By C. Michael White, University of Connecticut
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the big idea
According to my new study, published in the journal Annals of Pharmacotherapy, the Food and Drug Administration took 130 enforcement actions against counterfeit medication rings between 2016 and 2021. Such actions may include arrests, confiscation of products, or disbanding of counterfeit rings.
These counterfeit operations involved tens of millions of pills, more than 1,000 pounds of active ingredient powder that could be converted into pills in the US and sold hundreds of millions of dollars worth of money. Unfortunately, these actions barely surface with more than 11,000 rogue pharmacy sites selling drugs on the Internet.
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 their enforcement actions. In total, in that five-year period, 64.6% of the counterfeit products were sold over the internet and in 84.6% of the enforcement actions taken, the products were obtained without a prescription.
Many of the counterfeit drugs were for 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 for anxiety and sleep. China, India, Turkey, Pakistan and Russia were the most common countries supplying US consumers with counterfeit drugs.
Why it matters
The World Health Organization states that approximately 11% of drugs sold in developing countries are counterfeit, resulting in 144,000 additional deaths each year from counterfeit antibiotics and antimalarial drugs alone. My previous study also documented 500 child deaths attributed to diethylene glycol — a common additive in antifreeze — added as a sweetener to knock-off cough suppressants.
In addition, counterfeit versions of drugs used for chronic conditions — such as the transplant drug tacrolimus, sold under the brand name Limustin, and the anticoagulant rivaroxaban or Xeralto — were found on Mexican pharmacy shelves from November 2021 to February 2022.
In the US, the Drug Quality and Security Act of 2013 secures drug supply through a national electronic track-and-trace system that allows tracking of a specific drug from the manufacturer to the pharmacy. Although the drugs are safe in licensed U.S. pharmacies, a Kaiser Family Foundation survey found that 19 million people in America received prescription drugs that were likely counterfeit through non-U.S. licensed Internet pharmacies or while traveling abroad. The National Association of Boards of Pharmacy found that 96% of the 11,688 Internet pharmacies they analyzed failed to comply with U.S. federal or state laws. Of these, 62% did not disclose their physical location and 87% were affiliated with “rogue internet drug store networks”.
The FDA provides some guidance to help consumers determine whether 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 incorrectly or used together. While these counterfeit drugs may seem legitimate, the active ingredients that should be in these controlled substances are often replaced by more dangerous alternatives such as fentanyl. Four in ten counterfeit opioid pills containing fentanyl contain a potentially lethal dose.
According to the Drug Enforcement Administration, the US seized 9.5 million counterfeit pills between April 2020 and April 2021, more than the two previous years combined. This is a likely cause of the 100,306 overdose deaths in the US during that time.
Rogue online pharmacies often use social media platforms to reach out to potential customers. This suggests that more needs to be done by online platforms such as social media, online forums and search engines to identify and stop illegal sellers of prescription drugs online.
People who buy controlled substances over the Internet usually try to get around the doctor’s control over the medication or the amounts they can get. However, most people who use uncontrolled counterfeit drugs just try to buy them at an affordable price. These trends make clear 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.
C. Michael White, professor of pharmacy practice, University of Connecticut
This article is republished from The Conversation under a Creative Commons license. Read the original article.