Closed-system transfer device use with oncology biologics: A survey of Canadian healthcare practitioners.

INTRODUCTION: Closed-system transfer devices (CSTDs) were introduced into clinical practice to protect healthcare practitioners (HCPs) from exposure to hazardous drugs. However, ambiguous guidelines have led to confusion as to when CSTD use is required, as institutes are instructed to maintain their own hazardous drug lists and determine the appropriate level of personal protective equipment for their staff. This study seeks to understand the current use of CSTDs by Canadian oncology HCPs, the influence of various stakeholders on their use and the challenges faced by HCPs surrounding the use of these medical devices. METHODS: The researchers compiled a set of questions to inform on the current use of CSTDs in clinical practice and administered an online survey to oncology HCPs across Canada. RESULTS: The results indicate that though CSTD use is common in Canadian oncology practice settings, there is variation in the extent of the use of these devices across provinces and with which products these devices are used. The survey results also show that the top challenges with the use of CSTDs include cost, lack of information on the compatibility of a CSTD with a drug product, and CSTD impact on drug quality. Many respondents are aligned that regulatory bodies are more likely to influence the use of CSTDs with specific drug products than drug manufacturers. CONCLUSION: Guidelines for the application of CSTDs in clinical practice vary and are often ambiguous. Regulatory bodies are uniquely positioned to provide healthcare institutions with more clarity on when CSTD use is appropriate.

Adopting alternatives for the regulatory monitoring of shellfish for paralytic shellfish poisoning in Canada: Interface between federal regulators, science and ethics.

To ensure the safety of Canada's shellfish, the Canadian Shellfish Sanitation Program (CSSP) relies on the mouse bioassay to detect toxins known to cause paralytic shellfish poisoning (PSP). This assay uses a large number of mice and requires death as an endpoint. Canadian research has led to the development of a pre-column High Performance Liquid Chromatography (HPLC) method that is more sensitive and more reliable than the mouse bioassay. However, it is not being used by Canadian regulators despite its acceptance by the AOAC and adoption by the United Kingdom. An ethnography study of stakeholders in the CSSP was conducted to determine the opportunities and obstacles to adopting analytical testing methods. The results of the study indicate that the major obstacles are a lack of certified reference materials (CRMs) and the direction of resources towards the development of new instrument-based methods rather than towards the refinement of the existing pre-column HPLC method for regulatory use. To move away from the mouse bioassay, Canada should invest in: basic research to develop a complete set of CRMs for PSP toxins; method refinement to increase sample throughput; and exercises to gain international acceptance of the pre-column HPLC method.