According to my new study published in the journal, from 2016 to 2021, the Food and Drug Administration took 130 enforcement actions against counterfeit drug rings Annals of Pharmacotherapy.
Such action may include arrests, product confiscations, or disbanding of counterfeiting rings.
These counterfeiting operations involved tens of millions of pills, more than 1,000 kilograms (2,200 pounds) of drug powder that could be made into pills in the US, and hundreds of millions of dollars in sales.
Unfortunately, with over 11,000 fraudulent pharmacy sites selling drugs online, these actions hardly scratch the surface.
The FDA’s Office of Criminal Investigations conducts and coordinates criminal investigations into manufacturers and individuals who violate federal drug laws. The Agency maintains a database of links to press releases for its enforcement actions.
Overall, over this five-year period, 64.6 percent of the counterfeit products were sold over the internet and 84.6 percent of the enforcement actions taken were the products purchased without a prescription.
Many of the counterfeit drugs were for controlled substances such as opioids like oxycodone and hydromorphone, and stimulants commonly used to treat attention-deficit/hyperactivity disorder, as well as benzodiazepines, used for anxiety and sleep.
China, India, Turkey, Pakistan and Russia were the countries most likely to supply counterfeit medicines to US consumers.
Why it matters
The World Health Organization states that about 11 percent of medicines sold in developing countries are counterfeit, resulting in 144,000 additional deaths annually from counterfeit antibiotics and antimalarials alone.
My previous study also documented 500 childhood deaths resulting from diethylene glycol — a common additive in antifreeze — being added as a sweetener to imitation cough suppressants.
In addition, from November 2021 to February 2022, counterfeit versions of drugs for chronic diseases, such as the transplant drug tacrolimus, sold under the brand name Limustine, and the anticoagulants rivaroxaban or Xeralto, were found on Mexican pharmacy shelves.
In the United States, the Drug Quality and Security Act of 2013 secures drug supply through a national electronic track-and-trace system that allows a specific drug to be traced from manufacturer to pharmacy.
While drugs are safe at licensed US pharmacies, a survey by the Kaiser Family Foundation found that 19 million people in America have received prescription drugs that are likely counterfeit, through non-US licensed internet pharmacies, or while traveling abroad.
The National Association of Boards of Pharmacy found that 96 percent of the 11,688 online pharmacies they analyzed did not comply with US federal or state laws. Of these, 62 percent did not reveal their physical location, and 87 percent were connected to “malicious internet drug store networks.”
The FDA offers some guidance to help consumers determine if an online product is legitimate.
Opioids, benzodiazepines and stimulants are highly addictive and dangerous if taken improperly or used together.
While these counterfeit drugs may look legitimate, the active ingredients claimed to be in these controlled substances are often substituted with more dangerous alternatives such as fentanyl. Four out of ten counterfeit opioid pills containing fentanyl contain a potentially lethal dose.
According to the Drug Enforcement Administration, from April 2020 to April 2021, the US seized 9.5 million counterfeit pills — more than the previous two years combined. This is likely a reason for the 100,306 drug overdose deaths in the US during this period.
Fraudulent online pharmacies often 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 illegal prescription drug sellers online.
People who buy controlled substances over the internet are usually trying to circumvent doctors’ control over the drugs or the amounts they can receive. However, most of the people who access counterfeit drugs without controlled substances are simply trying to buy them at an affordable price.
These trends make it clear that the US needs a long-term strategy to reduce prescription drug costs to reduce demand for counterfeit drugs, although there are some strategies that can save money in the short term.
C. Michael White, Professor of Pharmaceutical Practice, University of Connecticut.
This article was republished by The Conversation under a Creative Commons license. Read the original article.