All marketing authorisation holders of medicines containing liposomal drug delivery systems have been requested to submit to EU regulators a variation to change the names of these medicines as soon as possible and before the end of September 2019.
This recommendation was made jointly by the European Medicines Agency’s (EMA’s) human medicines committee (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) at their July meetings.
To date, there is no agreed approach to the naming of medicines containing liposomal or pegylated liposomal formulations. However, since the two formulations may have different biodistribution and release properties, medication errors can pose serious risks to the health of patients.
The announcement by the EMA follows reports of a number of medication errors, including deaths, related to these medicines.
It aims to make a clearer distinction between liposomal and non-liposomal formulations of the same active substance to avoid medication errors.
The EMA says this is a particular concern when electronic prescribing and dispensing tools are used, as in the absence of a more descriptive term for the liposomal medicines, they can be mixed up with non-liposomal medicines.
It adds that this recommendation should enable healthcare professionals and patients to better distinguish them from conventional non-liposomal medicines.