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Rational use of drugs: an overview

Rational use of drugs: an overview. Kathleen Holloway Technical Briefing Seminar 2003 Essential Drugs and Medicines Policy WHO Geneva.

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Rational use of drugs: an overview

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  1. Rational use of drugs:an overview Kathleen Holloway Technical Briefing Seminar 2003 Essential Drugs and Medicines Policy WHO Geneva

  2. 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 WHO, Dept. Essential Drugs and Medicines Policy

  3. % PHC patients treated according to guidelines Africa/Asia 1990/1 1992/3 1994/5 1996/7 1998/9 2000/1 no.countries 5/5 3/3 10/3 12/5 12/5 3/2 no.surveys 9/7 4/6 16/6 15/6 14/73/4 Source: WHO database on drug use 2003

  4. % drugs that are prescribed unnecessarilyestimated by a comparison of expected versus actual prescriptionChalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000 WHO, Dept. Essential Drugs and Medicines Policy

  5. Adequacy of diagnostic processThaver 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. WHO, Dept. Essential Drugs and Medicines Policy

  6. 5-55% of PHC patients receive injections - 90% may be medically unnecessary • 15 billion injections per year globally • half are with unsterilized needle/syringe • 2.3-4.7 million infections of hepatitis B/C and up to 160,000 infections of HIV per year associated with injections % of primary care patients receiving injections Source: Quick et al, 1997, Managing Drug Supply

  7. 30 to 60 % of PHC patients receive antibiotics - perhaps twice what is clinically needed % of PHC patients receiving antibiotics Source: Quick et al, 1997, Managing Drug Supply

  8. Overuse and misuse of antimicrobials contributes to antimicrobial resistance • Malaria • choroquine resistance in 81/92 countries • Tuberculosis • 2 - 40 % primary multi-drug resistance • Gonorrhoea • 5 - 98 % penicillin resistance in N. gonorrhoeae • Pneumonia and bacterial meningitis • 12 - 55 % penicillin resistance in S. pneumoniae • Diarrhoea: shigellosis • 10-90+ % amp, 5-95% TMP/SMZ resistance WHO, Dept. Essential Drugs and Medicines Policy Source: DAP, EMC, GTB, CHD (1997)

  9. Adverse drug eventsReview by White et al, Pharmacoeconomics, 1999, 15(5):445-458 • 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 WHO, Dept. Essential Drugs and Medicines Policy

  10. Drug Purchases through the Private Sector • 50-90% of all drug purchases are private • 25% to 75% illness episodes self-medicated • 1/2 consumers buy 1-day supply at a time • 50% of people worldwide fail to take drugs correctly • Results not always therapeutic • over-treatment of mild illness • inadequate treatment of serious illness • mis-use of anti-infective drugs • over-use of injections WHO, Dept. Essential Drugs and Medicines Policy

  11. Prescribing by dispensing and non-dispensing doctors in ZimbabweTrap et al 2000 WHO, Dept. Essential Drugs and Medicines Policy

  12. 1. EXAMINE Measure Existing Practices (Descriptive Quantitative Studies) 4. FOLLOW UP improve diagnosis 2. DIAGNOSE Measure Changes Identify Specific in Outcomes Problems and Causes (Quantitative and Qualitative (In-depth Quantitative Evaluation) and Qualitative Studies) improve intervention 3. TREAT Design and Implement Interventions (Collect Data to Measure Outcomes) Changing a Drug Use Problem:An Overview of the Process WHO, Dept. Essential Drugs and Medicines Policy

  13. Intrinsic Prior Knowledge Scientific Information Habits Information Social &Cultural Factors Influenceof Drug Industry Treatment Choices Societal Economic & Legal Factors Workload & Staffing Workplace Infra-structure Authority & Supervision Relationships With Peers Workgroup Many Factors Influence Use of Medicines WHO, Dept. Essential Drugs and Medicines Policy

  14. Use of Medicines Strategies to Improve Use of Drugs Educational: • Inform or persuade • Health providers • Consumers Managerial: • Guide clinical practice • Information systems/STGs • Drug supply / lab capacity Economic: • Offer incentives • Institutions • Providers and patients Regulatory: • Restrict choices • Market or practice controls • Enforcement WHO, Dept. Essential Drugs and Medicines Policy

