Abstract
Background
In Canada, adverse drug reaction (ADR) reporting was initiated in 1965. Since 2003, consumers have been able to report ADRs directly to Health Canada. This study compares consumer-reported ADRs with physician-reported ADRs based on seriousness, system organ class (SOC), and anatomical therapeutic chemical (ATC) classification.
Methods
This retrospective observational study evaluated ADR reports received by the Canadian Vigilance ADR Reporting Database from January 2000 to December 2014. A total of 198,781 spontaneous ADR reports were analyzed in terms of who reported the ADR, the seriousness of the ADR, and category of ADR by SOC and ATC group. Chi-square tests for independence and odds ratios were used to detect statistically significant differences between reporters (consumers and physicians) based on seriousness, SOC, and ATC classification.
Results
Of 198,781 serious and non-serious ADR reports, 28.7% were from consumers, 26.6% from physicians, 22.9% from pharmacists, 21.4% from other healthcare professionals, and 0.5% from lawyers, with consumers reporting significantly more ADRs than physicians (p < 0.0001). Significant differences in ADR reporting were found between consumers and physicians, in terms of ADR seriousness, ATC classification, and SOC involved. ‘General disorders and administrative site conditions’ was the most common SOC in both consumer and physician reports of serious ADRs.
Conclusion
This study, the first Canadian study to compare consumer and physician ADR reports, showed that consumers and physicians reported ADRs differently with regard to SOC and ATC classification. Consumer and physician reports should be included in post-marketing surveillance. Further research is required to investigate the extent to which additional information from consumer reports contribute to signal identification when assessing drug safety.
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Change history
14 August 2020
While typesetting the article the word “physician” has been inadvertently deleted.
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RD contributed to the concept, literature review, and drafting of the manuscript. SY, DK, and DS contributed to the revision of the article. All authors proofread and approved the submitted version of the article.
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Al Dweik, R., Kohen, D., Stacey, D. et al. Adverse drug reaction reporting in Canada: consumer versus physician reports. Drugs Ther Perspect 36, 469–475 (2020). https://doi.org/10.1007/s40267-020-00762-6
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DOI: https://doi.org/10.1007/s40267-020-00762-6