Rational use of drugs:
an overview
Kathleen Holloway
Technical Briefing Seminar 2004
Essential Drugs and Medicines Policy
WHO Geneva
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
WHO, Dept. Essential Drugs and Medicines Policy
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
WHO, Dept. Essential Drugs and Medicines Policy
% PHC patients treated according to guidelines
Africa/Asia 1990/1
no.countries
5/5
no.surveys
9/7
1992/3
3/3
4/6
1994/5
10/3
16/6
1996/7
12/5
15/6
1998/9
12/5
14/7
2000/1
3/2
3/4
1994/5
1996/7
1998/9
2000/1
70
60
50
40
30
20
10
0
1990/1
1992/3
Africa
Asia
Source: WHO database on drug use 2003
% drugs that are prescribed unnecessarily
estimated by a comparison of expected versus actual prescription
Chalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000
80
70
60
50
40
30
20
10
0
Nepal
% antibiotics
Yemen
% injections
Nigeria
% drugs
WHO, Dept. Essential Drugs and Medicines Policy
% cost
5
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.
Pakistan
Bangladesh
Burkino Faso
Senegal
Angola
Tanzania
0
10
20
30
40
50
60
% observed consultations where the diagnostic process was adequate
WHO, Dept. Essential Drugs and Medicines Policy
5-55% of PHC patients receive injections 90% may be medically unnecessary
A F R IC A
G ha na
C a m e ro o n
N ige ria
S uda n
T a nza nia
Z im ba bwe
A S IA
Yemen
Indo ne s ia
15
billion injections per year globally
half are with unsterilized needle/syringe
2.3-4.7 million infections of hepatitis B/C
and up to 160,000 infections of HIV per
year associated with injections
N e pa l
L.A M E R . & C A R .
E c ua do r
G ua t e m a la
E l S a lv a do r
J a m a ic a
E a s t e rn C a ribe a n
0%
10%
20%
30%
40%
50%
60%
% of primary care patients receiving injections
Source: Quick et al, 1997, Managing Drug Supply
30 to 60 % of PHC patients receive antibiotics perhaps twice what is clinically needed
AFRICA
Sudan
Sw aziland
Cam eroon
Ghana
Tanzania
Zim babw e
ASIA
Indonesia
Nepal
Bangladesh
L.AMER. & CAR.
Eastern Caribean
El Salvador
Jam aica
Guatem ala
0%
10%
20%
30%
40%
50%
60%
70%
% of PHC patients receiving antibiotics
Source: 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
WHO, Dept. Essential Drugs and Medicines Policy
Source: DAP, EMC, GTB, CHD (1997)
Adverse drug events
Review 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
WHO, Dept. Essential Drugs and Medicines Policy
10
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
WHO, Dept. Essential Drugs and Medicines Policy
11
Prescribing by dispensing and non-dispensing doctors in Zimbabwe
Trap et al 2000
13
8.65
consultation time (mins)
48
% Px with antibiotics
9.5
% Px with injections
58
28.4
1.67
2.31
no.drug items/Px
0
10
20
30
dispensing doctors
40
50
60
70
non-dispensing doctors
WHO, Dept. Essential Drugs and Medicines Policy
12
Changing a Drug Use Problem:
An Overview of the Process
1. EXAMINE
Measure Existing
Practices
(Descriptive
Quantitative Studies)
4. FOLLOW UP
Measure Changes
in Outcomes
(Quantitative and Qualitative
Evaluation)
improve
diagnosis
improve
intervention
2. DIAGNOSE
Identify Specific
Problems and Causes
(In-depth Quantitative
and Qualitative Studies)
3. TREAT
Design and Implement
Interventions
(Collect Data to
Measure Outcomes)
WHO, Dept. Essential Drugs and Medicines Policy
13
Many Factors Influence Use of Medicines
Information
Scientific
Information
Influence
of Drug
Industry
Habits
Social &
Cultural
Factors
Treatment
Choices
Workload &
Staffing
Workplace
Intrinsic
Prior
Knowledge
Infrastructure
Relationships
With Peers
Societal
Economic &
Legal Factors
Authority &
Supervision
Workgroup
WHO, Dept. Essential Drugs and Medicines Policy
14
Strategies to Improve Use of Drugs
