Q&A with Scott Soefje, PharmD, MBA, BCOP, FCCP
Pharmacy Purchasing & Products: How important is closed system drug-transfer device (CSTD) use for preparing and administering hazardous drugs (HDs)?
Scott Soefje: Our understanding of the importance of CSTD use has grown dramatically over recent years as recognition of the dangers of HD handling has likewise increased. Moreover, with the advent of USP <800> Hazardous Drugs—Handling in Healthcare Settings, which will be enforceable on July 1, 2018, CSTD use will become exponentially more critical as the chapter requires CSTD use for drug administration and recommends use for medication preparation. Regulatory requirements aside, organizations with a safety focus should recognize that CSTD use is quickly becoming a standard of practice; furthermore, investing in these devices is simply the right thing to do. Hospitals are responsible for protecting their employees from HD exposure.
PP&P: What can pharmacy do to gain buy-in from administration to invest in CSTDs and other HD safety initiatives?
Soefje: Because CSTDs currently are not reimbursable, gaining administration’s buy-in for purchasing them must be wholly based on safety. While most pharmacy-led purchasing initiatives require a return-on-investment (ROI) analysis, implementing CSTDs is not one of these initiatives. Gaining support from decision-makers should be based on science, which shows that HD contamination is widespread in hospitals; indeed, wipe studies have identified HD residue on desks and floors outside of the pharmacy, potentially exposing staff and patients. Clinical evidence shows that CSTD use reduces staff exposure to HDs. The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) Web site lists a wealth of resources that can be used to educate administration and staff regarding HD exposure, safety, and CSTD use (available at www.cdc.gov/niosh/topics/antineoplastic/).1
Gaining buy-in for higher cost safety improvements—for example, facility upgrades required by USP <800>—is easy in states such as Texas, where USP compliance is required for licensing, but can be challenging to obtain in states where it is not. Again, gaining buy-in should focus on the moral imperative to ensure the safety of staff members and patients.
PP&P: What are the considerations when choosing a CSTD?
Soefje: One of the challenges of choosing a CSTD is that until recently a standardized CSTD vapor containment performance protocol did not exist, which complicated the process for determining the best device for an organization’s needs. However, in August 2015, NIOSH released for public comment A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs, whose purpose is to provide a testing mechanism for the containment performance of CSTDs of the physical barrier type. The protocol is not intended for CSTDs designed to operate using air-cleaning or filtration technologies; on January 19, 2016, NIOSH expanded the scope of the protocol to include a request for information concerning CSTDs that use air-cleaning or filtration technologies. The protocol has multiple applications, and can be utilized by manufacturers to evaluate prototype CSTDs, by consumers to compare CSTDs, or by jurisdictions that wish to adopt the protocol for a CSTD performance certification procedure. (See the NIOSH Web site for more information: www.cdc.gov/niosh/docket/review/docket288/default.html.2)
After this protocol is finalized, evaluating the efficacy of CSTDs will become simpler. However, evaluating the utility of each CSTD in pharmacy and nursing workflows is still a critical consideration. Earlier in my career, I worked in a clinic where pharmacy had selected a CSTD with little input from nursing. I was curious to see how the nurses were using the CSTD, so I observed them in the units. Image how disconcerting it was to witness the nurses removing the CSTD and discarding it! When asked to explain why this was happening, nurses responded that the device did not work for them and so they chose not to use it.
Clearly, choosing a CSTD is not a decision that a pharmacy department should make in a silo; pharmacy and nursing must work together to review their options. First, the two departments must be in agreement that adopting a CSTD for use in preparing and administering HDs is necessary, and second, pharmacy and nursing must work together to identify which CSTD fits the needs of both departments.
Some hospitals use a hybrid system where one CSTD is used for drug preparation and another for drug administration. Although this is an intriguing approach that allows each group to use their preferred device, at the University Medical Center Brackenridge in Austin, Texas, we made the decision to implement a single CSTD for both drug preparation and administration throughout our 11-hospital Seton Healthcare Family. Of the 11 facilities, only four mix chemotherapy, one of which is a pediatric hospital. This was a complex selection process that involved pharmacy and nursing staff from the four hospitals meeting to perform a hands-on review of the available CSTDs. We narrowed the choices down to three products and piloted each of these devices throughout the health system; later, another CSTD came on the market and that was piloted as well.
