The Social Impact of Suspected Adverse Drug Reactions: An analysis of the Canada Vigilance Spontaneous Reporting Database
Some 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.
Our objective was to describe the ADRs consisting of direct social issues that have been recorded in the Canadian national spontaneous reporting system (Canada Vigilance).
We 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.
Among 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.
Findings from this study support the consideration of direct social issues as ADRs in the detection of drug safety signals.
Compliance with Ethical Standards
No funding was obtained for this study.
Conflict of interest
Genaro Castillon, Francesco Salvo, and Yola Moride have no conflicts of interest.
The datasets analysed during the current study are available at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html
- 1.WHO. Constitution of WHO: principles [Internet]. WHO. 1946. http://www.who.int/about/mission/en/. Accessed 14 Mar 2017.
- 6.Park-Wyllie L, van Stralen J, Castillon G, Sherman SE, Almagor D. Differences in adverse event reporting rates of therapeutic failure between two once-daily extended-release methylphenidate medications in Canada: analysis of spontaneous adverse event reporting databases. Clin Ther. 2017;39:2006–23.CrossRefGoogle Scholar
- 7.Government of Canada. Consolidated Federal Laws of Canada, Food and Drug Regulations [Internet]. 2017. http://laws-lois.justice.gc.ca/PDF/C.R.C.,_c._870.pdf. Accessed 16 May 2017.
- 8.Government of Canada HC. MedEffect Canada—Glossary of Fields in the Canada Vigilance Adverse Reaction Online Database [Internet]. 2005. http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/glossary_definition-eng.php. Accessed 30 Jan 2017.
- 9.Government of Canada HC. MedEffect Canada—Adverse Reaction Reporting—Health Canada [Internet]. 2002. http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php. Accessed 27 Feb 2017.
- 10.MedDRA hierarchy [Internet]. MedDRA; 2013. https://www.meddra.org/how-to-use/basics/hierarchy. Accessed 8 Dec 2016.
- 11.Government of Canada HC. Side Effect Reporting Form [Internet]. 2016. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/report-declaration/ser-des_form-eng.pdf. Accessed 27 Feb 2017.
- 12.Post-Approval safety data management: definitions and standards for expedited reporting [Internet]. ICH; 2003. http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/post-approval-safety-data-management-definitions-and-standards-for-expedited-reporting.html. Accessed 10 Jul 2018.
- 13.WHOCC—Home [Internet]. 2002. https://www.whocc.no/. Accessed 24 Jul 2018.
- 16.Martin DC. The mental status examination. In: Walker HK, Hall WD, Hurst JW, editors. Clin methods hist phys lab exam [Internet]. 3rd ed. Boston: Butterworths; 1990. http://www.ncbi.nlm.nih.gov/books/NBK320/. Accessed 29 May 2017.
- 17.Wallace M, Shelkey M. Katz Index of independence in activities of daily living (ADL). Nurs Clin N Am. 2007;39:473–93.Google Scholar
- 18.Bhagat V. Extroversion and academic performance of medical students. Int J Humanit Soc Sci Invent. 2013;2:55–8.Google Scholar
- 20.Selwood K. Side effects of chemotherapy. Cancer child young people [Internet]. Wiley-Blackwell; 2009. p. 35–71. https://onlinelibrary.wiley.com/doi/abs/10.1002/9780470988145.ch4. Accessed 5 June 2018.