Outbreak of Serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy.

BACKGROUND Compounding pharmacies often prepare parenteral nutrition (PN) and must adhere to rigorous standards to avoid contamination of the sterile preparation. In March 2011, Serratia marcescens bloodstream infections (BSIs) were identified in 5 patients receiving PN from a single compounding pharmacy. An investigation was conducted to identify potential sources of contamination and prevent further infections. METHODS Cases were defined as S. marcescens BSIs in patients receiving PN from the pharmacy between January and March 2011. We reviewed case patients' clinical records, evaluated pharmacy compounding practices, and obtained epidemiologically directed environmental cultures. Molecular relatedness of available Serratia isolates was determined by pulsed-field gel electrophoresis (PFGE). RESULTS Nineteen case patients were identified; 9 died. The attack rate for patients receiving PN in March was 35%. No case patients were younger than 18 years. In October 2010, the pharmacy began compounding and filter-sterilizing amino acid solution for adult PN using nonsterile amino acids due to a national manufacturer shortage. Review of this process identified breaches in mixing, filtration, and sterility testing practices. S. marcescens was identified from a pharmacy water faucet, mixing container, and opened amino acid powder. These isolates were indistinguishable from the outbreak strain by PFGE. CONCLUSIONS Compounding of nonsterile amino acid components of PN was initiated due to a manufacturer shortage. Failure to follow recommended compounding standards contributed to an outbreak of S. marcescens BSIs. Improved adherence to sterile compounding standards, critical examination of standards for sterile compounding from nonsterile ingredients, and more rigorous oversight of compounding pharmacies is needed to prevent future outbreaks.

[1]  Peggi Guenter,et al.  Safe Practices for Parenteral Nutrition. , 2004, JPEN. Journal of parenteral and enteral nutrition.

[2]  Philip J Schneider,et al.  ASHP national survey of pharmacy practice in hospital settings: dispensing and administration--2011. , 2012, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[3]  Robert L. Swain,et al.  National Association of Boards of Pharmacy , 1954 .

[4]  Philip J Schneider,et al.  ASHP national survey of pharmacy practice in hospital settings: dispensing and administration--2002. , 2003, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[5]  ASHP guidelines on the safe use of automated compounding devices for the preparation of parenteral nutrition admixtures. Developed through the ASHP Council on Professional Affairs and approved by the ASHP Board of Directors on April 27, 2000. , 2000, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[6]  M. Goldberger,et al.  FDA's role in responding to drug shortages. , 2002, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[7]  J. Gervasio,et al.  A.S.P.E.N. parenteral nutrition safety consensus recommendations. , 2014, JPEN. Journal of parenteral and enteral nutrition.

[8]  Benjamin J Park,et al.  Multistate Outbreak of Fungal Infection Associated With Injection of Methylprednisolone Acetate Solution From a Single Compounding Pharmacy—United States, 2012 , 2012, MMWR. Morbidity and mortality weekly report.

[9]  C. Goodman American Society for Parenteral and Enteral Nutrition , 1988 .

[10]  J. Hadler,et al.  Life-Threatening Sepsis Caused by Burkholderia cepacia From Contaminated Intravenous Flush Solutions Prepared by a Compounding Pharmacy in Another State , 2006, Pediatrics.

[11]  T. Hays Special considerations for managing food allergies. , 2012, JPEN. Journal of parenteral and enteral nutrition.

[12]  L. McDonald,et al.  A multistate outbreak of Serratia marcescens bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacy. , 2007, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[13]  K. Carroll,et al.  Sphingomonas paucimobilis Bloodstream Infections Associated with Contaminated Intravenous Fentanyl , 2009, Emerging infectious diseases.

[14]  M. Arduino,et al.  An outbreak of postoperative gram-negative bacterial endophthalmitis associated with contaminated trypan blue ophthalmic solution. , 2009, Clinical Infectious Diseases.

[15]  T. Kuwahara,et al.  Growth of Microorganisms in Total Parenteral Nutrition Solutions Without Lipid , 2010, International journal of medical sciences.

[16]  D. Driscoll Compounding TPN admixtures: then and now. , 2003, JPEN. Journal of parenteral and enteral nutrition.

[17]  L. Saiman,et al.  Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy. , 2008, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[18]  D H Persing,et al.  Interpreting chromosomal DNA restriction patterns produced by pulsed-field gel electrophoresis: criteria for bacterial strain typing , 1995, Journal of clinical microbiology.

[19]  Darlene Miller,et al.  An outbreak of streptococcus endophthalmitis after intravitreal injection of bevacizumab. , 2012, American journal of ophthalmology.

[20]  K. Zahradka Pulsed-field gel electrophoresis (PFGE) , 2007 .

[21]  B. V. Sweet,et al.  Impact of drug shortages on U.S. health systems. , 2011, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[22]  Frank X Liu,et al.  Bloodstream infections associated with parenteral nutrition preparation methods in the United States: a retrospective, large database analysis. , 2012, JPEN. Journal of parenteral and enteral nutrition.

[23]  M. Kainer,et al.  Safe preparation and administration of intravitreal bevacizumab injections. , 2011, The New England journal of medicine.

[24]  M. Arduino,et al.  Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy--United States, July-November 2002. , 2002, MMWR. Morbidity and mortality weekly report.

[25]  T. Kuwahara,et al.  Growth of Microorganisms in Total Parenteral Nutrition Solutions Containing Lipid , 2010, International journal of medical sciences.

[26]  M. DeLegge Parenteral nutrition therapy over the next 5-10 years: where are we heading? , 2012, JPEN. Journal of parenteral and enteral nutrition.

[27]  D. Vugia,et al.  Outbreak of Serratia marcescens infections following injection of betamethasone compounded at a community pharmacy. , 2006, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.