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José Ramón Azanza, Director of the Clinical Pharmacology Service. Clínica Universidad de Navarra
programs of study of drug utilization
The authorization for the marketing of a new drug is the culmination of the process of research , which closes the stage in which the balance between the benefit and the favorable risk of a given dosage has been demonstrated, in specific indications and conditions that are specifically described in the technical data sheet approved at that time. This document is not a text similar to a guide of use, but a whole regulation of use that must be followed with the meticulousness required by any legal rules and regulations by the prescribing physician.
Unfortunately, the premarketing research process does not include information on all the possibilities that can occur in the daily life of the drug; hence, from the first prescriptions, hypotheses begin to emerge regarding new dosing schedules, interactions with other drugs, indications that have not been evaluated, aspects related to adverse effects, as well as use in special patients, among others. The usual goal of each of them is to improve the expectations of the use of the drug in order to increase its benefit-risk balance in situations typical of the daily internship , which are not the usual ones in clinical trials, on selected patients.
The usefulness of these programs of study, known as programs of study post-authorization (EPA), is evident, although at the same time it is easy to deduce that the chances of a single prescriber demonstrating any of the hypotheses reliably are minimal. For this reason, the cooperative programs of study with corporate promotion, which start as an initiative of a group of physicians and even scientific societies, acquire great importance when it comes to achieving adequate results. These are the so-called Drug Utilization programs of study .
However, it is vital to remember that any study that raises as hypotheses or objectives aspects related to a drug, even if it is marketed and used under the conditions of use defined by the technical data sheet, must comply with some essential requirements described in the Order SAS/3470/2009 of December 16, 2009, prior to its initiation requirements .