Parenteral amphotericin B: reminder of risk of potentially fatal adverse reaction if formulations confused
Following receipt of a third case of fatal medication error caused by the administration of Fungizone (a non-lipid-based formulation of amphotericin B) instead of a lipid-based formulation (AmBisome, Abelcet), we remind healthcare professionals that these formulations are not interchangeable. Prescribers, pharmacists, and nurses need to be fully aware of the formulation being used and the associated dose regimen.
Advice for healthcare professionals:
- when prescribing, communicating and dispensing amphotericin products, use both the complete generic name and the proprietary name:
- non-lipid amphotericin (Fungizone)
- liposomal amphotericin (AmBisome)
- lipid-complex amphotericin (Abelcet)
- verify the product name and dose before administration, especially if the dose prescribed exceeds 1·5 mg/kg—the maximum recommended dose for Fungizone.
- report suspected adverse reactions associated with amphotericin B, including medication error with associated harm to patients, on a Yellow Card
- report medication errors or near misses without harm to patients via local risk management systems that feed into the National Reporting and Learning System
Background
Parenteral amphotericin B is available as lipid-based (AmBisome, Abelcet) and non-lipid-based (Fungizone) formulations for the treatment of severe fungal infections. These different formulations of amphotericin B have different dose requirements. The appropriate dose and method of administration differ markedly between the marketed parenteral formulations of amphotericin B and they are therefore not interchangeable.
Amphotericin B overdoses may result in potentially fatal cardiac or cardiorespiratory arrest. The total daily dose of Fungizone should not exceed 1·5 mg/kg.
Fatal cases due to confusion
We are currently aware of three fatal overdoses which were caused by medication error in which Fungizone was administered (a non-lipid-based formulation of amphotericin B) instead of a lipid-based formulation.
Particular care must be taken in prescribing and dispensing the correct parenteral formulation of amphotericin B: prescribers, pharmacists, and nurses need to be fully aware of the formulation being used and the associated dose regimen.
Following earlier cases of medication error (see Drug Safety Update, March 2010), cautionary statements are present on Fungizone packages, cartons, and vial labels.
Latest MHRA review
We are currently reviewing available data to determine whether further measures are required to minimise the risk to patients. Further advice will be communicated as appropriate when the review is complete.
Further information
NPSA Alert. Non-lipid and lipid formulations of injectable amphotericin. 2007.
Article citation: Drug Safety Update volume 11, issue 12; July 2018: 4.