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CHMP and CMDh have recommended that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.
In a July 31, 2019 news release from the European Medicines Agency (EMA), it was announced that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.
The recommendation has been made jointly by the Committee of Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralized Procedures-Human (CMDh) during the July meetings. The recommendation is aimed at ensuring there is a clearer distinction between liposomal and non-liposomal formulations of the same active substance, so that errors can be avoided.
There are concerns about serious health issues, which in some instances may lead to death, that have arisen as a result of a number of reports of medication errors. As liposomal and non-liposomal medications have different biodistribution and release properties, medication errors pose a significant risk to patient health.
Particular concern has been raised over electronic prescribing and dispensing, as potential medication mix-ups may happen in the absence of clear distinction between liposomal and non-liposomal medicines. Name changes to the medicines will also help healthcare professionals and patients to more easily distinguish the medicines.
All MAHs of medicines with liposomal and pegylated liposomal delivery systems have been requested to submit an A.2.a variation before the end of September 2019 to update product names in line with the recommendation.