Society for Healthcare Epidemiology of America
Contact: Tamara Moore / tmoore@thereisgroup.com / 202-868-4008
Author Contact: Lindsey Fox / lbfox@texaschildrens.org / 832-824-2040

Infectious Outbreak in Critically Ill Children Leads to Recall of Contaminated Medication

Investigation Uncovers Novel Bacteria Strain in Stool Softener from Compounding Pharmacy

NEW YORK (February 9, 2017) – Infection prevention and control experts at Texas Children’s Hospital halted a 24-patient outbreak of Burkholderia cepacia in critically ill children after identifying docusate, a liquid stool softener, as the underlying source of the bacteria. Details of the six-month investigation, published online in Infection Control & Hospital Epidemiology, the journal for the Society for Healthcare Epidemiology of America, led to a national recall of all liquid products manufactured by PharmTech.

“Using a multidisciplinary approach and by sharing information with other institutions, our detailed investigation stopped short a national outbreak of B. cepacia” said Lucila Marquez, MD, MPH, lead author of the study. “This work also provided our team an opportunity to improve our infection prevention practices for the care of all patients.”

After identifying a cluster of critically ill-infected patients, the infection control and prevention team launched a detailed investigation to identify risk factors for infection. The team also sought to audit infection control practices by assessing hand hygiene and other care practices of the health care team and performing environment of care rounds with members of the clinical care and environmental services teams.

Testing of patient samples identified the bacteria and showed that the samples were the same strain of B. cepacia, a bacterium found in water and previously linked with contaminated products. The team cultured various water sources, products, medications, and formulas. This testing identified unopened syringes of liquid docusate revealing the same bacteria strain as found in the patients. The team determined that a median of 13.5 doses (range 2-78) of the docusate were given to each patient before positive culture with a median time of 16.5 days (range 1-81) from the first dose.

The team submitted the strain to the Research Laboratory and Repository at the University of Michigan. The laboratory confirmed the strain and that it had never before been identified in the 20-year-old repository of bacteria, but shortly thereafter was identified in samples submitted by another pediatric healthcare institution.

As a result of the investigation, the FDA announced a voluntary nationwide recall of the product, and the Centers for Disease Control and Prevention recommended that liquid docusate generally not be used in any patients.

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Lucila Marquez, Katie Jones, Tjin Koy, Elaine Whaley, Paula Revell, Ruston Taylor, M. Brooke Berhardt, Jeffrey Wagner, James Dunn, John LiPuma, Judith Campbell. “Outbreak of Burkholderia cepacia complex Infections Associated with Contaminated Liquid Docusate.” Web (February 9, 2017).

About ICHE
Published through a partnership between the Society for Healthcare Epidemiology of America and Cambridge University Press, Infection Control & Hospital Epidemiology provides original, peer reviewed scientific articles for anyone involved with an infection control or epidemiology program in a hospital or healthcare facility. ICHE is ranked 19th out of 83 Infectious Disease Journals in the latest Web of Knowledge Journal Citation Reports from Thomson Reuters.

The Society for Healthcare Epidemiology of America (SHEA) is a professional society representing more than 3,000 physicians and other healthcare professionals around the world who possess expertise and passion for healthcare epidemiology, infection prevention, and antimicrobial stewardship. The society’s work improves public health by establishing infection-prevention measures and supporting antibiotic stewardship among healthcare providers, hospitals, and health systems. This is accomplished by leading research studies, translating research into clinical practice, developing evidence-based policies, optimizing antibiotic stewardship, and advancing the field of healthcare epidemiology. SHEA and its members strive to improve patient outcomes and create a safer, healthier future for all. Visit SHEA online at www.shea-online.org, www.facebook.com/SHEApreventingHAIs and @SHEA_Epi.

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