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Infarmed reinforces transparency in disclosure of drug reactions
The National Authority of Medicines (Infarmed) will present on Wednesday a new tool for the disclosure of suspected adverse reactions to medicines, created to reinforce the transparency of pharmacovigilance in Portugal.
© Global Imagens
País Infarmed
In practice, the tool will allow anyone to access information on notifications of suspected adverse drug reactions (ADRs), explained Infarmed.
The information included in the ADR portal refers to notifications of suspected adverse reactions (undesirable effects), that is, clinical events that were observed after the use of a medicine or vaccine, but which are not necessarily related to or caused by it.
Since the beginning of the surveillance system, Infarmed has registered a sustained increase in the number of notifications, which went from just nine in 1992, the first year of operation, to 39,267 in 2021.
In 2022, it received 26,932 notifications of suspected adverse reactions, of which 5,902 (22%) were received directly and 21,030 (78%) through the pharmaceutical industry.
Before any medicine is authorized, it is subject to an experimental phase in which it is the target of studies to prove its quality, efficacy and safety.
These clinical trials allow the detection of the most frequent adverse reactions - known as side effects - however, there may be rare or late-onset adverse reactions that are not detected during the experimental phase of the medicine.
According to Infarmed, any health professional can report suspected adverse reactions, but also any citizen, whether it is the patient who suffered the reaction, or a family member or caregiver.
Read Also: Infarmed replaced out-of-stock cancer medicine. Thousands arrived here (Portuguese version)
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* Estudo da e Netsonda, nov. e dez. 2023 produtodoano- pt.com
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