November 24, 2014 — Bracco Diagnostics Inc. announced the availability of its Isovue (iopamidol injection) Imaging Bulk Package (IBP), a specific combination multi-patient, multi-dose compliant contrast medium approved by the U.S. Food and Drug Administration (FDA) for point-of-care use in the computed tomography (CT) suite.
The Isovue IBP was designed to increase safety and improve workflow, while minimizing risk and maintaining compliance regarding the use of multi-dose contrast media for radiological procedures in the CT suite.
Pharmacy Bulk Packages (PBPs) for multi-dose contrast media were originally approved in the 1990s with prescribing information for use in a “suitable work area, such as laminar flow hood, using an aseptic (sterile) technique,” typically found in the hospital pharmacy setting. Over time, The Joint Commission, which accredits and certifies healthcare organizations nationwide, began issuing citations to medical centers for using PBPs to transfer contrast media outside of the pharmacy in conditions that were not fully compliant with prescribing information. In 2012, the Institute for Safe Medication Practices called for hospital pharmacy oversight on the purchase, distribution, storage and use of intravenous contrast media, the use of single dose vials or pre-filled syringes for radiological use, and the proper use of PBPs.
The Isovue IBP allows for easy and cost-effective intravenous contrast enhancement of CT imaging of the head and body in adult and pediatric patients. It provides 10-hour on-demand dosing from the same container without the risk of incurring multi-dosing citations associated with transferring contrast media outside the hospital pharmacy setting.
For more information: www.braccoimaging.com