1. Promoting Rational Use of Drugs Krisantha Weerasuriya MD

2. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 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 for the countries ?

3. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 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

4. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 Variation in outpatient antibiotic use in 26 European countries in 2002 Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.

5. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 How many of your countries 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?

6. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 Source: Bavestrello & Cabello, ICIUM 2004 DDD/1000 inhabitants/day

7. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 Top 10 drugs by Prescription counts in Australia 2007-2008 Source: Australian Prescriber | Volume 31 | NUMBER 6 | DECEMBER 2008 1.atorvastatin 2.simvastatin 3.esomeprazole 4.perindopril 5.omeprazole 6.paracetamol 7.atenelol 8.pantoprazole 9.irbesartan 10.metformin

8. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 Data from EMP Pharmaceuticals Database

9. Department of Essential Medicines and Pharmaceutical Policy TBS 2011

12. 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

13. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 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 Pharmaceutical Policy TBS 2011 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 Pharmaceutical Policy TBS 2011 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 Pharmaceutical Policy TBS 2011 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 Pharmaceutical Policy TBS 2011 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 Pharmaceutical Policy TBS 2011 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 Pharmaceutical Policy TBS 2011 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)

20. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 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 Pharmaceutical Policy TBS 2011 What are countries doing to promote the rational use of medicines? national policies Source: EMP pharmaceutical policy database

22. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 Basic training and obligatory continuing medical education (CME) available for health professionals Source: EMP pharmaceutical policy database

23. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 Making a list of Medicines – how it affects Rational Use

24. Department of Essential Medicines and Pharmaceutical Policy TBS 2011

25. 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

26. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 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?

27. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 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.

28. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 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 the dominance of state health care sector 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?

29. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 Some issues to think about Can we achieve RUM in a health sector dominated by the private sector? How can we get Ministries to spend on drug information from the drug budget? Is quality of medicines an important issue in RUM? Is Information Technology important in promoting RUM? What is the most important lessons that we can learn from high income countries in RUM ?

30. Department of Essential Medicines and Pharmaceutical Policy TBS 2011 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 Skype WHOHQGVA1 (then dial 12357) email: weerasuriyak@who.int Comments and Questions welcome