rational use of drugs: an overview kathleen holloway technical briefing seminar november 2008...
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Rational use of drugs:an overview
Kathleen HollowayTechnical Briefing Seminar
November 2008
Department of Essential Medicines and Pharmaceutical Policy TBS 2008
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Adequacy of diagnostic processSource: 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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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 injections
Source: 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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
DD
D p
er
1000 in
h. p
er
day
Variation in outpatient antibiotic use in 26 European countries in 2002
Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
% compliance with clinical guidelines over time by region
0
10
20
30
40
50
60
70
<1992 1992-5 1996-9 2000-3 2004-7
Africa (n=125) Asia/Pacific (n=61)
Central Asia/Mediterranean (n=22) Latin America (n=31)
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Treatment of diarrhoea in private and public sectors
0
10
20
30
40
50
60
70
ORS use Antibiotic use Antidiarrhoealuse
STG compliance
% d
iarr
ho
ea c
ases
tre
ated
Private-for-profit (n=43,33,35,4) Public (n=119, 100, 67, 80)
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Treatment of ARI by prescriber type
0
10
20
30
40
50
60
70
80
Cough syrup use Approp.ABs inpneumonia
Inapprop.ABs inviral URTI
STG compliance
% A
RI c
ases
tre
ated
Doctor (n=20,18,40,12) Paramedic/nurse (n=13,94,69,61)
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Educational StrategiesGoal: 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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC Facilities
Intervention Control0
20
40
60
80
% Prescribing Injections
PrePre
PostPost
Source: Hadiyono et al, SSM, 1996, 42:1185
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
RCT in Uganda of the effects of STGs, training and supervision on % of Px conforming to guidelines
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%
Source: Kafuko et al, UNICEF, 1996.
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Pre-post with control study of an economic intervention (user fees) on prescribing quality in Nepal
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)
Source: Holloway, Gautam & Reeves, HPP, 2001
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Regulatory strategiesGoal: 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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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)
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Varying intervention impact in developing countriesSource: WHO database 2007
Intervention type No.studies Median impact Range
Printed materials 5 6% +1% to +8%
Community education 3 13% 0% to +26%
Provider education 24 10% -2% to +31%
Provider+Comm.educ 14 11% -4% to +32%
Provider supervision 23 14% +1% to +39%
Community case mgt 6 19% +3% to +29%
Provider group process 9 20% +4% to +41%
Essential drug program 2 21% +16% to +25%
Provider & Community education + supervision
7 21% +11% to +49%
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
What are countries doing to promote the rational use of medicines? national policies
0 20 40 60 80 100
EML updated in last 2 years (n=78)
STGs updated in last 2 years (n=42)
EML in insurance reimbursement (n=90)
Drug Info Centre for prescribers (n=118)
DTCs in most referral hospitals (n=92)
Public education on antibiotic use (n=107)
Antibiotic OTC non-availability (n=60)
National strategy to contain AMR (n=102)
Drug use audit in last 2 years (n=87)
% countries implementing policies
Source: EMP pharmaceutical policy database
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Basic training and obligatory continuing medical education (CME) available for health professionals
0 20 40 60 80 100
Essential Medicines(n=68-89)
Clinical Guidelines(n=68-80)
Prescribing concepts(n=63-76)
Pharmaco-therapy(n=60-73)
Obligatory CME(n=99-105)
% countries with basic training available
Doctors Nurses and paramedics
Source: EMP pharmaceutical policy database
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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?
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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)
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
2nd International Conference for Improving Use of Medicines, Chiang Mai, Thailand, 2004472 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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Modifying action plans
Implement & evaluate national action plans
WHO facilitating multi-stakeholder action in countries
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
WHO Goal: to support establishment of national programs coordinated by mandated, resourced, multi-disciplinary, national bodies
Specific Objectives
1. Develop and pilot a standardised tool to undertake situational analysis and then undertake it in selected countries
2. Support establishment of national programs in selected countries using a multi-stakeholder approach, involving civil society & professional bodies and based on situational analysis
3. Establish global mechanism for sharing info & lessons learnt– Global steering committee to guide global program– Meetings for stakeholders from participating countries
4. External evaluation of strategy after 5 years to review progress with recommendations next 6 years
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
Identifying effective strategies to promote more rational use of drugs
• Joint research initiative between WHO/PSM, MSH, Harvard and Boston Universities, and ARCH– over 20 intervention research projects in
developing countries
• WHO/EMP databases on drug use and policy– quantitative data on drug use and interventions to
improve drug use over the last decade– data from MOHs on pharmaceutical policies
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
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.
Department of Essential Medicines and Pharmaceutical PolicyTBS 2008
ActivityDiscuss in groups the following questions
• What should be the roles of:• government, • NGOs and donors, • WHO,
in promoting the rational use of medicines?