Tbsrud3nov09

Rational use of drugs:
an overview
Kathleen Holloway
Technical Briefing Seminar
November 2009
Department of Essential Medicines and Pharmaceutical Policy
TBS 2009

TBS 2009
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

TBS 2009
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

TBS 2009
Adequacy of diagnostic process
Source: 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.
0 10 20 30 40 50 60
Tanzania
Angola
Senegal
Burkino Faso
Bangladesh
Pakistan
% observed consultations where the diagnostic process was adequate

TBS 2009
5-55% of PHC patients receive injections -
90% may be medically unnecessary
0% 10% 20% 30% 40% 50% 60%
Ea s tern C a ribe a n
J a m a ic a
El S a lv a do r
G ua te m a la
Ec ua do r
L.A M ER . & C A R .
N e pa l
Indo ne s ia
Ye m e n
A S IA
Z im ba bwe
T a nza nia
S uda n
N ige ria
C a m e ro o n
G ha na
A F R IC A
% of primary care patients receiving injections
Source: Quick et al, 1997, Managing Drug Supply
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

TBS 2009
0
5
10
15
20
25
30
35
FR GR LU PT IT BE SK HR PL IS IE ES FI BG CZ SI SE HU NO UK DK DE LV AT EE NL
DDDper1000inh.perday
Variation in outpatient antibiotic use
in 26 European countries in 2002
Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.

TBS 2009
Database on medicines use
• Database of all medicines use
surveys using standard indicators in
primary care in developing and
transitional countries
• Studies identified from INRUD
biliog, PUBMED, WHO archives
• Data on study setting, interventions,
methods and drug use extracted &
entered
• All data extraction and entry
checked by 2 persons
• Now > 900 studies entered
• Systematic quantitative review
• Evidence from analysis used for
WHA60.16 in 2007

TBS 2009
% compliance with guidelines by WB region
0
10
20
30
40
50
60
1982-1994 1995-2000 2001-2006
Sub-Saharan Africa (n=29-48) Lat. America & Carrib (n=5-13)
Middle East & C. Asia (n=4-8) East Asia & Pacific (n=7-11)
South Asia (n=6-12)

TBS 2009
Public / private treatment of acute diarrhoea
by doctors, nurses, paramedical staff
0
10
20
30
40
50
60
70
80
% diarrhoea cases
prescribed antibiotic
% diarrhoea cases
prescribed anti-diarrhoeals
% diarrhoea cases
prescribed ORS
Public (n=54-90) Private-for-profit (n=5-10)

TBS 2009
Treatment of ARI by prescriber type
0
10
20
30
40
50
60
70
80
% viral URTI cases
% pneumonia cases
% ARI cases treated with
cough syrup
Doctor (n=26-62) Nurse/paramedic (n=12-86) Pharmacy staff (n=9-17)

TBS 2009
Overuse and misuse of antimicrobials
contributes to antimicrobial resistance
• Malaria
– choroquine resistance in 81/92 countries
• Tuberculosis
– 0-17 % primary multi-drug resistance
• HIV/AIDS
– 0-25 % primary resistance to at least one anti-retroviral
• Gonorrhoea
– 5-98 % penicillin resistance in N. gonorrhoeae
• Pneumonia and bacterial meningitis
– 0-70 % penicillin resistance in S. pneumoniae
• Diarrhoea: shigellosis
– 10-90% ampicillin resistance, 5-95% cotrimoxazole resistance
• Hospital infections
– 0-70% S. Aureus resistance to all penicillins & cephalosporins
Source: WHO country data 2000-3

TBS 2009
Community surveillance
of AMR and use (1)
• Developing & piloting method for
integrated surveillance of AMR & AB
use & collection of baseline data in 2
resource-constrained settings
• 3 sites in India & 2 in S. Africa
• AMR & AB use data collected
monthly for 1-2 years from same
communities
• 4 sites measured AMR in E.Coli & 1
in S.pneum & H.influenzae
• AB use by private GPs, retailers,
public & priv hospitals & PHCs by
exiting patient interview or
prescribing & dispensing records
• Qualitative study (FGDs) into
provider & consumer behaviour

