Pharmacovigilance

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 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-240-SSA-1-2016, defines it as:

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

What is a 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.

Helpline in Mexico: 800 627 7799
e-mail: complaintriage@pisa.com.mx

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Techno-surveillance

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, works in the way that is indicated and intended by the manufacturer. In case it is not, its purpose is to take the corresponding actions to correct the probability of adverse incidents.

According to the Official Méxican Standard, NOM-240-SSA-2012, Techno-surveillance is:

“(…) Surveillance of the safety of medical devices (…) set of activities that indentify and evaluate the adverse incidents produced by the use medical devices, as well as the detection of rick factors linked to such devices. This based on the notification, registration, and systematic evaluation of the reports of adverse incidents (…)”

What is and 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. 

Attention Number: 01800 627 779 (Mexico)
e-mail: Farmacovigilancia@pisa.com.mx

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Tecnovigilancia
“( … ) Vigilancia de la seguridad de los dispositivos médicos ( … )”
NOM-240-SSA-2012