023-Rational Use of Drugs

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 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

% PHC patients treated according to guidelines
Africa/Asia 1990/1 1992/3 1994/5 1996/7 1998/9 2000/1
no.countries 5/5 3/3 10/3 12/5 12/5 3/2
no.surveys 9/7 4/6 16/6 15/6 14/7 3/4
70
60
50
40
30
20
10
0
1990/1 1992/3 1994/5 1996/7 1998/9 2000/1
Africa Asia
Source: WHO database on drug use 2003

4
% 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 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.
Pakistan
Bangladesh
Burkino Faso
Senegal
Angola
Tanzania
0 10 20 30 40 50 60
% observed consultations where the diagnostic process was adequate

5-55% of PHC patients receive injections -
90% may be medically unnecessary
A FR IC A
Ghana
C ameroon
Nigeria
Sudan
Tanzania
Zimbabwe
A SIA
Yemen
Indonesia
Nepal
L.A M ER . & C A R .
E cuador
➤15 billion injections per year globally
Guatemala
El Salvador
➤half are with unsterilized needle/syringe
J amaica
Eastern C aribean ➤2.3-4.7 million infections of hepatitis B/C

and up to 160,000 infections of HIV per
0% 10% 20% year
30%associated
40% with
50% injections
60%
% of primary care patients receiving injections

Source: Quick et al, 1997, Managing Drug Supply 7
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.AM ER. & CAR.
Easte rn 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
8
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 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

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
c o ns u lt a t io n t im e ( m in s ) 8 .6 15 3
% P x w it h a n t ib io t ic s 48
58
% P x w it h inj e c t io n s 9 .5
2 8 .4
no .d ru g it e m s / P12x.6.371
0 10 20 30 40 50 60 70
dis p e n s ing d o c t onrso n - d is pe ns in g d o c t o rs

Changing a Drug Use Problem:
An Overview of the Process
1. EXAMINE
Measure Existing
Practices
(Descriptive
Quantitative Studies)
4. FOLLOW UP improve 2. DIAGNOSE

Measure Changes diagnosis Identify Specific
in Outcomes Problems and Causes
(Quantitative and Qualitative (In-depth Quantitative
Evaluation) and Qualitative Studies)
improve
intervention
3. TREAT
Design and Implement
Interventions
(Collect Data to
Measure Outcomes)

Many Factors Influence Use of Medicines
Intrinsic
Prior
Knowledge
Scientific
Habits
Information Information
Influence Social &

of Drug Cultural
Factors
Industry
Treatment Societal
Workload &
Choices Economic &
Staffing Legal Factors
Workplace Infra- Authority &

structure Relationships Supervision
With Peers
Workgroup
Strategies to Improve Use of Drugs
Educational: Managerial:
 Inform or persuade  Guide clinical practice
– Health providers – Information systems/STGs
– Consumers – Drug supply / lab capacity
Use of
Medicines
Economic: Regulatory:
 Offer incentives  Restrict choices
– Institutions – Market or practice controls
– Providers and patients – Enforcement

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

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

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
40 Post
20
0
Intervention Control 18
Effects of Opinion Leader on Choice Antibiotic
for Prophylaxis in a Teaching Hospital
% of all C-sections Discuss-
0.7 ion with
Obstetric
Chief   
0.6 
Cefazolin
 
0.5  recommend-
 
  ed
  
   
0.4   
 Cefoxitin
 
 not
0.3
 
 recommended

0.2 


0.1
.1  
 
    

0          
Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct
84 85 86

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 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
RCT in Uganda of the effects of STGs, training &
supervision on the % of Px conforming to guidelines
Kafuko et al, UNICEF, 1996.
Randomised No. health Pre- Post- Change

group facilities intervention intervention
Control group 42 24.8% 29.9% +5.1%
Dissemination of 42 24.8% 32.3% +7.5%

guidelines
Guidelines + on- 29 24.0% 52.0% +28.0%

site training
Guidelines + on-
site training + 4 14 21.4% 55.2% +33.8%
supervisory visits
Pre-post with control study of an economic
intervention (user fees) on prescribing in Nepal
Holloway, Gautam & Reeves, HPP, 2001
Fees (complete control fee / Px 1-band item fee 2-band item fee
drug courses) n=12 n=10 n=11
Av. no. items 2.9 2.9 2.9 2.0 2.8 2.2

per prescription (+/- 0) (-0.9) (-0.6)
% prescriptions 23.5 26.3 31.5 45.0 31.2 47.7

conforming to (+2.7%) (+13.5%) (+16.5%)
STGs
Av.cost ( NRs) 24.3 33.0 27.7 28.0 25.6 24.0

per prescription (+8.7) (+0.3) (-1.6)

PHC prescribing with & without Bamako
initiative in Nigeria Scuzochukwu et al, HPP, 2002
n o .E D L d ru g s a v a il 1 5 .3
3 5 .4
% p re s E D L d ru g s 21
93
% P x w ith a n tib io tic s 2 5 .6
6 4 .7
% P x w ith in je c tio n s 38
7 2 .8
n o .d ru g ite m s /P2x.1
5 .3
0 20 40 60 80 100
2 1 B a m a k o P H C1s2 n o n -B a m a k o P H C s

Tetracycline prescription rate & tetracycline-resistant
E.Coli in hospital isolates, 2 municipalities in Denmark,
01/1994-12/1999
Isolates (%, 5-month moving average)

per 1,000 inhabitants)
5 Change in subsidization: from 50 to 0% (01/1996)
Tetracycline-R E. coli Hospital

40
4
Tetracycline Use
30
3
20
2
10
(# prescriptions
0 0
4
95
96
97
98
99
9
19
19
19
19
19
19
Sources: Danish Medicines Agency & H. Westh, Hvidovre Hosp, 2000.

