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Volume 15, Number 1—January 2009

Sphingomonas paucimobilis Bloodstream Infections Associated with Contaminated Intravenous Fentanyl1

Lisa L. MaragakisComments to Author , Romanee Chaiwarith, Arjun Srinivasan, Francesca J. Torriani, Edina Avdic, Andrew Lee, Tracy R. Ross, Karen C. Carroll2, and Trish M. Perl2
Author affiliations: Johns Hopkins University School of Medicine, Baltimore, Maryland, USA (L.L. Maragakis, A. Lee, K.C. Carroll, T.M. Perl); Johns Hopkins University Bloomberg School of Public Health, Baltimore (R. Chaiwarith); Centers for Disease Control and Prevention, Atlanta, Georgia, USA (A. Srinivasan); University of California, San Diego, California, USA (F.J. Torriani); The Johns Hopkins Hospital, Baltimore (E. Avdic, T.R. Ross)

Main Article

Table 1

Recently published reports of infectious outbreaks associated with contaminated medications prepared at compounding pharmacies, United States, 2002–2007

Reference Organism Infection ( no. patients) Mode of transmission Location of outbreak
(3) Serratia marcescens Bloodstream infections (18) Intravenous magnesium sulfate California, New Jersey, North Carolina, New York, Massachusetts
(4) S. marcescens Meningitis, epidural abscess, or joint infection (11)* Epidural or intra-articular injection of betamethasone California
(6) Burkholderia cepacia Bloodstream infections and sepsis (2 pediatric patients) Intravenous antibiotic-lock flush solution Connecticut
(7) Hepatitis C Acute hepatitis C (16) Injected radiopharmaceutical for myocardial perfusion study 3 clinics in Maryland
(8,10) Pseudomonas fluorescens Bloodstream infections (64) Heparin/saline intravenous flush Missouri, New York, Texas, Michigan, South Dakota
(9) Exophiala dermatitidis Meningitis (5)† Epidural injection of methylprednisolone‡ 2 pain management clinics in North Carolina

*3 case-patients died.
†1 case-patient died.
‡Prepared by a compounding pharmacy in South Carolina and supplied to hospitals and clinics in 5 states.

