Revision of SAMHSA’s 42 CFR Part 2: Better Coordination of Care Balanced with Patient Privacy

The federal law holds providers of services to patients with mental health and substance use disorders to a higher standard of privacy than ordinary medical providers. While other providers must obey HIPPA privacy laws, physicians in our field have always had to meet the more stringent 42 CFR standards.

This year, long-standing rules guarding the confidentiality of patients in treatment for substance use disorders were revised, with the intent of allowing better coordination of care for these patients.

Last week, a group of medical providers who work in North Carolina’s opioid treatment programs met on a teleconference when this issue was discussed. (Pre-COVID we held a conference once a month; now we meet once a week). It was obvious that most of us, including me, didn’t know the exact changes made in the revision. Out of curiosity, I decided to dive deeper into this issue and thought I’d pass it along on my blog.

SAMHSA has a great Fact Sheet that describes all of these changes at this website: https://www.hhs.gov/about/news/2020/07/13/fact-sheet-samhsa-42-cfr-part-2-revised-rule.html

The major changes boil down to a few items. Chief among them is that non-opioid treatment program providers can query a central registry of patients receiving care at opioid treatment programs, in order to prevent double enrollment and (hopefully) prevent adverse drug interactions. In the past, providers who didn’t work at opioid treatment programs didn’t have access to this sensitive information.

On the plus side, advocates of this change say that patients being prescribed methadone or buprenorphine at opioid treatment programs will get better care, because their non-OTP doctors will see which of their patients are receiving methadone or buprenorphine from opioid treatment programs, and won’t prescribe medications which may interact.

On the negative side, we worry patients on methadone or buprenorphine could face discrimination and judgmental attitudes from providers who don’t know any better.

I don’t think this revision will change anything at all. It’s difficult enough getting physicians and other providers to check our state’s prescription monitoring program. I doubt any providers will be savvy enough to know they can get access to our state’s central registry of patients in opioid treatment programs, let alone have the enthusiasm to access this registry.

And speaking of prescription monitoring programs…under the revision, opioid treatment programs are now permitted to report the medications they dispense (nearly always methadone or buprenorphine) to their state’s prescription monitoring program.

Again, proponents of this new rule say it will allow for better coordination of care and will prevent medication interactions. Opponents say, as mentioned for the other change outlined above, that it could lead to discrimination against patients getting treatment for opioid use disorder with medications.

Of course, the wording of the revised CFR 42 says the OTP “may” report prescribing data, not that they “must” report. For now, it’s up to the OTP to decide. At present, I don’t think a system is in place to receive this data anyway. During our latest teleconference here in NC, none of the providers said their OTP was reporting to the state’s PMP.

My opinion – and why have a blog in the first place if I can’t blather about my views – is that this new rule is a mistake. I am opposed to OTPs reporting their dispensing data to the prescription monitoring program.

In my county, patients are sometimes treated differently by medical personnel after they reveal they have opioid use disorder and are in treatment with us. And by differently, I don’t mean they are congratulated on their recovery and offered words of encouragement. Instead, they are told something like, “I hope you aren’t here to ask for any pain medication because I’m not going to prescribe it,” even if they are at a routine office visit for treatment of hypertension.

In some cases, patients are told they can’t be accepted as a new patient because the doctor isn’t comfortable treating them. These providers pretend that the patient’s issues are just so complicated that they don’t have the medical expertise. This is an excuse meant to hide an attitude of judgment and contempt for our patient who have the disease of opioid use disorder, and who are viewed as “difficult” patients.

I don’t think patients know about this recent change to privacy law, and I worry they won’t be happy about it. I hope it won’t deter people from entering treatment at opioid treatment programs. Before these changes become operational, we should tell our OTP patients, so they won’t be caught off guard. Of course, patients receiving buprenorphine products at doctors’ offices (so-called office-based practices) already have their data reported to the state’s prescription monitoring program, so it won’t be any change for them.

This revision also said that natural disasters which disrupt treatment facilities should be considered medical emergencies, allowing for patient information to be disclosed without patient consent. I interpret that to mean that if our facility is swallowed by a giant sink hole (not an unreasonable fear in our little town), we could send patient data to another OTP so that our patients could be dosed, without waiting for individual consent forms to be signed. This would streamline care and be more practical. We could also give patient data to hospital emergency departments or other facilities helping those patients during emergencies.

