The case of the theft and recycling of various packages of the drug trastuzumab (Herceptin) - initiated by Aifa and the Carabinieri Nas following a report sent by an English wholesaler who had found anomalies on some packages of the drug, purchased through an Italian wholesaler and destined for Germany - is expanding. The competent European national authorities and the EMA are in fact collaborating in response to criminal activities. It has been ascertained that the vials, partly tampered with, were subsequently reintroduced illegally in some countries in the distribution chain. Also part of the theft are vials of two other drugs, Alimta (pemetrexed) and Remicade (Infliximab). "The situation goes beyond the European Union and current national procedures for the management of product quality or defects," underlines an EMA note. "These are exceptional circumstances in response to criminal activity that require special measures and strong cooperation from authorities across the EU." In practice, the competent national authorities are working rapidly to identify all the lots in question and are taking appropriate measures to protect the health of European citizens. At the same time, all suspected vials were recalled from the EU market. Furthermore, Member State authorities are planning temporary measures, including placing suspect products in quarantine or restricting parallel distribution of the products concerned. "Only a small number of vials of the three medicines are believed to have been affected, so far there are no reports that there has been any harm to patients in relation to the falsified medicines, and these precautionary actions are not expected to result in a shortage of medicines for patients," the statement said. Any element that suggests tampering or doubts about authenticity must be immediately reported to the local health authorities".
AZ.
Tuesday, April 22, 2014 – Doctor
