HYDROmorphone Labeling Revisions Approved

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HYDROmorphone Labeling Revisions Approved

Pa Patient Saf Advis 2011 Dec;8(4):152.

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.

Note

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.

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HYDROmorphone Labeling Revisions Approved
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	THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS
	The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s Web site at www.patientsafetyauthority.org .
	ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for more than 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology.
	The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.