The purpose of this ethical assessment is to identify and discuss ethical issues related to optimal use recommendations for solvent/detergent-treated human plasma (Octaplas) (S/D plasma) — a blood product derivative — in Canada. This assessment compliments a set of clinical and cost-effectiveness analyses done for the purpose of informing a reasonable funding decision on S/D plasma.

Contents

• ABBREVIATIONS
• 1. PREFACE
• 2. INTRODUCTION
  • 2.1 History and Philosophical Context
• 3. METHODOLOGICAL CONSIDERATIONS
  • 3.1 Ethical Issues Related to Quality-Adjusted Life-Years
  • 3.2 Issues Raised in the Preface Regarding Evidence
  • 3.3 The “Accountability for Reasonableness” Framework
• 4. CONSIDERATIONS: OPEN ACCESS TO SOLVENT/ DETERGENT-TREATED HUMAN PLASMA
• 5. CONSIDERATIONS: RESTRICTED ACCESS TO SOLVENT/DETERGENT-TREATED HUMAN PLASMA
• 6. KEY ETHICAL CONSIDERATIONS
• REFERENCES

Authorship: This report has been prepared by Michael Kekewich and Dr. Thomas Foreman. Dr. Thomas Foreman is the Director of Clinical and Organizational Ethics at The Ottawa Hospital and Michael Kekewich is the Coordinator for the Department of Clinical and Organizational Ethics at The Ottawa Hospital. Dr. Thomas Foreman holds a DHCE (Doctorate of Health Care Ethics) from Dusquesne University in Pittsburgh, and was a Post-Doctoral Fellow at the University of Toronto’s Joint Centre for Bioethics in 2009. Michael Kekewich holds an MA in Public Ethics from Saint Paul University in Ottawa.

This report was prepared between November 24, 2010 and January 11, 2011, at CADTH’s request.

Disclosures: The authors have no scientific or economic conflicts of interest to disclose.

Production of this report is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and Yukon. The Canadian Agency for Drugs and Technologies in Health takes sole responsibility for the final form and content of this report. The views expressed herein do not necessarily represent the views of Health Canada or any provincial or territorial government.

CADTH is funded by Canadian federal, provincial, and territorial governments.

Suggested citation:

Kekewich, M, Foreman, T. Ethical Assessment: Open versus Restricted Access and Optimal Use of Solvent/Detergent-Treated Human Plasma (Octaplas) [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2011 (CADTH Optimal Use Report).

CADTH Disclaimer: This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). This report contains a comprehensive review of existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) available to CADTH at the time it was prepared and has not been reviewed by peers.

The information in this report is intended to help health care decision-makers, patients, health care professionals, health systems leaders and policy-makers make well-informed decisions and thereby improve the quality of health care services.

The information in this report should not be used as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision making process nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or as a result of the use (or misuse) of any information contained in or implied by the information in this report.

CADTH takes sole responsibility for the final form and content of this report. The statements, conclusions and views expressed herein do not necessarily represent the view of Health Canada or any provincial or territorial government.

Production of this report is made possible through a financial contribution from Health Canada.

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