Design and Validation of a Questionnaire in Pharmacovigilance

The pharmacovigilance program (FV) on a global scale is a program that was developed for the timely detection of security problems that are inherent to the prescription drugs and to the medical technologies. Mexico is part of this program since 1998, when it became a member of the world association based in Uppsala, Sweden [1,2]. The above-mentioned membership entails rights and advantages, but also obligations, like making periodical reports of the results summaries of the management of the FV from the reports sent by the physicians to the national system to further contribute with the international vigilance. The Mexican Official NORM NOM-220-SSA1-2022, “Installation and Operation of the Pharmacovigilance” [3] mentions the obligatory nature of the report of such adverse events by the practicing physicians, in this case called spontaneous report, which is the most appropriate report known to detect the so-called signs that serve as guide in the detection of the drugs security problems (López-González, 2009) [4].