Posts Tagged ‘diversion of buprenorphine’

Buprenorphine Regulations

Map is from vox.com

In response to the rise of opioid use disorders in this country, lawmakers in heavily affected states are passing laws they hope will help. But well-intentioned laws may have unintended consequences, requiring re-evaluation of those laws.

Nearly one year ago, The Virginia legislature asked the Virginia Board of Medicine to regulate prescribing of buprenorphine. Legislators were worried about the diversion of prescribed monoproduct buprenorphine to the streets. You can read about this in more detail in my blog entry dated February 24, 2017.

It’s been a year since that blog entry, and I have a little bit of data regarding some of the consequences of Virginia’s new rules.

Initially, the new Virginia Board of Medicine (VBOM) regulations said the buprenorphine monoproduct could only be prescribed for pregnant ladies and nursing mothers. They did this because the monoproduct, containing only buprenorphine and no naloxone, has a higher street value and is more likely to be injected and misused than the combination product.

The VBOM received so many complaint letters that they finally changed the regulations to say that each buprenorphine physician could prescribe buprenorphine monoproduct to up to three percent of their patients. Each of these patients must have documentation of their intolerance in their chart.

It was hoped that this compromise would limit the amount of buprenorphine monoproduct being prescribed, while still making allowances for some patents with intolerance to naloxone in the combination product.

The VBOM didn’t stop there. They passed regulations about care at opioid treatment programs (OTPs), which are already the most heavily regulated medical providers in the nation. The VBOM said if buprenorphine monoproduct was used, the patient had to consume it on site, with observed dosing, and that no take home doses could be allowed for the monoproduct.

To clarify, this meant that OTP patients dosing with buprenorphine monoproduct had to either switch to the combination product, buprenorphine/naloxone, to get their usual take homes, or dose daily at the OTP on the monoproduct and forfeit all the take homes they had earned.

Or they could switch to methadone, where take homes are still allowed, following standard guidelines.

This is the irony – methadone is a heavier and stronger opioid than buprenorphine, and more likely to cause overdose death if taken illicitly or diverted. Virginia patients can get methadone take home doses, after they have a period of stability and meet the guidelines which have been in place for decades.

OTPs must follow both state and federal guidelines, and must obey the stricter of the two. The federal guidelines dropped the time in treatment requirement for buprenorphine, meaning the federal agency decided to allow the admitting physician to decide how many take home doses were appropriate, from day one, for a buprenorphine patient.

Essentially, Virginia went the opposite direction, and eliminated take homes, at least for the monoproduct.

At the time the new regulations were implemented, there were 600 Virginia patients on buprenorphine at OTPs. Monoproduct was used because was about half the price of the combination product, and kept treatment more affordable for patients. Also, because OTPs already followed stricter regulations than office-based programs, the risk of diversion was felt to be lower than at office-based programs.

Of those 600 patients, 384 patients attended one of the four OTPs owned by Acadia Healthcare in Virginia. They collected data on what happened to their Virginia patients after these new regulations were implemented. Since I work for Acadia, that data was released to me for an upcoming presentation, but I’ll give my readers an early view.

Of those 384 patients, 260 made the switch to the combination product so that they could continue to get take home doses. In other words, two-thirds of the patients switched, and one-third did not.

The cost of medication doubled, but rather than pass this on to the patients, Acadia Healthcare absorbed all the extra cost. The patients paid the same as if they were getting the cheaper monoproduct. This was fortunate, since an overnight doubling of costs could have caused hundreds of patients to leave treatment.

To some lawmakers, an extra couple of hundred dollars per month might not seem like much. But to many patients, it’s the difference between being able to stay in treatment or having to leave and go back to illicit drug use.

So, what happened to the patients who didn’t make the switch?

