Guidelines for the Safe Preparation of Sterile Compounds: Results of the ISMP Sterile Preparation Compounding Safety Summit of October 2011

Abstract

Significant patient safety incidents related to sterile drug compounding have occurred for many years. Previous guidelines have focused on ensuring sterility, but serious compounding errors have occurred as well. National efforts are needed to identify and reduce the potential for such errors and their causative factors. In response, the Institute for Safe Medication Practices (ISMP) convened in October 2011 a summit of 60 invited experts in the field for the purpose of establishing by consensus guidelines, safe practices, and standard operating procedures needed to ensure the safe preparation of compounded sterile preparations, especially intravenous admixtures. The resulting guidelines were categorized into 14 core processes: policies and procedures, order entry and verification, drug storage, assembling products and supplies, compounding, drug conservation during drug shortages, preparation of source/bulk containers, technology/automation used, IV workflow software, automated IV compounding devices, quality control/final verification, product labeling, record keeping, and staff management. They were also classified into 3 levels: mandatory, standard, and recommendation. The guidelines presented in this article were felt to be applicable to any health care organization that prepares sterile compounded products. The consensus of the group was that adherence to these guidelines will improve the safety of sterile product compounding and reduce harmful errors in patients receiving these products. Incorporation of these guidelines into sterile compounding practices of health care organizations is an important component of improving patient safety.