POLICY

Cold Chain Collaborations a Key to Success

When 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 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, 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 fi nancial disclosures beyond stated employment.

8 Tips for Evaluating Vendors

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.

The Vendors’ Take

As 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 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,

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.

TJC Eyes USP Compliance

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compounding areas (SCAs) to meet requirements for the 2019 revision of USP <797> guidance on sterile compounding, USP’s decision to uphold stakeholder appeals for more expert deliberation on the new revision was reassuring. “The organizations that were not able to get the funding for such significant projects can breathe a sigh of relief that their current setup is adequate to keep them in compliance with USP <797>,” said Susan Reed, RPh, a pharmacy consultant at Steve Hirsch and Associates, in Fountain Valley, Calif.

In contrast, organizations that had upgraded their facilities to comply with the 2019 revision will likely meet or exceed the 2008 version from a structural perspective, Reed noted during the virtual ASHP 2020 Midyear Clinical Meeting and Exposition, while in her former role as a consultant at Joint Commission Resources, Inc.

One of the more stringent rules in the 2019 USP <797> revision is a requirement for anterooms and buffer rooms to be supplied with HEPA-filtered air through outlets located at the ceiling level, with returns placed low on the walls, Reed noted. In addition, unlike the 2008 revision of USP <797>, which only permits low-risk nonhazardous compounding in SCAs, the latest revision allows hazardous drug compounding in SCAs, assuming facilities are upgraded, she said.

“The two revisions address sterile product compounding differently,” Reed explained. Whereas the 2008 revision categorized sterile products by the number and type of ingredients used in the preparation, the 2019 revision still under expert review categorizes compounded sterile products by the location in which products are prepared.

USP Chapter <800>

According to Reed, organizations that have geared up to comply with USP <800> can continue with early adoption and ask surveyors to assess their adherence to this chapter. However, they should expect scrutiny of everything from staff training and competencies to receipt of product, through to compounding preparation and appropriate use of personal protective equipment (PPE).

One detail that surveyors will want to see in place for organizations requesting assessment for USP <800> compliance is that an individual has been designated to oversee hazardous medication compounding, Reed noted. “This individual needs to ensure that staff that handle and prepare hazardous medications receive appropriate training, including the appropriate use of PPE for their role,” she said.

“The individual needs to work with a multidisciplinary team to perform an assessment of risk for hazardous medications and to determine proper handling, including PPE for receipt and storage, product preparation, disposal, and decontamination and cleaning requirements,” Reed added.

USP Interim Guidance During Pandemic

The USP has made exceptions to some rules during the COVID-19 pandemic. For example, to help with management of drug shortages, pharmacies may perform medium-risk compounding in SCAs until the public health emergency is declared over, Reed noted. “However, if you’re following this interim guidance, make sure that when the pandemic has cleared, you return to the 2008 revision of USP <797>,” she cautioned.

Interim guidance issued by the USP during the pandemic includes these other allowances: • For as long as the public health emergency continues, institutions may extend beyond use dating (BUD) for low- and medium-risk, nonhazardous compounded sterile preparations that have been prepared in an SCA to 12 hours at a controlled room temperature, or to 24 hours when refrigerated (bit.ly/3958yjq). • If there are PPE shortages, organizations may conserve PPE by storing garb in a way that minimizes contamination or maintain garb within the perimeter of the SCA, or use other measures that USP has outlined (bit.ly/3165IX3). • Pandemic-era interim guidance also allows organizations to delay recertification of primary and secondary engineering controls as long as these controls are being continuously monitored, and assuming the time between certifications does not exceed 12 months. • If there is a supply shortage of sterile 70% isopropyl alcohol, institutions may compound the product in-house.

“USP understood that organizations have really been challenged in maintaining compounded sterile areas and coping with limited product,” Reed said, urging facilities to increase the frequency of personnel monitoring to every six months while adhering to interim guidance to ensure they are maintaining standards of performance.

With the exceptions listed, organizations need to comply with all the usual USP rules, Reed reminded meeting attendees. This year, surveyors will be looking to make sure: • there is standardized training in place

for staff who prepare and verify compounded sterile preparations; • annual assessments for donning and doffing garb are done; • gloved fingertip sampling is performed, and • media fill challenges and didactic assessments are conducted.

Surveyors will want to see that staff members who perform surface cleaning are adequately trained and have documented competency in this task, and that they clean surfaces in the correct sequence using only products approved by the organization, Reed added.

Another aspect of compounding compliance that surveyors will be placing emphasis on this year is ensuring prior certification reports have been reviewed for completeness, and that positive culture results from air and surface sampling have been addressed.

“Perhaps the most common area of noncompliance with regard to engineering controls is staff or pharmacy leadership not knowing how to read certification reports and not acting on the results,” Reed said. Remediation strategies need to be documented, and contaminated surfaces and air samples should be retested, she stressed.

Although the Joint Commission has found that organizations do a “really good job training staff and assessing their competencies, some have been challenged in documenting this training and competency,” Reed noted. For example, “organizations that still use paper documents in particular tend to have a problem if they group their papers by date rather than individual, because it makes it difficult to retrieve the information in a timely manner. By filing paper-based competencies by individual, all tasks completed can be found in a single record and location.”

USP Compliance at MGH

Paul Baker, PharmD, the compounding compliance coordinator at Massachusetts General Hospital, in Boston, said he and his colleagues are making sure they have all the proper documentation for compliance in place this year. This is particularly important given that some surveys are being conducted virtually, he noted, and this shifts surveyor attention away from direct observation and toward checking documents.

“We’ve gotten everything in order by conducting internal audits of our documentation pertaining to certifications, environmental monitoring, scheduled tasks, cleaning logs and other items,” said Baker, who was not part of the ASHP session.

Monthly Meetings

To be certain his facility is complying with USP requirements, Baker and his team hold monthly meetings to review documentation and results of reports, and update standard operating procedures (SOPs). “Each of our five compounding pharmacies’ managers of record, their lead technicians, the quality compliance team and the chief pharmacy officer have a seat at the table.”

Another strategy that the team uses to increase the likelihood of full compliance with USP standards ahead of a survey is auditing reports that have been issued by vendors’ engineering control certifiers. The team is making sure this equipment is being tested to current standards and is properly calibrated, Baker said.

“For our environmental monitoring, too, we work with a third-party vendor to ensure that sampling frequency, selection of sites and media use, for example, meet or exceed the USP standard and follow SOPs,” Baker added.

Mock quarterly audits, in which a member of the compliance team observes personnel to see if SOPs are being followed as written, also have been useful in identifying potential issues with compliance, Baker said. “These [drills] have helped us to ensure that what is written in procedures is practiced by staff.”

Technicians at Massachusetts General Hospital prepare daily compounded sterile preparations.

—David Wild