Hazard Alert!
ISMP urges immediate replacement of Brethine ampuls with vials!

From the October 21, 2004 issue of MSA Acute Care Edition Newsletter

ISMP is issuing a hazard alert for healthcare providers at hospitals and birthing centers, calling for immediate replacement of BRETHINE (terbutaline) ampuls with vials. This alert was prompted by yet another report of an error resulting from look-alike ampul packaging of Brethine and METHERGINE (methylergonovine), which are frequently used in labor and delivery settings but have opposite effects.

Brethine is used in obstetrics to treat preterm labor and Methergine is used primarily after delivery of the placenta to treat hemorrhage and failure of the uterus to contract. Both continue to be available as 1 mL ampuls packaged in amber plastic tubs covered by a foil label with the product name in tiny print, making them difficult to tell apart (see photo in PDF version of the newsletter). Both ampuls have similar colored "rings" around the ampul necks that can be seen through the plastic, which further adds to their similarity. Since Methergine has abortifacient properties, it is contraindicated in pregnancy and would be especially dangerous to a patient in preterm labor. Thus, to better differentiate these two products, healthcare providers should replace Brethine ampuls with vials.

Since 2000, we've published three alerts to warn about the potential for Brethine-Methergine mix-ups. These alerts were issued in response to reports of errors and patient injuries, including a possible case of fetal demise and cases of premature uterine contractions requiring emergency treatment. These continuing incidents expose serious weaknesses in our medication safety and recall systems - long delays often occur in gaining product improvements after significant problems are recognized, and dangerous items remain on the market long after safety problems have been corrected. We need to do better.

Brethine manufacturer aaiPharma acquired the product from Novartis in 2001. In a recent communication with ISMP, the company noted that they have taken steps to distinguish the appearance of Brethine to reduce the chance of errors, including repackaging the product in vials instead of ampuls. Brethine ampuls were last shipped in January 2004 - however, they have not been recalled and likely remain in the supply chain. In fact, although the company has indicated they now ship only vials, two of the major drug wholesalers listed only the Brethine ampuls in their computer system when accessed this week. Generic terbutaline is available from other manufacturers in vials.

ISMP also has notified the FDA and aaiPharma about the most recent error and asked the company to voluntarily recall the ampul product. Clearly, in the interest of patient safety, this is the right thing to do. Neither FDA nor aaiPharma has responded to our request.