College of Psychiatric and Neurologic Pharmacists

Potential additions to health system formularies are reviewed for safety, efficacy, therapeutic need, and cost.  Formularies in mental health have separate issues that must be considered.  Clinical decision-making without knowledge from well-designed, controlled, randomized trials with adequate sample size, can incorrectly estimate the efficacy and safety risks associated with specific drug therapy.  The practice of evidence-based medicine (EBM) involves integrating clinical expertise with the best available evidence from systematic research.

The application of EBM principles is very important in making formulary management decisions.  However, in some instances this proves difficult as data is lacking.  Drugs that offer significant clinical advantages over current alternatives at a lesser cost are typically added to all formularies with minimal effort.  However," me too” agents may not differ much from other available medications and are more closely scrutinized.  Pure enantiomer products which offer subtle differences from the original compound pose a special quandary to those involved in formulary decision-making as often, the clinical differences may not be detectable especially if there are no head-to-head trials available.

Further complicating this picture is the role of marketing with these medications.  ”Me too” drugs are frequently released well before the patent expires on the original medication, when the costs should decrease substantially.  Formulary managers should take all information into account and use the evidence available when deciding where to place these medications in their health care system.  A systematic EBM process can assist with this challenge.  This session will discuss the activity and issues of formulary management and provide a 5-step EBM process that ensures clinical decisions are made based on the available evidence.

1. Identify steps for formulary addition of medications in different practice settings.
2. Compare common reasons for medications to be added or deleted from medication formularies.
3. Explain concerns associated with the decision making process of approving a medication onto a formulary when the medication is a specific isomer of or has a different delivery mechanism from an existing product.
4. Describe the basic principles in preparing and completing an evidence-based medicine review.
5. Explain the critical analysis 5-Step EBM Process and provide an example of its application in the formulary review process.
6. Discuss options for formulary decision-making when the desired quality or level of data does not exist.

Activity Dates: 04/18/2010 - 04/18/2013
ACPE Contact Hours: 2.0
ACPE Number: 0284-0000-10-003-H01-P (Knowledge)
Nursing Credit Reminder: Note that ACPE and ACCME credit is accepted for certification renewal.

This course is provided online at cpnp.org and consists of the speaker audio and slides. A PDF file of the slides is also provided and access is available to participants indefinitely although ACPE credit is available only through the course expiration date.

Participants in this course must complete an examination and achieve a score of 60% or greater. Successful completion of the course also requires the completion of a course evaluation. ACPE statements of credit can be retrieved by participants online at cpnp.org immediately upon successful completion of the course.

If you are a pharmacist, nurse practitioner or other healthcare professional involved in the medication therapy management of psychiatric and/or neurological patients, we invite you to participate in this online course.

This programming was supported in part by grants from Janssen, Ortho-McNeil Janssen Scientific Affairs, LLC, supported by an educational grant from Janssen, Division of Ortho-McNeil Janssen Pharmaceuticals, Inc. administered by Ortho-McNeil Janssen Scientific Affairs, LLC. and Lilly USA, LLC.