Sharing Matters! Concerned Reporting Results in a Safer Product Name

ISMP Canada received several reports (including one about an incident that resulted in severe patient harm) describing inadvertent 11-fold dosing errors with Doloral 1, a morphine 1 mg/mL syrup. A key contributing factor in all of the incidents was health care providers’ misinterpretation of the product concentration—understood to be 11 mg/mL instead of the actual 1 mg/mL—due to the proximity of the numeral 1 in the brand name and in the product concentration when displayed in drug information systems (Figure 1).

FIGURE 1. Re-creation of a product display in a drug information system (image shared with ISMP Canada in an incident report).

The display in this drug information system had been populated from the Health Canada Drug Product Database (Figure 2), which is based on submissions from the manufacturer, as authorized by Health Canada.

FIGURE 2. Display in Health Canada Drug Product Database (image shared with ISMP Canada in an incident report).

The manufacturer, Laboratoire Atlas, was informed of the incident reports. In communication with Health Canada and in accordance with the Good Label and Package Practices Guide for Prescription Drugs, which recommends that “numbers without units of measure should not be used to express product strength”, the numeral was removed from the name of both products.

ISMP Canada is grateful to the health care providers and organizations who submitted reports and also appreciates the focus on patient safety demonstrated by Laboratoire Atlas.