The Food and Drug Administration has authorized the importation of propofol 1% injection from the European Union to deal with an ongoing shortage of the drug in the United States.
APP, manufacturer of Diprivan (propofol 1%), is working with the FDA to make Fresenius Propoven 1% available to U.S. providers. The drug "is manufactured in FDA inspected facilities by APP's parent company, Fresenius Kabi AG," and "contains the same active ingredient, propofol, in the same concentration as" Diprivan, APP explains in a letter being distributed with the imported product. Although the European product is "a clinically acceptable substitute to other currently marketed generic propofol products in the U.S.," there are important formulation and labeling differences between it and the U.S. version. The FDA encourages practitioners to review those differences, which are outlined in APP's letter.
If your facility has been hit by the propofol shortage, here are some other do's and don'ts experts say you should follow:
Do get listed early with your supplier for product delivery upon its availability, says pharmacy consultant Sheldon Sones, RPh, FASCP.
Do order the branded product Diprivan if it's available or consider ordering imported propofol; both are distributed by APP. The company says you can order the imported product either through your wholesaler or directly from APP by calling (888) 386-1300.
Don't hoard propofol supplies.
Don't try to stretch single-use vials of propofol across multiple cases. In a conference call early last month, FDA officials stressed that all propofol vials are intended for single use and that splitting doses poses an infection risk.
Do reserve some sulfite-free propofol for use in the 1% of the population that is truly allergic, says Mr. Sones, noting that the shortage hit sulfite-free supplies particularly hard.
Do keep in close contact with your supply representative and check the FDA's Web site for updates. If you have trouble obtaining adequate supplies, e-mail the FDA's Drug Shortage Group for assistance.
Irene Tsikitas
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