DRUG INFORMATION SERVICES

Prescribing Information & Off-Label Resources

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Prescribing Information [aka Package Insert] (PI)

 

• Find the most up-to-date PI 

• Manufacturer's website 

• www.brandname.com (ex. www.invokana.com) 

• Drugs@FDA: www.fda.gov 

• At the top right-hand side of the page, click “Menu,” then “Drugs.” Scroll down and click “Drug Approvals and Databases”, then click “Drugs@FDA Search.” Alternatively, you can Google “Drugs at FDA” and arrive at the same site.  

• Search for the drug you’re looking for, once on the website for that drug, scroll down and find “Labels for NDA ###” and click on the link to the most recent “label (pdf).” The most current package insert will be the one with the most recent “Action Date” as indicated on the left-hand side. 

• Daily Med: http://dailymed.nlm.nih.gov  

• Limitation: Using it for drugs that are off-patent (generics), yields numerous PIs available, all with different revision dates so it is often difficult and time-consuming trying to locate the most recently revised PI. 

• On the product itself (attached on top or inside packaging) 

• For a Review of FDA Product Labeling Format: https://www.medscape.com/viewarticle/566885  

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Medication Guides:  

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• About Medication Guides: https://www.fda.gov/drugs/drug-safety-and-availability/medication-guides 

• Medication Guides can be found where you find the PI at Drugs@FDA or in the Medication Guides Database: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=medguide.page  

 

Off-Label Resources 

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• Official Compendia for Off-Label Uses According to Medicare Part D (i.e. considered to be medically acceptable off-label uses):1 

• American Hospital Formulary Service Drug Information (AHFS DI found in LexiComp)  

• http://www.ahfsdruginformation.com/off-label-uses-overview/  

• Sample print monograph http://ahfs.ashp.org/docs/ahfsdi_monograph.pdf  

• DRUGDEX (found under "Non-FDA Uses" in Micromedex) 

• United States Pharmacopeia-Drug Information (USPDI or its successor publications) 

• Out of print- incorporated into DRUGDEX 

• Official Compendia for Anticancer Off-Label Chemotherapy Treatment According to Medicare:2 

• AHFS-DI (found in LexiComp) 

• Off-label oncology uses review process http://www.ahfsdruginformation.com/review-process/  

• Off-label Final Determinations List http://www.ahfsdruginformation.com/final-determinations/  

• National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium https://www.nccn.org/  

• DrugDex (found in Micromedex) 

• Clinical Pharmacology (not available at SJU) 

• Lexi-Drugs (found in LexiComp)  

• For Off-Label Uses NOT in Official Compendia 

• To ensure patient safety, research should be conducted in other tertiary resources (i.e. reviews of clinical trials, clinical guidelines and Off-Label Facts & Comparisons, found in LexiComp or Facts & Comparisons eAnswers), as well as original research articles (primary studies found via secondary databases such as PubMed/Medline). 

References: 

1. Medicare Prescription Drug Benefit Manual Chapter 6 – Part D Drugs and Formulary Requirements; Section 10.6. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf. Accessed on 7/28/20. 

1. Medicare Benefit Policy Manual Chapter 15 – Covered Medical and Other Health Services; Section 50.4.5. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Accessed on 7/28/20.