What is Pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The goal of pharmacovigilance is to improve patient safety by monitoring the use of medicinal products and detecting and evaluating adverse reactions, and taking appropriate preventative measures.
Pharmacovigilance encompasses all aspects of detecting, assessing, understanding and preventing adverse effects or any other drug-related problems. It includes the collection, analysis and evaluation of data from various sources, such as clinical trials, spontaneous reporting systems and other observational studies. The information gathered through pharmacovigilance helps to identify potential safety issues and allows for a more complete understanding of a drug’s benefits and risks. This information can then be used to inform decision-making processes such as drug labeling, risk management plans and regulatory actions, ultimately aimed at improving patient safety. Additionally, pharmacovigilance also plays a critical role in the post-marketing surveillance of medicinal products to monitor their long-term safety and effectiveness.
Pharmacovigilance is a key aspect of the overall process of drug development and regulatory approval. Before a new drug can be approved for marketing, it must undergo a rigorous evaluation process that includes pre-clinical testing, clinical trials, and post-marketing surveillance. During this process, pharmacovigilance helps to identify any potential safety concerns and to determine the risk-benefit profile of the drug.
Once a drug has been approved and is on the market, pharmacovigilance continues to play a crucial role in monitoring its safety and effectiveness. This is achieved through various spontaneous reporting systems, such as the FDA’s MedWatch program in the United States, which allow healthcare professionals and patients to report adverse events and other drug-related problems. These reports are then analyzed by pharmacovigilance experts to identify any patterns or trends that may indicate a potential safety issue.
In addition to spontaneous reporting systems, pharmacovigilance also utilizes other sources of information such as electronic healthcare records, claims data, and observational studies to gather information on the safety and effectiveness of drugs in real-world settings. This information is then used to inform decision-making processes such as label changes, risk management plans, and regulatory actions.
In conclusion, pharmacovigilance plays a critical role in ensuring the safety and effectiveness of medicinal products by continuously monitoring their use and identifying any potential safety concerns. Through its various activities, pharmacovigilance helps to improve patient safety and support informed decision-making in the use of medicinal products.