Archive for the ‘Governmental solutions to addiction’ Category

Update on Jail Death Lawsuits

 

 

 

 

Long-time readers of my blog will remember the story of Eric Stojcevski, a young man who died from withdrawal from prescribed medication while in jail in Macomb County, Michigan, for unpaid traffic tickets in 2014.

I blogged about this case on November 3, 2017, February 5, 2016, and October 20, 2015.

I’ve given readers periodic updates because to me, this case is the most extreme example of how poorly sick inmates are treated by jailers. I feel this is one of our country’s biggest moral failings, because it goes on all the time, usually with little to no publicity.

Someone once said we can judge the quality of a society by how we treat the most vulnerable members of that society. Incarcerated people are among the most vulnerable, since they can’t take themselves to a hospital for medical care if they get sick. They are dependent on the jailers to get them care when ill.

This did not happen in the case of David Stojcevski. In June of 2014, he went to jail for failure to pay parking tickets, and it turn into a death sentence. According to news sources, he was being prescribed methadone, clonazepam, and alprazolam by a physician. He was not given any of these prescribed medications when he was in jail.

According to his autopsy, he died from acute drug withdrawal on the seventeenth day of his thirty-day sentence. Despite intense suffering, his pleas for medical attention were ignored. When he exhibited bizarre (withdrawal) behavior, he was sent to a mental health cell, where his last eleven days on earth were videotaped. His family, livid at the lack of medical care that resulted in his death, released the videotape online, where it went viral. The recording showed him naked, having repeated seizures on the jail floor as he died.

His family filed a civil case against jail personnel, and against Correct Care Solutions, the health organization that was contractually obligated to provide medical care to prisoners in the Macomb County jail.

There was a criminal investigation that went nowhere.

The Department of Justice investigated, and said they found no evidence of criminal intent on the part of jail personnel or personnel of Correct Care Solutions. The FBI had to be forced by the family to release its investigation records, and only released part of them.

These records should be helpful to the family’s civil case, and now depositions for this civil case are underway.

According to news reports, [1] Sheriff Wickersham’s sworn testimony revealed that David lost forty pounds in his last seventeen days, spent in the county jail. Over the last three days of his life, he drank almost no water. Of the thirty-three meals served to him over the last eleven days of his life, he ate perhaps three of them.

According to news reports, jail guards thought the medical staff was responsible for deciding when a patient should go to the hospital. Medical staff thought it was the guards’ responsibility to monitor the amount of food and water inmates are consuming.

Sheriff Wickersham admitted he was responsible for the well-being of the inmates, but also admitted he rarely enters the jail. Even though his office is located a few feet from the jail, he enters the jail perhaps once per month. He said he delegated oversight of medical care to another employee, who had no medical training.

News reports didn’t say whether Correct Care Solutions employees had been contacted about the state of health David was in during his last days.

News reports did say that David’s prescribing physician, Dr. Bernard Shelton, was charged with unlawful delivery of controlled substances. [2] This report says he prescribed four million “addictive pills” to Macomb County residents, though it didn’t specify over what period of time or what type of pills they were. From what he prescribed David Stojcevski, it appears to have been opioids and benzodiazepines.

In 2017, according to the state of Michigan’s medical board documentation, Dr. Shelton lost his medical license for inappropriate prescribing of controlled substances that were outside acceptable practice. His charts were reviewed by other physicians, who have the knowledge to judge such things. They said he didn’t check patients on the Michigan prescription monitoring website, he didn’t keep complete records, and lacked essential documentation.

The medical board suspended his medical license for fifteen months, fined him $10,000, and said he wouldn’t be considered for license re-instatement unless he could prove, with clear and convincing evidence, that he had good moral character, the ability to practice medicine with reasonable skill and safety, the ability to follow the guidelines of re-instatement, and for it to be in the public interest that he be licensed again. At present, he does not have a license to practice in Michigan.

Now it appears Dr. Shelton will face criminal charges as well as losing his medical license.

But getting back to David Stojcevski’s case…even if his doctor prescribed opioids recklessly and inappropriately, it doesn’t release the sheriff of his obligation to make sure inmates receive medical care. Watching David suffer on the recordings made by the jail, I can’t help but wonder why no one took any action to help a man obviously in serious need of medical attention.

What if Sheriff Wickersham (or one of his deputies) walked down the street of whatever town is in Macomb County, Michigan, and he came to a man lying on the sidewalk, barely conscious, having a seizure. What would he do? I expect he would squat down beside the sick man, check for a pulse, and summon 911 for help. That’s what most citizens would do, out of common decency and concern for a fellow human.

In other words, it did not take any medical knowledge to know David was in serious need of medical help, yet no one in the whole jail called 911.

You can believe I’ll be watching this case unfold. It has the potential to be a multi-million -dollar case. In other similar cases, awards were in the three-million-dollar range. It’s sad that is takes a large financial award to change the way people do things, but in this case, it appears necessary.