The revision document takes pains to declare that many things have not changed under this revised rule. For example, the document clearly states that law enforcement is still prohibited from obtaining substance use disorder treatment records without a court order. In other words, random police officers can’t come into the OTP and ask if an individual is a patient. We are still prohibited from releasing this information.

This is how things are at the federal level. At state levels, there are different laws about who can access prescription monitoring programs.

In North Carolina, the law changed in 2018, with the HOPE (Heroin and Opioid Prevention and Enforcement) Act. Prior to this, law enforcement had to have a court order to look at a subject’s data on the prescription monitoring program. After HOPE was passed, law enforcement officers can access PMP data if they have a “reasonable, good-faith belief based on specific facts and circumstances,” to access the data. The law has a few safeguards in place; the officer has to a “certified diversion investigator” before given access to the PMP.

I don’t know how this law slipped past me. I don’t like it. It makes me uneasy. With the previous court-ordered access, at least there was a judge who balanced (thoughtfully, one would hope) patient privacy against legitimate law enforcement goals. Now it appears to be left to the judgment of law enforcement officers who may be predisposed to believe their goal is justified.

I remember all the caution that abounded in 2007, when the NC prescription monitoring program first became operational. There was argument about whether the NC PMP could be accessed without patient consent (it could). I was told not to store the printed record of a patient’s PMP report with the rest of the chart, least it inadvertently be forwarded with any request to send records to other providers. The prescription monitoring program was hush-hush private, only for doctors’ eyes, and only to be used to provide better healthcare.

Now, law enforcement doesn’t even need a court order to access it.

I worry law enforcement officers won’t be able to interpret the data they find on the prescription monitoring program. For example, if they look at one of my patients being prescribe buprenorphine/naloxone films, will they look at the “overdose score” that is usually very high for patients on buprenorphine products? Despite warnings from the American Society of Addiction Medicine and other experts, who say it’s not possible to assign an MME (morphine milligram equivalent) to buprenorphine…our prescription monitoring program does just that, thereby implying a patient on sixteen milligrams of buprenorphine is more likely to overdose than a patient on oxycodone and a benzodiazepine. Ridiculous.

I’d like to hear from readers about how you feel about the changes to privacy laws. I don’t think patients, at least in North Carolina, know about the HOPE law that passed in 2018.

Update of the ASAM National Practice Guidelines for the Treatment of Opioid Use Disorder

 

 

 

 

Last week I got the updated guidelines from ASAM (American Society of Addiction Medicine) regarding the treatment of opioid use disorder with medications. This new focused update replaces the 2015 guidelines, with minor and major changes, based on new scientific literature and expert opinion. The committee responsible for the revision was composed of some of the most knowledgeable experts in our field. I’m grateful for their efforts and read these new guidelines in detail.

I made note of some newer statements that stood out to me, either because I agree with them so vehemently, or because I’m not enthusiastic about them. For the latter, I need to adjust my thinking and my practices, something that’s never comfortable.

Starting with Part 1, which covers the assessment of the patient and the diagnosis of opioid use disorder, I saw this new recommendation: while a comprehensive assessment of a new patient is critical, it shouldn’t delay treatment with medication. In other words, these guidelines give us permission to get some data after treatment initiation. Assessment should be an ongoing process as OTP (opioid treatment program) staff get to know a new patient and their unique needs.

It takes time to get data from a new patient for a comprehensive assessment. On day one, patients usually feel lousy. They are in withdrawal and anxious for relief. However, some state regulatory authorities dictate we formulate a person-centered treatment plan on that first day. Then there are consent forms, release of information forms, and educational procedures we must do for new patients. We are mandated to get personal information on the first day about their past traumas, legal problems, sex lives, housing situations, and the like. If counselors don’t get that information, the program risks censure by regulatory authorities and we also risk not getting paid by insurance companies or Medicaid.

In other words, this guideline is wonderful, but OTPs will need buy-in from the agencies that oversee the function of OTPs.

Next, a major revision to existing guidelines says that current use of benzodiazepines or other sedatives shouldn’t be a reason to suspend or withhold treatment with methadone or buprenorphine. The new guideline says harm from untreated opioid use disorder can outweigh the risks of combining treatment medications with sedatives, and that a risk-benefit analysis should be done, and extra support given to the patient to minimize overdose risk.

