Battle against phony pharmacy

Fight the Fakes calls for international co-operation to stamp out a deadly problem.

The International Council of Nursing (ICN) is continuing the fight to stamp out fake medicines.

The Fight the Fakes campaign brings together organisations that are engaged in fighting counterfeits. It aims to raise the profile of potential dangers and outline opportunities for action.

ICN has been campaigning and lobbying for increased caution and management of fake medicines since 2005.

“Fake medicines are a growing threat to global health that puts patients and the public at risk,” Fight the Fakes director public affairs and global health policy Mario Ottiglio says. These include deliberately mislabelled products that are smuggled into regular supply chains and passed off as normal generic, prescription and over-the-counter medicines.

Incorrect ingredients or dosages, a lack of active ingredients or even dangerous and potentially deadly substances can be found in these fakes.

“700,000 people die each year because of fake malaria or tuberculosis medicines,” Ottiglio says.

“The largest [proportion] of counterfeit medicines [comprises] common antibiotics, tuberculosis and malaria medicines.”

Although there is a view that these fakes are often limited to lifestyle pills purchased online, hormones and cystostatics are the two fastest-growing types of fake medicine.

The World Health Organisation (WHO) estimates that up to 10 per cent of medicines available globally are fake; this figure rises to almost a third in some areas of Asia, Africa and Latin America.

In wealthier countries it is estimated that up to 1 per cent of medicines are falsified.

Australia is not immune to this problem. For example, in 2010, an Australian man had unwittingly taken a counterfeit version of Cialis, a drug for male sexual dysfunction, and was admitted to hospital with severe hypoglycaemia.

David Benton, CEO of ICN, says unfortunately this is not a unique case. “According to The Partnership for Safe Medicines, Australian customs officials catch 24 packages of fake drugs every month.

“In 2009 in Nigeria, at least 84 children died after taking a syrup for teething pain that contained diethylene glycol – an industrial solvent and an ingredient in antifreeze and brake fluid,” Benton said. “In 2011, nearly 3000 Kenyans were affected by a falsified batch of their antiretroviral therapy.”

Ottiglio said many countries that aren’t wealthy have weak national drug regulation and little or no regulatory authority to combat the problem, meaning counterfeits increasingly make their way into hospitals and pharmacies.

“People believe they are taking genuine medicines, but these fake products do not treat illness and they can worsen a patient’s condition,” he said. In people with infectious diseases, fake medicines also result in prolonged infection and can potentially result in drug-resistant bacteria and parasites.

“One myth is that fake medicines just don’t work, but they don’t do any harm,” Ottiglio says. “Fake medicines won’t treat the illness; what’s more, they can worsen the patient’s condition, leading to further illness, disability and even death.”

He adds that they also increase resistance to genuine treatments and often have harmful ingredients such as mercury, rat poison, paint and antifreeze.

Benton says, “They also undermine people’s trust in health professionals and health systems to provide adequate treatment.

“If patients do not trust where their medicines come from or that their medicines are safe and effective, they may fail to take them correctly, if at all.”

ICN communication officer Lindsey Williamson says nurses need to know the extent of the threat and how they can help combat the problem.

Nurses are well positioned to monitor drug effects, being on the frontline of health, and in the administration and prescription of medicines, Benton says. He adds they must be aware of signs of counterfeiting, such as improper packaging and labelling. “Nurses also have a key role in educating the public of the dangers of buying medicines on the internet or on the streets from unauthorised sources.”

Ottiglio says increasing public awareness is the first step in the fight against fakes and agrees it is important for nurses to be vigilant in paying attention to the appearance of medicines to ensure that the packaging and date are correct and there are no anomalies on the instructions or blister packs. “As drug counterfeiters get better and better at passing off fake medicines in packages that look genuine, nurses should pay attention to patients with unusual side effects and contact health authorities to report suspicious cases,” he says.

A toolkit, titled Be Aware, Take Action, is designed to help educate health professionals and improve their capacity to detect and report counterfeit medical products.

ICN also released a toolkit on counterfeit medicines called International Nurses Day 2005. The Fight the Fakes website also holds educational materials and other resources. The document includes a checklist

Checking out the type of packaging is an important step in spotting a counterfeit drug, as packaging materials are often difficult to mock up; however, makers of such drugs are quick to copy unique labelling and holograms.

Other steps health professionals can take include ensuring the container protects the drugs from the exterior environment, checking to see that the container and closure are appropriate for the medicine and making sure the medicine is sealed.

Making certain that labels match and are legible, and that trade names are spelled correctly can make a difference in spotting a fake as well.

Experts also suggest checking that the numbering system on the package corresponds to that of the producing company and that the manufacture and expiry dates are clearly indicated, as well as ensuring all the data on the label is correct.

The kit also recommends looking out for breaks, crack and splits and confirming that there is uniform coating, colour, shape, markings and size, as well as establishing that the paper quality of the package insert is matched against the original and the ink is smudge-proof.

Other senses are encouraged to be used as well, such as using smell to determine whether the new medicine is the same as the original.

“ICN believes that nurses, as the world’s largest group of healthcare providers, are the key partners in fighting falsified medicines and informing the public of the dangers,” Williamson says.

It takes a global effort

• Fake medicines are everybody’s business: A comprehensive strategy to combat manufacturing and distribution of fake medicines requires an active participation that involves all stakeholders (in particular, public and private organisations, governments, national regulatory and enforcement agencies, health professionals, patients, scientific societies, NGOs, research-based and generic pharmaceutical manufacturers, medicine distributors, wholesalers, retailers and their organisations, service providers, etc.)
• People must be aware: Addressing fake medicines requires general education and knowledge of the dangers. All stakeholders across the supply chain should receive sufficient education on what they can do if they suspect a medicine to be fake.
• A global co-ordinated approach: Strong co-ordination amongst international organisations is vital to ensure this problem is correctly tackled. As the leader on global health matters, the World Health Organization has an unparalleled role to play.
• Adequate legislation and regulation: Tackling fake medicines requires strong pharmaceutical policies, legislation and penalties for those producing phoney products. Strict enforcement in countries where laws are already on the books, and putting them in place in nations where there are none, are crucial elements to winning this battle.

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