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Selection of Closed-System Transfer Devices: Tips for Engaging Nursing and Pharmacy Stakeholders in Purchasing Decisions

March 24, 2016
Michael R. Page, PharmD, RPh

 

The first closed system drug transfer device (CSTD) was approved by the FDA in 1998 for prevention of hazardous drug leakage into the environment. Since then, several products have been approved, each with different characteristics. A selection of available products is listed in the Figure.1,2

 All CSTDs have several factors in common2-4:

• CSTDs are supplemental engineering controls designed to protect health care professionals from hazardous medications.

• CSTDs equalize the pressure gradient between the syringe and the container from which liquid medication is drawn or expelled, reducing the risk that hazardous medication will escape into the surrounding environment.

• CSTDs are used in both compounding and administration of hazardous medications.

However, CSTDs also vary in several respects, including2-4:

• Ease of use

• The quality of data supporting each product’s performance in containing medication and reducing worksite contamination

• The type of interface between the syringe and the infusion set or vial

• Compatibility with bedside use by nurses and compounding use by pharmacists

• Plastic components in CSTDs are not compatible with all chemotherapeutic medications; reviewing compatibility before using a CSTD with reactive medications is critical to operational safety

 Considering these and other factors is important in determining which CSTD is appropriate for a given institution. Because CSTDs can be used in both compounding in the pharmacy and bedside administration of chemotherapeutic drugs, selection of a CSTD is a multidisciplinary process that may involve discussions between nursing directors and pharmacy directors.4

 Currently, many hospitals do not have access to CSTD systems. In a 2011 survey of 1401 pharmacy directors at hospitals throughout the United States conducted by Pederson and colleagues, researchers found that CSTDs were used in 41% of all hospitals. Of these hospitals, the vast majority (92%) used CSTDs in compounding medications, while a smaller percentage (70.2%) used CSTDs during bedside administration.5

 In hospitals where CSTDs are unavailable, nurses administer chemotherapeutic medications to patients without the benefit of these devices. As a result, nurses may be exposed to hazardous drugs, potentially leading to adverse health effects. In the coming years, CSTDs will be used in most hospitals as a result of a provision in USP <800>. This provision mandates that nursing departments have access to CSTDs when administering chemotherapeutic medications to patients.6

 Recent data indicate that hospital pharmacy departments are slightly more likely to have access to CSTDs than hospital nursing departments. In a 2014 survey of US hospitals, 35% of pharmacy departments were estimated to have access to CSTDs versus 32% of nursing departments. When the provisions of USP <800> are adopted by state pharmacy boards, this difference in access is likely to reverse, with more nursing departments than pharmacy departments having access to the technology.6

 The potential disparity in access to CSTDs between pharmacy and nursing departments is one reason why pharmacy department leaders would be wise to discuss CSTD systems with nursing departments to ensure that all stakeholders ultimately have access to systems that are optimized for use in both pharmacy and nursing environments. Without the additional protection of CSTDs, both pharmacists and nurses may be at increased risk of health effects occurring secondary to hazardous drug exposure. 7,8

 In a 1999 study published in the Journal of Occupational and Environmental Medicine, Valanis and colleagues analyzed pregnancy outcomes in nearly 3000 nurses, pharmacists, and pharmacy technicians and compared those outcomes with those in more than 4000 women who were not health care workers. In health care workers, spontaneous abortion or stillbirth was 40% more likely (OR 1.4; 95% CI, 1.2 to 1.7) to occur in individuals who reported handling hazardous drugs.7

 In 2010, McDiarmid and colleagues published a study in the Journal of Occupational and Environmental Medicine identifying a higher rate of chromosome 5 and 7 abnormalities among health care workers frequently handling antineoplastic medications than in health care workers who handled such medications less frequently.8 Researchers collected blood samples from more than 100 health care workers and analyzed the likelihood of chromosomal abnormalities related to the frequency of hazardous drug handling in each individual. Study results indicated significantly higher rates of structural chromosomal abnormalities in a high-exposure subset of health care workers than in a low exposure group (0.18/ person vs 0.02/person, respectively; P = .04). Significant outcomes included a 24% greater risk of chromosome 5 abnormalities (P = .01) and a 20% greater risk of chromosome 5 or 7 abnormalities (P = .01) in high-exposure individuals.8

 Considering that both pharmacists and nurses may have an elevated risk of adverse health outcomes as a result of exposure to hazardous drugs, both pharmacists and nurses would ideally have access to CSTDs. However, CSTD devices that may be ideal for use in the pharmacy may not be ideal for administration of medication. For some institutions, CSTDs for nursing personnel may be different from the CSTDs used by pharmacy personnel.1,7,8

 Because pharmacists use CSTDs in controlled compounding environment, they are less likely to be concerned about needle sticks. However, nurses administering medication at the bedside may be more amenable to using a CSTD that does not have a metal needle, which may reduce the risk of accidental puncture wounds.