This revision isn’t a surprise. OTP providers have talked frequently over the past several years about the increased risk of overdose since fentanyl appeared on the scene. Like so many of my colleagues, I’ve gradually changed my practice. I’ve admitted patients with known benzodiazepine use disorder to treatment with buprenorphine or methadone. After admission, we work with the patient, trying to figure out strategies to help reduce or eliminate benzodiazepine use.

I’ve been happy with some results. Some patients have done very well, much better than I feared. Other patients haven’t done as well, and I worry about them.

Each case is different. A patient who uses an occasional benzodiazepine doesn’t worry me as much as a patient who comes to our facility so impaired on benzodiazepines that she can’t be dosed safely. I worry about patients when friends or family members call to say their loved one fell asleep at dinner, and about patients who have auto or other accidents likely caused by sedative use. I worry about patients who got fired from their job due to impairment. All of these incidents speak to a severe lack of control over benzodiazepine use.

For these patients, continuing methadone may not be the right treatment plan. They may need to switch to buprenorphine, or even better, to depot naltrexone (Vivitrol). These patients need extra help and counseling. Most also need better treatment for underlying anxiety disorders.

Ideally, I’d send patients with uncontrolled benzo use to inpatient treatment, to taper them off benzos safely while they do an induction onto methadone. We now have state-run facilities that offer this service, at least in theory. In real life, it takes weeks to get a patient admitted, and they don’t stay long. One patient with severe alcohol use disorder stayed two days. The facility that takes patients in our catchment area is overwhelmed with too many patients who need admission compared to their small number of beds.

The guidelines do advocate a balanced approach; in another section, they recommend using caution when prescribing sedatives including benzodiazepines to patients who are prescribed methadone or buprenorphine, due to the risks of serious side effects and interaction.

Next, I saw an interesting statement in the guidelines, which was that opioid use disorder is diagnosed based on the history given by the patient. You would think that would be obvious, but OTPs have been criticized in the past for “taking the patient’s word” about their opioid use disorder. We have other data that we consider besides patient history; for example, the physical exam findings, presence of opioid withdrawal signs, multiple opioids on the prescription monitoring program, old records from other treatment programs, and collateral information from family. But patient history is the foundation of the diagnosis of opioid use disorder.

Another new guideline statement was that all FDA-approved medications should be available to patients seeking treatment for opioid use disorder.  I heartily agree with this. I think OTPs that offer only methadone are behind the times. We offer all three medications at the OTP where I work. However, depot naltrexone (brand name Vivitrol) is logistically difficult to start at an outpatient facility, because few patients can refrain from opioid use long enough to start naltrexone. It’s easier to start on an inpatient unit, where patients are physically separated from illicit opioids. Vivitrol is covered by Medicaid, but it’s still costly for patients with no insurance, even with the patient assistance program.

The guidelines say there should be no time limit for medications used to treat opioid use disorder. That statement was much needed. Even today, too many OBOT (office-based opioid treatment) providers push patients to taper off buprenorphine products to meet an arbitrary timeline, and that’s not in patients’ best interests.

Here’s one that may be controversial: The new guidelines repeatedly state, in various sections, that a patient’s “decision to decline” psychosocial therapy shouldn’t delay treatment with medication to treat opioid use disorder.

This is big:  In other words, if a patient won’t or can’t participate in counseling, the patient should still be able to get treatment with medication. Patients can benefit tremendously from counseling, but the medication reduces the risk of overdose death, a worthy goal. Medication shouldn’t be withheld from patients who decline counseling help.

That’s a frequent dilemma of office-based opioid treatment physicians. I’ve talked to many doctors and we feel guilty if we don’t insist our patients get counseling of some kind, whether it’s individual, group, or 12-step recovery. While we still need to encourage patients to participate in counseling, we no longer need to feel guilty for writing buprenorphine prescriptions for patients who decline it. Science says the medication benefits patients, even without counseling.

Another guideline says the opioid dosing guidelines developed for chronic pain, which talk about MMEs, or morphine milligram equivalents, don’t apply to treatment medication. This is a pet peeve of mine. How it irritates me to see a high “overdose risk score” on my state’s prescription monitoring program for a patient who is doing well on a stable dose of buprenorphine/naloxone for over five years! Despite this recommendation that MMEs can’t be applied to medications like methadone and buprenorphine, our PMP insists on doing just that. I heard this was going to be changed, but it hasn’t…yet.

