Haittavaikutusilmoitukset

Haittavaikutusilmoitukset, known in English as adverse event reporting, are a crucial part of pharmacovigilance and medical device safety. These reports are submitted by healthcare professionals, patients, and sometimes manufacturers to regulatory authorities about suspected side effects or adverse reactions experienced after using a medicinal product or a medical device. The primary purpose of collecting these notifications is to monitor the safety of products once they are available on the market and to identify any new or unexpected risks.

The information gathered from haittavaikutusilmoitukset is used to assess the benefit-risk balance of a product. If a significant safety concern arises, regulatory bodies can take appropriate action, such as updating product information, issuing warnings, restricting the use of the product, or even withdrawing it from the market. This continuous monitoring process helps protect public health by ensuring that the medicines and devices available are as safe as possible.

In many countries, there are specific systems and guidelines in place for submitting these reports. Healthcare professionals are often legally obligated to report certain types of adverse events. Patients can also play a vital role by reporting their experiences, contributing valuable real-world data. The confidentiality of the reporter and the patient is typically protected throughout the reporting process.