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Learning Objectives

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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.

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Key Concepts

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  • 1 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.

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

  • 3 A definite recommendation must 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.

  • 4 The recommendation must be supported by objective evidence.

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

  • 6 Cost is heavily emphasized in formulary decisions and must be properly accounted for given the complexities of drug acquisition pricing and reimbursement.

  • 7 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.

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Introduction

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1 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, effectiveness, risk, and cost (overall, including monitoring costs, discounts, rebates, and so forth)—often in that order. 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, patient/nursing convenience, advertising, possible discrimination issues,2 and consumer expectations.3 There is increasingly more emphasis on evaluating clinical outcomes from high-quality trials, continuous quality assurance information, comparative efficacies,4 pharmacogenomics, and quality of life.5

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PURPOSE OF DRUG EVALUATION MONOGRAPH

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When completing an evaluation, special consideration should be given to how a drug, if added to formulary, will safely be implemented at the institution. Example questions should be considered (e.g., Does the medication need an order set? Will the medication ...

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