Packaging and Labeling Promote Safe Use of New Morphine Sulfate

FDA and Roxane Laboratories Inc. worked together to ensure that the packaging and labeling of Roxane's newly approved Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) promote safe use and minimize medication errors, reports the Institute for Safe Medication Practices (ISMP) in its February 11 ISMP Medication Safety Alert! newsletter.

ISMP writes that FDA and ISMP had received reports of medication errors involving the labels and labeling of unapproved morphine sulfate oral solutions 20 mg/mL that resulted in serious adverse events. Similarity to other products and strengths may have led to confusion. "The newly approved product labeling and packaging feature revisions [intend] to reduce the risk of these medication errors," ISMP reports. To see examples of the old and new labeling and read more packaging and labeling details, click here.

For instance, "the strength is presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is to help differentiate this product from the 20 mg/5 mL morphine sulfate product," ISMP reports.

FDA approved Morphine Sulfate Oral Solution CII, 100 mg per 5 mL (20mg/mL) 30mL and 120mL bottles in January. In its press release on the product's FDA approval, Roxane Labs states that Morphine Sulfate Oral Solution CII, 100mg per 5mL (20mg/mL) is the only FDA-approved Morphine Sulfate Oral Solution CII available at this concentration. 

To read more from Roxane, including the product's medication guide, click here. An oral syringe accompanies the new product, and Roxane advises practitioners to only use this syringe.

In its newsletter, ISMP thanked Roxane and FDA for the packaging and labeling changes, which it says will "help reduce the risk of confusion between the different strengths of morphine sulfate oral solution."

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