Educational:
Inform or persuade
Health providers
Consumers
Managerial:
Guide clinical practice
Information systems/STGs
Drug supply / lab capacity
Use of
Medicines
Economic:
Offer incentives
Institutions
Providers and patients
Regulatory:
Restrict choices
Market or practice controls
Enforcement
WHO, Dept. Essential Drugs and Medicines Policy
15
Educational Strategies
Goal: 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
WHO, Dept. Essential Drugs and Medicines Policy
16
Training for prescribers
The 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
WHO, Dept. Essential Drugs and Medicines Policy
17
Impact of Patient-Provider Discussion Groups on
Injection Use in Indonesian PHC Facilities
Hadiyono et al, SSM, 1996, 42:1185
% Prescribing Injections
80
60
Pre
Post
40
20
0
Intervention
Control
18
Effects of Opinion Leader on Choice Antibiotic
for Prophylaxis in a Teaching Hospital
Discussion with
Obstetric
Chief
% of all C-sections
0.7
0.6
0.5
0.4
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Apr
Jul
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Oct
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WHO, Dept. Essential Drugs and Medicines Policy
Apr
Jul
Oct
86
19
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
WHO, Dept. Essential Drugs and Medicines Policy
20
Review of 59 evaluations of clinical guidelines
Grimshaw & 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
WHO, Dept. Essential Drugs and Medicines Policy
21
RCT in Uganda of the effects of STGs, training &
supervision on the % of Px conforming to guidelines
Kafuko et al, UNICEF, 1996.
Randomised
group
No. health
PrePostfacilities intervention intervention
Change
Control group
42
24.8%
29.9%
+5.1%
Dissemination of
guidelines
42
24.8%
32.3%
+7.5%
Guidelines + onsite training
29
24.0%
52.0%
+28.0%
14
21.4%
55.2%
+33.8%
Guidelines + onsite training + 4
supervisory visits
WHO, Dept. Essential Drugs and Medicines Policy
22
Pre-post with control study of an economic
intervention (user fees) on prescribing in Nepal
Holloway, Gautam & Reeves, HPP, 2001
Fees (complete
drug courses)
control fee / Px 1-band item fee 2-band item fee
n=12
n=10
n=11
Av. no. items
per prescription
2.9 2.9
(+/- 0)
2.9 2.0
(-0.9)
2.8 2.2
(-0.6)
% prescriptions
conforming to
STGs
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)
WHO, Dept. Essential Drugs and Medicines Policy
23
PHC prescribing with & without Bamako
initiative in Nigeria Scuzochukwu et al, HPP, 2002
15.3
no.EDL drugs avail
35.4
21
% pres EDL drugs
93
25.6
% Px with antibiotics
64.7
38
% Px with injections
72.8
2.1
5.3
no.drug items/Px
0
20
21 Bamako PHCs
40
60
80
100
12 non-Bamako PHCs
WHO, Dept. Essential Drugs and Medicines Policy
24
Tetracycline Use
19 (# prescriptions per 1,000 inhabitants)
Tetracycline prescription rate & tetracycline-resistant
E.Coli in hospital isolates, 2 municipalities in Denmark,
01/1994-12/1999
5
Change in subsidization: from 50 to 0% (01/1996)
40
4
30
20
19
99
19
98
19
97
0
19
96
0
19
95
10
94
Sources: Danish Medicines Agency & H. Westh, Hvidovre Hosp, 2000.
25
Monnet DL., 40th ICAAC, Toronto, Canada, 527 [abstr. 628].
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
WHO, Dept. Essential Drugs and Medicines Policy
26
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
WHO, Dept. Essential Drugs and Medicines Policy
27
Review of 30 studies in developing countries
size of drug use improvements with various interventions
Minor
Moderate
Large
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
0
10
20
30
40
50
60
Improvement in outcome measure (%)
Source: Ross-Degnan et al, Plenary presentation, Conference on
Improving the Use of Medicines, 1997, Chiang Mai, Thailand.
