FEATURE
BY SAHELY MUKERJI
C
omplications surrounding drug shortages stemming from the
COVID-19 pandemic continue to emerge. In May, the US Food & Drug Administration (FDA) issued an emer- gency use authorization (EUA) allow- ing 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 continu- ous infusion in patients older than 16 years of age who require mechanical ventilation in an intensive care unit set- ting 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, Con- necticut, and a pharmacy consultant to
When ASCs look up the drug, it should not even show up in the search. It should show up for hospitals only.”
— Sheldon S. Sones, Associates of Newington
ASCs. “The substituted product of con- cern 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 prod- uct instead of Diprivan or generic pro-
16 ASC FOCUS SEPTEMBER 2020 |
ascfocus.org
pofol or, due to shortages going for- ward, 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, con- sultant 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 manufactur- ers’ 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 imag- ine 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
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30
