The European Medicines Agency (EMA) was informed in April 2014 that vials of certain medicines had been stolen in Italy, including from hospitals, and re-introduced under false credentials into the supply chain in some European Union (EU) countries. This page describes the EMA's actions, in cooperation with national authorities in the EU Member States, to respond to the situation.
The Italian law enforcement authorities are carrying out a criminal investigation into the theft of a number of medicines, which took place during transit or from hospitals. The medicines were then supplied to wholesalers and parallel importers in a number of EU Member States. These medicines cannot be considered safe or effective due to their illegal removal and reintroduction to the supply chain, since it is not known if they have been stored and handled appropriately.
Although this is primarily a matter for law enforcement agencies, the EMA is monitoring the situation and helping Member States in co-ordinating information.
The initial investigative findings confirmed that the theft involved vials of Herceptin (trastuzumab), but subsequent investigation showed that the theft was considerably broader than originally thought. It is currently believed to involve more than 80 medicines. However, only small quantities of these medicines have been distributed.
There are no reports that any harm has come to patients in relation to the affected medicines.
Precautionary measures
National competent authorities are taking a series of measures to trace and remove any concerned products from the supply chain, to minimise the likelihood of them reaching patients. This is being carried out in close co-operation with the Italian police and Europol.
Member State authorities began to quarantine suspected products soon after the investigation began. On 8 August 2014, competent authorities in the European Economic Area (EEA) began to recall units of over 80 different medicines of Italian origin that had been illegally supplied to parallel distributors, which were confirmed as having a falsified origin. Many of these had already been held back from further distribution.
It is not expected that the precautionary actions will result in shortage of medicines for patients.
Advice to healthcare professionals
Healthcare professionals are reminded to pay extra attention when handling or administering any of the concerned medicines. Any suspicion of tampering or question of authenticity should be reported immediately to the local health authorities.
Some concerned batches of Herceptin were reintroduced into the supply chain. A letter has been sent to EU healthcare professionals with advice on identifying falsified Herceptin vials, this including:
- Batch numbers and expiry dates on most vials do not match those on the outer package;
- There is liquid present in some vials of Herceptin powder for solution (Herceptin is a white to yellow powder);
- Evidence of tampering with the rubber stoppers, crimping caps or lids;
- Falsified vials are labelled as 'Italian Herceptin® 150 mg' (may have been re-labelled and re-packaged in the local language).
Patients who have any concerns should speak to their doctors who are best placed to confirm the authenticity of their medicine and assess their condition.
Further information
For the latest information on the medicines concerned and the regulatory actions taken in the context of this investigation, please refer to the medicines regulatory authorities in Italy and Germany: