Pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems associated with pharmaceutical products. It involves the continuous monitoring and evaluation of the safety and effectiveness of medications once they are on the market.

The primary goal of pharmacovigilance is to ensure patient safety by identifying and managing the risks associated with the use of medications. It plays a crucial role in collecting and analyzing data on adverse drug reactions (ADRs), which are any harmful or unintended reactions caused by the use of medications. This information is used to identify potential safety concerns, take appropriate regulatory actions, and communicate the risks and benefits of medications to healthcare professionals and the general public.

Pharmacovigilance activities typically include:

  1. Adverse Event Reporting: Healthcare professionals, patients, and other stakeholders are encouraged to report suspected adverse reactions to regulatory authorities or pharmaceutical companies. These reports provide important data for the evaluation of drug safety.

  2. Signal Detection: Pharmacovigilance professionals analyze large databases of adverse event reports and other sources of data to identify potential safety signals, which are indications of a possible association between a drug and an adverse event.

  3. Risk Assessment: Once a safety signal is detected, further assessment is conducted to determine the strength and validity of the association and to estimate the risk-benefit

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