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10% of Drugs in Developing Countries are Substandard or Fake-WHO

An estimated one in 10 medicines in poor countries are counterfeit and likely responsible for the deaths of tens of thousands of children from diseases such as malaria and pneumonia every year, the World Health Organization said.

According to WHO, these medicines not only fail to treat or prevent diseases but can also cause serious illness or even death.

Substandard and falsified medicines particularly affect the most vulnerable communities,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable. Countries have agreed on measures at the global level – it is time to translate them into tangible action.

Since 2013, WHO has received 1500 reports of cases of substandard or falsified products. Of these, antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from the WHO African Region, 21% from the WHO Region of the Americas, and 21% from the WHO European Region.

10% of Drugs in Developing Countries are Substandard or Fake-WHO

This is likely just a small fraction of the total

problem and many cases may be going unreported. For example, only 8% of reports of substandard or falsified products to WHO came from the WHO Western Pacific Region, 6% from the WHO Eastern Mediterranean Region, and just 2% from the WHO South-East Asia Region.

Many of these products, like antibiotics, are vital for people’s survival and wellbeing,” says Dr Mariângela Simão, Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals at WHO. “Substandard or falsified medicines not only have a tragic impact on individual patients and their families, but also are a threat to antimicrobial resistance, adding to the worrying trend of medicines losing their power to treat.

WHO has received reports of substandard or falsified medical products ranging from cancer treatment to contraception. They are not confined to high-value medicines or well-known brand names and are split almost evenly between generic and patented products.

Along with this report, WHO also published research that estimates a 10.5 percent failure rate in all medical products used in low- and middle-income countries. This study was based on more than 100 published research papers on medicine quality surveys done in 88 low- and middle-income countries involving 48,000 samples of medicines.

However, lack of accurate data means that these estimates are just an indication of the scale of the problem, and that more research is needed to more accurately estimate the threat posed by substandard and falsified medical products.

10% of Drugs in Developing Countries are Substandard or Fake-WHO

Based on 10% 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. A second model done by the London School of Hygiene and Tropical Medicine estimates that 116 000 (64 000 – 158 000) additional deaths from malaria could be caused every year by substandard and falsified antimalarials in sub-Saharan Africa, with a cost of US$ 38.5 million (21.4 million – 52.4 million) to patients and health providers for further care due to failure of treatment.

The bottom line is that this is a global problem,” says Dr Simão. “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.

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