AnnMarie L. Walton, PhD, MPH, RN, OCN, CHES
Duke University School of Nursing
Seth Eisenberg, RN, OCN, BMTCN
Professional Practice Coordinator for Infusion Services
Seattle Cancer Care Alliance Ambulatory Clinic
MiKaela Olsen, DNP, APRN-CNS, AOCNS, FAAN
Oncology and Hematology Clinical Nurse Specialist
Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins Hospital
Pharmacy Purchasing & Products: How important is the use of closed system drug-transfer devices for preparing and administering hazardous drugs in compliance with USP <800>?
AnnMarie Walton: The National Institute for Occupational Safety and Health (NIOSH) Hierarchy of Controls is an informative framework for hazard prevention and control (see FIGURE 1).1 Because the most effective controls, elimination and substitution of hazardous drugs (HDs), are not possible in the hospital environment, closed system drug-transfer devices (CSTDs) provide an engineering control that isolates HDs from health care workers. Although many nurses and pharmacists have used CSTDs for years, USP <800> marks the first time that the devices are required for HD administration; USP <800> also recommends CSTD use for preparation of HDs.
Seth Eisenberg: HD administration occurs in a less controlled environment in comparison to HD compounding, where drug preparation is conducted in a relatively confined area and is sequential by design. Although HDs handled by nurses are considerably more dilute than HDs handled in the pharmacy, there are multiple avenues for HD exposure to occur. For example, some circumstances, such as how the tubing is primed and connected to the pump and patient, are within the control of the nurse, whereas other situations, such as accidental patient disconnection, may not be controllable. Use of a CSTD adds a layer of safety throughout the entire medication-use process: from compounding, transporting, connecting and disconnecting to the patient, to disposal.
MiKaela Olsen: HD surface contamination increases the potential for dermal exposure, and CSTDs can be employed to minimize this risk. When the devices are utilized during compounding and then dispensed on the HD bag or tubing, the nurse is thereby protected when spiking and pushing HDs. Nurses must use CSTDs while administering HDs, and whenever a connection needs to be opened. Evidence also suggests that using CSTDs may help reduce the risk of HD spills.2
PP&P: What CSTD training should be in place for pharmacy and nursing?
Eisenberg: Always begin with initial training by the CSTD manufacturer, as the vendor’s representatives are experts in using their devices. I have spoken with nurses who have had major HD leaks and exposure resulting from poor education. I have also spoken with pharmacists who had unfortunate experiences with devices because they had not been correctly trained on how to use them. Such experiences not only unfairly influence a CSTD trial, but they can result in a general attitude that CSTDs are too much trouble. Thus, be sure all pharmacy and nursing staff receive robust education prior to compounding or administrating HDs with a CSTD.
Institutions must have an education plan in place for training new staff, who are more likely to experience a spill due to an incomplete understanding of how a device works. Training also should be included in an annual HD safety competency to ensure that practice drift does not occur.
Olsen: The most important initial steps are to document workflows and develop corresponding protocols. While a CSTD manufacturer’s representatives can provide effective hands-on training on how to use a device, they may not be familiar with the specific type of IV pumps or tubing used at your facility. Therefore, nurse educators, nurse managers, lead nurses, and/or clinical nurse specialists employed by the organization must champion the changes associated with implementing CSTDs for drug administration. Similarly, a pharmacy champion should support CSTD use for compounding.
Standardizing procedures and providing detailed guidance for the integration of CSTDs into nursing administration processes is critical. Train using an actual IV pump and CSTDs in common drug administration scenarios. Education should start with the instructions for use of the device; in addition, this is a perfect opportunity to educate or re-educate staff about the evidence related to HD exposure and risk prevention strategies to increase the likelihood that nurses will use CSTDs and PPE consistently. Nurses must understand the why behind any new practice, especially if the new practice requires an increased time commitment.
PP&P: How can pharmacy gain buy-in from administration to support safety initiatives, including CSTD purchases?
Eisenberg: Gaining support for CSTD use begins by establishing a culture of safety. If the institution has already made this commitment, then utilizing CSTDs is simply another link in the safety chain. But for institutions that have resisted CSTDs, it is best to start by presenting the studies that identify the risks associated with HD exposure. A wealth of information has been amassed since the early 1980s and it is now impossible to deny the dangers associated with HD handling (see: www.cdc.gov/niosh/topics/hazdrug/resources.html).
The next step is to discuss how HD exposure occurs. Recent wipe test studies have repeatedly shown significant levels of HD residue in pharmacies, and especially in administration areas, when CSTDs are not utilized.3-6 These studies illustrate the fact that HD residue commonly appears on objects that C-suite executives are familiar with: computer mice, keyboards, pens, telephones, and doorknobs. To reduce HD contamination, it is critical to establish how residue is tracked through a facility. While investigations often point to complex causes, the common thread is that drug leakage occurs at multiple points, from compounding to administration to disposal.
To look at this in another way, CSTDs are analogous to air bags in cars. Air bags do not replace seat belts; nevertheless, they are required because they reduce death and injury. While CSTDs will not prevent 100% of all HD exposures, their use will significantly reduce the amount of HD exposure in the work environment.
Olsen: The most important factor in gaining administration’s support for safety initiatives is interprofessional collaboration. Nurses, technicians, pharmacists, and administration should meet and tour one another’s practice settings, in order to fully understand each other’s workflows. This partnership, as well as continuous, open communication, is key to successful collaboration.
PP&P: How can an organization improve its culture of safety in terms of HD handling?
Walton: Studies have shown that the safety climate in the workplace (ie, perceptions of organizational leadership’s approach to safety) is a predictor of how much PPE staff use, and in turn, how safely they maintain the environment in which they work.6-8 Thus, management must value and model safe behaviors in the workplace. We know that the majority of exposures to HDs are dermal and that engineering controls (such as CSTDs), training, and the use of PPE are effective at decreasing the amount of contamination in the work environment. Keeping our workplaces safe is a shared responsibility of all employees.
Eisenberg: Administration first must understand the risks and be actively committed to keeping their employees safe. Maintaining a culture of safety is a multifaceted responsibility, requiring a multidisciplinary approach.
Olsen: Identifying a safety champion in both the pharmacy and nursing environments is paramount. Hospital leadership must be committed to employee safety. Whether in a physician practice or a large academic hospital, nurses, technicians, and pharmacists deserve to be protected when caring for patients, regardless of the setting.
AnnMarie L. Walton, PhD, MPH, RN, OCN, CHES, assistant professor at the Duke University School of Nursing, has worked in oncology for 16 years. Her program of research focuses on understanding and minimizing occupational exposures to carcinogens. AnnMarie is active in local, state, and national legislative efforts to afford more protections to health care workers handling antineoplastic drugs.
Seth Eisenberg, RN, OCN, BMTCN, professional practice coordinator for infusion services at the Seattle Cancer Care Alliance Ambulatory Clinic, has worked in the field of oncology since 1983. His experience includes 34 years in hematopoietic stem cell transplantation.
MiKaela M. Olsen, DNP, APRN-CNS, AOCNS, FAAN, is an oncology and hematology clinical nurse specialist at the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Hospital in Baltimore, Maryland. She also serves as adjunct faculty for the Johns Hopkins School of Nursing and as a faculty associate at the University Of Maryland School of Nursing. MiKaela received her BS in nursing from Texas Christian University in Fort Worth, Texas, and an MS with special emphasis in oncology nursing from the University of California at San Francisco. She graduated with her Doctor of Nursing Practice degree from the University of Maryland in 2019.