Adverse drug reaction reporting in Canada: consumer versus physician reports
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ORIGINAL RESEARCH ARTICLE
Adverse drug reaction reporting in Canada: consumer versus physician reports Rania Al Dweik1 · Dafna Kohen2 · Dawn Stacey3 · Sanni Yaya4 Published online: 4 August 2020 © Springer Nature Switzerland AG 2020, corrected publication 2020
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
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