Closed system transfer device technology is founded in the need to protect patients an caregivers from exposure to hazardous drugs. The risks of occupational exposure to hazardous drugs has been known since the 1970s. Since 1980, guidance documents from the American Society of Health-System Pharmacists (ASHP) and the National Institute for Occupational Safety and Health (NIOSH) have provided advice to healthcare providers who manage these agents, but many organizations have not taken the necessary steps to ensure safety. On February 1, 2016, United States Pharmacopeia (USP) General Chapter 800: “Hazardous Drugs: Handling in Healthcare Settings” was published, and will provide the first enforceable standards concerning hazardous drugs beginning on July 1, 2018.
The Lingering Role of Cytotoxics
The market for closed system transfer device (CSTDs) drug compounding and administration is dominated by a handful of companies that supply one or more approved closed system transfer device products. The primary application for these systems is oncology therapeutics, a disease sector that still relies heavily on cytotoxic drugs for the treatment of most cancers, in spite of the increasing promise of targeted antibody treatments based on tumor-specific biomarkers. As a class cytotoxics include alkylating agents and antimetabolites drugs and chemicals that can also harm normal cells and their DNA, and these drugs are believed to represent a significant occupational exposure risk for hospital pharmacy and infusion center personnel.
Since a number of cytotoxic drugs are supplied in lyophilized form requiring reconstitution prior to administration, the cytotoxic drug delivery segment is closely aligned with the drug reconstitution segment, There are currently about a dozen important players in the drug reconstitution system market. While the barriers to entry are relatively low – particularly by proprietary drug standards – sales strategies and value messages suffer from the low-tech image associated with reconstitution devices.
The Competitive Landscape for Closed System Transfer Device Products
Although CSTDs do not guarantee 100% protection, they provide significantly more of it than without them. Many studies have been done to evaluate the use of a CSTD. These studies include assessing fluid and vapor leakage during preparation and administration, the impact of CSTDs on environmental contamination and personnel exposure, and the impact of CSTDs on workflow and staffing.
Source: Greystone from Published Sources
Material Selection Issues for Closed System Transfer Device Designs
In April 2015, the Institute for Safe Medication Practices (ISMP) and the FDA issued warnings that closed system transfer devices made out of polycarbonate plastic should not be used with chemotherapy agents containing the solvent N,N-dimethylacetamide. The ISMP cited bendamustine, amsacrine and busulfan as agents that when diluted with the solvent can melt or dissolve the polycarbonate plastic found in some CSTDs. Possible outcomes include spills and potential infusion of the dissolved plastic into the patient.
Oncology Drug Administration & Dosing
Balancing the benefits and risks of cancer therapies is critical in order to provide longer survival while maintaining or improving quality of life. For any drug dose, a range of beneficial and toxic effects can be anticipated that will vary based on the unique characteristics of each patient receiving the agent. An evaluation of recently approved oncology drugs reportedly demonstrated that many of these agents are labeled for use at doses that may be either too high or too low, at least for some patients.
For the clinician and caregiver at the point of care, this dynamic translates to variability in dosing and dose preparation. Variability in turn translates into complexity and higher risk of exposure. When every patient represents a unique drug preparation sequence, the probability of error increases. Because of the available infrastructure and experiential repetition, compounding antineoplastics in the pharmacy is considered a risk mitigating step that reduces the opportunity for error and accidental exposure.
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