FDA re­ports more short­ages of drugs used to put Covid-19 pa­tients on ven­ti­la­tors

In­creas­ing de­mand for seda­tives used to help put Covid-19 pa­tients on­to ven­ti­la­tors means the FDA added two more — this time the in­jecta­bles propo­fol and dexmedeto­mi­dine — to its list of drug short­ages.

Michael Ganio

The propo­fol short­age was al­so pre­vi­ous­ly list­ed by the Amer­i­can So­ci­ety for Health-Sys­tem Phar­ma­cists (ASHP) ear­li­er this month, with man­u­fac­tur­ers not­ing in­creased de­mand. Michael Ganio, se­nior di­rec­tor of phar­ma­cy prac­tice and qual­i­ty at ASHP, pre­vi­ous­ly told Fo­cus via email: “We have mul­ti­ple re­ports of in­creas­es in pur­chas­es and uti­liza­tion of seda­tives like mi­da­zo­lam, fen­tanyl, and propo­fol to treat COVID-19 pa­tients who re­quire me­chan­i­cal ven­ti­la­tion.”

In FDA’s propo­fol short­age list­ing, gener­ic drug­mak­er Dr. Red­dy’s said it ex­pects to re­sup­ply in Oc­to­ber. In­for­ma­tion is still pend­ing from Sagent Phar­ma­ceu­ti­cals, Fre­se­nius Kabi and Te­va Phar­ma­ceu­ti­cals, al­though Sagent told ASHP that it has propo­fol 20 mL, 50 mL, and 100 mL vials on al­lo­ca­tion.

The FDA list­ing for Pfiz­er’s Hos­pi­ra, mean­while, says that for 1000 mg/100 mL (10 mg/mL) Sin­gle Dose/Sin­gle Pa­tient Use Glass Flip­top Vials, sup­plies will re­cov­er next month. But for two oth­er ver­sions of its propo­fol, sup­plies are not ex­pect­ed un­til Au­gust. Pfiz­er told ASHP that it has propo­fol 20 mL, 50 mL, and 100 mL vials avail­able in lim­it­ed sup­ply.

A Pfiz­er spokesper­son told Fo­cus via email: “As of to­day, Pfiz­er’s man­u­fac­tur­ing and dis­tri­b­u­tion net­work con­tin­ues to op­er­ate at high per­for­mance with no op­er­a­tional dis­rup­tions due to Covid-19. His­tor­i­cal­ly, Pfiz­er has had a mar­ket share of ap­prox­i­mate­ly 15% for Propo­fol. We re­cent­ly have ob­served an un­prece­dent­ed surge in de­mand for Propo­fol be­yond Pfiz­er’s his­tor­i­cal de­mand which is lim­it­ing our abil­i­ty to ful­ly sat­is­fy cus­tomer or­ders in the short-term. We are mak­ing every ef­fort to ad­vance the or­der­ing of ad­di­tion­al ma­te­ri­als, in­crease our pro­duc­tion, re­duce lead times and ex­pe­dite or­ders to cus­tomers, es­pe­cial­ly those in high-im­pact ar­eas.”

In ad­di­tion, the in­jectable seda­tive dexmedeto­mi­dine was list­ed by FDA on Fri­day as be­ing in short­age. San­doz said Mon­day that it’s dis­con­tin­u­ing its pro­duc­tion of the drug, which is in­di­cat­ed for the se­da­tion of ini­tial­ly in­tu­bat­ed and me­chan­i­cal­ly ven­ti­lat­ed pa­tients dur­ing treat­ment in an in­ten­sive care set­ting. But sev­er­al man­u­fac­tur­ers of dexmedeto­mi­dine said they ex­pect sup­plies to be back next month.

FDA Drug Short­ages

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

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