Lääkehaittailmoitus

Lääkehaittailmoitus, also known as a suspected adverse drug reaction report, is a critical component of pharmacovigilance. It is a system designed to detect, assess, and prevent adverse effects of medicines. Healthcare professionals, patients, and pharmaceutical companies can submit these reports when they suspect a medicine has caused an unintended and harmful reaction.

The primary purpose of lääkehaittailmoitus is to collect real-world data on the safety of medicines after they have been approved and are in use by the general population. This is crucial because clinical trials, while extensive, cannot always identify rare or long-term side effects. By gathering information from a broad range of users and clinical settings, a more complete picture of a drug's safety profile can be developed.

In Finland, the authority responsible for collecting and analyzing these reports is the Finnish Medicines Agency (Fimea). Fimea uses the collected information to monitor the safety of medicines on the market. If a significant safety concern is identified, Fimea can take regulatory action. This might include updating the product information leaflet, issuing safety warnings to healthcare professionals and the public, or in severe cases, withdrawing a medicine from the market.

Reporting suspected adverse drug reactions is a shared responsibility. Healthcare professionals are often obligated to report, but patient participation is also highly encouraged. Patients experiencing any unusual or severe symptoms they believe might be related to their medication should consult their doctor or pharmacist and consider submitting a report. This collective effort ensures that medicines remain as safe as possible for all users.