Currently submitted to: JMIR Preprints
Date Submitted: Aug 29, 2026
Open Peer Review Period: Aug 29, 2026 - Aug 14, 2027
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Case for a Standardized Pharmacovigilance Metadata Flag in Published Literature
ABSTRACT
Adverse drug reaction reports lose their pharmacovigilance value if literature searches fail to find them. Current filters, despite achieving roughly 90% recall, still infer safety relevance from unstructured titles and abstracts, since no existing standard (CONSORT Harms, MEDLINE indexing, ISPE/ISoP guidelines) creates a machine-readable flag for it. This paper proposes a mandatory, controlled keyword (e.g., "Drug safety data") that authors and journals would attach to any article reporting a suspected ADR, spanning case reports, trials, and observational studies. The flag would not replace MeSH/Emtree or validated search filters, but would add a low-burden, auditable, author-declared signal that improves precision and recall for both manual screening and AI-based triage, shifting the fix upstream to the point of publication rather than downstream to ever more sophisticated search algorithms.
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© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.