Rational use of drugs: an overview
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Transcript of Rational use of drugs: an overview
Rational use of drugs:an overview
Kathleen HollowayTechnical Briefing Seminar 2003Essential Drugs and Medicines Policy
WHO Geneva
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
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% PHC patients treated according to guidelines
0
10
20
30
40
50
60
70
1990/1 1992/3 1994/5 1996/7 1998/9 2000/1
Africa Asia
Africa/Asia 1990/1 1992/3 1994/5 1996/7 1998/9 2000/1no.countries 5/5 3/3 10/3 12/5 12/5 3/2no.surveys 9/7 4/6 16/6 15/6 14/7 3/4
Source: WHO database on drug use 2003
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% drugs that are prescribed unnecessarilyestimated by a comparison of expected versus actual prescription
Chalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000
0
10
20
30
40
50
60
70
80
Nepal Yemen Nigeria
% antibiotics % injections % drugs % cost
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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.
0 10 20 30 40 50 60
Tanzania
Angola
Senegal
Burkino Faso
Bangladesh
Pakistan
% observed consultations where the diagnostic process was adequate
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5-55% of PHC patients receive injections - 90% may be medically unnecessary
0% 10% 20% 30% 40% 50% 60%
Eastern Caribean
J amaica
El Salvador
Guatemala
Ecuador
L.AMER. & CAR.
Nepal
Indonesia
Yemen
ASIA
Zimbabwe
Tanzania
Sudan
Nigeria
Cameroon
Ghana
AFRICA
% of primary care patients receiving injectionsSource: Quick et al, 1997, Managing Drug Supply
15 billion injections per year globally half are with unsterilized needle/syringe2.3-4.7 million infections of hepatitis B/C
and up to 160,000 infections of HIV per year associated with injections
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30 to 60 % of PHC patients receive antibiotics -
perhaps twice what is clinically needed
0% 10% 20% 30% 40% 50% 60% 70%
Guatemala
Jamaica
El Salvador
Eastern Caribean
L.AMER. & CAR.
Bangladesh
Nepal
Indonesia
ASIA
Zimbabwe
Tanzania
Ghana
Cameroon
Swaziland
Sudan
AFRICA
% of PHC patients receiving antibioticsSource: Quick et al, 1997, Managing Drug Supply
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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)
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Adverse drug eventsReview 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
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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
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Prescribing by dispensing and non-dispensing doctors in Zimbabwe Trap et al 2000
2.31
28.4
58
8.65
1.67
9.5
48
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0 10 20 30 40 50 60 70
no.drug items/Px
% Px with injections
% Px with antibiotics
consultation time (mins)
dispensing doctors non-dispensing doctors
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Changing a Drug Use Problem:An Overview of the Process
1. EXAMINEMeasure Existing
Practices(Descriptive
Quantitative Studies)
2. DIAGNOSEIdentify Specific
Problems and Causes(In-depth Quantitative and Qualitative Studies)
3. TREATDesign and Implement
Interventions (Collect Data to
Measure Outcomes)
4. FOLLOW UPMeasure Changes
in Outcomes (Quantitative and Qualitative
Evaluation)
improveintervention
improvediagnosis
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Treatment Choices
Prior Knowledge
HabitsScientific Information
RelationshipsWith Peers
Influenceof DrugIndustry
Workload & Staffing
Infra-structure
Authority & Supervision
Societal
Information
Intrinsic
Workplace
Workgroup
Social &CulturalFactors
Economic &Legal Factors
Many Factors Influence Use of Medicines
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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
Strategies to Improve Use of Drugs
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Educational StrategiesGoal: 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
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Training for prescribersThe 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
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Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC Facilities
Hadiyono et al, SSM, 1996, 42:1185
Intervention Control0
20
40
60
80
% Prescribing Injections
PrePre
PostPost
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Effects of Opinion Leader on Choice Antibiotic for Prophylaxis in a Teaching Hospital
Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct84 85 86
0
0.1.1
0.2
0.3
0.4
0.5
0.6
0.7
% of all C-sections Discuss-ion withObstetricChief
Cefazolinrecommend-ed
Cefoxitinnot recommended
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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
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Review of 59 evaluations of clinical guidelinesGrimshaw & 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
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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.