 Some CSTDs may also not be compatible with a hospital’s existing intravenous administration equipment. The extra cost of these proprietary administration sets and the training required to implement their use may lead some nursing departments to find this aspect of certain CSTD systems unfavorable.

 The closing mechanism of the CSTD system, assembly requirements, and integration with automated systems are also important considerations to discuss, as the importance of these factors may vary between pharmacist and nurse stakeholders. For instance, pharmacists may be more concerned about the potential for repetitive stress injury if a product requires intensive manipulation for use, whereas nurses may be more concerned about safeguards ensuring that CSTD components are firmly joined together before use.

 Regardless of the differences between the needs of nursing departments and pharmacy departments, the primary concern with any CSTD system is the quality of the evidence showing that these systems prevent the escape of hazardous drugs. For example:

• More than 25 published studies support the performance and efficacy of the BD PhaSeal System in protecting health care workers from hazardous drugs.9

• In a 2003 study, Wick and colleagues determined that the BD PhaSeal system led to real-world reductions in personnel exposure. Before, and 6 months after implementation of BD PhaSeal CSTD use in a hospital pharmacy, all personnel were evaluated using 24-hour urine samples. Of 8 employees, 6 showed evidence of exposure to cyclophosphamide and 2 showed evidence of ifosfamide exposure prior to use of the BD PhaSeal System. After implementation, none of the 8 employees had evidence of cyclophosphamide or ifosfamide in urine samples.10

• In a 2011 study, Sessink and colleagues reported levels of surface contamination of antineoplastic drugs in 22 US hospitals before and several months after adoption of the BD PhaSeal CSTD system. Researchers, however, found significantly lower levels of surface contamination for all 3 antineoplastic drugs sampled: cyclophosphamide (95% reduction; P <.0001), ifosfamide (90% reduction; P <.001), and 5-fluorouracil (65% reduction; P <.01).11

• In a 2013 study, Clark and colleagues reported the efficacy of the EquaShield CSTD on reducing surface contamination at a single cancer center before and after the system’s adoption. Researchers used a kit to collect samples from 5 areas of the pharmacy, 5 areas of the infusion suite, and 2 areas in offices. Approximately half of the samples showed contamination before, but no contamination with cyclophosphamide or 5-fluorouracil in the pharmacy was identified in the final sample collection.12

Protective efficacy of CSTD systems is the most important consideration for both pharmacy and nursing stakeholders. However, other considerations may also be worth discussing. Some of these considerations are discussed in the Table.

 Although pharmacy and nursing departments share the common goal of providing optimal patient care, departments may have different priorities and needs that may affect departmental CSTD preferences. As a result, proactively discussing CSTD systems and their use across departments is an important component of smooth implementation of USP <800>. Proactive engagement now may help ensure that more pharmacies and nursing departments have access to CSTDs with qualities well suited to both practice settings.

References

1. Massoomi F. The Evolution of the CSTD. Pharm Purch Prod. 2015;12(2).

2. FDA. 510(k) Premarket Notification Database. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.

3. Page MR. Protecting health care workers from chemotherapeutic medication. Specialty Pharmacy Times website. www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2015/june-2015/protecting-health-care-workers-from-chemotherapeutic-medication. Published June 9, 2015. Accessed September 2015.

4. Page MR. USP <800>: new regulations to protect health care workers from hazardous drugs. Specialty Pharmacy Times website. www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2015/april-2015/usp-800-new-regulations-to-protect-health-care-workers-from-hazardous-drugs. Published April 15, 2015. Accessed September 2015.

5. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration–2011. Am J Health Syst Pharm. 2012;69(9):768-785.

6. Massoomi F. USP <800> and the expected impact on health systems. http://www.pharmacyadvisor.com/resources/uploads/webinar_handouts/55/usp_800_and_the_expected_impact_on_health_systems.pdf. Accessed September 2015.

7. Valanis B, Vollmer WM, Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. J Occup Environ Med. 1999;41(8):632-638.

8. McDiarmid MA, Oliver MS, Roth TS, Rogers B, Escalante C. Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs. J Occup Environ Med. 2010;52(10):1028-1034.

9. BD Phaseal Studies. BD website. www.bd.com/pharmacy/phaseal/evidence/studies.asp. Accessed September 2015.

10. Wick C, Slawson MH, Jorgenson JA, Tyler LS. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J Health Syst Pharm. 2003;60(22):2314-2120.

11. Sessink PJ, Connor TH, Jorgenson JA, Tyler TG. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed-system drug transfer device. J Oncol Pharm Pract. 2011;17(1):39-48.

12. Clark BA, Sessink PJ. Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents. J Oncol Pharm Pract. 2013;19(2):99-104.