AppendixC–SamplePTCommitteeMonograph.docVIP

AMCP – Sample P T Committee Monograph [Instructions: This is a generic template for PT Monographs. Delete this and other bracketed instruction paragraphs when you are finished. Replace text in square brackets [ ] with your text. The brackets [ ] should be replaced too. Parentheses ( ) should be left in the text. Just replace the text inside them.] [HEALTH SYSTEM NAME] FORMULARY MONOGRAPH Generic Name (Brand) [Manufacturer] Therapeutic Use: [Disease State(s) or Clinical Use(s)] Similar Drugs: [List all applicable] Issues for Consideration by the Formulary Committee: [These Issues are automatically numbered paragraphs. If you delete one, the others will renumber. If you add a hard return ( after the last issue, another issue number will appear.] Should [generic name] be added to the formulary? Is there a specific therapeutic niche and/or subpopulation of patients to which its use should be restricted? If so, how are they to be defined/identified? Should [generic name] be declared to be therapeutically equivalent to [similar drug(s)]? [text] INDICATIONS [Per FDA approved manufacturer’s labeling. If appropriate, may include off-label indications, identifying them as such.] CLINICAL PHARMACOLOGY [Keep very brief. Focus on pharmacology which is clinically relevant to the drug’s Formulary status.] PHARMACOKINETICS [Keep brief, bulleted. List only clinically relevant parameters.] Rt of Admin: [text] Peak Levels: [text] Time to Peak: [text] Elimination: [text] Half Life: [text] ADVERSE EFFECTS Summary: [text] Monitoring: [text] Table I. Reported Adverse Effects Reported Incidence in Trials(%) Adverse Effect Drug Therapy Placebo ALLERGIES AND INTERACTIONS [text] AVAILABILITY AND DOSING [Use indication headings below to break down the dosing information for different indications (if dosing varies with indication) or for different age groups and special populations, e.g. infants, children ages 6-12, re