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How fake medical products endanger lives

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Imagine going to a nearby pharmacy or health facility for a prescription to treat an infection. After a few days you observe you are not getting better after taking the medication, but rather your situation becomes worse.

It may just be possible that the medicine you purchased or obtained from the health facility contains only corn starch, potato starch or chalk.

Or simply that it has no active ingredient to treat the disease or infection for which the medication was bought.

The World Health Organisation (WHO) in its recent factsheet on substandard and falsified medical products has estimated that one in 10 medical products in low and middle income countries are substandard or falsified.

War against fake drugs

The war against the spread of fake medications began several years ago. It is still an ongoing one. The dangers of fake medical drugs and pharmaceutical products have been an issue that the WHO has been waging war on, having described the situation years ago as “complex” and “politically sensitive”.

A WHO bulletin issued in 2010 under the title, “Growing threat from counterfeit medicines” had indicated that it was working with the International Criminal Police Organization (Interpol) to dislodge the criminal networks raking in billions of dollars from this illicit trade.

The organization has been working actively on the growing threat from counterfeit medicines and this issue was first discussed in May 1998, at the World Health Assembly.

However, enforcement efforts stepped up a notch in 2006 when it launched the International Medical Products Anti-Counterfeiting Task Force (IMPACT), drawing members from international organizations, enforcement agencies, industry and non-governmental organizations.

WHO sources have said that the threat from counterfeit pharmaceutical products is hardly new with many national authorities fighting long battles against the fake medicine industry.

The WHO bulletin had made it clear that in 2010, worldwide sales of counterfeit medicines could top $75 billion, based on estimates published by the Center for Medicine in the Public Interest in the United States.

It said in 2009, 20 million pills, bottles and sachets of counterfeit and illegal medicines were seized in a five-month operation coordinated by Interpol across China and seven of its south-east Asian neighbours.

For countries such as Ghana, fake medical products are bad news. The reason is that antimalarials and antibiotics, common medicines used in Africa, are said to be among the most commonly reported substandard and falsified medical products.

What is worrying is that WHO has recently pointed out that some substandard and falsified medical products are toxic in nature with either fatal levels of the wrong active ingredient or other toxic chemicals.

The globalized fake drugs market

According to the fact sheet released this year, the WHO says no country is free from these fake drugs since it extends globally from “North America and Europe through to sub-Saharan Africa, South East Asia, and Latin America. What was once considered a problem limited to developing and low-income countries has now become an issue for all.”

“With the exponential increase in internet connectivity those engaged in the manufacture, distribution and supply of substandard and falsified medical products have gained access to a global market place. This extends both to consumers and business forums,” the WHO points out.

Globalization, online businesses and the emergence of a lucrative international market for fake products are at the heart of the spread of fake medical products.

Behind all these is profit making, which has remained the one big reason why this industry has thrived over the years.

The World Bank over a decade ago addressing specific issues on pharmaceuticals, counterfeits, substandard drugs and drug diversion in a document, mentioned among others, that the key drivers of this counterfeiting is the monetary gain and the huge sums of money that can be made.

The March 2005 document had said that “the estimated value of the overall global trade in fake and sub-standard medicines is more than $30 billion.”

“Low manufacturing costs and high profits for fake medicines attract criminals, who see this as an easy way to make money. Profits are higher for copies of branded drugs from international manufacturers, but counterfeiters also copy generic drugs if there is enough volume to make a profit,” it had added.

The World Bank had warned that the “problem is substantial in parts of the world that do not have effective regulatory systems.”

However, recent events are showing that it is not just a question of poor countries and poor regulatory systems. This is because even rich countries with sophisticated regulatory systems are having their fair share of this global phenomenon.

Not too long ago, the international news outlet, the Guardian, published an article in February this year warning of a global alert by the WHO cautioning patients, doctors and pharmacies of a cancer drug circulating in Europe and the Americas, which contains only paracetamol.

The fake cancer drug made from paracetamol resembled the leukaemia drug, Iclusig, sold in Europe and Americas for £5,000 a pack, it states.

“There’s no active ingredient so it’s a really high value product. It’s dangerous. We’re concerned about this one,” the article quotes Michael Deats, who leads the vigilance group on fake medicines at the WHO in Geneva.

Deats had said that although it is more common to see falsified or ineffective antibiotics and antimalarials, reports of fake cancer drugs are not infrequent.

The WHO has already said that “unregulated websites, social media platforms, and smartphone applications can also be direct conduits of substandard and falsified medical products.”