TBS 2009
Community surveillance of AMR and use (2):
results
• Antimicrobial resistance
– pathogenic E.Coli in pregnant women's urine in India
• Cotrim 46-65%; Ampi 52-85%; Cipro 32-59%; Cefalex 16-50%
– S.Pneumoniae & H.influenzae in sputa in S. Africa
• Cotrim > 50% (both organisms); Ampi >70% (H.influenzae)
• Antibiotic use
– About ½ patients in India & ¼ or less of patients in S.Africa get ABs
– Much inappropriate AB use especially in India e.g. use of fluoroquinolones
for coughs and colds in private sector
• Motivation of providers & consumers
– Patient demand – looking for quick cure
– Lack of CME & unwillingness to attend for fear of losing custom
– Uncontrolled pharmaceutical promotion, involving financial gain

TBS 2009
Adverse drug events
• 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
Source: Review by White et al,
Pharmacoeconomics, 1999, 15(5):445-458

TBS 2009
Changing a Drug Use Problem:
An Overview of the Process
1. EXAMINE
Measure Existing
Practices
(Descriptive
Quantitative Studies)
2. DIAGNOSE
Identify Specific
Problems and Causes
(In-depth Quantitative
and Qualitative Studies)
3. TREAT
Design and Implement
Interventions
(Collect Data to
Measure Outcomes)
4. FOLLOW UP
Measure Changes
in Outcomes
(Quantitative and Qualitative
Evaluation)
improve
intervention
improve
diagnosis

TBS 2009
Treatment
Choices
Prior
Knowledge
Habits
Scientific
Information
Relationships
With Peers
Influence
of Drug
Industry
Workload &
Staffing
Infra-
structure
Authority &
Supervision
Societal
Information
Intrinsic
Workplace
Workgroup
Social &
Cultural
Factors
Economic &
Legal Factors
Many Factors Influence Use of Medicines

TBS 2009
Strategies to Improve Use of Drugs
Economic:
 Offer incentives
– Institutions
– Providers and patients
Managerial:
 Guide clinical practice
– Information systems/STGs
– Drug supply / lab capacity
Regulatory:
 Restrict choices
– Market or practice controls
– Enforcement
Educational:
 Inform or persuade
– Health providers
– Consumers
Use of
Medicines

TBS 2009
Educational Strategies
Goal: to inform or persuade
• Training for Providers
– Undergraduate education
– Continuing in-service medical education (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

TBS 2009
Impact of Patient-Provider Discussion Groups
on Injection Use in Indonesian PHC Facilities
Intervention Control
0
20
40
60
80
% Prescribing Injections
PrePre
PostPost
Source: Hadiyono et al, SSM, 1996, 42:1185

TBS 2009
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

TBS 2009
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

TBS 2009
RCT in Uganda of the effects of STGs, training and
supervision on % of Px conforming to guidelines
Randomised
group
No. health
facilities
Pre-
intervention
Post-
intervention
Change
Control group 42 24.8% 29.9% +5.1%
Dissemination of
guidelines
42 24.8% 32.3% +7.5%
Guidelines + on-
site training
29 24.0% 52.0% +28.0%
Guidelines + on-
site training + 4
supervisory visits
14 21.4% 55.2% +33.8%
Source: Kafuko et al, UNICEF, 1996.

TBS 2009
Economic strategies:
Goal: to offer incentives to providers an consumers
• Avoid perverse financial incentives
– prescribers’ salaries from drug sales
– insurance policies that reimburse non-essential
drugs or incorrect doses
– flat prescription fees that encourage polypharmacy
by charging the same amount irrespective of
number of drug items or quantity of each item

TBS 2009
Pre-post with control study of an economic
intervention (user fees) on prescribing quality in Nepal
Fees (complete
drug courses)
control fee / Px
n=12
1-band item fee
n=10
2-band item fee
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)
Source: Holloway, Gautam & Reeves, HPP, 2001

