As overdose deaths skyrocket, DEA-Wary pharmacies are reluctant to distribute drug addiction

When Martin Njoku watched opioid addiction devastate his West Virginia community, he felt compelled to help. It was the place where he had made his home for three decades, where he had raised his two daughters and made his dream of owning a pharmacy come true.

In 2016, after flooding displaced people in neighboring counties, Njoku began distributing buprenorphine to them and local customers at his pharmacy in Oak Hill Hometown, Fayette County.

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

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

But a few years later, the Drug Enforcement Administration raided Njoku’s pharmacy and accused the facility of contributing to the opioid epidemic rather than curbing it. The agency revoked the pharmacy’s registration for the distribution of controlled substances, saying it posed “imminent danger to public health and safety.” Although two judges separately ruled in Njoku’s favor, the DEA’s actions effectively shut down his business.

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

Lawyers, pharmacists, harm reduction advocates and a former DEA employee say Njoku’s case is emblematic of the DEA’s aggressive stance on buprenorphine. An opioid itself, the drug can be misused, which is why the DEA is working to limit its diversion on the street. But many say the agency’s policies are exacerbating the opioid epidemic by dissuading pharmacies from dispensing the drug when it is desperately needed.

Drug overdose deaths reached record highs last year, and although medical experts consider drugs like buprenorphine to be the gold standard, less than 20% of people with drug use disorders opioids usually get them. The federal government has taken steps to increase the number of clinicians who prescribe buprenorphine, but many patients are struggling to get those prescriptions filled. A recent study found that one in five US pharmacies do not provide buprenorphine.

“Pharmacies are terrified of losing their DEA registration and going out of business,” said Charles “Buck” Selby, former inspector and compliance officer for the West Virginia Board of Pharmacy, who retired in 2018. .

The ramifications can be particularly acute in rural areas, where a shortage of drug treatment providers, lack of transportation, and stigma against these drugs are already creating barriers. If pharmacies also refuse to provide buprenorphine, patients will 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 streets. There are unscrupulous doctors who dispense prescriptions and pharmacists who fill them. Subutex, which consists of buprenorphine alone, is easier to abuse and generally has a higher market value than Suboxone, a combination of buprenorphine and naloxone, an anti-overdose drug.

Dr Nathan Mullins, director of the Addiction Medicine Fellowship at Mountain Area Health Education Center in North Carolina, says changing medications in patients recovering from an opioid use disorder can cause a unnecessary anxiety. (Courtney Ingram)

In the Njoku pharmacy case, a deputy US prosecutor explained that the DEA “was slapped for falling asleep on the switch as the opioid crisis escalated. … They are trying to make sure that Subutex does not become the next problem, ”according to court transcripts.

But research suggests that buprenorphine abuse has waned in recent years even as the prescription has increased, and that most people who use hijacked buprenorphine do so to avoid withdrawal symptoms and because they cannot. not get a prescription.

Buprenorphine is less likely to overdose than other opioids because its effects wane at higher doses, said Dr. Aaron Wohl, medical director of the Florida-based Project Opioid coalition.

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

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

“The practical reality and context of West Virginia makes these additional flags turn from red to yellow,” US District Judge Joseph Goodwin wrote in his opinion. Patients can go out of their way for the drug as there are not enough nearby doctors prescribing it or pharmacies stocking it, he wrote. They may pay in cash because they are uninsured or Medicaid will not cover prescriptions written by an off-grid doctor. And they might prefer Subutex because it’s often cheaper than Suboxone.

By 2020, Goodwin and a DEA administrative law judge 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.

Across the country, when a pharmacy stops providing buprenorphine, the ripple effects can be significant.

Trish Mashburn works in two independent pharmacies in western North Carolina. When a nearby pharmacy stopped dispensing buprenorphine, it began receiving five calls a day from potential customers trying to fill their prescriptions, she said. Although both of his employers stock buprenorphine, they only order a fixed amount, so Mashburn often has to turn away patients.

Research in North Carolina and Kentucky has found that many pharmacists are concerned that ordering more buprenorphine could trigger a DEA investigation. The DEA does not specify thresholds for controlled substances, but it does require wholesalers to report suspicious orders. In turn, wholesalers limit the amount a pharmacy can buy or create algorithms to detect orders that exceed expected needs.

They base those limits, in part, on DEA enforcement action, said Larry Cote, a former DEA lawyer who now advises wholesalers, pharmacies and other customers on regulatory compliance. Since pharmacies are generally unaware of how these limits are set, many simply order small batches of buprenorphine out of caution.

This creates a “limitation cliff,” said Bayla Ostrach, lead author of an article studying this issue in North Carolina. Doctors can prescribe buprenorphine for more patients, but pharmacies order enough for only a certain number of customers. Since many people take buprenorphine for years, once the pharmacy hits their self-established quota, there may rarely be openings for new patients.

Research shows that buprenorphine, a drug that treats opioid use disorders, halves the risk of overdose and doubles the chances of a long-term cure. Dr Aaron Wohl, medical director of Project Opioid, says buprenorphine is also less likely to overdose because its effects wane at higher doses. (Aaron Wohl)

Many pharmacists are concerned that ordering too much buprenorphine could trigger a DEA investigation, according to research in Kentucky and North Carolina. This creates a “prescription cliff,” says Bayla Ostrach, who studies substance use disorder treatment and health policies. Doctors can prescribe more, but if pharmacies don’t fill the prescription, patients can’t get their drugs. (Ainsley Bryce)

A man in Lee County, Florida thought he was one of the lucky ones. James, 34, had been having his Subutex prescription refilled at the Publix supermarket chain for seven years. During this time, he held stable jobs and looked after his wife and children. (James asked KHN to withhold his last name so future employers wouldn’t judge him on his history of substance abuse.)

Then last year, James said, he went to get his prescription refilled and was told Publix was no longer stocking Subutex – the drug the DEA saw as a “red flag” in Njoku’s case.

Publix did not respond to requests for comment.

Ten years ago when James started the drug he chose Subutex because it was cheaper than Suboxone. Today, most insurance plans cover Suboxone and the price difference has narrowed somewhat.

James wasn’t eager to switch to a potentially more expensive drug. And he was concerned that another drug would disrupt his recovery – a common sentiment among patients in long-term recovery, said Dr Nathan Mullins, director of the Addiction Medicine Fellowship at the Mountain Area Health Education Center in North Carolina. Changing their medications is unnecessary and can cause unnecessary anxiety, Mullins said.

Fortunately, James has found an independent pharmacy that supplies Subutex. It’s more expensive because the new place doesn’t accept his insurance, he said. He pays around $ 40 per week, up from $ 40 per month previously.

But James said it was worth it.

“I did 10 detox treatments and a million detox treatments, and the only thing that worked for me was a sublingual pill,” James said. In addition to the therapy, “it saved my life.”

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