
3/4 within 5 years No NEDL (19)
Unknown (16)

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.

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 Achievements

Treatment guidelines and formulary manuals put the

essential drugs concept into clinical practice

 135 countries have treatment guidelines, formularies

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 Achievements
DAP’s role
Training in rational prescribing has expanded in
universities throughout the world

 Problem-based pharmacotherapy
 In 21 languages
 For medical students,
clinical officers
 Measurable improvement in
prescribing
 Now also: Teacher’s Guide to
Good Prescribing

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 Interventions

Impact of problem-based pharmacotherapy teaching

on examination scores (Argentina, 1999-2002)

1999(n=802) 52 36 9,5 2,4

2000(n=559) 41,5 37,6 15 5,9

2001(n=855) 40 36 16 6,9

2002(n=131) 25,2 42,7 24,4 8,4

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

3 4-5 6-7 >8

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 Measuring drug use

Example of an indicator survey time series:

Percent prescriptions by generics, from EDL, and actually
dispensed (Delhi State, 1995-2000)

120

100 Availability

80

60 Generics
40

20
EDL
0
1995 1997 1999 2000

Year under review

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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 research
Example: Is it reproducable and cost-effective?

Mexico (1992-1994) Research District State

Adequate treatment
Diarrhoea: % change 46.7 25.6 29.3
ARI: % change 32.6 28.8 8.5

Cost-benefit ratio
Diarrhoea: 3.3 3.9 4.4
ARI: 16.2 18.4 21.6

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

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 Interventions

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

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 Interventions

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

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 Interventions

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

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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

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 Thank you

www.who.int / medicines