TBS 2009
PHC prescribing with and without Bamako
initiative in Nigeria
5.3
72.8
64.7
93
35.4
2.1
38
25.6
21
15.3
0 20 40 60 80 100
no.drug items/Px
%Px with injections
%Px with antibiotics
%pres EDL drugs
no.EDL drugs avail
21 Bamako PHCs 12 non-Bamako PHCs
Source: Scuzochukwu et al, HPP, 2002

TBS 2009
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

TBS 2009
Intervention impact: largest % change in any
medicines use outcome measured in each study
Intervention type No. studies Median impact 25,75th
centiles
Printed materials 5 8% 7%, 18%
National policy 6 15% 14%, 24%
Economic strategies 7 15% 14%, 31%
Provider education 25 18% 11%, 24%
Consumer education 3 26% 13%, 27%
Provider+consumer education 12 18% 8%, 21%
Provider supervision 25 22% 16%, 40%
Provider group process 8 37% 21%, 59%
Essential drug program 5 28% 26%, 50%
Community case mgt 5 28% 28%, 37%
Providr+consumr ed & supervis 7 40% 18%, 54%
source: database on medicines use 2009

TBS 2009
Impact of multiple interventions on injection
use in Indonesia
Source: Long-term impact of small group interventions, Santoso et al., 1996
0%
20%
40%
60%
80%
100%
1 3 5 7 9 11 13 15 17 19 21 23 25
Months
Proportionofvisits
withinjection
Comparison group Interactive group discussion
Interactive group discussion (IGC group only)
Seminar (both groups)
District-wide monitoring
(both groups)

TBS 2009
What national policies do countries have to promote rational use?
Source: MOH Pharmaceutical policy surveys 2003 and 2007
0 20 40 60 80 100
EML updated in last 2 years
STGs updated in last 2 years
UG doctors trained on EML/STGs
Obligatory CME for doctors
Drug Info Centre for prescribers
DTCs in >half general hospitals
Public education on antibiotic use
Antibiotic OTC non-availability
National strategy to contain AMR
Drug use audit in last 2 years
% countries implementing policies2007 (n>85) 2003 (n>90)

TBS 2009
Percent change in antibiotic consumption,
out-patient care in 25 European countries 1997-2003
Data from ESAC
-20
-15
-10
-5
0
5
10
15
20
25
PolandC
roatiaG
reeceIrelandPortugal
D
enm
ark
Luxem
bourgH
ungary
ItalySlovakia
IsraelN
orw
aySw
edenAustriaSloveniaEstoniaFinland
Spain
The
N
etherlandsG
erm
anyBelgium
Iceland
C
zech
R
epublic
U
KFrance
Percentchange
For Iceland, total data (including hospitals) are used
Increase
Decrease
Slide courtesy of Otto Cars, STRAMA, Sweden

TBS 2009
Percent change in antibiotic consumption,
out-patient care in 25 European countries 1997-2003
Data from ESAC
-20
-15
-10
-5
0
5
10
15
20
25
PolandCroatiaG
reeceIrelandPortugal
Denm
ark
Luxem
bourgHungary
ItalySlovakia
IsraelNorw
aySw
edenAustriaSloveniaEstoniaFinland
Spain
The
N
etherlandsG
erm
anyBelgiumIceland
Czech
R
epublic
UKFrance
Percentchange
For Iceland, total data (including hospitals) are used
Co-ordination programs and national campaigns
Slide courtesy of Otto Cars, STRAMA, Sweden

TBS 2009
Why does irrational use continue?
Very few countries regularly monitor drug
use and 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?

TBS 2009
What are we spending to promote rational
use of medicines ?
• Global sales of medicines 2002-3 (IMS): US$ 867 billion
• Drug promotion costs in USA 2002-3: US$ >30 billion
• Global WHO expenditure in 2002-3: US$ 2.3 billion
– Essential Medicines expenditure 2% (of 2.3 billion)
– Essential Medicines expenditure on
promoting rational use of medicines 10% (of 2%)
– WHO expenditure on promoting
rational use of medicines 0.2% (of 2.3 billion)

