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Revista de Bioética y Derecho

On-line version ISSN 1886-5887


BIERZYCHUDEK, Laura. Off-label prescription of drugs: Definition and ethical-regulatory considerations in Argentina. Rev. Bioética y Derecho [online]. 2022, n.55, pp.165-191.  Epub Jan 20, 2023. ISSN 1886-5887.

Physicians have the authority to prescribe medications in a manner different from that approved by the regulatory agency, this means, outside of what is indicated in the package leaflet, for a specific patient. This may result in the use of the medicine in an indication other than the approved indication; or, in the same approved indication, but in a different patient subgroup; or, under different conditions. Off-label prescriptions are the sole responsibility of the treating physician. The question then arises as to what precautions the professional should take in the prescribing act, what rights the patient has in this regard, whether such treatment should also be covered by health insurance, and what actions the State should take, if any, as the ultimate guarantor of the health of people residing in Argentina. The need and the special circumstances surrounding health issues determine that it is ethically and regulatory permissible to prescribe medicines off-label. This should be done under certain conditions, set by the treating physician himself, but also by the authorities, in order to coordinate the participation of various actors in the system and the application of monitoring tools and to promote adequate scientific information, all of which will support the off-label use of medicines to provide rational access in a specific case and accepted by the patient.

Keywords : Health law; medicines; prescription; off label prescription; patient's right; doctor's liability.

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