(Story updated with FDA information at 5:10 p.m. ET.)
The method for mixing drugs that led to 53 deaths in an outbreak of fungal meningitis in 20 states last fall is inherently risky, but seldom-used by hospitals, a new survey finds.
Meanwhile, officials with the Food and Drug Administration are wrapping up final inspection reports on 31 drug-mixing facilities that were examined for safety issues in the past seven weeks. Copies of the reports are publicly posted on the FDA's website. All but one of the companies received a report documenting “objectionable conditions.”
“During the course of both our proactive and reactive inspections over the past few months, we observed concerning sterility practices, inappropriate conditions for sterile processing and other practices that create risk of contamination,” FDA Commissioner Dr. Margaret Hamburg wrote on her blog Thursday.
The new survey of U.S. hospitals by HHS' inspector generals' office finds that the risky drug-mixing technique—known as “nonsterile-to-sterile” drug compounding—was used for only 666 doses per year in larger hospitals, or less than 1% of the time. The less-risky “sterile-to-sterile” drug mixing method was used more than 200,000 times per year in larger hospitals. Only 25% of the hospitals used any nonsterile-to-sterile mixed drugs at all.
Drug compounding is a method that pharmacists have long used to tailor bulk drugs for individual use, for example to convert pill-based medications in injectable form. However, recent drug shortages have caused hospitals to rely on mass-produced compounded drugs as a way to preserve the shelf life of sought-after medications and stretch limited supplies.