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Promoting the rational use of medicines Hans V. Hogerzeil, MD, PhD, FRCP Edin WHO Essential Drugs and Medicines Policy October 2002 Overview of the presentation Access framework Examples of irrational use of medicines Measuring drug use (indicators) How to promote rational prescribing 2 RDU Proven effective interventions Probably effective interventions Probably ineffective interventions Promoting rational prescribing in the private sector Access framework Practical implications of the access framework 1. Rational selection 3. Sustainable financing ACCESS TO ESSENTIAL MEDICINES 2. Affordable prices 3 RDU 4. Reliable systems Example irrational use Irrational use of medicines is a widespread hazard to health 4 RDU Only half of 102 countries surveyed regulate drug promotion In some areas, by age 2 children have had more than 20 injections 15 billion injections aregiven per year - and half of them are unsterile Example irrational use Published examples of irrational prescribing in teaching hospitals in developing countries 5 RDU Yemen 1990: 68% of hypertensive patients receive diazepam; 80% of UTI receive furosemide, 80% of osteoarthritis receive vitamins Ilorin 1991: 33% of inpatients are on tranquillizers Kathmandu 1992: Only 70% of medicines prescribed are from the national list of essential medicines Thailand 1991: 79% of surgical antibiotic prophylaxis is inappropriate (choice, dose and/or duration) South Africa 1991: 54% of antibiotic treatment in gynaecology inpatients is inappropriate Example irrational use Examples of irrational prescribing from 4800 general practices in the UK (1995) 6 RDU Ulcer healing medication used “presumptively” In 0-90% of patients,SSRIs have replaced tricyclic antidepressants In 0-56% of patients, buspirone has replaced diazepam (300x as expensive) 0-97% of patients on beta-blockers receive long-acting betablockers (16-25x as expensive) Other inhalors prescribed instead of salbutamol: (cost 8x) Combination medicines (cost up to 16x) Measuring drug use How to measure irrational drug use? WHO/INRUD indicators (1) 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%) 7 RDU Measuring drug use How to measure irrational drug use? WHO/INRUD indicators (2) Patient care indicators Average consultation time Average dispensing time Percentage of drugs actually dispensed (100%) Percentage of drugs adequately labelled (100%) Patients’ knowledge of correct dosage (100%) Facility indicators Availability of copy of EDL or formulary (100%) Availability of key drugs (100%) 8 RDU Interventions Promoting rational prescribing: Proven effective interventions 9 RDU Standard treatment guidelines, when evidence-based, developed with end-users, with active dissemination and follow-up Essential Medicines lists, when linked to treatment guidelines and used for training and supply Hospital Drugs and Therapeutic Committees Undergraduate training Comprehensive approach, with all components Selection The Essential Medicines Target National list of essential medicines Registered medicines All the drugs in the world Levels of use S CHW S dispensary Health center Hospital Referral hospital Private sector 10 RDU Supplementary specialist medicines Selection Clinical guidelines and a list of essential medicines lead to better prevention and care List of common diseases and complaints Treatment choice Treatment guidelines Essential medicines list / National formulary Training and Supervision Financing and Supply of drugs Prevention and care Health Technology and Pharmaceuticals 11 RDU Challenges Example of challenge: New essential drugs are expensive Antibiotics for gonorrhoea: Antimalarial drugs: Antituberculosis: Antiretrovirals: 12 RDU 50-90x price of penicillins chloroquine $0.10 per treatment artemether-lumefantrine $2.50/pp (25x) atovaquone-proguanil $40/pp (400x) $15 for DOTS vs $300 for MDR (20x) $300-600/year; but 38 countries with a drug budget <$2 pp/year Selection WHO Model List of Essential Drugs 1977 First Model list published, ± 200 active substances List is revised every two years by WHO Expert Committee Last revision (April 2002) contains 325 active substances 2002 Revised procedures approved by WHO The first list was a major breakthrough in the history of medicine, pharmacy and public health Médecins sans Frontières, 2000 13 RDU Selection The WHO Model List of Essential Medicines is a model product, model process and public health tool Model product: list of essential drugs with information Core list: minimum drug needs for a basic health care system, listing the most cost-effective drugs for priority conditions (selected on the basis of public health relevance and potential for safe and cost-effective treatment). Complementary list: essential drugs for which specialised diagnostic or