Main Article

  1. US Food and Drug Administration. Guidance for FDA staff and industry compliance policy guides manual; section 460.200; pharmacy compounding; 2002 [cited 2008 Mar 28]. Available from
  2. Pegues  DA. Improving and enforcing compounding pharmacy practices to protect patients. Clin Infect Dis. 2006;43:83840. DOIPubMedGoogle Scholar
  3. Sunenshine  RH, Tan  ET, Terashita  DM, Jensen  BJ, Kacica  MA, Sickbert-Bennett  EE, A multistate outbreak of Serratia marcescens bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacy. Clin Infect Dis. 2007;45:52733. DOIPubMedGoogle Scholar
  4. Civen  R, Vugia  DJ, Alexander  R, Brunner  W, Taylor  S, Parris  N, Outbreak of Serratia marcescens infections following injection of betamethasone compounded at a community pharmacy. Clin Infect Dis. 2006;43:8317. DOIPubMedGoogle Scholar
  5. Perz  JF, Craig  AS, Stratton  CW, Bodner  SJ, Phillips  WE Jr, Schaffner  W. Pseudomonas putida septicemia in a special care nursery due to contaminated flush solutions prepared in a hospital pharmacy. J Clin Microbiol. 2005;43:53168. DOIPubMedGoogle Scholar
  6. Held  MR, Begier  EM, Beardsley  DS, Browne  FA, Martinello  RA, Baltimore  RS, Life-threatening sepsis caused by Burkholderia cepacia from contaminated intravenous flush solutions prepared by a compounding pharmacy in another state. Pediatrics. 2006;118:e2125. DOIPubMedGoogle Scholar
  7. Patel  PR, Larson  AK, Castel  AD, Ganova-Raeva  LM, Myers  RA, Roup  BJ, Hepatitis C virus infections from a contaminated radiopharmaceutical used in myocardial perfusion studies. JAMA. 2006;296:200511. DOIPubMedGoogle Scholar
  8. Centers for Disease Control and Prevention. Pseudomonas bloodstream infections associated with a heparin/saline flush—Missouri, New York, Texas, and Michigan, 2004–2005. MMWR Morb Mortal Wkly Rep. 2005;54:26972.PubMedGoogle Scholar
  9. Centers for Disease Control and Prevention. Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy—United States, July–Nov 2002. MMWR Morb Mortal Wkly Rep. 2002;51:110912.PubMedGoogle Scholar
  10. Centers for Disease Control and Prevention. Update: delayed onset Pseudomonas fluorescens bloodstream infections after exposure to contaminated heparin flush—Michigan and South Dakota, 2005–2006. MMWR Morb Mortal Wkly Rep. 2006;55:9613.PubMedGoogle Scholar
  11. Hsueh  PR, Teng  LJ, Yang  PC, Chen  YC, Pan  HJ, Ho  SW, Nosocomial infections caused by Sphingomonas paucimobilis: clinical features and microbiological characteristics. Clin Infect Dis. 1998;26:67681. DOIPubMedGoogle Scholar
  12. Adams  WE, Habib  M, Berrington  A, Koerner  R, Steel  DH. Postoperative endophthalmitis caused by Sphingomonas paucimobilis. J Cataract Refract Surg. 2006;32:123840. DOIPubMedGoogle Scholar
  13. Kilic  A, Senses  Z, Kurekci  AE, Aydogan  H, Sener  K, Kismet  E, Nosocomial outbreak of Sphingomonas paucimobilis bacteremia in a hemato/oncology unit. Jpn J Infect Dis. 2007;60:3946.PubMedGoogle Scholar
  14. Perola  O, Nousiainen  T, Suomalainen  S, Aukee  S, Karkkainen  UM, Kauppinen  J, Recurrent Sphingomonas paucimobilis bacteraemia associated with a multi-bacterial water-borne epidemic among neutropenic patients. J Hosp Infect. 2002;50:196201. DOIPubMedGoogle Scholar
  15. Lemaitre  D, Elaichouni  A, Hundhausen  M, Claeys  G, Vanhaesebrouck  P, Vaneechoutte  M, Tracheal colonization with Sphingomonas paucimobilis in mechanically ventilated neonates due to contaminated ventilator temperature probes. J Hosp Infect. 1996;32:199206. DOIPubMedGoogle Scholar
  16. Tenover  FC, Arbeit  RD, Goering  RV. How to select and interpret molecular strain typing methods for epidemiological studies of bacterial infections: a review for healthcare epidemiologists. Molecular Typing Working Group of the Society for Healthcare Epidemiology of America. Infect Control Hosp Epidemiol. 1997;18:42639. DOIPubMedGoogle Scholar
  17. US Food and Drug Administration. FDA regulation of compounded drugs; 2008 [cited 2008 May 15]. Available from
  18. Galson  SK. Statement before the Senate committee on health, education, labor and pensions hearing on “federal and state role in pharmacy compounding and reconstitution: exploring the right mix to protect patients”; 2003 [cited 2008 Mar 28]. Available from
  19. US Food and Drug Administration. Guidance for industry; sterile drug products produced by aseptic processing—current good manufacturing practice; 2004 [cited 2008 Apr 2]. Available from
  20. Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001).
  21. Thompson v. Western States Medical Center, 535 U.S. 357 (2002).
  22. Harteker  LR. Federal court strikes down compounding regulations. Am J Health Syst Pharm. 2001;58:638, 640,643.PubMedGoogle Scholar
  23. American Society of Health-System Pharmacists. ASHP guidelines on quality assurance for pharmacy-prepared sterile products. Am J Health Syst Pharm. 2000;57:115069.PubMedGoogle Scholar
  24. United States Pharmacopeia. Guidebook to pharmaceutical compounding—sterile preparations. Rockville (MD): The Pharmacopeia; 2008 [cited 2008 20 Nov]. Available from
  25. Kastango  ES, Bradshaw  BD. United States Pharmocopeia chapter 797: establishing a practice standard for compounding sterile preparations in pharmacy. Am J Health Syst Pharm. 2004;61:192838.PubMedGoogle Scholar
  26. Morris  AM, Schneider  PJ, Pedersen  CA, Mirtallo  JM. National survey of quality assurance activities for pharmacy-compounded sterile preparations. Am J Health Syst Pharm. 2003;60:256776.PubMedGoogle Scholar
  27. Candy  TA, Schneider  PJ, Pedersen  CA. Impact of United States Pharmacopeia chapter 797: results of a national survey. Am J Health Syst Pharm. 2006;63:133643. DOIPubMedGoogle Scholar
  28. US Food and Drug Administration. Report: limited FDA survey of compounded drug products 2003. [cited 2008 Mar 28]. Available from
  29. Schweitzer  SO. Trying times at the FDA—the challenge of ensuring the safety of imported pharmaceuticals. N Engl J Med. 2008;358:17737. DOIPubMedGoogle Scholar
  30. Wood  AJ. Playing “kick the FDA”—risk-free to players but hazardous to public health. N Engl J Med. 2008;358:17745. DOIPubMedGoogle Scholar

Main Article

1Data presented in part at the 18th Annual Meeting of the Society for Healthcare Epidemiology of America; Orlando, Florida; April 6, 2008 (abstract 478).

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