Practitioners' Reporting News

Ben Venue/Bedford Labs Changes Acetazolamide Labeling

Issued July 1, 2003

Two reports were submitted to the USP Medication Errors Reporting Program regarding the similarity between Ben Venue/Bedford Laboratories acyclovir and acetazolamide 500 mg vials. In response to labeling similarity complaints, Ben Venue/Bedford Laboratories has changed the labeling of their acetazolamide 500 mg vials.

In the first report, a pharmacist discovered an acetazolamide vial stocked with the acyclovir vials. The reporter indicated that the vials are almost identical and that they are stored next to each other alphabetically. This facility separated these products and placed a "look-alike/sound-alike" sign near both products to prevent this error from occurring again.

The second report describes a similar scenario but involves an automated dispensing device. A nurse was retrieving acyclovir from the device and discovered acetazolamide stocked in that location. Upon closer examination, the vials looked very similar: both have taupe flip-top caps, have light blue borders on white with black lettering, are available in 500 mg vials, and the drug names start with the letters "AC." The facility discovered that the two medications were stocked side by side in the pharmacy and that one of the medications was overflowing into the other bin. The facility presumed that when the technician was restocking the automated dispensing device, the mix-up was overlooked both by the technician who pulled the product off the shelf and by the pharmacist checking the fill list. The facility's preventative measure was to separate the two drugs, placing acyclovir with the other antibiotics for injection, and found two other brands of acyclovir that could be ordered.

Picture of products showing similarity of vials (provided by reporter)

The Food and Drug Administration's Office of Generic Drugs conducted a Name Differentiation Project which spanned a two-month period. The Office requested manufacturers of 16 look-alike name pairs to supplement their applications with revised labeling that visually differentiated their established names with the use of "Tall Man" letters. Acetazolamide was one of the products involved and the recommended name revision was "AcetaZOLAMIDE."

USP received correspondence from Ben Venue/Bedford Laboratories that acetazolamide lots manufactured from April 1, 2003, will bear the new labeling. The new label for acetazolamide will have green coloring instead of blue and the product name will utilize "Tall Man" letters to differentiate the products, as recommended above. Ben Venue/Bedford Laboratories has not only adopted the Office of Generic Drugs recommendation, but has gone a step further to distinguish their products by changing the coloring of the label.

Picture of new acetazolamide labeling (provided by Ben Venue/Bedford Laboratories)

Healthcare practitioners that stock Ben Venue/Bedford Laboratories acetazolamide can expect to start seeing the lots with the new labeling as they are released for distribution. Practitioners should take precautionary measures to distinguish acetazolamide from acyclovir (e.g., separate products, educate staff, highlight look-alike/sound-alike products, etc.) and continue to monitor current stock for the old product and new similarly labeled products as a result of this change.

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.