1. Promoting Rational Use of Drugs Krisantha Weerasuriya MD

2. 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

3. 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" ?

4. Department of Essential Medicines and Health Products TBS 2012 Snapshots in Low and Middle Income Countries

5. Department of Essential Medicines and Health Products TBS 2012

7. Data from EMP Pharmaceuticals Database

8. 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

9. Department of Essential Medicines and Health Products TBS 2012 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

10. Department of Essential Medicines and Health Products TBS 2012 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?

11. 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.esomeprazole 3.simvastatin 4.rosuvastatin 5.paracetamol 6.perindopril 7.pantoprazole 8.metformin 9.atenelol 10.irbesartan Snapshots High Income Countries

12. Department of Essential Medicines and Health Products TBS 2012 2008 Generic Uptake after Patent Expiry in 2000 Data Source IMS Health 2009 Expensive access with potential for enormous savings – Policy?

13. Department of Essential Medicines and Health Products TBS 2012 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 improve diagnosis

14. Department of Essential Medicines and Health Products TBS 2012 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 Many Factors Influence Use of Medicines

15. 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

16. Department of Essential Medicines and Health Products TBS 2012 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

17. Department of Essential Medicines and Health Products TBS 2012 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

18. 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

19. 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)

20. Department of Essential Medicines and Health Products TBS 2012 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. Department of Essential Medicines and Health Products TBS 2012 What are countries doing to promote the rational use of medicines? national policies Source: EMP pharmaceutical policy database

22. Department of Essential Medicines and Health Products TBS 2012 Basic training and obligatory continuing medical education (CME) available for health professionals Source: EMP pharmaceutical policy database

23. Department of Essential Medicines and Health Products TBS 2012 However, is it all Doom and Gloom? Having a Policy does help Comparison of countries with and without specific policies Weighted mean of differences for 12 INRUD/IMCI indicators (bars denote % difference and 95% CI)

24. Department of Essential Medicines and Health Products TBS 2012 Source: WHO Policy Perspectives no.5 Reminder: 10 national strategies to promote RUM need political support, investment and staff 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. 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?)

26. 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!)

27. Department of Essential Medicines and Health Products TBS 2012 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. 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?

29. 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: weerasuriyak@who.int Comments and Questions welcome Some notes in individual slides