definition of pharmacovigilance

  • definition of pharmacovigilance

    Posted by Sudheer Vanguri on November 26, 2023 at 11:51 pm

    Pharmacovigilance, as defined by the World Health Organization (WHO) in 2002, encompasses the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. The four crucial terms in this context are Detection, Assessment, Understanding, and Prevention.

    1. Detection: In scenarios such as clinical trials, detection involves the reporting of adverse events by the investigator. In post-marketing trials, it can be the responsibility of the physician, prescriber, or even the patient to report any adverse event or drug-related problem.
    2. Assessment: Health care professionals, such as investigators, evaluate whether the adverse event or drug-related problem is directly linked to the drug or if there are other contributing factors.
    3. Understanding: The process of understanding involves collaboration between the reporter and safety specialists to comprehend the nature of the adverse event or drug-related problem.
    4. Prevention: Proactive reporting of adverse events or drug-related problems to regulatory authorities, coupled with precautionary actions, plays a crucial role in preventing similar incidents in the future.

    Pharmacovigilance, considered a subset of pharmacoepidemiology, is synonymous with drug monitoring. It involves the systematic monitoring, evaluation, and enhancement of the safety of medicines in use. This field encompasses the collection, monitoring, research, assessment, and evaluation of information from healthcare providers and patients regarding the adverse effects of medications, biological products, herbal products, and traditional medicines.

    Key aspects of Pharmacovigilance include:

    • Proactive monitoring and reporting: Actively monitoring and reporting on the quality, safety, and efficacy of drugs.
    • Assessment of risks and benefits: Evaluating the risks and benefits associated with marketed medicines.
    • Monitoring corrective actions: Tracking the impact of any corrective actions taken in response to identified issues.
    • Providing information: Offering information to consumers, practitioners, and regulators on the effective use of drugs.
    • Designing programs: Developing programs and procedures for the collection and analysis of reports from patients and clinicians.
    • Early detection: Identifying unknown safety problems and detecting increases in the frequency of Adverse Drug Reactions (ADRs).
    • Identification of risk factors: Analyzing and identifying risk factors for ADRs.
    • Risk analysis and mitigation: Assessing risks and implementing strategies for mitigation.

    Finally, paramount in this entire process is Patient Safety, emphasizing the overarching commitment to safeguarding the well-being of patients throughout the lifecycle of drug development, approval, and usage.


    Let this forum be a space for insightful discussions, shared experiences, and the exchange of knowledge as we collectively navigate the intricate landscape of pharmacovigilance in our pursuit of a safer and healthier tomorrow.

    Warm regards,


    Sudheer Vanguri replied 6 months, 3 weeks ago 1 Member · 0 Replies
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