28
Combined Intervention Strategy
Prescribing for Acute Diarrhea in Mexico City
% cases treated in line with algorithm
100
After
Workshop
80
60
AfterPeer
Review
(n = 20)
37/52
Study Physicians
Control Physicians
79/115
BaselineStage
(n = 20) 42/82
18-months
Follow-up
40
31/110
25/102
20/84
16/70
11/46
20
WHO, Dept. Essential Drugs and Medicines Policy
29
Impact of Training on Use of Diarrhea Treatment
Algorithm in Three Mexico Settings
Intervention
given by:
Prescribers Baseline
%
Post
%
Change
%
"Experts" in 2 clinics
(San Jeronimo)
31
24.5
71.2
+46.7
"Leaders" in 18 clinics
(Coyoacan)
65
17.7
43.4
+ 25.6
"Coordinators" in 124
clinics (Tlaxcala)
157
24.7
31.2
+ 6.5
Source: Munoz, et al, unpub. (1993); Guiscafre, et al, Arch. Med. Res. (1995)
WHO, Dept. Essential Drugs and Medicines Policy
30
Proportion of visits
with injection
Impact of multiple interventions on
injection use in Indonesia
100%
Interactive group discussion (IGC group only)
80%
Seminar (both groups)
District-wide monitoring
(both groups)
60%
40%
20%
0%
1
11
13 15
17 19
21 23
25
Months
Comparison group
Interactive group discussion
Source: Long-term impact of small group interventions, Santoso et al., 1996
WHO, Dept. Essential Drugs and Medicines Policy
31
Drug & Therapeutic Committee Activities
very little data on drug use impact
100
80
60
40
20
0
Australia 1996 USA 2001
% hospitals with a DTC
Strategies to improve drug use
Netherlands Germany 1995
1999
Drug use monitoring / DUE
WHO, Dept. Essential Drugs and Medicines Policy
32
10 national strategies to promote RUD
needs 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
WHO, Dept. Essential Drugs and Medicines Policy
33
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, Dept. Essential Drugs and Medicines Policy
34
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
WHO, Dept. Essential Drugs and Medicines Policy
35
Creating the WHO Essential Drugs Library
to facilitate the work of national committees
Evidencebased Clinical
guideline
Summary of clinical
guideline
Reasons for
inclusion
Systematic reviews
Key references
Cost:
- per unit
- per treatment
- per month
- per case prevented
WHO Model
Formulary
WHO
Model List
Quality information:
- Basic quality tests
- Internat.
Pharmacopoea
- Reference standards
WHO, Dept. Essential Drugs and Medicines Policy
36
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
WHO, Dept. Essential Drugs and Medicines Policy
37
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
WHO, Dept. Essential Drugs and Medicines Policy
38
Promoting DTCs : impact of magt., training &
planning though hospital DTCs in Laos
% Px with
Abs/Inj.
Av.no.drugs / Px
100%
80%
No.drugs
60%
Antibiotics
40%
Injections
20%
0%
0
1
Months
WHO, Dept. Essential Drugs and Medicines Policy
8
39
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
WHO, Dept. Essential Drugs and Medicines Policy
40
ICIUM2004
2nd 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
Hospitals
Private pharmacies
- Natl. policy & systems
- Primary care
- Community use
WHO, Dept. Essential Drugs and Medicines Policy
41
ICIUM2004: topic tracks
Meetings Within a Meeting
Key constituencies and interest groups working on
pharmaceutical issues researchers, policy makers,
donors and NGOs
Summarize topical lessons and research needs
Topic tracks include
Child health
TB
Malaria
Impact of access on use
- Adult health
- HIV/Aids, STIs
- Antimicrobial resistance
WHO, Dept. Essential Drugs and Medicines Policy
42
Activity
Discuss 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?
WHO, Dept. Essential Drugs and Medicines Policy
43
