Closed System Transfer Devices and The Smoking Gun: Why Wait?
It took 32 infant deaths for federal authorities to outlaw drop-side cribs. Since June 28, 2011, it has been illegal to manufacture, sell or even donate these cribs, due to the safety issues. In this instance, it took a smoking gun for change to come about.
When it comes to making changes in healthcare — whether to regulation, procedure, equipment or technologies, there are three situations that can effectively drive change.
1) A smoking gun — as mentioned above. Proof of harm/death leads to changes.
2) Proven efficacy of a treatment. A treatment is so effective that not introducing it would be negligent.
3) Money in the bag. A change would either provide significant cost savings or add revenue to an institution or market.
Hazardous Drug Exposure Still Requires More Attention
The Occupational Safety and Health Administration (OSHA) reports that, “Antineoplastic cytotoxic medications, anesthetic agents, anti-viral agents, and others…are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects.” And both the American Society of Hospital Pharmacists (ASHP) and the National Institute for Occupational Safety and Health (NIOSH) include genotoxicity as a potential risk factor for hazardous drug exposure — that is, the ability for hazardous drugs to mutate genes, which can lead to cancer.
That said, with all of these warnings and all of the existing studies pointing to these conclusions, we still don’t have a smoking gun. That’s because it’s difficult to prove that a pharmacist’s cancer diagnosis was directly caused by his/her exposure to hazardous drugs and lawsuits brought over the years by healthcare workers regarding these issues were always settled in closed court under secrecy agreements, so the outcomes are held privately.
With USP 800 coming into effect December 1, 2019, we are getting closer to the levels of safety necessary to provide proper protection to pharmacy and nursing professionals who handle hazardous drugs on a daily basis. Currently, pharmacists are required to wear Personal Protective Equipment (PPE) and compound hazardous drugs within a Biological Safety Cabinet (BSC). The use of Closed System Transfer Devices (CSTDs) is highly recommended, but not mandated, despite the mounting evidence that truly closed CSTDs significantly reduce the surface contamination in hazardous drug compounding environments. However, in nursing, CSTDs are mandated devices for the administration of hazardous drugs.
Must We Wait for a Smoking Gun?
Why not simply mandate the use of CSTDs for compounding pharmacists, as USP 800 does for oncology nurses administering hazardous drugs? Why should we wait for a case study demonstrating that detrimental consequences as a result of occupational exposure to hazardous drugs?
In an ideal world, we could make this argument. But, as outlined above, if there is no smoking gun, there must be proven efficacy (not a factor here, since we are trying to prevent disease, rather than cure it) or money in the bag.
Money in the Bag
Mount Sinai Hospital (MSH) studied the economic impact practicing Drug Vial Optimization (DVO) with chemo Single-dose vials (SDV) through the use of Equashield’s CSTD. Usually, SDVs must be discarded six hours after the first vial access if the drug was kept in ISO class 5 air conditions. If accessed outside of such conditions, the vial must be discarded after one hour. However, this standard results in major wastage of chemotherapy drugs, which are already in short supply in many cases.
MSH found that “the Equashield® closed-system transfer device (CSTD) was shown to prevent microbial contamination of preservative-free SDV for 9 days after being accessed 10 times over a 7-day period,”[i] and consequently, in May 2014 was substantiated by the FDA “to prevent microbial ingress up to a time period of 7 days…and for multiple reconnections of components up to 10 times.” As such, Equashield can be safely used for DVO of SDV in the correct conditions for up to 7 days and 10 reconnections. [ii].”
Consequently, during the one-month study at the hospital, MSH found a cost savings of $44,192, which translates to an estimated annual cost savings of approximately $530,000. So, while MSH’s annual expenditure at this time of this study was around $235,000, the cost savings not only offset the investment in CSTDs; it resulted in significant cost savings to the institution on chemo/ biotherapy SDVs.
Where is Regulation on this?
On April 11, 2018, the Ministry of Health in Japan issued a statement on DVO of SDVs. Japanese regulation now allows the use and storage of single use vials, stating, “when using [a] CSTD with a clear print of a multiple usage count, a multiple usage up to the limit set by each manufacturer is allowed.”[iii] In fact, the regulations outline various scenarios which would allow for the storage of SDVs for between two and seven days, dependent on the storage conditions.
While authorities in Japan have now outlined their regulations on this matter, the US is still unclear, and issues surrounding SDVs and optimizing such vials remains undefined by federal regulation. State boards of pharmacies decide whether DVO practice is allowed within state guidelines, and many states have prohibited this practice. Additionally, the Joint Commission recently commented that DVO on SDVs should not be performed. However, many institutions have invested in a validation process to introduce DVO into facilities and in verification processes to monitor drug quality on an ongoing basis.
What does this mean in terms of regulation?
The verdict is still out on whether the practice of DVO is or will be allowed in the US. Pharmacy professionals should consult state boards of pharmacy and local regulations, and work accordingly.
The Real Question Concerning CSTDs
CSTDs can provide major benefits to hospital pharmacies, with increased worker safety being prime among them. Decision-makers assessing whether to implement CSTDs, or deciding which CSTD to select, still ask for a smoking gun.
But, short of a true smoking gun, the reality is that hospitals can implement truly closed systems, protect their workers from a future proof of causation, and if the regulatory bodies decide that DVO is acceptable under certain circumstances, experience the financial benefits of extending the BUD.
— — — — — — — — — — — — — — — — — — — — — — — — — — — — — —
[i] Microbial Ingress Test and Assessment for Extending the Beyond Use Date of Single Use Vials Utilizing the EQUASHIELD® Closed System Drug Transfer Device. Study performed by Nelson Laboratories, Salt Lake City, Utah in March 2013. Available at: http://www.equashield.com/uploads/0use_date_study.pdf (accessed 15 September 2014)
[ii] US Food and Drug Administration. 510(K) Summary of Safety and Effectiveness. 12 May 2014, http://www.accessdata.fda.gov/cdrh_docs/pdf13/k132899.pdf (accessed 15 September 2014)
[iii] Translation of Japanese Ministry of Health Guidelines on the Safe Use of Single Dose Vials
