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BACKGROUND: Pharmacy-compounded sterile preparations (P-CSPs) play a critical role in the U.S. healthcare delivery system; however, the Centers for Disease Control and Prevention (CDC), along with its federal and state public health partners, have been increasingly responding to serious and large outbreaks linked to contaminated P-CSPs. Here, we review the burden, characteristics, and underlying factors associated with outbreaks linked to contaminated P-CSPs, and suggest potential strategies aimed at preventing similar outbreaks in the future.
METHODS: Internal CDC reports, as well as Medline, CINAHAL, and Embase databases were searched to identify outbreaks that resulted in infectious illnesses or deaths and that were linked to contaminated P-CSPs from January 1, 2001 through December 31, 2013. Excluded were incidents not resulting in infectious illness or deaths (e.g., those that led only to warning letters), as well as incidents involving P-CSP dispensing errors (e.g., dosage calculation error), intentional adulteration, extrinsic contamination (e.g., unsafe injection practices at point-of-care), or veterinary medicines.
RESULTS: We identified 17 outbreaks linked to P-CSPs over a 12-year period, resulting in almost 1000 adverse events and impacting over one-half of states; 11 of 17 outbreaks involved pharmacies supplying P-CSPs across state lines. Injectable steroids (5/17) and bevacizumab for intraocular use (3/17) comprised almost one-half of the products involved in these outbreaks. The most commonly-identified pathogens linked to P-CSP contamination were gram-negative bacteria (9/17) and dematiaceous fungi (4/17). Over one-half of outbreaks involved P-CSPs prepared from non-sterile ingredients that required sterilization by the pharmacy. Failure of compounding personnel to adhere to aseptic practices, poor environmental quality control, inadequate sterilization procedures, and lapses in sterility/endotoxin testing were the leading contributors to contamination. An increased need for products that were commercially unavailable due to drug shortages, clinician preference for alternate variations of commercially-available products, and lower costs of P-CSPs relative to commercially-available counterparts appeared to be major drivers of sterile compounding.
CONCLUSIONS: Outbreaks linked to P-CSPs have been associated most commonly with compounding using non-sterile ingredients and were consistently characterized by lack of adherence to regulatory and professional standards for sterile compounding, including those described in U.S. Pharmacopeial Convention (USP) Chapter <797>. If P-CSPs are to be considered safe medical products, federal and state partners will have a critical role to play in facilitating improvements in compounding personnel competency and quality assurance processes, as well as in ensuring pharmacies are acting within regulatory and professional standards.