It’s too late for David, but a large settlement or award against Macomb County and against Sheriff Wickersham could be another paving stone on the road of appropriate medical care for vulnerable inmates.

  1. https://www.clickondetroit.com/news/defenders/sheriff-answers-questions-under-oath-about-death-of-inmate-at-macomb-county-jail (accessed 7/4/18)
  2. https://www.clickondetroit.com/news/defenders/doctor-charged-with-distributing-opioids-to-inmate-who-died-from-withdrawal-at-macomb-county-jail (accessed 7/4/18)
Advertisements

When the DEA Raids Buprenorphine Doctors

 

 

I had another blog post ready to go this week, but I’m postponing it to blog about another situation.

So far this year, two well-known and respected Addiction Medicine physicians have had their offices raided by the DEA.

The first one occurred in March of this year. Dr. Stuart Gitlow, the past president of ASAM (American Society of Addiction Medicine), who has a small buprenorphine (Suboxone and other name brands) practice in Woonsocket, Massachusetts, was raided by the DEA.

According to news reports, [1] the DEA raided his home and office, looking at patient records for evidence of wrongdoing. They wouldn’t tell him what they were looking for, and wouldn’t comment to reporters later because, they say, the raid was part of an ongoing investigation.

I searched the internet for some sort of follow up story, but found none.

Dr. Gitlow is an unlikely target for a DEA raid. He is so famous for his work in the field of Addiction Medicine that he has a Wikipedia page. According to that page, he is a psychiatrist specializing in the treatment of addiction. He earned an MBA from University of Rhode Island, and went to Mt. Sinai School of Medicine where he earned his M.D. degree. He did a psychiatry residency at University of Pittsburgh, along with a Master’s degree in Public Health. Then he went to Harvard University for a forensic fellowship.

I’ve heard him give lectures at ASAM meetings and he’s as good as lecturers get. He teaches at the University of Florida, and he’s on the editorial board of the Journal of Addictive Diseases.

Dr. Gitlow confirmed in an interview that the DEA looked at patient records, but he had no idea what they were looking for.

Then in early May of this year, the offices of Dr. Tom Reach were raided by the DEA. Dr. Reach, like Dr. Gitlow, is an outspoken advocate of medication-assisted treatment.

A news article [2] described how Dr. Reach’s nine treatment centers were closed for the DEA inspection, disrupting patient care. Dr. Reach’s home was also raided. In the interview, he said he heard the DEA thought he was doing something wrong, but he had no idea what it could be.

They also looked for controlled substances, but Dr. Reach, like most buprenorphine physicians, has never stored these drugs on-site. The record keeping that is necessary for storing controlled substances is considerable. He doesn’t contract with public insurance, so it couldn’t be problem with that.

Dr. Reach said the DEA took hard drives and cell phones, making it harder to continue with patient care.

Dr. Reach was the past president of the Tennessee chapter of ASAM. Dr. Reach was one of several physicians who were on the expert panel convened last year to draft Tennessee’s new guidelines around physician prescribing of buprenorphine. He’s spent his own time at the Tennessee statehouse, advocating for patients with opioid use disorder and their physicians.

Thus far, no charges have been filed against either physician.

Both physicians are politically active. Dr. Gitlow ran unsuccessfully, twice, for state representative in Massachusetts, as a Democrat. Dr. Reach contributes money – some would say a large amount of money – to political candidates he supports. [3]

These two leaders in addiction medicine are far from the only doctors being raided. Dr. Larry Ley, who had several treatment programs in Carmel, a suburb of Indianapolis, was ultimately acquitted of felony drug charges that he faced. Law enforcement personnel, posing as patients, lied about their need for opioid use disorder treatment. Dr. Ley was then charged when he issued prescriptions for Suboxone. [4]

I thought it was a felony to obtain a prescription for a controlled substance under false pretenses. How can a DEA agent pose as a patient and lie about their substance use history to obtain a prescription? Wouldn’t that be an illegal act? Maybe that’s why Dr. Ley was acquitted.

In this case, it seems the county’s head of drug task force didn’t agree with the idea of medication-assisted treatment, saying, ““This type of ruse of a clinic perpetuates the problem because people are still addicted to the drug, and this is what is happening,” said the head of the drug task force, in a press conference held after Ley’s arrest. “This is not fixing the problem.” [4]

Dr. Ley had to close his treatment centers, was left penniless due to legal fees, and is now suing both the city of Carmel and the DEA for conspiring to force him out of business.

Meanwhile, the opioid overdose death rate in Indiana has risen by double digits.

The DEA is authorized to inspect buprenorphine practices at any time. If you are a long-time reader of my blog, you’ll recall my office was inspected in late 2012. I wrote about the experience in a blog post on 12/16/12. The agents were pleasant and cordial. They were willing to meet with me when patients were not scheduled, so it didn’t interrupt my practice at all. They asked about how many patients I had, asked to see copies of patient prescriptions, and asked if I stored any controlled substances on site (of course not). The two agents were polite and cordial.

