Drug and Therapeutics Committees

1. Drug and Therapeutics Committees Drug Use Evaluation (DUE)

2. Objectives • Understand the mechanism for implementing and performing a drug use evaluation (DUE) • Discuss the use of a DUE program for improving drug therapy • Prepare criteria and thresholds for a DUE

3. Outline • Introduction • Key definitions • Need for a DUE • Stepwise approach to implementing a DUE • When DUEs go wrong • Activities • Summary

4. Introduction • Strategies to improve drug use • Educational • Managerial • Standard treatment guidelines • Education • Clinical pharmacy programs • Drug Use Evaluations • Regulatory

5. Key Definitions • Drug use evaluation (DUE) • Ongoing, systematic, criteria-based program of drug evaluations that will ensure appropriate drug use. Interventions are necessary when inappropriate therapy is identified.

6. Key Definition • A Drug Use Evaluation will: • Define appropriate use of a drug (by establishing criteria • Audit criteria against what is being prescribed • Provide feedback to prescribers on all identified problems • Monitor to see if criteria is followed and prescribing is improved

7. Need for Drug Use Evaluation • Opportunity abounds to use drugs incorrectly • The DTC must ensure that drugs are being used appropriately • Structured DUE will provide one method to identify, monitor, and help correct drug therapy problems

8. Need for Drug Use Evaluation (2) • Indicators that suggest a need for a DUE • High number adverse drug reactions • Signs of treatment failures • Overuse or underuse of medications • WHO or MSH indicator studies • Excessive Non-formulary medications used • Use of high-cost drugs where less expensive alternatives exist

9. The Need for a DUE (3)Kenya DTC Course Examples • Extensive use of insulin products where morbidity and mortality data may be lacking • inappropriate use of non-formulary drugs • Antipsychotic drug use in a general hospital (haloperidol and fluphenazine, 1st and 3rd in SA hospital)

10. The Need for a DUE (4)Kenya DTC Examples • Excessive number of drugs within a category of drugs (antihypertensives) • High use of expensive “statins” (atorvastatin and simvastatin)

11. The Need for DUE (5)Examples

12. The Need for a DUE (6)

13. Objectives of a DUE • Ensure that drug therapy meets current standards • Create criteria (or guidelines) for drug use • Enhance accountability in drug use • Control drug costs

14. Objectives of a DUE (2) • Promote optimal medication therapy • Prevent medication-related problems • Identify areas in which further evaluation is needed

15. Stepwise Approach to DUE 1. Establish responsibility 2. Develop scope of activities 3. Establish criteria and thresholds 4. Collect data and organize results 5. Analyze data 6. Develop recommendations and plan of action 7. DUE follow-up

16. Step 1 – Establish Responsibility • Drug and Therapeutics Committee is logical choice • Multidisciplinary committee dealing with all facets of drug therapy–has the drug experts and expertise • Subcommittee of the DTC • Other functional committees dealing with quality assurance of drug therapy

17. Step 2 – Develop Scope of Activities • Identify drug therapy problems to be addressed • ABC, adverse drug reactions, aggregate data, antibiotic sensitivities report • Concentrate on drugs with the highest potential for having problems • High volume • Low therapeutic index (or high ADR rate) • Expensive drugs

18. Step 2 – Develop Scope of Activities (2) • Concentrate on drugs with the highest potential for having problems (cont’d.) • Critically important drugs • Antimicrobials • Drugs undergoing evaluation for addition to the formulary • Drugs used for nonlabeled indicators • Drugs used for high-risk patients

19. Step 3 – Establish Criteria and Thresholds • Establish criteria (guidelines) that define correct drug use (using evidenced-based medicine) • Appropriate drug for medical condition • Correct dose • Quantity dispensed • Preparation for administration • Monitoring is appropriate (e.g. lab test) • Contraindications

20. Step 3 – Establish Criteria and Thresholds (2) • Drug interactions • Drug administration (especially for injections) • Patient education (written and oral instructions) • Patient outcomes (e.g., blood glucose, AIC) • Pharmacy administration indicators (correct cost, billing)

21. Step 3 – Establish Criteria, and Thresholds (3) • Establish thresholds (benchmarks)– • These define the expectations or goals for complying with the criteria (e.g., 90% of prescriptions for 3rd generation cephalosporins are for predefined serious infections).

22. Ciprofloxacin DUE Example • Table 1. Sample DUE Criteria for Ciprofloxacin • Criteria (Guidelines) Threshold • Use • Complicated, chronic, or relapsing UTI, • Gonorrhea • Resistant respiratory tract infections • Bone and joint infections • Prostatitis • GI infections 90% • Dose • Complicated or recurrent infections: 500-750mg bid • GI infections: 500mg bid • Gonorrhea: 250mg in 1 dose • renal disease – decrease as follows: CrCl 30-50ml/min – 250-500 q 12 h 5-29ml/min – 250-500 q 18 h Hemodialysis – 500mg q 24 h 95%

23. Ciprofloxacin DUE Example (2) • Criteria (Guidelines) Threshold • Duration • Complicated UTI—10-21 days • Respiratory—7-14 days • Osteomyelitis—4-6 weeks • GI—5 days 95% • Contraindications • Pregnancy • Children less than 18 100% • Drug interactions • theophylline, antacids, iron, sucralfate, probenecid • Food: decreased absorption with milk 90% • Outcome • Negative cultures • Improved symptomatology 90%

24. Step 4 – Collect Data • Prospective evaluation • Retrospective evaluation • Manual systems • Computerized Systems

25. Step 4 – Collect Data (2) • Sources of information for data • Prescription records • Drug profiles • Laboratory files • Patient’s medical record • Computer files

26. Step 5 – Analyze Data • Tabulate results for each indicator • Analyze to see if criteria are met and threshold is met (e.g., 70% of patients prescribed 3rd generation cephalosporins were given for predefined criteria—20% short of threshold) • Determine why thresholds or benchmarks are not met • Analyze data quarterly or more frequently

27. Step 6 – Develop Recommendations andPlan of Action • Recommendations to address— • Inappropriate drug use • Unacceptable patient outcomes • Methods to resolve any drug use problems

28. Step 6 – Develop Recommendations andPlan of Action (2) • Methods to resolve any drug use problems • Education • Drug order forms • Prescribing restrictions • Formulary manual changes • STG changes

29. Step 7 – DUE Follow-up • Check to see that recommendations have been implemented • Reevaluate DUE to see if problems with drug therapy have been resolved

30. When DUEs Go Wrong • Lack of authority • Poor prioritization of problems • Poor documentation • Inadequate follow-up • Overly intrusive data collection and evaluation

31. Activities • Activity 2–Assessing possible over-prescribing and inappropriate use of an expensive antibiotic

32. Summary (1) • DUE is an audit and feedback intervention where drug use can be reviewed against approved criteria and thresholds • Requires establishing criteria and thresholds and then reviewing drug use to determine if therapy is appropriate • Feedback to prescribers is necessary to improve prescribing (educational, managerial, regulatory interventions may be required)

33. Summary (2) • DUE will help improve drug use by— • Ensuring therapy meets current standards • Creating criteria for appropriate drug utilization • Enhancing responsibility / accountability in the drug use process • Controlling drug cost

34. Summary (3) • Promoting optimal medication therapy • Preventing medication-related problems • Evaluating the effectiveness of a drug • Identifying areas in which further information is needed