1. Perspectives and achievements with Rational Pharmacotherapy Meeting under Danish EU presidency Implementation of Rational Pharmacotherapy Copenhagen, November 6, 2002 WHO/EURO Kees de Joncheere, Regional Adviser Pharmaceuticals

2. Overview of the presentation Pharmaceutical policies in Europe Rational use of medicines Comparing European countries Improving the prescribing and use of medicines Concluding remarks

3. Challenges for pharmaceutical policies in Europe Equitable access for patients to effective, safe and good quality medicines Enhancing appropriate use of medicines for better health outcomes Ensuring value for money Balance with industrial policy objectives Values underpinning health systems : equity, quality, solidarity, participation and accountability

4. Pharmaceutical policies and the EU EU regulatory framework and legislation National responsibilities on pricing and reimbursement (“subsidiarity”) Transparency directive Industrial policy communication 1995 Single market communication 1998 Public health communication 2000 Portugal 2000, EU MINE, DG5/health High Level committee, G 10, … Review 2000-1

5. Medicines and Public health in EU Future of the European system for evaluations and supervision of medicinal products Relevance of the added therapeutic value of medicinal products ( registration criteria ? Placebo or comparator?) Aspects determining innovation and research Rational use of medicinal products Importance and evolution trends for the information systems Increasing use of generic medicines Adoption of EU public health action plan, 2002

10. Rational use of medicines Right patient with right indication Right medicine Right dose/administration Right information Right moment to stop or change

11. Inappropriate use leads to Adverse effects Sub-optimal outcomes Waste of resources ( money, health professionals and patients time)

12. Why are drugs not used rationally ? Lack of training and knowledge Marketing practices Financial incentives for irrational use Availability problems Patient expectations Prescribing as a means to finish the consultation Health systems and services effects …

18. Measuring and monitoring the use of medicines Describe and compare existing situations and patterns Identify differences and potential problems Monitor results of interventions Lessons drawn from other countries` experiences

19. From drug utilisation to cost- effective intervention (1) Drug utilisation studies tend to be descriptive, aggregated data : WHAT? Indicator studies more focused on rational drug use: WHAT?  HOW MUCH? Qualitative studies WHY?

20. From drug utilisation to cost- effective intervention (2) Intervention studies HOW MUCH? WHY? (intervention) HOW MUCH NOW? Conclusion  DOES IT WORK? IS THE INTERVENTION EFFECTIVE? Management studies IS THE INTERVENTION REPRODUCABLE? IS IT COST-EFFECTIVE?

21. Examples of indicators (WHO/INRUD) Prescribing indicators Average number of drugs per encounter (<2) Percentage of drugs prescribed by generic name (close to 100%) Percentage of encounters with an antibiotic prescribed (<30%) Percentage of encounters with an injection prescribed (<10%) Percentage of drugs prescribed from EDL or formulary (close to 100%)

22. Examples of indicators (EU countries ) Rate indicators –NSAIDs –antibiotics –benzodiazepines –anti-ulcer drugs –inhaled corticosteroids Choice indicators –inhaled corticosteroids/beta agonists –quinolones/total antibiotics –short/long acting NSAIDs –PPI/total anti-ulcer –trimethoprim/cotrimoxazole

23. Examples of indicators (con`t) Appropriateness –drugs of limited value –agreement with clinical practice guidelines ASA after AMI ACE-s in CHF Statins in secondary prevention Economic –choice of branded/generic agents –cheaper drug classes –compliance with budgets Errors –drug-drug interactions –duplication (drug or class) –dosage

24. Challenges on monitoring drug use Pharmaco-epidemiology is often concerned with links between exposure and outcomes (usually adverse) Drug prescribing data-sets have other uses –Budget tracking and forecasting –Examining trends in drug use –Assessing appropriateness of drug selection and accuracy and safety of prescribing Clear need for going beyond basic statistics and for developing better analytical methods and benchmarking tools

25. Challenges for monitoring drug use Intercountry variability as ‘learning device’ Improving networking of researchers and policy makers Gap between sales/aggregated consumption data and individual patient data (privacy!)

26. Financial measures on improving prescribing and containing costs  Fixed and indicative budgets for prescribers  Budgeting for regions, PHC groups with pay-back mechanisms  Price regulations and reference prices  Patient co-payment  Financial incentives to pharmacies for better dispensing  Differential reimbursement rates  Promote generics

27. Managerial measures on improving prescribing and containing costs  Positive and negative lists  Disease management  Restrict distribution and prescription  Prescribing support systems  Regulate marketing, approved indications and commercial information  Practice guidelines

28. Improving prescribing and containing costs : educational and informational measures  Formularies  University training and continuing information  EBM - evidence based practice guidelines  Pharmaceutical care  Prescriber information  Drug committees in hospitals and primary care, coordinated approach  Feedback and discussion of drug use data  Behavioural approaches  Patient information

29. Promoting rational prescribing Effective interventions Combination of strategies Participation and ownership by health professionals Follow-up to avoid relapse Feedback and active discussion Best practices

30. Promoting rational prescribing proven effective interventions Standard treatment guidelines, when evidence- based, developed with end-users, with active dissemination and follow-up Essential Medicines lists, Hospital Drugs and Therapeutic Committees Undergraduate training Discussion groups with feedback of prescribing data “Academic detailing” Comprehensive approach, with all components

31. Promoting rational prescribing interventions that need more testing Mixed results, probably effective: Pharmacists interventions Public education Financial incentives and reimbursement measures Mixed results, probably ineffective: Drug information bulletins and other printed materials used in isolation Arbitrary prescription limitations Traditional stand-up lecturing

32. Promoting rational use : involving patients and sharing experience Patient experience of illness social circumstances attitude to risk values preferences Health professional diagnosis disease aetiology prognosis treatment options outcome probabilities Picker Institute

33. Conclusions Room for improving drug use, e.g minimising risk and improving outcomes Important role for health professionals, patients and coordinated team approach Need for better evidence and information on interventions that work