TBS 2009
2nd International Conference for Improving
Use of Medicines, Chiang Mai, Thailand, 2004
472 participants from 70 countries
Recommendations for countries to:
• Implement national medicines programmes to
improve medicines use
• Scale up successful interventions
• Implement interventions to address community
medicines use
http://www.icium.org

TBS 2009
WHO priorities
• Resolution WHA60.16
– Urges Member States " to consider establishing and/or
strengthening…a full national programme and/or
multidisciplinary national body, involving civil society and
professional bodies, to monitor and promote the rational use
of medicines "
– WHO to support countries to implement resolution
• Continue to give technical advice to countries
– Model EML and formulary
– Training on promoting RUM in community, PHC, hospitals
– Research to identify cost-effective interventions
– Advocacy

TBS 2009
Health systems with no national
programs:
•No coordinated action
•No monitoring of use of medicines
Health systems with national programs:
•Coordinated action
•Regular monitoring of use of medicine
Develop
national plans
of action
Situational analysis
Modify
action plans
Implement & evaluate
national action plans using
govt & local donor funds
WHO facilitating
multi-stakeholder
action in countries

TBS 2009
Health system rapid appraisal tool (1): structure
for national stakeholders to rapidly appraise their own health systems in
order to develop evidence-based national plans of action
• Introduction
– How to use the tool (in workbook format) and carry out the assessment
(preparation, data collection, analysis)
– Systematic data collection using document review, key informant
interviews and observation with triangulation of results
• Key respondent questionnaires
– MOH senior dept managers (incl. dept pharmacy, DRA),
– national drug supply organisation, insurance organisation(s),
– health training institutions, health professional organisations,
– health facility staff and health facility survey
• Data collation and analysis by component
– Identify recommendations for each component
• Cross-cutting analysis & presentation to govt & donors
– Analysis across components, prioritisation and formulation of national
recommendations (to be completed)

TBS 2009
Health system rapid appraisal tool (2):
components
• Components
– Medicines use surveys and activities
– Medicines policy framework
– Health system factors
• Service delivery & human resources, insurance, drug supply,
regulation, financial (dis)incentives
– Specific technical areas for RUM
• National program coordination, MTCs, EMLs, STGs, monitoring,
provider & consumer education, independent medicines info, AMR
• Data for each component
– Taken from key informant questionnaires & health facility survey,
identifying relevant data from coding system of questions
• Analysis for each component
– Compares actual practice against best practice, choosing solutions from
a menu of interventions

TBS 2009
Creating the WHO Essential Drugs Library
to facilitate the work of national committees
WHO
Model List
Summary of clinical
guideline
Reasons for inclusion
Systematic reviews
Key references
WHO Model
Formulary
Cost:
- per unit
- per treatment
- per month
- per case prevented
Quality information:
- Basic quality tests
- Internat. Pharmacopoea
- Reference standards
Evidence-
based clinical
guideline

TBS 2009
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, The Netherlands / WHO:
Promoting rational use of drugs in the community
• Newcastle, Australia / WHO: Pharmaco-economics
• Boston University, USA / WHO: Drug Policy Issues

TBS 2009
Global monitoring and identifying effective
strategies to promote rational use of medicines
• WHO/EMP databases on drug use and policy
– quantitative data on medicines use and interventions to
improve medicines use from 1990 to present day
– data from MOHs on pharmaceutical policies every 4 years –
1999, 2003, 2007
• ICIUM3 in 2011
– 3rd
international conference on improving the use of
medicines (ICIUM3)
• Surveillance of antimicrobial use & resistance
– method for community-based surveillance in poor settings
– interventional approach for improving use in private sector

TBS 2009
Conclusions
• Irrational use of medicines is a very serious global
public health problem.
• Much is known about how to improve rational use of
medicines but much more needs to be done
– policy implementation at the national level
– implementation and evaluation of more interventions,
particularly managerial, economic and regulatory interventions
• Rational use of medicines could be greatly improved if
a fraction of the resources spent on medicines were
spent on improving use.

TBS 2009
Activity
Discuss in groups the following questions
• What should be the roles of:
• government,
• NGOs and donors,
• WHO,
in promoting the rational use of medicines?

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