Clinical Research Insider Summit No. 11

Pharmacovigilance Units; adverse event reporting in Vigiflow, E2B and e-Reporting

Pharmacovigilance in Mexico is an activity aimed at the detection, identification, quantification, evaluation, and prevention of possible risks derived from use of medicines. Its scope includes the monitoring of adverse drug reactions/events, medication errors, failures in efficiency, counterfeit drugs, as well as drug abuse, misuse, and interactions.

This surveillance, in Mexico, is integrated into different levels, starting from the National Center for Pharmacovigilance, to state and institutional centers, the pharmaceutical industry, hospitals and health professionals inside and outside the facilities. All are governed by the World Health Organization (WHO). The WHO has established different efficient Pharmacovigilance mechanisms, one of them being

VigiFlow, which is a program that functions as the basis for Pharmacovigilance in each country. This program allows the collection, process, and analyze the data provided by the Adverse Drug Reactions (ADR) and Events Supposedly Attributable to Vaccination or Immunization (ESAVI) reports. In addition, it has the feature of being able to share this information with the WHO-UMC global databases or other national centers.

It has very useful features, such as using software with medical terminologies, like MeDRA and WHODrug, as well as causality analysis, like WHOUMC causality, Naranjo, and WHO AEFI systems. Undoubtedly, technological progress has favored Pharmacovigilance; it is important to be at the forefront of these changes. However, the scope of Pharmacovigilance in our country, and probably in the rest of the world, is more focused on Adverse Drug Events (ADE), than really adequate prevention and early detection of all the scopes that Pharmacovigilance has.

Thus, as health personnel, institutions, and even patients, it is our responsibility to carry out Effective Pharmacovigilance, that is, give timely follow-up on the appropriate storage and distribution of medications, always review clinical interactions, interactions with food and between the drugs to be used, prepare an adequate prescription, follow schedules and the established dosage, as well as continuous monitoring of the patient in terms of efficacy and safety, and finally report adverse events.

Saul Flores Unzueta, PhD

Doctor of Science in Biotechnology. CEO of Lahoja Association for Research and Pharmacovigilance.