lääketurvallisuudessa

Lääketurvallisuus, also known as pharmacovigilance, is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. The primary goal of lääketurvallisuus is to ensure the safe and effective use of medicines throughout their lifecycle, from development and clinical trials to post-market surveillance. This involves identifying potential risks associated with a medicine and implementing measures to minimize harm to patients.

Key activities within lääketurvallisuus include the collection and analysis of suspected adverse drug reactions (ADRs) reported by healthcare professionals, patients, and pharmaceutical companies. These reports are crucial for identifying new or rare side effects that may not have been apparent during clinical trials. Regulatory authorities, such as the European Medicines Agency (EMA) and national competent authorities, play a vital role in reviewing these reports, assessing the benefit-risk balance of medicines, and taking appropriate regulatory actions. These actions can range from updating product information to withdrawing a medicine from the market if the risks outweigh the benefits.

Lääketurvallisuus also encompasses proactive measures, such as risk management plans developed by marketing authorization holders. These plans outline strategies to identify, characterize, and prevent or minimize risks associated with a specific medicine. Furthermore, ongoing monitoring and research are essential to continually evaluate the safety profile of medicines and adapt practices as new information emerges. Ultimately, effective lääketurvallisuus contributes to public health by ensuring that medicines available to patients are both effective and as safe as possible.