​1 in 10 medical products in developing countries is substandard

 #WHO, #UnitedNations, #developingCountries, #vulnerablecommunities, #DrMariângelaSimão, #GlobalSurveillanceandMonitoringSystem, #substandardMedicalproducts
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Toronto, Nov 30 (Canadian-Media):  According to new research from World Health Organization (WHO) -- a specialized agency of the United Nations that is concerned with international public health -- 1 in 10 medical products in developing countries were reported to be substandard or falsified which fail to treat or prevent disease, is a burden on health systems and can even can cause serious illness or even death.

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WHO. Credit: Official logo

​“Substandard and falsified medicines particularly affect the most vulnerable communities. 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,” Dr Tedros Adhanom Ghebreyesus, WHO Director-General was reported by the media to state.​

Of the total of approximately 1500 substandard or falsified products received by WHO since 2013, antimalarials and antibiotics were 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.
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This reflects just a small fraction of the total problem and many cases may be going unreported. Only 8% of reports of substandard or falsified products to WHO, for example, 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,” Dr Mariângela Simão, Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals at WHO was reported by the media to state.
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 “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”.

There was no global reporting of this information prior to 2013.  Many countries had actively started to report suspicious medicines, vaccines and medical devices since the Global Surveillance and Monitoring System (GSMS) for substandard and falsified medical products (SFMP) was established by WHO.
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WHO has also trained 550 regulators from 141 countries to detect and respond to this issue and with more people being trained, more cases are consequently being reported to WHO.

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

​A study 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, an estimates of 10.5 percent failure rate in all medical products used in low- and middle-income countries is being In published in conjunction with the first report from the GSMS published on Nov 28.

More research is needed, to reportedly get more accurate estimate of the threat posed by impact of sales of SFMP.
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Patients have access to SFMP when technical capacity to enforce quality standards in manufacturing, supply and distribution are limited. Falsified products, on the other hand, tend to circulate where inadequate regulation and governance are compounded by unethical practice by wholesalers, distributors, retailers and health care workers. A high proportion of cases reported to WHO reportedly occur in countries with limited access to medical products.

Globalization is also making it harder to regulate medical products as many falsifiers manufacture and print packaging in different countries, shipping components to a final destination where they are assembled and distributed.

Offshore companies and bank accounts sometimes facilitate the sale of falsified medicines.

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

WHO has published two reports today. WHO launched its GSMS for SFMP, vaccines and in-vitro diagnostic tests in July 2013. This first report is based on data collected during the first 4 years of operation up to 30 June 2017.

A study on the public health and socioeconomic impact of SFMP conducted by WHO and the Member State Mechanism is based on 100 literature reviews provide data for more than 48 000 samples of medicines from 88 countries. Because only 178 samples were taken in high-income countries, prevalence estimates of substandard or falsified medical products were limited to low- and middle-income countries.
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These two reports represent, despite these limitations, present the most comprehensive compilation to date of data related to substandard and falsified medical products and facilitate better understanding of their public health and socioeconomic impact.