Review of Use of Drugs for Conditions Not Included in Product Characteristics

Abstract

Off-label use of medication is common in hospital clinical practice and should be applied together with follow-up of a healthcare treatment protocol and in compliance with a procedure which ensures that the patient is informed and that he or she provides informed consent.

A review of the literature on controlling 310 disorders showed that off-label use was indicated for 69 of them (22.3%) with the minimum required scientific evidence.

It would be useful for the Pharmacy and Therapeutics Committee to have a list of the disorders that can be controlled using off-label drugs, providing a reference to those disorders which must follow a healthcare treatment protocol.

A list of the mentioned characteristics is also useful for the hospital pharmacist for validating prescriptions, as it would provide a reference for assessing prescriptions which at first sight could seem questionable.

Finally, this list would be very useful if a search index of all the drugs by disorder was to be included in the Pharmacotherapeutic Guide. It would complement the usual indices which include active ingredients and specialities.