The Opioid Crisis: Fentanyl and the Safety of Prescription Drugs

The opioid crisis continues to rage. As of this writing, the Centers for Disease Control and Prevention (CDC) reports 108,174 people died in the United States from drug overdoses in 2022, and the majority of those deaths — an astounding 75 percent — involved synthetic opioids like fentanyl.1 The number of opioid-involved drug overdose deaths in the United States increased nearly seven percent during the 12-month period ending in April 2022, from 76,383 in 2021 to 81,692 in 2022.¹

Fentanyl is approximately 50 times more potent than heroin and 100 times more potent than morphine. Just two milligrams — about the size of 10 to 15 grains of table salt — is a deadly dose.²

Synthetic opioids like fentanyl are often used recreationally along with heroin and/or cocaine to increase the drug’s euphoric effects, sometimes with the user’s knowledge and sometimes without it.³ But it doesn’t stop there: Fentanyl is increasingly being folded into counterfeit pills that look like legitimate prescriptions for controlled substances such as OxyContin, Xanax and Percocet, among others, without consumer knowledge or consent. Counterfeit pills pose an alarming risk to the health and life of everyday Americans, since the majority of them contain a potentially lethal dose of fentanyl, according to the U.S. Drug Enforcement Agency (DEA), and it’s difficult to discern which pills are real and which are fake.⁴

Compounding the problem are illegal, unregulated “rogue” online pharmacies selling fake pills made to look like the real thing. Unsuspecting consumers — even patients with credible medical needs and legitimate documented doctors’ orders — are at grave risk for incidental ingestion of a life-threatening dose of fentanyl they don’t even know is there.

But how does the fentanyl get into the pills in the first place, and how can consumers be sure their prescription pills are safe?

Legitimate vs. Counterfeit Pills

To answer that question, we must first sort out the difference between legitimate prescription pills and counterfeit pills.

Legitimate prescription pills are medicines regulated by the U.S. Food and Drug Administration (FDA), made in registered pharmaceutical production facilities, prescribed by medical providers and dispensed by state-board certified pharmacies. They contain the correct amount of active ingredients needed to elicit a desired therapy. When used correctly under a healthcare provider’s supervision, legitimate prescription medications are safe and effective, but misuse of them carries a slew of risks, including abuse, addiction and overdose.⁵

Counterfeit pills are made to look like real brand-name medications, but they have different ingredients than their legitimate counterparts.⁶ While the active ingredient(s) may be present, the amount is often incorrect; but the active ingredient might not be present at all, and the pills may contain harmful substances instead. Counterfeits are illegal, unlicensed, sold without a prescription and not regulated; of unknown origin, safety and effectiveness; dispensed without adequate directions for safe use; and do not include FDA-required consumer warnings about the serious health risks associated with the prescription drug.⁷

Perhaps what’s most concerning, though, is not what’s missing from the counterfeit pills but what may be added to them. According to Interpol, “some fake medicines have been found to contain mercury, arsenic, rat poison or cement.”⁸ Counterfeit prescriptions pose a threat to the health and safety of consumers regardless of whether they are laced with fentanyl or not, but when they do contain fentanyl, the danger to consumers sharply increases.

DEA found that of the fentanyl-laced fake prescription pills seized and analyzed in 2022, six out of 10 contained a potentially lethal dose of fentanyl. This is an increase from DEA’s previous announcement in 2021 that four out of 10 fentanyl-laced fake prescription pills were found to contain a potentially lethal dose.⁴ According to the agency, the sharp surge in pills laced with fentanyl can be traced to Mexican drug cartels that buy precursor chemicals from China or India, convert them into fentanyl, then press lethal doses into pills made to look like legitimate prescription pills.⁹ In addition to including dangerous ingredients, counterfeits are also typically produced in substandard conditions without quality control protocols, and they are often labeled to look like real medications. The pills are then illegally trafficked into the United States where they are often sold online, primarily via social media.^6,10

Rogue Online Pharmacies

Internet-based pharmacies sound ideal: lower costs, faster service, no lines and home delivery. Shopping for prescription medications online sounds like a practical solution to sky-high drug prices, and sometimes it is. When an online pharmacy is legitimate, consumers can use it with confidence. But not all online pharmacies are the real deal. In fact, according to the National Association of Boards of Pharmacy’s July 2015 report, 96 percent of them are noncompliant with federal and state laws or their own safety and practice standards.¹¹

Rogue online pharmacies illegally capitalize on consumers who either want easy access to controlled substances without a prescription (for either medicinal purposes or recreational use) or want convenient access to legitimate prescriptions at a lower cost. According to a 2021 survey conducted by the Association for Safe Online Pharmacies (ASOP), one in five Americans relies on online platforms or social media sites to find an Internet-based pharmacy.12 While some legitimate online pharmacies are regulated by FDA, rogue online pharmacies are not, and they intentionally target unsuspecting consumers to illegally sell counterfeit drugs. Consumers who purchase from these illegitimate retailers are likely not getting the active ingredient they want or need, and if they do, it is often not in the amount needed to make a meaningful difference, which significantly impacts patient outcomes for those genuinely using prescription drugs for therapeutic purposes.⁸

But despite the dangers, ASOP found many Americans assume online sales of prescription medications are legitimate, regulated and safe. While nearly half of the study participants acknowledged it is at least somewhat risky to purchase medications on the Internet, the majority also mistakenly believe FDA has oversight of any medication sold there.¹² The survey also showed nearly half of Americans aged 18 years and older have ordered prescription medication over the Internet, either for themselves or someone in their care, and 29 percent said they would likely buy prescription medications online without consulting a medical provider first.¹² Risk did not seem to be a significant deterrent to the behavior, while cost and convenience were primary drivers of it.

