Manipulación y uso de medicamentos en condiciones diferentes a las estipuladas en su ficha técnica

Although up until a relatively recent time, these practices were not regulated in our country, the manipulation, split and other forms of modification of the commercial presentations of medicinal products, for administration to the patient in doses, patterns or conditions other than those established in its Product Label, has been a common practice of hospital pharmacy services to attend the special needs of certain groups and patients.

Nowadays, these practices are only admissible insofar as a series of requirements established under our legal system are observed: (i) such practices must be exceptional, (ii) specific and justified doctor prescription must be obtained, (iii) there must not be any therapeutic alternatives already authorized, (iv) such practices must be carried out by those pharmacies of hospitals which are duly authorized to carry out such activities, and (v) the informed consent of the patient must be previously obtained.

Failure to observe these requirements may entail the legal responsibilities for the professionals and healthcare centres involved, as well as for the public administrations that they may depend on; not only as potential subjects of disciplinary or administrative sanctions, but also facing civil and/or criminal liabilities, in case of damage or injury to the patient, because in such case the activities performed would not be consistent with the obligations arising from the so-called lex artis ad hoc.