Amphotericin B liposomal MHRA Drug Safety Updates

MHRA Drug Safety Update July 2020

Make a clear distinction between liposomal, pegylated-liposomal, lipid-complex and conventional formulations when prescribing, dispensing, administering, and communicating about these medicines. Medicines with these formulations that have a high risk of medication error will explicitly include ‘liposomal’, ‘pegylated-liposomal’ or ‘lipid-complex’ within their name to reduce potentially fatal medication errors.

Advice for healthcare professionals

• serious harm and fatal overdoses have occurred following confusion between liposomal, pegylated-liposomal, lipid-complex, and conventional formulations of the same drug substance

• never interchange liposomal, pegylated-liposomal, lipid-complex, and conventional formulations that contain the same drug substance

• make a clear distinction between liposomal, pegylated-liposomal, lipid-complex, and conventional formulations of the same drug substance when prescribing, dispensing, administering, and communicating about these medicines

• verify the product name and dose before administration and ensure the maximum dose of the specific medicine is not exceeded

• report suspected adverse drug reactions, including medication error with associated harm to a patient, to the Yellow Card scheme

Reference

MHRA. Drug Safety update (July 2020). Liposomal and lipid-complex formulations: name change to reduce medication errors. Accessed at https://www.gov.uk/drug-safety-update/liposomal-and-lipid-complex-formulations-name-change-to-reduce-medication-errors

MHRA Drug Safety Update July 2018

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

Reference

MHRA. Drug Safety update (July 2018). Parenteral amphotericin B: reminder of risk of potentially fatal adverse reaction if formulations confused. Accessed at https://www.gov.uk/drug-safety-update/parenteral-amphotericin-b-reminder-of-risk-of-potentially-fatal-adverse-reaction-if-formulations-confused