The Pharmacovigilance working party (PhVWP) of the EMEA has recommended that the product information of all epoetins includes a request to maintain patient medication records.

The PhVWP considers the maintenance of accurate medication histories to be important for patients treated with epoetins – i.e. documentation of the tradename or scientific name of the epoetin used and the manufacturer in the patient’s medical records.  The identification and traceability of epoetin products used in patients will help to assess if cases of pure red cell aplasia (PRCA) and other reported cases of adverse reactions are related to any quality specifications of a certain epoetin product.

The PhVWP’s recommendation was transmitted to France as the Reference Member State for the product Eprex© and to the CHMP for all other epoetin products, which are subject to a central marketing authorisation in the EU.