European Medicines Agency recommends change in names of liposomal medicines to avoid errors

European Medicines Agency has recommended change in names of liposomal medicines to avoid errors.

All marketing authorization 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.

European Medicines Agency with human medicines committee (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) jointly made this recommendation 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 European Medicines Agency follows reports of a number of medication errors, including deaths, related to these medicines.After consultation with safety committee of European Medicines Agency(PRAC), the CHMP and CMDh agreed on the following actions to reduce the risk of confusion between these medicines:

• In section one of the summary of product characteristics (SmPC), the qualifier ‘liposomal’ or ‘pegylated liposomal’ should be added after the invented name and before the strength. This is in line with the standard practice for qualifiers


• Where a medicine is approved with an ‘international non-proprietary name (INN) and company or trademark’ name, the qualifier ‘liposomal’ or ‘pegylated liposomal’ will be placed between the INN and the company name or trademark in section 1 of the SmPC


• The currently existing EDQM standard term ‘dispersion’, which includes liposomes in its definition, should be used consistently throughout the product information.

It aims to make a clearer distinction between liposomal and non-liposomal formulations of the same active substance to avoid medication errors.

The European Medicines Agency 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.