The Snare of Social Media

Medical use of prescription medication is risky enough when pills are obtained through rogue online pharmacies, but nonmedical use of prescription medication (NUPM) makes an already risky practice more dangerous, especially when the pills are obtained through social media. Rogue online pharmacies are increasingly using sites such as TikTok, Twitter and Snapchat (among others) to target customers ­— particularly young people — to make counterfeit prescription-strength drugs such as Xanax, Percocet and Vicodin, among others, incredibly easy, inexpensive and somewhat anonymous to obtain.

Data shows the overwhelming majority of teens have regular access to and use of the Internet, and the majority of them regularly use social media. According to a 2018 report from the American Academy of Child and Adolescent Psychiatry, two-thirds of teens have their own mobile devices with Internet capabilities; 90 percent of teens ages 13 to 17 have used social media; 75 percent report having at least one active social media profile; and 51 percent report visiting a social media site at least daily.¹³

Further complicating matters, CDC reported that the estimated prevalence of NUPM among high school students is 20.7 percent, and the U.S. Department of Justice says one in six teens have used a prescription drug to deliberately alter their mood or get high.^14,15 A 2021 study of trends in drug overdose deaths among teens aged 14 to 18 reported that in 2010, 518 died from drug overdoses. By 2021, that number more than doubled to 1,146, and fentanyl was identified in 77.14 percent of the deaths.16 While the study did not discuss how victims had obtained the drugs, the National Center on Addiction and Substance Abuse identified an increased risk associated with substance abuse for youth who use social media.¹⁷

The phenomenon of illegally obtaining controlled substances via social media is not new, nor is it limited to teenagers. In 2011, the National Survey on Drug Use and Health showed young adults aged 18 to 25 have the highest annual and monthly rates of NUPM of any age group in the United States.¹⁸ Ryan Haight was one such young adult. The 18-year-old honors student and varsity athlete died from an overdose of Vicodin, an opioid drug available by prescription only. He obtained the drug via an illicit online environment.¹⁷ His death led to the passage of the 2008 U.S. federal legislation, formerly known as the Ryan Haight Online Pharmacy Consumer Protection Act, but now known as the Ryan Haight Act (RHA), which established regulatory provisions and tools for DEA to control the sale and dispensing of controlled substances over the Internet.¹⁷

But the provisions of the Act did not adequately deal with the problem. By 2013, the International Narcotics Control Board (INCB) warned that illegitimate, rogue online pharmacies use social media to target young audiences, hoping to sell illicit drugs to the vulnerable population.¹⁹ Hamid Ghodse, president of INCB, noted that “illegal Internet pharmacies have started to use social media to get customers for their websites, which can put large, and especially young, audiences at risk of dangerous products, given that the World Health Organization has found that over half of the medicines from illegal Internet pharmacies are counterfeit.”¹⁹

In the years since the INCB’s warning regarding social media and teen substance abuse, the problem has just gotten worse, and some experts say the COVID-19 pandemic may have exacerbated the problem. During that time, “many young people felt isolated due to limitations of attending school, engaging in activities or seeing friends,” says Kelsey Bradshaw, PhD, licensed clinical psychologist and intern supervisor at Sharp’s Mesa Vista’s Child and Adolescent Unit. “For some, this may have increased consideration of trying drugs as something to do or to cope with distressing emotions. The challenge with fentanyl is that some young people may not intend to use fentanyl but end up with it, thinking it is something safer.”²⁰

Twenty-two-year-old Sam Cioffi is one such young person who did not intend to use fentanyl but ended up with it anyway. On May 1, 2022, he took what he believed to be a Percocet, which he had purchased from a dealer he knew from the social media sites Instagram and Snapchat. He was dead the next morning; a toxicology report showed Sam had ingested fentanyl.²¹ Sam’s story is just one of many that underscores the importance of DEA’s urgent message: “Never take a pill that wasn’t prescribed directly to you. Never take a pill from a friend. Never take a pill bought on social media. Just one pill is dangerous and one pill can kill.”²²

What About Naloxone?

But doesn’t naloxone reverse the effects of fentanyl and other opioids?

