HYDROmorphone Labeling Revisions Approved
In response to medication errors reported to the U.S. Food and Drug Administration (FDA), the Institute for Safe Medication Practices, the Pennsylvania Patient Safety Authority, and other reporting programs, FDA has approved labeling revisions to HYDROmorphone products to promote safe use and prevent associated medication errors.1 In June 2011, FDA approved the revisions for Dilaudid® (1 mg/mL, 2 mg/mL, 4 mg/mL) and Dilaudid-HP (10 mg/mL). These revisions pertain to the prescribing information, container labels, and carton labels; for example, revisions addressed better organization of information in the labeling, such as placing dosing information and warnings first. In addition, the intravenous starting dose has been reduced to 0.2 mg to 1 mg (originally 1 mg to 2 mg). The complete prescribing information is available from the manufacturer at http://www.purduepharma.com/PI/prescription/DilaudidInjectionsPI.pdf.
The Authority has previously published on medication errors associated with HYDROmorphone. A patient safety toolkit, including the previous Pennsylvania Patient Safety Advisory articles, a process measures and outcomes tool, and excerpted prescribing information, is available from the Authority.
- Institute for Safe Medication Practices (ISMP). FDA Advise-ERR:FDA approves HYDROmorphone labeling revisions to reduce medication errors. ISMP Med Saf Alert 2011 Oct 20; 16(21):1-2.