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ISMP Calls for Action In Response to Infections Caused By Contaminated TPN; NABP Helps Educate Boards
In response to the infections of 19 Alabama patients by contaminated total parenteral nutrition (TPN), the Institute for Safe Medication Practices (ISMP) has called upon Food and Drug Administration (FDA) to take several actions, including collaborating with boards of pharmacy in enforcing compounding standards. An investigation lead by Alabama Department of Public Health (ADPH) and Centers for Disease Control and Prevention (CDC) determined that a failure in a step of the sterilization process for the compounded TPN most likely led to its contamination with Serratia marcescens bacteria. Of the 19 cases of infection that resulted in Birmingham, AL, area hospitals, nine were fatal.
ADHP was notified of an outbreak of the infection in two area hospitals on March 16, 2011, and an investigation revealed that TPN produced by Meds IV was likely the common source of the infections. The product was recalled by Meds IV on March 24, 2011. Further investigation has revealed that a container and stirrer, and a tap water spigot at Meds IV are likely the sources of the bacteria. The investigation is ongoing and additional details are available in an April 7, 2011 ADPH press release.
In an April 7, 2011 article, ISMP expresses support for the provision of additional resources to boards of pharmacy so that boards can survey compounding pharmacies to enforce compliance with United States Pharmacopeia <797 standards>. ISMP also calls upon FDA to work with state boards of pharmacy to support enforcement efforts. Further, ISMP calls on FDA to provide guidance documents for industry on relevant good pharmacy compounding practices. As reported in the April 6, 2011 e-News, the American Society for Parenteral and Enteral Nutrition, an organization that partners with ISMP, has also issued a statement reminding practitioners of the availability of its complimentary publications providing information on practice recommendations for safe compounding and administration of parenteral nutrition.
To help educate boards of pharmacy on issues related to enforcing compounding standards, NABP will be providing two Continuing Pharmacy Education (CPE) opportunities at the Association’s Annual Meeting, May 21-24, 2011, in San Antonio, TX. CPE Session, “FDA Update – A Guide for APIs and INDs,” will provide compliance officers with information on inspecting active pharmaceutical ingredients when conducting a compounding pharmacy inspection and on educating pharmacists about how investigative new drugs may be legally compounded. In addition, the Texas State Board of Pharmacy will present a poster on the Board’s Program Related to Sampling of Compounded Preparations that includes information on the criteria used to evaluate whether compounded preparations meet standards for potency, sterility, and endotoxin testing. More information about these CPE opportunities is available on the NABP Web site.
