What is Pharmacovigilance?
Pharmacovigilance is a concept that encompasses the observation of all the effects that a drug produces, both beneficial and harmful. It is an instrument for learning about the safe and rational use of drugs when they are already used in the population that consumes them in real conditions.
It is a shared activity between health authorities, the pharmaceutical industry, health professionals, and patients. When a new drug is released on the market, the benefit-risk ratio is evaluated on an ongoing basis, with an emphasis on risk. For this reason, strict monitoring of drug behavior in the population is essential for Pharmacovigilance.
The Official Mexican Standard for the Installation and Operation of Pharmacovigilance, defines it as:
[Texto] “… activities related to the detection, evaluation, understanding and prevention of adverse effects, suspected adverse reactions, adverse reactions, events supposedly attributable to vaccination or immunization, or any other related safety problem with the use of medicines and vaccines…” (DOF, 19/Julio/2017)
Suspected Adverse Drug Reaction (SRAM)
A Suspected Adverse Drug Reaction (SRAM) is any unwanted clinical or laboratory manifestation that occurs after the administration of one or more medications.