Know the numbers of ANVISA’s post-market monitoring of products in 2021.April 12, 2022
Last year, 216,406 notifications were received by Anvisa’s monitoring area regarding adverse events, technical complaints and deviations in product quality, as well as reports of intoxications. Of these notifications, 124,523 were divided by the agency into specific surveillance, namely pharmacovigilance, techno vigilance , haemovigilance and nutrivigilance, among others.
The information belongs to the Health Surveillance Notification and Investigation System (Vigipós) and is present in the 1st Newsletter on Post-Market Monitoring, released by Anvisa this Monday (4/4). It deals with products and services that are subject to sanitary surveillance. See below for some of the main results.
From 2018 to 2019, a 7,732.4% increase in the number of pharmacovigilance notifications was recorded on VigiMed, and many factors contributed to this increase. The main one was the creation of a channel that allowed notifications made by citizens who actively participated in the monitoring of vaccines against Covid-19. A second aspect that influenced the increase in reports was the launch of the module for companies to register. As for clinical trials, they also started reporting using the same technological platform. Regarding the period between 2020 and 2021, notifications grew by 371%, totaling 75,453 records of adverse events involving vaccines and medicines.
These records represented 25% (31,130) of the notifications in 2021, and the reason for the increase is related to the citizen’s interest in the subject and the campaigns to encourage vaccination.
According to the newsletter, in 2021, this type of monitoring led to the restriction of the use of some vaccines in pregnant women, the identification of new adverse events and the analysis of application in children from 5 years old to adolescents aged 17.
From these measures, there were nine changes to package inserts, in addition to the publication of eight risk communications, ten safety alerts and five letters to health professionals about vaccines.
In this surveillance, 14,940 reports were received, of which 12,364 (82.8%) were technical complaints and 2,576 (17.2%) adverse events. Regarding medical-hospital articles, there were 12,644 notifications (84.6%), and 1,883 (12.6%) about medical-hospital equipment. Another 413 reports (2.76%) were about products for in vitro diagnostic use, and 332 reports of field actions, carried out by manufacturers in order to reduce the risk of adverse events related to products in this category.
Initially, 15,987 reports of adverse events were registered in the surveillance of the blood cycle, most of which were linked to reactions that occurred in transfusions (96.7%). As for the severity of the notifications, 93.3% were considered non-serious and only 6.4%, serious.
In 2021, 31 nutrivigilance notifications were received, with 23 of adverse events and 8 of technical complaints. Food supplements are in the lead (52%), followed by food additives (9%) and ready-to-eat foods in third place (9%). According to the newsletter, 48% of these reports are isolated or associated gastrointestinal signs and symptoms. Of this total, citizens made 87% of the records and health professionals made 13%.
National Food Monitoring Program
It was not just the area of surveillance of adverse events and technical complaints that gained improvements, as the monitoring area established the National Food Monitoring Program (Pronama): an action coordinated by the Agency and carried out by the state, district and municipal Health Surveillance, together with Central Public Health Laboratories (Lacens), the National Institute for Quality Control in Health (INCQS), and other public laboratories that analyze food.
5 monitoring activities were carried out under Pronama in 2021: iodization of salt for human consumption; fortification of wheat and corn flours with iron and folic acid; sodium and sugar contents in processed foods; additives and contaminants in food; and lactose in special-purpose foods.
For more information about ANVISA and product regulation, contact Licempre and find out how we can help your company with product registration.