Drug and Therapeutics Committee

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

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 Objectives

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

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 useevaluation (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 Key Definitions

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

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 (1)

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 Consequences of Irrational Use of Medicines (2)

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 Medicine Use Problem:An Overview of the Process

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

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) Educational Methods: To Inform and Persuade

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 (1)

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 (2)

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 Printed Educational Materials (3)

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 (1)

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

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 (3)

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

Discussion with Chief of Obstetrics 0.7 ! ! ! ! 0.6 ! , ! -- Cefazolin recommended , 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 an Opinion Leader on Choice Opinion Antibiotic for Prophylaxis in a U.S. Teaching Hospital Percentage of all cesarean sections

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 Face-to-Face Educational Methods (5)

Pre Post Impact of Patient-Provider Discussion Groupson Injection Use in Indonesian PHC Facilities* % PrescribingInjections 80 60 40 20 0 Control Intervention *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.

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

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

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 Standard Treatment Guidelines

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

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

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) Clinical Pharmacy Programs

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

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 Controlling Pharmaceutical Promotion

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) Avoiding Perverse Economic Incentives

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 Improving Prescribing by Changing Financial Incentives from User Fees* *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 80 4 Average number of medicines per patient % patients treated with antibiotics 3 60 2 40 1 20 0 0 2-band item fee Px fee 1-band item fee Px fee 1-band item fee 2-band item fee 1992 1995 1992 1995 Holloway et al. (2001).

% patients treated with injections 25 20 15 10 5 0 Px fee 1-band item fee 2-band item fee Injection and Vitamin or Tonic Use:On changing from a flat medicine fee to a fee per medicine item % patients treated with vitamins/tonics 30 25 20 15 10 5 0 1-band item fee 2-band item fee Px fee 1992 1995 1992 1995 Holloway et al. (2001).

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 40 60 50 30 40 20 30 20 10 10 0 0 1-band item fee Px fee 1-band item fee 2-band item fee Px fee 2-band item fee 1992 1995 1992 1995 *NR = Nepalese rupees Holloway et al. (2001).

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 Regulatory Methods: To Restrict or Limit Decisions

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 (1)

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. Choosing an Intervention (2)

% cases treated in line with algorithm Study Physicians Control Physicians 100 After Peer Review (n = 20) After Workshop 37/52 80 79/115 Baseline Stage (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

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 Using Diarrhea Treatment Algorithm in Three Mexican Settings Intervention given by: Experts in 2 clinics (San Jeronimo) Leaders in 18 clinics (Coyoacan) Coordinators in 124 clinics (Tlaxcala) Source: Munoz, et al., unpublished (1993)

Review of 30 Studies in Developing Countries— Medicine Use Improvements with Different Interventions* None, minor Large Moderate 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 50 0 10 20 30 40 60 Improvement in outcome measure (%) Source: Ross-Degnan et al. 1997. Plenary Presentation, Conference on Improving the Use of Medicines. Chiang Mai, Thailand.

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? Activity 1. Case Study: Generic and Brand Name Antibiotics

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 (1)

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

Drug and Therapeutics Committee