Infarmed received almost 27,000 notifications of suspected Adverse Drug Reactions (ADRs) last year and at least one in five cases were considered serious.
According to the activity report of the National Pharmacovigilance System corresponding to the year 2022, the notification of adverse reactions decreased (-31%) compared to 2021, which makes Infarmed warn of the need to “increase awareness” of everyone for the importance of this communication.
The document also states that the year 2022 was marked by a decrease in notifications of suspected ADRs in relation to covid-19 vaccines, from 24,885 (2021) to 16,486 (2022).
Data released by Infarmed show that in the last 30 years the RAM Portal has registered 144,344 notifications of suspected adverse reactions.
Of the 26,932 reports of suspected ADRs recorded, 5,902 (22%) were received directly and 21,030 (78%) through the pharmaceutical industry (Marketing Authorization holders).
In 2022, most suspected adverse reactions were reported by healthcare professionals (70%), of which 32% from doctors, 25% from pharmacists and 10% from nurses. Users contributed 30% of the notifications received.
Spontaneous notifications represent 95% of the total. The remainder (requested), which result from observational and follow-up studies of patients with access to the use of medicines that are not yet approved in Portugal, represent the remaining 5%.
Of the spontaneous notifications, 23% were considered serious and in the requested ones this figure rises to 29%.
The reports received are analyzed and assessed to see, for example, whether they are considered valid reports or whether they are duplicates. After this assessment, 25,602 cases of adverse drug reactions have been reported so far.
The most frequently reported adverse reactions during 2022 were those related to general disorders and changes at the site of administration, “which can be explained by the reports of ADR cases related to covid-19 vaccines”, the document states.
This was followed by diseases of the nervous system (7,143 cases), musculoskeletal and connective tissue disorders (5,989) and gastrointestinal diseases (3,525).
The largest number of notifications received is concentrated in the Central and Northern coasts of the Mainland, with a special incidence in the areas of Lisbon (33%) and Porto (27%), which is explained by a higher population density, a greater concentration of large hospitals and health centers, which are the basis for a greater occurrence of consultations and prescription of medicines.
At this level, Infarmed points out a future challenge: “to promote the notification of suspected AMR among the various notifiers in the interior of the Mainland and the Autonomous Regions, through the promotion of awareness and training campaigns”.
