mellékhatásvizsgálatok

Mellékhatásvizsgálatok, also known as pharmacovigilance or post-marketing surveillance, are the ongoing scientific and regulatory processes that aim to detect, assess, understand, and prevent adverse effects or any other drug-related problem. These investigations are crucial for ensuring the safety of medicines after they have been approved and made available to the public. The primary goal is to identify potential risks that may not have been apparent during clinical trials, which are typically conducted on a limited number of patients under controlled conditions.

Mellékhatásvizsgálatok involve collecting and analyzing reports of suspected adverse drug reactions (ADRs) from various sources, including healthcare professionals, patients, and pharmaceutical companies. These reports are then evaluated by regulatory authorities to determine if a causal relationship exists between the medicine and the reported event. If a significant risk is identified, regulatory bodies may take action, such as updating the product information, issuing safety warnings, or even withdrawing the medicine from the market.

The process is continuous throughout the lifecycle of a drug. It plays a vital role in maintaining a favorable benefit-risk balance for medicines, ensuring that the therapeutic advantages continue to outweigh any potential harms. Effective mellékhatásvizsgálatok are essential for protecting public health and fostering trust in the safety of pharmaceutical products.