haittavaikutusrekisterit

The Finnish term "haittavaikutusrekisterit" translates to adverse event registers in English. These are systematic collections of information concerning adverse effects experienced by individuals after receiving a medical product, such as a medication, vaccine, or medical device. The primary purpose of these registers is to monitor the safety and potential risks associated with these products once they are in widespread use.

In Finland, the responsibility for maintaining such registers typically lies with regulatory authorities, most notably Fimea, the Finnish Medicines Agency. Healthcare professionals, patients, and pharmaceutical companies are encouraged or obligated to report suspected adverse events to these registers. This reporting is crucial for identifying potential safety signals that may not have been apparent during clinical trials, which are conducted on a smaller, more controlled population.

The data collected in haittavaikutusrekisterit can include details about the product in question, the nature of the adverse event, its severity, the patient's demographic information, and any concomitant treatments. This information is then analyzed by experts to assess the frequency and pattern of adverse events. Identifying a trend of specific adverse events can lead to updates in product labeling, warnings, or in rare cases, the withdrawal of a product from the market. These registers are therefore vital components of pharmacovigilance and post-market surveillance, contributing to public health and patient safety.