WASHINGTON, DC—Compounding sterile medications for parenteral use, such as allergy drugs, in a private physician’s office is potentially subject to almost as much scrutiny and regulation as are visited upon commercial preparers of such medicines.
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November 2007Otolaryngologists, with their many allergy patients, are among the specialists most affected by these rules, regulations, and standards. These standards have been established in order to reduce some of the 17 billion adverse medical events that occur each year in the United States. Of that number, 44,000 deaths result from medical error, of which mistakes in mixing and compounding allergy medicines are a part.
USP: The Gold Standard
Steven M. Houser, MD, Assistant Professor of Otolaryngology at Case Western Reserve University in Cleveland, told the miniseminar audience that the US Pharmacopeia (USP) is the gold standard of vial mixing. He said that although USP is not a government entity, it does have enforcement power, and it is the basis for procedure and safety in compounding sterile medications for parenteral use. USP has five major criteria in this area: