World Patient Safety Day: The impact of fake and poor quality medicines in developing countries

By Tallulah Gordon

In December 2014, several patients arrived at health centres in the Democratic Republic of the Congo’s Ituri district experiencing shivers, stiffness, and muscle spasms. Initially suspecting meningitis, health workers were left puzzled after tests for the disease returned negative. As environmental poisoning and a new unknown disease were also ruled out, cases continued to rise. Then toxicologists identified the likely cause: a toxic drug. With no local laboratory available, urine samples sent to France determined that the now 930 patients had overdosed on haloperidol, an antipsychotic drug. None of the patients, however, had knowingly used the drug, instead purchasing what they believed was the anxiety medication diazepam. More commonly known as Valium, diazepam is widely used in Ituri to treat malaria symptoms as a poor substitute for scarce antimalarials. Though packaged in genuine diazepam bottles, the tablets the patients had taken contained an entirely different drug.

These events that took place in Ituri are not an isolated incident, but one of many examples from the developing world of the harm caused by falsified and substandard medical products, including medicines, vaccines, and diagnostic tests. Though found in every part of the world, these products present the greatest risk to low- and middle-income countries, where an estimated 1 in 10 of all available medical products are falsified or substandard. To achieve Sustainable Development Goal 3.8: “Access to safe, effective, quality and affordable essential medicines and vaccines for all”, greater international cooperation is needed to address this serious issue.

A display of counterfeit medicines in Malacca, Malaysia. Photo credit: Shutterstock

What are falsified and substandard medicines, and what impact are they having?

Substandard medicines are made by registered manufacturers but fail to meet quality standards, while falsified medicines are counterfeits designed to deceive consumers or healthcare providers into believing they are genuine products. Either kind may contain no active ingredient, the wrong active ingredient, or the right active ingredient in the wrong quantities. Falsified medicines also include legitimate but expired products that have been repackaged to look like they are still in date. In some cases, falsified medicines even claim to provide treatments or cures for which there is no genuine equivalent product, such as the many fake coronavirus “cures” currently being sold across Ghana.

It is unsurprising that counterfeiters disproportionately target developing regions, where 2 billion people lack access to the genuine medical products they need. Medicines of questionable quality may be the only ones that buyers can afford, or the only ones available at all. This was likely the case in Ituri, a remote area with a history of conflict and displacement, where essential medicines are often in short supply. That the fake diazepam was being dispensed in pharmacies and government health centres also shows that genuine healthcare providers can fall prey to falsified medicines. Facing supply issues or competition from street markets – where counterfeit medical products are often found – a pharmacy might turn to cheaper suppliers selling products of dubious origin.  

The harm these products cause to developing countries is substantial. Every year, 100,000 people across Africa die because of falsified or substandard medical products. This is sometimes simply because the product failed to treat the illness it was intended for, with counterfeit medicines in developing regions unfortunately usually used for life-threatening illnesses such as tuberculosis, malaria, and HIV/AIDS. In other cases, however, falsified and substandard medicines contain toxic ingredients that cause serious illness or even death. In one particularly tragic example from 2006, 219 people in Panama died after consuming counterfeit cough syrup containing diethylene glycol, the active ingredient found in antifreeze. Falsified and substandard medicines also have a severe economic impact – according to the World Health Organization, their cost to developing countries may have totalled US$30.5 billion in 2014 alone.

Medicines being tested for legitimacy at a laboratory in Kiev, Ukraine. Photo credit: Shutterstock
Medicines being checked for legitimacy in a laboratory in Kiev, Ukraine. Photo credit: Shutterstock

How can this be addressed?

With a lack of public awareness, poor pharmaceutical regulations and short supplies of genuine products all contributing to the prevalence of falsified and substandard medicines in developing countries, complex solutions are required. More needs to be done to ensure that consumers, patients, and healthcare workers know how to identify counterfeits. Local innovations can play a role – in Nigeria, for example, five teenage girls have created a mobile app (FD (Fake Drug) Detector) that can be used to check medications for authenticity.

But with substandard medicines much more difficult to identify by eye than falsified ones, relying on consumers to spot these products is not enough – they must be prevented from entering the supply chain. With many developing countries increasing their manufacture of medical products to tackle poor supplies, enforcement of strict regulations, quality standards and routine testing are needed to ensure these are of high quality. Despite the obvious harm they cause, falsified and substandard medicines also remain surprisingly low on the international agenda. Since counterfeiters deliberately make use of complex and unusual global supply chains to avoid detection (for example, falsely-labelled HIV medication being given out in east Africa may have been manufactured in India, before being procured by an American company), greater international cooperation is needed. The WHO’s Global Surveillance and Monitoring System, which issues global alerts when a falsified or substandard medicine is identified in one country, has helped to prevent the spread of several of these products across borders. But many healthcare professionals believe that a global treaty on falsified and substandard medicines is required.

Read more:

WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products (2017). This publication by the WHO provides an in-depth insight into the consequences, causes, and possible solutions to the problem of substandard and falsified medical products worldwide.

Tallulah is Blog Officer at Development in Action and is studying for a masters’ degree in Public Policy at the London School of Economics.

The views expressed in this article are those of the author and do not necessarily represent the views of Development in Action.


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