  • 15 switched to methadone, and will be able to get take home doses once they meet criteria. It’s takes a while, but at least they can get take homes eventually.
  • 21 transferred to out-of-state opioid treatment programs because they had an intolerance to the combination product.
  • 24 (6%) patients dropped out of treatment.
  • 58 remained on the monoproduct and accepted that they will have to dose every single day that they are in treatment. Since all these clinics are in rural areas of Southwestern Virginia, I suspect some of these people are driving long distances daily, and incurring extra expenses for that travel.
  • 6 patients were lost to follow up, and couldn’t be contacted to see what happened.

Studies show the risk of death increases as much as eight-fold for patients who leave treatment, so those 24 people are at high risk. I suspect the 6 people who couldn’t be found are also in that risk group.

I have a little bit of data about what’s happened on the receiving end with patients on buprenorphine at Virginia OTPs. One OTP located in Boone, NC, received 12 patients in transfer from Virginia. Those patients could have been OTP patients or office-based patients; I don’t have that data.

I have my own office-based buprenorphine practice in the Lake Normal area of North Carolina, which is 73 miles from the North Carolina-Virginia border. My practice got around twenty phone calls last year, just after Virginia’s law changed. These patients were willing to drive from Virginia to my office if I would prescribe buprenorphine monoproduct. I declined to accept any of those patients, both because it is unworkable in the long run to come from such a distance, and because I was concerned about regulatory scrutiny in my own state.

You can draw your own conclusions based on this limited data. It appears that roughly two-thirds of patients, if forced to switch to the combination product, can do so and remain in treatment.

But remember, costs weren’t increased for those patients enrolled at Acadia OTPs.

That would not have been the case for office-based self-pay patients, who would have paid roughly double each month for their prescriptions for combo products at the pharmacy. Community pharmacies would not have absorbed the extra cost.

I combed the internet, trying to discover data on what happened to office-based patients in Virginia on the monoproduct. If data is out there, I haven’t found it. Or perhaps it’s still being collected and analyzed. I also looked to see if overdose death data changed much in 2017, but it’s likely too early for this.

The American Society of Addiction Medicine has written a public policy statement addressing regulations on office-based buprenorphine policy. This document outlines the most reasonable approach to assure appropriate care for patients while limiting onerous regulations for providers. State legislators would do well to read this policy and abide by its specific recommendations.

https://www.asam.org/docs/default-source/public-policy-statements/statement-on-regulation-of-obot.pdf?sfvrsn=df8540c2_2

I’m tempted to give a summary of ASAM’s statement, but ASAM warns against this, at least without their permission. They don’t want people to use just a section of their policy to justify a position; they want their statement to be read in full.

I think that’s smart of ASAM. I encourage interested readers to check it out.

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Dealing With Disillusionment

 

“You know what? Let’s just switch every patient over to methadone and be done with buprenorphine!” I said angrily during case staffing last week.

This all started several weeks ago, when an angry patient was leaving my office. I don’t recall why he was unhappy with me, but on his way out of my office, he was venting about how he was being treated harshly, compared to patients doing much worse things. He said many patients leave our facility after dosing with buprenorphine with much of the medication packed between their teeth and lips. He said some people sold it, and some injected it, and that we were too stupid to see it.

I didn’t think much about it, but later that day at case staffing, we discussed asking patients to show us the area between teeth and lips, just to see if diversion in this manner was occurring.

I need to explain why we don’t want patients to leave with buprenorphine still in their mouths. Because we are administering this medication at an opioid treatment program, we must abide by different rules than an office-based buprenorphine practice. While physicians in office-based practices can prescribe as many days’ supply of medication as they see fit, different rules apply to opioid treatment programs.

In my state, buprenorphine patients still have to meet time in treatment requirements, same as methadone patients, before they can get any take home doses. Fortunately, our State Opioid Treatment Authority (SOTA) leaders are intelligent and reasonable people, and allow us to ask for take home exceptions early, at the four to six-week mark, for patients on buprenorphine who are doing well and have a couple of drug screens showing only the prescribed medications. This is because buprenorphine is so much safer than methadone.

But when patients first start, or if they’re still using other illicit drugs, or if their lives are unstable in some other way, they must do daily observed dosing with us.

