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Drug information pharmacists, along with students and residents on rotation, are valuable in creating, evaluating, and editing these monographs.

Information is initially gathered on general information (e.g., pharmacology, adverse effects, storage) with the help of common online tertiary databases such as Micromedex, Facts and Comparisons, or Lexicomp.

A thorough primary literature review is then necessary to evaluate the available clinical trials for the medication. This can be researched through commonly used secondary databases such as PubMed, SCOPUS, or Medline.

Investigation of the studies for the patient population included, outcomes used, and the results obtained should be performed to identify the external validity of the study to one’s own institution and patients.

The clinical evaluation of efficacy and safety can then be combined with cost and reimbursement to develop general guidance or recommendation for whether or not to add the particular product to the institution’s formulary.

An evaluation of a medication can be put together in a drug monograph and submitted to the P&T Committee for review. These monographs should have a standardized format.

A complete formulary Monograph Should include the following sections,

General information

Brand name
Generic name
Drug class

Indications

Labeled indications
Off-label indications

Pharmacology

Mechanism of action
Pharmacokinetics
Dosing

Operations

Dosage forms
Storage and stability
Special handling

Literature review

Clinical trial analysis
Grading of evidence
Presence in guidelines

Safety review

Contraindications
Adverse effects
Warnings and precautions
Pregnancy and lactation
Drug interactions
Required monitoring
Risk analysis

Costs

Formulary alternatives
Reimbursement
Pharmacoeconomic analysis

Conclusion

Summary of information
Place in therapy
Recommendation
Attachments:
Drug FORMULARY REVIEW & MONOGRAPH SECTIONS.png
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