1. 1 Drug and Therapeutics Committee Session 9. Strategies to Improve Medicine Use—Overview

2. Objectives  Identify effective strategies to improve medicine use  Choose an appropriate strategy for improving medicine use based on an identified problem  Understand the importance of educational, managerial, and regulatory interventions in promoting rational use of medicines

3. Outline  Key definitions  Introduction  Methods to improve medicine use  Educational  Managerial  Regulatory  Activity 1  Summary

4. Key Definitions  Standard treatment guideline (STG)—Systematically developed statement that assists practitioners and patients in making decisions about appropriate health care for specific clinical circumstances  Formulary manual—Document that describes medicines that are available for use in hospitals or clinics (provides information on indications, dosage, length of treatment, interactions, precautions, contraindications)  Drug use evaluation (DUE)—Ongoing, systematic, criteria-based program of medicine evaluations that helps ensure appropriate medicine use; if therapy is determined appropriate, interventions with providers or patients will be necessary to optimize pharmaceutical therapy

5. Introduction  Drug and Therapeutic Committee (DTC) responsibilities—  Selecting medicines for the formulary  Identifying medicine use problems  Developing and implementing strategies to improve medicine use

6. Consequences of Irrational Use of Medicines (1)  Waste of resources Up to half the value of all medicines may be wasted through inappropriate use  Morbidity due to adverse drug reactions (ADRs) In the United States, ADRs cost 30–130 billion U.S. dollars per year and causes significant morbidity and mortality

7. Consequences of Irrational Use of Medicines (2)  Antimicrobial resistance through misuse and overuse  2–4% multidrug resistance in TB, 12–55% resistance to penicillin in N. Gonorrhoea and S. Pneumonia, 10–90% resistance to ampicillin or co-trimoxazole in Shigella  Increased disease due to dirty or unnecessary injections  2.3–4.7 million hepatitis B and C infections and up to 160,000 HIV infections per year

8. Changing a Medicine 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

9. Strategies to Improve Medicine Use Managerial: to structure or guide decisions Regulatory: to restrict or limit decisions Educational: to inform or persuade

10. Educational Methods: To Inform and Persuade  Printed materials  Pharmaceutical bulletins and newsletters  Formulary manuals and STGs  Face-to-face activities  Group: in-service education, workshops, seminars  Individual: face-to-face (academic detailing)

11. Printed Educational Materials (1)  Newsletters and bulletins  International newsletters  Local newsletters  Brief, to the point, articles of interest to medical staff  Tailor to problems seen at hospitals and clinics  Produce regularly  Need to be coupled with other approaches

12. Printed Educational Materials (2)  Pharmaceutical newsletters are more likely to be effective in improving rational use of medicines if they do the following—  Describe the reasons for prescribing behavior  Offer concise, up-to-date information that can be used immediately  Provide limited information and repetition of key points  Have attractive graphics  Provide references in the newsletter to information derived from reputable journals and services  Provide information oriented toward actions and decisions  Obtain feedback from the professional staff on the value of newsletter and institute changes as necessary

13. Printed Educational Materials (3)  Formulary manuals  Reference source for education and training for all providers  Provide a listing of medicines available and information on the formulary medicines  Source of price information  STGs  Reference source for education and for prescription audit  Lists the preferred pharmaceutical and nonpharmaceutical treatments

14. Face-to-Face Educational Methods (1)  In-service education, workshops, seminars  Focuses on information of local relevance  Is kept brief (i.e., messages are few and clear, descriptions of what to do are concise)  Supports the repetitive information needed for individuals to learn  Is run by a presenter who has in-depth knowledge and an effective teaching style

15. Face-to-Face Educational Methods (2)  Person-to-person educational outreach (academic detailing)—most effective form of education  Focuses on specific problems and targets the prescribers  Addresses the underlying causes of prescribing errors such as inadequate knowledge

16. Face-to-Face Educational Methods (3)  Person-to-person educational outreach (continued)  Allows for interactive discussion with targeted audience  Uses concise and authoritative materials to augment presentations  Gives sufficient attention to solving practical problems encountered by prescribers in real settings

17. Face-to-Face Educational Methods (4)  Influencing opinion leaders  Chiefs of service  Dominant and experienced physicians in community settings  University professors  Important and respected traditional healers

18. Effects of an Opinion Leader on Choice Opinion Antibiotic for Prophylaxis in a U.S. Teaching Hospital,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,! ! !!! ! ! ! ! ! ! ! ! !! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! JanAprJulOctJanAprJulOctJanAprJulOct 8485 86 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 Discussion with Chief of Obstetrics -- Cefazolin recommended — Cefoxitin not recommended Percentage of all cesarean sections

19. Face-to-Face Educational Methods (5)  Patient education  Patients provided with education will—  Have fewer demands for medicines  Show improved compliance with pharmaceutical therapy  Have improved quality of care and outcomes  Must be provided by authoritative persons, such as physicians, pharmacists, and nurses in an organized, systematic approach

20. Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC Facilities* % Prescribing Injections Intervention Control 0 20 40 60 80 Pre Post *Hadiyono, J.E., S. Suryawati, S.S. Danu, et al. 1996. Interactional Group Discussion: Results of a Controlled Trial Using a Behavioral Intervention to Reduce the Use of Injections in Public Health Facilities. Social Science Medicine 42:1177–83.

21. Sites for Face-to-Face Education  Health centers  Hospitals  Pharmacies  Universities  District-level education

22. Strategies to Improve Medicine Use Managerial: to structure or guide decisions Regulatory: to restrict or limit decisions Educational: to inform or persuade

23. Managerial Methods: To Structure and Guide Decisions  STGs  DUEs  Clinical pharmacy programs  Medicine restrictions and control

24. Standard Treatment Guidelines  Advantages  Standardized treatment guidance to all practitioners  Dictates the most appropriate medicines  Provides basis for evaluating quality of care  Disadvantages  Difficult to produce accurately  Inaccurate or incomplete guidelines will provide the wrong information and do more harm than good  Guidelines may not be based on the most reliable information

25. Randomized Controlled Trial In Uganda— Effects of Treatment Guidelines, Training, and Supervision on the Percentage of Prescriptions Conforming to STGs*

26. Audit and Feedback  DUE  Program of ongoing, systematic, criteria-based evaluations of pharmaceutical therapy

27. Clinical Pharmacy Programs Last check on correct use, doses, side effects  Medicine information and patient education  Correct labeling and course of treatment packaging  Generic substitution programs—bioequivalence issues  Therapeutic substitution (interchange)—substitution of medicines that differ in active ingredients but have similar therapeutic activities in terms of efficacy and safety (e.g., lisinopril for enalapril)

28. Pharmaceutical Restrictions and Control  Formulary list (essential medicine list)  Structured order forms  Automatic stop orders

29. Controlling Pharmaceutical Promotion  All promotional claims concerning medicines should be reliable, accurate, truthful, informative, balanced, capable of substantiation, and in good taste  Control access of medical representatives to prescribers in the hospital during working hours  Organize meetings of discussion between medical representatives and prescribers to allow DTC to evaluate the medicine of interest

30. Avoiding Perverse Economic Incentives  Separation of the prescribing and dispensing functions  Avoidance of flat prescription fees that encourage polypharmacy  Avoidance of percentage dispensing fees that encourage the sale of more expensive medicines  Avoidance of polypharmacy where prescribers earn part of their income from the sale of medicines (including the use of expensive medicines where cheaper one would be just as good)

31. Improving Prescribing by Changing Financial Incentives from User Fees*  Pre- and post-study with control  1992: All three areas used flat fee covering all medicines in whatever quantities (perverse financial incentive)  1993–94: Two areas changed to a fee per pharmaceutical item (positive incentive)  1992–95: One area continued with the flat fee covering all medicines (control)  Prescription (Px) surveys done in pre-intervention (1992) and post-intervention (1995)  10–12 health facilities per area, > 30 prescriptions per facility *Holloway, K.A., B.R. Gautam, and B.C. Reeves. 2001. The Effects of Different Kinds of User Fees on Prescribing Quality in Rural Nepal. Journal of Clinical Epidemiology 54(10):1065–71.

32. Polypharmacy and Antibiotic Use: On changing from a flat medicine fee to a fee per medicine item Holloway et al. (2001). % patients treated with antibioticsAverage number of medicines per patient 0 20 40 60 80 0 1 2 3 4 Px fee1-band item fee 2-band item fee 19921995 Px fee1-band item fee2-band item fee 19921995

33. Injection and Vitamin or Tonic Use: On changing from a flat medicine fee to a fee per medicine item Holloway et al. (2001). % patients treated with injections 0 5 10 15 20 25 Px fee1-band item fee2-band item fee 19921995 % patients treated with vitamins/tonics 0 5 10 15 20 25 30 Px fee 1-band item fee2-band item fee 19921995

34. Treatment Cost and Compliance with STGs: On changing from flat medicine fee to fee per medicine item % patients treated according to STGs 0 10 20 30 40 50 60 Px fee1-band item fee2-band item fee Average medicine cost per patient (NRs)* 0 10 20 30 40 Px fee 1-band item fee 2-band item fee 19921995 19921995 Holloway et al. (2001). *NR = Nepalese rupees

35. Strategies to Improve Medicine Use Managerial: to structure or guide decisions Regulatory: to restrict or limit decisions Educational: to inform or persuade

36. Regulatory Methods: To Restrict or Limit Decisions  Country pharmaceutical registration—ensure only registered medicines are used  Professional licensing—employ only licensed staff for the level of prescribing required  Licensing of pharmaceutical outlets—buy medicines only from licensed outlets  Regulation pharmaceutical promotion activities

37. Choosing an Intervention (1)  A single educational strategy is usually not too effective and the impact is not sustainable.  Printed materials alone are not effective or advisable.  A combination of strategies, particularly of different types (e.g., educational and managerial) always produces better results than a single strategy.

38. Choosing an Intervention (2)  Focused small groups and face-to-face interactive workshops have been shown to be effective.  Monitoring (audit) and feedback and peer review are effective strategies to improve medicine use.  Economic strategies are powerful strategies to change medicine use but may be difficult to introduce.  Treatment guidelines are effective when used with other interventions.

39. Combined Intervention Strategy Prescribing for Acute Diarrhea in Mexico City 0 20 40 60 80 100 % cases treated in line with algorithm Study Physicians Control Physicians 37/52 79/115 20/84 Baseline Stage (n = 20) After Workshop After Peer Review (n = 20) 18-months Follow-up 11/46 31/110 16/70 25/102 42/82

40. Impact of Training on Using Diarrhea Treatment Algorithm in Three Mexican Settings Source: Munoz, et al., unpublished (1993) Intervention given by: Experts in 2 clinics (San Jeronimo) Leaders in 18 clinics (Coyoacan) Coordinators in 124 Prescribers 31 65 157 Baseline (%) 24.5 17.7 24.7 Post (%) 71.2 43.4 31.2 Change ( %) +46.7 + 25.6 + 6.5 clinics (Tlaxcala)

41. Review of 30 Studies in Developing Countries— Medicine Use Improvements with Different Interventions* Improvement in outcome measure (%) 0 10203040 50 60 None, minor Moderate Large Large group training Small group training Diarr. community case mgt ARI community case mgt Info/guidelines Group process Supervision/audit EDP/medicine supply Economic strategies Source: Ross-Degnan et al. 1997. Plenary Presentation, Conference on Improving the Use of Medicines. Chiang Mai, Thailand.

42. Activity 1. Case Study: Generic and Brand Name Antibiotics  What are the major pharmaceutical management problems in this case presentation?  Clearly define the beliefs and motivations of the prescribers that may contribute to the observed behavior.  Once the problem has been defined, what kinds of strategies or interventions would you use to improve pharmaceutical therapy and to lower medicine costs in this hospital?

43. Summary (1)  Strategies to improve medicine use include the following types of interventions—  Educational programs  In-service education  Pharmaceutical bulletins and newsletters  Formulary manuals  Face-to-face education

44. Summary (2) Interventions (continued)—  Managerial programs  DUE  STG  Clinical pharmacy programs  Medicine restrictions and control  Regulatory programs—registration of medicines, professionals, facilities