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Blogging from the PDA Microbiology Conference: Compounding Pharmacies and Fungal Meningitis

Another year has passed and once again, I am blogging from the PDA Global Conference on Pharmaceutical Microbiology. This is the 7th year for this signature scientific meeting, where microbiologists from around the world gather to learn about the latest technologies, industry best practices and regulatory expectations with regard to contamination control and microbiological considerations during the manufacture of drug product.

The conference began with an outstanding first keynote address entitled Outbreaks Associated with Pharmaceutical Product: Steps for Prevention presented by Matthew J. Arduino, Dr. Ph., Lead Microbiologist, Chief Clinical and Environmental Microbiology Branch, Centers for Disease Control and Prevention.

During his presentation, Dr. Arduino reviewed the role of the CDC, key outbreaks that have occurred over the past few decades, where contamination has occurred, and how to prevent outbreaks and adverse events. It is interesting to note, that in light of very recent events associated with the fungal contamination of pharmacy compounded injectable product (see below), the number of products that have been contaminated by compounding pharmacies have increased since the 1990's. Microbial contaminants isolated from patients and products (contaminated at the compounding pharmacy level) have included Burkholderia cepacia, Pseudomonas aerugnosa, P. fluorescens, P. putida, Serratia marcescens, Exophiala dermatitidis, Elizabethkingae meningosepticum, Enterobacter cloacae, Fusarium spp, Bipolaris, Bullera spp and Rhodotorula.

Dr. Arduino concluded that outbreaks highlight the potential of certain products, manufacturing processes and infection control practices to cause high morbidity and mortality. There continues to be unsafe injection practices, and medication handling. Finally, we continue to see problems associated with compounding pharmacies.

Of course, the session wold not have been complete without a discussion of the fungal (Exserohilum rostratum) meningitis outbreak that has now affected patients in at least 17 states within the U.S. Nearly 14,000 patients may have received contaminated steroid injections since May 21, 2012, which have been produced by the New England Compounding Center (NECC) of Framingham, Mass. The potentially tainted drugs were sent to pain clinics and health care facilities in 23 states. As of today, infections related to the outbreak reached 308, with 23 deaths. That includes 304 cases of meningitis, stroke or other nervous system problems tied to epidural injections of contaminated steroids (methylprednisolone acetate), plus four infections in patients who received pain shots in joints such as the hip, knee shoulder or elbow. The death toll has held steady for a few days, but officials with the CDC said that doesn't necessarily mean that the outbreak is waning.

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