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U.S. Compounding Pharmacy-Related Outbreaks, 2001–2013

Public Health and Patient Safety Lessons Learned

Shehab, Nadine, PharmD, MPH*; Brown, Megan N., BA*†; Kallen, Alexander J., MD, MPH*; Perz, Joseph F., DrPh*

doi: 10.1097/PTS.0000000000000188
Review Article

Objectives Pharmacy-compounded sterile preparations (P-CSPs) are frequently relied upon in U.S. health care but are increasingly being linked to outbreaks of infections. We provide an updated overview of outbreak burden and characteristics, identify drivers of P-CSP demand, and discuss public health and patient safety lessons learned to help inform prevention.

Methods Outbreaks of infections linked to contaminated P-CSPs that occurred between January 1, 2001, and December 31, 2013, were identified from internal Centers for Disease Control and Prevention reports, Food and Drug Administration drug safety communications, and published literature.

Results We identified 19 outbreaks linked to P-CSPs, resulting in at least 1000 cases, including deaths. Outbreaks were reported across two-thirds of states, with almost one-half (8/19) involving cases in more than 1 state. Almost one-half of outbreaks were linked to injectable steroids (5/19) and intraocular bevacizumab (3/19). Non–patient-specific compounding originating from nonsterile ingredients and repackaging of already sterile products were the most common practices associated with P-CSP contamination. Breaches in aseptic processing and deficiencies in sterilization procedures or in sterility/endotoxin testing were consistent findings. Hospital outsourcing, preference for variations of commercially available products, commercial drug shortages, and lower prices were drivers of P-CSP demand.

Conclusions Recognized outbreaks linked to P-CSPs have been most commonly associated with non–patient-specific repackaging and nonsterile to sterile compounding and linked to lack of adherence to sterile compounding standards. Recently enhanced regulatory oversight of compounding may improve adherence to such standards. Additional measures to limit and control these outbreaks include vigilance when outsourcing P-CSPs, scrutiny of drivers for P-CSP demand, as well as early recognition and notification of possible outbreaks.

From the *Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and

Kennedy Krieger Institute, Baltimore, Maryland.

Correspondence: Nadine Shehab, PharmD, MPH, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, MS A-24, Atlanta, GA 30333 (e-mail:

The authors disclose no conflict of interest.

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

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