Observed dosing means that they stay on premises while the medication is consumed. With methadone, it’s a quick swallow, and the patient says goodbye, and it’s done. With sublingual buprenorphine, our patients sit in a designated and monitored area until their medication is fully dissolved. We’ve had some patients walk out of the building with buprenorphine still in their mouths, and inject that buprenorphine. Because of that, we ask the patients to show a nurse under their tongue that the med has dissolved before they leave our facility.

But this idea that some patients may be packed medication between their teeth and lip was new. The nurses picked one day to ask all patients to show them their whole mouth – all around teeth, under tongue, after dissolving.

They discovered a handful of patients who had packed medication into a cheek, clearly with the intent of taking that buprenorphine outside the premises.

What did they intend to do with it? I don’t know. Maybe they planned to give part of their dose to a loved one. Maybe they planned to take it later, or maybe they planned to inject it. Maybe they sell the buprenorphine. I have no idea, but I have clear evidence that the patient isn’t taking the medication I’m prescribing.

I have an obligation to prevent diversion of medication I prescribe into the black market. If I know a patient is engaging in behavior that’s suspicious for diversion, I can’t in good conscience continue to prescribe that medication.

We could enter a discussion about how diverted buprenorphine is really a harm reduction method, by providing a safer opioid to the people in the community with opioid use disorders. But opioid treatment programs, called “methadone clinics” in the past, have long histories of stigma. Law enforcement types and regulatory inspectors do not want to hear about harm reduction. Some of these people barely tolerate our existence as it is. I support harm reduction, but I must deal with the world as it is now.

Diversion from an opioid treatment program can get that facility shut down.

When the nurse called me with a list of names of people engaged in diversion of buprenorphine, I had to tell her I will not prescribe any further buprenorphine for those patients. They must either switch to methadone or seek treatment elsewhere.

About half chose to leave and the other half chose to start methadone.

We felt like we had to start checking patients’ entire mouths every day, and found more patients who were diverting their medication. All in all, about ten patients were found to be attempting to divert.

I did not react well. I was furious.

Before you write a comment to me saying how unruly behavior is often a symptom of the disease of opioid use disorder, and that I shouldn’t take such things personally, and that the majority of patients were dosing correctly and that’s what I should concentrate on…yes, I know all of that.

But I had to go through a process to get there, and maybe writing about it is my way of dealing with these feelings.

I get particularly upset when a patient does something that threatens my view of myself as an effective helper. When it starts to look like I’m making it easier for some patients to inject themselves with buprenorphine, I feel anger initially, but underneath that emotion is a whole lot of fear.

I fear I’m not really making any differences in the lives of these people, and that they all look at treatment as a joke. I’m afraid I’ve been deluding myself that medication-assisted treatment helps patients. I wonder if I should go back to primary care practice, where nothing I ever said or did seemed to make a bit of difference in the lives of people with chronic illnesses. I fear that the MAT detractors are right, and that I’ll end my days by regretting the action and advocacy I’ve taken over the past decades.

I feel disillusionment.

As you can see, my strong negative emotions sometimes trigger a runaway train in my mind. Thankfully, as I age and mature, the train slows much faster than it used to.

I’m better now. Thankfully, I can go back to the information that lead me to this field in the first place…the decades of scientific information that show beyond a reasonable doubt that while individual patients may fail to improve with MAT, overall it saves lives. Then I can look at the smiling faces of patients who have completely changed their lives while in treatment.

When I get to the point I can look at reality uncolored by emotion, I see the vast majority of patients at the opioid treatment program are doing very well. Nearly all have improved in some way, some more than others, of course. Some of them do have rocky starts, but can do well if we address the issues and get them to stay in treatment.

Early into the New Year, I’ve re-learned a lesson about disillusionment, fear, and the process of working through all of that to a more reasonable view.

I suspect many people in the helping professions deal with this process over and over. It can be challenging, but such jobs are rewarding as well.