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insufficiently precise regulation. What has emerged from the work of Christian and others is that the unified CSTD test protocol to assess the performance of CSTD systems does not look in depth at the potential incompatibility of drug products with the individual components in any given CSTD.


Human error


The research around CSTDs is consistently shifting, which makes regulation difficult to predict and interpret.


healthcare workers are not exposed to their effects. But while much has been done to evaluate the performance of CSTDs for small molecule drug containment, there has been very little evaluation of such devices for use with biological products, such as monoclonal antibody drugs, which specifically target cancer cells, but are also classified as antineoplastic agents. “Another important consideration is that there likely needs to be studies that look at whether these devices truly need to be used with biologic drugs,” says Christian. “Data we have seen suggests that the potential risk/benefit with biological drugs may not be positive.”


“In recent years, NIOSH has begun including some biologics on the list, which has resulted in increased use of CSTDs with biologic drugs.”


Both NIOSH and the US Pharmocopoeia (USP) Convention’s delayed USP 800 Hazardous Drugs protocol recommend the use of CSTDs in the compounding and administration of hazardous drugs. “USP recently developed a new chapter with guidelines, which includes the use of CSTDs, for handling drugs that are considered hazardous and references the Hazardous Drug List published by NIOSH,” explains Christian. “In recent years, NIOSH has begun including some biologics on the list, which has resulted in increased use of CSTDs with biologic drugs.”


“This is important because most biologics are very different to traditional antineoplastic drugs in that there is very low risk of exposure from inhalation or absorption through the skin,” she adds. Given some of the contamination risks with biologic drugs, the USP decision could soon be looked on as further evidence of the limitations of


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In essence, the problem is not with the devices themselves, but with the approach taken for their use. As CSTD designs proliferate, as their complexity increases and as the nature of the agents they contain evolves, regulation must keep pace and more research must be done to assess specific devices in specific use cases. At present, statements forbidding the use of CSTDs with incompatible hazardous drugs in USP 800 are compromised by the fact no guidance is provided for how or by whom an incompatibility is established, or what constitutes an incompatibility. It’s just one example Christian and her co-authors highlight in arguing that the lack of clarity around CSTD requirements and the room for interpretation across facilities “make it challenging for drug manufacturers to anticipate how their products will be handled, to understand how compatibility with CSTDs should be established, or to place limits around the application of CSTDs to their products”. Christian and her colleagues recommend a number of actions. The first and, by implication, most important is for regulators to give feedback on the use of CSTDs for biological drug products. Their belief is that a comprehensive compatibility study with each commercial CSTD type should be undertaken for each investigational product, though they recognise that this would cause delays in bringing drugs to market. Nevertheless, health authorities need to understand the interaction between new drugs and the CSTDs with which they might be used.


Alongside the need for more in-depth analysis comes a need for healthcare professionals to be trained in how to use CSTDs in specific settings, so that neither the device nor the person using it is introducing more risk. The report advocates for more CSTD education and in-person training at clinics to promote better understanding of how each component – and each unique combination of components – will perform. This would be a big task and no one is suggesting it would be simple, but the adoption of a standard operating procedure for the handling of CSTDs would be a good starting point.


While it may not be possible to study in detail the interaction of every type of commercially available CSTD with a new biological product, more clarity about potential risks and procedures for mitigating those risks is sorely needed. This will only come from a combined effort by regulators, device manufacturers, drug developers and front-line healthcare workers. ●


World Pharmaceutical Frontiers / www.worldpharmaceuticals.net


Numstocker/www.shutterstock.com


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