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Publication Type: Safety Notice
Single or Multiple Incident: Multiple
Date: 9/10/2021 12:00:00 AM
Country: Australia
This safety notice highlights the potential medication incidents which could occur with new labelling of concentrated potassium chloride by Pfizer. The previous labelling of 10 mmol (0.75 g) in 10 mL Sterile Potassium Chloride Concentrate has been changed to 75 mg in 1 mL. Healthcare professionals typically prescribe and dispense potassium chloride using millimoles (mmol). While Pfizer will be revising the labelling to use the mmol designation, interim measures are required for this product. The notice provides details to be implemented to reduce the risk of medication errors.

Additional Details

Medication/Gas/Fluid:
potassium chloride concnetrate injectable
Medication/IV List:
potassium chloride for injection concentrate

Rules / Policies / Procedures
  1. Pharmacy staff should: a. Ensure that products supplied with the outer carton packaging label ‘Sterile Potassium Chloride Concentrate 75 mg in 1 mL’ are appropriately over-labelled to prominently display the potassium chloride concentration in millimoles (mmol), prior to distribution to clinical areas. b. Identify any clinical areas where this product may already be held and if required, ensure that the outer carton packaging is appropriately over-labelled. c. Ensure that dispensing labels for intravenous potassium chloride include the millimole (mmol) quantity in the product description, and where required, in the directions for use
  2. Clinicians should continue prescribing intravenous potassium chloride in millimoles (mmol), on both paper medication charts and in EMM systems.
  3. Local ICT teams should confirm that EMM systems continue to list the product concentration and prescribed dose appropriately in millimoles (mmol). Weight units such as grams (g) or milligrams (mg) may also be included.
Training
  1. Relevant clinical staff should be educated about the labelling change on the outer carton packaging.
  2. Facilities should assess if there is variation in how this product description is locally expressed and whether this could confuse staff. Standardisation is highly desirable, but if this is not possible staff education may be needed to highlight equivalent expressions which are locally used.

Safety risks due to new labelling on the outer carton packaging of intravenous potassium chloride ampoules