IMPLEMENTATION PLAN FOR ACTIVE SURVEILLANCE
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- Create Date January 4, 2026
- Last Updated September 4, 2026
IMPLEMENTATION PLAN FOR ACTIVE SURVEILLANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities related to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems.” There are two major approaches for pharmacovigilance: passive and active. Passive pharmacovigilance entails spontaneous (voluntary) reporting while active pharmacovigilance involves the use of active surveillance methods to gather information on adverse events. Active surveillance is the collection of case study information as a continuous pre-organized process. It involves proactive measures to identify adverse events, extending beyond merely encouraging healthcare providers (HCPs) and others to report voluntarily.
Active surveillance systematically documents and quantifies the incidence rate of adverse events associated with Health Products and Technologies (HPTs). In addition, it generates data to provide better estimates of risk benefit profiles and help prevent and minimize such risks to patients on treatment. Active surveillance may be conducted for the purpose of identifying previously unrecognized safety concerns (hypothesis generation) or for investigating potential and identified risks (hypothesis-testing in order to substantiate a causal association). Consequently, this will decrease the negative impact of these events on the health of individuals and public health programs and maintain or increase the confidence of HCPs and the general population on HPTs use.
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