ChemoCLAVE from ICU Medical

July 2010 - Vol. 7 No. 7 - Page #14

The Cancer Therapy & Research Center (CTRC) is an academic-based, multidisciplinary outpatient cancer center serving under the leadership of the University of Texas Health Science Center at San Antonio. Including two major campuses and three satellite locations, CTRC brings together physicians and staff specially trained in all forms of cancer treatment and offers a full spectrum of clinical and support services to meet the needs of the patient, from diagnosis through treatment, rehabilitation, discharge, and follow-up care. CTRC also has affiliations with three area hospitals that provide inpatient care when needed.

The pharmacy at CTRC is staffed with five full-time pharmacists, three full-time technicians, as well as a technician devoted to drug assistance programs. We compound approximately 35 to 40 treatments a day, 60% in the form of conventional chemotherapy. The remaining 40% of our compounded medications consist of investigational drug therapies. The only non-chemotherapy products we handle are used for conditions related to cancer treatment such as hydration therapy and antiemetic and bisphosphonate drugs.

Adopting the Right System
At CTRC, we have been using vial transfer devices to complement our aseptic compounding technique for several years now. When I joined CTRC three years ago, we were using a different transfer device, but realized over time that our nursing staff was bypassing the device. When pharmacy would send a chemo compound with the transfer device applied, the nurses would commonly remove the adapters, throw them away, and attach the bag’s line directly to the patient’s IV line. Upon review of this process, nursing informed us that they found the system too cumbersome and frustrating to use. Given the recent influx of vial transfer devices in the market, it was time to identify a system that would better fit our operations.

After a formal review of the available systems, nursing and pharmacy collectively agreed that ICU’s ChemoCLAVE system was easy to use and front-line staff felt comfortable with it. Pharmacy was satisfied from an antineoplastic safety standpoint, but as with any medical device, it is only effective if used properly. For a device that will be used by multiple departments, all parties need to be involved in the decision-making process, and a consensus must be reached. If one group attempts to force its opinion on the other, the outcome is usually not beneficial to either group. Collectively, test as many systems as you can to identify the one that best fits your operations. What works at another institution may not work for you, so it is best to conduct your own evaluations rather than rely on someone else’s opinion.

Using the System
The ChemoCLAVE system consists of the Genie—a needle-free, closed vial-access device designed with an internal balloon for extracting hazardous medications from vials and closed bags—and the Spiros—a closed male connector with an integrated locking spin collar. Once the Spiros is attached to any male luer-lock device, it will remain permanently attached. The Spiros remains closed whenever it is disconnected to protect the integrity of the IV fluid container, whether it is on a syringe for transfer or on the end of an IV set. The clave is the one-piece, closed, needle-free connector that attaches to both the Spiros and the Genie. One of the reasons we chose the ChemoCLAVE system was because the Spiros collar, once attached, cannot be removed from the syringe. Thus, we are assured that the nursing staff is using the vial transfer device during administration.

When we first agreed to field test the system, ICU sent us a week’s supply of devices, a common practice for transfer device suppliers. We were then able to test the device in real applications. ICU also had representatives on-site to train and help pharmacy and nursing staff with any questions. The training process was straightforward and our users found the devices to be intuitive. Our selection criteria included ease-of-use, cost, safety, and overall satisfaction with the system. After asking both nursing and pharmacy personnel as to which system best fit these criteria, the ChemoCLAVE was the unanimous choice.

Weighing the Pros and Cons
While vial transfer devices are generally not required, most regulatory bodies recommend using these devices to bolster patient and staff safety. In light of this, it is important to weigh the benefits based on your own criteria. In our case, moving from one type of transfer device to another was not a cost issue, as both devices cost about the same per unit. The ease of use identified by our nursing staff combined with outstanding customer service were the determining factors for us. The team at ICU is always available and they are committed to improving and expanding the use of the system.

Future Improvements
The nature and function of drug delivery is constantly changing. Particularly with chemotherapy agents, there are often unique formulations that require filters or special tubing that needs to be primed. ICU has been open to these concepts and is working on developing a clave system with built-in filters. The company also is looking at adaptors for the different vial sizes on the market. Additionally, drug makers continue to transition chemotherapy from IV to PO. All of these changes will require additional methods to ensure safe handling. Providing feedback to your vendor can help shape the course of these safety measures.

While ensuring the safe handling of hazardous drugs throughout your institution may seem somewhat daunting, implementing a vial transfer device is a fairly easy step to assist in that endeavor. Keep in mind that any device is only as effective as the operator’s technique, making ongoing training imperative. Using both proper aseptic technique and a drug transfer system that is comfortable for pharmacy and nursing is paramount.

Scott Soefje, PharmD, BCOP, is director of the investigational drug section of the Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio. He earned his bachelor’s degree in pharmacy from The University of Texas in 1985. Following almost five years of hospital practice, he earned a PharmD from the combined program at The University of Texas Health Sciences Center at San Antonio and The University of Texas at Austin. Scott was a founding faculty member at the Texas Tech Health Sciences Center School of Pharmacy, and has practiced as a hematology/oncology specialist at The University of Texas Medical Branch, and as the oncology clinical pharmacist and oncology residency director at the South Texas Veterans Health Care System. Scott was board certified in oncology pharmacy in 2000 and re-certified in 2007.



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