Vol.:(0123456789) Drugs & Therapy Perspectives (2020) 36:469–475 https://doi.org/10.1007/s40267-020-00762-6 ORIGINAL RESEARCH ARTICLE Adverse drug reaction reporting in Canada: consumer versus physician reports Rania Al Dweik 1  · Dafna Kohen 2  · Dawn Stacey 3  · Sanni Yaya 4 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) classifcation. Methods This retrospective observational study evaluated ADR reports received by the Canadian Vigilance ADR Report- ing 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 signifcant diferences between reporters (consumers and physicians) based on seriousness, SOC, and ATC classifcation. 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 signifcantly more ADRs than physicians (p < 0.0001). Signifcant diferences in ADR reporting were found between consumers and physicians, in terms of ADR seriousness, ATC classifcation, 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 frst Canadian study to compare consumer and physician ADR reports, showed that consum- ers and physicians reported ADRs diferently with regard to SOC and ATC classifcation. 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 identifcation when assessing drug safety. Introduction Adverse drug reactions (ADRs) afect drug users worldwide. The market for a new drug, once it has been approved, most often includes patient and disease groups that were not assessed in pre-market clinical trials. This means that some ADRs are often not reported until years after the drug is frst on the market [1]. ADR reporting is one of the key elements of the medica- tion safety process. Since 1960, the World Health Organization (WHO) has been monitoring ADRs via spontaneous reporting systems [2]. The main aim of these systems is to gather new information about possible serious, rare, and unknown ADRs at an early stage of post-marketing surveillance [2]. In 1965, when existing ADR reporting systems began, only physicians and dentists were allowed to report ADRs [3]. In 1995, WHO mandated drug manufacturers to report ADRs. However, substantial under-reporting of ADRs by healthcare professionals (HCPs) was noticed [4]. Thus, phar- macists, nurses, and consumers in Canada were allowed to * Rania Al Dweik raldw034@gmail.com Dafna Kohen Dafna.Kohen@statcan.gc.ca Dawn Stacey dstacey@uottawa.ca Sanni Yaya sanni.yaya@uOttawa.ca 1 Faculty of Health Science, Public Health Department, Abu Dhabi University, Abu Dhabi, United Arab Emirates 2 Health Analysis Division, Statistics Canada, Ottawa, Canada 3 Faculty of Health Sciences, Ottawa Hospital Research Institute, Clinical Epidemiology Program, School of Nursing, University of Ottawa, Ottawa, Canada 4 School of International Development and Global Studies, Faculty of Social Sciences, University of Ottawa, Ottawa, Canada