Urgent Situation for Buprenorphine Patients

  Ukrainian art by Anastasiia Grygorieva

We have an urgent situation afflicting rural areas in North Carolina and across our nation. Patients new to buprenorphine treatment can’t find pharmacies willing to fill their prescriptions.

Here’s the problem:

Last week I tried to switch a patient from dosing on buprenorphine at the opioid treatment program (once every 28 days with 27 take home doses) to filling a prescription for the same medication at a community pharmacy once per month. In other words, he was transferring from dosing under the OTP license to our office-based program allowed under the DATA 2000 law.

This patient has been doing very well for many months and just got insurance which makes it cheaper for him to fill his medication at a pharmacy. This means – or was supposed to mean – that he would have more freedom and flexibility in his treatment, as he could get his medication at a pharmacy once a month when it was convenient for him, rather than having to come to the OTP on a set day every 28 days.

I met with the patient and sent his prescription to his preferred pharmacy, for buprenorphine/naloxone 8/2mg tablets, #30 with no refills.

He couldn’t get it filled at that pharmacy or any other.

The original pharmacy, small and independently owned, said they couldn’t accept new patients wanting to fill buprenorphine products. He called two Walmart pharmacies in two small towns, one Walgreens, and another small family-owned pharmacy. He was told the same thing by each: they could not accept new buprenorphine patients because they couldn’t get buprenorphine products to fill them.

In a panic and starting to go into withdrawal from missing a day of dosing, he called back to our opioid treatment program. I got on the phone with him and told him to come to the OTP and we will make sure he gets his dose. In the meantime, I called pharmacies to see what their issue was.

Earlier this month, I wrote about why primary care providers don’t want to prescribe buprenorphine products for their patients with opioid use disorder. Now we have another hassle to add to the burden of prescribing, which is finding a pharmacy able to fill prescriptions for buprenorphine products of all types. I’ve written about this problem in the past, in blogs late in 2023, but the problem seems to be getting worse.

I called this patient’s first choice pharmacy. I knew the pharmacy manager there, and I knew she was smart and savvy, and has helped our community in the past by advocating for Narcan access. She’s also participated in grant programs for patients prescribed buprenorphine/naloxone. I knew she understood how essential buprenorphine is, and that it is lifesaving.

I called her, and asked what was happening. She was apologetic, and said she knew this created an obstacle for patients to get treatment, but that if she took more buprenorphine patients, she wouldn’t be able to fill the prescriptions of her existing patients. I appreciated that, since some of them are also my patients, and I don’t want them to have problems either.

I asked her why she couldn’t get buprenorphine products. She said she could order them, but she wouldn’t get extra from the distributor. She said each pharmacy was limited in the number of controlled substances they can sell, and they must maintain a ratio of the controlled substances to non-controlled medications that they sell.

I thanked her for her time and efforts but remained puzzled about this situation. She wasn’t blaming the DEA or the distributors, and clearly believed that she was unable to receive more buprenorphine from her distributor.

I searched online for explanations for this bottleneck for buprenorphine supply. I already knew that some pharmacies didn’t order much buprenorphine because they worried it would be a trigger for a DEA inspection, but this pharmacist wasn’t concerned with the DEA.

Patients are facing this difficulty across the U.S.

I found a document titled “Policy Priority Roundtable Summary Report,” published by SAMHSA, from a two-day meeting held in the fall of 2022. This meeting’s participants were leaders from governmental agencies such as the Department of Health and Human Services, Centers for Disease Control, National Institute on Drug Abuse, the ONDCP, and state agencies of Health and Human Services. There were representatives from top universities, from treatment programs, from organizations such as the American Society of Addiction Medicine, the National Alliance of State Pharmacy Associations, and the American Pharmacists Association. There were several representatives from the DEA and two from the drug company Indivior, which manufactures the name brand Suboxone.

I did not see any representatives from the big distributors – Cardinal, Amerisource Bergen, or McKesson – but I did see a representative from the Healthcare Distribution Alliance. After going to their website, it seems likely they could have represented the distributors.

Anyway, people from all these organizations got together and talked about why there are limitations on access to buprenorphine in community pharmacies. They came up with five broad reasons why patients have trouble accessing buprenorphine: stigmatization, patient barriers, classification of buprenorphine in the same category as other opioids, fear of violating threshold rules, and pharmacies losing money of dispensing buprenorphine prescriptions.

The stigmatization we’ve known about for years. Some pharmacists fear dispensing buprenorphine because they think it has high street value and suspect patients sell this medication on the black market. Pharmacists may believe that providers ought not prescribe buprenorphine since this is only replacing one opioid with another. They fear buprenorphine dispensing will bring an undesirable element to their pharmacy or get a bad reputation if they dispense opioids for known drug addicts.

For patient barriers, the problems they list have been discussed in the past, such as pharmacists refusing to fill out-of-town prescriptions or telehealth prescriptions. And some pharmacies will carry only one type of buprenorphine, which forces the physician to change formulations. Some problems relate to early refills.

Some panel participants felt the problem lies with treating buprenorphine as just another opioid, despite it being a schedule 3 instead of schedule 2 like most other opioids. Pharmacies and distributors cap the amount of controlled substances that they distribute and fill, and buprenorphine is lumped in with the more dangerous Schedule 2 opioids.

Participants felt pharmacists feared violating the rules, and that a high number of buprenorphine prescriptions filled meant they would be subjected to extra scrutiny.

Lastly, participants felt the significant regulations regarding storage and paperwork, combined with low reimbursement meant pharmacies lose money on buprenorphine prescriptions.

Really? Surely it doesn’t take more storage and manpower hours for buprenorphine as a Schedule 3 than it does for Schedule 2 opioids? But I know nothing about the reimbursement rates.

This document left me scratching my head. Certainly, this panel discussed obstacles for patients trying to fill buprenorphine prescriptions. But when I talked to this local pharmacy manager, she didn’t have any qualms about filling buprenorphine. I didn’t have to convince her of buprenorphine’s benefits because she already knew about them. She had no worries about the DEA. She knew me and I assume she would have voiced her concerns if she felt I prescribed in a careless way.

Her problem was that she could not get buprenorphine from her distributor.

In other words, none of the causes listed in the paper describing this panel’s conclusions really fit this situation, except for this statement: “Because pharmacies and distributors cap the total amount of controlled substances distributed, this limits the amount of buprenorphine that can be distributed.”

The big distributors – McKesson, Cardinal Health, and AmerisourceBergen – got spanked hard in the Opioid Settlements. Along with Janssen Pharmaceuticals, these companies were ordered to pay $26 billion to settle the lawsuits against them brought by state and local litigants.

These companies were sued because they “…flagrantly and repeatedly violated its obligation to notify DEA of suspicious orders for controlled substances…” as one document pronounced. In other words, they were taken to task for distributing millions of OxyContin pills to small towns with populations of a few thousand people. (I might be exaggerating but you get the idea).

Are these distributors now being a little stubborn about distributing buprenorphine and other opioids as retribution? I don’t know, but I could understand them being a little cranky about the issue. I have no way to know if this is a factor. But doesn’t it seem as if it might be? Doesn’t it feel like human nature for the distributors to be a little maliciously compliant with DEA rules now, after getting fined such a large amount?

There was an interesting article in the New York Times – https://www.nytimes.com/2023/03/13/us/drug-limits-adhd-depression.html  that gave some interesting insights into this problem, written nearly a year ago. In the article, pharmacists talk about hitting some threshold for ordering opioids and then getting cut off from ordering more. The trouble is, they don’t know what that threshold is.

In the end, we moved my patient back to treatment under the opioid treatment program. He will go back to dosing once every 28 days with us, then get take homes for 27 days. He’s done well with this strategy for months so I hope that will continue.

What do I do for the next patient that wants to get his buprenorphine product filled at a pharmacy? Fortunately I can quickly and easily admit these patients into the OTP…but present distributor policies appear to be limiting the pharmacy option.