Life-threatening sepsis caused by Burkholderia cepacia from contaminated intravenous flush solutions prepared by a compounding pharmacy in another state

Pediatrics

Volumn 118, Issue 1, 2006, Pages

  Held, Melissa R ^a,g   Begier, Elizabeth M ^b,c   Beardsley, Diana S ^a   Browne, Frederick A ^e   Martinello, Richard A ^a,f   Baltimore, Robert S ^a   McDonald, L Clifford ^d   Jensen, Bette ^d   Hadler, James L ^b   Dembry, Louise Marie ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Connecticut Department of Public Health ^*  (United States)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES   (United States)

^e YALE NEW HAVEN HOSPITAL   (United States)

^f VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^g Division of Pediatric Infectious Diseases   (United States)

Author keywords

Antibiotic lock solution; Burkholderia cepacia; Compounding; Contamination; Sepsis

Indexed keywords

CEFEPIME; CEFTAZIDIME; CEFTRIAXONE; COTRIMOXAZOLE; GENTAMICIN; BLOOD CLOTTING FACTOR 8; F8 PROTEIN, HUMAN; HEPARIN; VANCOMYCIN;

ANAMNESIS; AQUEOUS SOLUTION; ARTICLE; BACTERIUM CULTURE; BURKHOLDERIA CEPACIA; CASE REPORT; CLINICAL FEATURE; DRUG SUBSTITUTION; HUMAN; MALE; MICROBIAL CONTAMINATION; PHARMACIST; PHYSICAL EXAMINATION; PRESCHOOL CHILD; PRIORITY JOURNAL; PULSED FIELD GEL ELECTROPHORESIS; QUALITY CONTROL; SEPSIS; BACTEREMIA; BACTERIAL INFECTION; CENTRAL VENOUS CATHETERIZATION; CHEMISTRY; CHILD; DRUG CONTAMINATION; DRUG FORMULATION; EQUIPMENT; INFECTION CONTROL; INTRAVENOUS DRUG ADMINISTRATION; MICROBIOLOGY;

BACTEREMIA; BURKHOLDERIA CEPACIA; BURKHOLDERIA INFECTIONS; CATHETERIZATION, CENTRAL VENOUS; CHILD; CHILD, PRESCHOOL; DISEASE NOTIFICATION; DRUG COMPOUNDING; DRUG CONTAMINATION; ELECTROPHORESIS, GEL, PULSED-FIELD; EQUIPMENT CONTAMINATION; FACTOR VIII; HEPARIN; HUMANS; INFUSIONS, INTRAVENOUS; MALE; VANCOMYCIN;

EID: 33746855984     PISSN: 00314005     EISSN: 02105721     Source Type: Journal    
DOI: 10.1542/peds.2005-2617     Document Type: Article

References (23)

1. Young D. Outsourced compounding can be problematic: community pharmacies linked to contaminated injectable. Am J Health Syst Pharm. 2002;59:2261-2262, 2264
2. American Society of Health-System Pharmacists. ASHP guidelines on quality assurance for pharmacy-prepared sterile products. Am J Health Syst Pharm. 2000;57:150-169
3. Tenover FC, Arbeit RD, Goering RV, et al. Interpreting chromosomal DNA restriction patterns produced by pulsed-field gel electrophoresis: criteria for bacterial strain typing. J Clin Microbiol. 1995;33:2233-2239
4. Centers for Disease Control and Prevention. Manufacturer's recall of nasal spray contaminated with Burkholderia cepacia complex. MMWR Morb Mortal Wkly Rep. 2004;53:246
5. Centers for Disease Control and Prevention. Notice to readers: nosocomial Burkholderia cepacia infections associated with exposure to sublingual probes - Texas 2004. MMWR Morb Mortal Wkly Rep. 2004;53:796
6. Mohr CD, Tomich M, Herfst CA. Cellular aspects of Burkholderia cepacia infection. Microbes Infect. 2001;3:425-435
7. Maschmeyer G, Gobel UB. Stenotrophomonas maltophilia and Burkholderia cepacia. In: Mandel, Douglas and Bennett's Principles and Practice of Infectious Diseases. 6th ed. New York, NY: Churchill Livingstone Inc; 2004:2615-2620
8. Belchis DA, Simpson E, Colby T. Histopathologic features of Burkholderia cepacia pneumonia in patients without cystic fibrosis. Mod Pathol. 2000;13:369-372
9. Kaslow RA, Mackel DC, Mallison GF. Nosocomial pseudobacteremia. Positive blood cultures due to contaminated benzalkonium antiseptic. JAMA. 1976;236:2407-2409
10. Oie S, Kamiya A. Microbial contamination of antiseptics and disinfectants. Am J Infect Control. 1996;24:389-395
11. Centers for Disease Control and Prevention. Nosocomial Burkholderia cepacia infection and colonization associated with intrinsically contaminated mouthwash: Arizona, 1998. MMWR Morb Mortal Wkly Rep. 1998;47:926-928
12. Doit C, Loukil C, Simon AM, et al. Outbreak of Burkholderia cepacia bacteremia in a pediatric hospital due to contamination of lipid emulsion stoppers. J Clin Microbiol. 2004;42:2227-2230
13. Magalhaes M, Doherty C, Govan JR, Vandamme P. Polyclonal outbreak of Burkholderia cepacia complex bacteraemia in haemodialysis patients. J Hosp Infect. 2003;54:120-123
14. Siddiqui AH, Mulligan ME, Mahenthiralingam E, et al. An episodic outbreak of genetically related Burkholderia cepacia among non-cystic fibrosis patients at a university hospital. Infect Control Hosp Epidemiol. 2001;22:419-422
15. Kastango ES, Bradshaw BD. USP chapter 797: establishing a practice standard for compounding sterile preparations in pharmacy. Am J Health Syst Pharm. 2004;61:1928-1938
16. Harteker LR. Federal court strikes down compounding regulations. Am J Health System Pharm. 2001;58:638, 640, 643
17. O'Grady NP, Alexander M, Dellinger EP, et al. Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2002;30:476-489
18. DeLisle S, Perl TM. Vancomycin-resistant enterococci: a road map on how to prevent the emergence and transmission of antimicrobial resistance. Chest. 2003;123(5 suppl):504S-518S
19. Trissel LA, Ogundele AB, Ingram DS, Saenz CA, Gentempo JA. Using medium-fill simulation to establish a benchmark microbiological contamination rate for low-risk-level compounding. Am J Health Syst Pharm. 2003;60:1853-1855
20. Sterile drug products for home use. In: The United States Pharmacopeia, 26th rev, and National Formulary. 21st ed. Rockville, MD: United States Pharmacopeial Convention; 2002:2234-2247
21. Pharmaceutical compounding: sterile preparations. Pharmacopeial Forum. 2003;29:940-965
22. Centers for Disease Control and Prevention (CDC). Exophiala infection from injectable contaminated steroids prepared by a compounding pharmacy: United States, July-November 2002. MMWR Morb Mortal Wkly Rep. 2002;51:1109-1112
23. Centers for Disease Control and Prevention (CDC). Pseudomonas bloodstream infections associated with a heparin/saline flush: Missouri, New York, Texas, and Michigan, 2004-2005. MMWR Morb Mortal Wkly Rep. 2005;54:269-272