What happened to Drs. Reach and Gitlow was very different. They were both raided by the DEA, with a warrant that says material can be seized. In a raid, the DEA is so convinced that there’s criminal activity that they take computers, cell phone, and records. Inevitably this disrupts the medical treatment of patients. For both Dr. Reach and Dr. Gitlow, patients had to be turned away from scheduled appointments because of the raids. As Dr. Reach pointed out in a newspaper interview, this can have very real and possibly fatal outcomes for patients depending on buprenorphine to provide stability and keep them from using illicit opioids like heroin.

For a DEA raid to take place, investigators have expectations of finding criminal activities. They would not raid for issues like overprescribing, substandard care and the like. These types of problems would be handled by the state’s medical board.

Of course, I don’t know the circumstances that lead to these DEA raids. It’s remotely possible that a Harvard-educated physician leader of ASAM is slinging dope on some corner of Woonsocket, Massachusetts, in his free time…but I doubt it.

The trouble with these DEA raids is that while they make the papers when they happen, no news releases state what was found. If no wrongdoing was discovered in the masses of material seized by the DEA, the public won’t hear about this. All that remains is the taint of criminal investigation.

I’ve been working with some organizations to try to get more office-based physicians interested in treating patients with opioid use disorder with buprenorphine, a potentially life-saving medication. I’ve reassured worried doctors that they won’t become DEA targets just because they prescribe buprenorphine. I told them that unless they store medication on premises, the chances of getting raided are very small.

I hope I haven’t erred in telling new doctors this. I legitimately thought the nation’s leading health experts are pushing treatment for opioid use disorders, to stem the tide of opioid overdose deaths we’ve been having oer the past twenty years.

Now, with raids on well-respected practitioners, I don’t know what to think.

  1. http://www.woonsocketcall.com/news/city-doctor-s-home-office-raided-by-fbi/article_1e4270a0-2bb5-11e8-be84-b7f0c2501d63.html
  2. http://www.wjhl.com/local/dea-agents-raid-watauga-recovery-centers-in-tn-va-and-nc/1156361147
  3. http://doctorsofcourage.org/ralph-thomas-reach-md/
  4. https://www.thedailybeast.com/addiction-doctor-dea-shut-me-down-so-mayor-could-clean-up-town?ref=scroll

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.

More About Tennessee’s Buprenorphine Guidelines

Funding Information

 

 

 

 

Last week I was contacted by Dr. Tom Reach, one of the premier Addiction Medicine physicians in Tennessee, about last week’s blog entry. He supplied background information about the development of Tennessee’s office-based buprenorphine prescribing guidelines.

Dr. Reach contacted state Representative Matthew Hill about a proposed requirement for office-based buprenorphine providers that would have set treatment in that state back into the dark ages. The state legislation nearly approved legislation that would have required that all buprenorphine physicians apply for a certificate of need.

I know what you’re thinking. How could anyone in Tennessee, a state with one of the highest opioid overdose death rates in the whole U.S., even question the need for treatment? By now, surely even the slowest-witted people in the state know there’s a desperate need for opioid use disorder treatment.

This legislation wasn’t proposed because there were too many treatment facilities. It was proposed because bad treatment facilities were located in the areas of powerful legislators. It was also proposed because some areas of Tennessee have many office-based providers, while other areas have few. This legislation was proposed to control the quality and location of office-based buprenorphine prescribers.

Powerful legislators were sick of poorly run clinics, basically pill mills for buprenorphine, and these legislators believed a certificate of need process would weed out the bad providers. They hadn’t considered it would also limit the number of good providers, who probably couldn’t or wouldn’t want to go through an onerous certificate of need process.

Dr. Reach found out this bill was coming up for vote immediately. He flew into action immediately, educating Representative Hill about opioid addiction, its treatment with buprenorphine, and how treatment is best done. Then he quickly moved on to educated what sound like every member of the subcommittee voting on the certificate of need proposal.

It was a nail-biter.

Initially, only one out of the ten committee members opposed this idea to require certificate of need for OBOT treatment. After much conversation, half were still in favor of the requirement, but the other half had begun to believe it might not be good for the state. After more discussion, the committee eventually voted to table this discussion, and allow a panel of experts to gather more information and form a recommendation.

A coalition of stakeholders in the state was formed, but few members were physicians with experience treating opioid use disorder. Eventually, Dr. Reach was able to influence other members.

It turns out that the final document, about which I blogged last Sunday, was the result of a compromise between people with extremely different views about how medication-assisted treatment should be done.

While I think the guidelines are too restrictive…it could have been so much worse, had Dr. Reach not persisted in his efforts to educate other committee members. Also, the requirements initially ran to 78 pages, so the final 50 page document is comparatively brief.

Dr. Reach informed me that some buprenorphine providers in Tennessee have tainted public opinion about this medication and this form of treatment. He and other physicians, dedicated to providing quality care, are lumped together with prescribers running buprenorphine mills.

