Faculty
Health Sciences
Supervisor Name
Maxwell Smith; Andrew Johnson
Keywords
Pharmacovigilance, Health Policy, Health Canada
Description
Paramount attention is often afforded to pharmacotherapies being brought to market. The anticipation from companies, their shareholders, and the patients poised to benefit are met with stiff statistical and methodological requirements set forth by Health Canada’s Health Products and Food Branch (HPFB). Once a pharmacotherapy has been approved by the HPFB, however, the onus to monitor these drugs falls largely on the shoulders of Health Canada, the manufacturers, and to a lesser degree, the Drug Safety and Effectiveness Network (DSEN). This scoping review identified existing pharmacovigilance frameworks recommendations from SCOPUS, PubMed and EMBASE and compared the guidelines employed by Health Canada, the US FDA, and the European Union Medicines Agency. The review found that the current system disproportionately relies on manufacturers to “self-regulate” and passively report adverse reactions, posing an obvious conflict of interest as to the safety of pharmacotherapies. As well, there remains a lack of clarity from Health Canada regarding their statistical methods and vision for improving risk mitigation strategies for post-market surveillance. This lack of centralization and standardization in the recall process lends itself to a suboptimal piecemeal solution meant to protect Canadians.
Acknowledgements
Thank you to my supervisors Professor Andrew Johnson and Professor Maxwell Smith.
Document Type
Poster
Included in
Health Services Administration Commons, Health Services Research Commons, Patient Safety Commons, Public Health Education and Promotion Commons
Investigating the Statistical and Policy Frameworks Used to Gauge Potential Pharmacotherapy Recalls: A Scoping Review
Paramount attention is often afforded to pharmacotherapies being brought to market. The anticipation from companies, their shareholders, and the patients poised to benefit are met with stiff statistical and methodological requirements set forth by Health Canada’s Health Products and Food Branch (HPFB). Once a pharmacotherapy has been approved by the HPFB, however, the onus to monitor these drugs falls largely on the shoulders of Health Canada, the manufacturers, and to a lesser degree, the Drug Safety and Effectiveness Network (DSEN). This scoping review identified existing pharmacovigilance frameworks recommendations from SCOPUS, PubMed and EMBASE and compared the guidelines employed by Health Canada, the US FDA, and the European Union Medicines Agency. The review found that the current system disproportionately relies on manufacturers to “self-regulate” and passively report adverse reactions, posing an obvious conflict of interest as to the safety of pharmacotherapies. As well, there remains a lack of clarity from Health Canada regarding their statistical methods and vision for improving risk mitigation strategies for post-market surveillance. This lack of centralization and standardization in the recall process lends itself to a suboptimal piecemeal solution meant to protect Canadians.