Each CSTD manufacturer sent representatives to provide training in the infusion area and trained our pharmacy technicians and nurses. We then conducted a pilot study for 2 to 4 days with each device, wherein the nursing and pharmacy staff used that product exclusively and then evaluated that CSTD using a CSTD pilot evaluation form created by the oncology clinical specialist (see FIGURE 1). Each week we piloted a different CSTD, and over the course of 6 weeks we completed our analysis. The group reconvened and reached consensus on the preferred product. Only at that point did we evaluate pricing, because we did not want cost concerns to influence identification of our preferred device. Ultimately, the product we selected was approved and implemented throughout the health system.
Pharmacy’s primary considerations in choosing a CSTD were ease of use, comfort, and efficacy of the closed systems, while nursing’s concerns centered on the sturdiness of the devices and prevention of needle exposure. One reason for nursing’s focus was that we had experienced a device break and an exposed needle. Evaluation of that incident showed that the nurse was disconnecting the product incorrectly with enough pressure to break the device. It was unclear whether the failure was due to a lack of training or resulted from a device malfunction. Regardless, this event reinforces the need for adequate CSTD staff training; it is important to remember that without proper training, even veteran nurses may experience similar incidents.
Our health system is part of a not-for-profit, national health system, which is in the process of evaluating CSTDs. Our recommendations will be part of the group’s initiative that will ultimately make a recommendation for the national system. Hopefully, their decision will mirror ours, so we can avoid having to switch devices, but we will adopt the national recommendation once it is made. The decision is expected by the end of the year.
PP&P: What are the concerns with CSTD-incompatible HDs?
Soefje: Perhaps the most familiar CSTD-incompatible product is Treanda Injection (bendamustine hydrochloride), which is available in two formulations: a solution and a lyophilized powder. The solution should not be used with CSTDs, adaptors, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). The solution contains N,N-dimethylacetamide, making it incompatible with polycarbonate and ABS. This incompatibility can lead to device failure and possible product contamination. One CSTD, BD’s PhaSeal, does not contain polycarbonate or ABS and thus can be used with Treanda.3 (For vial adaptors, polypropylene syringes, and disposable gloves that also are compatible, see FDA’s Web page: www.fda.gov/Drugs/DrugSafety/ucm437469.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.4) Additional HDs that are incompatible with polycarbonate and ABS include busulfan and amsacrine.5
CSTD-incompatible HDs pose a challenge with USP <800> compliance, which states that CSTDs must be used for HD administration and should be used for preparation. Therefore, this is a question that pharmacy directors must address. Should the hospital carry a second CSTD just for that drug? This solution is clearly imperfect and presents logistical considerations. CSTD and drug manufacturers must work closely to ensure compatibility between CSTDs and HDs, which would assuage incompatibility concerns for pharmacy directors.
PP&P: How can an organization document that a CSTD was used during HD compounding and administration?
Soefje: In an effort to improve our documentation efforts, the University Medical Center Brackenridge plans to implement an IV workflow management system that will take images of compounded products with the closed system attached; we also plan to set up the IV workflow system so that it requires scanning of the CSTD bar code, which will provide documentation in the preparation log that a CSTD was used. For organizations without an IV workflow management system, pharmacy could state on the IV label that a CSTD was used during the preparation process, and nurses could state that a CSTD was used during drug administration in the administration record. Each health system must examine its own processes to identify the documentation method that will work best for them.
Scott Soefje, PharmD, MBA, BCOP, FCCP, is the director of pharmacy at the University Medical Center Brackenridge (soon to be Dell Seton Medical Center at The University of Texas) in Austin, Texas. He also is 2015-2016 president of the Hematology/Oncology Pharmacy Association (HOPA). Scott earned his bachelor’s degree in pharmacy from The University of Texas at Austin and his PharmD from the combined program at The University of Texas Health Sciences Center at San Antonio and The University of Texas at Austin. He is board certified in oncology pharmacy and recently earned an MBA from George Washington University.