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
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
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.