COVID-related EUAs challenge hospitals to adapt their processes
The emergence of COVID-19 in early 2020 created urgency for the Food and Drug Administration (FDA) to authorize drugs targeting the novel coronavirus. The swiftness of these approvals rippled down to hospital pharmacists, causing them to speed up their therapy reviews to determine the impact on facility formularies.
By mid-January 2021, the FDA granted emergency use authorization (EUA) status to nine agents to treat or prevent COVID-19, including hydroxychloroquine, remdesivir, various monoclonal anti-bodies, convalescent plasma and two vaccines, says Jason Braithwaite, PharmD, MS, BCPS, Senior Director of Pharmacy Services at HealthTrust. (A third vaccine was approved in February.)
Abbreviated from the FDA’s normal drug-approval process, EUA approvals expedite treatments that appear safe and effective but haven’t necessarily undergone rigorous, lengthy clinical trials, Braithwaite explains. Hospitals must then compress their own such evaluations to bring the treatments bedside.
“Normally with a formulary approval, we’ll have published literature in hand on Phase 3 trials, package inserts from drug companies about how to use and mix a drug, and contraindications for recommending a drug,” Braithwaite says. “But with the pandemic, this information came out the day of or even after the announcement of EUA approval, and sometimes after the delivery or receipt of the drug itself.
“Three to four months is not unusual in a normal formulary process,” he adds. “In this scenario, we weren’t given that timeline. Sometimes, it was condensed to three or four days.”
Dealing with downsides
Granting EUAs to various COVID-19 therapies—especially in the case of the first three vaccines—unquestionably helped attack the virus from multiple angles, Braithwaite says. And there are other pros to the rapid process, since the release of data surrounding EUA treatments is also expedited.
But this speed also comes with distinct downsides to hospitals, he says, including time, cost and space challenges. Regarding cost, for example, the antiviral remdesivir was at first distributed free to providers by the pharmaceutical manufacturer Gilead Sciences, creating inherent demand.
Hospitals later had to purchase the expensive drug, which costs between $3,100 and $5,700 per patient course.
The above scenario “trains people to use drugs maybe more frequently than they normally might. Now that they have to purchase them, it’s really impacting the bottom line for many facilities,” he says.
EUAs created space challenges when outpatient infusion centers—which primarily serve to treat cancer and other immunocompromised patients—needed to make room for COVID-19 patients receiving infusions of monoclonal antibodies. But since cancer patients are often immunocompromised from chemotherapy treatments, they can’t be near actively infected virus patients, Braithwaite explains.
“Hospitals quickly had to figure out ways to avoid patient risk,” he adds.
Creating a ‘small & nimble’ team
Hospitals have also adapted to COVID-related EUA approvals by developing processes to review these therapies much faster. Many formed emergency response committees of physicians, nurses, pharmacists and other specialists to operationalize all these treatments.
Additionally, many health systems have temporarily halted updates to electronic health records (EHRs) to prioritize any COVID-related changes needed. “They’re placing COVID expectations at the highest priority and putting other things on hold,” he adds, noting that these delays could mean the overall slowing of quality improvement efforts to EHRs, new drugs or products not being added to the formulary or order sets, and minimal expansion of new services to avoid a strain on the bandwidth during the pandemic.
How can HealthTrust members smooth their formulary processes in light of the pandemic and related EUAs? Braithwaite suggests assembling a “small, flexible and really mobile” interdisciplinary team that includes infectious disease, critical care, nursing, pharmacy and respiratory therapists who are tasked with and have the autonomy to make quick decisions on behalf of the hospital and its prescribing professionals.
“It’s easy to rely on old processes, which will slow things down,” he says. “The more people you involve, the more sluggish it becomes. An interdisciplinary team can be a huge asset at a time like this. Keep it as small and nimble as possible, allow it to meet as frequently as needed, and assign responsibility to make sure decisions are made on behalf of all those involved in the care of the patient.”
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