When I use a word . . . Medical definitions: Pharmacovigilance signals

Abstract

In seeking evidence of adverse drug effects and adverse drug reactions, those working in pharmacovigilance recognise the phenomenon of a signal that raises the suspicion of a causal relation between a drug and an adverse effect or reaction. Manfred Hauben and I, based on etymology, usage, previous definitions, and the processes involved, have defined a signal of suspected causality as follows: signal of suspected causalityn. information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, which would command regulatory, societal, or clinical attention, and is judged to be of sufficient likelihood to justify verificatory and, when necessary, remedial actions This definition, with small variations, was republished by the Council for International Organizations of Medical Sciences (CIOMS) in 2010 and was adopted by one of its working groups in 2020. We take this as a signal of approval of the definition.

Health Disinformation Use Case Highlighting the Urgent Need for Artificial Intelligence Vigilance

“…Key pillars of pharmacovigilance include transparency, communication, clear reporting procedures, surveillance, and regulation. These contribute to the monitoring and management of the risk tolerance profiles of medicines in the community, concepts urgently needed in the AI realm . More important, as we move forward, we should anticipate that AI tools and their guardrails will evolve; however, so too will the strategies of malicious actors seeking to exploit these systems.…”

“…However, current regulatory measures are insufficient to ensure public safety. Drawing from pharmacovigilance, which seeks to detect, understand, and prevent adverse effects of medicine use, we call on the opportunity for health care professionals to be involved in developing similar robust frameworks for preventing adverse effects of AI use. Key pillars of pharmacovigilance include transparency, communication, clear reporting procedures, surveillance, and regulation.…”

When I use a word . . . Medical definitions: Goldfinger events

“…Among the many other meanings of “signum” is “Something perceived by the mind or senses from which an inference may be drawn, a sign, mark or indication (of a fact, event, condition, quality, etc,” which is not a bad definition, although lacking specific detail, of a pharmacovigilance signal 1…”

“…That’s a between-the-eyes signal of an adverse reaction, although in this case it could be called between-the gums. I have described various subtypes of these elsewhere 9…”

“…Most are by themselves of little value in determining whether an association between an intervention and an adverse event is likely to be causative. However, when large numbers of anecdotal reports are brought together in databases and subjected to complex statistical analysis, signals can merge through data mining 9. In this case the signal that emerges is called a signal of disproportionate reporting.…”