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FDA Updates Extended Use Drugs List to Meet COVID-19 Demands

Protocols ASCs need to put in place to use these medications safely and avoid citations

BY SAHELY MUKERJI | APRIL 2020

In light of the COVID-19 pandemic and the consequent demand for certain medications, the US Food & Drug Administration (FDA) updated its list of extended use drugs on April 3. The updated list now includes 569 drugs that may be used beyond the manufacturer’s labeled expiration date.

“That listing is limited to certain drugs but the excess in demand applies to more drugs beyond that listing,” says Sheldon Sones, president of Sheldon S. Sones and Associates of Newington, Connecticut, and a pharmacy consultant to ASCs. “In effect, there are two kinds of drugs that are in high demand now due to COVID-19: those that are on the FDA listing and those that are not. The ones that are on the list are relatively easy to manage.”

Drugs on the FDA List

Most of the drugs on the FDA listing are first-line medications used for acute-care treatment in cardiac emergencies, says Robert Taylor, RN, clinical director of Constitution Surgery Center East in Waterford, Connecticut, and surveyor for Accreditation Association for Ambulatory Health Care. “We were ecstatic when FDA updated the list because an ASC has to have those drugs present and we were unable to get them.”

Best practice dictates that an ASC labels the drugs that are allowed extended use and documents attempts to find replacement supply, Taylor says. “I print custom-made labels that I dog-ear on the side of the box,” he says. “The labels say ‘extended use per FDA’ with the date on it, usually an additional six months.” The extended date varies and could be up to a year, he says. “The manufacturer has to recommend the efficacy of a certain drug to the FDA. These are all done by lot numbers. For example, Atropine comes in many different sizes and forms, and they all have different efficacy dates.”

These labels are useful during surveys, as well, Taylor says. “As a surveyor, if I walk into an ASC, open up a crash cart and see a box of Atropine with an expiry date of March 2020 without a label to identify the extended use, that’d be reason for a citation. The label shows that the ASC is paying attention to the extended use guidelines and doing its due diligence to keep everyone informed.”

Aside from labeling, an ASC needs to be cognizant of what is on the FDA list, Taylor says. “ASCs need to check monthly the list of extended use medications on the FDA site and cross-reference it with their own list of extended use drugs,” he says. “They have to have a person dedicated to checking and buying these medications because extended use is a crutch only.”

Certain state surveyors ask centers to provide evidence that they are trying to acquire the replacement drug. “So, you cannot be asleep at the wheel,” he says. “You would have to show documented communication with your supplier/wholesaler—like emails or canceled orders—that shows you are trying to acquire the said extended use medication.”

Larger centers with multiple ORs might find it useful to create a list checklist that shows the extended use medications they have in stock and their location, Taylor says. “Ideally, you want those extended use medications to be used first. It’s basically triaging your supplies. The checklist would tell you where your extended use drugs are, so you are not searching for them under every leaf when you need them.”

When these extended use drugs become available in the market, try not to be over-reactive and hoard, Sones recommends. “Stay on top of your supply chain and work with two or more wholesalers. Learn about each supplier’s allocation policies and enlist your projected needs.”

Keep your staff informed, Taylor recommends. “ASCs often contract anesthesiologists,” he says. “You have to educate your contracted workers/end users of the extended-use drugs protocols you put in place in your ASC. Education and awareness are critical.”

To complete the circle, anytime you have your medication management or board of director meetings, document the extended use drugs situation in the minutes. “That keeps your medical staff informed,” Taylor says.

Drugs Not on the FDA List

“My main concern is propofol,” Sones says. “A high percentage of propofol comes from Italy, which has been severely hit by COVID-19. This drug will become problematic exacerbated by shrinkage from Italy. Equally of concern are cefazolin/i.e. Ancef, fentanyl, midazolam, epinephrine-containing products, dantrolene (Revonto made in Italy) and IV solutions.”

Review formulary options with your medical director, anesthesia lead and governing body, if one of the five drugs mentioned above disappears from the market, he says. “In the case of cefazolin, one drug for consideration is cefuroxime (Ceftin, Zinacef). Perhaps more costly, but it is a therapeutic option. Antibiotic use in most routine GI procedures continues to not be recommended by the American Society for Gastrointestinal Endoscopy.”

Should the fentanyl shortage evolve, consider less desirable opioids, i.e., meperidine. “Some compounders have begun to provide fentanyl product. Assure the vetting process should you engage a new compounder. Cost basis will be higher,” Sones says.