The World Health Organization (WHO) has renewed its warning to travellers not to buy medications overseas following new reports of counterfeit antimalarial medications.
Labelled Sulfadoxine-Pyrimethamine and Quinine Sulphate, the counterfeit drugs were uncovered late last month in Central and West Africa.
The pills, which contained less than 2% of the active ingredients, turned up in several locations, including a drug wholesaler’s warehouse and a hospital.
Unlike more sophisticated fakes, the latest haul had obvious flaws, including misspelt labels on the package and a WHO Essential Drugs Programme logo that is no longer in use.
“Travellers should obtain all anti-malarials and other medicines before travel,” the WHO said in its alert. “Do not buy anti-malarials and other medicines directly from shops, markets, or street traders.”
Marketplace ‘pharmacies’ risky
To date this year, 94 Aussies have contracted malaria overseas. More than 400 returned home with the mosquito-borne disease last year.
Budget-conscious Australians who buy malaria medications overseas are not just risking a potentially life-threatening bout of the disease, said Travelvax Australia’s Medical Director, Dr Eddy Bajrovic.
“Besides offering little or no protection against disease, some counterfeit drugs contain harmful toxic ingredients,” he warned.
“Anti-malaria drugs are a particular favourite with counterfeiters, especially in countries where malaria is a major health risk, such as across Africa and Asia.
“These criminals target young foreign travellers whose only mistake was to try to save money.
“But, travellers of any age need to be aware that any drug purchased outside a licensed pharmacy could be counterfeit. At best they could be ineffective, at worst dangerous – even deadly.
“The only way to avoid the risk is to ensure that you purchase anti-malarials and other medication recommended for your trip before leaving home.”
Sophisticated copies hard to pick
Counterfeit pills and capsules used to be relatively easy to spot. They often had a strange smell, taste, or colour, were brittle, poorly packaged. Critically, they usually sell for a fraction of the drug’s normal retail price.
However, obvious fakes are no longer the exception: counterfeiters use state-of-the-art equipment to produce flawless copies of drugs and sophisticated printing techniques to create identical packaging – right down to seemingly authentic holograms. Some even add just enough active ingredients to allow their dodgy products to pass cursory quality control tests, according to researchers writing in the Lancet.
And, the copies aren’t restricted to high-demand malaria medications. US customs agents have intercepted scores of counterfeit Tamiflu, the antiviral drug being stockpiled in anticipation of a bird flu pandemic. The fake drugs had none of Tamiflu’s active ingredients and information on the packages was written in Chinese.
Last Thursday, French customs announced the seizure of 10 tonnes of fake aspirin, erectile dysfunction, and diarrhoea drugs from China in what’s been described as the European Union’s biggest-ever seizure of counterfeit medicine.
Fakes adding to malaria risk
Peter Pitts, a former Associate Commissioner of America’s Food & Drug Administration (FDA) calculates that the counterfeit drug trade grows by more than 13% annually – nearly twice the rate of legitimate pharmaceutical products. He estimates 2010 revenues at $75 billion – a 92% increase from 2005.
“The bad news is that international prescription drug counterfeiting is on the rise and it’s nothing less than international health care terrorism,” Mr Pitts said in a statement.
“The profits are high and the risks are low. That’s a deadly combination.”
Experts have long warned that anti-malaria drugs containing suboptimal amounts of active ingredients, such as the front-line treatment medication artesunate, are contributing to the development of resistant strains of the disease.
The issue has reached alarming proportions in parts of Southeast Asia, particularly on the Thailand – Cambodia border.
First-world countries targeted
Because of the clandestine nature of the counterfeit drug trade, the WHO struggles to provide accurate, up-to-date figures on its true size. In a current overview, it concedes that only 38 (20%) of its 191 member states have well developed drug regulations.
Of the remainder, about 50% implement drug regulations to varying levels. The remaining 30% either have no drug laws in place or regulations that barely function.
A large proportion of the world’s counterfeit medicines originate in Asia and an estimated 40% end up in first-world markets, particularly in North America and Europe, despite their more advanced customs and regulatory systems.
The WHO has grouped the fake products reported by member countries into six categories:
- No active ingredients - 32.1%
- Incorrect quantities of active ingredients - 20.2%
- Wrong ingredients - 21.4%
- Correct quantities of active ingredients but with fake packaging - 15.6%
- Copies of an original product - 1%
- Drugs with high levels of impurities and contaminants - 8.5%
Alarming impact worldwide
Even the WHO’s dated snapshot of the impact of fake drugs in individual countries presents an alarming picture of their pervasive reach over the past decade. Among countries popular with Australian travellers were:
CAMBODIA – 13% of drugs on the domestic market were counterfeit or substandard, including anti-malaria drugs and antibiotics.
CHINA – about 8% of over-the-counter drugs sold in China are counterfeit, its research and development-based Pharmaceutical Association estimated.
INDIA – 1-in-5 medicines sold in major cities are fakes, making up more than 20% of the total market.
INDONESIA – fake or pirated drugs made up 25% of the $2 billion pharmaceutical market in 2005.
KENYA – a survey found that almost 30% of the drugs were counterfeit, the national pharmaceutical industry body estimates. Some of the drugs were simply chalk and water.
Deadly decisions for poor
The global counterfeit drug trade is thriving in Africa, where the poor have no choice but to buy the cheaper marketplace medicines in the often vain hope that it will be effective.
The majority of the average 600,000 malaria deaths each year occur in Africa so the routine decision to purchase malaria medication can have deadly consequences. Ironically, local criminal groups are now entering the market in Africa, making copycat drugs for sale locally as well as exporting them, the WHO warns.
However, Africa remains a principal market for unscrupulous criminal groups from China and India, which are at the heart of the counterfeit drug trade.
(Perhaps not surprisingly, it’s estimated that as many as 300,000 Chinese die each year due to counterfeit or substandard medicine. And, these are only the reported cases: the true number could well be far higher.)
In India, the WHO estimates that 1-in-5 drugs are fakes, while a survey of New Delhi pharmacies in 2010 found that 12% of the drugs sampled were ‘knock offs’.
Technology providing solutions
Meanwhile, new technology is helping to tip the balance against the counterfeiters.
TruScan, a handheld spectrometer, is being used to analyse the chemical composition of drugs being carried through airports and border posts, spotting fakes in just seconds.
New systems allow legitimate drug manufacturers to label their packages with an encrypted code.
Consumers scratch off the label on the package and text the code to the company that maintains the system. An instantaneous text informs the consumer if the drug is the real deal.
Not only do counterfeit drugs kill, they erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, and the pharmaceutical industry.
Just like individual countries, the WHO is frustrated by the enormity of the problem.
As the agency’s overview of fake drugs concludes: “There is no simple solution or remedy that can be applied to eliminate counterfeit medicines, nor can the problem be solved by an individual company or government. The problem has reached а global dimension and needs а global approach.”