EMA orders medicine name changes for first time to reduce errors

Pharmacy shelf

For the first time, drug companies across Europe have been told to change the names of medicines containing liposomal in their drug delivery systems following reports of medication errors that have led to patient deaths.

In the first decision of its kind, published on 31 July 2019, the European Medicines Agency (EMA) has told companies to make a clearer distinction between liposomal and non-liposomal formulations of the same active substance to avoid future medication errors.

Companies have until the end of September 2019 to make the changes to the drug names.

The two formulations may have different biodistribution and release properties, which means medication errors can pose serious risks to patient safety, it warned.

It said that the two formulations are at particular risk of being mixed up when electronic prescribing and dispensing tools are used.

The EMA wants companies to make a clear distinction between ‘liposomal’ or ‘pegylated liposomal’ in the summary of product characteristics and product information.

The recommendations come jointly from the EMA’s Committee for Medicinal Products for Human Use and its Coordination Group for Mutual Recognition and Decentralised Procedures — Human.

The EMA confirmed to The Pharmaceutical Journal that this was the first time that it had requested marketing authorisation holders to update their product name to avoid medication errors.

Last updated
The Pharmaceutical Journal, EMA orders medicine name changes for first time to reduce errors;Online:DOI:10.1211/PJ.2019.20206891

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