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LEARNING OBJECTIVES

Learning Objectives

After completing this chapter, the reader will be able to:

  • Describe and perform an evaluation of a drug product for a drug formulary.

  • List the sections included in a drug evaluation monograph.

  • Describe the overall highlights included in a monograph summary.

  • Describe the recommendations and restrictions that are made in a monograph.

  • Describe the purpose and format of a drug class review.

  • Describe and perform an evaluation of a therapeutic interchange.

KEY CONCEPTS

Key Concepts

  • image The establishment and maintenance of a drug formulary requires that drugs or drug classes be objectively assessed based on scientific information (e.g., efficacy, safety, uniqueness, cost), not anecdotal prescriber experience.

  • image The drug evaluation monograph provides a structured method to review the major features of a drug product.

  • image A definite recommendation should be made based on need, therapeutics, side effects, cost, and other items specific to the particular agent (e.g., evidence-based treatment guidelines, dosage forms, convenience, dosage interval, inclusion on the formulary of third-party payers, hospital antibiotic resistance patterns, potential for causing medication errors), usually in that order.

  • image The recommendation must be supported by objective evidence.

  • image The most logical decision to benefit the patient and the institution should be recommended to the pharmacy and therapeutics (P&T) committee.

  • image Cost is heavily emphasized in formulary decisions and must be properly accounted for, given the complexities of drug acquisition pricing, payor coverage, cost to the hospital, and reimbursement.

  • image Preparation of a drug evaluation monograph requires a great amount of time and effort, using many of the skills discussed throughout this text to obtain, evaluate, collate, and provide information. However, the value of having all of the issues evaluated and discussed can be invaluable in providing quality care.

INTRODUCTION

image The establishment and maintenance of a drug formulary requires that drugs or drug classes be objectively assessed based on scientific information (e.g., efficacy, safety,1 uniqueness, cost), not anecdotal prescriber experience. A rational evaluation of all aspects of a drug in relation to similar agents provides the most effective and evidence-based method in deciding which drug is appropriate for formulary addition. In particular, it is necessary to consider need, level of evidence for the drug’s efficacy, effectiveness, safety, risk, and cost (overall, including monitoring costs, discounts, rebates, economic impact on other medical costs, and so forth)—often in that order, although a committee may mostly be concerned about efficacy/indications, evidence of need, operational issues, cost, and safety.2 Some other issues that are evaluated include dosage forms, packaging, requirements of accrediting or quality assurance bodies, evidence-based treatment guidelines, prescriber preferences, regulatory issues (including risk evaluation and mitigation strategies [REMS]), distribution pathways, patient/nursing convenience, advertising, possible discrimination issues,3 consumer expectations,4 and patent expiration dates for similar drugs or treatments. Additional issues are continually added to the depth of a drug review, including assessment of risk to meet new regulatory requirements from the ...

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