“A culture of self-diagnosis and self-prescribing has led to the emergence of thousands of unregulated websites providing unsupervised access to substandard and falsified medical products. However, it is in low- and middle-income countries and those in areas of conflict, or civil unrest, where health systems are weak or non-existent that bear the greatest burden of substandard and falsified medical products,” it adds.

Impact on lives

In November 2017, the WHO in a release, urged governments to take action against fake medical and pharmaceutical.

It said based on 10 per cent estimates of substandard and falsified medicines, a modelling exercise developed by the University of Edinburgh estimates that 72 000 to 169 000 children may be dying each year from pneumonia due to substandard and falsified antibiotics.

The release said a second model done by the London School of Hygiene and Tropical Medicine estimates additional deaths from malaria could be caused every year by substandard and falsified antimalarials in sub-Saharan Africa, with a cost of $38.5 million to patients and health providers for further care due to failure of treatment.

It quotes Dr  Mariângela  Simão, Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals at WHO as saying: “The bottom line is that this is a global problem…..Countries need to assess the extent of the problem at home and cooperate regionally and globally to prevent the traffic of these products and improve detection and response.”

The WHO has made it clear that tens of thousands are dying from the fake drugs trade.

The Reuters news outlet in an article titled, tens of thousands dying from $30 billion fake drugs trade, stated that some pharmacists in Africa, for example, say that they are compelled to buy from the cheapest but not necessarily the safest suppliers to compete with illegal street traders.

According to the article, “since 2013 the WHO has received 1,500 reports of fake and low-quality products, with antimalarials and antibiotics the most commonly reported categories.”

The problem extends to everything from cancer drugs to contraceptive pills. Sub-Saharan Africa accounted for 42 percent of all the reports. There was no global reporting of this data before 2013,” it adds.

SciDev.Net, a leading science and technology news outlet and another news organisation carried news on a study just this year, where research conducted in Uganda and the Democratic Republic of Congo showed that fake and poor-quality antimalarials account for up to 43 per cent of annual economic cost of malaria in children under-five years in Sub-Saharan Africa.

“We estimated that substandard (poor-quality)] and falsified antimalarials are responsible for US$20.9 million (35 per cent) of $59.6 million in malaria costs in Kinshasa Province and $130 million (43 per cent) of $301 million in malaria costs in the Katanga region annually,” says the study in the Democratic Republic of Congo, which was published in the American Journal of Tropical Medicine and Hygiene in January.

In Uganda, the researchers estimated that substandard and fake antimalarials accounted for $31 million, or eight per cent cost of the annual burden of malaria among children under-five years who sought care, according to the findings published in the Malaria Journal also in January.

The WHO has also estimated that fake and poor-quality antimalarials contribute to 31,000 -116,000 additional deaths annually in the sub-Saharan Africa region, with children under five years being the most affected.

It is in the light of these that individuals must also take some personal responsibility to safeguard their lives and those of family members.

The decision of access to safe medical products cannot be left to government agencies and regulatory bodies such the Food and Drugs Authorities of countries alone.

For consumers and others concerned about these products some alerts have been issued by the WHO to serve as pointers to aid in tracking these fake products.

It gives cautions on some of the things to look out for online such as checking for spam email advertising medicines, with no verification logo or certificates on products.

Also, spelling mistakes and poor grammar on the packaging of these pharmaceutical products should also be of concern including websites that do not display a physical address or landline or websites offering prescription only medicines without a prescription and “suspiciously low-priced products.”

Equally when purchasing drugs, consumers have been warned to be on the lookout for the packaging of medical products to make sure they are in good condition, clean and with a patient information leaflet.

Other areas of concerns are verifying if the medicine looks, feels and smells as it should. The security seals should be intact with no signs of tampering and also check if any customs declaration or postal labels declare the contents as medicines.

The WHO has also pointed out the need to check if the “batch number and expiry date on the primary internal packaging match the batch number and expiry date on the secondary (external) packaging.”

These are all pointing individuals to take active interest and get involved in securing their wellbeing and safety, when getting medical products by personally examining all details about such products.

Also, medical professionals, regulatory bodies and other stakeholders, who are directly involved and work in this industry, must be proactive in reining in the growth of fake pharmaceutical products to save thousands of lives.

By Eunice Menka
Copyright ©2019 by Creative Imaginations Publicity
All rights reserved. This article or any portion thereof may not be reproduced or used in any manner whatsoever without the express written permission of the publisher except for the use of brief quotations in reviews.

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