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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

,
,

0.2

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Apr

Jul
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Oct

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Cefazolin
recommended

Cefoxitin
not
recommended

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Jan

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0.3

Jan

Apr

Jul
85

Oct

Jan

WHO, Dept. Essential Drugs and Medicines Policy

Apr

Jul

Oct

86

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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

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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

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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

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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

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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

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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.


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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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