Pharmacovigilance is the science and practice of monitoring the safety and adverse effects of medications that are prescribed, sold, or otherwise in use. The term is derived from "pharmaco-" (relating to drugs) and "vigilance" (the state of being watchful or alert). It involves the collection, identification, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Key aspects of pharmacovigilance include:
1.Adverse Drug Reaction (ADR) Monitoring: The systematic detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems.
2.Post-Marketing Surveillance: The ongoing monitoring of the safety of a drug after it has been marketed, which includes gathering data on ADRs and analyzing it to identify safety concerns.
3.Reporting Systems: The establishment of systems for healthcare professionals and patients to report suspected ADRs to regulatory authorities and drug manufacturers.
4.Risk Management: The development and implementation of strategies to minimize risks associated with drug use while maximizing the benefits.
5.Regulatory Compliance: Ensuring that all activities related to pharmacovigilance meet the legal requirements set forth by regulatory agencies.
6.Patient Safety: The central focus of pharmacovigilance is to protect patient safety by ensuring that the benefits of medications outweigh their risks.
7.International Collaboration: Pharmacovigilance is a global effort, with international organizations and networks facilitating the exchange of safety information across borders.
8.Education and Training: Providing healthcare professionals and the public with the knowledge and skills necessary to report and understand drug safety issues.
Pharmacovigilance plays a critical role in the pharmaceutical lifecycle, helping to ensure that medications are safe for public use and contributing to the overall safety of healthcare systems worldwide.