K. Kicenuik1, N. Northrup1, A. Dawson1, J. Locke2, J. A. Villamil3, J. Chretin4, G. Sfiligoi5, C. Clifford6, M. Rosenberg7, T. Hamilton8, R. Regan8, M. ParsonsDoherty9,‡, C. Mallett10, J. Philibert11, J. Impellizeri12 and E. Hofmeister1
1Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA
2Southeast Veterinary Oncology, Orange Park, FL, USA
3Animal Cancer Care Clinic, Ft. Lauderdale, FL, USA
4VCA West Los Angeles Animal Hospital, Los Angeles, CA, USA
5Wheat Ridge Animal Hospital, Wheat Ridge, CO, USA
6Hope Veterinary Specialists, Malvern, PA, USA
7Veterinary Cancer Group, Woodland Hills, CA, USA
8BluePearl Georgia Veterinary Specialists, Sandy Springs, GA, USA
9Department of Small Animal Medicine and Surgery, University of Guelph Ontario Veterinary College,
Guelph, Ontario, Canada
10Columbia River Veterinary Specialists, Vancouver, WA, USA
11Portland Veterinary Specialists, Portland, ME, USA
12Veterinary Oncology Services, NY, Middletown, NY, USA
In 2004, the NIOSH published the alert, ‘Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings’.1 In that alert, use of closed-system transfer devices was recommended. Since then, the United States Food and Drug Administration (FDA) created a product code (ONB) for closed antineoplastic and hazardous drug reconstitution and transfer systems to ensure their efficacy and inform health care professionals. Clearance of these devices by the FDA is based on prevention of escape of hazardous drug into the environment and transfer of environmental or microbial contaminants into the drug. Our study evaluated the efficiency, EOU, and cost of two FDA-approved CSTD, Equashield™and PhaSeal®. Based on the results presented here, use of a CSTD does not increase administration time of IV bolus chemotherapy. Both systems were readily accepted and recommended over no CSTD by VT who administered chemotherapy as part of their primary job responsibilities. Equashield™ was easier to use, but neither closed system was rated more difficult to use than no CSTD. For bulk purchases, Equashield™ would be more cost effective. For an individual unit or small numbers of units, PhaSeal® would be more cost effective.
Participating VT rapidly gained familiarity and skill with CSTD use, whether or not they had previous experience with Equashield™ or PhaSeal®. Administration time became significantly faster for both closed systems as VT progressed from the first to tenth simulation. In fact, by the 10th administration, administration times were faster for Equashield™ than for no CSTD.
While administration times were fastest with Equashield™, it must be acknowledged that the 2-5s difference between median administration times would not appreciably affect case flow. For example, in a practice administering 20 chemotherapy treatments per day, this would equate to 1–2 min saved. Importantly, however, neither CSTD was less efficient than no CSTD. Our results are in agreement with two other studies of antineoplastic drug preparation using PhaSeal® that demonstrated no impact on efficiency or significant time savings.11,17 Concern for decreased practice efficiency should not deter veterinarians from adopting CSTD use.
Perceived ease of use was significantly higher for Equashield™ (median VAS rating of 8.3/10, with 10 representing easiest possible) than PhaSeal® (6.3/10) or no closed system (6/10). Ratings of 6–8.3 suggest that chemotherapy administration with either or no CSTD requires training but is reasonably easy. Participating VT were much more likely to recommend use of a CSTD than no CSTD (median VAS ratings of 7.7/10 for Equashield™ and 6.8/10 for PhaSeal® versus only 1.8/10 for no CSTD, with 10 representing ‘would always recommend’), suggesting not just a willingness to accept use of CSTD in their practice, but that VT would actually promote use of the systems.
Technicians were asked to provide comments about their VAS ratings. They reported that Equashield™ was easier to learn how to use, less bulky, and easier to connect and disconnect, but they expressed concern about the security of the connection and fragility of the components. Subjectively, VT were more comfortable with the security of the PhaSeal® connection but reported that this system was more cumbersome, difficult to connect and disconnect, and time consuming to use, at least at first. Technicians commented that they were not likely to recommend use of no CSTD for chemotherapy administration due to occupational safety concerns. It is clear that VT in oncology specialty practice are aware of the dangers of chemotherapy exposure and are interested in implementing CSTD use in their practice. This study shows that CSTD are not difficult to use, and VT acceptance is high. These concerns should not impede their implementation in veterinary practice.
A weakness of this study is that 21 of 46 VT had experience using more than one CSTD or administering chemotherapy with and without a CSTD. During recruitment, we found that some VT using CSTD had experience administering chemotherapy with no CSTD prior to adoption of CSTD in their practice and some had used more than one CSTD system. In particular, because Equashield™ was newer, there were few sites using this system and most (11/15) VT using Equashield™ had experience with another CSTD or no CSTD.
