Spot the difference?

Around the world the prevalence of counterfeit drugs is skyrocketing. Kirrilly Burton reports.

IT’S a common brand-name medication. The packaging and the tablets look like the real McCoy, but on closer inspection the bottle is slightly taller, there is no safety seal and the expiration date is incorrect. 

The medicine is a fake, or “deliberately and fraudulently mislabelled with respect to identity and/or source”, according to the official WHO definition, and may include incorrect ingredients, the wrong amount of active ingredients, or no active ingredient at all.1

The scourge of counterfeit medicines penetrating the global market is tainting the image of trusted brands and killing unsuspecting patients. These range from the man with erectile dysfunction buying medicines online to avoid an embarrassing trip to the doctor, to the patient on dialysis receiving contaminated heparin. 

The WHO estimates that in many countries in Africa, Asia and Latin America with weak regulatory and legal control, more than 30% of medicines are counterfeit.

Tipped to reach $83 billion globally this year, the threat of counterfeit medicines is increasing dramatically with annual international rates of incidents relating to counterfeiting, theft and illegal diversion of pharmaceuticals rising from 196 in 2002 to 1834 in 2008.2,3

On the counterfeit hit list are medicines that dwell in the genito-urinary, anti-infectives and central nervous system therapeutic categories.3

Cytostatic chemotherapy agents have had the greatest surge in counterfeit incidents, increasing by 46% in 2008, followed by genito-urinary medications and hormone drugs.3

Among the litany of global counterfeiting scandals, China has figured heavily. For example in January 2008, heparin imported from China was contaminated with chondroitin sulfate, killing 81 people in the US. It was supplied to 11 countries, including Australia. 

In developing countries, medicines used to treat malaria, tuberculosis and HIV/AIDS are also commonly counterfeited.  Between 1999 and 2000, up to 38% of artesunate, an antimalarial drug, manufactured in China and sold in Burma, Cambodia, Vietnam and on the Thai/Burma border, contained no detectable artesunate.4

A MAJOR CONCERN?

More recently, the US Food and Drug Administration warned that counterfeit versions of the over-the-counter weight-loss drug Alli (orlistat), manufactured by GlaxoSmithKline in the US, were being sold online with orlistat substituted with prescription drug sibutramine. 

Despite this international trend, according to the WHO, in most industrialised countries with effective regulatory systems and market control, counterfeit medicines comprise less than 1% of the market value.1 

So is the threat of counterfeit drugs a major concern in Australia?

Kos Sclavos, national president of the Pharmacy Guild of Australia, believes Australia is less vulnerable than countries like the US, UK and Europe due to different wholesaling practices. 

In Europe, where counterfeit medicines are a growing menace, he says parallel importing practices – in which non-counterfeit products are imported from another country without the permission of the intellectual property owner – are driving the problem. 

“You can be buying [a statin] and one minute it looks like one shape and the next day it looks like another, because it might be that your wholesaler has purchased one lot from Spain because that’s the cheapest,” he says.

“When you are not seeing a standard pack and standard consistent packaging, it’s very hard to pick up the differences,” he says. 

DRUG DEFENCES

In contrast, Mr Sclavos says the infiltration of counterfeit medicines into Australia is more difficult due to medicines being distributed under the PBS. 

“The pack looks exactly the same, so as a pharmacist, if there was something different, we would notice it straight away,” he says. 

However, despite manufacturers using sophisticated authentication technologies – such as barcodes, blister packaging, complex holograms, logos, colour shifting ink and taggants (chemical markers embedded in packaging) burgeoning global Internet sales have increased the entry of counterfeit medicines into the supply chain, heightening the threat of counterfeit medicines here.4

WHO figures show that in over half of cases, medicines purchased online from illegal sites that conceal their physical address have been identified as counterfeit.2

A recent review highlights the significant health risks associated with the use of counterfeit phosphodiesterase type 5 inhibitors in men with erectile dysfunction.

In one case, 150 Singaporean men were hospitalised and four died from neuroglycopenia after taking counterfeit tadalafil and herbal preparations containing glibenclamide.2

Associate Professor Doug Lording, of Andrology Australia, says most of these men were obtaining these medications without a prescription or without seeing a doctor.

“They often bypass a medical assessment, and therefore the cause of the erectile dysfunction is not determined,” he says.5 

While the TGA says it’s unknown how many Australians buy medications online, Mr Sclavos believes it’s an increasing problem. For example, he says one woman, who was overseas at the time, bought counterfeit Tamiflu (oseltamivir) from a website purporting to be Australian.

“The sad thing was this person may have had symptoms [of swine influenza] and the key thing with antivirals is to take them on early sign of symptoms and they were dodgy,” he says.Roche, manufacturer of Tamiflu, says it monitors and follows up all reports of counterfeit drugs. 

“There has not been a Roche-confirmed incidence of counterfeit Tamiflu during this swine flu outbreak,” an Australian Roche spokesperson says. 

Dr Ken Harvey, a senior lecturer in the School of Public Health at La Trobe University, Melbourne, says patients should only consider buying medicines from Australian Internet pharmacies that provide details of an Australian-registered pharmacist owner. 

On a national front, the Australian Customs and Border Protection Service works closely with the TGA to monitor and control the importation of medicines into Australia. 

While Customs could not provide a figure on how many illegally imported medicines it had intercepted on their way into the country, it says: “Private imports, both through the post or as personal baggage, must be no more than three months’ supply and must be accompanied by a valid or original doctor’s prescription.” 

Importation of controlled substances without a permit has heavy penalties, attracting a fine of up to $275,000 and/or 10 years’ jail. And under the Therapeutic Goods Act 1989, importers of counterfeit medical products and medications without a prescription can be fined and/or imprisoned for up to seven years. 

Our tough laws and geographical location mean Australia hasn’t been a significant target for counterfeiters, but Mr Sclavos says periodic examples of counterfeit medicines in Australia mean we need to remain vigilant.

REFERENCES

1. www.who.int/impact/FinalBrochureWHA2008a.pdf
2. Int J Clin Prac, online 2010
3. www.psi-inc.org/index.cfm
4. Postgrad Med J 2009; 85:251-56
5. MO, 29 January 2010