Pharmacovigilance

Pharmacovigilance involves the detection, evaluation, understanding and prevention of adverse reactions or undesirable effects of medicinal products. Pharmacovigilance can be used to systematically monitor the safety of a medicinal product in humans and animals and to minimise risks.

In clinical studies, pharmacovigilance involves the recording of adverse drug reactions (ADRs), but is also of great importance after market launch, as it can also reveal rare side effects of drugs. Rare side effects are often not detected in clinical studies because the number of patients is usually too low. There is therefore a legal obligation to collect evaluations of adverse events that occur in connection with the use of a drug. In Germany, there is a spontaneous reporting system through which the reports received by the Drug Commission and pharmaceutical companies from doctors, dentists and veterinarians or pharmacists are recorded. Doctors are obliged by the professional code of conduct to report adverse drug reactions. The report must also be made if only a suspicion exists and a causal connection is uncertain. In addition to the spontaneous reporting system, there is a pharmacovigilance system in Germany, which was introduced after the 12th amendment to the German Medicines Act (§ 62). According to § 63 of the AMG, pharmaceutical companies are obliged to maintain comprehensive pharmacovigilance systems and, depending on the severity of the adverse drug reaction, must report to the competent drug authority without delay, but no later than 15 days after the occurrence of the event.

In the EU, pharmaceutical companies are obliged to report adverse drug reactions electronically to the responsible higher drug authority. This enables international data to be collected and evaluated via the Eudra Vigilance network.

A vigilance system also exists for medical devices.