In Part 3, the guidelines state that opioid withdrawal management (what has been traditionally been called detox) is not recommended without ongoing treatment. The risk of overdose and overdose death increases when opioid withdrawal management is used without any other treatment options, such as ongoing maintenance medication.

I’m in the “Amen!” corner for this statement. Are there any other treatments that have been used over and over, with less than a 10% chance of being effective, for any other chronic illness? And worse than low efficacy, this treatment (detox only) increases the risk of death after the treatment is done. If we did that for any other chronic illness, malpractice attorneys would parachute from the sky in their haste to file lawsuits.

In Part 4, about methadone, induction recommendations say that for most patients, initial dose should be in the range of 10 to 30mg, with re-assessment as clinically indicated in 2-4 hours. In patients with no or low opioid tolerance, they recommend initial doses of 2.5 to 10mg. They also say methadone should be increased by no more than 10mg every five days, based on patient symptoms of opioid withdrawal.

The guidelines say that methadone daily doses usually range from 60 – 120mg per day, but that some patients need doses lower than that and some higher.

Part 5, about buprenorphine, pushes for the acceptance of doses higher than 16mg per day. In the past, many experts said no patient should ever need doses higher than 16mg per day. Now, the updated guidelines say, “Evidence suggests that 16mg per day or more may be more effective than lower doses.” Well yeah. I don’t know why it’s taken so long for the experts to get on board with that. (You can check out my blog entry of October 8, 2017)

I’ve touched on only a few of the many points in the guidelines. You can read them in full at this website: https://www.asam.org/Quality-Science/quality/2020-national-practice-guideline

I think the guidelines were well-researched, well-written, and much needed. Thank you, ASAM, for your continued efforts to help providers give good care to our patients.

Book Review: “Dopesick: Dealers, Doctors, and the Drug Company that Addicted America,” by Beth Macy

Dopesick, by Beth Macy

This well-written book has it all: compact information about how the opioid epidemic started, how our nation failed to act early to mitigate the damage of the epidemic, and how the epidemic shifted into our present predicament. The author did a great deal of research and talked to experts with vital information, but she humanized this data with personal stories about people affected by the opioid epidemic. She told this story not only from the view of the person with opioid use disorder, but also illustrated the grief of families who lost loved ones. The prolonged grief of families who have lost loved ones to opioid overdose deaths is rarely examined as well as it is in this book.

This is a book that will be staying on my shelf for a re-read.

The author is a journalist who works for the Roanoke Times newspaper, so this book focuses mostly on events in the western part of Virginia.

Avid readers on this topic will recall the book “Painkiller,” by Barry Meier, who also covered rural Western Virginia. Ms. Macy’s book picks up where Mr. Meier’s left off. They talk about many of the same communities and the same treatment providers, fifteen years later.

Mr. Meier’s book, published in 2003, could have been an early warning to the U.S. healthcare system. Unfortunately, the book wasn’t widely read, so few people took any note of what was going on, other than those of us already working in the field. I understand Mr. Meier wrote a second edition of “Painkiller” this year, and I plan to read and review it.

The most remarkable theme of Ms. Macy’s book is how the opioid use disorder epidemic grew worse over the past fifteen years. After physicians finally stopped prescribing so many opioid pain pills, these pills were less available on the black market. Many people with opioid use disorder switched to cheap and potent heroin.

In Ms. Macy’s book, she tells the experience of a rural physician, Dr. Art Van Zee, who was also interviewed for Barry Meier’s book. He was one of the brave people who stood up at conferences and raised the question about the ethics of Purdue Pharma, manufacturer of OxyContin, when it wasn’t easy to question anything about that drug company. He’s the first physician I can recall who actively sought answers about his perceived over-prescribing and mis-marketing of OxyContin.

This isn’t in the book: I remember Dr. Van Zee at an Addiction Medicine conference called “Pain and Addiction: Common Threads,” that I attended in 2003 o4 2004. I bought the recordings of the conference, because I was so excited to learn more about Addiction Medicine. I remember a recorded session where Dr. Van Zee asked a question after a lecture, asking – as I remember it many years later – why Purdue Pharma was still peddling their OxyContin as a relatively harmless opioid for chronic pain, while he was seeing patients with lives destroyed by this drug.