Consequently, because we would not have been able to recruit a sufficient number of participants to carry out the study otherwise, we adjusted our recruitment goal to include 15 VT currently using each system or no CSTD, irrespective of previous experience.
Another point to consider is VT participating in this study worked in oncology specialty practice so their assessments of CSTD may not be representative of the opinions of all VT.
Additional costs of using CSTD in chemotherapy administration might be a concern for veterinarians and VT-treating cancer patients. Based on our cost analysis, an additional cost of $16–25 would be incurred to administer an IV bolus of chemotherapy.This does not seem prohibitive, especially when considering the value of these devices in protecting veterinarians, staff, and owners from exposure to hazardous agents. In addition, in a study performed by Edwards et al. 2013, the use of PhaSeal® resulted in a noticeable cost saving ($700,000/year in the pharmacy studied) by allowing the unused portion of single-use vial to be salvaged, thereby cutting down on drug waste.19 The cost of Equashield™ was approximately 65% of the cost of PhaSeal®, but this system is sold only in bulk quantities. Therefore, based on cost, Equashield™ is a reasonable choice for practices with a high volume of patients receiving chemotherapy and PhaSeal® for practices treating an occasional patient with chemotherapy.
This study demonstrates that the amount of time required to administer an intravenous dose of chemotherapy is not increased by the use of a CSTD. Equashield™ is easier to use, but both Equashield™ and PhaSeal® are reasonably easy to use and are recommended over no closed system by VT working in oncology specialty practice. CSTD are not cost prohibitive. These systems should be adopted by all veterinary practices administering cancer chemotherapy.
Figure 1. PhaSeal® closed system transfer device. The three main components are the protector (left), injector (bottom right) and connector (top right). The injector contains a needle enclosed within a protective sleeve sealed by a double membrane. It attaches to a syringe or IV tubing. The protector is a drug vial adaptor with a flexible expansion bulb that is permanently attached to the vial and used for closed drug reconstitution and pressure equalization. The connector attaches to an IV catheter to provide a closed connection with the injector.
Figure 3. Model canine antebrachium with cephalic vein catheter for simulated administration of chemotherapy.
Table 4. Median rating of how likely a veterinary technician (VT) would be to recommend a system to a colleague (with ranges) for no closed system transfer device (CSTD), Equashield™ or PhaSeal® by 46 VT following 10 trials with each system. Results are presented for all VT and grouped according to prior experience. Visual analog scale ratings were converted to 0–10 numerical values, with 0 indicating would never recommend and 10 indicating would always recommend.
K. Kicenuik1, N. Northrup1, A. Dawson1, J. Locke2, J. A. Villamil3, J. Chretin4, G. Sfiligoi5, C. Clifford6, M. Rosenberg7, T. Hamilton8, R. Regan8, M. ParsonsDoherty9,‡, C. Mallett10, J. Philibert11, J. Impellizeri12 and E. Hofmeister1
1Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA
2Southeast Veterinary Oncology, Orange Park, FL, USA
3Animal Cancer Care Clinic, Ft. Lauderdale, FL, USA
4VCA West Los Angeles Animal Hospital, Los Angeles, CA, USA
5Wheat Ridge Animal Hospital, Wheat Ridge, CO, USA
6Hope Veterinary Specialists, Malvern, PA, USA
7Veterinary Cancer Group, Woodland Hills, CA, USA
8BluePearl Georgia Veterinary Specialists, Sandy Springs, GA, USA
9Department of Small Animal Medicine and Surgery, University of Guelph Ontario Veterinary College,
Guelph, Ontario, Canada
10Columbia River Veterinary Specialists, Vancouver, WA, USA
11Portland Veterinary Specialists, Portland, ME, USA
12Veterinary Oncology Services, NY, Middletown, NY, USA
In 2004, the NIOSH published the alert, ‘Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings’.1 In that alert, use of closed-system transfer devices was recommended. Since then, the United States Food and Drug Administration (FDA) created a product code (ONB) for closed antineoplastic and hazardous drug reconstitution and transfer systems to ensure their efficacy and inform health care professionals. Clearance of these devices by the FDA is based on prevention of escape of hazardous drug into the environment and transfer of environmental or microbial contaminants into the drug. Our study evaluated the efficiency, EOU, and cost of two FDA-approved CSTD, Equashield™and PhaSeal®. Based on the results presented here, use of a CSTD does not increase administration time of IV bolus chemotherapy. Both systems were readily accepted and recommended over no CSTD by VT who administered chemotherapy as part of their primary job responsibilities. Equashield™ was easier to use, but neither closed system was rated more difficult to use than no CSTD. For bulk purchases, Equashield™ would be more cost effective. For an individual unit or small numbers of units, PhaSeal® would be more cost effective.
Participating VT rapidly gained familiarity and skill with CSTD use, whether or not they had previous experience with Equashield™ or PhaSeal®. Administration time became significantly faster for both closed systems as VT progressed from the first to tenth simulation. In fact, by the 10th administration, administration times were faster for Equashield™ than for no CSTD.
