DEA cracks down on pharmacies that prescribe Suboxone and Subutex: gunshots

DEA cracks down on pharmacies that prescribe Suboxone and Subutex: gunshots


Suboxone and a similar drug, Subutex, have been shown to help people with opioid addictions stay in recovery. But the Drug Enforcement Administration often makes it difficult for pharmacies to dispense it.

George Frey / Bloomberg via Getty Images


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George Frey / Bloomberg via Getty Images


Suboxone and a similar drug, Subutex, have been shown to help people with opioid addictions stay in recovery. But the Drug Enforcement Administration often makes it difficult for pharmacies to dispense it.

George Frey / Bloomberg via Getty Images

When Martin Njoku saw his West Virginia community devastated by opioid addiction, he felt compelled to help. Here he had called home for three decades, raised his two girls and realized his dream of having his own pharmacy.

In 2016, after inundating displaced people in the surrounding counties, Njoku began dispensing buprenorphine to them and local customers at his Oak Hill Hometown Pharmacy in Fayette County.

Buprenorphine, a controlled substance sold under the brand names Subutex and Suboxone, is a drug used to treat opioid use disorders. Research shows that it cuts the risk of overdose in half and doubles people’s chances of long-term recovery.

“I thought I was doing what is righteous for sick people,” said Njoku.

But a few years later, the Drug Enforcement Agency raided Njoku’s pharmacy, accusing the facility of contributing to the opioid epidemic rather than containing it. The agency revoked the pharmacy’s registration to dispense controlled substances on the grounds that it posed an “imminent threat to public health and safety”.

Although two judges ruled separately in Njoku’s favor, the DEA’s actions ended his business.

“I lost everything I worked for,” said Njoku.

Lawyers, pharmacists, harm reduction advocates and a former DEA employee say Njoku’s case is emblematic of the DEA’s aggressive stance on buprenorphine. Because the drug itself is an opioid, it can be abused, so the DEA is working to limit its diversion onto the street. But many say the agency’s guidelines are making the opioid epidemic worse by preventing pharmacies from selling this drug when it is urgently needed.

Deaths from drug overdose reached record highs last year, and although medical experts view drugs like buprenorphine as the gold standard, fewer than 20% of people who use opioids receive these drugs. The federal government has taken steps to increase the number of doctors who prescribe buprenorphine, but many patients have difficulty keeping these prescriptions. A recent study found that 1 in 5 US pharmacies don’t offer buprenorphine.

“Pharmacies are afraid they will lose their DEA registration and go out of business,” said Charles “Buck” Selby, a former inspector and chief compliance officer for the West Virginia Board of Pharmacy who retired in 2018.

Many pharmacists fear that ordering too much buprenorphine will trigger a DEA exam, research in Kentucky and North Carolina has shown. This creates a “prescription cliff,” says Bayla Ostrach, who deals with the treatment of addictions and health policy. Doctors may prescribe more, but if pharmacies don’t fill out the prescription, patients cannot get their medication.

Ainsley Bryce / KHN


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Ainsley Bryce / KHN

The effects can be particularly acute in rural areas, where a lack of addiction treatment providers, lack of transportation, and the stigma of these drugs are already barriers. If pharmacies don’t offer buprenorphine either, patients have few options, Selby said.

The DEA did not respond to requests for comment.

Like many other prescription drugs, buprenorphine can be found illegally on the street. There are unscrupulous doctors who write prescriptions and pharmacists who fill them out. Made from buprenorphine alone, Subutex is easier to abuse and typically has a higher market value than Suboxone, a combination of buprenorphine and the overdose reversal drug naloxone.

In the case against Njoku’s Pharmacy, a US assistant attorney stated that the DEA “was slapped hard for falling asleep at the counter as the opioid crisis worsened. … They’re trying to make sure Subutex doesn’t become the next problem, “court minutes read.

However, research suggests that buprenorphine abuse has decreased in recent years, although prescriptions have increased, and that most people using diverted buprenorphine do so to avoid withdrawal symptoms and because they cannot get a prescription .

Buprenorphine is less likely to cause overdoses than other opioids because its effects wear off at higher doses, said Dr. Aaron Wohl, medical director of the Florida-based coalition project Opioid.

