The Medicines and Healthcare products Regulatory Agency has ordered a recall of Eli Lilly’s antipsychotic Zyprexa, after three counterfeit batches were identified in the supply chain.

The Agency says it is believed that two of these batches have reached patient level but that, at present, there is no evidence of any adverse reactions to them. Initial tests show that the fakes contain around 60% of Zyprexa’s active ingredient olanzapine, but whether any harmful substances are present is yet to be established.

Even if all the substances in the counterfeit version are harmless, inadequate amounts of active ingredient will probably render a therapy useless, which can be very dangerous for patients in itself. The MHRA says it is taking the matter “very seriously, and a criminal investigation is being carried out.” Currently, one person has been arrested and is on bail.

Patients have been advised to contact their pharmacists immediately if taking the following batches of Zyprexa: A229505, A200127 or A216454, or any of these with a prefix or suffix.

A growing problem

Counterfeiting is seen as one of the big problems facing pharma, and one that is growing at an alarming rate. Earlier this year, the MHRA said there is clear evidence that drug counterfeiters are switching their operations from trading small quantities of weaker or totally fake products on the internet to targeting wholesalers who supply the UK National Health Service.

At the time, the Agency was investigating 25 cases of medicine counterfeiting, which is twice the number it had to deal with five years ago.

“In the past couple of years the counterfeiters have become more confident. They have realised the profits to be made," the Agency's head of intelligence, Naeem Ahmed, said. “If you trade over the Internet, the risk of detection is low but you only sell a pack here and a pack there. If you penetrate the supply chain there is a higher risk but you can make a lot of money.”

The issue has also recently been thrown to the fore by Pfizer’s claim that its move to a single drug distribution channel in the UK with a sole supplier, Boots’ Alliance UniChem, was spurred by its need for tighter control over its supply chain, making it much harder for fake drugs to invade it. Last year, counterfeit Lipitor (atorvastatin) entered the supply chain on no less than three occasions.

Many other pharmaceutical companies have since stated their intention to evaluate their supply chains, and the Office of Fair Trading is currently in the midst of an investigation into the implication of a direct-to-pharmacy distribution model and the impact of a single supplier agreement.