The UK’s health regulator has issued a warning that a counterfeit batch of AstraZeneca’s prostate cancer treatment Casodex has been found in the supply chain, the third such case in a week.
The Medicines and Healthcare products Regulatory Agency said that it has been alerted to a counterfeit batch of Casodex (bicalutamide) 50mg tablets with the batch number 65520 and has issued a drug alert to recall the product from the market “to minimise the risk to patients”. The agency noted that it had been contacted by a wholesaler, who was offered a suspicious batch of Casodex by another wholesaler, adding that “we take this very seriously and a criminal investigation is being carried out”.
The MHRA stated that “at present there is no evidence of patients having any adverse reactions specifically related to the counterfeits” and it advised people to consult their GP if they have any treatment or health concerns. However this latest case, coming on the back of the discovery of fake batches of Eli Lilly's antipsychotic Zyprexa (olanzapine) and Sanofi-Aventis and Bristol-Myers Squibb's clotbuster Plavix (clopidogrel) has set off alarm bells across the whole of Europe.
Just as in the cases of Zyprexa and Plavix, the fake Casodex "was supplied in French livery via parallel distributors into the UK supply chain" and noted that initial tests on the seized samples showed that they contained about 75% of the active ingredient stated on the label.
EFPIA backs 2D bar codes
More than 500,000 counterfeit medicines were seized at Europe’s borders in 2005, twice the rate of 2004 and the European Federation of Pharmaceutical Industries and Associations, at its annual meeting in Brussels, backed plans for new technology to be implemented to secure the supply chain.
EFPIA is championing a technology called 2D Data-Matrix Bar Coding, instead of what it believes is “the less reliable and more expensive” radio frequency identification (RFID) system. Thomas Cueni, chair of the association’s Economic and Social Policy Committee which is overseeing the proposal, said that EFPIA will introduce “unique bar-coding on every medicine pack in Europe before it leaves its manufacturer” so that thereafter, “at every stage of its distribution, up to the point at which it reaches the patient, the medicine can be authenticated to make sure it is genuine.”
EFPIA’s new president Arthur Higgins, head of Bayer Healthcare, spoke about the need to “strengthen the integrity and transparency of our drug supply chain by addressing the safety concerns of parallel trade," raising public awareness on the risk of counterfeits and increasing the traceability of pharmaceuticals, while Heinz Zourek, director general for enterprise and industry at the European Commission, noted that while parallel trade is perfectly legal, EU officials would look closely at potential safety issues.