Reports of deathly errors spark the EMA to order name changes
In an announcement, the European Medicines Agency (EMA) requested from all marketing authorisation holders of such medicines to submit a variation to change the names ‘as soon as possible,’ with a deadline of September.
This order aims to make a clearer distinction between liposomal and non-liposomal formulations of the same active substance, as they may have different biodistribution and release properties.
According to the regulatory agency, this action aims to reduce the risk of a mix-up between these medicines, following “a number of reports of serious medication errors, some leading to death.”
The recommendation was made by a joint agreement between the EMA’s human medicines committee (CHMP) and the coordination group for mutual recognition and decentralised procedures - human (CMDh) at their meetings in July.
Specifically, the regulator requests from drug developer to add qualifier 'liposomal' or 'pegylated liposomal' in section 1 of the summary of product characteristics (SmPC), after the invented name and before the strength.
Additionally, in medicines approved with an 'international non-proprietary name (INN)+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 EMA also advised that the standard term ‘dispersion’, which includes liposomes in its definition, should be used consistently throughout the product information.