He says there are buprenorphine programs that get “patients” from West Virginia and Kentucky who drive to Tennessee, get prescriptions for the buprenorphine monoproduct, and sell them for $60 per 8mg tablet in their home states. These Tennessee programs have huge lines and run patients in and out, providing only prescriptions for medication and no counseling. No time is taken to get to know the patient and find out what’s going on with them, or how they are progressing in their recovery. Some programs don’t even do drug testing.

I commiserate with Dr. Reach. Bad programs damage the reputations of physicians dedicated to doing the right thing for their patients.

I still think there’s room in this conversation for harm reduction approach, which might say the more buprenorphine reaches the hands of people with opioid use disorder, the fewer people might die from opioid overdose. But Tennessee’s no Canada, and I doubt anyone could convince the law-and-order types that diverted buprenorphine could reduce heroin overdose deaths.

I am indebted to Dr. Reach, for his willingness to give background information about this whole issue in Tennessee. Thanks to his efforts, and the open-mindedness of committee members willing to be educated, patients with opioid use disorder in Tennessee have dodged a bullet. Yes, there are restrictions, but it could have been so much worse.

North Carolina legislators can learn from Tennessee’s experience. We can watch to see if these relatively restrictive Tennessee buprenorphine guidelines improve the quality of care in the state. And we also need to watch their numbers of opioid overdose deaths.

 

Tennessee’s New Guidelines for Office-Based Buprenorphine Prescribing

Advertisement for Buprenorphine Physician

I’ve spent a great deal of time puzzling through a document titled “Tennessee Nonresidential Buprenorphine Treatment Guide,” released early this year. This document was created, as it says on page 2 of the document, because of the “growing prevalence of individuals who have an opioid use disorder, an increased number of individuals using medication-assisted treatment with buprenorphine, and diversion issues associated with buprenorphine.”

I’ll give my readers a warning – this blog entry is dense with the finer points of Tennessee’s document, and it’s not light reading.

This document outlines the standards of care that Tennessee’s office-based buprenorphine prescribers will be asked to follow. The physicians’ licensing board, the Tennessee Board of Medicine, will use this document to assess the quality of care OBOT physicians provide.

It was written with the help of many experts: doctors from Tennessee’s psychological and psychiatric associations, doctors from the Board of Pharmacy, from Tennessee’s Department of Mental Health and Substance Abuse Services, from Tennessee Department of Public Health, from drug courts, law enforcement personnel, specialists from Vanderbilt University, the state medical association, nurses’ associations, physicians from the medical society and physicians actively practicing addiction medicine. The document is fifty pages long, probably because more than forty people helped write it.

This document acknowledges that buprenorphine can be a valuable tool to treat patients with opioid use disorder, when used appropriately. The guideline describes the consolidated opinion of these experts as to what constitutes appropriate use.

Moving on to the actual guidelines, the document first outlines what must be done before the patient enters treatment.

The physician must:

  • Make sure the patient has opioid use disorder, and determine the length, severity, and consequences of use, including all prior treatments, if any, and the results of those treatments
  • Must document other substances used, and the extent they are used, and how treatment for these substances will be incorporated into the treatment plan
  • Must assess “process” addictions and decide how they can affect substance use disorders. This means assessing the patient for compulsive gambling, sexual practices, spending, or other impulsive and out of control behaviors.
  • Must assess the patient’s other mental health and physical health conditions, and determine how, when, where these problems will be treated
  • Must assess the patient’s social supports, employment status, housing situation, financial status and legal issues
  • Determine the patient’s readiness for treatment
  • Determine the patient’s wishes regarding pregnancy, if she is capable to becoming pregnant. She should be referred for long-acting birth control if she does not wish to become pregnant.
  • The physician must check the state’s prescription monitoring website before initial prescription and before each office visit
  • Must obtain an observed drug screen and document the results, prior to the start of treatment
  • Must do proper patient selection, which means the patent is told about all options for treatment, the patient is willing to start this treatment, and that there are no reasons not to start the patient in treatment
  • Signed agreement to start treatment must be obtained
  • The physician must complete required elements about consent to treatment dealing specifically with pregnancy and NAS prevention

I say physician and not provider, because Tennessee won’t allow physician extenders like nurse practitioners and physician assistants prescribe buprenorphine, despite the changed federal rule that does allow extenders to prescribe. In other states, extenders first need to take a 24-hour course about opioid use disorder and its treatment with buprenorphine, compared to the 8-hr course physicians take. But Tennessee prohibits extenders from prescribing buprenorphine.

Anyway, Tennessee is recommending a thorough assessment of the patient prior to office-based treatment with buprenorphine. In fact, what they describe above is much like what’s called a diagnostic assessment in the substance abuse treatment world. It’s a full evaluation of the patient’s bio-psycho-social needs.

