Prescripción off-label de medicamentos

Definición y consideraciones ético-regulatorias en Argentina

Abstract

Physicians are empowered to prescribe medications in a different manner than that it was approved by the regulatory agency, this means, outside of what is indicated in their package insert, for a specific patient. This may lead to the use of the drug in an indication other than that approved; or, in the same approved indication, but in a different subgroup of patients; or under different conditions.

Off-label indications are the sole responsibility of the treating physician. So we wonder what precautions the professional should take in the prescriptive act, what rights the patient has in this regard, if said treatment should also be covered by medical insurance and what actions should the State take, if applicable, as the ultimate guarantor of the health of people residing in Argentina.

The need and the special circumstances surrounding health issues determine that the prescription of off-label drugs is ethically and regulatory permissible. This must occur under certain conditions, arranged by the physician himself, but also from the authorities, in order to coordinate the participation of various actors in the system and the application of monitoring tools and favor adequate scientific information, all of which will support the off-label use of drugs to provide rational access in a specific case and accepted by the patient.