Inductive Risk and OxyContin: The Ethics of Evidence and Post-Market Surveillance of Pharmaceuticals in Canada

2020 ◽  
Vol 13 (3) ◽  
pp. 300-313
Author(s):  
Itai Bavli ◽  
Daniel Steel

Abstract The argument from inductive risk claims that judgments about the moral severity of errors are relevant to decisions about what should count as sufficient evidence for accepting claims. While this idea has been explored in connection with evidence required for the approval of pharmaceuticals, the role of inductive risk in the post-approval process has been largely neglected. In this article, we examine the ethics of inductive risk in connection with revisions to the product monograph for OxyContin in Canada, which understates the risks of addiction and abuse associated with this drug. Using the concept of inductive risk, we consider what evidence should have been sufficient for Health Canada (HC) to revise the product monograph for OxyContin. Given the stakes involved, we argue that a less strict standard of evidence would have been appropriate, yet HC in fact took the opposite course, insisting upon a higher standard of evidence than it normally requires. In addition to providing a novel perspective on the opioid crisis in Canada, this article contributes to existing philosophical work by demonstrating that inductive risks in the post-approval stage are important and linked to pre-approval inductive risks.

1996 ◽  
Vol 43 (4) ◽  
pp. 339 ◽  
Author(s):  
J. Lavergne ◽  
K. Fields ◽  
J.S. Barkin ◽  
D.L. Carr-Locke ◽  
R.A. Kozarek ◽  
...  

Author(s):  
Ellen S.M. Hilbers ◽  
Claudette G.J.C.A de Vries ◽  
Robert E. Geertsma

Objectives: This study aimed to investigate the technical documentation of manufacturers on issues of safe use of their device in a home setting.Methods: Three categories of equipment were selected: infusion pumps, ventilators, and dialysis systems. Risk analyses, instructions for use, labels, and post market surveillance procedures were requested from manufacturers. Additionally, they were asked to fill out a questionnaire on collection of field experience, on incidents, and training activities.Results: Specific risks of device operation by lay users in a home setting were incompletely addressed in the risk analyses. A substantial number of user manuals were designed for professionals, rather than for patients or lay carers. Risk analyses and user information often showed incomplete coherence. Post market surveillance was mainly based on passive collection of field experiences.Conclusions: Manufacturers of infusion pumps, ventilators, and dialysis systems pay insufficient attention to the specific risks of use by lay persons in home settings. It is expected that this conclusion is also applicable for other medical equipment for treatment at home. Manufacturers of medical equipment for home use should pay more attention to use errors, lay use and home-specific risks in design, risk analysis, and user information. Field experiences should be collected more actively. Coherence between risk analysis and user information should be improved. Notified bodies should address these aspects in their assessment. User manuals issued by institutions supervising a specific home therapy should be drawn up in consultation with the manufacturer.


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