Description of outbreaks of health-care-associated infections related to compounding pharmacies, 2000-12.

PURPOSE: Outbreaks of health-care-associated infections related to compounding pharmacies from 2000 through 2012 are described.
METHODS: PubMed and the websites for the Centers for Disease Control and Prevention and the Food and Drug Administration were searched to identify infectious outbreaks associated with compounding pharmacies outside the hospital setting between January 2000 and November 2012.
RESULTS: Between January 2000 and before the 2012 fungal meningitis outbreak, 11 outbreaks were identified, involving 207 infected patients and 17 deaths after exposure to contaminated compounded drugs. The 2012 meningitis outbreak had a similar mortality rate but increased these totals almost fivefold. Half of the outbreaks involved patients in more than one state. Three outbreaks involved ophthalmic drugs. The remaining outbreaks involved corticosteroids, heparin flush solutions, cardioplegia solution, i.v. magnesium sulfate, total parenteral nutrition, and fentanyl. The outbreaks were caused by pathogens commonly associated with health-care-associated infections, common skin commensals, and organisms that rarely cause infection. Morbidity was substantial, including vision loss. Half the outbreaks resulted in recall of all sterile drugs from the pharmacy due to systemic problems with sterile procedures.
CONCLUSION: Before the nationwide 2012 fungal meningitis outbreak, drugs produced by compounding pharmacies were associated with 11 other smaller, but equally serious, outbreaks that occurred sporadically over the past 12 years. Lapses in sterile compounding procedures led to contamination of compounded drugs, exposure to patients, and a threat to public health in these outbreaks. Recognition and subsequent public health investigation were usually triggered by the occurrence of illness among multiple patients in a single health care setting.