WASHINGTON, United States, Monday, December 4, 2017 – It is estimated that one in 10 medical products circulating in low and middle income countries, including those in the Caribbean, is of inferior quality or is counterfeit, according to new research. of the World Health Organization (WHO).
This means that people are taking medications that do not treat or prevent diseases. Not only is it a waste of money for the people and health systems that buy these products, but inferior or false quality medical products can cause serious illness or even death.
"Substandard and counterfeit medicines especially affect the most vulnerable communities," says Dr. Tedros Adhanom Ghebreyesus, Director General of the WHO. "Imagine a mother who stops eating or other basic needs to pay for her son's treatment, not knowing that the drugs are of inferior quality or falsified, and then that treatment causes the death of her son." This is unacceptable. they have agreed on measures worldwide: it is time to translate them into tangible actions ".
Since 2013, WHO has received 1500 case reports of substandard or counterfeit products. Of these, antimalarials and antibiotics are the most commonly reported. The majority of reports (42%) come from the WHO African Region, 21% from the WHO Region of the Americas and 21% from the WHO European Region.
This is only a small fraction of the total problem and many cases may not be reported. For example, only 8% of reports of deficient or falsified products to WHO came from the WHO Western Pacific Region, 6% from the WHO Eastern Mediterranean Region and only 2% from the South East Asia Region. of WHO.
These products, like antibiotics, are vital for the survival and well-being of people, "says Dr. Mariângela Simão, WHO Assistant Director-General for Access to Medicines, Vaccines and Pharmaceutical Products." Substandard drugs or Counterfeits not only have a tragic impact on individual patients and their families, but they are also a threat to antimicrobial resistance, which increases the worrisome tendency for drugs to lose their power to treat. "
Before 2013 There have been no global reports of this information Since WHO established the Global Surveillance and Monitoring System for counterfeit and substandard products, many countries are now active in reporting suspect medicines, vaccines and medical devices. 550 regulators from 141 countries to detect and respond to this problem As more people are trained, they are notified to WHO more cases.
WHO has received reports of deficient or falsified medical products ranging from cancer treatment to contraception. They are not limited to high-value medicines or well-known brands and are almost equally divided between generic and patented products.
Along with the first report of the Global Surveillance and Monitoring System, the WHO publishes research that estimates a failure rate of 10.5% in all medical products used in low and middle income countries.
This study was based on more than 100 published research papers on drug quality surveys conducted in 88 low and middle income countries with 48,000 samples of medicines. The lack of accurate data means that these estimates are only an indication of the magnitude of the problem. More research is needed to more accurately estimate the threat posed by counterfeit and substandard medical products.
Based on estimates of 10% of deficient and counterfeit drugs, a modeling exercise developed by the University of Edinburgh estimates that 72,000 to 169,000 children may be dying each year of pneumonia due to falsified and substandard antibiotics. A second model conducted by the London School of Hygiene and Tropical Medicine estimates that 116,000 (64,000 – 158,000) additional deaths from malaria could be caused each year by deficient and counterfeit antimalarials in sub-Saharan Africa, at a cost of $ EE .US. 38.5 million (21.4 million – 52.4 million) to patients and health providers for additional care due to treatment failure.
Poor medical products reach patients when the tools and technical capacity to apply quality standards in manufacturing, supply and distribution are limited. Counterfeit products, on the other hand, tend to circulate where inadequate regulation and governance are compounded by unethical practices by wholesalers, distributors, retailers and health workers. A large proportion of the cases reported to WHO occur in countries with restricted access to medical products.
The WHO said that modern shopping models, such as online pharmacies, can easily bypbad regulatory oversight. These are especially popular in high-income countries, but more research is needed to determine the proportion and impact of sales of counterfeit or substandard medical products.
He added that globalization makes the regulation of medical products difficult, with the manufacture of many counterfeiters and prints packages in different countries, sending the components to a final destination where they are badembled and distributed. Sometimes, offshore companies and bank accounts have been used to facilitate the sale of counterfeit drugs.
"In short, it is a global problem," says Dr. Simão. "Countries need to badess the scope of the problem at home and cooperate regionally and globally to avoid trafficking in these products and improve detection and response."
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