(June 17, 2013) In the wake of the deadly infections in 2012 from drugs compounded at the New England Compounding Center (NECC), a new study examines similar outbreaks in the U.S. over the last 12 years in an effort to discover factors that may hinder outbreak detection. The article, Description of Outbreaks of Health-Care-Associated Infections Related to Compounding Pharmacies, 2000-12, by Catherine Staes, M.P.H., Ph.D.; Jason Jacobs; Jeanmarie Mayer, M.D.; and Jill Allen, Pharm.D., BCPS; is published by the American Journal of Health-System Pharmacy (AJHP) online, ahead of print, because of its significant contributions concerning this current public health issue.
The study, which is the first of its kind, is based on a literature review of 850 articles, as well as content on the Food and Drug Administration (FDA) website. The analysis focuses on outbreaks due to drugs that were likely contaminated during preparation at compounding pharmacies outside the hospital setting. The authors discovered 12 outbreaks resulting in 65 deaths, including the recent outbreak associated with NECC. The authors then identified key factors of the outbreaks, including triggers that lead to detection, number and location of patients involved, drug name and route of administration, infectious organisms and clinical outcomes, name and location of the compounding pharmacy, and findings from the investigation.
Some affected patients lost their vision; some required hospitalization, surgeries, or treatments; and about seven percent died. Each of the 12 outbreaks had root causes that could have been prevented, according to the authors.
Key findings include:
To help prevent future outbreaks, the authors recommend addressing the root causes, including regulatory gaps, compounding processes, awareness among clinicians, and the public health systems required to monitor compounding practices and identify and respond to outbreaks. They also recommend that compounding pharmacies fully comply with USP chapter 797, the standard for sterile compounding safety in the U.S. In addition, they call for enhancing electronic health record systems to recognize links between compounded drugs and infections.
In addition, AJHP is concurrently publishing a related article, History of Sterile Compounding in U.S. Hospitals: Learning from the Tragic Lessons of the Past, by Charles E. Myers, M.S., M.B.A., that examines the evolution of sterile compounding in the U.S. and explores what measures are needed to better ensure the safety of compounded products.