It does, and there is a growing push to combat the surge of opioid-involved overdoses by making naloxone (generic for Narcan) widely available nationwide, getting it to the people who need it, where they need it, before they need it (and hoping they never do). And it’s no wonder: Naloxone blocks the effects of opioids and can reverse an overdose within minutes. It restores normal breathing in a person whose breath has slowed or stopped due to opioid overdose. But time is of the essence: It must be administered quickly. (And, it’s important to note that when overdose is due to stronger opioids like fentanyl, more than one dose of naloxone may be required.²³)

In many states, naloxone is available at pharmacies without a prescription. Many community-based naloxone distribution programs also provide naloxone kits to anyone who requests them for free. Carrying naloxone is increasingly common among law enforcement officials and first responders to preemptively prepare for responding to accidental overdoses, including those that occur due to accidental exposure to fentanyl in the course of duty.²⁴ Even everyday citizens are being asked to regularly carry doses of naloxone with them so the emergency medication is on hand where and when it is needed. Good Samaritan laws protect bystanders from negative repercussions of administering it to someone they suspect is overdosing on opioids.²³

Getting naloxone in the hands of those who are most likely to overdose on opioids is already a tall order, but predicting when and where otherwise low-risk individuals may need it is far more difficult. People who unknowingly purchase what turn out to be counterfeit pills from illegitimate pharmacies don’t realize they may need naloxone because they don’t suspect their pills are fake in the first place, let alone that fentanyl could be hidden inside them. While naloxone is increasingly easy to get without a prescription, those who are merely trying to save money by filling a legitimate prescription online may not see a need for it themselves, let alone preemptively get a “just in case” dose to carry with them. While co-prescribing naloxone for people at high risk of opioid overdose (such as those who are taking high doses of opioid medication that have been prescribed by their doctor, and especially those struggling with opioid use disorder) is an effective strategy to get lifesaving naloxone in their hands in case they ever need it, unknowingly buying counterfeit pills from rogue online pharmacies precludes that layer of protection for people who never intend to take opioids at all.

Safeguards for Prescription Medications

Even amid the alarming influx of fentanyl into the United States, especially in the form of counterfeit prescription pills, FDA emphasizes its focus is on ensuring the quality of legitimate prescription drugs and safeguarding the integrity of pharmaceutical distribution to Americans, stating “FDA implements key provisions of the Drug Supply Chain Security Act (DSCSA), which outlines steps to achieve interoperable, electronic tracing of product at the package level to identify and trace certain prescription drugs as they are distributed in the U.S.”²⁵ The Act is meant to enhance FDA’s ability to help protect consumers from “exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful.”²⁵

While DEA is focused on targeting rogue online pharmacies for prosecution and shutting down the illegal websites, DSCSA prevents harmful drugs from entering the legitimate supply chain in the first place, detects harmful drugs if they do enter the supply chain and enables rapid response when such drugs are found.26 Legitimate pharmaceutical producers work within the confines of DSCSA to determine whether trading partners (including manufacturers, repackagers, wholesale distributors, third-party logistics providers and other pharmacies) are licensed or registered. Pharmacies must only accept medicines accompanied by three pieces of product tracing documentation, including transaction information, transaction history and transaction statement. This information must be stored for six years and provided when selling a prescription drug to a trading partner.²⁵

When suspected illegitimate drugs are found, pharmacies must quarantine and investigate them; work with the manufacturer to ensure they are not distributed to patients; and notify FDA and trading partners from whom they bought them and to whom they sold the drug products.²⁶

Additionally, all imported shipments of FDA-regulated drug products are reviewed electronically by FDA, and they must meet FDA’s standards for quality, safety and effectiveness. “FDA verifies compliance with the following requirements as applicable: registration, listing, drug application, drug labeling and drug current good manufacturing practices […] FDA also randomly samples and tests imported products.”²⁵

Further, FDA issued a draft guidance for industry on anti-counterfeiting for pharmaceutical manufacturers who may want to use physical-chemical identifiers (PCIDs) in solid oral dosage forms. A PCID is a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.²⁵

FDA: Legitimate Drugs Remain Safe

Illegitimate, counterfeit drugs pose a major threat to the health and well-being of the American people — no doubt about that. But despite the danger, FDA insists that “the U.S. drug supply is among the safest in the world,” and emphasizes that consumers can be confident their prescription drugs are safe and effective when obtained with a valid prescription by a credentialed medical provider through state licensed pharmacies.²⁵

The best strategies to guard against mistakenly purchasing fraudulent medications are to 1) never buy from a social media site; 2) never accept or take pills from anyone else (one should always purchase his or her own medications from a verified pharmacy); and 3) always verify online pharmacies are state licensed before purchasing medications. Consumers who wish to purchase medication online should only use pharmacies that require a doctor’s prescription, have licensed pharmacists on staff, have a physical, brick-and-mortar address in the United States and are licensed by a state board of pharmacy. The FDA state boards of pharmacy online search tool is a great resource to verify legitimacy (See www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-state-licensed-online-pharmacy).

But perhaps more importantly, talk openly and often to young people about the extreme danger of buying pills over the Internet, especially via social media. Reinforce DEA’s “one pill can kill” message and emphasize the risk just isn’t worth it. If controlled substances are necessary for a medical need, doctors should emphasize the importance of obtaining a legitimate prescription — and verifying the pharmacy is the real deal before filling it.