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- 10/22/2018

The Uphill Fight Against Fake Prescription Drugs

Pharma Horizon

Tosh Ackerman took part of what he thought was a Xanax pill to help him sleep one night three years ago. His girlfriend found the 29-year-old dead the next day. The Xanax he obtained from an acquaintance was counterfeit, says his mother, Carrie Luther, who lives in Mount Hermon, Calif. Toxicology reports found it contained a fatal dose of fentanyl, a synthetic opioid often produced illicitly for the black market.

“It looked like Xanax to the untrained eye,” says Ms. Luther, who now regularly speaks about the dangers of counterfeit drugs. The issue of counterfeit prescription medications like Xanax is a growing problem, attracting the attention of law enforcement organizations and pharmaceutical companies like Pfizer, which manufactures Xanax.


In June the U.S. Food and Drug Administration convened a meeting around the problem of illegal opioids sold online and through social media.

“Millennials and those younger rely heavily on social media,” says Alex Khu, assistant director of the U.S. Immigration and Customs Enforcement’s Global Trade Investigations division. “Criminal organizations recognize that trend and we’re starting to see advertisements and sales of counterfeit or substandard prescription drugs on social media sites.”

In a survey conducted last year by the Alliance for Safe Online Pharmacies (ASOP Global) 55% of U.S. consumers said they have or would consider purchasing medications online, notes Libby Baney, a senior adviser to the Washington, D.C.-based nonprofit. At best, counterfeit medications aren’t what they are supposed to be, like sugar pills. At worst, they’re dangerous and even deadly, particularly when fentanyl is involved. “The biggest danger is that these sites do not require a medical examination or a prescription, and the sites do not impose limitations on how much or how often the consumer purchases drugs,” Mr. Khu says. The National Association of Boards of Pharmacy selling prescription medications to U.S. patients. Of these, about 95% were found noncompliant with state and federal laws and NABP standards, according to a report published in September, which highlighted the role social media sites play.


Pfizer manufactures Xanax, an antianxiety medication also known as alprazolam, but its patent has expired. That means the vast majority of the medication is made and sold by other companies and available in a generic form. Pfizer’s global security team provides counterfeit-awareness training to law enforcement and customs agencies around the world, in addition to helping with investigations. Recently they spoke with a group of psychiatrists and separately, state attorneys general. Over the past three years Pfizer has reported more than 10,000 Facebook accounts or profiles selling counterfeit Pfizer medications to the social media company, says Neil Campbell, director of strategic intelligence at Pfizer. They’ve referred more than 1,000 Instagram accounts selling counterfeit Pfizer products over the past six months to Facebook, Instagram’s parent company. The company says it works hard to find and remove drug sales by blocking and filtering terms associated with them, and says it works quickly to shut down suspicious accounts that people report to them. It is also working on developing new technology to identify when someone is trying to sell drugs.

Lev Kubiak, vice president and deputy chief security officer at Pfizer, says in 2017 authorities from 49 countries seized more than 12 million counterfeit doses of Pfizer products. More than 5,000 vendors were advertising Xanax for sale on the dark web—websites on an encrypted network that can’t be found through most search engines or browsers—without requiring a prescription. Last year Pfizer global security conducted a pilot program with law enforcement and bought 138 Xanax samples on the dark web. They tested them and found only seven, or 5%, were authentic. Products included pills that looked exactly like Xanax but were counterfeit, as well as gummies. A red version of the pill purported to be 2 milligrams actually contained 5.5 milligrams of the active ingredient. Ms. Baney of ASOP Global says consumers face multiple risks from buying medications from an unverified source online. The drugs can have too much or too little of an active ingredient, be substandard or expired, or contain poisons and contaminants such as floor wax, mercury, boric acid, paint or antifreeze.

The ASOP Global survey also found that more than 80% of doctors don’t talk to patients about where they get their drugs. If a patient tells her doctor her medication isn’t working, a doctor unaware that she bought the drugs from a questionable source could mistakenly prescribe a higher dose or different product. ASOP Global advises consumers buying prescription medications online to only buy from sites that end with “pharmacy”, as these sites are verified and approved by the NABP. They also suggest checking URLs for websites through NABP or at the website LegitScript. And they suggest avoiding websites that claim to sell products from Canada. Many have no connection to Canada. Thomas Kubic, president and CEO of the Pharmaceutical Security Institute, a Virginia-based nonprofit, says there are roughly 15,000 to 17,000 annual cases of counterfeit drugs reported globally to his organization from its members, who include security directors from 33 pharmaceutical companies. The number of new reported cases was 1,178 from 134 countries in 2107, up 7% from 2016, he says. Cases ranged from small quantities to millions of units. The bulk of counterfeits appear to be found in China, India and the U.S., he says.

The latest and most dangerous ingredient authorities are finding in counterfeit medications is fentanyl, says Shabbir Safdar, executive director of Partnerships for Safe Medicines, a San Francisco-based nonprofit. He says officials found counterfeit drugs made with fentanyl in 44 states and confirmed it to be a cause of death in 26 states. “Right now you’re seeing Xanax and opioids like oxycodone and hydrocodone made both oversees and domestically with fentanyl, which is super cheap and easy to get,” Mr. Safdar says. Oct. 27 will mark the third anniversary marking the death of Ms. Luther’s son. She plans to get together with family and friends to celebrate his life.

“You don’t have to be an addict to die from counterfeit medication,” Ms. Luther says. “It’s just rampant now and it’s all about greed. There’s no way to tell if what you’re getting is the real thing unless you get it from your local brick and mortar store.”

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