El uso off-label de los medicamentos: reflexión ético-legal y propuesta de mejora

Abstract

The use of off-label drugs may be defined as the utilization of drugs in conditions other than the ones included on their authorized data sheet (1).The off-label prescriptions or the off-label uses are comprehended in the Spanish legislation in the Royal Decree Act 1059/2009 and, previously, in the article 24 of the Law of Guarantees of Drugs and Health Products (Law 29/2006 from July 26th). The existence of this legal support, despite being seen as exceptional in clinical practice, is essential to the patients’ benefit. For example, it allows the use of certain drugs without having to wait for the long bureaucratic procedures required for the authorization of a new indication. Despite the big benefit which this type of prescriptions provide and the amount of scientific literature which can be found, they are unknown and unacknowledged by many health professionals. In this sense, it should be clarified that the off-label use of drugs is often mistaken with the unlicensed drugs or the use of drugs in research (compassionate use), therefore not approved or commercialized. The off-label use of drugs is exclusively referred to the utilization of already approved drugs which are in a different way from what is indicated in their approved data sheet, either in their indication, dose, route of administration and/or population. Researches reveal that between an 11 to 80% (2) of the prescriptions could be off-label depending on the specialty and age group. When a pharmacist faces a medical prescription which does not match the data sheet of the prescribed drug, it may be due to two reasons: a doctor’s mistake or an off-label use of the drugs. The pharmacist’s attention will be proper way to differentiate between mistake and off-label use.