Randomisedgroup
No. healthfacilities
Pre-intervention
Post-intervention
Change
Control group 42 24.8% 29.9% +5.1%
Dissemination ofguidelines
42 24.8% 32.3% +7.5%
Guidelines + on-site training
29 24.0% 52.0% +28.0%
Guidelines + on-site training + 4supervisory visits
14 21.4% 55.2% +33.8%
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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 (completedrug courses)
control fee / Pxn=12
1-band item feen=10
2-band item feen=11
Av. no. itemsper prescription
2.9 2.9(+/- 0)
2.9 2.0(-0.9)
2.8 2.2(-0.6)
% prescriptionsconforming toSTGs
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)
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0
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2
3
4
5
1994
1995
1996
1997
1998
1999
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10
20
30
40
Sources: Danish Medicines Agency & H. Westh, Hvidovre Hosp, 2000.Monnet DL., 40th ICAAC, Toronto, Canada, 527 [abstr. 628].
Change in subsidization: from 50 to 0% (01/1996)
Tet
racy
clin
e-R
E.
coli
Ho
spit
alIs
ola
tes
(%,
5-m
onth
mov
ing
aver
age)
Tetracycline prescription rate & tetracycline-resistant E.Coli in hospital isolates, 2 municipalities in Denmark, 01/1994-12/1999
T
etra
cycl
ine
Use
(#
pre
scrip
tions
per
1,0
00 in
habi
tant
s)
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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
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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
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Review of 30 studies in developing countries size of drug use improvements with various interventions
0
Improvement in outcome measure (%)
10 20 30 40 50 60
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
Minor Moderate Large
Source: Ross-Degnan et al, Plenary presentation, Conference on Improving the Use of Medicines, 1997, Chiang Mai, Thailand.
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Combined Intervention StrategyPrescribing for Acute Diarrhea in Mexico City
0
20
40
60
80
100
% cases treated in line with algorithm
Study PhysiciansControl Physicians
37/5279/115
20/84
BaselineStage (n = 20)
After Workshop
AfterPeer Review (n = 20)
18-months Follow-up
11/46
31/110
16/7025/102
42/82
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Impact of Training on Use of Diarrhea Treatment Algorithm in Three Mexico Settings
Source: Munoz, et al, unpub. (1993); Guiscafre, et al, Arch. Med. Res. (1995)
Intervention given by:
"Experts" in 2 clinics(San Jeronimo)
"Leaders" in 18 clinics (Coyoacan)
"Coordinators" in 124
Prescribers
31
65
157
Baseline %
24.5
17.7
24.7
Post%
71.2
43.4
31.2
Change %
+46.7
+ 25.6
+ 6.5 clinics (Tlaxcala)
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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
Pro
po
rtio
n o
f vi
sits
wit
h i
nje
ctio
n
Comparison group Interactive group discussion
Interactive group discussion (IGC group only)
Seminar (both groups)
District-wide monitoring(both groups)
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Drug & Therapeutic Committee Activitiesvery little data on drug use impact
0
20
40
60
80
100
Australia 1996 USA 2001 Netherlands1999
Germany 1995
% hospitals with a DTC Drug use monitoring / DUEStrategies to improve drug use
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10 national strategies to promote RUDneeds 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
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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?
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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
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Creating the WHO Essential Drugs Libraryto facilitate the work of national committees
WHOModel List
Summary of clinical guideline
Reasons for inclusionSystematic reviewsKey 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
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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
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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
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Promoting DTCs : impact of magt., training & planning though hospital DTCs in Laos
0%
20%
40%
60%
80%
100%
1 2 3 4 5 6 7 8Months
% Px with Abs/Inj.
0
1
2
3
4
5
Av.no.drugs / Px
Injections
Antibiotics
No.drugs
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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
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ICIUM20042nd 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
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ICIUM2004: topic tracks
• “Meetings Within a Meeting”– Key constituencies and interest groups working on
pharmaceutical issues– Summarize topical lessons and research needs
• Preliminary topic tracks include– Child health - Malaria– TB - HIV/Aids, STIs– Chronic diseases - Antimicrobial
resistance– Impact of access on use
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ICIUM2004: who should attend?
• Researchers– Leading drug use researchers & methodologists
– Fertilization across interest areas
• Policymakers– Learn cutting edge behavior change approaches
– Assessment of pharmaceutical policy impacts
• NGOs and Donors– Add value to existing programs
– Coordinate with global medicines initiative
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ActivityDiscuss 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?