WHO: Unfit medical products common in developing countries

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Substandard or counterfeit medical products likely cause thousands of human deaths in low- and middle-income countries, according to the World Health Organization.

The organization reported in late November 2017 that use of unfit products has the greatest effect in the most vulnerable communities.

The report, "WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products," provides analysis of 1,500 reports in four years on fraudulent or otherwise insufficient human-use medical products, through June 30, 2017. The U.S. Food and Drug Administration is among contributors to the report.

"Much of the media coverage around ‘fake' medicines, particularly those purchased over the Internet, has focused on what are known as lifestyle medicines, such as slimming tablets and treatment for impotence," an executive summary document states. "But over the past four years, WHO has received reports of substandard or falsified medical products in all therapeutic categories, covering everything from cancer medicines to contraception, from antibiotics to vaccines."

Forty-two percent of the reports were from Africa, 21 percent each from the Americas and Europe, 8 percent from the Western Pacific, 6 percent from the Eastern Mediterranean, and 2 percent from Southeast Asia.

The organization published the report along with a literature review that indicated 10.5 percent of products examined—in 100 published papers and one database—failed quality tests. Those papers were published in 2007-16 on field studies or surveys on quality of medicines, and they together involved 48,000 samples.

That review, "A study on the public health and socioeconomic impact of substandard and falsified medical products," indicates unfit antimicrobials alone could have caused tens of thousands of deaths from childhood pneumonia.

WHO announcements indicate, using figures from the literature review, that one in 10 medical products in developing countries is substandard or fraudulent. The review text states that the research has limitations, one being that researchers are more likely to conduct product studies where unfit products are more likely to exist.

Michael Deats, WHO group leader for substandard and falsified medical products, said in a message that most studies took a convenience or risk-based approach, and random studies showed higher failure rates. The review examined the most rigorous studies published and peer-reviewed from 2007-16 and, while limitations exist and medicine quality surveys are difficult and costly, the team is confident that the publication used the best publicly available data.

The WHO surveillance report states that the pharmaceutical market is a "trillion-dollar, hyperglobalized business," and knowing how many fraudulent, poorly made, or degraded products are on the market is impossible.

WHO officials want to work with member countries to identify the causes for counterfeit and substandard medical product emergence, establish detection and response programs, provide a global regulator network, implement track and trace systems for medical products, understand technologies used to authenticate products, and reach consensus on how to define unfit products, the report states.