1. Promoting Rational Use of Drugs
Krisantha Weerasuriya MD

2. 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

3. Could there have been a better term than "Rational" ?
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
No definition BUT a description. The difficulty of defining " Rational" use – other words "Quality" use?
Could there have been a better term than "Rational" ?

4. Snapshots in Low and Middle Income Countries
Why is the public sector better? No financial incentive to prescribe medicines?

5. But non-profts may have income from medicines which gives them incentive to prescribe.

7. Snapshots High Income Countries
Variation in outpatient antibiotic use in 26 European countries in 2002
Total outpatient antibiotic use in 26 European countries in 2002 (WHO ATC/DDD version 2003).
This are ESAC data to position Belgium among other European countries…
This lead to action in France and consumption has decreased – Greece still remains at the top.
Source: Goosens et al, Lancet, 2005; 365: ; ESAC project.

8. 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?
This strongly illustrious the principle that there must be data to define the problem. While date at national level would be ideal, interventions can be done when data is available at an institutional level.
A drug consumption study using the standard WHO methodology for classifying medicines and quantifying doses – WHO ATC DDD (search the Internet for that) would give very useful information on what the medicines that are being consumed. Such a drug utilisation study could be done very easily with a simple spreadsheetwhich incorporates the ATC DDD classification.

9. 2008 Generic Uptake after Patent Expiry in 2000
Despite cheaper generics being available, the more expensive brand name drugs are the majority in some countries.
Expensive access with potential for enormous savings – Policy?
Data Source IMS Health 2009

10. AN EXAMPLE FOR FEDBACK SYSTEM AVERAGE COST PER PRESCRIPTION (Country?)
This was data from Turkey. The top line shows the consumption by a profligate prescriber who was able to be tracked because the data is available; the intervention was a call from the Minister of Healthand as can be seen it was very successful!
Very detailed drug consumption data is available in Turkey – this is because the government reimburses the cost of medicines to the social welfare system and therefore requires detailed drug use data. The Rational Use of Medicines Department took her "piggyback" ride on this data and was able to quantifydrug consumption data in the country. It is very unlikely that such a system could have been put in place solely to monitor medicines consumption – the government would not have seen it as being cost-effective. However when it came to reimbursing medicines and therefore monitoring the costs, such a detailed system was extremely cost-effective. It was put in place by the social welfare system; the Ministry of health took a ride on it and did activities on rational use of medicines.
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11. Changing a Drug Use Problem: An Overview of the Process
1. EXAMINE
Measure Existing
Practices
(Descriptive
Quantitative Studies)
2. DIAGNOSE
Identify Specific
Problems and Causes
(In-depth Quantitative
and Qualitative Studies)
3. TREAT
Design and Implement
Interventions
(Collect Data to
Measure Outcomes)
4. FOLLOW UP
Measure Changes
in Outcomes
(Quantitative and Qualitative
Evaluation)
improve
intervention
diagnosis
Here again, note the necessity to "measure".

12. NO. OF UNIT-ATC (ITS/2011) (PHARMACY SALE DATA)
No. of Units %
J01
,00
15,46
J02
,00
0,20
D01AB
,00
0,12
J04AB
,00
0,24
J05
,00
0,09
P01AB
,00
0,27
A07AA
,00
0,05 J0
,00
16,11
TOTAL (all types)
,00
100,00
Again data from Turkey.
sssssssss

13. ITS DATA FOR JUNE-JULY 2012 Monthly Average No of Units Yearly Average
Monthly Average
No of Units
Yearly Average
P. Warehouses-P. Warehouses
P. Warehouses-Pharmacies
P. Warehouses-Hospitals
Clearly the activities should be focused on the pharmacies – this was useful data to see where the majority of the consumption was.
Where should the focus of activities be ? Hospitals or Pharmacies?
sssssssss

14. Many Factors Influence Use of Medicines
Treatment Choices
Prior Knowledge
Habits
Scientific Information
Relationships
With Peers
Influence of Drug
Industry
Workload & Staffing
Infra- structure
Authority & Supervision
Societal
Information
Intrinsic
Workplace
Workgroup
Social & Cultural
Factors
Economic &
Legal Factors
Rank them in importance? During the Technical Briefing Seminar about 20 of the 25 that answered said that the most important influence was NOT scientific information. Medicines should be used on rational clinical scientific basis and if not being used in that manner, clearly that use is not rational and providing the maximum benefit. Some said that the influence of the drug industry is predominant others said that social and cultural factors were number one.
Emerging if a pilot in an aeroplane were to pilot the plane according to social and cultural factors or the influence of the aviation industry? Would they are travel be as safe as it is now?
On the other hand, if the pilot makes a mistake he dies along with his or her passengers – the prescriber does not have to die along with the patient!

15. 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

16. 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
Now with smartphones, information at the bedside; has it changed practice?
May change practice but it may also be that false dawn of hope. When the WHO model formulary was available is a CD and could be installed on a personal computer, it was thought having the information accessible would improve prescribing. Unfortunately there was no measurable change.
However this depended on the computer being available – in the case of smart phones, it is an individual posession and would be "at hand" much more than a computer or a book.

17. 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
Needs to be updated

18. 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
Drug utilisation databases down to the facility level – there is feedback on what is being used.
The impetus for such databases has been financial – reimbursement but can be used for medicines utilisation studies.

19. 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)

20. 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

21. What are countries doing to promote the rational use of medicines
What are countries doing to promote the rational use of medicines? national policies
Source: EMP pharmaceutical policy database

22. Basic training and obligatory continuing medical education (CME) available for health professionals
Source: EMP pharmaceutical policy database
How many of the countries present in TBS teach Essential Medicines concept in undergraduate teaching?

23. However, is it all Doom and Gloom? Having a Policy does help
Countries that have it vs Countries that do not have the plicies.
Comparison of countries with and without specific policies Weighted mean of differences for 12 INRUD/IMCI indicators (bars denote % difference and 95% CI)

24. Reminder: 10 national strategies to promote RUM need political support, investment and staff
Source: WHO Policy Perspectives no.5
1. Evidence-based standard treatment guidelines
2. Essential Medicines Lists based on treatments of choice
3. Drug & Therapeutic Committees in hospitals
4. Problem-based pharmacotherapy teaching in universities
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 medicines
9. Avoidance of perverse financial incentives
10. Appropriate and enforced drug regulation

25. 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?)
Out of Pocket Payment (OOP)..
All these factors contribute but the main factor may be the last – when governments do not have to bear the cost of irrational treatment, they can afford to ignore it.

26. 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!)
Some discussion on what percentage of the medicines budget would be sufficient to produce a good Drug Information Service.
If a country were to spend hundred million USD on medicines, if 1% is given for drug information (that be sufficient to produce a formulary, have a few drug information centres), would it save more than 1% of the drug budget?
Remains a strong theoretical possibility but we do need studies to prove it.

27. Some issues to think about
There are textbook cases of Technical Success in RUM Tools 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?

28. 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?

29. 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
Comments and Questions welcome
Some notes in individual slides