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Sarah Houlton, PhD, is Pharmaceutical Executive’s international correspondent.
The fakes likely entered the market through internet commerce, yet the government seems to be encouraging online pharmacies by discussing a shakeup of retail drugstores.
Some countries, notably those in Southeast Asia where industry oversight is minimal, have a big problem with counterfeit medicines. However, in European countries, where the drug supply chain is strictly controlled, it shouldn't be a concern.
Yet recently, counterfeit versions of two prescription drugs turned up in the United Kingdom. First, a patient found something wrong with his erectile dysfunction medication Cialis (tadalafil)—the tablets were crumbly. He'd obtained them from a pharmacy, and he reported the problem to the manufacturer, Lilly/ ICOS. The company tested the tablets, found they were likely fake, and reported it to the Medicines and Healthcare products Regulatory Authority (MHRA).
Ten days later, a wholesaler spotted an unusual batch number on packs of Abbott's anti-obesity medicine Reductil/ Meridia (sibutramine). The eagle-eyed wholesaler noticed the normal alphabetical suffix on the batch numbers was missing, and he alerted the authorities.
The MHRA is investigating both cases. David Pruce, director of quality improvement at the Royal Pharmaceutical Society, a UK pharmacists' group, says, "So far the problem has been kept under control. But it is absolutely vital that the way in which counterfeit medicines entered the legitimate supply chain is discovered and stopped."
The UK department of health has moved to reassure the public that medicines dispensed in pharmacies are unlikely to be fakes, noting that these cases are the first since 1994 when counterfeit Zantac (ranitidine) was found in the supply chain. In fact, there have only been four cases in the United Kingdom before—three involving Zantac, and the fourth Ventolin (albuterol) inhalers. However, the government agency does admit that fakes are available by mail order and on the internet, where there is little control over the supply chain.
Both Cialis and Reductil are so-called lifestyle drugs—the type of products in which internet pharmacies do a roaring trade—and it is likely that this is the source of the fakes found in British pharmacies. The UK pharma supply chain is very closely regulated. It starts with licensed manufacturers, who supply products to licensed wholesalers. These wholesalers are allowed to purchase medicines only from properly licensed sources. In turn, retailers can only source their medicines from licensed wholesalers. This way, the integrity of the supply chain is assured and documented, and it is very difficult for fake products to reach patients. The only slight complication is the presence of parallel imports, which come from other member states. But these, too, need to be properly licensed.
Most UK patients still purchase their medicines directly from a pharmacy. If the drugs have been prescribed by a doctor on the National Health Service (NHS)—as the vast majority of medicines are—there is no financial incentive to buy them elsewhere. There is a flat-rate charge of Â£6.40 ($11.50) per prescription item, regardless of whether it's cheap aspirin or expensive heart medication. Lifestyle medicines are a different issue. Even though they may be part of the NHS program, people are much more likely to self-prescribe diet pills or erectile dysfunction treatments and, therefore, they have to find an alternative source such as the internet.
That these counterfeits managed to infiltrate the legitimate supply chain is a worrisome development. The UK government, meanwhile, appears to be encouraging internet pharmacies as it discusses a possible shakeup of the retail pharmacy market. If internet pharmacies are properly licensed and regulated, the supply chain should not be in danger. Just one unscrupulous site, however, could jeopardize the entire distribution system.
If the counterfeiting problem transpires to be more than a couple of isolated cases, the reputation of the pharma industry will also be at stake. "This incident highlights the need for the greatest vigilance and scrutiny, especially when medicines are introduced into the system other than from their original manufacturers," says Richard Barker, the new director general of the Association of British Pharmaceutical Industry. "The best protection against counterfeiting is to ensure that the products bought are those supplied by the authentic manufacturer. Only then can the industry feel confident that its products are reaching patients in the same condition as they left the factory, and that patients are receiving medication that they can trust absolutely."