Liposomal and lipid-complex formulations: name change to reduce medication errors
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
New naming recommendations
Some medicines (examples later) are available in liposomal, pegylated-liposomal, or lipid-complex formulations. These formulations can have substantially different dosing and drug release profiles between each other and when compared with conventional formulations of the medicines.
Following reports of serious medication errors (some leading to deaths), liposomal and lipid-complex medicines with a high risk of medication error will explicitly include the qualifier ‘liposomal’, ‘pegylated-liposomal’ or ‘lipid-complex’ within their name. This recommendation aims to reduce the risk of mix-up between different formulations of these medicines. The product information and labelling of new injectable liposomal-formulated medicines will also include reference to ‘dispersion’, which is the accepted descriptor term for these types of formulations.
For medicines administered topically or via non-injectable routes, ‘liposomal’, ‘pegylated-liposomal’ or ‘lipid-complex’ will only be added to the name if a clear risk to patient safety has been identified.
Actions required from healthcare professionals
Although the new naming recommendations will help to reduce serious and fatal medication errors, healthcare professionals must remain vigilant around these medicines.
Prescribers should be explicit in which medicine they are prescribing when stating the product and the dose. Electronic prescribing and dispensing tools enable a clear distinction between available formulations, and it is the responsibility of the prescriber to ensure that the correct medicine is selected. These formulations should be clearly distinguished when communicating with colleagues about these medicines. The dose should be verified against the selected product before administration.
Examples of reported medication errors
Errors due to the mix-up between these different formulations of medicines are well documented.[footnote 1]
Doxorubicin – medication errors
A recent European review of worldwide data identified 5 reported cases of mix-up between liposomal and conventional doxorubicin (one of which reported as an adverse reaction with a fatal outcome).
Amphotericin B – medication errors
We are currently aware of 3 fatal overdoses in the UK caused by administering conventional amphotericin B instead of the liposomal or lipid-complex formulations. In 2018 we advised that particular care must be taken in prescribing and dispensing the correct parenteral formulation of amphotericin B.
New naming recommendations
Examples of affected medicines includes those containing amphotericin, daunorubicin, doxorubicin, cytarabine and irinotecan. This list is not exhaustive, and the new naming convention will also apply to similarly formulated products licensed in the future.
Table: Examples of name changes
| Formulation | Original Name of the medicine | Amended name of the medicine |
|---|---|---|
| Doxyrubicin | ||
| Pegylated-liposomal doxorubicin | Caelyx 2mg/ml Concentrate for Solution for Infusion | Caelyx pegylated-liposomal 2mg/ml Concentrate for Solution for Infusion |
| Liposomal doxorubicin | Myocet 50mg powder, dispersion and solvent for concentrate for dispersion for infusion | Myocet liposomal 50mg powder, dispersion and solvent for concentrate for dispersion for infusion |
| Conventional doxorubicin | Doxorubicin Accord 2mg/ml Concentrate for Solution for Infusion | Unchanged |
| Amphotericin* | ||
| Liposomal amphotericin | AmBisome 50mg Powder for dispersion for infusion | AmBisome Liposomal 50mg Powder for dispersion for infusion |
| Lipid-complex amphotericin | Abelcet 5mg/mL Concentrate for Suspension for Infusion | Abelcet LipidComplex 5mg/mL Concentrate for Dispersion for Infusion |
| Conventional amphotericin | Fungizone 50mg Powder for Sterile Concentrate | Unchanged |
*Amphotericin products, while now complying with the new naming convention, have contained formulation particulars and equivalency/interchangeability warnings on the label in the UK for several years.
Report any suspected adverse drug reactions
Any suspected adverse drug reactions (ADR), including medication errors with associated harm to a patient, should be reported to the Yellow Card scheme. Report on the Yellow Card website or via the Yellow Card app (download via iTunes Yellow Card for iOS devices or via PlayStore Yellow Card for Android devices).
Medication errors resulting in harm should be reported to the Yellow Card scheme. Report medication errors or near misses without harm to patients via local risk management systems that feed into the National Reporting and Learning System.
Article citation: Drug Safety Update volume 13, issue 12: July 2020: 2.
-
WHO Pharmaceuticals Newsletter. Lipid-based drug products - errors due to confusion with conventional products: USA. 1998, 9 and 10. ↩
Updates to this page
Last updated 31 July 2020 + show all updates
-
Republished in order to change the display order of articles; content unchanged
-
First published.