ArticleDrug safety2019
The Social Impact of Suspected Adverse Drug Reactions: An analysis of the Canada Vigilance Spontaneous Reporting Database.
Article in Drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 15 citations in OpenAlex.
- Adverse Drug Reaction-Related Hospital Admissions and Adverse Drug Events and Their Association with Short- and Long-Term Health Outcomes in Older Adults.Geriatrics (Basel, Switzerland) · 2026Article
- Precision Adverse Drug Reactions Prediction with Heterogeneous Graph Neural Network.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System.Drug safety · 2024Article
- The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis.Cannabis and cannabinoid research · 2023Article
- Socio-historical analysis of the social importance of pharmacovigilance.Frontiers in sociology · 2022Review
- Pragmatic pharmacoeconomic analyses by using post-market adverse drug reaction reports: an illustration using infliximab, adalimumab, and the Canada vigilance adverse reaction database.BMC health services research · 2021Article
- Article
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSome adverse drug reactions (ADRs) may involve direct social issues, such as impaired quality of life, work productivity, or social functioning, as opposed to being social consequences of medical adverse events. Data on ADRs with a direct social impact remain scarce in the literature.
objectiveOur objective was to describe the ADRs consisting of direct social issues that have been recorded in the Canadian national spontaneous reporting system (Canada Vigilance).
methodsWe conducted an analysis of the online Canada Vigilance spontaneous reporting database from 1 January 1965 (inception) to 31 December 2015 (last date available). We manually examined all Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) found in the Canada Vigilance database to identify those that involved direct social issues. We then used those PTs to search for relevant individual case safety reports (ICSRs). We conducted a descriptive analysis of the following ICSR characteristics: patient and reporter characteristics, type of ADR, seriousness (as assessed by the reporter and according to the International Conference on Harmonisation criteria of seriousness), and suspected drug(s). We compared the characteristics of ADRs with and without direct social impact.
resultsAmong the 11,946 MedDRA PTs recorded in Canada Vigilance, we retained 40 that had a direct social impact. Using these PTs, we identified 9557 relevant ICSRs (corresponding to 6670 patients). The proportion of ADRs consisting of direct social issues increased over time, with a sharp transient peak in 2008. The majority were reported by healthcare professionals and consumers (56.7 and 37.8%, respectively). The mean age of patients was 45.4 years, and 53.3% were females. Direct social issues consisted of personality disorders and behaviour disturbances (41.6%) followed by neurological disorders (34.2%). The majority of ADRs were considered serious by reporters (76.5%), with 26.8% resulting in hospitalization. Commonly suspected health products included nervous system drugs (63.3%) and antineoplastic and immunomodulating agents (23.6%). Compared with other ADRs, those with a direct social impact were more often reported by consumers, involved patients who were on average 5 years younger, and were more frequently assessed as being serious by the reporters.
conclusionsFindings from this study support the consideration of direct social issues as ADRs in the detection of drug safety signals.
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