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BY OUR PHARMA CORRESPONDENT
4 August, 2005: UK authorities recalled packs of Pfizer's anti-cholesterol blockbuster, Lipitor, after discovering that counterfeit tablets of the drug had entered the legitimate supply chain.
The Medicines and Healthcare products Regulatory Agency (MHRA) said that a batch of the 20mg dose of Lipitor had been seized at an undisclosed location. It added that initial tests of the counterfeit drugs indicated that they did not pose an immediate risk to patients.
The affected product is 20 mg is sold in packages of 28 tablets. The drug packages are marked with batch number 004405K1 and an expiration date of "11 2007." The batch number can be found on the end of the box next to the expiration date and on the foil backing of the drug’s blister pack. Legitimate UK Lipitor also has this same batch number.
Pfizer UK officials expressed shock saying that the company was “seriously alarmed” at the incident.
The company added that the British government should consider outlawing the repackaging of original manufacturers' medicines by third parties, a well-known practice in parallel trade. It has also called for the introduction of tamper-resistant medicines packaging and a standardised European barcode system for medicines, to enhance safe recall and identification.
Patient safety is at risk if counterfeit products can easily be introduced into the supply chain through cross border trade, as patients will not gain the benefits their doctor intended when taking their medicine, the company sources said.
Meanwhile, in a statement, the Association of the British Pharmaceutical Industry Association (ABPI) highlighted parallel trade and internet pharmacies as `two possible weak areas in the system”.
However, MHRA confirmed that the Lipitor recall had no connection to the practice of parallel trade. “This is all about organised crime and, as part of our investigation, we're trying to find out how these criminals penetrated the legitimate medicines supply chain,” it said in a release
Heinz Kobelt, secretary-general of the European Association of Euro-Pharmaceutical Companies (EAEPC) representing parallel traders said there was no evidence of any safety issue on the parallel distribution chain.
“In the middle of June, one of our British members came across a box of original Pfizer Lipitor which had neither a batch number nor an expiration date on its outer package - it was fished out from a Portuguese importer.” Therefore, he noted: “We believe that by opening packs, parallel importers add a layer of safety to the supply chain.”
While the MHRA said it had taken note of Pfizer's proposals, it reiterated that it already had effective and comprehensive measures in place to tackle counterfeit medicines.
“Clearly no system is perfect and we can't say that this will never happen again but the MHRA remains at the forefront of international regulatory agencies and, due to the safeguards we have in place, the UK legitimate supply is difficult to penetrate with counterfeit medicines,” MHRA noted.
Lipitor contains atorvastatin, a drug beloning to the statin famili. Statins are known as cholesterol lowering drugs. It is used in addition to diet and exercise for the treatment of people with high cholesterol levels. Atorvastatin works by blocking an enzyme that is needed to make cholesterol in the liver. Therefore, less cholesterol is made and levels of cholesterol in the blood are decreased. Reduction of cholesterol levels in the blood has been shown to reduce the risks associated with heart disease, such as heart attack.
BY OUR PHARMA CORRESPONDENT
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