Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature.

ABSTRACT:

Background

Signals of adverse drug reactions (ADRs) form the basis of some regulatory risk-minimization actions in pharmacovigilance. Reviews of limited scope have highlighted that such signals are mostly supported by reports of ADRs or multiple types of evidence. The time that elapses between a report of a suspected ADR and the communication of a signal has not been systematically characterized. Neither has the features of reports of suspected ADRs that authors used to support putative causal relationships, although difficulties with establishing causal relationships between medicinal products and adverse events have been highlighted. The objectives of this study will be to describe the evidence underpinning signals in pharmacovigilance, the features of reports of ADRs supporting

SUBMITTER: Sartori D 

PROVIDER: S-EPMC7425142 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature