USA Today on Tuesday examined the safety of compounded medicines that are made for hospital patients either at hospitals' own pharmacies or at contracted outside pharmacies. According to USA Today, almost all hospital pharmacies perform some drug compounding, "ranging from low-risk procedures, such as adding medications to intravenous solutions, to high-risk work, such as making sterile treatments from scratch." USA Today reports that hospitals in most states are not required to test the sterility or potency of compounded drugs, and the "frequency and thoroughness of state inspections of the pharmacies vary widely." FDA's ability to monitor the drugs' safety "is sometimes hampered by questions over whether it has jurisdiction over what generally is a state matter," according to USA Today. U.S. Pharmacopeia, a not-for-profit drug safety organization, in 2004 released new standards for drug compounding, but only 12 states have adopted them. Sarah Sellers, a consulting pharmacist who served on an FDA advisory panel on drug compounding until 2002, said some high-risk, sterile drugs should not be made at pharmacies. Sellers added that standards for compounding are rarely enforced. Steve Silverman, acting assistant director at an FDA compliance office, said, "Sterility is an area that we're very concerned about," but he added that if outside pharmacies were to stop compounding drugs for hospitals, "then sterile compounding likely would return to hospital and local pharmacies that may be less well-equipped." USA Today profiles Mary Washington Hospital in Virginia, where at least 11 cardiac surgery patients developed serious bacteria infections last year after their hearts were injected with a contaminated solution mixed at a pharmacy that contracted with the hospital. Three of the patients died (Appleby, USA Today, 8/8).
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