Drug appropriateness criteria: potential for indications creep

1. Drug appropriateness criteria: potential for indications creep Amy Lodolce, PharmD, BCPS Mike Koronkowski, PharmD

2. Learning Objectives • Describe off-label drug use and populations where it is most prevalent • Explain the key components of appropriate use criteria for drugs • Judge the appropriateness of a given drug for an off-label use • Justify whether or not the formulary should restrict drugs based on indications

3. Issues surrounding off-label prescribing • Legality • Prevalence • Level of evidence • Potential risks to patients • Cost to healthcare system

4. How common is this? • 21% (150 million) of 725 million prescriptions • 73% (109 million) little or no scientific support • 27% (41 million) strong scientific evidence Ann Intern Med 2006;166:1021-6.

5. Which patients? • Children • Patients with HIV • Patients with psychiatric disorders • Pregnant women Ann Intern Med 2006;166:1021-6.

6. Which drugs? • Anticonvulsants (notably gabapentin) • Antiasthmatic medications • Cardiac drugs • Antibiotics Ann Intern Med 2006;166:1021-6.

7. Examples • Gabapentin • Botulinum toxin type A (Botox)

8. Level of evidence Tertiary: • Drugdex on Micromedex • AHFS (the formulary service) Secondary: • Medline Primary: • Critically evaluate a trial

9. Potential harms • Adverse drug reactions • Potential for polypharmacy • Cost to healthcare system

10. Role of the pharmacist As defined by ASHP: • Patient advocate, drug info specialist • Evaluate orders (policies and procedures) • Proactive approaches to promote informed decisions by third-party payers (http://www.ashp.org/s_ashp/bin.asp?CID=1276&DID=5393&DOC=FILE.PDF)

11. Medication use policy • Evaluate medications (MUE) formally and report to P&T committee • P&T can restrict or limit use, but this is difficult for certain classes of drugs • State of Illinois Department of Healthcare and Family Services criteria

12. Medication Use Evaluation • MUE Goal – provide pts. with safe and effective drug therapy • Accomplished through assessment and improvement of medication use process • Focus can be single drug or therapeutic class OR component of medication use process/outcomes

13. Medication Use Evaluation • Objectives of MUE • Improve medication use process • Reduce medication-related problems • Reduce cost through appropriate use criteria • Provide education to staff

14. Medication Use Evaluation Step 1 • Form the committee • Multidisciplinary • Can be a sub-committee of P&T • Assign responsibility

15. Medication Use Evaluation Step 2 • Choose a topic • Focus on high volume, high risk, problem-prone medications • Can also focus on aspect of medication use process • Overall, topics should be selected to cover the scope of the institution

16. Medication Use Evaluation Step 3 • Develop criteria (methods) • Standards that define performance expectations • Phrase explicitly (yes/no) • Evidence based • Define outcomes • Indicators

17. Medication Use Evaluation Steps 4 and 5 • Develop data collection form • User friendly • Many boxes to check vs. free response • Collect data • Prospective • Concurrent • Retrospective

18. Medication Use Evaluation Step 6 • Data analysis Step 7 • Corrective action • Education • Guidelines/clinical pathway • Restrictive approach