  15. Educational StrategiesGoal: to inform or persuade • Training for Providers • Undergraduate education • Continuing in-service medical education e.g. 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 WHO, Dept. Essential Drugs and Medicines Policy

  16. Training for prescribersThe 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 WHO, Dept. Essential Drugs and Medicines Policy

  17. Pre Post Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC FacilitiesHadiyono et al, SSM, 1996, 42:1185 % Prescribing Injections 80 60 40 20 0 Intervention Control

  18. Discuss-ion with ObstetricChief % of all C-sections 0.7 ! ! ! ! 0.6 ! Cefazolin recommend-ed , ! , 0.5 ! ! ! ! ! ! , ! , ! , ! ! , 0.4 , , Cefoxitin not recommended ! ! , ! ! , 0.3 ! , ! ! , , 0.2 , ! ! , , 0.1 , , , ! , , , ! , , , , , ! ! ! ! ! ! ! , , , , , , , 0 Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct 84 85 86 Effects of Opinion Leader on Choice Antibiotic for Prophylaxis in a Teaching Hospital WHO, Dept. Essential Drugs and Medicines Policy

  19. Managerial strategiesGoal: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 • Avoidance of perverse financial incentives • prescribers’ salaries from drug sales, flat prescription fees, • insurance policies that reimburse non-essential drugs or incorrect doses WHO, Dept. Essential Drugs and Medicines Policy

  20. Review of 59 evaluations of clinical guidelinesGrimshaw & Russell, Lancet, Nov.27 1993, 342:1317-1322 • Significant improvement found in: • 55/59 studies concerning the process of care • 9/11 studies concerning patient outcome • Size of the improvement varied 5-60% and was higher if there was: • involvement of users in guideline development • a specific educational intervention • a patient-specific reminder at consultation e.g. a decision by a funding body not to reimburse prescriptions not meeting guidelines WHO, Dept. Essential Drugs and Medicines Policy

  21. RCT in Uganda of the effects of STGs, training & supervision on the % of Px conforming to guidelinesKafuko et al, UNICEF, 1996. WHO, Dept. Essential Drugs and Medicines Policy

  22. Pre-post with control study of an economic intervention (user fees) on prescribing in NepalHolloway, Gautam & Reeves, HPP, 2001 WHO, Dept. Essential Drugs and Medicines Policy

  23. Tetracycline prescription rate & tetracycline-resistant E.Coli in hospital isolates, 2 municipalities in Denmark, 01/1994-12/1999 Change in subsidization: from 50 to 0% (01/1996) Tetracycline-R E. coli Hospital Isolates (%, 5-month moving average) Tetracycline Use (# prescriptions per 1,000 inhabitants) Sources: Danish Medicines Agency & H. Westh, Hvidovre Hosp, 2000. Monnet DL., 40th ICAAC, Toronto, Canada, 527 [abstr. 628].

  24. Regulatory strategiesGoal: 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 WHO, Dept. Essential Drugs and Medicines Policy

  25. Choosing an Intervention • A single educational strategy is often not effective and does not have a sustainable impact • Printed materials alone are not effective • Combination of strategies, particularly of different types (e.g. educational + managerial) always produces better results than a single strategy • Focused small groups and face to face interactive workshops have been shown to the effective • Audit and feedback, peer review, are very effective • Economic strategies are very powerful strategies to change drug use but may be difficult to introduce WHO, Dept. Essential Drugs and Medicines Policy

  26. Review of 30 studies in developing countries size of drug use improvements with various interventions Minor Moderate Large Large group training Small group training Diarr. community case mgt ARI community case mgt Info/guidelines Group process Supervision/audit EDP/Drug supply Economic strategies 10 20 30 40 50 60 0 Improvement in outcome measure (%) Source: Ross-Degnan et al, Plenary presentation, Conference on Improving the Use of Medicines, 1997, Chiang Mai, Thailand.

