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FDA Advise-ERR: FDA approves HYDROmorphone labeling revisions to reduce medication errors
October 20, 2011

The Food and Drug Administration (FDA) and ISMP have received reports of medication errors involving DILAUDID and other HYDROmorphone products. The Pennsylvania Patient Safety Authority (PSA) has received similar reports(1-3) as have other professional(4) and national(5) reporting programs. Errors reported with these products(1) commonly involve selecting the wrong drug—predominantly mix-ups with morphine(2,6)—and overdoses,(7) including those resulting from incorrect dose conversion between HYDROmorphone and morphine.(3,8) 

Some of the medication error reports suggest that the labeling of Dilaudid,  Dilaudid-HP, and other HYDROmorphone products may have caused confusion and contributed to these medication errors. This is concerning because wrong drug errors and overdoses caused by incorrect dose conversions between HYDROmorphone and morphine have resulted in serious outcomes including hospitalization and death. ISMP has previously published and continuously promotes strategies for minimizing the risk of medication errors related to HYDROmorphone products.(4-9)  

On June 30, 2011, FDA approved revisions to the Prescribing Information, container labels, and carton labeling for Dilaudid (1 mg/mL, 2 mg/mL, 4 mg/mL) and Dilaudid-HP (10 mg/mL). Dilaudid and Dilaudid-HP were originally approved on January 11, 1984. FDA and Purdue Pharmaceuticals recently worked together to modernize the labeling as required by the new Physician Labeling Rule (www.ismp.org/sc?k=plrule). FDA and Purdue also used this opportunity to make additional label revisions to promote the safe use of the product and avoid medication errors.  

Prescribing Information. Prior to the most recent labeling approval, the Dilaudid Prescribing Information was not presented in the format required by the Physician Labeling Rule. The way the information was organized made it difficult to locate important information. The Physician Labeling Rule format organizes the information more effectively by providing a table of contents, a Highlights section, and other standardized sections. The Rule also moves the most utilized information such as dosing information and warnings to the front of the Prescribing Information. In addition, the intravenous starting dose was significantly reduced.

The following revisions were made to the Dilaudid Prescribing Information:

  • The format includes a Highlights page and table of contents
  • The dosing instructions for subcutaneous and intramuscular routes are now separated from the intravenous route of administration; the abbreviations SC and IM have been removed
  • The intravenous starting dose has been reduced to 0.2-1 mg (previously 1-2 mg)  
  • A revised bolded warning has been placed at the front of the Prescribing Information to warn practitioners that HYDROmorphone and morphine are not milligram-to-milligram equivalents and to use the conversion table (moved up to section 2.4) to convert doses from other opioids to Dilaudid.

 The updated Prescribing Information is available at: www.purduepharma.com/PI/prescription/DilaudidInjectionsPI.pdf.

 Container and Carton Labeling. Prior to the most recent approval, the container and carton labels did not display the generic name with tall man lettering (i.e., HYDROmorphone). ISMP recommends using tall man letters to help differentiate morphine from HYDROmorphone; these drugs represent the most commonly confused name pair.(1) FDA agrees that the use of tall man lettering will help minimize the risk of name confusion between these products. Although HYDROmorphone and morphine are not on FDA’s current list of look-alike name pairs to use tall man lettering,(10) the agency will be adding them to the list and asking all HYDROmorphone product manufacturers to adopt this presentation on their labels and labeling (see new labeling in Figure 1 in the PDF version of the newsletter).

 Revisions were also made to the product label. Although FDA did not identify specific errors related to how the total drug content and concentration was presented, some of the older container and carton labels did not list the total drug content and concentration in the currently used format (total dose/total volume). The Dilaudid-HP container and carton label presented the concentration most prominently and the total drug content in a less prominent manner. FDA and Purdue worked together to revise the labels of Dilaudid and Dilaudid-HP to include tall man lettering and to prominently present the total drug content and concentration. The new container and carton labeling should be available early in 2012.

 ISMP note: Typically, generic manufacturers are required to label products similar to the reference product (in this case, Dilaudid). 

 FDA Advise-ERR was provided by the FDA Office of Medication Error Prevention and Risk Management, in cooperation with ISMP. We thank Zachary Oleszczuk, PharmD, for contributing this article.

 References

1) PA Patient Safety Authority. Adverse drug events with hydromorphone: how preventable are they? Pa Patient Saf Advis. 2010;7(3):69-75.
2) PA Patient Safety Authority. Common medication pairs that contribute to wrong drug errors. Pa Patient Saf Advis. 2007;4(3):89.
3) PA Patient Safety Authority. Inadvertent mix-up of morphine and hydromorphone: a potent error. Pa Patient Saf Advis. 2007;4(3):86-88.
4) ISMP. HYDROmorphone alert. ISMP Medication Safety Alert! 2007;12(11):1.
5) ISMP. High-alert medication feature: reducing patient harm from opiates. ISMP Medication Safety Alert! 2007;12(4):1-3.
6) ISMP. Risk of deadly mix-up exists in most hospitals. ISMP Medication Safety Alert! 2004;9(13):1-2.
7) ISMP. Beware of basal opioid infusions with PCA therapy. ISMP Medication Safety Alert! 2009;14(5):1-3.
8) ISMP. Investigation of naloxone use uncovered an error in converting oral HYDROmorphone to IV route. ISMP Medication Safety Alert! 2003;8(10):2.
9) ISMP. Risk control strategies for reducing patient harm with HYDROmorphone. www.ismp.org/tools/hydromorphone.asp. Accessed June 16, 2011.
10) FDA. Name Differentiation Project. June 18, 2009. www.fda.gov/Drugs/DrugSafety/Medication Errors/ucm164587.htm. Accessed June 16, 2011.

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