OFF-LABEL MEDICATION USE AND PRESCRIBING PRACTICES

The FDA requires that the labels of approved medications list the intended use (ie, the conditions or diseases that the medication is approved to treat).1 Licensed prescribers may use (or order use of) FDAapproved medications in an off-label manner to treat a specific condition if they judge that it is medically appropriate for the patient1 A licensed prescriber may determine off-label medication use is appropriate if there is no FDA-approved medication available or if other approved treatments have been tried unsuccessfully.1 Off-label use could be as simple as using a different dosage or formulation (eg, an oral solution instead of a capsule), oras complex as treating a completely different condition than the stated approved use (eg, an antineoplastic agent used to treat one type of cancer instead of the cancer for which it was originally approved).12 Off-label use of FDA-approved medications is common in certain specialties (eg, oncology, psychiatry) as well as in specific populations, such as pediatric patients,3 obstetric patients, or patients living with AIDS.2 Leaders at facilities where licensed prescribers order FDA-approved medications for off-label use should consider the following: * if a policy and procedure is necessary to guide this practice;3 * if shared decision making about the reasons for and the risks and benefits of off-label use of the medication is occurring;3 * if the shared decision-making process requires documentation and, if so, which individuals are responsible for it;3 and * if additional education for RNs administering medications or monitoring patients for effectiveness or adverse effects after administration is needed to ensure patient safety.4 Editor's note: Dr Cahn has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. State Operations Manual Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.