Policy
Pharmacy Practice News • April 2021
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Purchasing
Cold Chain Collaborations a Key to Success W
hen adding technology to pharmacy operations, strong vendor partnerships often are cited as a key to success. Whether it’s tweaking features to ensure interoperability or making last-minute install changes to match workflow, having an engaged vendor can ensure a seamless launch. That certainly has been the case as hospitals race to expand and improve their storage and temperature monitoring capabilities to protect the current crop of COVID-19 vaccines. Mark Lyons, RPh, the interim vice president of pharmacy at the University of North Carolina (UNC) Health Care System, in Durham, N.C., noted that such vendor guidance has been critical to UNC’s cold chain strategy. At the pandemic’s start, Lyons noted, UNC Health ordered three ultracold freezers to raise its safe storage capacity across all 11 hospitals to 1.2 million doses. “We collaborated intensively with vendors in two areas—which freezers we should buy for the vaccine volumes we’d need to receive and store, and the procurement, handling, storage and replenishment of dry ice because we didn’t have a lot of experience with it,” he said. UNC Health administers COVID-19 vaccinations at its hospitals and megasites statewide, including two sites that aim to vaccinate at least 1,000 people per day. UNC also employs community outreach programs, including small neighborhood clinics and mobile sites that help to increase vaccine access to all eligible people. Lyons said UNC Health is ready for the
8 Tips for Evaluating Vendors expected higher flow of vaccinations that should come as a result of these outreach efforts, not to mention the emergency use authorization (EUA) granted to the Janssen COVID-19 vaccine. Storage, transport, thawing, mixing and inoculation processes and vital equipment are in place, he noted, such as ultracold and regular medical freezers, refrigerators, data loggers, and automated temperature monitoring and alarm systems. All of these tech installations were done with vendor support, which is ongoing, he noted. Indeed, “at UNC, we strive to be a customer of choice by building longterm relationships with our vendors,” Lyons said. “This helps us create solutions that benefit us in the long run. Often times, we’re able to gain insight from vendors that we might not be able to obtain on our own.” (For tips on how to make these partnerships a success, and suggestions from vendors, see sidebars.)
Reason for Optimism Lyons said that beyond strong pharmacy–vendor partnerships, there are several added reasons to be optimistic about the future direction of COVID-19 vaccinations, including the Biden administration’s commitment to have 600 million vaccine doses available by July,
The Vendors’ Take
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s hospitals raced to expand their storage capacities and temperature monitoring capabilities to protect the integrity of the COVID-19 vaccines, they gleaned insights from cold chain vendors. When Primex consults with hospitals about managing COVID-19 vaccines with its OneVue automated temperature monitoring system, it asks strategic questions, such as what changes they’re putting in place, noted Katie McMillan, PhD, the company’s director of health care solutions. “We like when hospitals scale processes already familiar to them. If they’re flexing to a different approach, such as drive-up locations or pop-up vaccination centers in their parking lots, we support with our analytics team and introduce them to other hospitals doing something similar for additional advice. We’ve seen many workflows from smaller rural hospitals to major health systems.” Primex predicts that the messenger RNA (mRNA) technology created by Pfizer/BioNTech and Moderna “will be used in other vaccines. This isn’t a one-shot deal. The need to monitor extreme temperatures will continue into 2021 and beyond,” added Rob Klinck, Primex’s senior vice president of sales. The company’s automated OneVue system single- and dual-probe sensors continually monitor between –200° C and 150° C; eliminate manual monitoring and data logging; comply with CDC, FDA and
as well as the use of the Defense Production Act to escalate manufacturing of specialized “low dead space” syringes to extract a sixth dose from the Pfizer/ BioNTech vials. Moderna also is getting in on the effort to stretch its own vaccine supplies, he noted: In mid-February, the FDA announced that it will allow Moderna to increase the amount of vaccine in its vials by 40%, which will enable the company to boost the number of doses from 10 to 14 per vial. But potential potholes remain, Lyons said. Although he confirmed that Pfizer low dead space syringes arrived with his February vaccine shipments, he expressed “deep concern” if this doesn’t continue. “The problem with this and limited vaccine supplies and a two-dose series is if you have low dead space syringes for the first injections and get six doses out of each vial, you’re committed to the same for the second injections 21 days later,” he said. “If you don’t have them, you either have to borrow from a new batch of first doses, which you can do if you receive the same brand, or else cancel some appointments.” —Al Heller The sources reported no relevant financial disclosures beyond stated employment.
