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Specialty Pharmacy Continuum • July/August 2020
POLICY
Keeping the Cold Chain Strong During COVID-19 Pharmaceutical manufacturers and accreditors will scrutinize cold-chain packaging and processes more closely in the COVID-19 and post-COVID eras, according to Jon Pritchett, PharmD, the pharmacy program director at the Accreditation Commission for Health Care (ACHC), in Cary, N.C. Some manufacturers already go so far as to show specialty pharmacies the precise package materials and packout configurations they’ve validated to optimize temperature integrity of highvalue medications and ensure patient safety, Dr. Pritchett added. “They even state the size of cooling packs and how to layer them in the box to maintain temperature for specific medications for set time periods,” he told Specialty Pharmacy Continuum. COVID-19 has added further pressure to pack out and ship or courier properly because insurers now approve 90-day prescriptions for patients sheltering at home. The 90-day extension is being applied to refrigerated nonspecialty items such as insulin, and patients want their medications dropped off at their doorstep while carriers struggle to meet delivery demand for all kinds of merchandise.
More Cold Chain Rigors Specialty pharmacies address this added complexity in different ways, even as some ship beyond their geography due to the demands of limited and sole distribution networks. “Packages that go from, say, New York to Arizona or Alaska, for example, must thermally protect medication efficacy under widely diverse environmental conditions year round,” Dr. Pritchett explained. Accreditors are on top of this. The Utilization Review Accreditation Commission (URAC), in Washington, D.C., raised its Performance Qualification testing standards last October to twice a year from once for all medications— refrigerated, frozen and room temperature—for each packout size and shipment method. ACHC is “waiting to see how finalization of USP [Chapters] <800>, <797> and <795> standards flesh out before we issue a more prescriptive standard for cold chain,” Dr. Pritchett said. Until that happens, pharmacies must do as much as they can to ensure they are following optimal cold chain strategies, he stressed. “If a medication doesn’t work, you want to know that it’s a pharmacological issue with the drug rather than it went out of temperature in transport.”
UIC’s Approach To comply with the new URAC standards, the specialty pharmacy at University of Illinois Hospital, in Chicago (UIC), has validated a room temperature
medication packout for the 55° to 105° F temperature range, using room temperature ice packs instead of refrigerated and frozen ice packs, and less insulating material—in their case, bubble wrap, explained Lisa Kumor, PharmD, the accreditation coordinator for UIC’s specialty pharmacy services. “We’re still working on the proper amount of insulation for room temperature packouts less than 55° F, and we need to educate patients not to refrigerate room temperature medications despite our new packouts,” Dr. Kumor said. Room temperature packouts “will be a hurdle for specialty pharmacies overall because they generally haven’t yet done extensive testing to make sure they’re maintaining controlled room temperature requirements,” said Katie Kraverath, a senior business development manager at Temptime. “There will be an increase in mail-order medications in light of COVID-19, and guidelines will continue to tighten to make sure they’re protected.”
Hospital-Based Specialty Pharmacies Innovate “The COVID crisis sheds light on our need to be very local and patient-specific,” said JoAnn Stubbings, BSPharm, a clinical associate professor of pharmacy practice at UIC College of Pharmacy, referring to the UIC specialty pharmacy where she recently retired from the post of associate director. “Our concierge-style courier service has served us phenomenally well during this crisis.” The pharmacy, she noted, “experienced zero disruption to timely deliveries” while maintaining temperature integrity. Ms. Stubbings added that “it was almost overkill when we set up this service in 2016. But when COVID-19 hit, nothing changed in our ability to serve patients.” Part of that success was due to the use of a refrigerated van, which helped ensure no wasteful packouts at the pharmacy. Fast forward to the pandemic, with social distancing and a “no-touch” approach to cold chain management, and adjustments were needed, such as full cold chain packs. The pharmacy also monitors the van’s temperature in real time while en route, Ms. Stubbings noted. Mike Gannon, PharmD, a business coordinator of specialty pharmacy services at UIC, pointed to another key driver of cold chain success, one that may well be unique to health systems: the fact that
such facilities have medical centers near its patients. That type off structure, he noted, adds ds “value when you consider der [their specialty] pharmacy’s cy’s ability to integrate with h the medical record, which expedites prior authorizations ns and allows for better communication nication across health care providers.” ers.” Successful cold chain manage management also requires dedicated partners, and for UIC, one was the local courier Webber Logistics, which averaged about 20 daily deliveries to specialty pharmacy patients in southwestern Chicago in March 2020. Courier owner Bryant Webber said the average delivery time was three hours, 44 minutes. But speed is not the only service goal, he stressed. It’s also important to take a few extra customer service steps, such as calling or texting patients when a delivery is imminent. That way, Mr. Webber noted, patients can be ready to retrieve and store their medications properly upon no-contact delivery.
