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Description of outbreaks of healthcare associated infections related to compounding pharmacies, 2000-2012
Filetype[PDF - 504.62 KB]


Details:
  • Funding:
    5P01HK000069/HK/PHITPO CDC HHS/United States
    T15 LM007124/LM/NLM NIH HHS/United States
    T15LM007124/LM/NLM NIH HHS/United States
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  • Description:
    Purpose

    The 2012 multistate fungal meningitis outbreak caused by contaminated methylprednisolone suggests that contaminated compounded drugs can pose a public health threat. The problem has not been well described. Our objective was to systematically review the literature to describe: a) features of infectious outbreaks associated with exposure to contaminated drugs produced by compounding pharmacies, b) sterile compounding procedures that caused microbial contamination, and c) outbreak features relevant for detection and investigation.

    Methods

    We searched PubMed (reviewing 850 citations) and the CDC and FDA Web sites to identify infectious outbreaks associated with compounding pharmacies outside the hospital setting between January 2000 and November 2012. We extracted information from peer-reviewed literature, FDA and CDC documents, meeting abstracts, and congressional testimony.

    Results

    Between 2000 and prior to the 2012 fungal meningitis outbreak, 11 infectious outbreaks from contaminated compounded drugs were reported involving 207 case-patients with 17 deaths (8.2% case fatality rate). The 2012 meningitis outbreak increased totals almost 5-fold. Half the outbreaks involved case-patients in more than 1 state. Three outbreaks involved ophthalmic drugs: trypan blue and Brilliant Blue-G ophthalmic solutions used during surgery, and triamcinolone and bevacizumab for intravitreal injection. Remaining outbreaks involved corticosteroids (n=2), heparin flush solutions (n=2), cardioplegia, intravenous magnesium sulfate, total parenteral nutrition, and fentanyl. The outbreaks were caused by pathogens commonly associated with healthcare associated infections (n=6), common skin commensals (n=1), and organisms that rarely cause infection (n=5). Morbidity was substantial, including vision loss; mortality rates during earlier outbreaks were similar to the 2012 meningitis outbreak. A variety of problems with sterile procedures were found. No single source reported all outbreaks.

    Conclusion

    Sporadic but serious infectious outbreaks associated with contaminated drugs from compounding pharmacies occurred before the 2012 fungal meningitis outbreak. These outbreaks illustrate root causes that could be addressed with preventive policies and practices.