Straight from the headlines: what is going on in compounding pharmacies, and how can clinical microbiologists help?

In late 2004, I was the outgoing Chair of the American Society for Microbiology’s (ASM’s) Committee on Professional Affairs in Microbiology. The U.S. Pharmacopeial Convention sent a letter to ASM asking us to comment on their newly minted chapter 797 , regarding compounded sterile preparations (CSPs) in pharmacies. In 2005, I was appointed the ASM delegate to the USP for a 5-year term; that term was renewed in 2010. During the 9 years that I have been involved in working with sterile-compound pharmacists, I have learned a lot about their profession. I would like to be able to say that they learned a lot about what we do as clinical microbiologists, but unfortunately, they did not feel that they had much to learn from us. In fact, over the years, I found that anyone with one semester of microbiology thought that he or she was a clinical microbiologist. The disaster at the New England Compounding Center (NECC) promises to change that. The contamination of a CSP, preservative-free methylprednisolone acetate, prepared by NECC and administered intrathecally for management of back pain has so far affected 730 patients and caused 51 deaths (1); the CDC website http://www.cdc.gov /hai/outbreaks/meningitis-map.html is updated every Monday. There is a bill before the Senate introduced by Senator Harkin of Iowa that will improve oversight of compounding pharmacies (2). It reminds me of the legislation that resulted in the Clinical Laboratory Improvement Act of 1967 (CLIA-67) (3) following problems with “sink testing” in clinical laboratories in the 1960s. There are a number of similarities in calls for personnel competency assessment, a robust quality assurance program, and testing for the sterility of supposedly sterile products. We have a lot to teach our pharmacy colleagues about compliance programs, which likely will become mandatory and will be enforced. There are also five parts of their quality assurance program with which clinical microbiologists can help. These are discussed later in this paper. Working with the pharmacy in this regard is actually an extension of our infection prevention duties and our participation in hospital antibiotic stewardship programs. Simply put, how could so many patients get fungal meningitis from a CSP?