Outbreak of Bacteremia Due toBurkholderia contaminansLinked to Intravenous Fentanyl From an Institutional Compounding Pharmacy

Abstract

IMPORTANCE Many health care facilities compound medications on site to fulfill local demands when customized formulations are needed, national supply is critically low, or costs for manufactured pharmaceuticals are excessive. Small, institutional compounding facilities may perform the same high-risk procedures as large distributors of compounded medications. OBJECTIVES To investigate an outbreak related to contamination of compounded sterile preparations and to determine processes to prevent future outbreaks. DESIGN, SETTING, AND PARTICIPANTS We performed an outbreak investigation of inpatients at Duke University Hospital from August 31 through September 6, 2012. The investigation included a case-control study, compounding facility inspection and environmental sampling, observation of a mock compounding demonstration, and microbiologic and molecular testing of sequestered medication. EXPOSURES Intravenous fentanyl prepared by an institutional compounding pharmacy. MAIN OUTCOMES AND MEASURES Microbiologic and molecular evidence of contamination of a compounded sterile preparation and failure of routine sterility testing. RESULTS Blood cultures of 7 patients during a 7-day period at Duke University Hospital yielded pan-susceptible Burkholderia cepacia complex bacteria. The risk factor common to all patients was receipt of continuous fentanyl infusion prepared by our institutional compounding pharmacy (odds ratio, 11.22; 95% CI, 2.09-ϱ; P = .01). The outbreak was terminated after sequestration of compounded fentanyl. An intensive evaluation of the compounding facility, its practice, and its procedures was completed. Investigators evaluated the clean room, collected targeted microbiologic samples within the compounding pharmacy environment, and observed a mock demonstration of compounding practice. The B cepacia complex was found in the anteroom sink drain and pH probe calibration fluid from the compounding clean room. Multiple microbiologic analyses of sequestered fentanyl initially failed. Ultimately, a batched, vacuum-assisted filtration method produced B cepacia complex from a single lot. Molecular analyses using repetitive element polymerase chain reaction and pulsed-field gel electrophoresis confirmed a clonal Burkholderia contaminans strain from patients, fentanyl, and environmental samples. CONCLUSIONS AND RELEVANCE An outbreak of B contaminans bacteremia was linked to contamination of locally compounded intravenous fentanyl. Health care facilities that house institutional compounding facilities must be vigilant in efforts to prevent, recognize, and terminate medication-related outbreaks.

Rapid detection of Candida parapsilosis contamination in the infusion fluid

“…Fentanyl injections have been reported to be susceptible to microbial contamination. [10][11][12][13][14] In this case, colonization on the inner wall of the extension tube during fentanyl administration was considered. We hypothesize that the contamination may have occurred by not exchanging the extension tube for more than 30 days.…”

Draft Genome Sequences of Burkholderia contaminans FFI-28, a Strain Isolated from a Contaminated Pharmaceutical Solution

“…B. contaminans is prevalent in Argentina (7) and Portugal (8) and is being increasingly isolated in CF patients from Spain (9) and Ireland (10). B. contaminans has been linked to outbreaks due to contaminated pharmaceutical products (11, 12). Genome sequences of B. contaminans isolated from an Argentinian CF patient (13) and from soil (14) have been reported; however, there are no genomic data of isolates obtained from PPCPs.…”

Design Considerations of a Compounded Sterile Preparations Course

“…[1][2][3] The Accreditation Council for Pharmacy Education (ACPE), the American Association of Colleges of Pharmacy, and the National Association of Boards of Pharmacy have all promulgated competency statements related to CSP for pharmacy education, though none of these statements address the methodology for CSP instruction in the classroom or the cleanroom. [4][5][6] In modern health care systems, compounding pharmacies meet special patient care needs.…”

“…[4][5][6] In modern health care systems, compounding pharmacies meet special patient care needs. 2,7 However, while the role of compounding pharmacies continues to expand, the fundamental teaching of compounding has decreased. 8 Reports show the utility of simulation in compounding education, but pharmacists require hands-on training to be competent in aseptic technique.…”