August 10, 2018
More than 13 percent of essential medicines in low- and middle-income countries are substandard or fake, according to recent findings from the University of North Carolina at Chapel Hill.
Sachiko Ozawa, Ph.D., M.H.S., an associate professor at the UNC Eshelman School of Pharmacy, led a meta-analysis of 96 studies that examined the problem of substandard or falsified medicines in low- and middle-income countries. The researchers found that 13.6 percent of medicines were substandard or falsified, including 18.7 percent of medicines in African countries.
“The prevalence of substandard and falsified medicines is a substantial public health problem,” she said. “Our study shows that a concerted global effort is needed to improve supply chain management for medicines and identify solutions to this understudied issue.”
The World Health Organization defines substandard medicines as real medical products that fail to meet their quality standards or specification. Failing to meet standards could be because of poor manufacturing, shipping or storage conditions or when the drug is sold beyond the expiration date. WHO defines falsified medicines as medical products that deliberately and fraudulently misrepresent their identity, composition or source.
Substandard and falsified medicines can be ineffective or harmful, which can prolong illnesses, cause poisoning or lead to dangerous drug interactions, said Ozawa.
The researchers searched five databases for studies related to substandard and falsified medicines. They reviewed 256 studies and included 96 studies in their meta-analysis. The included studies all tested more than 50 medications. Their findings were published by JAMA Network Open.
Among the 96 studies, antimalarials and antibiotics were the most commonly examined medicines. In low- and middle-income countries, 19.1 percent of antimalarials and 12.4 percent of antibiotics were found to be substandard or falsified, according to Ozawa’s research.
For example, in 2017 the WHO issued a warning about two falsified versions of quinine sulfate, a drug used to treat malaria, that were circulating in Congo. The fakes contained no active ingredients at all. And in early 2018, the WHO warned against a falsified version of the antibiotic Augmentin circulating in the street markets of Cameroon. Laboratory analysis of fake Augmentin found none of the active ingredients that are supposed to be present in the drug.
“We need more global collaboration to implement laws on drug quality, increase quality control capacity, and improve surveillance and data sharing,” said James Herrington, Ph.D., a professor in the UNC Gillings School of Global Public Health and author of the study. “This can strengthen the global supply chain against poor quality medicines, improve health outcomes by reducing antimicrobial and anti-parasitic resistance and, ultimately, help governments, businesses and patients save money.”
The UNC analysis found limited information on the economic impact of poor quality medicines: the estimates of market size ranged widely from $10 billion to $200 billion. Substandard and falsified medicines can burden health systems by diverting resources to ineffective or harmful therapies and cause additional treatment costs and reduced worker productivity due to treatable illnesses, but these effects have not been measured, Ozawa said.
“More rigorous economic studies are needed to accurately assess the scope of the issue and inform efforts to address it,” she said.
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