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

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Presentation on theme: "Rational use of drugs: an overview Kathleen Holloway Technical Briefing Seminar 2003 Essential Drugs and Medicines Policy WHO Geneva."— Presentation transcript:

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

2 WHO, Dept. Essential Drugs and Medicines Policy2 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

3 3 % PHC patients treated according to guidelines Africa/Asia 1990/11992/3 1994/5 1996/7 1998/9 2000/1 no.countries5/5 3/3 10/3 12/5 12/5 3/2 no.surveys9/7 4/6 16/6 15/6 14/7 3/4 Source: WHO database on drug use 2003

4 WHO, Dept. Essential Drugs and Medicines Policy4 % drugs that are prescribed unnecessarily estimated by a comparison of expected versus actual prescription Chalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000

5 WHO, Dept. Essential Drugs and Medicines Policy5 Adequacy of diagnostic process 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.

6 6 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 million infections of hepatitis B/C and up to 160,000 infections of HIV per year associated with injections

7 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 WHO, Dept. Essential Drugs and Medicines Policy8 Overuse and misuse of antimicrobials contributes to antimicrobial resistance Malaria –choroquine resistance in 81/92 countries Tuberculosis – % primary multi-drug resistance Gonorrhoea – % penicillin resistance in N. gonorrhoeae Pneumonia and bacterial meningitis – % penicillin resistance in S. pneumoniae Diarrhoea: shigellosis – % amp, 5-95% TMP/SMZ resistance Source: DAP, EMC, GTB, CHD (1997)

9 WHO, Dept. Essential Drugs and Medicines Policy9 Adverse drug events Review by White et al, Pharmacoeconomics, 1999, 15(5): th 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

10 WHO, Dept. Essential Drugs and Medicines Policy10 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

11 WHO, Dept. Essential Drugs and Medicines Policy11 Prescribing by dispensing and non-dispensing doctors in Zimbabwe Trap et al 2000

12 WHO, Dept. Essential Drugs and Medicines Policy12 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 WHO, Dept. Essential Drugs and Medicines Policy13 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 WHO, Dept. Essential Drugs and Medicines Policy14 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 Strategies to Improve Use of Drugs

15 WHO, Dept. Essential Drugs and Medicines Policy15 Educational Strategies Goal: 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

16 WHO, Dept. Essential Drugs and Medicines Policy16 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

17 17 Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC Facilities Hadiyono et al, SSM, 1996, 42:1185 InterventionControl % Prescribing Injections Pre Post

18 WHO, Dept. Essential Drugs and Medicines Policy18 Effects of Opinion Leader on Choice Antibiotic for Prophylaxis in a Teaching Hospital

19 WHO, Dept. Essential Drugs and Medicines Policy19 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 Avoidance of perverse financial incentives –prescribers’ salaries from drug sales, flat prescription fees, –insurance policies that reimburse non-essential drugs or incorrect doses

20 WHO, Dept. Essential Drugs and Medicines Policy20 Review of 59 evaluations of clinical guidelines Grimshaw & Russell, Lancet, Nov , 342: 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

21 WHO, Dept. Essential Drugs and Medicines Policy21 RCT in Uganda of the effects of STGs, training & supervision on the % of Px conforming to guidelines Kafuko et al, UNICEF, 1996.

22 WHO, Dept. Essential Drugs and Medicines Policy22 Pre-post with control study of an economic intervention (user fees) on prescribing in Nepal Holloway, Gautam & Reeves, HPP, 2001

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

24 WHO, Dept. Essential Drugs and Medicines Policy24 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

25 WHO, Dept. Essential Drugs and Medicines Policy25 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

26 26 Review of 30 studies in developing countries size of drug use improvements with various interventions 0 Improvement in outcome measure (%) 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 MinorModerateLarge Source: Ross-Degnan et al, Plenary presentation, Conference on Improving the Use of Medicines, 1997, Chiang Mai, Thailand.

27 WHO, Dept. Essential Drugs and Medicines Policy27 Combined Intervention Strategy Prescribing for Acute Diarrhea in Mexico City % cases treated in line with algorithm Study Physicians Control Physicians 37/52 79/115 20/84 BaselineStage (n = 20) After Workshop AfterPeer Review (n = 20) 18-months Follow-up 11/46 31/110 16/70 25/102 42/82

28 WHO, Dept. Essential Drugs and Medicines Policy28 Impact of Training on Use of Diarrhea Treatment Algorithm in Three Mexico Settings Source: Munoz, et al, unpub. (1993); Guiscafre, et al, Arch. Med. Res. (1995) Intervention given by: "Experts" in 2 clinics (San Jeronimo) "Leaders" in 18 clinics (Coyoacan) "Coordinators" in 124 Prescribers Baseline % Post % Change % clinics (Tlaxcala)

29 WHO, Dept. Essential Drugs and Medicines Policy29 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)

30 WHO, Dept. Essential Drugs and Medicines Policy30 Drug & Therapeutic Committee Activities very little data on drug use impact

31 WHO, Dept. Essential Drugs and Medicines Policy31 10 national strategies to promote RUD needs 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

32 WHO, Dept. Essential Drugs and Medicines Policy32 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?

33 WHO, Dept. Essential Drugs and Medicines Policy33 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

34 WHO, Dept. Essential Drugs and Medicines Policy34 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 WHO, Dept. Essential Drugs and Medicines Policy35 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

36 WHO, Dept. Essential Drugs and Medicines Policy36 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

37 WHO, Dept. Essential Drugs and Medicines Policy37 Injections Antibiotics No.drugs

38 WHO, Dept. Essential Drugs and Medicines Policy38 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

39 WHO, Dept. Essential Drugs and Medicines Policy39 ICIUM nd 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

40 WHO, Dept. Essential Drugs and Medicines Policy40 ICIUM 2004: 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

41 WHO, Dept. Essential Drugs and Medicines Policy41 ICIUM 2004: 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

42 WHO, Dept. Essential Drugs and Medicines Policy42 Activity Discuss 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?


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