The American Society of Health-System Pharmacists (ASHP) outlined principles for off-label use of a drug.



(1) The safety of the patient is the primary concern.

(2) The use of a drug off-label should be based on a thorough, unbiased and ongoing review of the published evidence.

(3) A protocol for using the drug should be developed if the off-label use is expected to occur frequently.

(4) The Pharmacy and Therapeutics (P & T) Committee should provide oversight to off-label drug use.

(5) The ultimate responsibility for off-label use resides with the prescriber.

(6) A prescriber should consult with a pharmacist knowledgable about the drug when necessary.


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