Read Part 1 of this article online at: pppmag.com/3Perspectives
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: What are key considerations for utilizing CSTDs for HD administration versus preparation?
Walton: Choosing CSTDs for HD administration should be a joint decision between nursing and pharmacy. It is critical to evaluate how CSTDs work on a variety of delivery devices (eg, pediatric syringe pumps vs adult IV pumps) and be sure that they are compatible with existing pumps and tubing. These are important concerns that may not be top of mind for pharmacy.
In addition, if a CSTD can be used for the particular route/dosage, it must be used. For example, a CSTD cannot be used for oral chemotherapy but can be used for most other forms. Subcutaneous administration is often in the spotlight as being cumbersome for use with a CSTD, but it can be done with education and practice.
Eisenberg: Pharmacists and pharmacy technicians utilize engineering devices (eg, C-PECs) that afford limited protection from HD exposure. Should HDs be compounded via traditional methods using needles, everything that leaves the pharmacy has the potential to be contaminated, including the exterior of the IV bags and even the IV tubing, if the drug is primed in the pharmacy. Therefore, while USP <800> does not require CSTDs for compounding, CSTDs should be utilized to protect staff and to mitigate transference of drug residue to the patient care areas. Not only is this important to protect nursing staff, but consider that unlike pharmacy cleanrooms, patient care areas are heavily trafficked by ancillary staff and visitors.
The spread of HD residue to personnel not involved with HD administration has been detailed in a series of studies, one of which identified the support staff in the oncology unit as having the highest amount of HD residue on their hands. These employees also had the highest levels of HDs in their urine, demonstrating that once the HD leaves the pharmacy, its residue can travel to multiple locations and affect a significant number of personnel.1,2
CSTDs have evolved in recent years; multiple options are currently available for adding the drug to the IV bag and for attaching the tubing. All CSTD manufacturers offer variations on direct spikes, which facilitate compounding with a CSTD and allow the nurse to safely connect IV tubing with a mating CSTD. This is significant for pharmacy, because it eliminates the burden of priming IV tubing in the pharmacy and also removes the tubing from the BSC, where workspace is limited. Another variation is the dry spike, which also utilizes a CSTD for compounding; their reinforced design allows nurses to spike neutrally primed tubing without risk of puncturing the HD bag.
Determining the best option may depend on nursing workflow (eg, whether drugs are administered via primary or secondary tubing sets). Our clinic, the Seattle Cancer Care Alliance Ambulatory Clinic, switched from having pharmacy pre-prime secondary sets with normal saline to using a direct spike, and it immediately freed up 3 hours of pharmacy technician time every day, as they no longer had to prime these sets with a neutral solution. Moreover, the process added virtually no additional time to the nursing workflow.
Olsen: Numerous infusion pumps, tubing sets, syringes, and CSTDs are available for purchase. Therefore, each organization must standardize nursing HD administration workflows for different types of administrations (eg, IV, IV push, intramuscular, intracavitary) to ensure that protocols, education, and training are consistent and that CSTDs are used correctly and consistently. Be sure to dedicate sufficient time to these tasks, as they are essential to the success of an HD containment program.
PP&P: What role do CSTDs play in a comprehensive safety plan to minimize HD exposure?
Walton: USP <800> covers the entire lifecycle of a drug, from the time that it enters the facility until it is disposed. CSTD use serves as one part of a comprehensive plan to minimize exposures to all health care workers who come into contact with HDs, as well as to the environment.
Eisenberg: Over the years, pharmacy and nursing leadership have correctly emphasized the importance of using personal protective equipment (PPE). However, it is important to note that metaphorically, PPE is simply the bandage applied to a bleeding wound, while CSTDs are designed to prevent the bleeding from occurring in the first place, hence their higher level in the NIOSH Hierarchy of Control pyramid.3 Preventing HD leakage into the environment is crucial, as contamination can spread like a virus and is notoriously difficult to detect and eliminate.
Olsen: Reducing surface contamination and spills is a goal of any HD risk reduction strategy, and CSTDs are a critical part of a safety program to reduce the risks associated with HD use. In addition, note that surface wipe study results can be leveraged to demonstrate the importance of drug containment strategies, and to improve staff compliance with PPE and CSTD use.
PP&P: What is the process for choosing a CSTD, and who should be involved?
Eisenberg: Although it is possible for nursing to choose and utilize a CSTD without pharmacy participation, ideally this should be an interdepartmental process. Devices that work well in the pharmacy may not work well for nursing, depending on the brand of needless connectors and/or IV pumps used.
Because an approved, standardized CSTD efficiency test is not yet available, it is difficult to ascertain how well a device contains HDs. While published literature supporting the use of select devices is available, it is problematic to compare results from studies conducted under different conditions by different labs; CSTDs should be tested side-by-side, using an approved protocol, by an independent laboratory, in order to determine which devices are truly closed systems. However, note that while some devices may be more effective than others, using any CSTD is preferable to not using one at all.
To choose a device, trial at least two CSTDs in both pharmacy and nursing areas, using evaluation tools specific to each area. It is also important to note that some organizations may opt to use different CSTDs for HD compounding and administration. This hybrid approach, while potentially more complex, can prove effective in achieving one of the main objectives of CSTD use—compliance. Forcing nurses to use a device that does not integrate well with existing equipment results in poor compliance, with nurses simply removing or failing to use the CSTD, negating the entire objective of CSTD use and wasting valuable financial resources.
Olsen: My organization, Johns Hopkins Medical Institute, found it helpful to use a lemon juice litmus test to detect leakage when evaluating CSTDs. Vapor tests have also been published to help evaluate devices.4 Ideally, one CSTD should be used for both compounding and administration; thus, I agree it is important that compatibility be assessed with both pharmacists and nurses at the table. Until an approved testing procedure is available, use the best available evidence to choose a CSTD. We have found that the most critical determinations when choosing a CSTD are effectiveness and ease of use. Note that if pharmacists attach a CSTD to the HD prior to dispensing and nursing has to remove it and apply a different CSTD, the risk of exposure is increased.
PP&P: How often should organizations evaluate the new or updated CSTDs that enter the market?
Eisenberg: It is prudent to keep abreast of evolving technology, as a CSTD that has worked well for several years may still be improved upon. Conversely, if the current device works as designed and there are no chronic challenges (eg, failure rate, difficulty in training, recurrent back orders, etc), then change only for the sake of change is unwarranted.
Olsen: I look forward to new and improved technology in this field. CSTD users should maintain awareness of product upgrades, be involved in testing new devices, and provide constructive feedback to the manufacturers regarding improvements.
With the emergence of a CSTD testing protocol, product switches may be necessary, and our CSTD choices may become more limited. Nurses, pharmacists, and technicians must evaluate any new evidence together and make decisions accordingly.
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