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.
- 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, and other appropriate items), not anecdotal prescriber experience.
- The drug evaluation monograph provides a structured method to review the major features of a drug product.
- A definite recommendation must be made based on need, therapeutics, side effects, cost, and other items specific to the particular agent (e.g., dosage forms, convenience, dosage interval, inclusion on the formulary of third-party payers, hospital antibiotic resistance patterns, and potential for causing medication errors), usually in that order.
- The recommendation must be supported by objective evidence.
- The most logical decision to benefit the patient and the institution should be recommended to the pharmacy and therapeutics (P&T) committee.
- While some think that cost is emphasized too much in formulary decisions, it is still an extremely important item.
- 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.
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, and other appropriate items), not anecdotal prescriber experience. The way to decide which drug is best for formulary addition is to rationally evaluate all aspects of the drug in relation to similar agents. 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, prescriber preferences, regulatory issues, patient/nursing convenience, advertising, and consumer expectations.1 It is expected that in the future there will be more emphasis on evaluating clinical outcomes from high-quality trials, continuous quality assurance information, comparative efficacies, pharmacogenomics, and quality of life (QOL).2 Even such a factor as the public image of the institution may have an impact on the decision to add a drug to the formulary. An in-depth drug evaluation monograph can be prepared to assist in this process as described in the following.
The drug evaluation monograph provides a structured method to review the major features of a drug product. Once a monograph is prepared, it can easily be used as a structured template or overview of a drug product. That allows ...