Practitioners' Reporting News

Follow Up to Ophthalmic Labeling Change

Issued May 27, 2003

On May 8, 2002, a Practitioners' Reporting News item was posted regarding the proposed labeling change of Bausch & Lomb's Neomycin/Polymyxin B Sulfates/Dexamethasone ophthalmic ointment to reflect the American Academy of Ophthalmology's recommendation. This proposed labeling change was prompted by a report submitted to the USP Medication Errors Reporting Program.

In this report, the reporter indicated that the coloring and labeling of Bausch & Lomb's Neomycin/Polymyxin B Sulfates/Bacitracin Zinc ophthalmic ointment and Neomycin/Polymyxin B Sulfates/Dexamethasone ophthalmic ointment are so similar that distinction between the products was very difficult.

Bausch & Lomb responded by contacting the American Academy of Ophthalmology, who recommended changing the color of the product labeling for the steroid combination to pink. According to Bausch & Lomb, the first lot reflecting the new labeling was implemented in May 2003, and should be available for distribution in a couple of months.

Picture of new labeling, provided by Bausch & Lomb.

This example serves as positive reinforcement for practitioners who are considering reporting a medication error. The USP Center for the Advancement of Patient Safety applauds Bausch & Lomb for taking a proactive role in the prevention of medication errors. Practitioners are encouraged to be vigilant during the color change and to take precautions to ensure a smooth transition to products labeled with the new color.

Readers are advised that official USP cautions and warnings for drugs appear in the USP–NF or USP DI. Unless otherwise indicated, any advice or opinions expressed herein reflect solely the judgment of USP staff. Such statements are intended for further consideration and evaluation and may or may not be applicable to a particular practice. The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices.