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Rational use of drugs: an overview

Rational use of drugs: an overview. Kathleen Holloway Technical Briefing Seminar September 2004 Essential Drugs and Medicines Policy WHO Geneva. Objectives. Define rational use of medicines and identify the magnitude of the problem Understand the reasons underlying irrational use

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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 September 2004 Essential Drugs and Medicines Policy WHO Geneva

  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 WHO, Dept. Essential Drugs and Medicines Policy

  3. 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

  4. 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

  5. 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

  6. 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

  7. % 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

  8. 10-year trends in antibiotic & injection useWHO database, ICIUM 2004 N= 9 per year (on average) WHO, Dept. Essential Drugs and Medicines Policy

  9. 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)

  10. 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

  11. 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

  12. Public/private diarrhoea treatment for all yearsWHO database, ICIUM 2004 WHO, Dept. Essential Drugs and Medicines Policy

  13. Prescribing by prescriber type for all years WHO, Dept. Essential Drugs and Medicines Policy

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  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. PHC prescribing with & without Bamako initiative in NigeriaScuzochukwu et al, HPP, 2002 WHO, Dept. Essential Drugs and Medicines Policy

  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. DDD/1000 inhabitant-days This is where a large graphic or chart can go. Source: Bavestrello & Cabello, ICIUM 2004 WHO, Dept. Essential Drugs and Medicines Policy

  26. 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

  27. 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.

  28. 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

  29. 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

  30. 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

  31. WHO priorities • Developing a model formulary process, the WHO Essential Drugs Library • Training programmes • Promoting drug & therapeutic committees • Pilot projects to contain antimicrobial resistance • 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

  32. 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

  33. 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

  34. DTC training course results 2000-3 • 361 people trained from 56 countries • 87 (24%) responded to follow-up e-mail request • 57 (16%) participants had undertaken 152 DTC related activities • 24 (7%) participants from 10 countries attended the follow-up workshop for active participants Requires more support from donors WHO, Dept. Essential Drugs and Medicines Policy

  35. No.drugs Antibiotics Injections 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. Looking at trends in cotrimoxazole resistance and use in Mumbai, India, 2002Thatte et al, ICIUM 2004 WHO, Dept. Essential Drugs and Medicines Policy

  38. 30 8 7 25 6 % Ecoli resistance 20 5 % Drug use 15 4 3 10 2 5 1 0 0 Aug Sep Oct Nov Dec Jan Pharmacy shop use GP use Hospital use Ecoli resistance % patients receiving Fluoroquinolones and resistance of E. coli in rural Vellore, India, 2003 Thomas et al, ICIUM 2004 WHO, Dept. Essential Drugs and Medicines Policy

  39. Gray and Essack et al, ICIUM 2004 WHO, Dept. Essential Drugs and Medicines Policy

  40. 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

  41. ICIUM20042nd International conference for improving use of medicines • Chiang Mai, Thailand, Mar 30-Apr 2, 2004 • Objective: to identify what is known and not known on improving medicines use at all levels of health care: • Policy implications • Future research agenda • Disseminate findings and develop future research and policy agenda • Possible discussion at World Health Assembly • http://www.icium.org WHO, Dept. Essential Drugs and Medicines Policy

  42. Major findings of ICIUM20042nd International conference for improving use of medicines • Countries should implement national medicines programmes to improve medicines use • Long term, since implementation takes time, continued stakeholder commitment and adequate human resources • Cover all levels of health care in public and private sectors • Based on local evidence, from inbuilt monitoring system • Separate prescribing and dispensing functions • Extend broad-based insurance coverage • Measure drug prices which influence access to medicines • Avoid flat patient visit fees which encourage polypharmacy • Encourage generic prescribing and dispensing policies provided there are drug quality assurance programmes WHO, Dept. Essential Drugs and Medicines Policy

  43. Major findings of ICIUM20042nd International conference for improving use of medicines • Successful interventions should be scaled up • 3-day antibiotic therapy for pneumonia • Multi-faceted coordinated interventions rather than single ones • Structured quality-improvement process possibly through DTCs • Monitor impact of interventions • Interventions should address community medicines use • Improve patient adherence as an integral part of global treatment programmes • Encourage school programmes • Regulate pharmaceutical promotion • Evaluate medicines use in chronic diseases and how to promote more cost-effective long-term use WHO, Dept. Essential Drugs and Medicines Policy

  44. 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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