In Njoku’s case, the DEA said in court documents that several “red flags” indicated that the pharmacy’s actions were irresponsible. First, many of the recipes were for Subutex instead of Suboxone. Patients also traveled – sometimes outside of the state – to get prescriptions, drove long distances within West Virginia to get to Njoku’s pharmacy, and often paid in cash.

In traditional prescription drug cases, these are all signs of problems. But – as Njoku’s lawyers argued, and two judges later agreed – they can also reflect the difficulty of obtaining addiction treatment, which is sometimes more difficult than obtaining illicit drugs.

“The practical reality and context of West Virginia turn these additional flags from red to yellow,” US District Judge Joseph Goodwin wrote in his statement. Patients could go out of their way to get the drug because there aren’t enough doctors around to prescribe it or pharmacies to stock it, he wrote. You may be paying cash because you are not insured, or Medicaid may not cover prescriptions issued by a doctor outside of the network. And they may prefer Subutex because it’s often cheaper than Suboxone.

Dr. Nathan Mullins, director of addiction medicine at the Mountain Area Health Education Center in North Carolina, says drug switching can cause unnecessary anxiety in patients recovering from opioid use disorder.

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Dr. Nathan Mullins, director of addiction medicine at the Mountain Area Health Education Center in North Carolina, says drug switching can cause unnecessary anxiety in patients recovering from opioid use disorder.

Courtney Ingram / KHN

By 2020, Goodwin and an administrative judge at the DEA had both ruled in Njoku’s favor. But several insurers and drug suppliers had already stopped doing business with him. Njoku closed the pharmacy in April 2021.

When a pharmacy across the country stops supplying buprenorphine, the effects can be far-reaching.

Trish Mashburn works for two independent pharmacies in western North Carolina. When a nearby pharmacy stopped supplying buprenorphine, it received five calls a day from potential customers trying to have their prescriptions filled out, she said. Although her two employers have buprenorphine in stock, they only order a certain amount, so Mashburn often has to turn patients away.

Research in North Carolina and Kentucky has found that many pharmacists fear that ordering more buprenorphine will trigger a DEA test. The DEA does not set thresholds for controlled substances, but requires wholesalers to report suspicious orders. In turn, wholesalers limit how much a pharmacy can buy or create algorithms to detect orders that exceed forecast needs.

They’re basing those restrictions in part on the DEA’s enforcement efforts, said Larry Cote, a former DEA attorney who now advises wholesalers, pharmacies, and other customers on regulatory compliance. Since pharmacies usually do not know how these limits are set, many only order small amounts of buprenorphine as a precaution.

That creates a “prescribing cliff,” said Bayla Ostrach, lead author of an article examining the problem in North Carolina. Doctors can prescribe buprenorphine to more patients, but pharmacies only order enough for a certain number of customers. Since many people have been taking buprenorphine for years, it is possible that once the pharmacy has reached the quota it has set itself, there are seldom free places for new patients.

A man from Lee County, Florida thought he was one of the lucky ones. James, 34, had been filling his Subutex recipe at the Publix supermarket chain for seven years. During this time he had a permanent job and looked after his wife and children. (James asked KHN to withhold his last name so future employers wouldn’t judge him based on his history of addiction.)

Then, James said, he went to have his prescription refilled last year and learned that Publix has run out of Subutex – the drug the DEA considered a “red flag” in Njoku’s case.

Publix did not respond to requests for comment.

When James started the drug a decade ago, he chose Subutex because it was cheaper than Suboxone. Today, most insurances cover Suboxone, and the price differential has narrowed a bit.

James wasn’t keen on switching to a potentially more expensive drug. And he feared another drug might interfere with his recovery – a common belief among patients regarding long-term recovery, said Dr. Nathan Mullins, director of the Addiction Medicine Scholarship at the Mountain Area Health Education Center in North Carolina. Switching medications is unnecessary and can cause unnecessary anxiety, Mullins said.

Fortunately, James found an independent pharmacy that sells Subutex. It’s more expensive because the new apartment doesn’t accept his insurance, he said. He’s paying about $ 40 a week compared to $ 40 a month earlier.

But James said it was worth it.

“I’ve been to 10 rehab clinics and a million detoxes and the only thing that worked for me was a sublingual pill,” said James. Together with the therapy, it “saved my life”.

KHN (Kaiser Health News) is an editorially independent program of KFF (Kaiser Family Foundation).



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Rachel Meadows

Rachel Meadows

Trending topics news writer who enjoys cooking, walking her dog and travel.

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