Off-label use of medicines in Argentina. Who wins and who loses?

REAL, JUAN PABLO; PALCHIK, VALERIA; SALAMANO, MERCEDES; TRAVERSO MARIA LUZ; PALMA, SANTIAGO DANIEL

Pharmaceuticals Policies and Law

IOP Press

Año: 2012 vol. 14 p. 209 - 222

1389-2827

The use of medicines out of the technical specifications or off-label use is legal and a common medical practice all around the world. However, there is a lack of unanimity of criteria and specific regulations about this special situation in a lot of countries. This lack of clear regulation of this particular situation, with strong ethical implications, may involve greater risks to the population and worse health outcomes. The aim of this article is to present a theoretical framework about the problem of off-label use of drugs with particular emphasis on the situation Argentina and the example of the use of Bevacizumab in the treatment of Neovascular Age-Related Macular Degeneration. The role of pharmacist may be crucial ensuring the correct use of medicines, and his intervention gen- erate benefits for both the patient and the institutions in an interdisciplinary approach to pharmacotherapy.