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ISMP Canada News

December 2007: Positive Response from Manufacturer to Your Reports

A number of facilities have reported concerns about the look-alike labelling and packaging of the following parenteral products (Figure 1):
  • dimenhydrinate 50 mg/mL, 5 mL vial
  • diltiazem 5 mg/mL, 5 mL vial
  • flumazenil 0.1 mg/mL, 5 mL vial
The reports submitted to ISMP Canada have documented a variety of problems, including a substitution error in the operating room (flumazenil administered instead of dimenhydrinate) and incorrect storage in an emergency department (diltiazem vials with dimenhydrinate vials).
 Figure 1: From left to right: dimenhydrinate 50 mg/mL, diltiazem 5 mg/mL, and flumazenil 0.1 mg/mL. The volume of each vial is 5 mL and each vial has a grey cap and a white label with blue bands. (ISMP Canada thanks the reporters who submitted photographs, such as this one, with their online reports.)

ISMP Canada has corresponded with Sandoz Canada Inc., the manufacturer of all 3 products, regarding these reports. As a result, the labels for flumazenil and dimenhydrinate will be changed. The new flumazenil label is expected to be in use early 2008 and the new dimenhydrinate label is expected to be in use spring 2008. ISMP Canada thanks Sandoz for their receptiveness to these reports.
In the interim, ISMP Canada suggests the following measures to limit the possibility of error:
  • Consider purchasing one or more of these products in a different volume. For example, one hospital switched from the 5 mL (multidose) dimenhydrinate vials to the 1 mL (single-dose) vials.
  • Ensure that these products are not stored in close proximity to each other, including in the pharmacy.
  • Re-evaluate the need to have more than one of these products as stock in patient care areas.
  • Inform all staff of the potential for mix-ups.