Courtesy of C. Michael White, University of Connecticut
The research summary is a brief overview of interesting scholarly work.
The big idea
The Food and Drug Administration took 130 enforcement actions against counterfeit drug rings from 2016 to 2021, according to my new study published in the journal Annals of Pharmacotherapy. Such actions may involve arrests, confiscation of products, or the disbanding of counterfeit rings.
These counterfeit operations involved tens of millions of pills, over 1,000 kilograms (2,200 pounds) of active ingredient powder that could be made into pills in the United States, and hundreds of millions of dollars in sales. Unfortunately, with over 11,000 rogue pharmacy sites selling drugs on the internet, these actions only scratch the surface.
The FDA’s Office of Criminal Investigations conducts and coordinates criminal investigations of manufacturers and individuals who violate federal drug laws. The agency maintains a database with links to press releases for their enforcement actions. Overall, in 64.6% of cases over this five-year period, counterfeit products were sold over the Internet, and in 84.6% of enforcement actions taken, products were obtained without a prescription. .
Many counterfeit drugs involved controlled substances such as opioids such as oxycodone and hydromorphone and stimulants such as those commonly used to treat attention deficit/hyperactivity disorder, as well as benzodiazepines, which are used to anxiety and sleep. China, India, Turkey, Pakistan and Russia were the most common countries supplying American consumers with counterfeit drugs.
why is it important
The World Health Organization reports that about 11% of medicines sold in developing countries are counterfeit, resulting in 144,000 additional deaths per year from antibiotics and antimalarials alone. My previous study also documented 500 child deaths attributed to diethylene glycol – a common additive in antifreeze – added to cough suppressants as a sweetener.
In addition, from November 2021 to February 2022, counterfeit versions of drugs used for chronic conditions – such as the transplant drug tacrolimus, sold under the brand name Limustin, and the blood thinner rivaroxaban, or Xeralto – were found. on the shelves of Mexican pharmacies.
In the United States, the Drug Quality and Security Act of 2013 secures the drug supply through a national electronic track and trace system that tracks a specific drug from the manufacturer to the pharmacy. While drugs in licensed US pharmacies are safe, a Kaiser Family Foundation survey found that 19 million people in America obtained prescription drugs that are likely counterfeit through licensed non-US internet pharmacies or while traveling to the stranger. The National Association of Boards of Pharmacy found that 96% of the 11,688 online pharmacies analyzed did not comply with US federal or state laws. Of these, 62% did not reveal their physical location and 87% were affiliated with “rogue internet drug outlet networks”.
The FDA offers guidance to help consumers determine if an online product is legitimate.
How counterfeit drugs can end up in your medicine cabinet.
Opioids, benzodiazepines and stimulants are highly addictive and dangerous when taken improperly or when used together. Although these counterfeit drugs may appear legitimate, the active ingredients believed to be in these controlled substances are frequently replaced with more dangerous alternatives such as fentanyl. Four out of 10 counterfeit opioid pills containing fentanyl contain a potentially lethal dose.
According to the Drug Enforcement Administration, the United States confiscated 9.5 million counterfeit pills from April 2020 to April 2021, more than the previous two years combined. This is likely a driver of the 100,306 drug overdose deaths in the United States during this period.
Fraudulent online pharmacies frequently use social media platforms to reach potential customers. This suggests that online platforms like social media, online forums and search engines need to do more to identify and stop illegitimate online prescription drug sellers.
People who buy controlled substances over the Internet usually try to circumvent the doctor’s control over the drugs or the quantities they can receive. However, most people who access counterfeit drugs of uncontrolled substances are simply trying to buy them at an affordable price. These trends clearly show that the United States needs a long-term strategy to reduce the cost of prescription drugs in order to reduce the demand for counterfeit drugs, although there are money-saving strategies that can be used in the short term.
C. Michael White, Professor of Pharmacy Practice, University of Connecticut
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