  27. % cases treated in line with algorithm Study Physicians Control Physicians 100 AfterPeer Review (n = 20) After Workshop 37/52 80 79/115 BaselineStage (n = 20) 18-months Follow-up 42/82 60 40 31/110 11/46 25/102 20/84 16/70 20 0 Combined Intervention StrategyPrescribing for Acute Diarrhea in Mexico City WHO, Dept. Essential Drugs and Medicines Policy

  28. Prescribers Baseline Post Change % % % 31 24.5 71.2 +46.7 65 17.7 43.4 + 25.6 157 24.7 31.2 + 6.5 Impact of Training on Use of Diarrhea Treatment Algorithm in Three Mexico Settings Intervention given by: "Experts" in 2 clinics (San Jeronimo) "Leaders" in 18 clinics (Coyoacan) "Coordinators" in 124 clinics (Tlaxcala) Source: Munoz, et al, unpub. (1993); Guiscafre, et al, Arch. Med. Res. (1995) WHO, Dept. Essential Drugs and Medicines Policy

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

  30. Drug & Therapeutic Committee Activitiesvery little data on drug use impact WHO, Dept. Essential Drugs and Medicines Policy

  31. 10 national strategies to promote RUDneeds sufficient govt. investment for medicines & staff ! 1. Evidence-based standard treatment guidelines 2. Essential Drug Lists based on treatments of choice 3. Drug & Therapeutic Committees in hospitals 4. Problem-based training in pharmacotherapy in UG training 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 drugs 9. Avoidance of perverse financial incentives 10. Appropriate and enforced drug regulation WHO, Dept. Essential Drugs and Medicines Policy

  32. Why does irrational use continue? Very few countries regularly monitor drug use & 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? WHO, Dept. Essential Drugs and Medicines Policy

  33. WHO future priorities • Developing a model formulary process, the WHO Essential Drugs Library • Training programmes • Pilot projects to contain antimicrobial resistance • Promoting drug & therapeutic committees • Intervention research to promote RUD • cost-effectiveness of interventions, policies • Advocacy for the rational use of drugs (RUD) • Essential Drug Monitor, effective drug information • ICIUM2004 WHO, Dept. Essential Drugs and Medicines Policy

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

  35. 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/WHO: Promoting rational use of drugs in the community • Newcastle, Australia/WHO : Pharmaco-economics • Boston University, USA/WHO: Drug Policy Issues WHO, Dept. Essential Drugs and Medicines Policy

  36. Local pilot projects to contain AMR • Objectives • develop, implement & evaluate interventions to contain AMR using surveillance data in local sites • to develop a new method for the integrated surveillance, at community level, of antimicrobial use and resistance that can be used in many different countries • to build local capacity in developing a multi-disciplinary approach to the containment of AMR • 3 phases • (1) set up surveillance, • (2) develop, implement & evaluate interventions • (3) expand to other sites WHO, Dept. Essential Drugs and Medicines Policy

  37. No.drugs Antibiotics Injections WHO, Dept. Essential Drugs and Medicines Policy

  38. Identifying effective strategies to promote more rational use of drugs • Joint research initiative between WHO/EDM, MSH and ARCH • over 20 intervention research projects in developing countries • WHO database on drug use • quantitative data on drug use and interventions to improve drug use over the last decade WHO, Dept. Essential Drugs and Medicines Policy

  39. ICIUM20042nd International conference for improving use of medicines • Next milestone in assessing progress on global medicines agenda • Chiang Mai, Thailand, Mar 30-Apr 2, 2004 • Objective: Examine state of the art in improving medicines use in focus areas: • Intl. policy & systems -Natl. policy & systems • Hospitals - Primary care • Private pharmacies -Community use WHO, Dept. Essential Drugs and Medicines Policy

  40. ICIUM2004: topic tracks • “Meetings Within a Meeting” • Key constituencies and interest groups working on pharmaceutical issues • Summarize topical lessons and research needs • Preliminary topic tracks include • Child health - Malaria • TB - HIV/Aids, STIs • Chronic diseases - Antimicrobial resistance • Impact of access on use WHO, Dept. Essential Drugs and Medicines Policy

  41. ICIUM2004: who should attend? • Researchers • Leading drug use researchers & methodologists • Fertilization across interest areas • Policymakers • Learn cutting edge behavior change approaches • Assessment of pharmaceutical policy impacts • NGOs and Donors • Add value to existing programs • Coordinate with global medicines initiative WHO, Dept. Essential Drugs and Medicines Policy

  42. ActivityDiscuss in groups the following questions • Choose a major drug use problem in your country or project • Identify the causes underlying the problem • What are the main 1-2 strategies being undertaken to address this problem? • Are these 1-2 strategies being evaluated? If so, how? • What should be the roles of government, NGOs, donors, and WHO be in filling the gap in strategies/policies to address this problem? WHO, Dept. Essential Drugs and Medicines Policy

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