I don’t do this in my office-based practice. Right now, I schedule an hour’s visit with a new patient, enough time for me to do a standard history and physical exam, as I would for any other new primary care patients. I certainly do get a full history of the opioid use disorder, and other substance use, along with psychiatric and medical issues. I get a drug screen prior to treatment, and I always check the prescription monitoring program. But I don’t delve into process addictions, support systems, or figure out how all other issues will be treated. All of this can’t be done in an hour. But as I get to know my patients over the next few weeks, we talk about all of this, albeit in a more casual way.

However, this data doesn’t necessarily need to be collected by a physician. A trained and licensed therapist could go through much of the background information gathering, and pass this along to the physician prescribing buprenorphine. Plus, physician extenders can help the physician gather information about the patient; they just can’t prescribe the buprenorphine.

At the opioid treatment program where I work, counselors gather the data and compose a bio-psycho-social evaluation or diagnostic assessment. This is built into the system, and it’s done before the patient sees me. This whole intake process takes us about two to three hours, but is required at OTPs.

Next comes a section on how to provide care after the patient enters treatment:

  • Women of childbearing age must do an observed urine screen for pregnancy upon admission, and then once per month. The woman must be asked about the possibility of pregnancy at each visit.
  • All patients should be prescribed the combination product buprenorphine/naloxone, unless the patient is pregnant, nursing, or has a documented adverse reaction to naloxone. A physician can prescribe the buprenorphine monoproduct to no more than 5% of his total patients. Going over this limit will subject the prescriber to scrutiny by Tennessee’s medical board, the guidelines say.
  • Under a section titled, “General dosing guidelines,” there is the statement, “Target buprenorphine dose range should be 6-12mg (or equivalent) per day.”

That requirement of monthly pregnancy screens sounds a bit…twitchy…to me. Of course, we want to know when a woman is pregnant as soon as possible, to get prenatal care started. But other medications, some of which actually cause birth defects during pregnancy, carry no requirements of monthly pregnancy testing (ACE inhibitors come to mind).

I worry Tennessee is allowing some of that “criminally pregnant” mindset into their guidelines. It feels like authorities in Tennessee strongly disapprove of women on medication-assisted treatments becoming pregnant. All things being equal, I think it would be best if they could delay pregnancy until off medication, but often that’s unrealistic. It should be the woman’s choice when she wants to start a family, and she shouldn’t be judged for getting pregnant while on medication-assisted treatment.

As for the prohibition of the buprenorphine monoproduct: the authors of this guideline appear to doubt the truthfulness of the many patients who say they feel better on the monoproduct buprenorphine than on the combination product buprenorphine/naloxone. I remain convinced that some patients do absorb some of the naloxone, leading to unpleasant symptoms of nausea, headache, and muscle aches.

Clearly, I hold a minority opinion. However, I’ve found some interesting data about the urine drug screens of patients on the combination product, all testing positive for naloxone. But I digress. That could be a whole other blog.

Why do these dosing guidelines say the target dose should beget dose of 6-12mg per day? The FDA has approved doses up to 24mg per day.

Again, it’s that “less is better” mindset. It’s as if Tennessee health officials have been forced to recognize medication-assisted treatment is necessary, but to show their underlying disapproval, they want physicians to be stingy with dosing.

We saw that same attitude with methadone in the past, too, before we had conclusive data showing better outcomes with adequate dosing.

Tennessee state law already says that any physician who prescribes more than 16mg per day for more than 30 days must document in the record why that dose is needed. I don’t know how that law is helpful, since the only reason to go above 16mg per day is that a lower dose didn’t suppress withdrawal signs and symptoms.

A buprenorphine prescriber who has a patient on more than 16mg per day for more than 30 days must either obtain consultation from an addiction medicine specialist or turn that patient over to such a specialist.

Next, this document gave very specific guidelines about benzodiazepine prescribing in patients on buprenorphine:

  • Benzodiazepines should not be initiated in a patient with opioid use disorder if that patient has never been on them before, or if that patient has misused them in the past.
  • Patients with a longstanding benzodiazepine prescription for a legitimate medical condition may be prescribed buprenorphine, but only with careful coordination of care with the prescriber, which must be documented
  • The buprenorphine provider may take over prescribing the benzodiazepine if the patient is willing to start a taper
  • If the patient with opioid use disorder also has a clear history of benzodiazepine use disorder, the duration and extent of that use must be clearly documented, and the patient may be switched to a long-acting benzodiazepine like clonazepam to taper the dose.
  • Doses of benzodiazepines that are at, or higher, than the equivalent of clonazepam 2mg per day are considered to be on a “high dose.” Reasons for such a high dose must be documented, and these patients should be tapered as rapidly as possible to below that benzo equivalence.
  • Patients on high dose benzodiazepine therapy for more than six weeks shall be managed by a physician who is board-certified in addiction medicine, or by a physician who has obtained a formal consult from such a specialist.

I’m going to refrain from commenting on this section, since I’m more rabidly opposed to benzodiazepines than many physicians.

