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 signals, and the time that it takes to communicate a signal. Methods: We shall retrieve records from PubMed, EMBASE, Web of Science, and PsycINFO (from inception onwards), without language/design restrictions, and apply backward citation screening. We shall hand-search the websites of 35 regulatory agencies/authorities, restricted publications from the Uppsala Monitoring Centre, and drug bulletins. Signals will be requested from the competent stakeholder, if absent from websites. We shall use VigiBase, the World Health Organization's Global Individual Case Safety Report database, to determine the dates on which ADRs were reported. We shall manage records using EndNote (v. 8.2); one reviewer will screen titles/ abstracts and full texts, a second will cross-validate the findings, and a third will arbitrate disagreements. Data will be charted via the Systematic Reviews Data Repository, following the same procedures as for data retrieval. Evidence will be categorized according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Features of reports of ADRs will be coded. Tables will display frequencies of types of evidence and features of reports of ADRs. We shall use plots or pictograms (if appropriate) to represent the time from the first report of a suspected ADR to a signal. Discussion: We expect the findings from this review will allow a better understanding of global patterns of similarities or differences in terms of supporting evidence and timing of communications and identify relevant research questions for future systematic reviews.

Pharmacovigilance education to healthcare professionals: Will it affect their performance in reporting adverse drug reactions?

“…These actions depend on the severity and the frequency of reported signals of ADRs and the level of evidence supporting these signals. 36 It is worthy to mention that the reported number in this work was still very low and did not reflect the significant improvement in knowledge and attitude. In accordance with a study conducted in India which evaluated the link between knowledge, attitude and practice of PV with reporting of ADRs, and remarked that even though positive attitude for ADRs reporting existed among most participants, it had no impact on practice of ADRs reporting because of lack of motivation and training on reporting process.…”

Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature

“…This study follows the 2018 Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews [ 7 ]. We have previously published [ 8 ] and registered the protocol of this work on the Open Science Framework (registration number: osf.io/a4xns). We report all protocol deviations and additional information in the Electronic Supplementary Material (ESM).…”