This article is more than 5 years old. Information may no longer be current.
S. marcescens BSI outbreak linked to compounding pharmacy
Click Here to Manage Email Alerts
An outbreak of bloodstream infections caused by Serratia marcescens was linked to parenteral nutrition prepared by a single compounding pharmacy, according to a CDC report in Clinical Infectious Diseases.
“Failure to comply with established standards for sterile compounding was one of the primary factors allowing for [parenteral nutrition] contamination and serious patient harm,” the researchers wrote. “Improved adherence to sterile compounding standards, critical examination of the adequacy of standards for compounding [compounded sterile preparations] from non-sterile ingredients and more rigorous oversight of compounding pharmacies are needed to mitigate the risks of potential contamination and prevent future outbreaks.”
The investigation began after five patients receiving parenteral nutrition developed S. marcescens bloodstream infections (BSIs) in March 2011. CDC investigators linked the infection to a compounding pharmacy in Birmingham, Ala., which supplied parenteral nutrition to six health care facilities. After reviewing records from the six facilities, they identified 19 case patients. Nine patients died of the infection.
The pharmacy had recently begun compounding and filter-sterilizing 15% amino acid solution from nonsterile powders because of a national shortage of sterile solution. Two of the amino acid lots that were reported sterile when originally tested had detectable endotoxin. In addition, environmental cultures of the pharmacy identified S. marcescens on the amino acid mixing container and stirrer, the tap water faucet used to clean the mixing container, the 15% amino acid solution and from the parenteral nutrition preparations from the pharmacy.
“The United States is currently facing an unprecedented number of drug shortages, which significantly impact patient care and health care costs,” the researchers wrote. “As in the case during this outbreak, interruption in supply of amino acids from one manufacturer led to an increase in demand that could not be met by other manufacturers, resulting in a critical national shortage. Despite these challenges, adherence to sterile compounding standards is necessary to ensure the provision of safely-prepared [compounded sterile preparations] during periods of drug shortages.”
Disclosure: The researchers report no relevant financial disclosures.
Click Here to Manage Email Alerts