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Hazard Warning! Baxter small volume critical care drug packaging


From the March 24, 1999 issue

In 1998, Baxter International Inc. acquired Ohmeda's Pharmaceutical Products Division from BOC Group, Inc. and integrated it into the Anesthesia Group of Baxter's I.V. Systems/Medical Products business. The new company is called Baxter Pharmaceutical Products Division. We recently received a complaint from a pharmacist and anesthesiologist about the labeling and packaging of various Baxter critical care drug products. The products look strikingly similar. For example, 2 mL vials of pancuronium bromide (4 mg/2 mL), phenylephrine 1% (10 mg/mL), metoclopramide (10 mg/2 mL) and atropine (0.4 mg/mL) have white caps and aluminum ferrules. Although product names appear in different colors, when these vials are partially turned, the same logo and black band with imprinted expiration date and lot number is seen. This might occur when vials are heaped together in a drug storage bin. Also, there is inconsistency in the way that small volume parenteral products are packaged by various manufacturers. Some companies use a different color cap for each product. Practitioners who rely in part on the cap color to differentiate drugs may easily be fooled into believing that the white cap represents one specific product.

These products are actively used in various settings including the pharmacy, anesthesia/operating room, intensive care unit, emergency department and emergency transport vehicles. We are extremely concerned that the new packaging might lead to fatal medication errors if the product identification is missed. Such a scenario is not difficult to imagine. In 1995, an emergency room nurse, administering influenza vaccine to area residents during a community vaccination program, accidentally gave 7 individuals 0.5 mL of pancuronium injection, a neuromuscular blocker, instead of the vaccine. The small vials of vaccine were the same size, shape and color as pancuronium vials stored on the same shelf in the ER's refrigerator. Fortunately, the dose and IM route of administration in these cases precluded fatalities. However, if a vial of pancuronium rolls across a flat surface and accidentally combines with a supply of metoclopramide vials, patients may not be so lucky. If the drugs wind up stored in the same location, someone seeking metoclopramide might see metoclopramide labels nearby but fail to recognize that the label of the product they've retrieved is actually pancuronium. If this goes unrecognized, the full contents may be injected IV and could result in a respiratory arrest. In light of the remarkably similar appearance, merely telling people to read labels carefully is unlikely to solve the problem. Improved labeling is needed. We've asked Baxter to address the problem as soon as possible. These situations could be avoided by having practitioners review new or modified product packaging before it is applied. For now, it is probably safest to purchase high alert drugs like pancuronium from a different supplier, to make the products look different from one another.



Figure 1. Left to right are black and white portions of the labels on pancuronium, phenylephrine, metoclopramide and atropine.

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