Pharmacovigilance

Topic of this lecture is pharmacovigilance, the science of detecting and preventing adverse effects of medicines and vaccines after their approval. We will discuss the importance of ongoing safety monitoring, the systems and agencies involved, and the process of adverse event reporting by healthcare professionals and patients. The lecture will cover how new risks are identified and managed and the critical role pharmacovigilance plays in ensuring patient safety and maintaining public trust in healthcare. We will explore pharmacovigilance, a field focused on the safety of medicines and vaccines after their release to the public. Pharmacovigilance involves the detection, assessment, understanding, and prevention of adverse effects or other drug related problems. While medicines are tested in clinical trials, these are conducted on limited populations and short timespans. Pharmacovigilance ensures ongoing safety monitoring and helps protect patients and maintain public confidence in healthcare. Once a medicine is approved and in use, post marketing safety monitoring is essential. Regulatory agencies like the FDA in the US and the MHRA in the UK, along with groups such as the WHO, collect and analyze real world safety data. Systems include spontaneous reporting databases, electronic health record analysis, and active surveillance programs. These measures help detect issues not seen in pre approval trials, as medicines are now used by millions, sometimes for longer periods and in diverse populations.