Contrast developer Bracco Diagnostics has launched a new bulk packaging option for its Isovue CT contrast agent that supports the delivery of multiple contrast doses to multiple patients.
Isovue Imaging Bulk Package (IBP) is designed to help hospitals operate more efficiently by enabling them to tailor contrast doses to specific patients at the point of care in a manner not possible with single-dose and prefilled syringes.
Pharmacy bulk packages for contrast administration were originally approved in the 1990s, but the prescribing information for these packages was so restrictive that many facilities began receiving citations from the Joint Commission if they used them outside the hospital pharmacy setting.
In response, 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 prefilled syringes for radiological use; and the proper use of bulk packaging. Bracco began working with the U.S. Food and Drug Administration (FDA) to develop a system that would comply with regulations covering multiple doses and multiple patients within the CT suite.
Isovue IBP dispenses with the concept of one-size-fits-all dosing, according to Bracco, allowing contrast dose to be customized for each patient. It provides 10 hours of on-demand dosing from the same container, without the risk of incurring citations for multidosing that are associated with transferring contrast media outside the hospital pharmacy setting.
