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

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

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

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:

Which patients? Children Patients with HIV Patients with psychiatric disorders Pregnant women Ann Intern Med 2006;166:

Which drugs? Anticonvulsants (notably gabapentin) Antiasthmatic medications Cardiac drugs Antibiotics Ann Intern Med 2006;166:

Examples Gabapentin Botulinum toxin type A (Botox)

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

Potential harms Adverse drug reactions Potential for polypharmacy Cost to healthcare system

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 (

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

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

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

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

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

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

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

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