BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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8 BioPharm International eBook October 2021 WHO IS AT GREATEST RISK? T he Med ic ine Q ua l it y Resea rc h Group, Centre of Tropical Medicine & Global Health, Nuffield Department of Medicine, and the University of Oxford published a report in April of 2021, which stated that low- and mid- dle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines (3). In March of 2021, Mexican author- ities at Campech International Airport found 5775 doses of counterfeit sput- nik v vaccines (which contained spell- ing errors) in an icebox that were due to be transported to Honduras by plane (3). In addition, in April of 2021, Pfizer identified falsified COVID-19 vaccines in Mexico and Poland, according to an article in The Wall Street Journal (4). There were fraudulent labels on the vials in Mexico, while the vials in Poland con- tained a treatment for wrinkles, Pfizer stated (4). Approximately 80 people in Mexico were believed to have received these falsified vaccines. More recently, in July of 2021, an estimated 2500 peo- ple in India thought they were receiving coronavirus vaccines and instead were injected with saline, according to an arti- cle on (5). In the same article, a senior official of the Mumbai police department shared there were at least 12 fake vaccination drives in Mumbai (5). But the counterfeit vaccines didn't just start cropping up in 2021. Yet a n o t h e r e x a m p l e o f c o u nt e r f e it COVID-19 vaccines, according to an article in The Wall Street Journal, was in November of 2020 when authorities in Germiston, South Africa uncovered 2400 doses of falsified vaccines in 400 ampuls in a refrigerator (6). US VS. GLOBAL SUPPLY CHAIN SECURITY The US drug supply is among the saf- est in the world, according to FDA's website, which states that there is a closed drug distribution system and falsif ied drugs in the United States a re ra re —relat ive to t he nu mber of prescription drugs used (7). FDA works with U.S. Customs and Border Protection to monitor substandard and falsified drug products that are made abroad and distributed in the US. "Drugs prescribed for patients must be pure, sterile, and produced in an FDA-compliant facility that is within the supply chain that FDA oversees," said an FDA spokesperson in an inter- view. "Since 2013, the FDA has oper- ated an electronic, interoperable system that identifies and traces certain pre- scription drugs as they are distributed in the US. This system enhances the FDA's ability to help protect consumers from exposure to drugs that may be coun- terfeit, stolen, contaminated, or other- wise harmful. The system also improves detection and removal of potentially dangerous drugs from the drug supply chain to protect US consumers." In an interview, Justin D. Green, Office of Criminal Investigations dep- uty director, FDA, added, "Our Office of Criminal Investigations will con- tinue to pursue and bring to justice those manufacturers and illicit actors who would violate the public's trust and endanger their health by attempting to avoid the agency's oversight authority." However, estimating the scale of the problem of substandard and counterfeit COVID-19 vaccines is very challenging, WHO stated in an interview. "In a world of globalized supply chains, the risk of substandard/falsified medical products affects all countries," WHO added. "In 2017, WHO released statistics based on surveys conducted over the past 10 years, which suggest the failure rate of medicines surveyed in LMICs [low- and middle-income coun- tries] is approximately 10.5%" (8). Some of the challenges to the supply chain are in unregulated online mar- ketplaces, said WHO in an interview, which has provided opportunities for manufacturers and suppliers of sub- standard and falsified medical products to gain access to the global market- place. WHO also added that self-di- agnosis and self-prescribing have led to an increase in unregulated websites that claim to diagnose illness and pro- vide access to substandard and falsified medical products. WHERE DO WE GO FROM HERE? As of August 2021, Our World in Data estimates that approximately 1.2% of people in low-income countries have received at least one dose of the COVID- 19 vaccine (1). Moreover, low- and middle-income countries spend approxi- mately $30.5 billion on substandard and falsified medicines, according to Member State Mechanism on Substandard and Falsified Medical Products (9). With an inequitable distribution of legitimate vaccines, particularly in low- and middle-income countries, where can the industry go from here? How can supply chain vulnerabilities be addressed on a global scale? WHO made the following recom- mendations in an interview: • "Member States are encouraged to work with WHO and procure via the COVAX system. • "National health regulatory authorities must coordinate with other key Regulatory Sourcebook Drug Safety FDA has operated an electronic, interoperable system since 2013 that identifies and traces certain prescription drugs as they are distributed in the US.

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