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A day after fake batches of Eli Lilly’s antipsychotic Zyprexa® (olanzapine) were discovered in the supply chain, the UK’s health regulator issued a warning about counterfeits of Sanofi-Aventis and Bristol-Myers Squibb’s clotbuster Plavix® (clopidogrel) being smuggled into the country as parallel imports.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said that in conjunction with the European Medicines Agency, Sanofi and BMS, it was recalling “any parallel distributed stock of lots 3098 and 6Y098” of tablets branded as Plavix, “following the discovery of counterfeit tablets in the legitimate supply chain”. The MHRA goes on to note that, as with the counterfeit batches of Zyprexa, the fake Plavix “was supplied in French livery via parallel distributors into the UK supply chain”.
The agency added that “stock presenting a patient risk may be present as French-livery cartons with an overlabel applied by a parallel distributor may have been recartoned into an English carton by the parallel distribution repacking process”. The aforementioned lots are genuine numbers used by Sanofi and BMS for which the original unchanged lots were supplied to France in French livery, the MHRA added, noting that the EMEA has allowed more than 30 UK parallel distributors to supply Plavix.
The similarity of the Zyprexa and Plavix cases could suggest the same counterfeiter is behind both fakes. However, the MHRA said initial tests showed that the Plavix samples only contain 70–80% of the labelled active ingredient and while work is ongoing to obtain more information, “in the interim we consider a recall is needed to minimise patient risk”.
Two cases in as many days have once again highlighted the problem of fake drugs. Speaking about the Zyprexa case, David Pruce, director of practice and quality improvement at the Royal Pharmaceutical Society of Great Britain, said: “Counterfeiting in the UK is a rare occurrence but nevertheless a worldwide problem. The society has been working with the MHRA through our team of inspectors and we ask pharmacists to cooperate with the MHRA’s investigation and to be alert for counterfeit medicines.”
However, there are other people who feel that the problem in the UK is not so rare. Earlier this year the MHRA said it was investigating 25 cases of counterfeiting – twice the number it had to deal with five years ago. Pfizer has claimed its move to a single drug distribution channel in the UK with a sole supplier, Boots Alliance UniChem, was provoked by counterfeit Lipitor® (atorvastatin) entering the supply chain last year. Several other drug companies have since stated their intention to evaluate their distribution models.