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Introduction

The purpose of this activity is to utilize Journal Club skills to develop a pharmacy formulary. This activity is suitable for students with knowledge of how to constructively critique an article summarizing a clinical trial and with knowledge of basic pharmacoeconomics.

Learning Objectives
  1. Analyze efficacy and safety of a drug for a specific disease condition by evaluating peer-reviewed clinical trials.

  2. Determine a classification for clinical trial articles evaluated (Class I, II, III, or IV).

  3. Determine the level of evidence of the drug for the disease state (Level A, B, C, or U).

  4. Select a drug to list on an outpatient pharmacy formulary based on consideration of: a) safety, b) efficacy, c) cost (from both payer [direct medical] and patient [out-of-pocket medical and nonmedical related costs] perspectives), and d) benefit to the patient.

  5. Prepare and present to peers findings from the individual and group effort.

Foundational Knowledge Required

Article critique (a.k.a., Journal Club), basic pharmacoeconomics, creating PowerPoint, verbal presentation skills

Suggested Resources
    Level of Evidence:
  • Miyasaki JM, Martin W, Suchowersky O, Weiner WJ, Lang AE. Practice parameter: initiation of treatment for Parkinson's disease: an evidence-based review: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2002;58(1):11-17.

Assignment Instructions

Determine the evidence of two antiepileptic drugs (eslicarbazepine and lacosamide) for focal seizures. Select a drug to list on an outpatient pharmacy formulary based on consideration of: a) safety, b) efficacy, c) cost (from both payer [direct medical] and patient [out-of-pocket medical and nonmedical related costs] perspectives), and d) benefit to the patient. Assume that the formulary is for a commercially insured patient population of 500,000 individuals (as opposed to Medicare or Medicaid), and assume that the cost for the “new” drug will be the Average Wholesale Price (AWP) less 15%.

Individual assignment

Select one article for each drug among the articles listed below.

For eslicarbazepine:

  1. Ben-Menachem E, Gabbai AA, Hufnagel A, Maia J, Almeida L, Soares-da-Silva P. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89(2-3):278-285.

  2. Elger C, Halász P, Maia J, Almeida L, Soares-da-Silva P, Group B--IS. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009;50(3):454-463.

  3. Gil-Nagel A, Lopes-Lima J, Almeida L, Maia ...

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