What is Pharmacovigilance?



Pharmacovigilance is a concept that encompasses the observation of all the effects that a medicine produces, both beneficial and harmful. It is an instrument for learning about the safe and rational use of medication 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 medication 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.
According to the Official Mexican Standard for the Installation and Operation of the Pharmacovigilance, NOM-220-SSA-1-2016, defines it as:

“(…) activities related to the detection, evaluation, understanding and prevention of adverse events, suspected adverse reactions, adverse reactions, events supposedly attributable to vaccination or immunization, or any other safety problem related to the use of medicines and vaccines (…) ”



What is a Suspected Adverse Drug Reaction (SADR)?


A Suspected Adverse Drug Reaction (SADR) is any unwanted clinical or laboratory manifestation that occurs after the administration of one or more medications.




(México)

What is Techno-surveillance?



Techno-surveillance is a discipline that aims to ensure that medical devices that are available in the health markets for the public and private segments, work in the manner indicated according to the intention of use of the manufacturer, and if not, the corresponding actions are taken to correct and the probability of recurrence of adverse incidents.

According to the Official Mexican Standard, NOM-240-SSA1-2012 , Techno-surveillance is:
"(...) surveillance of the safety of medical devices (...) joint of activities aimed at identifying and evaluating adverse incidents produced by medical devices in use, as well as identifying the risk factors associated with them, based on the notification, recording and systematic evaluation of notifications of adverse incidents (...)"



What is an adverse incident?



An adverse incident is any event proved to be related to the use of medical device, counting with convincing evidence causally relating the incident and the medical devise. Thin can be cause by a malfuntion or an alteration of the device’s characteristics, which can cause death or a severe deteroration of the user’s health.



(México)