With approximately 12 billion hazardous medication doses handled by US providers annually, the dangers posed to health care workers are of significant concern.1 To mitigate risk, the US Pharmacopeial Convention (USP) published General Chapter <800>,2 which established practice and quality standards for hazardous medication handling; although the enforcement date for USP <800> is unknown, individual states may currently require compliance.3
Engineering controls designed to minimize worker and environmental exposure to hazardous medications are required by the chapter. Supplemental engineering controls, such as closed system drug-transfer devices (CSTDs), provide additional protection when compounding and administering hazardous medications. USP <800> recommends use of CSTDs during hazardous drug (HD) compounding and requires use during administration of antineoplastic HDs. An exception is permissible if the dosage form does not allow for a CSTD or if the agent is physically or chemically incompatible with the CSTD.4 In these cases, provider technique must minimize the risk of an open system. Implementation of CSTDs is critical to ensuring USP <800> compliance and the safety of pharmacists, technicians, and nurses handling hazardous medications.
CSTD Use at Joe DiMaggio Children’s Hospital
Joe DiMaggio Children’s Hospital (JDCH) is a 226-bed teaching and community hospital located in Hollywood, Florida. As one of six hospitals comprising the Memorial Healthcare System (MHS), JDCH provides a variety of clinical services to pediatric patients in South Florida. The inpatient oncology unit has 24 private patient rooms and a treatment room for procedures, such as the administration of intrathecal chemotherapy. The outpatient oncology unit includes 12 private patient rooms and one treatment room.
The CEO of MHS targeted five major goals during his tenure, one of which is for MHS to become the most technologically advanced health care system in South Florida.5 In accordance with this goal, a wide array of technology is used throughout MHS on a daily basis, including smart infusion pumps that are integrated with the EMR, IV workflow management software, an automated tray management system, and an automated inventory management system. With technology at the forefront of initiatives at MHS, the decision to implement a CSTD for HD compounding and administration was simple. The process to do so, however, was more complex and required a committed effort from a multidisciplinary team.
Gaining Buy-In for CSTD Use
With regulatory bodies, such as The Joint Commission, enforcing USP <800> standards, obtaining support from administration for adopting CSTDs was necessary; pharmacy leadership initiated transparent conversations with key stakeholders to communicate the need for CSTDs. A number of CSTD vendors were asked to provide literature demonstrating how their device’s mechanisms prevent HD exposure, which was shared with hospital administrators. After gaining the necessary support, pharmacy leadership followed the hospital’s budget process to request funding for CSTDs.
In addition to gaining administration’s support, obtaining buy-in from the health care team was imperative. Education was provided to increase awareness about the risks of HD exposure, how the risks can be mitigated, which medications are considered hazardous and why, and how HDs can be identified. Staff members at JDCH who worked in oncology were already well versed in the risks of hazardous medications; however, the inclusion of non-antineoplastic agents in the definition of HDs was something many were not familiar with.
Selecting a CSTD
Several factors were considered when determining which CSTD to purchase; efficacy, ease of use, and cost were the most critical. Given the lack of a universal performance standard for CSTD evaluation, independent research and reviews of published literature were required to determine each CSTD’s ability to contain environmental contaminants. JDCH nursing and pharmacy leadership sought a device with a limited number of pieces that was easy to manipulate. Identifying a product and negotiating a contract with an affordable cost ensured use of the CSTD could be sustained and potentially expanded to encompass other HDs. Additional factors considered included the ease of purchasing and the level of product support offered by the CSTD manufacturer.
Because USP <800> requires the use of CSTDs for antineoplastic medication administration, it was essential to involve nursing in the selection process. At JDCH, nursing leadership and educators were involved at the outset. In response to the request for proposal, the CSTD vendors presented information about their products to a value analysis team, which comprised nurses, pharmacists, pharmacy technicians, and supply chain leaders. The team evaluated the devices and then voted on which CSTD to select.
Nursing and pharmacy worked closely to determine what workflow changes would be necessary to utilize the chosen CSTD. For example, chemotherapy IV bag tubing would no longer arrive from the pharmacy primed. The addition of CSTDs for administration allowed nursing the ability to back prime the tubing prior to administration while maintaining the closed system.
