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Format for Drug Monograph

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INSTITUTION NAME HEADING

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Generic Name: Can include other common, nonofficial names, e.g., TPA for alteplase.

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Trade Brand Name: If more than one, indicate company that each is from.

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Manufacturer (or source of supply): Include Web site address.

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Therapeutic Category: For example, Thromobolytic Agent for alteplase

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Classification: Note—other classifications, such as the VA Class, can also be used.

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  • AHFS Number and Classification: If not in the book yet, see the list in the front of the AHFS Drug Information book and determine the most appropriate classification.

  • FDA Classification: Include specific FDA Web site URL concerning approval.

  • Status: Prescription, Nonprescription, and/or Controlled Substance Schedule (if applicable).

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Similar agents: A list of common treatments used for the same indication(s).

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Summary: Includes a short summary of advantages and disadvantages of the drug, particularly in relation to other drugs or treatments used for each major indication, and any other significant information. Must include indications allowed in the institution.

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Recommendations: Indicate whether or not the drug should be added to the drug formulary of an institution, including specifying the indications that it is approved for use in the institution, assuming they would have patients that would be treated for illnesses where this drug might be used. Also indicate specific formulary status for the drug (i.e., uncontrolled, monitored, restricted, conditional—see ASHP guidelines) and whether the drug will replace any other product that might already be on the formulary. In addition, include any information on how the drug is to be placed in any clinical guidelines. For third-party payer monographs, information will need to be included on the payment tier.

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Page one of the drug monograph consists of the above information

++ Pharmacological Data:
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  • Mechanism of Action (usually brief)

  • Bacterial Spectrum (if applicable)

++ Therapeutic Indications:
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  • FDA-Approved Indications (see package insert)—Clearly state which indications are FDA approved.

  • Potential Unlabeled Uses (list only if they are considered to be acceptable medical practice, although it is allowable to mention others that are early in investigation with a statement that the drug should not be used for them or that they require more study)—Clearly indicate they are not FDA approved.

  • How the drug, and similar drugs, fit into clinical guidelines.

  • Clinical Comparison (abstract at least two studies; see Appendix 9–2 for more guidelines. Include human efficacy studies and, where available, studies comparing the product to standard therapy. Note: If there are other supportive studies for an indication, they can be covered briefly, if you desire, along with the major study covered in detail. Be sure to note any deficiencies in the studies). Also, pharmacogenomic information may need to be included here and elsewhere.

++ Bioavailability/Pharmacokinetics:...

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