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Articles from April 2008

The pills that kill

Read the comprehensive, alarming article on the escalating threat of counterfeit medicines and the dangers of purchasing medicines via the internet, published in the Daily Telegraph Newspaper. (5 April 2008, Telegraph online, UK)

New Zealand authorities warn against buying drugs online

Health officials in Wellington, New Zealand have warned against buying medicines on the internet, saying substandard or counterfeit drugs for erectile dysfunction had been seized, entering the country from India, China and Thailand.

Stephen McKernan, the director general of health in New Zealand, issued a specific warning about four products illegally promoted in Singapore for treating erectile dysfunction that had been found to contain dangerous levels of a prescription medicine used to treat diabetes.

He said the products – Power 1 Walnut, Santi Bovine Penis Erecting Capsule, Zhong Hua Niu Bian and a counterfeit Cialis – contained the diabetes drug glibenclamide and were believed to have caused one death and up to 89 adverse reactions in Singapore.

McKernan said glibenclamide lowers blood sugar levels and its use by consumers who did not have diabetes could produce serious side effects, including coma and possible death. (24 April 2008, Top News – Health and Fitness online)

McCreevy says EU must ‘counteract’ rise in counterfeits

EU Commissioner Charlie McCreevy has said that The European Union must tackle the rise in piracy and the ‘massive diversification’ in the number of counterfeit products. He said that customs officers, companies and governments must cooperate to fight the sale of fake products that has gone ‘way beyond’ designer bags and DVDs – he continued to state that piracy and counterfeiting have ‘an increasingly serious effect’ on governments and people’s safety.

The ‘misappropriation’ of intellectual property rights costs about 150 billion euros ($235 billion) a year, according to the Organization for Economic Cooperation and Development. The EU last year reported a 50 percent increase in the number of counterfeit items that threaten human health, such as fake cigarettes, Viagra and food being removed from sale. All products and industries that could generate a profit are affected and production is happening on an industrial scale, said McCreevy. “We have to attack the infringers at the place where it hurts them most: in their wallet,” he said. (28 April 2008, Bloomberg News)

Five Chinese jailed over lethal fake medicine scandal

Five people involved in a lethal fake medicine scandal that killed 13 patients in 2006 were jailed for between four and seven years, a court in Guangzhou, China said on Tuesday. The five people, all from the Qiqihar No. 2 Pharmaceutical Company of Heilongjiang Province, were responsible for allowing diglycol, a lethal chemical that can cause kidney failure, to be used in the production of Armillarisin A, a medicine to treat liver and gallbladder diseases.

In April, 2006, the counterfeit Armillarisin A drops were administered in the form of injections to 15 patients in a hospital in Guangzhou. Thirteen died after suffering kidney failure and the drops also exacerbated symptoms of the two other patients. The company responsible has been shut down following the fake medicine incident. Xun Fubo, deputy director of the Food and Drug Administration of Qiqihar, has been sacked for negligence. Eleven other officials in the city and province were punished. (29 April 2008, chinaview.cn)

Counterfeit Drugs: Decisive and Global Action Is Needed

In a market where counterfeit drug sales are estimated to reach $75B by 2010 according to the World Health Organization (WHO), it is clear that drug counterfeiting is on the increase. Yet there is too much talk and not enough decisive action being taken in the industry to harness this problem, which is affecting national economies, damaging pharmaceutical brands and above all threatening patient safety, concludes a new study by Frost & Sullivan.

The study, commissioned by patient safety communications company Aegate, entitled Working Together on Mass Serialisation: Whose Responsibility is Ensuring Patient Safety?, reviews the steps that have been taken to try and address this burgeoning issue both from a national legislative level and through the use of new technologies. The analysis concludes that as counterfeit medicines impact patients’ health and have such a negative effect on all involved in the supply chain, a collective push towards a solution with tangible benefits for all parties is urgently needed.

“It is Frost & Sullivan’s opinion that with the current growth of the counterfeit drug market, the industry needs to stop talking about finding a solution and start working together to put one in place,” says Frost & Sullivan Vice President – Financial and Business Services, Europe and Africa Andrew Calvert. “To do this successfully there needs to be an acceptance right across the supply chain of shared liability.”

Frost & Sullivan believes that mass serialisation, a process by which a unique number is assigned to each saleable unit (pallet, case or individual package of drugs), can provide the foundation to develop a workable solution to help combat the trade in counterfeit drugs.

It is important to note however, that the application of the mass serialisation technology alone will not make a difference. It only provides the key to authentication processes that can validate drugs at critical points in the pharmaceutical supply chain, which can often involve more than 20 stages. This enables the assurance of product quality before dispensing and the opportunity to identify sources within the supply chain at which counterfeits may have leaked in.

Although there are costs involved in setting up mass serialisation systems, pharmaceutical companies and governments stand to benefit from a secure supply chain, improved product recall, brand protection, point of sale security, and improved service to pharmacists and patients. However, with a few notable exceptions, the industry has been slow to recognise the rewards of this approach. “With mass serialisation ready and accessible to make a difference now, the industry is running out of excuses for not facing up to their moral responsibilities and putting patients first,” Calvert says.

The WHO and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are however working to encourage adoption. In addition, Frost & Sullivan identified that countries such as Belgium and Greece, who are early adopters of mass serialisation, have seen great benefits. However, while mass serialisation provides an effective and immediately available solution, its impact will not be felt on the global stage if it is only embraced by individual market participants or at a country level. In an increasingly globalised world, solutions to combat the trade in counterfeits must be globally applied.

The report concludes that an element of compulsion and collective action is needed by all market participants to combat drug counterfeiting and to drive interest and uptake in patient safety solutions that make use of mass serialisation. The responsibility for this ultimately rests with Governments who have the power to enact legislation.

“We applaud moves by individual stakeholders to help combat counterfeit drugs, however we support Frost and Sullivan’s findings,” says CEO of Aegate, Gary Noon. “The industry as a whole still needs to do more to eradicate this alarming trend. We are committed to playing our role in supporting the industry, by having a workable authentication solution available now that will enable collective responsibility to be taken for the benefit of the patient. Aegate has patient safety at the heart of what we do.” (30 April 2008, Pharmaceutical online)