(ORDO NEWS) — Between 2016 and 2021, the Food and Drug Administration took 130 enforcement actions against counterfeit drug chains, according to my new study published in the Annals of Pharmacotherapy.
Such actions may include seizures, confiscation of products, or dismantling of counterfeit networks.
These counterfeiting operations involved tens of millions of tablets, over 1,000 kilograms (2,200 pounds) of active ingredient powder that could be made into tablets in the US, and hundreds of millions of dollars in sales.
Unfortunately, with over 11,000 illegal pharmacy sites selling drugs online, these activities barely touch the surface.
The FDA’s Office of Criminal Investigation conducts and coordinates criminal investigations of manufacturers and individuals who violate federal drug laws. The agency maintains a database with links to press releases on its enforcement activities.
Overall, in 64.6% of cases during this five-year period, counterfeit drugs were sold over the Internet, and in 84.6% of enforcement cases drugs were purchased without a prescription.
Many of the counterfeit drugs were for controlled substances such as opioids such as oxycodone and hydromorphone, stimulants such as those commonly used to treat attention deficit/hyperactivity disorder, and benzodiazepines that are used to treat anxiety and sleep.
China, India, Turkey, Pakistan were the most common countries supplying US consumers with counterfeit drugs.
Why is it important
The World Health Organization claims that about 11 percent of medicines sold in developing countries are counterfeit, resulting in 144,000 additional deaths each year from counterfeit antibiotics and antimalarials alone.
My previous study also recorded 500 childhood deaths related to diethylene glycol, a common antifreeze additive, being added to counterfeit cough suppressants as a sweetener.
In addition, from November 2021 to February 2022, counterfeit versions of medicines used to treat chronic diseases, such as the transplant drug tacrolimus, sold under the brand name Limustin, and the anticoagulant rivaroxaban, or Xeralto, were found on the shelves of Mexican pharmacies.
In the United States, the Drug Quality and Safety Act of 2013 secures the supply of medicines through a national electronic traceability system that traces a particular drug from the manufacturer to the pharmacy.
While drugs are safe in licensed US pharmacies, a Kaiser Family Foundation study found that 19 million people in America received prescription drugs that are most likely counterfeit through unlicensed US online pharmacies or while traveling overseas.
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 and state laws. Of these, 62 percent did not indicate their physical location, and 87 percent were associated with “fraudulent online pharmacy networks.”
The FDA offers some guidance to help consumers determine if an online product is legal.
Opioids, benzodiazepines, and stimulants are highly addictive and dangerous if taken or used together incorrectly.
While these counterfeit drugs may look legitimate, the active ingredients that are supposed to be in these controlled substances are often replaced with more dangerous alternatives, such as fentanyl. Four out of 10 counterfeit fentanyl opioid pills contain a potentially lethal dose.
From April 2020 to April 2021, 9.5 million counterfeit pills were seized in the US, more than in the previous two years combined, according to the Drug Enforcement Administration. This most likely caused 100,306 drug overdose deaths in the US during that time.
Illegal online pharmacies often use social media to reach potential customers. This suggests that online platforms such as social media, online forums, and search engines need to do more to detect and stop illegal online prescription drug sellers.
People who buy controlled substances online are usually trying to get around a doctor’s control over the drug or the amount they can get. However, most people accessing counterfeit generic drugs are simply trying to buy them at an affordable price.
These trends clearly show that the US needs a long-term strategy to reduce the cost of prescription drugs to reduce the demand for counterfeit drugs, although there are some money-saving strategies that can be used in the short term.
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