Pharmaco vigilance

WHAT IS PHARMACOVIGILANCE ?

According to the World Health Organization (WHO), pharmacovigilance 'is defined as the science and activities related to detection, evaluation, understanding and prevention of the adverse effects of drugs or any other problem related to them.'

Therefore, one of the main objectives is to detect and prevent adverse reactions produced by the administration of drugs and, in this way, ensure the users’ safety.

To make this possible, it is necessary that health professionals, patients and users together, identify any suspected adverse reaction expected or unexpected, and notify it  to the Pharmaceutical Laboratory and / or Health Authority

WHAT IS AN ADVERSE REACTION?

The WHO defines as an adverse reaction to a drug 'any response to a drug that is harmful, unintentional and that occurs at usual doses for prophylaxis, diagnosis, or treatment'

However, in addition to adverse drug reactions, it is also necessary to report any problems and / or safety concerns related to them, such as:

·         Overdose and abuse

·         Use outside the authorized according to the Information to Prescribe (IPPA)

·         Occupational Exposure

·         Self-medication

·         Lack of effectiveness

·         Exposure to medications during pregnancy and / or lactation

·         Suspected forgery

·         Medication errors

WHAT IS TECHNOVIGILANCE IS?

NOM-240-SSA1-2012 defines technovigilance as 'the set of activities aimed to identify and evaluate adverse incidents produced by the use of medical devices as well as the identification of the risk factors associated with them, based on the comunication, registration and systematic evaluation of the notifications of adverse incidents, in order to determine its frequency, seriousness and incidence, for the porpuse of preventing their occurrence and minimize their risks ... “

Therefore, as with pharmacovigilance, its objective is focused on ensuring the users’ safety.

WHAT IS AN ADVERSE INCIDENT?

An adverse incident is any proven event that is related to the use of a medical device that has strong evidence of the causal relationship between the incident and the medical device, and that could be caused by a malfunction or alteration of the characteristics of the medical device and may cause death or serious deterioration of the user's health.

It is very important to know that the abnormal or different use of the medical device recommended by the producer laboratory is not considered as an adverse event.

If you have any questions about the identification of an adverse event with any of our medical devices, contact us and / or generate the form.



By means of the evaluation of the notifications of the adverse reactions as well as of any problem related to the medicines, strategies are generated to minimize the risks that are come to identify and to maintain a continuous analysis of the security of each medicine, and in this way to watch over the safety of patients and users.