666. Outbreak of Bacteremia due to Burkholderia contaminans Linked to Intravenous Fentanyl from an Institutional Compounding Pharmacy
Session: Oral Abstract Session: HAI Outbreaks Crossing Healthcare Settings
Friday, October 4, 2013: 11:00 AM
Room: The Moscone Center: 300

Background: Some healthcare facilities compound medications on site to fulfill local demands when national supply is critically low or costs for manufactured pharmaceuticals are excessive. Institutional compounding facilities may perform preparations involving non-sterile raw materials, the same type of high risk procedures implicated in the 2012 fungal meningitis outbreak. Burkholderia cepacia complex (BCC) bacteria grew from blood cultures of 7 patients at Duke University Hospital over a 1 week period in September 2012. An outbreak investigation was initiated to determine a common source.

Methods: The outbreak was confirmed using traditional epidemiologic methods. A 3:1 matched case control study using exact conditional logistic regression identified risk factors. We performed a comprehensive review of the compounding pharmacy, practice, and procedures. Targeted environmental sampling within the compounding area and microbiologic analyses of sequestered fentanyl were completed. Molecular analysis of outbreak-related isolates was performed using rep-PCR employing the BOX A1R primer.

Results: Seven patients in 5 hospital units developed BCC bacteremia. The major risk factor common to all case patients was receipt of continuous infusion fentanyl prepared by our compounding pharmacy (OR 11.22, 95% CI 2.09-infinity, p=0.01). No contamination was detected in routine, pre-distribution sterility testing performed by direct inoculation methods. The outbreak was terminated with sequestration of remaining compounded fentanyl. Environmental cultures in the compounding facility revealed BCC in the sink drain and in pH probe calibration fluid. After multiple attempts, BCC was cultured from a single lot of sequestered fentanyl using a batched filtration technique. Molecular analyses identified the species as Burkholderia contaminans and confirmed that patient, environmental, and medication isolates were an identical strain.

Conclusion: A 7-patient outbreak of B. contaminans bacteremia was linked to contamination of locally compounded intravenous fentanyl. Medical institutions that compound high risk preparations must be prepared to recognize, investigate, and terminate medication related outbreaks. Routine pre-distribution sterility testing cannot guarantee product safety.


Rebekah W. Moehring, MD, MPH1,2,3, Sarah S. Lewis, MD1,4, Pamela J. Isaacs, BSN MHA CIC4, Wiley A. Schell, MS4, Wayne R. Thomann, DrPH4, Mary M. Althaus, N(NRCM)4, Kevin C. Hazen, PhD4, Kristen V. Dicks, MD4, John J. Lipuma, MD5, Luke F. Chen, MBBS, MPH, CIC, FRACP1,4 and Daniel J. Sexton, MD, FIDSA1,4, (1)Duke Infection Control Outreach Network, Durham, NC, (2)Division of Infectious Diseases, Duke University Medical Center, Durham, NC, (3)Durham VA Medical Center, Durham, NC, (4)Duke University Medical Center, Durham, NC, (5)University of Michigan, Ann Arbor, MI


R. W. Moehring, None

S. S. Lewis, None

P. J. Isaacs, None

W. A. Schell, None

W. R. Thomann, None

M. M. Althaus, None

K. C. Hazen, None

K. V. Dicks, None

J. J. Lipuma, None

L. F. Chen, None

D. J. Sexton, None

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