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Managing Drug Supplies Effectively during COVID-19 Pandemic

Communicate, be aware of EUAs and create a policy

BY SAHELY MUKERJI | JUNE 2020

Complications surrounding drug shortages stemming from the COVID-19 pandemic continue to emerge.

Last month, the US Food & Drug Administration (FDA) issued an emergency use authorization (EUA) allowing the emergency use of Fresenius Propoven 2 percent (propofol 20 mg/ml) Emulsion 100 ml, an unapproved drug. Under the EUA, the drug can be used to maintain sedation via continuous infusion in patients older than 16 years of age who require mechanical ventilation in an intensive care unit setting during the COVID-19 pandemic.

“The propofol we traditionally use is 1 percent or 10 mg/ml,” says Sheldon Sones, president of Sheldon S. Sones and Associates of Newington, Connecticut, and a pharmacy consultant to ASCs. “The substituted product of concern is 2 percent or 20 mg/ml. Usual dose by volume has to be halved. While the 100 ml product does not make sense in the ASC, it is recommended that we take extra care in stocking propofol.”

In addition, wholesalers might unknowingly supply a Propoven product instead of Diprivan or generic propofol or, due to shortages going forward, might only have the resources to supply the Propoven, he says. “This is an ICU COVID intended product. It is important that we be mindful of this possible medical safety concern.”

Suppliers are supposed to lock out the 2 percent or 20 mg/ml dose for ASCs, says Gregory Tertes, consultant pharmacist and president of ASC Pharmacist Consultants Inc. in Oakland, California. “When ASCs look up the drug, it should not even show up in the search,” he says. “It should show up for hospitals only. But we do not know about computer systems. This information must be entered in all the big manufacturers’ and wholesalers’ systems. We do not know whether this information is programmed in, or maybe the person entering the information is not even aware of this at all. So, we can imagine it getting into a surgery center and causing problems.”

ASCs must be aware that this EUA is for ventilator-use COVID-19 patients only and be cognizant of this change when ordering the propofol, Tertes says. “When ordering a substitute medication, ASCs need to make sure that the information is carried further down the line from the per-son who is placing the order. Mark the boxes with the change in size/strength/concentration,” he says. “Email all anesthesiologists, surgeons and staff about the change. Post a note on your central communication board about the substitute medication. And, lastly, put a note at the point of use, whether it be the anesthesia cart, the medication drawer or wherever the medication will be pulled out of.”

Drug shortages cascade into potential problems as the example above demonstrates. “Additionally, we may have to clarify or revise pre-printed or electronic anesthesia records to reflect the actual product being used should this product find its way into your facility, as remote a possibility as it is.”

Medication error prevention is all done in advance, Tertes says. To prevent such errors, “have a list of all the drugs that you need that are on shortage,” he recommends. “Check for them on a very regular basis, at least weekly if not more often. Make sure that you communicate with your provider what medication is on shortage—so they use it only when needed—and when bringing in a replacement.”

In addition, it is critical that ASCs have updated policies and procedures in place, says Ernest P. Gates Jr., president and chief executive officer of Gates Healthcare Associates Inc. in Middleton, Massachusetts. “Without a policy, your staff can’t be trained on how to handle another similar situation or acquire drugs in case of another such shortage. No matter what may happen in the pharmacy or the drug supply chain, the surgeon will ultimately be accountable.”

Managing pharmaceutical supplies properly is more challenging during a period of drug shortages than at any other time, he says. “In your policy, include a list of sources for getting your drugs. If you are purchasing compounded versions of commercially unavailable medications, it is incumbent upon you to ensure that the medications are of the highest quality, and that there are no issues with the outsourcer you have chosen to purchase medications from.” The FDA publishes inspection results on its website, and it is important to review those before entering into a relationship with an outsourcing facility and as that relationship continues, he advises.

Manufacturers, wholesalers/distributors, 503B outsourcing facilities and, in emergency cases, the laws allow 503A compounding pharmacies to be a major source for drug shortage supply, Gates says. “Have some kind of a contractual agreement with your supplier.”

If you are stockpiling drugs, make sure to assign someone to manage it. “Someone who can keep track of expiration dates, extended use dates, changing labels in case of extended use or change in the size of a drug, proper disposal of unused drugs, and proper storage,” Gates says. “If your staff does not have the capabilities to create and implement these policies and procedures, engage a consultant who can do this important work.”