Sphingomonas paucimobilis bloodstream infections associated with contaminated intravenous fentanyl

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.

Figure 1

Epidemiologic curve showing the number of patients with Sphingomonas paucimobilis bacteremia at The Johns Hopkins Hospital, Baltimore, Maryland, USA, January 2006 through March 2008.

Figure 2

Results of pulsed-field gel electrophoresis (PFGE) of Sphingomonas paucimobilis isolates obtained in November 2007. Lanes 1 and 10, molecular weight marker; lanes 2–7, bloodstream isolates from patients 1–6, respectively; lane 8, isolate from contaminated fentanyl; lane 9, unrelated control isolate. Patients 2 through 6 received intravenous fentanyl within 48 hours before S. paucimobilis bacteremia developed and had isolates with a PFGE pattern indistinguishable from that of fentanyl isolates. Patient 1 did not receive intravenous fentanyl and had S. paucimobilis bacteremia with a distinct PFGE pattern.