The EMA (European Medicines Agency) said the drugs Avastin and Mabthera have been added to a list of those taken in an ongoing Italian investigation into the supply of stolen medicines. Law enforcement discovered in April that batches of Herceptin (Roche), Remicade (Johnson & Johnson) and Alimta (Eli Lilly) had been stolen in Italy and tampered with.
Roche’s spokeswoman Claudia Schmitt told BioPharma-Reporter.com while it was working with health authorities and law enforcement agencies to combat unsafe distribution of products by unauthorised sources, “at this time we have no evidence that the vials stolen in Italy have been turned into counterfeit products.”
She added that consumers should look out for any Avastin or MabThera vials with Italian-labelled primary and secondary packaging offered for sale outside Italy, as these “should be considered to be counterfeit/illegally distributed material.”
Temperature concerns
If the stolen drugs are resold, as biologics they will raise safety concerns surrounding proper storage, since large molecules need refrigeration, Schmitt confirmed. “Both drugs require a cool chain during transport. If a healthcare provider suspects a patient may have received [an] illegal/counterfeit drug, they should contact the national Roche Product Quality Assurance Department immediately to report this. The healthcare provider should also contact their local health authority.
“As the implications for public health and safety can be high we take this issue very seriously. We fully support governmental efforts and are committed to cooperating with the authorities whenever one of our products is concerned.”
Schmitt told us Roche’s global policy includes an action plan for rapid information, detection, co-ordination, analysis of suspect products, reporting and interaction with authorities.
The company also supports plans to develop stronger laws and improve enforcement, she said, includes working with authorities on a system to track and trace products from distribution to dispensary. Roche has implemented several anti-counterfeiting measures in the design, packaging and labelling of its products.
Diluted Herceptin
In the case of the Herceptin theft discovered in April, containers of the breast and stomach cancer biologic were found to have been tampered with and “and re-introduced under false credentials into the supply chain in some countries.”
None of the affected product was found to have reached hospital level, but Roche withdrew nine batches of Herceptin after tampered 150mg packages were found in the UK, Finland and Germany. In April Roche told us one of the vials contained none of the active ingredient, trastuzumab.
UPDATE: While Alimta was confirmed as being part of the thefts discovered in April, so far there has been no evidence of tampering with vials of Alimta.