At a time when the federal government is urging more widespread use of buprenorphine to treat opioid use disorders, pharmacists are fearful of running afoul of drug enforcement and may, as a result, limit access to the medication, ADAW has learned.

The story surfaced when Jana Burson, M.D., heard that her patients were not able to get buprenorphine from the Wilkesboro, N.C., Walmart anymore. She called the pharmacist and was told the rural store would no longer be stocking the medication. She blogged the news on July 24, and by July 26, the problem was solved — her 13 buprenorphine patients would once again be able to access buprenorphine. In the interim, however, the news spread like wildfire. Burson, who has an office-based opioid treatment (OBOT) DATA 2000 practice and also works in an opioid treatment program, both in North Carolina, told ADAW she is afraid that pharmacies that refuse to provide buprenorphine “could wipe out OBOT.”

What went wrong in that small pharmacy turned out to be a case of miscommunication — the pharmacist had been visited by an agent from the Drug Enforcement Administration (DEA) about a different buprenorphine prescriber. When this happens, pharmacists may overreact, said Norman P. Tomaka, spokesman for the American Pharmacists Association and a pharmacist in Florida.

“We don’t get a visit from the DEA unless something is wrong,” Tomaka told us. In the case of the Wilkesboro Walmart, the DEA was investigating another physician in the area — not Burson. “They saw that several patients were receiving oxycodone from that doctor, and they were also receiving Suboxone,” said Tomaka. “The pharmacist overreacted and decided they wouldn’t stock any of those products.” And Tomaka explained why that was the reaction. “The DEA visit isn’t the local person. It’s almost always a specially trained federal officer; they’re packing, they have arrest authority,” he said. “Any pharmacist would be overwhelmed by this.”

The Wilkesboro case isn’t an isolated story, said Tomaka. “None of us would want to withhold an opioid for pain, or buprenorphine,” he said.

We also spoke to the pharmacist in Wilkesboro, who told us we would have to speak with corporate. We already had; Walmart spokeswoman Molly Blakeman told us on July 25 that all Walmart pharmacies offer buprenorphine, and that the problem in Wilkesboro was being fixed.

ASAM concerned

The American Society of Addiction Medicine (ASAM) is concerned, said President-elect Kelly Clark, M.D. “ASAM has received multiple reports of pharmacies not filling prescriptions of buprenorphine,” Clark told ADAW last week. Sometimes the pharmacy doesn’t fill any, and sometimes just not those from a certain prescriber.

“Law enforcement, pharmacists and others don’t understand the difference between a pain pill mill and a legitimate buprenorphine practice,” said Clark. Pharmacists and the DEA are trained to look for certain red flags — such as a part-time physician, patients traveling from far away, and patients paying cash and not having insurance, she said. “While those things are true of pill mills, they’re also true for addiction medicine,” she said.

Any pharmacy that has a high rate of filling buprenorphine prescriptions is on the radar of the DEA, said Clark. This is particularly true in rural areas where there aren’t many pharmacies, and one pharmacy is likely to have a high fill rate.

In fact, there are barriers to access to buprenorphine at the pharmacy level in various rural locations where the opioid epidemic is at its worst. The access problem started in Kentucky two years ago, where pharmacies said they were running out of buprenorphine, said Tom Reach, M.D., president of Watauga Recovery Centers and president-elect of the Tennessee Society of Addiction Medicine. In fact, under a Kentucky statute, pharmacies could not fill buprenorphine prescriptions unless they were written by a DATA 2000 provider who accepted Medicaid, said Reach. “This put thousands of patients out of care,” he said. These patients would go to Virginia to try to get the prescriptions filled, he said. “At the epicenter, patients are just turned away by the pharmacist,” he said.

Reach has eight buprenorphine clinics with more than 3,000 patients, 34 physicians and midlevels.

Wholesaler limits

One problem is the capitation of wholesale distributors like McKesson and Cardinal, which can only provide a certain amount of buprenorphine in an area, as part of the DEA’s efforts to reduce diversion.

Stuart Gitlow, M.D., who has a DATA 2000 practice in Rhode Island, has never been able to pin down the wholesale cap issue. But he does think the big pharmacies have a role to play in access. “CVS is causing difficulties in various parts of the country, especially Tennessee,” he told ADAW. “I haven’t seen any corporate policy at CVS, and when I try to investigate it at the corporate level, they disavow any knowledge of it.” His patients in Rhode Island were unable to fill their buprenorphine at several local CVS pharmacies, he said. “Only after bumping it up to the chief medical officer at CVS could I get it resolved,” he said.

“It’s not a manufacturing problem,” said Reach, who said the manufacturers are diligently trying to get the product out. “We’re building a class action lawsuit against the big three — Walmart, Walgreens and CVS — and the distributors, saying they’re restricting access,” said Reach. “We have a database of all the pharmacies that refuse to provide buprenorphine in West Virginia and Tennessee.”

“Treating addiction is not the problem; it’s the solution to the problem,” said Reach.

No quotas, says the DEA

“The DEA does not set limits on the amount of controlled substances pharmacies can purchase and sell,” agency spokeswoman Barbara L. Carreno told ADAW, skirting the question of whether they set limits on distributors. “The DEA does not tell doctors how to practice medicine and does not limit how many prescriptions they can write,” she said. That is not the same as the limits set by the Substance Abuse and Mental Health Services Administration on the number of patients a physician can treat, she noted.

If the DEA finds a problem — or learns that one may exist — agents will inspect paperwork, and “use administrative means to address it,” said Carreno. “If a pharmacy’s conduct merits more than administrative actions, the U.S. Attorney in an area can levy civil fines or file criminal charges.”

DEA not health care

The DEA has the power to monitor all prescribers (physicians) and dispensers (pharmacies and OTPs). There have been multimillion-dollar settlements with pharmacies due to opioid prescriptions that were being filled in large amounts. So it’s not surprising that retail pharmacies, as well as prescribers, are cautious. There is also individual discretion at the agent level, making it difficult for large providers to determine what the rules are.

“They are not clinicians and they should not be clinicians,” says Clark of the DEA. “But the education that they have had — and what the pharmacists have had — is insufficient.”

Many pharmacists are under the misconception that the DEA has a medical understanding when it comes to buprenorphine, said Tomaka. “Their role is to prevent and stem diversion,” he said of the DEA. “So they don’t worry about hospice patients, they don’t worry about patients with chronic pain or end-of-life issues or addiction.” The physicians, on the other hand, have “self-stymied” their prescribing of opioids due to “paranoia.”

“I believe that if we’re doing the right thing, we’re fine,” said Tomaka of prescribing buprenorphine. “Documenting visits, verifying that the patient is taking the buprenorphine — I don’t see the DEA or any state agency going after you if you have that information,” he said. “The people who have had issues haven’t had the records to show that they’re treating addiction.”

Tomaka, who would like to see the buprenorphine cap raised even higher than the current 275 limit, said there is a wave of support for the medication from pharmacists. “We should have no problem providing for widespread and legitimate use of buprenorphine,” he said.

Bottom Line…

Access to buprenorphine from pharmacies is hampered in many areas due to miscommunication and fear of law enforcement.