When Martin Njoku saw opioid addiction devastate his West Virginia community, he felt compelled to help. This was the place he鈥檇 called home for three decades, where he鈥檇 raised his two girls and turned his dream of owning a pharmacy into reality.
In 2016, after flooding displaced people in nearby counties, Njoku began dispensing buprenorphine to them and to 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 medication to treat opioid use disorder. Research shows it halves and of entering long-term recovery.
鈥淚 thought I was doing what was righteous for people who have illness,鈥 Njoku said.
But a few years later, the Drug Enforcement Administration raided Njoku鈥檚 pharmacy and accused the facility of contributing to the opioid epidemic rather than curbing it. The agency revoked the pharmacy鈥檚 registration to dispense controlled substances, claiming it posed an 鈥渋mminent danger to public health and safety.鈥 Although two judges separately ruled in Njoku鈥檚 favor, the DEA鈥檚 actions effectively shuttered his business.
鈥淚 lost everything that I worked for,鈥 Njoku said.
Lawyers, pharmacists, harm-reduction advocates and a former DEA employee say Njoku鈥檚 case is emblematic of the DEA鈥檚 aggressive stance on buprenorphine. An opioid itself, the medication can be misused, so the DEA works to limit its diversion to the streets. But many say the agency鈥檚 policies are exacerbating the opioid epidemic by scaring pharmacies away from dispensing this medication when it鈥檚 desperately needed.
Drug overdose deaths , and despite medical experts considering medications like buprenorphine the gold standard, less than 20% of people with opioid use disorder typically The federal government to increase the number of clinicians who prescribe buprenorphine, but many patients struggle to get those prescriptions filled. A recent study found that .
鈥淧harmacies are terrified they鈥檙e going to lose their DEA registration and go out of business,鈥 said Charles 鈥淏uck鈥 Selby, a former inspector and chief compliance officer for the West Virginia Board of Pharmacy, who retired in 2018.
The ramifications can be particularly acute in rural areas, where a dearth of addiction treatment providers, lack of transportation and stigma against these medications already create barriers. If pharmacies decline to provide buprenorphine too, patients will have few options left, 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 and pharmacists who fill them. Subutex, which consists of buprenorphine alone, is easier to misuse and typically has higher street value than Suboxone, a combination of buprenorphine and the overdose-reversal drug naloxone.
In the case against Njoku鈥檚 pharmacy, an assistant U.S. attorney explained that the DEA 鈥済ot slapped hard for being asleep at the switch as the opioid crisis ramped up. … They’re trying to make sure that Subutex doesn’t become the next problem,鈥 according to court transcripts.
But research suggests that buprenorphine in recent years even as prescribing has increased, and that most people who use diverted buprenorphine do so to and because .
Buprenorphine is less likely to cause overdoses than other opioids because its effects taper off at higher doses, said Dr. Aaron Wohl, medical director of the Florida-based coalition .
In Njoku鈥檚 case, the DEA said in court documents that several 鈥渞ed flags鈥 had suggested the pharmacy鈥檚 actions were irresponsible. First, many of the prescriptions it filled were for Subutex instead of Suboxone. Patients also traveled 鈥 sometimes out of state 鈥 to get prescriptions, drove long distances within West Virginia to reach Njoku鈥檚 pharmacy, and often paid in cash.
In traditional prescription drug cases, these are all markers of trouble. But 鈥 as Njoku鈥檚 and two judges later agreed 鈥 they can also reflect the difficulty of getting addiction treatment, which is sometimes more challenging than obtaining illicit drugs.
鈥淭he practical reality and context of West Virginia turn these additional flags from red to yellow,鈥 U.S. District Judge Joseph Goodwin wrote in . Patients may go out of their way for the drug because there aren鈥檛 enough nearby doctors who prescribe it or pharmacies that stock it, he wrote. They might pay cash because they鈥檙e uninsured or Medicaid won鈥檛 cover prescriptions written by an out-of-network doctor. And they might prefer Subutex because it鈥檚 often cheaper than Suboxone.
By 2020, Goodwin and an administrative law judge at the DEA had both ruled in Njoku鈥檚 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 far-reaching.
Trish Mashburn works at two independent pharmacies in western North Carolina. When a nearby pharmacy stopped dispensing buprenorphine, she began getting five calls a day from prospective customers trying to get their prescriptions filled, she said. Although both her employers stock buprenorphine, they order only a set amount, so Mashburn often must turn patients away.
Research in and has found that many pharmacists worry that ordering more buprenorphine will trigger a DEA investigation. The DEA does not specify thresholds for controlled substances, but it requires wholesalers to flag suspicious orders. In turn, wholesalers limit how much a pharmacy can buy or create algorithms to detect orders that exceed projected need.
They base these limits, in part, on the DEA鈥檚 enforcement actions, said Larry Cote, a former DEA attorney who now advises wholesalers, pharmacies and other clients on regulatory compliance. Since pharmacies are not typically privy to how these limits are set, many simply order small batches of buprenorphine out of caution.
That creates a 鈥減rescribing cliff,鈥 said Bayla Ostrach, lead author of studying this issue in North Carolina. Doctors may prescribe buprenorphine to more patients, but pharmacies order enough for only a certain number of customers. Since many people stay on buprenorphine for years, once the pharmacy hits its self-established quota, it may rarely have openings for new patients.
A Lee County, Florida, man thought he was one of the lucky ones. James, 34, had been filling his Subutex prescription at the supermarket chain Publix for seven years. In that time, he held steady jobs and cared for his wife and children. (James asked KHN to withhold his last name so future employers wouldn鈥檛 judge him on his addiction history.)
Then, last year, James said, he went to get his prescription refilled and was told Publix no longer stocks Subutex 鈥 the medication the DEA considered a 鈥渞ed flag鈥 in Njoku鈥檚 case.
Publix did not respond to requests for comment.
A decade ago, when James began the medication, he chose Subutex because it was cheaper than Suboxone. Today, most insurance plans cover Suboxone, and the price difference has narrowed somewhat.
James was not eager to change to a potentially pricier medication. And he worried a different drug might disrupt his recovery 鈥 a common sentiment among patients in long-term recovery, said Dr. Nathan Mullins, director of addiction medicine fellowship at Mountain Area Health Education Center in North Carolina. Changing their medication is unnecessary and can cause needless anxiety, Mullins said.
Luckily, James found an independent pharmacy that provides Subutex. It鈥檚 more expensive, since the new place doesn鈥檛 accept his insurance, he said. He pays about $40 a week, compared with $40 a month previously.
But James said it鈥檚 worth it.
鈥淚鈥檝e been in 10 rehabs and a million detoxes, and the only thing that has worked for me was one sublingual tablet,鈥 James said. Along with therapy, 鈥渢his saved my life.鈥