After the CSTD was selected, the multidisciplinary management team met with the vendor to establish a timeline for implementation and training. To ease the implementation process, the decision made at JDCH was to go live with CSTDs only for antineoplastic agents at first. Those items that would not be compounded or administered via a CSTD were identified (see TABLE 1).
Implementation began with training on CSTD use for the nurses, pharmacy technicians, and pharmacists who would be utilizing the device. In the weeks prior to onsite CSTD training, staff members viewed training videos created by the selected vendor to establish baseline knowledge of CSTDs. Thereafter, the vendor’s representatives commenced multiple days of hands-on, onsite training. During this time, training presentations were developed by nursing and pharmacy leadership to use for the initial staff training and as a reference post go-live. The vendor provided a competency checklist, which pharmacy leadership updated to include CSTD practices specific to JDCH (see FIGURE 1). The checklist confirmed and documented that team members received proper CSTD training. Moreover, nursing and pharmacy superusers were identified to serve as CSTD training resources post go-live.
Managing CSTD-Incompatible HDs
Incompatibility of HDs with CSTDs is a topic requiring careful consideration. Certain medication components, such as N, N-dimethylacetamide (DMA), are known to be incompatible with CSTDs that contain polycarbonate or acrylonitrile-butadiene-styrene. When exposed to DMA, the polycarbonate or acrylonitrile-butadiene-styrene can dissolve, which may lead to device failure.6 Medications that contain DMA include busulfan, amsacrine, and a brand of bendamustine hydrochloride liquid (Treanda).7
Pharmacy leadership must be aware of such incompatibilities and establish clear workflow recommendations for the compounding and administration of these medications. If conducting an assessment of risk for hazardous medications, possible incompatibilities between medications and CSTDs used by the organization should be addressed.
Documenting CSTD Use
At JDCH, the pharmacy technicians utilize the IV workflow management system to take pictures of all parenteral antineoplastic doses prepared. The technicians include pictures of the CSTD pieces used to prepare each dose when documenting dose preparation; in addition, they include the CSTD in the image of the final dose. Exceptions may arise for items that are in large bags or are too big to fit in the pictured area. Additionally, if the IV workflow system must be bypassed for the preparation of a specific dose, the images will not be captured, and an alternative process for identifying the use of a CSTD is necessary, such as manual documentation on a dose dispensation log.
JDCH currently does not have a process in place for documenting that a CSTD has been used during HD administration. However, the JDCH chemotherapy administration policy was updated to reflect that CSTD use is mandatory during HD administration. In addition, practice change occurred following the implementation of CSTDs, which made utilization of a CSTD for IV antineoplastic agents the expectation.
CSTD use at JDCH has provided an added layer of protection from HD exposure for our employees. Looking to the future, a universal performance standard for CSTD evaluation is needed to determine the ability of the CSTD to contain environmental contaminants. The National Institute for Occupational Safety and Health (NIOSH) is developing a unified CSTD test protocol that could be used to evaluate both air cleaning and barrier-type CSTDs. Until this is established, independent research and published literature must be carefully evaluated to ensure appropriate protection is provided to health care workers.
Joanie Spiro Stevens, PharmD, BCPS, BCPPS, is the pharmacy clinical coordinator, PGY2 pediatric pharmacy residency program director, and pediatric hematology/oncology pharmacy manager at Joe DiMaggio Children’s Hospital (JDCH) in Hollywood, Florida. She received her PharmD from the University of Florida College of Pharmacy.
Leyner Martinez, PharmD, MS, MHA, is the director of pharmacy services at JDCH. He received his PharmD from the Lake Erie College of Osteopathic Medicine (LECOM) school of pharmacy.
Courtney Trace, RN, BSN, is the nurse clinician for inpatient and outpatient pediatric hematology-oncology and clinical grand rounds coordinator at JDCH. She received her Bachelor of Science in nursing from University of Florida College of Nursing. Her professional interests include the pathophysiology and treatment of sickle cell disease and care of central lines.
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