Heart patients get fake drugs supplied to NHS pharmacies

Counterfeit copies of Lipitor, a drug taken by more than a million Britons for cardiovascular conditions, have entered the NHS supply chain. Drug regulators are attempting to track how fake versions of the statin were supplied to chemists and reached "patient level". It is not known how many people may have taken the fakes, although the drugs in question are not thought to pose a serious risk to health.

A total of 320 fake packets, marked with an authentic Lipitor batch number - 004405K1 - have been discovered since the arrest in June of two men who are the focus of a criminal investigation. The same batch was subject to a national recall a year ago when 73 packets were discovered - the first time that counterfeits of a drug used for conditions as serious as heart disease had been detected in the legitimate supply chain.

The Times understands that there are broader concerns about the criminal network linked to the men arrested, and attempts to exploit other areas of the statin supply chain. The Medicines and Healthcare products Regulatory Agency (MHRA), which issued a second recall in the past fortnight after the discovery, is to adopt a national strategy next month to combat the trade in counterfeit medicines. Estimates from regulators in the United States suggest that 15 per cent of imported pharmaceuticals contain unapproved substances. Thousands of patients in developing countries are thought to have died as a result of medicine counterfeiting in recent years.

The Lipitor discovery is the fourth time in ten years that fakes have been detected in the drug supply chain in Britain. Experts are becoming increasingly concerned that criminal networks are exploiting the market in statins, which are taken by millions of people to lower cholesterol. The two Lipitor incidents involved the counterfeiting of a batch of 120,000 packets. Each packet contained 28 Lipitor pills of 20mg and were worth about 28 pounds. The fakes were found to contain a statin not marketed in Britain. Mick Deats, the head of enforcement and intelligence for the MHRA, said: "Our testing of the counterfeit product indicates that there is no immediate risk to patients, but we cannot guarantee its quality."

The latest recall was sent to 20,000 chemists and shops. The two men who were arrested in June are on police bail. The discovery of paperwork at premises used by the men led investigators to a wholesaler in North London, and to pharmacy clients. Neither the wholesaler nor the pharmacists are accused of wrongdoing In a business plan published last week by the MHRA, Kent Woods, its chief executive, outlined significant concerns about counterfeit products and internet sales. Describing the "increased threat across the world", he said that international relationships needed to be developed and "as much disruption as possible created to illegal and unsafe trade". The report says that an anti-counterfeiting strategy will be in place by September aimed at criminals importing, distributing and supplying fake drugs. Market surveillance, co-operation among regulators, increased public awareness and more forceful prosecution are the main plans of attack.

Pfizer, which makes Lipitor, said that it was working with regulators to determine how the criminals were operating and to help to thwart them. "Pfizer's first concern is for patient safety and takes counterfeiting of medicines extremely seriously," it said. "[The company] has introduced a number of policies and technologies to protect the integrity of its medicines, including the phased introduction of tamper-evident packaging, and is aggressively addressing this issue to ensure that patients can remain confident that they are taking genuine Pfizer medicines. "This discovery serves as a strong reminder of the vulner-ability of the medicines supply chain in much of Europe. Patient safety can only be maintained with a secure and safe medicines supply chain, which requires anti-counterfeiting efforts by all stakeholders."

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