OK, one comment.

Benzos are not first-line medications for anxiety disorders, and there are few indications for long-term (more than three months) benzo prescriptions, except possibly for end-of-life care. Besides, benzos have long-term side effects like increased incidence of dementia, falls, and the like.

Then the document shifts again to tasks that need to be completed upon admission:

  • Each patient must get a mandatory infectious disease screening, to include, at a minimum, HIV and Hepatitis B and C, tuberculosis, and sexually transmitted diseases. This doesn’t have to be done in the physicians’ office; patients may be referred to the local health department.
  • Each patient must be screened for the need for trauma-informed care, including an ACE (Adverse Childhood Event) score.
  • Before initiating treatment, the patient must sign an individualized treatment plan, to be documented in the patient’s record.

Tennessee’s Health Department must be able to do all this infectious disease testing, which is great. In North Carolina, Health Departments do all except Hepatitis C testing, due to its expense.

After patients needing trauma-informed care are identified, does Tennessee have enough counselors trained to provide Trauma-focused therapy?

At our opioid treatment program, more than 70% of the females entering treatment need this care, but there are few places that provide it, and long wait times to get it. Is Tennessee better equipped? Where are these patients going to get this treatment?

After this section, we get down to the nitty gritty of actual treatment. The guidelines divide treatment into three phases: induction, stabilization, and maintenance. Here are the guidelines:

  • During induction and stabilization phases, patients should have weekly office visits, one observed drug screen per week, counseling sessions every two weeks, at a minimum, and receive weekly case management services
  • For patients in the maintenance phase for less than one year, they must have office visits every 2-4 weeks, counseling sessions at least monthly, have 12 random and observed drug screens per year, and receive case management at least monthly
  • For patients on maintenance for more than one year, they must have office visits at least every two months, receive counseling monthly, get 8 random observed drug screens per year, and receive at least monthly case management services.
  • The prescriber needs to document which stage of treatment the patient is in.

Finally, I think these guidelines, for the most part, are good. There’s nothing wrong with establishing a mandatory minimum of services to be given to patients with opioid use disorder. It’s just that in so many aspects, this guideline for office-based care is almost exactly what is required of care given at opioid treatment programs, even down to the number of required counseling sessions for each patient.

That’s kind of ironic, considering how viciously Tennessee fought to keep OTPs out of their state. After all, the first OTP in Eastern Tennessee, an area with one of the highest overdose death rates in the world, just got their first OTP in August of 2017.

Now, almost comically, we have Tennessee advocating for the type of care OTPs have been providing for decades.

We need to consider the intent of the DATA 2000 law. It was enacted to give patients with opioid use disorder a different treatment option with less restrictive requirements than those found at OTPs. Tennessee’s new guidelines don’t provide a less restrictive option for patients and their physicians in Tennessee.

I worked in primary care for about a decade before switching to addiction medicine. Primary care doctors, faced with Tennessee’s guidelines, well-intentioned as they are, won’t want the headache and responsibility of trying to meet this standard of care. Buprenorphine treatment will remain in the hands of specialists. I’m not saying this is good or bad – just that it may not be Tennessee’s intention. Time will tell.

Perhaps DATA 2000 was overly hopeful. Maybe all patients, or at least patients new to treatment, need tighter guidelines like Tennessee’s.

Or maybe (as I have come to believe) all these patients need to start treatment at an OTP, then transfer to office-based setting after they are stable for a year or so, where they can be treated with fewer restrictions and more flexibility, as DATA 2000 physicians could to do before these new guidelines were passed.

Here’s another important consideration: who will pay for this treatment? Who pays for the therapists, counselors, observed drug screening and pregnancy testing? Who pays for the complete bio-psycho-social work up and the treatment plan development and updates? There was no mention of this in the guidelines.

I know it sounds like I’m critical of Tennessee’s efforts, and I am, a little. But it’s an exceptional accomplishment to get all the people and organizations together who are interested in this problem, get them talking, and get them to agree on a set of guidelines. All participants are to be commended, because that’s not easy work.

Hopefully, the experts can be flexible enough to try something, re-assess, change things that don’t work well, and keep things that do work well.

Concerned people in North Carolina also will be watching and hopefully learning from Tennessee’s efforts.

Canadian Vending Machine To Dispense Hydromorphone

 

 

 

 

Last month the Washington Post newspaper reported that British Columbia officials plan to set up three vending machines to dispense hydromorphone to people with opioid use disorder.

Canada has struggled with opioid overdose deaths just like the U.S., and they declared their opioid use disorder public health emergency in 2016. Projected data from 2017 estimates four thousand Canadians died from opioid use disorder that year. (In the U.S., an estimated sixty-four thousand people died from overdoses in 2016.) The extremely potent drug fentanyl has been detected in around 83% of the Canadian overdoses.

