Formulary Reviews and Drug Monograph Sections
Posted: 26 Aug 2019, 21:23
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
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