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8/8/2019 023-Rational Use of Drugs
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Rational use of drugs:an overview
Kathleen HollowayTechnical Briefing Seminar 2004Essential Drugs and Medicines Policy
WHO Geneva
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WHO, Dept. Essential Drugs and Medicines Policy 2
Objectives
Define rational use of medicines and identify the magnitude ofthe problem
Understand the reasons underlying irrational use
Discuss strategies and interventions to promote rational use ofmedicines
Discuss the role of government, NGOs, donors and WHO insolving drug use problems
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The rational use of drugs requires that patients receive
medications appropriate to their clinical needs, in doses
that meet their own individual requirements for anadequate 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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4
% 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 3/2
no.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
3040
50
60
70
80
Nepal Yemen Nigeria
% antibiotics % injections % drugs % cost
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Adequacy of diagnostic processThaver 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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7
5-55% of PHC patients receive injections -
90% may be medically unnecessary
0% 10% 20% 30% 40% 50% 60%
Eastern Caribean
J amaica
El S alvador
Guatemala
Ecuador
L.AME R. & CA R.
Nepal
Indonesia
Yemen
ASIA
Zimbabwe
Tanzania
Sudan
Nigeria
Cameroon
Ghana
AFRICA
% 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 peryear associated with injections
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8
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 antibiotics
Source: 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 inN. 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 ZimbabweTrap et al 2000
2 .3
2 8 .
5 8
8 .6
1 .6
9 .5
4 8
1 3
0 1 0 2 0 3 0 4 0 5 0 6 0 7 0
n o . d ru g it e m s / P x
% P x w i t h in j e c t i o n s
% P x w i t h a n t i b io t i c s
c o n s u l t a t io n t i m e ( m in s )
d i s p e n s i n g d o c t o r sn o n - d i s p e n s in g d
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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 Quantitativeand Qualitative Studies)
3. TREATDesign and Implement
Interventions(Collect Data to
Measure Outcomes)
4. FOLLOW UPMeasure Changes
in Outcomes(Quantitative and Qualitative
Evaluation)
improveintervention
improve
diagnosis
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Treatment
Choices
Prior
KnowledgeHabits
Scientific
Information
Relationships
With Peers
Influence
of DrugIndustry
Workload &
Staffing
Infra-
structureAuthority &
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 ofMedicines
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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18
Impact of Patient-Provider Discussion Groups on
Injection Use in Indonesian PHC Facilities
Hadiyono et al, SSM, 1996, 42:1185
Intervention Control
0
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 with
Obstetric
Chief
Cefazolin
recommend-
ed
Cefoxitin
not
recommended
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Managerial strategiesGoal: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 washigher 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 NepalHolloway, 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 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)
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PHC prescribing with & without Bamako
initiative in NigeriaScuzochukwu et al, HPP, 2002
5 .3
7 2 .
6 4 .
9 3
3 5 .
2 .1
3 8
2 5 .
2 1
1 5 .
0 20 40 60 8 0 1 0 0
n o . d ru g i te m s /P x
% P x w i th i n j e ct io n s
% P x w i th a n t i b i o t ic s
% p r es E D L d ru g s
n o . E D L d r u g s a v a il
2 1 B a m a k o P H C s1 2 n o n - B a m a k o P
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25
0
1
2
3
4
5
1994
1995
1996
1997
1998
1999
0
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)
Tetra
cycline-R
E.coliHospital
Isolates
(%,
5-monthm
ovingaverage)
Tetracycline prescription rate & tetracycline-resistant
E.Coliin hospital isolates, 2 municipalities in Denmark,
01/1994-12/1999
Tetracycline
Use
(#
presc
riptions
per1,
00
0
inhabitants
)
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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 anddoes not have a sustainable impact
Printed materials alone are not effective
Combination of strategies, particularly of different types
(e.g. educational + managerial) always produces betterresults 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 countriessize 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 onImproving 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 Physicians
Control Physicians37/52
79/115
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)
Interventiongiven 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
+ 6.5clinics (Tlaxcala)
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Drug & Therapeutic Committee Activitiesvery little data on drug use impact
0
20
40
60
80
100
Australia 1996 USA 2001 Netherlands
1999
Germany 1995
% hospitals w ith a D TC Drug use monitor ing / D UEStrategies 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 training5. Continuing medical education as a licensure requirement
6. Independent drug information e.g bulletins, formularies
7. Supervision, audit and feedback
8. Public education about drugs9. 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 thecost-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 theWHO Essential Drugs Library
to facilitate the work of national committees
WHO
Model List
Summary of clinical
guideline
Reasons forinclusion
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
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WHO-sponsored training programmes
INRUD/MSH/WHO: Promoting the rational use ofdrugs
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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P r o m o t in g D T C s : im p a c t o f m a g t . ,
p l a n n in g th o u g h h o s p i t a l D T C s i
0 %
2 0 %
4 0 %
6 0 %
8 0 %
1 0 0 %
1 2 3 4 5 6 7 8M o n t
% P x w i
A b s / I n j
0
1
2
3
4
5
A v . n o . d r u g s
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 indeveloping countries
WHO database on drug use
quantitative data on drug use and interventionsto improve drug use over the last decade
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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 -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 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
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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 addressthis 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 thisproblem?