Open AccessDeploying the Precautionary Principle to Protect Vulnerable Populations in Canadian Post-Market Drug Surveillance
Author(s) -
Maxwell J. Smith,
Ana Komparic,
Alison Thompson
Publication year - 2020
Publication title -
canadian journal of bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.163
H-Index - 3
ISSN - 2561-4665
DOI - 10.7202/1070232ar
Subject(s) - precautionary principle , risk analysis (engineering) , business , context (archaeology) , postmarketing surveillance , licensure , population , drug , public economics , actuarial science , environmental health , medicine , pharmacology , economics , microbiology and biotechnology , adverse effect , paleontology , nursing , biology
Drug regulatory bodies aim to ensure that patients have access to safe andeffective drugs; however, no matter the quality of pre-licensure studies, uncertainty willremain regarding the safety and effectiveness of newly approved drugs until a large anddiverse population uses those drugs. Recent analyses of Canada’s post-market drugsurveillance (PMDS) system have found that Canada’s PMDS system requires strengthening andthat efforts must be improved to monitor and address the safety and effectiveness ofapproved drugs among vulnerable populations. Given the uncertainty that exists when drugsenter the market, some have suggested that the precautionary principle is relevant toguiding decision-making in this context. This paper responds to recommendations that theCanadian PMDS system should be responsive to the health needs of vulnerable populations byassessing the utility of deploying the precautionary principle to guide a post-marketstrategy for vulnerable populations.