Joint Commission regulations; export data for compliance reports or regulatory audits; preconfigure to the hospital’s network; run on batteries, electric or PoE (Power over Ethernet); detect whether vaccine storage units are securely closed; and trigger audiovisual local alarms and customized email, text and phone temperature-excursion alerts. Primex has more than 38,000 sensors in about 700 hospitals. “We’re working nearly 24/7 to meet the large increase in demand. The same day we have supply, we ship out sensors to customers,” McMillan said. Grace Qiu, the vice president of operations at Across International, agreed that the persistence of mRNA technology for COVID-19 vaccinations will support the continued need for ultracold freezers. Indeed, the demand for such freezers is so high that there’s an industrywide eight- to 10-week backlog from suppliers on orders today, she noted, adding, “just because a supplier says it’s in stock doesn’t mean it’s the right purchasing decision.” Across International provides ultralow and medical freezers, as well as reusable, insulated, ultracold shipping cubes packed with dry ice “to help others bridge the gap until they get freezers for vaccine storage, transport and redistribution,” Qiu added. Maxwell Dubin, sales development, R&D and trainer at Across International, offered these tips for hospital buyers of cold chain technology: • Seek reputable brands that also offer data loggers,
Seek data that support what vendors claim, ask about their study methodology or hire a technical advisor to help if you don’t have the expertise in-house. Ask about staff training, equipment calibration, and setup, maintenance, custom service and performance at certain temperatures. Expect same-day replies to any query. Try to write into the agreement (nothing verbal) that you’ll be able to collect damages in case of mechanical failure, water leaks or a door not closing tightly; this will usually be in accord with the hospital’s local laws. Many vendors educate customers how to use their products only; seek one that’s neutral so you can make your own decisions. Be sure what you buy enables you to handle all vaccines according to label instructions. Regarding the vaccines: Work within proper channels to avoid falling victim to vaccine counterfeiting, tampering or diversion. Check that what arrives has a bill of shipment bearing the manufacturer’s logo, and that the vials match the images. Source: Rafik Bishara, PhD, technical advisor and chair, Pharmaceutical Cold Chain Interest Group of the Parenteral Drug Association, and member, URAC’s Pharmacy Advisory Council.
alarms and security features, biosafety cabinets, battery backups and compressor surge protection. • Insist on CDC, Vaccines for Children (VFC), and Underwriters Laboratories’ UL61010-1 (for U.S.A.) or CSA (Canada) compliances. • Acquire backup carbon dioxide systems connected to tanks to keep vaccines cold enough while technicians fix any problem. • Use 4-20mA wireless temperature transmitters to export data to automated temperature monitoring systems that use the common RS-232 and RS-485 interfaces to communicate with vaccine storage devices. • Require prompt service, including flying technicians to your practice sites, to help avoid downtime and product waste. Jed Dutton, the vice president of marketing at TemperPack, cited temperature tracking as an essential cold chain capability that health systems need to master. The company’s TransTracker monitors are being used to transport temperature-sensitive COVID-19 vaccines as a way to identify any temperature impact on the way from national distribution centers to health systems nationwide, said Mike Montana, the senior business development manager at Zebra/Temptime. More than 100 U.S. hospitals already use the company’s Edge smart sensors for storage and transport, and TransTracker for transport and redistribution of COVID-19 vaccines. —A.H.
