What is Pharmacovigilance?
Pharmacovigilance is a concept that encompasses the observation of all the effects produced by a medicine; both beneficial and harmful. It provides an instrument for knowledge about the safe and rational use of them, once they are used in the population that consumes them in real conditions. It is a shared activity among health authorities, the pharmaceutical industry, health professionals and patients. When a new drug is marketed, the benefit-risk ratio must be evaluated over time; emphasizing risk. Therefore, the close monitoring of the behavior of drugs in populations plays a fundamental role in Pharmacovigilance
Official Definition NOM-240-SSA1-2016
Pharmacovigilance are all the activities related to the detection, evaluation, comprehension, and prevention of an adverse event, the suspicion of adverse reactions, adverse reactions themselves, the events allegedly attributed to vaccination or immunization, or any other safety issue related to the use of medicines and vaccines.
What is a Suspicion of an Adverse Reaction to a Medicine (SARM)?
A Suspicion of an Adverse Reaction (SARM) to a Medicine is any undesired clinical or laboratory manifestation that occurs after the administration of one or more medicaments.