Transcript Rational use of drugs: an overview Kathleen Holloway Technical Briefing Seminar November 2008 Department of Essential Medicines and Pharmaceutical Policy TBS 2008

Rational use of drugs:
an overview
Kathleen Holloway
Technical Briefing Seminar
November 2008
Department of Essential Medicines and Pharmaceutical Policy
TBS 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 Policy
TBS 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 Policy
TBS 2008
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.
Pakistan
Bangladesh
Burkino Faso
Senegal
Angola
Tanzania
0
10
20
30
40
50
% observed consultations where the diagnostic process was adequate
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60
5-55% of PHC patients receive injections 90% may be medically unnecessary
Source: Quick et al, 1997, Managing Drug Supply
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
 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
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%
% of primary care patients receiving injections
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
60%
Variation in outpatient antibiotic use
in 26 European countries in 2002
35
DDD per 1000 inh. per day
30
25
20
15
10
5
0
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
Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.
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TBS 2008
% compliance with clinical guidelines over
time by region
70
60
50
40
30
20
10
0
<1992
1992-5
1996-9
2000-3
Africa (n=125)
Asia/Pacific (n=61)
Central Asia/Mediterranean (n=22)
Latin America (n=31)
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2004-7
% diarrhoea cases treated
Treatment of diarrhoea in private and public
sectors
70
60
50
40
30
20
10
0
ORS use
Antibiotic use
Private-for-profit (n=43,33,35,4)
Antidiarrhoeal
use
STG compliance
Public (n=119, 100, 67, 80)
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Treatment of ARI by prescriber type
% ARI cases treated
80
70
60
50
40
30
20
10
0
Cough syrup use
Approp.ABs in
pneumonia
Doctor (n=20,18,40,12)
Inapprop.ABs in
viral URTI
STG compliance
Paramedic/nurse (n=13,94,69,61)
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TBS 2008
Overuse and misuse of antimicrobials
contributes to antimicrobial resistance
Source: WHO country data 2000-3
• 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
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
Adverse drug events
Source: 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
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
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
3. TREAT
Design and Implement
Interventions
(Collect Data to
Measure Outcomes)
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TBS 2008
2. DIAGNOSE
Identify Specific
Problems and Causes
(In-depth Quantitative
and Qualitative Studies)
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
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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
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
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
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
Impact of Patient-Provider Discussion Groups
on Injection Use in Indonesian PHC Facilities
Source: Hadiyono et al, SSM, 1996, 42:1185
% Prescribing Injections
80
60
Pre
Post
40
20
0
Intervention
Control
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
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
Department of Essential Medicines and Pharmaceutical Policy
TBS 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 Policy
TBS 2008
RCT in Uganda of the effects of STGs, training and
supervision on % of Px conforming to guidelines
Source: 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
Department of Essential Medicines and Pharmaceutical Policy
TBS 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 Policy
TBS 2008
Pre-post with control study of an economic
intervention (user fees) on prescribing quality in Nepal
Source: Holloway, Gautam & Reeves, HPP, 2001
Fees (complete
drug courses)
control fee / Px 1-band item fee 2-band item fee
n=11
n=10
n=12
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)
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
PHC prescribing with and without Bamako
initiative in Nigeria
Source: 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
12 non-Bamako PHCs
Department of Essential Medicines and Pharmaceutical Policy
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80
100
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
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
Proportion of visits
with injection
Impact of multiple interventions on injection
use in Indonesia
Interactive group discussion (IGC group only)
100%
Seminar (both groups)
80%
District-wide monitoring
(both groups)
60%
40%
20%
0%
1
3
5
7
9
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
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
Varying intervention impact in developing countries
Source: 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 Policy
TBS 2008
What are countries doing to promote the rational
use of medicines? national policies
Source: EMP pharmaceutical policy database
Drug use audit in last 2 years (n=87)
National strategy to contain AMR (n=102)
Antibiotic OTC non-availability (n=60)
Public education on antibiotic use (n=107)
DTCs in most referral hospitals (n=92)
Drug Info Centre for prescribers (n=118)
EML in insurance reimbursement (n=90)
STGs updated in last 2 years (n=42)
EML updated in last 2 years (n=78)
0
20
40
60
80
% countries implementing policies
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TBS 2008
100
Basic training and obligatory continuing medical
education (CME) available for health professionals
Source: EMP pharmaceutical policy database
Obligatory CME
(n=99-105)
Pharmaco-therapy
(n=60-73)
Prescribing concepts
(n=63-76)
Clinical Guidelines
(n=68-80)
Essential Medicines
(n=68-89)
0
20
40
60
80
% countries with basic training available
Doctors
Nurses and paramedics
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
100
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 costeffectiveness of interventions?
Department of Essential Medicines and Pharmaceutical Policy
TBS 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 Policy
TBS 2008
2nd International Conference for Improving
Use of Medicines, Chiang Mai, Thailand, 2004
472 participants from 70 countries
http://www.icium.org
Recommendations for countries to:
• Implement national medicines programmes to
improve medicines use
• Scale up successful interventions
• Implement interventions to address community
medicines use
Department of Essential Medicines and Pharmaceutical Policy
TBS 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 Policy
TBS 2008
Health systems with no national programs:
•No coordinated action
•No monitoring of use of medicines
Situational analysis
Modifying
action plans
WHO facilitating
multi-stakeholder
action in countries
Implement & evaluate
national action plans
Health systems with national programs:
•Coordinated action
•Regular monitoring of use of medicine
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
Develop
national plans
of action
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 Policy
TBS 2008
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
WHO
Model List
Cost:
- per unit
- per treatment
- per month
- per case prevented
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
WHO Model
Formulary
Quality information:
- Basic quality tests
- Internat. Pharmacopoea
- Reference standards
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 Policy
TBS 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 Policy
TBS 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 Policy
TBS 2008
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?
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008