The Pandemic Effect “If COVID and sheltering at home continue to scale, the need for people to receive medication deliveries will increase,” said Stephen F. Eckel, PharmD, the associate dean of global engagement and a clinical associate professor at the University of North Carolina Eshelman School of Pharmacy, in Chapel Hill. “Specialty pharmacies need to educate patients to treat them like their perishable groceries, something they could easily relate to.” About 30% of the 800 to 1,200 prescriptions mailed every day by the UNC Shared Services Center Specialty Pharmacy, also in Chapel Hill, require cold chain packaging, according to director of pharmacy Jeff Reichard, PharmD. The pharmacy attaches a temperature tag to each product so patients can see if it deviated from “normal” conditions by 2° to 8° C; a color change on the tag would indicate a short, moderate or extended excursion period. The pharmacy also uses advanced tracking services to “rescue” packages at risk for being exposed to suboptimal conditions—for example, refrigerated items not delivered within 24 hours of their packout, Dr. Reichard said.
Top Priorities Specialty pharmacies that are able to comply with evolving thermal protection standards, save on shipping space and labor and materials costs on packouts, and keep the environment safer would come out on top while keeping pace in an era of increasing medication shipments.
‘If a medication doesn’t work, you want to know that it’s a pharmacological issue with the drug rather than it went out of temperature in transport.’ —Jon Pritchett, PharmD To this end, both Dr. Eckel and Ms. Stubbings said they would welcome clearer packout guidelines from pharmaceutical manufacturers, and more feasible, affordable solutions to show temperature variations from suppliers. Approaches by some vendors, among them two distinctive paths toward sustainability and shipping efficiencies, are being made. Jed Dutton, the vice president of marketing at TemperPack, in Richmond, Va., pointed to one key trend in cold chain materials and policy. “Styrofoam bans exist in many parts of the country. The National Institutes of Health has said styrene is a probable carcinogen to humans [Mutagenesis 2011;26(5):583-584]. Shipping lifesaving drugs in 70-year-old technology associated with cancer puts pharmaceutical makers and pharmacies in an uncomfortable position,” Mr. Dutton said. The company’s ClimaCell box liners, made largely of starch and paper, are a recyclable alternative. Additionally, TemperPack’s thermal transport lab, which he said is certified by the International Safe Transit Association, emulates external shipping conditions, which enables it to test and qualify packaging solutions that meet temperature range and shipping specifications for each user. Meanwhile, the shipper reclamation system by Coldchain Technology Services (CTS), in Spring Branch, Texas, allows pharmaceutical manufacturers to pay a variable cost for boxes as they use them, rather than purchasing and storing them. Specialty pharmacies with multiple sites “can use our pre-engineered systems to establish a uniform shipping and packout protocol across their organization, which decreases risk, improves product security and helps with accreditations,” said Scott Bullard, the company’s director of business development. KabaFusion, a Cerritos, Cal.–based chain of 28 URACand ACHC-accredited home infusion specialty pharmacies across the nation, “plans to deploy” the CTS shipping solution this summer, said Frank Esposito, RPh, the vice president of operations. —Al Heller The sources reported no relevant financial relationships other than their stated employment.
