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Having previously offered a long extensional definition of “pharmacovigilance,” I now offer a shorter, intensional definition: “A scientific activity related to the benefits and harms of any intended therapeutic intervention, primarily involving accurate identification and quantification, mechanistic analysis, continued surveillance, communication, and prevention of its adverse effects, adverse reactions to it, and adverse interactions with other interventions.” A major aspect of pharmacovigilance is continued surveillance for beneficial effects and particularly adverse events, effects, and reactions. Colleagues and I have proposed the following definition of “surveillance”: “a form of non-interventional public health research, consisting of a set of processes for the continued systematic collection, compilation, interrogation, analysis, and interpretation of data on benefits and harms (including relevant spontaneous reports, electronic medical records, and experimental data).” We have also proposed that instead of using qualifiers of surveillance, such as “active” and “passive,” a single definition of “surveillance” is sufficient, and that in any description of a particular method of surveillance the precise way in which the method is used should be detailed.
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Jeffrey K Aronson (2023) studied this question.
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