treatment facilities may be needed 14 RDU Selection WHO Essential Medicines Library Combining information from various partners WHO clusters Clinical guideline WHO/EC, Cochrane Reasons for inclusion Systematic reviews Key references WHO/EDM Summary of clinical guideline BNF WHO Model Formulary WHO Model List WHO/EDM MSH Cost: UNICEF - per unit - per treatment MSF - per month - per case prevented 15 RDU Statistics: - ATC - DDD WCCs Oslo/Uppsala Quality information: - Basic quality tests - Intern. Pharmacopoea - Reference standards Selection The WHO Model List of Essential Medicines is a model product, model process and public health tool Model process: example for national committees 16 RDU Independent Membership of the Committee, careful consideration of conflict of interest Transparent process, standard application, web review Link to evidence-based clinical guidelines Systematic review of comparative efficacy, safety, costeffectiveness and public health relevance Rapid dissemination, electronic access Regular review Achievements The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings By Dec.1999: 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years National Essential Drugs List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) Countries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists. 17 RDU Achievements Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice 135 countries have treatment guidelines, formularies 18 RDU DAP’s role Achievements Training in rational prescribing has expanded in universities throughout the world 19 RDU Problem-based pharmacotherapy In 21 languages For medical students, clinical officers Measurable improvement in prescribing Now also: Teacher’s Guide to Good Prescribing Interventions Impact of problem-based pharmacotherapy teaching on examination scores (Argentina, 1999-2002) 1999(n=802) 52 2000(n=559) 41,5 2001(n=855) 40 2002(n=131) 36 37,6 16 42,7 20% 40% 3 20 RDU 15 36 25,2 0% 9,5 2,4 4-5 24,4 60% 6-7 80% >8 5,9 6,9 8,4 100% Measuring drug use Example of an indicator survey time series: Percent prescriptions by generics, from EDL, and actually dispensed (Delhi State, 1995-2000) 120 Availability 100 80 60 Generics 40 20 EDL 0 1995 1997 1999 2000 Year under review 21 RDU Trends in research: 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: Qualitative studies 22 RDU WHAT? HOW MUCH? WHY? Trends in research: 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? 23 RDU Trends in research Example: Is it reproducable and cost-effective? Mexico (1992-1994) Adequate treatment Diarrhoea: % change ARI: % change Cost-benefit ratio Diarrhoea: ARI: Research District State 46.7 32.6 25.6 28.8 29.3 8.5 3.3 16.2 3.9 18.4 4.4 21.6 Source: Guiscafre et al. Arch Med Res 1995; 26, Supp. S31-39 24 RDU Interventions Promoting rational prescribing: Interventions which need more testing Probably effective: Drug sellers interventions Public education Changing fee structure Probably ineffective: Drug information bulletins and other printed materials Banning ineffective/dangerous medicines Arbitrary prescription limitations, counter signatures Traditional stand-up lecturing 25 RDU Interventions Promoting rational prescribing: Possible interventions in the private sector 26 RDU Regulation: market approval, re-licensing, re-evaluation per therapeutic category, regulation of promotion Training: basic training, national clinical guidelines, continuing medical education by universities and professional bodies, re-licensing of professionals on basis of education points, district DThCommittees, medical audit, patient information leaflets, public education Financial incentives: separate prescribing from dispensing, dispensing fee (flat or tiered), price controls on generic/brand drugs, contracting out Insurance: reimbursement limited to essential medicines, reference pricing Interventions Where to start in countries with a strong private sector? 27 RDU Regulation: market approval, re-licensing, re-evaluation per therapeutic category, regulation of promotion Training: basic training, national clinical guidelines, continuing medical education by universities and professional bodies, re-licensing of professionals on basis of education points, district DThCommittees, medical audit, patient information leaflets, public education Financial incentives: separate prescribing from dispensing, dispensing fee (flat or tiered), price controls on generic/brand drugs, contracting out Insurance: reimbursement limited to essential medicines, reference pricing Conclusion 28 RDU Good experiences, policy advice, training tools and national expertise are available Future of essential medicines lies with the public sector and insurance systems There are many effective interventions possible for the private sector Thank you www.who.int / medicines