Clear guidelines needed for closed-system transfer device use with cancer drugs

A survey of Canadian healthcare practitioners reveals a lack of clarity on closed-system transfer device (CSTD) compatibility with oncology biologics, as well as the lack of control drug manufacturers have as a single stakeholder to protect the quality of their products and the safety of patients who use them.

In addition, guidelines set by regulatory bodies for the application of CSTDs in clinical practice vary and are usually ambiguous.

“Health authorities are encouraged to seek more high-quality evidence from manufacturers of CSTDs by implementing more stringent compatibility testing criteria and establishing performance standards to mitigate the risks to patient safety and product quality, prior to granting regulatory approval and integrating these devices into clinical practice,” the researchers said.

In the survey, a set of questions was assembled to report on the current use of CSTDs in clinical practice and was administered online to oncology healthcare practitioners across Canada.

Results showed that use of CSTDs is common in Canadian oncology practice settings, but variation existed in the extent of the use of such devices across provinces and with which products CSTDs were used. [J Oncol Pharm Pract 2022;28:805-815]

More than 75 percent of respondents used CSTDs several times per day, and all of them used these devices at least once daily. All respondents reported using CSTDs with hazardous drugs either every time or most of the time.

Furthermore, majority of the respondents said they used CSTD with hazardous drugs either every time (83 percent) or most of the time (17 percent), while a quarter reported using these devices with nonhazardous drugs at least some of the time. Seventy-two percent of the respondents, however, stated that they very rarely used CSTDs with nonhazardous medications.

The survey also determined the most frequent difficulties encountered with the use of CSTDs, including cost, lack of information on the compatibility of a CSTD with a drug product, and CSTD impact on drug quality. In addition, most of the respondents agreed that regulatory bodies had greater influence than drug manufacturers as regards the use of CSTDs with specific drug products.

“Regardless of the reason for the use of CSTDs with oncology biologics, drug manufacturers are often unaware that these devices are being used with their products,” the researchers said. “This is especially concerning when these devices are used during clinical trials, as their potential to impact product quality and patient safety may ultimately impact study outcomes.”

In the survey, only one respondent stated that a drug manufacturer would always be informed if CSTDs are used in clinical trials, while >75 percent stated that drug manufacturers would either rarely or never be notified if these devices are used.

“Therefore, if patients enrolled in clinical trials experience adverse effects and the trial sponsor is not aware that CSTDs were used, the adverse events would be attributed to the drug product, without considering the potential risk associated with CSTDs, such as the introduction of extrinsic particles which are then inadvertently administered to patients,” the researchers said.

“[M]ore high quality research is needed in order to understand how these devices are used in clinical practice in order to prompt stakeholders to align and provide institutions with consistent and explicit messaging on which drugs require the use of CSTDs based on comprehensive risk-benefit analyses,” they added.