U.S. Compounding Pharmacy-related Outbreaks, 2001–2013—Public Health and Patient Safety Lessons Learned
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U.S. Compounding Pharmacy-related Outbreaks, 2001–2013—Public Health and Patient Safety Lessons Learned

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    • Alternative Title:
      J Patient Saf
    • Description:
      Objectives Pharmacy-compounded sterile preparations (P-CSPs) are frequently relied upon in U.S. healthcare, 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 one state. Almost one-half of outbreaks were linked to injectable steroids (5/19) and intraocular bevacizumab (3/19). Non-patient-specific compounding originating from non-sterile ingredients and re-packaging 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 re-packaging and non-sterile 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, and early recognition and notification of possible outbreaks.
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