In British Columbia, overdose death rates last year were estimated at 30 per 100,000 people, which is roughly the same as in Rhode Island. (Our highest state, West Virginia, had around 52 per 100,000).

I’ve blogged before about Vancouver’s heroin-assisted therapy (HAT). In a blog in 2013, I described results of trials in Vancouver and Montreal where pharmaceutical-grade heroin was provided, in specialized facilities, to people with opioid use disorder. Medical personnel were on site at the facilities in case of overdose, and new needles and equipment were provided to participants.

Vancouver’s results showed better retention in treatment with heroin-maintenance therapy (HAT) than patients enrolled in traditional medication-assisted treatment with methadone. Participants had lower rates of use for other illicit drugs, and lower rates of participation in criminal activities than patients not in any treatment. Overall, these programs reached a subset of people with opioid use disorder who would not consider more traditional treatments with methadone or buprenorphine.

These HAT programs work in urban settings, where people can come to a centralized facility manned with trained personnel. Logistically, this sort of facility is more difficult in more rural areas. Plus, since there’s no drug company manufacturing heroin, scientists had the idea of vending machines pre-set to deliver doses of pharmaceutical-grade, immediate release hydromorphone tablets. This medication would not be as hard to obtain for patients in the treatment program.

These machines will be set up to release two or three hydromorphone pills three times per day. The cost per patient would be around $3 per day.

This idea was based on a study published in 2016 in the Journal of the American Medical Association Psychiatry by Oviedo-Jones et al., that showed supervised injection of hydromorphone was non-inferior to supervised injection of heroin.

Pharmaceutical-grade hydromorphone reduces the risk of fatal overdose death from heroin, which is often cut with substances that can be lethal, like fentanyl. Plus, non-drug substances are frequently added to heroin to make the product go farther, exposing users to all sorts of contaminants.

Canada already has vending machines to dispense clean needles to drug users, so this idea takes the concept a step farther. I didn’t realize it, but while researching this article, I found that some cities in the U.S. also have clean needle vending machines. I think this is a wonderful idea, based on science that shows access to clean needles reduces spread of infectious diseases.

Of course, hydromorphone vending machines raised concerns. Law enforcement worried that the machines could be tampered with, and the hydromorphone stolen. Other people worry this medication could be sold on the black market. But the machines are supposedly difficult to break, more like ATMs than typical vending machines, and the small amounts dispensed each day per person are thought to make it less likely to sell these pills.

In Canada, harm reduction ideas do not cause the pearl-clutching outrage we tend to have in the U.S. Can you imagine a proposal in some state legislature for a vending machine to dispense hydromorphone? It probably would not be given a hearing.

In fact, we’ve taken the opposite route in the U.S. The pharmaceutical opioid oxymorphone, in the brand formulation Opana ER, was taken off the market because so many people were injecting it. In my area, six month ago, most new patients I admitted into treatment were using Opana as their main opioid drug. Over the past month, that has changed. Now, most patients are using heroin.

This has happened all over the U.S. – declining availability of prescription opioids fueled the sharp increase in heroin use, and with it, heroin overdose deaths.

I suspect Canada will see fewer heroin overdose deaths in areas with hydromorphone vending machines, but I’m not fully sold on their idea. I worry the medication dispensed by these machines may be diverted to new users, creating new cases of opioid use disorder. In the U.S., the increased access and availability of opioids starting twenty years ago was associated with increased rates of opioid use disorder, and got us into our present mess. Before I endorse the vending machine idea, I need research showing it won’t cause unintended harm.

I’m sure British Columbia health officials will track data that will show if this vending machine concept will work to reduce deaths. It’s an interesting concept, and we have a front row seat to watch what happens with our neighbors to the north.

The STOP Act of North Carolina

CDC DATA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In mid-2017, North Carolina Governor Roy Cooper signed the STOP (Strengthen Opioids Misuse Prevention) Act into law, and as of January 1, 2018, additional portions of the Act became effective.

The STOP Act has several parts, all of which are intended to reduce the epidemic of opioid use disorder by limiting excessive and inappropriate opioid prescribing.

Beginning last July, the STOP Act required physician extenders (nurse practitioners and physician assistants) working for pain management practices to consult with their physician supervisors prior to issuing any Schedule II or III opioids. Then, they must also consult with their physicians every three months while the opioid prescriptions continue.

Prior to this law, extenders had no requirements to consult with physicians prior to issuing these opioids or continuing them. Still, defining the meaning of the word “consult” is a little fuzzy…does it mean a face-to-face conversation, a phone conversation, or email communication? The NC medical board website doesn’t offer much concrete guidance about this.

Beginning last July, the STOP Act also said hospice organizations were to start telling families of patients who passed away while on strong opioids where the leftover medications could be disposed safely. The STOP Act also encouraged the distribution of naloxone kits for opioid overdose reversal, and streamlined the process by which prescribers could enroll delegates to query our state’s prescription monitoring program more easily.

