Drug and Therapeutics Committee Session 9. Strategies to Improve Medicine Use—Overview 1 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 Outline Key definitions Introduction Methods to improve medicine use Educational Managerial Regulatory Activity 1 Summary 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 Introduction Drug and Therapeutic Committee (DTC) responsibilities— Selecting medicines for the formulary Identifying medicine use problems Developing and implementing strategies to improve medicine use 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 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 Changing a Medicine Use Problem: An Overview of the Process 1. EXAMINE Measure existing practices (descriptive quantitative studies) 4. FOLLOW UP Measure changes in outcomes (quantitative and qualitative evaluation) Improve diagnosis Improve intervention 3. TREAT Design and implement interventions (collect data to measure outcomes) 2. DIAGNOSE Identify specific problems and causes (in-depth quantitative and qualitative studies) Strategies to Improve Medicine Use Educational: to inform or persuade Managerial: to structure or guide decisions Regulatory: to restrict or limit decisions 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) 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 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 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 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 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 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 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 Effects of an Opinion Leader on Choice Opinion Antibiotic for Prophylaxis in a U.S. Teaching Hospital 0.7 0.6 0.5 0.4 , , 0.2 ! ! ! , , , , !! !! ! !, !! , , , !! Jul 84 Oct -- Cefazolin recommended !! ! ! ! ! — Cefoxitin not recommended , , , , , , , , , ,, , , , , , ,, ! !! !!!! !! Apr ! !! ! , , 0.1 Jan ! ! , , , , 0.3 0 Percentage of all cesarean sections Discussion with Chief of Obstetrics Jan Apr Jul 85 Oct Jan Apr Jul 86 Oct 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 Impact of Patient-Provider Discussion Groups on Injection Use in Indonesian PHC Facilities* % Prescribing Injections 80 60 Pre Post 40 20 0 Intervention Control *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. Sites for Face-to-Face Education Health centers Hospitals Pharmacies Universities District-level education Strategies to Improve Medicine Use Educational: to inform or persuade Managerial: to structure or guide decisions Regulatory: to restrict or limit decisions Managerial Methods: To Structure and Guide Decisions STGs DUEs Clinical pharmacy programs Medicine restrictions and control 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 Randomized Controlled Trial In Uganda— Effects of Treatment Guidelines, Training, and Supervision on the Percentage of Prescriptions Conforming to STGs* Randomised group PostPreNo. health facilities intervention intervention Change Control group 42 24.8% 29.9% +5.1% Dissemination of guidelines 42 24.8% 32.3% +7.5% Guidelines + onsite training 29 24.0% 52.0% +28.0% 14 21.4% 55.2% +33.8% Guidelines + onsite training + 4 supervisory visits *Kafuko, J.M., C. Zirabumuzaale, and D. Bagenda. 1996. Rational Drug Use in Rural Health Units of Uganda: Effect of National Standard Treatment Guidelines on Rational Drug Use. Final report UNICEF/Uganda. Audit and Feedback DUE Program of ongoing, systematic, criteria-based evaluations of pharmaceutical therapy 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) Pharmaceutical Restrictions and Control Formulary list (essential medicine list) Structured order forms Automatic stop orders 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 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) 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. Polypharmacy and Antibiotic Use: On changing from a flat medicine fee to a fee per medicine item Average number of medicines per patient % patients treated with antibiotics 4 80 3 60 2 40 1 20 0 Px fee 1-band item fee 2-band item fee 1992 Holloway et al. (2001). 1995 0 Px fee 1-band item fee 2-band item fee 1992 1995 Injection and Vitamin or Tonic Use: On changing from a flat medicine fee to a fee per medicine item % patients treated with vitamins/tonics % patients treated with injections 25 20 15 10 5 0 30 25 20 15 10 5 0 Px fee 1-band item fee 1992 1995 Holloway et al. (2001). 2-band item fee Px fee 1-band item fee 2-band item fee 1992 1995 Treatment Cost and Compliance with STGs: On changing from flat medicine fee to fee per medicine item Average medicine cost per patient (NRs)* % patients treated according to STGs 60 50 40 30 20 10 0 40 30 20 10 0 Px fee 1-band item fee 2-band item fee 1992 Holloway et al. (2001). 1995 Px fee 1-band item fee 2-band item fee 1992 *NR = Nepalese rupees 1995 Strategies to Improve Medicine Use Educational: to inform or persuade Managerial: to structure or guide decisions Regulatory: to restrict or limit decisions 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 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. 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. Combined Intervention Strategy Prescribing for Acute Diarrhea in Mexico City % cases treated in line with algorithm 100 After Workshop 80 60 After Peer Review (n = 20) 37/52 Baseline Stage (n = 20) 42/82 18-months Follow-up 31/110 25/102 0 Control Physicians 79/115 40 20 Study Physicians 20/84 16/70 11/46 Impact of Training on Using Diarrhea Treatment Algorithm in Three Mexican Settings Intervention given by: Prescribers Baseline (%) Post (%) Change (%) Experts in 2 clinics (San Jeronimo) 31 24.5 71.2 +46.7 Leaders in 18 clinics (Coyoacan) 65 17.7 43.4 + 25.6 Coordinators in 124 clinics (Tlaxcala) 157 24.7 31.2 + 6.5 Source: Munoz, et al., unpublished (1993) Review of 30 Studies in Developing Countries— Medicine Use Improvements with Different Interventions* None, Large Moderate minor 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 0 10 20 30 40 50 60 Improvement in outcome measure (%) Source: Ross-Degnan et al. 1997. Plenary Presentation, Conference on Improving the Use of Medicines. Chiang Mai, Thailand. 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? 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 Summary (2) Interventions (continued)— Managerial programs DUE STG Clinical pharmacy programs Medicine restrictions and control Regulatory programs—registration of medicines, professionals, facilities