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Published on: July 11, 2016
Sphingomonas paucimobilis bloodstream infections associated with contaminated intravenous fentanyl
Lisa L Maragakis1, Romanee Chaiwarith, Arjun Srinivasan
1Division of Infectious Diseases, Department of Hospital Epidemiology and Infection Control, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA. lmaraga1@jhmi.edu
Abstract:
Nationally distributed medications from compounding pharmacies, which typically adhere to less stringent quality-control standards than pharmaceutical manufacturers, can lead to multistate outbreaks. We investigated a cluster of 6 patients in a Maryland hospital who had Sphingomonas paucimobilis bloodstream infections in November 2007. Of the 6 case-patients, 5 (83%) had received intravenous fentanyl within 48 hours before bacteremia developed. Cultures of unopened samples of fentanyl grew S. paucimobilis; the pulsed-field gel electrophoresis pattern was indistinguishable from that of the isolates of 5 case-patients. The contaminated fentanyl lot had been prepared at a compounding pharmacy and distributed to 4 states. Subsequently, in California, S. paucimobilis bacteremia was diagnosed for 2 patients who had received intravenous fentanyl from the same compounding pharmacy. These pharmacies should adopt more stringent quality-control measures, including prerelease product testing, when compounding and distributing large quantities of sterile preparations.
Insights
Contaminated fentanyl from compounding pharmacies caused Sphingomonas paucimobilis bloodstream infections in multiple states. Stricter quality control is needed for sterile drug preparations to prevent outbreaks.
Area of Science:
- Infectious Diseases
- Public Health
- Microbiology
Background:
- Compounding pharmacies may have less stringent quality control than manufacturers.
- Multistate outbreaks have been linked to nationally distributed medications.
Purpose of the Study:
- Investigate a cluster of Sphingomonas paucimobilis bloodstream infections.
- Determine the source of the outbreak and identify risk factors.
Main Methods:
- Case investigation of patients with S. paucimobilis bloodstream infections.
- Microbiological culturing of intravenous fentanyl samples.
- Pulsed-field gel electrophoresis (PFGE) for bacterial strain comparison.
Main Results:
- Five of six case-patients in Maryland received intravenous fentanyl before infection.
- S. paucimobilis was isolated from unopened fentanyl samples.
- PFGE confirmed the outbreak strain was present in the contaminated fentanyl lot.
- Two additional cases in California were linked to fentanyl from the same pharmacy.
Conclusions:
- Intravenous fentanyl from a compounding pharmacy was the source of S. paucimobilis outbreaks.
- Compounding pharmacies need enhanced quality control, including prerelease testing for sterile products.
- Stricter oversight is crucial to prevent future outbreaks linked to compounded medications.
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