Follow protocols when using medications from compounding pharmacies.

1 Follow protocols when using medications from compounding pharmacies C ompounding pharmacies have long been valued for their ability to tailor prescription drugs for specific patients. More recently, they have helped conserve scarce drugs by redistributing them from larger to smaller single-use vials. For an ambulatory surgery center (ASC) that is not associated with a hospital and therefore has no access to a hospital pharmacy, a local compounding pharmacy might be the key to keeping expenses down and providing needed drugs. However, a confluence of conditions has led to deeper scrutiny of the compounding industry and reluctance to rely on it to provide a safe alternative to mass-produced pharmaceuticals. There is another way, experts agree: ASCs can select compounding pharmacies with confidence in their safety and professionalism if managers understand those companies’ limitations and role in the pharmaceutical industry. National outbreak In September 2012, a patient developed fungal meningitis 19 days after receiving an epidural steroid injection at an ASC in Nashville, Tennessee. Thus began an outbreak that the Centers for Disease Control and Prevention (CDC) would soon trace to the New England Compounding Center (NECC) in Framingham, Massachusetts. NECC had shipped more than 17,000 doses to customers in 23 states before initiating a voluntary recall. More than 14,000 patients had received injections, resulting in 55 deaths and 741 serious illnesses in 20 states, the CDC reported. While the NECC episode was not the first distribution of contaminated drugs from a compounding pharmacy, it gained national attention and Congressional interest. Bills now pending in the Senate and several state legislatures aim to resolve a variety of conflicting laws, Food and Drug Administration (FDA) guidelines, and court decisions regarding compounding pharmacies. “Existing standards are not always enforced,“ Simpleman notes, “because there are not enough inspectors.” An April 2013 report by Rep Edward J. Markey (D-Mass) notes that while pharmacies, including those that compound, are regulated and certified by states, many ship products between states, including over the Internet. There is no requirement to inform the state of origin when an adverse incident occurs. Meanwhile, according to the Markey report, some compounding pharmacies have expanded their business from filling prescriptions for individuals with special medical needs to producing large quantities of drugs whose manufacture is otherwise highly regulated. Specifically, they produce sterile injectables used in connection with surgery—drugs that are among the most frequently in short supply.