While administration times were fastest with Equashield™, it must be acknowledged that the 2-5s difference between median administration times would not appreciably affect case flow. For example, in a practice administering 20 chemotherapy treatments per day, this would equate to 1–2 min saved. Importantly, however, neither CSTD was less efficient than no CSTD. Our results are in agreement with two other studies of antineoplastic drug preparation using PhaSeal® that demonstrated no impact on efficiency or significant time savings.11,17 Concern for decreased practice efficiency should not deter veterinarians from adopting CSTD use.
Perceived ease of use was significantly higher for Equashield™ (median VAS rating of 8.3/10, with 10 representing easiest possible) than PhaSeal® (6.3/10) or no closed system (6/10). Ratings of 6–8.3 suggest that chemotherapy administration with either or no CSTD requires training but is reasonably easy. Participating VT were much more likely to recommend use of a CSTD than no CSTD (median VAS ratings of 7.7/10 for Equashield™ and 6.8/10 for PhaSeal® versus only 1.8/10 for no CSTD, with 10 representing ‘would always recommend’), suggesting not just a willingness to accept use of CSTD in their practice, but that VT would actually promote use of the systems.
Technicians were asked to provide comments about their VAS ratings. They reported that Equashield™ was easier to learn how to use, less bulky, and easier to connect and disconnect, but they expressed concern about the security of the connection and fragility of the components. Subjectively, VT were more comfortable with the security of the PhaSeal® connection but reported that this system was more cumbersome, difficult to connect and disconnect, and time consuming to use, at least at first. Technicians commented that they were not likely to recommend use of no CSTD for chemotherapy administration due to occupational safety concerns. It is clear that VT in oncology specialty practice are aware of the dangers of chemotherapy exposure and are interested in implementing CSTD use in their practice. This study shows that CSTD are not difficult to use, and VT acceptance is high. These concerns should not impede their implementation in veterinary practice.
A weakness of this study is that 21 of 46 VT had experience using more than one CSTD or administering chemotherapy with and without a CSTD. During recruitment, we found that some VT using CSTD had experience administering chemotherapy with no CSTD prior to adoption of CSTD in their practice and some had used more than one CSTD system. In particular, because Equashield™ was newer, there were few sites using this system and most (11/15) VT using Equashield™ had experience with another CSTD or no CSTD.
Consequently, because we would not have been able to recruit a sufficient number of participants to carry out the study otherwise, we adjusted our recruitment goal to include 15 VT currently using each system or no CSTD, irrespective of previous experience.
Another point to consider is VT participating in this study worked in oncology specialty practice so their assessments of CSTD may not be representative of the opinions of all VT.
Additional costs of using CSTD in chemotherapy administration might be a concern for veterinarians and VT-treating cancer patients. Based on our cost analysis, an additional cost of $16–25 would be incurred to administer an IV bolus of chemotherapy.This does not seem prohibitive, especially when considering the value of these devices in protecting veterinarians, staff, and owners from exposure to hazardous agents. In addition, in a study performed by Edwards et al. 2013, the use of PhaSeal® resulted in a noticeable cost saving ($700,000/year in the pharmacy studied) by allowing the unused portion of single-use vial to be salvaged, thereby cutting down on drug waste.19 The cost of Equashield™ was approximately 65% of the cost of PhaSeal®, but this system is sold only in bulk quantities. Therefore, based on cost, Equashield™ is a reasonable choice for practices with a high volume of patients receiving chemotherapy and PhaSeal® for practices treating an occasional patient with chemotherapy.
This study demonstrates that the amount of time required to administer an intravenous dose of chemotherapy is not increased by the use of a CSTD. Equashield™ is easier to use, but both Equashield™ and PhaSeal® are reasonably easy to use and are recommended over no closed system by VT working in oncology specialty practice. CSTD are not cost prohibitive. These systems should be adopted by all veterinary practices administering cancer chemotherapy.
Figure 1. PhaSeal® closed system transfer device. The three main components are the protector (left), injector (bottom right) and connector (top right). The injector contains a needle enclosed within a protective sleeve sealed by a double membrane. It attaches to a syringe or IV tubing. The protector is a drug vial adaptor with a flexible expansion bulb that is permanently attached to the vial and used for closed drug reconstitution and pressure equalization. The connector attaches to an IV catheter to provide a closed connection with the injector.
Figure 3. Model canine antebrachium with cephalic vein catheter for simulated administration of chemotherapy.
Table 4. Median rating of how likely a veterinary technician (VT) would be to recommend a system to a colleague (with ranges) for no closed system transfer device (CSTD), Equashield™ or PhaSeal® by 46 VT following 10 trials with each system. Results are presented for all VT and grouped according to prior experience. Visual analog scale ratings were converted to 0–10 numerical values, with 0 indicating would never recommend and 10 indicating would always recommend.
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