38 Technology
Pharmacy Practice News • November 2020
Safe Handling
COVID-19 Prompts a Second Look at CSTDs I
n April, with COVID-19 cases increasing nationally, Cone Health oncology services in Greensboro, N.C., took a fresh look at closed system drugtransfer devices (CSTDs). The service, which operates five cancer care centers across the state’s North Central Piedmont region—with a sixth center slated to open in September 2021—had been tasked along with other Cone Health services to find ways to bolster operational effectiveness in light of the pandemic’s potential threat to health-system operations. Cone Health was not within an epicenter of coronavirus infections at that point, but organizational concern was rising over the likely revenue impact of a COVID-19 patient surge and about people losing health insurance and income due to local business closings. The aim was to get ahead of a possible crashing wave with a lean approach to costs, particularly of consumables. Medication use was an obvious target. “Drug costs were a huge driver, one of the largest cost centers out there,” said Andre D. Harvin, PharmD, the director of pharmacy oncology. For Cone Health’s cancer care clinics, which treat some 3,800 to 4,200 patients each year, medication use also meant the hefty costs associated with preparing and administering antineoplastics, including those associated
6 Steps For Vendor Evaluation
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ost health systems have already integrated closed system drugtransfer devices (CSTDs) into their compounding and administration processes. But for those still weighing their options, Fred Massoomi, PharmD, a senior director at the pharmacy consulting firm Visante, offered six steps to aid in decision making.
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A pharmacy technician compounds a hazardous medication using the BD PhaSeal Optima closed system drug transfer device. USP <800> requires CSTDs for administering antineoplastic compounds, but “recommends” the devices in preparing the drugs.
with disposable CSTDs and IV infusion bags and lines. Until April, the oncology clinics had been using BD’s PhaSeal CSTD system. “When COVID-19 hit, we saw it as an opportunity to sit down and say, ‘This is one of our more expensive consumables,’” Harvin said. “Should we reevaluate?” The answer was yes. The assessment that took place over the
Chemotherapy Robots an Aid In High Volume
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ike many other health systems with high-volume oncology clinics, Cone Health centers employ robots and other automation technology to increase productivity and dose accuracy while further shielding technicians from harmful chemotherapy exposure. Two of the health system’s largest clinics, at Wesley Long Hospital, in Greensboro, N.C., and Alamance Regional Medical Center, in Burlington, N.C., deploy APOTECAchemo robots (Apoteca USA, an affiliate of Italy’s Loccioni industrial engineering company) to automate compounding of most An inside look at the Apoteca Chemo hazardous drugs. Cone Health’s robot as it performs a manipulation of other clinics are equipped with a hazardous medication. The platform APOTECAps, a guided automated uses barcode scanning, gravimetrics system that uses gravimetrics and a sterile environment to perform its to weight dose ingredients and compounding independently. ensure compounding accuracy. “Everything we compound we try to push through gravimetrics, whether hazardous or nonhazardous,” said Andre D. Harvin, PharmD, BCPS, the director of pharmacy oncology at Cone Health, in Greensboro. “We are actually in the midst of expanding [APOTECAps] because we don’t have it in every hood.” Other compounding automation companies competing in the same space include Equashield, Grifols’ Kiro Oncology and Omnicell. —B.B.
following weeks was similar to ones that other integrated health networks have initiated to comply with USP General Chapter <800>, which took effect in December. Budget dollars have typically played an outsized role in these discussions, said Patricia C. Kienle, RPh, MPA, the director of accreditation and medication safety for Cardinal Health. “If money wasn’t the issue, nobody would be talking about this. We’d all be doing it. “But people need to be safe,” added Kienle, who is also a member of the USP Compounding Expert Committee. “So USP <800> requires CSTD use for administration of Table 1 antineoplastics when the dosage form allows.” (It also “recommends” use of the device in preparing the drugs.) Kienle also noted that “the vast majority” of people she had spoken to had already acted to implement the USP employee safety standards (surveys of health systems support that). “There’s some utility for using [CSTDs] for other drugs, but that’s up to individual organizations to look at what works for them.” Kienle added that vetting the merits and potential weaknesses of prospective CSTDs should not be done independently by either pharmacy or nursing. “This is a team sport,” she stressed. “It needs to be coordinated in a system, and it cannot just be the cheapest one on the buying group contract.”
Coordination Is Key At Cone Health, team coordination was central to an evaluation that led to the deployment of a new CSTD system at the end of May. The investigation included virtual presentations from device makers, including BD, that were asked to demonstrate, via Zoom, what made their
Look at the FDA 510(k) clearance document. The idea is to see what the device was approved for and what information was submitted to the FDA to obtain clearance. It will provide a good understanding of the thoughts behind the device and how and why it was developed.
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Go to company websites. These can be great resources for educational materials, as well as information on the size of the product portfolio for the device. If it has just a few pieces, it may not meet all of your needs.
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Schedule a visit. If a candidate looks promising, spend time with a company representative, virtually if need be. The meeting needs to cover detailed information on the device and how it would work within your compounding and administration workflow.
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Ask for a brief trial run. This is to allow pharmacists, technicians and nurses to see how well the device performs within your system. It really depends on your setup: how you use your primary engineering controls to move hazardous drugs through the compounding process and how well the device fits into nurses’ administration environment.
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Ask additional questions about materials used in making the device. Find out how the device was tested to demonstrate conformance with National Institute for Occupational Safety and Health standards for preventing toxic emissions and pathogenic ingress. Has it been tested on the drugs that will be used with the device to ensure compatibility, and will there be any leaching or other issues that can occur with certain drugs?
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Review all the materials sent to the FDA for clearance of the CSTD. This includes 510(k) letter, marketing clearance statements, comparative studies to the predicate devices, etc. —B.B.
CSTDs safer and easier to use—and to relate how much educational and other support would be forthcoming. Price was another consideration. Harvin said he also called peers at
