The Oncology Nursing Society (ONS), the National Institute for Occupational Safety and Health (NIOSH), the International Society of Oncology Pharmacy Practitioners (ISOPP), and the American Society of Health-System Pharmacists (ASHP) recommend the use of a closed system drug-transfer device (CSTD) to prevent hazardous drug (HD) exposure to health care workers handling these medications. Proposed USP Chapter <800> states that CSTDs should be used when compounding HDs and shall be used when administering HDs, when the dosage form allows.1
This increased focus on CSTDs highlights the importance of effective training for staff using these devices. Choosing one that staff will use and encouraging collaboration between nursing and pharmacy when selecting a device are crucial to success. Because workplace attitudes surrounding safety profoundly impact whether staff will buy in to adopting a CSTD, a strong safety culture that provides consistent and sustained support for the initiative is critical.
Provide a Rationale for Change
As with any change to systems or technologies, gaining buy-in from staff, as well as senior leadership and administration, is contingent upon answering a fundamental question: Why is this change necessary? Focus on convincing administration that using a CSTD is a best practice that is required to protect employees from the dangers of HD exposure, including skin rashes, infertility, miscarriages, birth defects, and malignancies, including leukemia and other cancers.2 In addition, remind administration that CSTD use is supported by ONS, NIOSH, ISOPP, ASHP, and proposed USP <800>.
Staff members who have been compounding for years without a CSTD may question the need for implementing such a device, especially if they perceive that no safety concerns exist. Educate all health care workers who will interact with the CSTD, beginning with providing a rationale for use that elucidates the safety implications of handling HDs and the benefits of using a CSTD.
At University Medical Center Brackenridge (UMCB), we educate administration and staff on HD handling dangers throughout the CSTD evaluation process, and this education also will be reinforced during training. Revisiting this critical issue more than once emphasizes its importance, so be sure to focus on the value of CSTD use upon hire and periodically thereafter.
Design Appropriate Training
When implementing a CSTD, be sure to provide adequate training for all nursing and pharmacy department members who will use the device. For many users, this will be a new experience. Fortunately, the training process for CSTDs is straightforward. With a comprehensive training program, most users will demonstrate mastery within 2 days.
Choose a Device Staff Will Use
UMCB evaluated four CSTDs to identify the right device for our organization. The four devices have been ranked, and we are now investigating pricing differences before we make a final selection. Full CSTD implementation is anticipated before the end of this year. Our top criterion in selecting a device is comfort and ease of use; it is critically important that staff who will be using the CSTD find it intuitive so that they use it every time.
Be sure both pharmacy and nursing are involved in the CSTD evaluation process. If pharmacy chooses a CSTD without input from nursing, there is a possibility that nursing may not use the device if they find it too cumbersome. As proposed USP Chapter <800> notes, a universal performance protocol by which all CSTDs are evaluated for containment does not yet exist. Until such a protocol is developed and adopted, hospitals must carefully evaluate each CSTD vendor’s performance claims when selecting a CSTD.
Evaluate the devices with hands-on testing in real-world situations. At UMCB, we are dedicating 3-4 days for testing each device. Experience has shown that upon evaluation, one device typically will become a clear favorite. However, if users indicate that all the devices are similarly user-friendly, cost may become the determinant. In the event that pharmacy and nursing disagree on which CSTD is preferred, some organizations opt to purchase one device for drug preparation and another for administration. However, we have found that gaining buy-in from both departments is easier and training is simpler when a single CSTD is used by both pharmacy and nursing.
Finally, be sure the CSTD is compatible with the current workflow and existing systems, and keep abreast of new safety and compatibility issues on an ongoing basis (see SIDEBAR: CSTD Compatibility).
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.
On March 9, 2015, Teva, the manufacturer of Treanda Injection (bendamustine hydrochloride) released important prescribing and safety information. Treanda is used to treat patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkins lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
Treanda is available in two formulations: a solution and a lyophilized powder. The solution (45 mg/0.5 mL or 180 mg/2 mL) should not be used with closed system drug-transfer devices (CSTDs), adaptors, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). The solution contains N,N-dimethylacetamide (DMA), making it incompatible with polycarbonate and ABS. This incompatibility leads to device failure (eg, leaking, breaking, or operational failure of CSTD components), and possible product contamination, which can cause potentially serious adverse health consequences to the practitioner, including skin reactions, or to the patient, including but not limited to, the risk of small blood vessel blockage.
FDA recommends that health care providers only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer the solution (polypropylene syringes are translucent in appearance). If a CSTD would be used with Treanda solution, FDA advises health care professionals to verify with the CSTD manufacturer or Teva US Medical Information (1-800-896-5855) that the CSTD is compatible prior to preparing the drug. Alternatively, the lyophilized powder can be used with a CSTD.
On March 10, 2015, FDA sent a letter to the Teva subsidiary responsible for Treanda stating that it must provide stickers or adhesive labels for the vials of the liquid formulation already in pharmacies and hospitals that bear the following statement: Not for use with devices that contain polycarbonate or acrylonitrile-butadiene-styrene.
Dear Health Care Provider Letter: Important Safety and Incompatibility Information for Treanda. Teva Pharmaceuticals Web site. http://www.tevausa.com/Pdf/NDA_22249_Treanda_DHCP_Letter.pdf. Accessed May 5, 2015.
US Department of Health and Human Services. US Food and Drug Administration. FDA warns health care professionals not to use Treanda Injection (solution) with closed system transfer devices, adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene. http://www.fda.gov/Drugs/DrugSafety/ucm437469.htm. Accessed May 5, 2015.