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Promoting Rational Use of Drugs
Krisantha Weerasuriya MD
Department of Essential Medicines and Health Products TBS 2012
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
• Some questions to ponder
Department of Essential Medicines and Health Products TBS 2012
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
Could there have been a better term than "Rational" ?
Department of Essential Medicines and Health Products TBS 2012
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 t
reate
d
Private-for-profit (n=43,33,35,4) Public (n=119, 100, 67, 80)
Snapshots in Low and Middle Income Countries
Department of Essential Medicines and Health Products TBS 2012
% STG compliance
05
1015202530354045
PR_NOPROF PR_PROF PUB
% STG compliance
Department of Essential Medicines and Health Products TBS 2012
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 Health Products TBS 2012
% Compliance w ith STGs over time
010203040506070
<1992 1992-4 1995-7 1998-00 2001-3 2004-6 2007-9
Africa L.America E.Mediterr
Europe SE.Asia W.Pacific
Data from EMP Pharmaceuticals Database
Department of Essential Medicines and Health Products TBS 2012
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 Health Products TBS 2012
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 1
000 in
h. p
er d
ay
Variation in outpatient antibiotic use in 26 European countries in 2002
Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.
Snapshots High Income Countries
Department of Essential Medicines and Health Products TBS 2012
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
How many LMICs can provide this data?
This provides antibiotics by class and total; how many of your countries can provide even the total?
Whose responsibility is it to collect the data?
Are health systems in LMICs comprehensive enough to collect this data?
Department of Essential Medicines and Health Products TBS 2012
Top 10 drugs by Prescription counts in Australia 2009-2010
Source: Australian Prescriber | 2010; 33: 181
1. atorvastatin 2. esomeprazole3. simvastatin 4. rosuvastatin5. paracetamol6. perindopril7. pantoprazole8. metformin9. atenelol 10. irbesartan
Snapshots High Income Countries
Department of Essential Medicines and Health Products TBS 2012
2008 Generic Uptake after Patent Expiry in 2000
Unprotected market segmentation volume (SU) 2000
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Vo
lum
e m
ark
et
share
% S
U
ORIGINAL & LICENSED OTHER BRANDS UNBRANDED
Data Source IMS Health 2009
Expensive access with potential for enormous savings – Policy?
Department of Essential Medicines and Health Products TBS 2012
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 Health Products TBS 2012
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 Health Products TBS 2012
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 Health Products TBS 2012
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 Health Products TBS 2012
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 Health Products TBS 2012
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 Health Products TBS 2012
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
– (reverse – Quebec, dispensing fee is given even if pharmacist does not dispense for good reason)
– Reimburse without treatment guidelines (ceftriaxone as an OPD medicine)
Department of Essential Medicines and Health Products TBS 2012
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 Health Products TBS 2012
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 Health Products TBS 2012
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 Health Products TBS 2012
However, is it all Doom and Gloom?Having a Policy does help
-15
-10
-5
0
5
10
15
20
Comparison of countries with and without specific policies Weighted mean of differences for 12 INRUD/IMCI indicators (bars denote % difference and 95% CI)
Department of Essential Medicines and Health Products TBS 2012
Source: WHO Policy Perspectives no.5
Reminder: 10 national strategies to promote RUMneed political support, investment and staff
1. Evidence-based standard treatment guidelines2. Essential Medicines Lists based on treatments of choice3. Drug & Therapeutic Committees in hospitals4. Problem-based pharmacotherapy teaching in universities5. Continuing medical education as a licensure requirement6. Independent drug information e.g bulletins, formularies7. Supervision, audit and feedback8. Public education about medicines9. Avoidance of perverse financial incentives10. Appropriate and enforced drug regulation
Department of Essential Medicines and Health Products TBS 2012
Why does irrational use continue?
Very few low and middle income 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?• they do not bear the cost of irrational use? (OOP?)
Department of Essential Medicines and Health Products TBS 2012
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.
• (WAIT!)
Department of Essential Medicines and Health Products TBS 2012
Some issues to think about
• There are textbook cases of Technical Success in RUMTools to identify the problem, design an intervention to measure the effect, feedback and adjust BUT
• What is more important than Technical Excellence?• What maybe the proportion spent for medicines from the
health budget if RUM is implemented?• What role does Universal Health Coverage play in the
success of RUM?• Can single interventions help in RUM in low and middle
income countries?• Can single interventions help in high income countries?
Department of Essential Medicines and Health Products TBS 2012
Some issues to think about
• Can we achieve RUM in a health sector dominated by the private sector?
• Is quality of medicines an important issue in RUM? (Does it differ between LMICs and HICs?)
• Is Information Technology important in promoting RUM?Can it accelerate progress or be the "fix" for irrational use?
• What is the most important lessons that we can learn from high income countries in RUM ?
• Would Universal Health Coverage be the driver for RUM?
• What would be stronger for RUM? Health? Cost to Health care systems?
Department of Essential Medicines and Health Products TBS 2012
• Dr K Weerasuriya, Medical Officer Medicines Access and Rational Use (MAR) Essential Medicines and Pharmaceutical Policies (EMP) World Health Organization CH-1211 Geneva 27 Switzerland
• email: [email protected] • Comments and Questions welcome• Some notes in individual slides