Monnet DL., 40th ICAAC, Toronto, Canada, 527 [abstr. 628]. 25
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

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
AfterPeer
Review Study Physicians
After Control Physicians
(n = 20)
80 Workshop 37/52
79/115
BaselineStage 18-months
60 (n = 20) 42/82 Follow-up
40 31/110
25/102 20/84 16/70 11/46
20

Impact of Training on Use of Diarrhea Treatment
Algorithm in Three Mexico Settings
Intervention Prescribers Baseline Post Change

given by: % % %
"Experts" in 2 clinics 31 24.5 71.2 +46.7

(San Jeronimo)
"Leaders" in 18 clinics 65 17.7 43.4 + 25.6

(Coyoacan)
"Coordinators" in 124 157 24.7 31.2 + 6.5

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

Impact of multiple interventions on
injection use in Indonesia
100%
Interactive group discussion (IGC group only)
Proportion of visits
80% Seminar (both groups)

with injection
60%
District-wide monitoring
40% (both groups)
20%
0%
1 3 5 7 9 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

Drug & Therapeutic Committee Activities
very little data on drug use impact
100
80
60
40
20
0
Australia 1996 USA 2001 NetherlandsGermany 1995
1999
% hospitals with a DTC Drug use monitoring / DUE

Strategies to improve drug use

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
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 Library
to facilitate the work of national committees
Evidence-
Summary of clinical
based Clinical
guideline
guideline
WHO Model
Reasons for Formulary
inclusion WHO
Systematic reviews Model List
Key references
Cost: Quality information:

- per unit - Basic quality tests
- per treatment - Internat.
- per month Pharmacopoea
- per case prevented
- Reference standards

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

P r o m o tin g D T C s : im p a ct o f m a g t., tra in in g &
p la n n in g th o u g h h o sp ita l D T C s in L a o s
% P x w ith
A v .n o .d ru g s / P x
A b s/Inj.
100% 5
80% 4
60% 3
40% 2
No.drugs
20% 1
0% 0 Antibiotics
1 2 3 4 5 6 7 8
M o n th s
Injections

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

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 - 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 – researchers, policy makers,
donors and NGOs
– Summarize topical lessons and research needs
• Topic tracks include
– Child health - Adult health
– TB - HIV/Aids, STIs
– Malaria - Antimicrobial resistance
– Impact of access on use

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?

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Rational use of drugs:

• Understand the reasons underlying irrational use

• Discuss strategies and interventions to promote rational use of

• Discuss the role of government, NGOs, donors and WHO in

WHO, Dept. Essential Drugs and Medicines Policy 2

WHO, Dept. Essential Drugs and Medicines Policy 3

Source: WHO database on drug use 2003

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

% antibiotics % injections % drugs % cost

WHO, Dept. Essential Drugs and Medicines Policy 5

WHO, Dept. Essential Drugs and Medicines Policy 6

Eastern C aribean ➤2.3-4.7 million infections of hepatitis B/C

% of primary care patients receiving injections

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

% of PHC patients receiving antibiotics

WHO, Dept. Essential Drugs and Medicines Policy 9

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

WHO, Dept. Essential Drugs and Medicines Policy 10

WHO, Dept. Essential Drugs and Medicines Policy 11

dis p e n s ing d o c t onrso n - d is pe ns in g d o c t o rs

WHO, Dept. Essential Drugs and Medicines Policy 12

4. FOLLOW UP improve 2. DIAGNOSE

WHO, Dept. Essential Drugs and Medicines Policy 13

Influence Social &

Workplace Infra- Authority &

WHO, Dept. Essential Drugs and Medicines Policy 15

WHO, Dept. Essential Drugs and Medicines Policy 16

• WHO has produced a Guide for Good

WHO, Dept. Essential Drugs and Medicines Policy 17

WHO, Dept. Essential Drugs and Medicines Policy 19

WHO, Dept. Essential Drugs and Medicines Policy 20

• Significant improvement found in:

Randomised No. health Pre- Post- Change

Control group 42 24.8% 29.9% +5.1%

Dissemination of 42 24.8% 32.3% +7.5%

Guidelines + on- 29 24.0% 52.0% +28.0%

Av. no. items 2.9 2.9 2.9 2.0 2.8 2.2

% prescriptions 23.5 26.3 31.5 45.0 31.2 47.7

Av.cost ( NRs) 24.3 33.0 27.7 28.0 25.6 24.0

WHO, Dept. Essential Drugs and Medicines Policy 23

WHO, Dept. Essential Drugs and Medicines Policy 24

Isolates (%, 5-month moving average)

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

Tetracycline-R E. coli Hospital

Sources: Danish Medicines Agency & H. Westh, Hvidovre Hosp, 2000.

WHO, Dept. Essential Drugs and Medicines Policy 27

Improvement in outcome measure (%)

Source: Ross-Degnan et al, Plenary presentation, Conference on

WHO, Dept. Essential Drugs and Medicines Policy 29

Intervention Prescribers Baseline Post Change

"Experts" in 2 clinics 31 24.5 71.2 +46.7

"Leaders" in 18 clinics 65 17.7 43.4 + 25.6

"Coordinators" in 124 157 24.7 31.2 + 6.5

WHO, Dept. Essential Drugs and Medicines Policy 30

80% Seminar (both groups)

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

WHO, Dept. Essential Drugs and Medicines Policy 31

% hospitals with a DTC Drug use monitoring / DUE

WHO, Dept. Essential Drugs and Medicines Policy 32

WHO, Dept. Essential Drugs and Medicines Policy 34

WHO, Dept. Essential Drugs and Medicines Policy 35

Cost: Quality information:

WHO, Dept. Essential Drugs and Medicines Policy 36