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

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 Discuss the role of government, NGOs, donors and WHO in solving drug use problems

3. 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

4. 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.

5. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 5-55% of PHC patients receive injections - 90% may be medically unnecessary % of primary care patients receiving injections Source: Quick et al, 1997, Managing Drug Supply ä 15 billion injections per year globally ä half are with unsterilized needle/syringe ä 2.3-4.7 million infections of hepatitis B/C and up to 160,000 infections of HIV per year associated with injections

6. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 Variation in outpatient antibiotic use in 26 European countries in 2002 Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.

7. Department of Essential Medicines and Pharmaceutical Policy TBS 2008

10. 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

11. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 Adverse drug events 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 Source: Review by White et al, Pharmacoeconomics, 1999, 15(5):445-458

12. 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) 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

13. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 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

14. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 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

15. 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

16. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC Facilities InterventionControl 0 20 40 60 80 % Prescribing Injections Pre Post Source: Hadiyono et al, SSM, 1996, 42:1185

17. 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

18. 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

19. 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.

20. 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

21. 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

22. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 PHC prescribing with and without Bamako initiative in Nigeria Source: Scuzochukwu et al, HPP, 2002

23. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 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

24. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 Impact of multiple interventions on injection use in Indonesia Source: Long-term impact of small group interventions, Santoso et al., 1996 Interactive group discussion (IGC group only) Seminar (both groups) District-wide monitoring (both groups)

25. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 Varying intervention impact in developing countries Source: WHO database 2007 Intervention typeNo.studiesMedian impactRange Printed materials56%+1% to +8% Community education313%0% to +26% Provider education2410%-2% to +31% Provider+Comm.educ1411%-4% to +32% Provider supervision2314%+1% to +39% Community case mgt619%+3% to +29% Provider group process920%+4% to +41% Essential drug program221%+16% to +25% Provider & Community education + supervision 721%+11% to +49%

26. 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

27. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 Basic training and obligatory continuing medical education (CME) available for health professionals Source: EMP pharmaceutical policy database

28. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 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?

29. 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 medicines10% (of 2%) –WHO expenditure on promoting rational use of medicines0.2% (of 2.3 billion)

30. 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 Recommendations for countries to: Implement national medicines programmes to improve medicines use Scale up successful interventions Implement interventions to address community medicines use http://www.icium.org

31. 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

32. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 Health systems with no national programs: No coordinated action No monitoring of use of medicines Health systems with national programs: Coordinated action Regular monitoring of use of medicine Develop national plans of action Situational analysis Modifying action plans Implement & evaluate national action plans WHO facilitating multi-stakeholder action in countries

33. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 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

34. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 Creating the WHO Essential Drugs Library to facilitate the work of national committees WHO Model List Summary of clinical guideline Reasons for inclusion Systematic reviews Key references WHO Model Formulary Cost: - per unit - per treatment - per month - per case prevented Quality information: - Basic quality tests - Internat. Pharmacopoea - Reference standards Evidence- based clinical guideline

35. Department of Essential Medicines and Pharmaceutical Policy TBS 2008 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

36. 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

37. 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.

38. 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?