By September 1, 2017, pharmacies were supposed to be reporting all controlled substance medications that they dispensed by the end of the business day. I don’t know if there are any penalties for not meeting that requirement, but I think we still have a way to go towards meeting this standard. Pharmacies also need to correct data quickly if they confirm it’s been entered in error.

This requirement pleases me a great deal, given my interactions with pharmacies over the years. On numerous occasions, when I’ve called about a goofy-looking entry for one of my office-based buprenorphine patients on the North Carolina Controlled Substances Reporting System (NC CSRS, our state’s prescription monitoring program), I’ve been told by pharmacists (usually a CVS) that the error can’t be corrected because it’s a system glitch. Now I can tell them they are required to fix the error!

But one of the most debated portions of the STOP Act took effect January 1, 2018. This was a provision that limits prescriptions for opioids for acute pain conditions to no more than a five-day supply. For post-operative pain, opioid prescriptions can be for up to seven days.

This doesn’t mean a physician can’t write a second prescription when needed. It only means the physician must see the patient again and carefully consider whether to write a second prescription, rather than OK more opioids with little thought.

Many people fear this law, worried they won’t get adequate pain control. However, it’s important to understand that this requirement will not apply to hospice patients and those in palliative care. This requirement is only for acute pain episodes: kidney stones, acute injuries, broken bones, and the like.

This portion of the STOP Act doesn’t apply to chronic pain conditions, either. Patients who are being prescribed opioids as part of an existing program to treat chronic non-cancer pain won’t fall under the five- and seven-day provisions.

However, parts of the STOP will eventually require prescribers to query the NC prescription monitoring program before starting opioids to treat chronic pain. Prescribers will need to review the patient’s prescriptions for at least the preceding twelve months. After beginning an opioid prescription, the physician will need to query the NC CSRS at least every three months., though there’s no deadline to start doing this yet.

Then in January 1, 2020, electronic prescriptions will be required for all targeted controlled substance prescriptions (Schedule II and III opioids).

Some people think the STOP Act is too severe, and will put patients at risk for under-treatment of pain. When medical practice is limited by legislation, opponents of the Act say, physicians are less able to use their clinical judgment and patients are all treated the same.

But this legislation is based on some crucial information.

In 2016, the Centers of Disease Control and Prevention (CDC) issued the CDC Guideline for Prescribing Opioids for Chronic Pain. This document, among other recommendations, stated that opioids are not the ideal way to treat chronic pain conditions, and that non-opioid treatments are preferred. Those guidelines also recommended that if opioids are used, reasonable goals should be set, and patients need to be informed about the risks of opioids. The Guidelines also gave specific recommendations for how to start opioid at a low dose, with short-acting agents, and ways to monitor patients to make this prescribing safer. [1]

Then last year, the CDC released information showing the risk of developing opioid use disorder increases with increased duration of opioid prescribing. This article, “Characteristics of Initial Prescription Episodes and Likelihood of Longer Term Opioid Use – United States, 2006-2015.” Shows us thought-provoking data based on a very large population study.

This interesting data showed that the risk of long-term opioid use increases sharply after the first five days of treatment, and again after the first thirty days of treatment. Therefore, limiting that first prescription to five days, as North Carolina legislature has done, makes good sense. This law is science-based, which isn’t always seen in legislation.

Treatment initiation with a long-acting opioid was associated with higher probability of remaining on opioids for longer than a year, underlining the importance of using short-acting opioids for acute pain situations.

More interesting, using tramadol initially to treat acute pain was associated with a significantly higher risk of remaining on opioid long-term. We need more studies to help clarify this, since many physicians perceive tramadol to be a lower-risk drug than simple opioid agonists like oxycodone or hydrocodone.

The authors of this article also looked at the cumulative dose of opioids given, and noted an increase in the likelihood a patient would remain on opioids long-term once they had consumed more than 700 morphine milligram equivalents.

This study was well-done. It was a random sampling of over a million patients over age 18 on a commercially insured health plan who were prescribed at least one opioid prescription between 2006 and 2015. Cancer patients, patients with a history of substance use disorder, and patients starting buprenorphine were excluded from the study.

Critics may ask how this data is relevant. They may say, for example, that just because a patient remains on opioids for more than a year doesn’t necessarily mean that person will develop opioid use disorder, and that’s true.

But at a population level, more opioid prescribes means more overdose deaths. Over the past fifteen years, the number of milligrams of opioids prescribed quadrupled. Mirroring that rate closely, our nation’s opioid overdose death rate quadrupled right along too.

Less available prescription opioids will mean less available to fall into the wrong hands. We know from NSDUH data that more than fifty percent of the time, the first opioids a youngster takes for experimentation are obtained from a friend or relative.

I support this law, and I’m hopeful the law will mean fewer medicine cabinets have leftover opioids lying about. I’m hopeful this will reduce youthful experimentation, which will reduce the risk for opioid use disorder.

Let’s stop making new patients, as we help established patients along their road to recovery

  1. https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm