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Counterfeit drugs threaten to roll back the gains

Mobile drug peddlers are a common sight virtually everywhere in Africa.  Carrying the medicine on their heads, they roam the streets and villages. The more adventurous ones ride the ubiquitous mini-vans as they chase a sale.

Many people have been victims of fake and counterfeit medicines. Imagine you have malaria and you are taking artesunate-amodiaquine, the recommended first line treatment in Ghana, only to find out later that the medication had no effect. In the case of children or non-immune adults, this could easily lead to death from untreated malaria.

Fake Malaria drug

Original Malaria drug

Some of these fake drugs have been established to be chalk in capsules and others contain little or none at all of the active ingredients. Occasionally, they may contain substitute active ingredients and in some cases they may actually contain harmful substances.

According to the World Health Organisation, the problem of counterfeit medicines was first addressed at the international level in 1985 at the Conference of Experts on the Rational Use of Drugs in Nairobi. The meeting recommended that WHO, together with other international and non-governmental organisations, study the feasibility of setting up a clearing house to collect data and to inform governments about the nature and extent of counterfeiting.
 
Fake coartem in Ghana?
Fake/counterfeit medicines came up again in Ghana in July, with the Food and Drugs Board warning the public about fake Coartem on sale in Kumasi. Coartem is one of the fastest selling antimalarial medicines in Ghana and one of the most expensive. It is so effective that patients accept the high price associated with it.

The board confiscated 150 packs of the product from nine wholesale and retail pharmacies involved in the distribution and sale of the fake products. The FDB said tests on the fake products showed that the fake tablets do not contain any Artemether and Lumefantrine, the main active ingredients of the genuine article. There were fears that the fake Coartem may have filtered to other parts of the country.
 
An expected consequence of the fake Coartem incident is that most people, being unable to tell the difference between the genuine article and the fake, abandoned Coartem altogether and opted for unapproved herbal remedies and chloroquine.

COUNTERFEIT DRUG

Ripple effects of counterfeit/substandard medicines
It has been estimated that up to 15 per cent of all drugs sold are fake, and in parts of Africa this figure exceeds 50 per cent. Dr Patrick Lukulay, the Director of the United States Pharmacopoeia Drug Quality and Information Programme, says there is need for more public education on the effects of substandard and counterfeit medicines. “People should be made to understand that medicine quality is not a luxury but rather a matter of life and death,” he stressed.

Dr Lukulay described fake/counterfeit medicines as “deliberately mislabeled with respect to identity, amount and source while substandard medicines refers to legally branded but falls short of meeting quality specifications”.

The effects of counterfeit/substandard medicines are numerous: they are a threat to public health and economic development and a burden on national health care. Taking counterfeit/substandard drugs leads to failed treatment and eventually to a lost opportunity to eradicate the parasite.

“People who take counterfeit drugs may have less of the active ingredient, meaning people could die because they are not receiving their life-saving treatment,” Dr Lukulay said.

It is estimated that about $12 billion is lost in wages due to counterfeit/substandard medicines since failed treatment leads to more days out of work. “Every counterfeit or substandard medicine one takes undermines investments in healthcare systems, erodes patient trust in conventional medicines and people go untreated, leading to prolonged illness or death. The wrong chemical in a medicine could lead to death while sub-potent treatment causes resistance and treatment failure,” Dr Lukulay adds.

China, India, Nigeria: Hubs of fake medicines?
In a story headlined “Health fears grow as fake drugs flood into Britain” in January this year, The Guardian said counterfeiting gangs based in China were producing sophisticated copies of the world’s bestselling pharmaceuticals. In 2008, an estimated eight million of these potentially deadly pills found their way to the United Kingdom’s National Health Service.

The problem is now so great that Interpol's Secretary-General, Ronald Noble, opened an anti-counterfeiting conference in Africa recently by admitting to being "shocked" at discovering that fake drugs were more deadly than terrorism. Forty years of terrorism, he said, had killed 65,000 people, compared with 200,000 in one year alone in China from counterfeit medicines.

In 2007, Zheng Xiaoyu, the former head of China’s Food and Drugs Administration, was executed after being found guilty of taking bribes to license fake drugs.

About 20 per cent of drugs sold in India are reported to be fake. Figures released by the Organisation for Economic Cooperation and Development's indicate that almost 75 per cent of fake drugs exported the world over accrue from India.

There are many fake drug makers and importers in Nigeria. Dr Dorothy "Dora" Akunyili, former head of the National Agency for Food and Drug Administration and Control and Nigeria’s current Minister for Information, had been waging a concerted war against them in the face of threats and intimidation. A survey conducted by the World Health Organisation found more than half the drugs on sale in Nigeria were fake or sub-standard.

"Counterfeit drugs are murder," says Dr Akunyili. "It is the highest form of terrorism against public health because it kills a mass number of people."

Her efforts yielded fruit but pitted her against some of the West African nation's wealthiest businessmen. There was even an attempt on her life, with investigators saying local drug distributors had hired contract killers to murder her.  Many offices of the agency were burnt down and there were more threats to kill her and her children.

She stood firm even when they shot at her car. The bullet grazed her skull but she survived. Dr Akunyili determination to wage this war was driven by memories of a personal tragedy. Her 21-year-old diabetic sister, Vivian, died in 1988 because of a fake insulin injection.

News reports credit Dr Akunyili and the agency for the reduction in the level of fake drugs in Nigeria to 35 per cent, down from around 70 per cent in 2001.

Winning the war against counterfeit/substandard drugs
The WHO notes that the increasing international trade of pharmaceuticals and sales via the internet has further facilitated the entry of counterfeit products into the supply chain.

In 2006, this led to WHO's launch of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which has been the main conduit for its work against counterfeits.

Dr Lukulay calls for robust legislation and regulation and proactive citizens who would serve as community watchdogs or whistleblowers in the fight against counterfeit or substandard medicines. He also suggests that scientists pursue new technologies for counterfeit detection.

In Ghana, there are sentinel sites for drug quality in Bolgatanga, Kumasi, Ho, Accra and Tarkwa. These sites could help identify counterfeit medicines although all avenues for medicine supply and distribution are also avenues for the proliferation of counterfeit medicines.

Mr Joseph Bennie, the Ashanti and Brong Ahafo Zonal Officer of the FDB, says the board adopted a “name-and-shame” strategy to fight counterfeit medicines. Additionally, the board has revamped its internal mechanisms for early detection of counterfeit medicines on the market.

Dr Alex Dodoo, the Acting Director of the Centre for Tropical Pharmacology and Therapeutics of the University of Ghana Medical School, says counterfeiting has become increasingly sophisticated and requires a multi-sectoral approach involving academicians, policy makers and civil society.

Dr Dodoo, who is also the President of the Pharmaceutical Society of Ghana and Board Chairman of the FDB, advises that people purchase medicines from registered and licensed outlets only since this reduces the likelihood of counterfeit medicines.

He adds: “The fake Coartem story shows how legitimate pharmacies and chemical shops can be used to supply counterfeit medicines. Vigilance is, therefore, needed always and consumers should check and check again all products they purchase. If in doubt, report to the FDB or the law enforecement agencies.”

He wants all countries to develop appropriate systems to quickly identify the supply route for all medicines, including unlicensed and fake products. "This is the best way of protecting the public who, most often, will not be able to tell the difference between a fake and genuine product.”

 

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