Sharing Matters! Sentinel Medication Incident Results in Safer Product Labelling
ISMP Canada received a sentinel event report describing inadvertent bolus administration of a HYDROmorphone product that was intended for continuous infusion.
ISMP Canada received a sentinel event report describing inadvertent bolus administration of a HYDROmorphone product that was intended for continuous infusion. A contributing factor was the misinterpretation of critical information on the label (see Figure 1). The practitioner misunderstood the information provided and believed the bag contained 1 mg of HYDROmorphone. As a result, the entire content of the bag (which contained 50 mg of HYDROmorphone) was administered as a bolus. The error was discovered after the patient was found to have an altered level of consciousness; naloxone was given.
The manufacturer, Baxter Corporation, embarked on a collaborative label enhancement initiative that included consultation with nurses, pharmacy representatives, and ISMP Canada. The following changes (see Figure 2), in line with the Good Label and Package Practices Guide for Prescription Drugs and within the constraints of labelling software, were introduced earlier this year:
- The primary label statement (in the red box) now states the following critical information: the drug name, total dose, total volume, and final concentration.
- A new secondary label statement has been added, which reads “SLOW INFUSION ONLY. FATAL if not infused slowly”.
FIGURE 1 (left). Previous Label Format, FIGURE 2 (right). New Label Format
ISMP Canada is grateful to the reporting organization for sharing this incident and thanks Baxter Corporation for prioritizing patient safety.
The Canadian Medication Incident Reporting and Prevention System (CMIRPS) is a collaborative pan-Canadian program of Health Canada, the Canadian Institute for Health Information (CIHI), the Institute for Safe Medication Practices Canada (ISMP Canada) and Healthcare Excellence Canada (HEC). The goal of CMIRPS is to reduce and prevent harmful medication incidents in Canada.
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The Institute for Safe Medication Practices Canada (ISMP Canada) is an independent national not-for-profit organization committed to the advancement of medication safety in all healthcare settings. ISMP Canada’s mandate includes analyzing medication incidents, making recommendations for the prevention of harmful medication incidents, and facilitating quality improvement initiatives.
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