It was one of those moments where all you hear are crickets. His question wasn’t answered, but rather he was reprimanded by the speaker. He was cautioned to remember our conferences were sponsored in part by Purdue money, and that appropriate prescribing of OxyContin was a huge benefit to patients. He was told it wasn’t the drug, it was the prescribing that needed to be fixed.

Fast forward to 2007. As described in “Dopesick,” Purdue Pharma pled guilty to fraudulent marketing of OxyContin, which was a felony misbranding charge. Purdue paid $600 million in fines. Its top three executives pled guilty to misdemeanor versions of the same crime, and ordered to pay a total of $34.5 million.

So yes, inappropriate prescribing was a big part of the problem, but Purdue deliberately misinformed physicians about potential dangers of the drug, which contributed to inappropriate prescribing. From a 2018 perspective, that speaker’s answer to Dr. Van Zee seems disingenuous at best.

Dr. Van Zee’s perceptions, based on his clinical experiences, were correct. Around that same time, I was seeing the same thing in rural Western North Carolina. I remember having twenty to thirty new patients show up on admission day, all of them were using OxyContin, almost exclusively. This drug was easy to crush to snort and inject, and Purdue knew it.

Purdue Pharma testified before congress in 2003 that they were nearly ready to release a new formulation of their OxyContin pill that was more abuse resistant. As it turns out, that new formulation wasn’t released until 2010. With that change, people with opioid use disorder changed to other opioids, easier to misuse, such as Roxicodone and Opana. Eventually Opana underwent reformulation to a less abused form.

But I digress; back to the book. The author’s first few chapters summarize the history of opioid use disorder and the factors that lead up to the release and promotion of OxyContin. It related how this drug crept into the social fabric of Southwestern Virginia, and how early attempts to sound an alarm about its abuse were met with contempt from drug company representatives.

Chapter Three tells of the “unwinnable” case brought against Purdue Pharma by Virginia attorney general John Brownlee. He went up against the famous Rudy Giuliani, who was one of the lawyers who represented the drug company, and successfully negotiated the eleventh-largest fine against a pharmaceutical company. This chapter contrasts this legal victory with the devastating grief of parents who lost their children to overdose death with OxyContin. The book describes the creation of the “OxyKills.com” message board, which became a sort of a database for overdose deaths. The chapter after that contains depressing descriptions of how Purdue Pharma’s corporation executives and the owners, the Sackler family, distanced themselves from the profound harm caused by their medication and criminal mis- marketing.

The next several chapters contain the tragic stories of people who became addicted to opioids, and their journeys through the criminal justice system, the addiction treatment system, and the pain their families felt, every step of the way. The author illustrates the ridiculousness of our patchwork system of care for people with opioid use disorder, and how ineffective treatments are often pushed as first-line options.

Then the book details efforts to pursue the heroin ring that sprang up in Virginia, and how the ringleader, a man named Ronnie Jones, was eventually arrested, charged and convicted of trafficking heroin from Baltimore to the Roanoke suburbs. Many of Jones’ drug runners were addicted young adults, many female, from Roanoke’s suburbs. Families were shocked when they found out their children were involved with the drug trade. Heroin used to be an inner-city drug, but times have changed. Heroin is now plentiful in suburban and rural areas, as this book illustrates repeatedly.

I was most interested in the author’s description of available treatments. Usually I dread reading writers’ summaries of treatment for opioid use disorder. If they describe medication-assisted treatment at all, it’s often couched in negative terms. However, this author did her homework.

She describes the accurate reasons why medication-assisted treatment with buprenorphine and methadone is the gold standard of treatment, and even writes about some of the success stories. However, she also writes about the more common public perception of buprenorphine: “shoddy” prescribers located in strip malls who don’t mandate counseling or do drug testing patients. She writes about the poor opinion of Virginia law enforcement officials, who criticize doctors for not weaning people off the drug, and for allowing patients to inject the drug & sell it on the street.

However, it’s clear the author was able to grasp harm reduction principles, and latest research findings, since she said (on page 219) the unyielding opposition to MAT was the single biggest barrier to reducing overdose deaths.

I felt gratified to read this in print. I underlined it.

She also pointed out how some states’ refusal to expand Medicaid when given the opportunity kept many people with opioid use disorder from being able to access treatment. That’s more perceptive than I expect from a writer who isn’t trained in public health or substance use disorder treatment.

But my favorite part of the book was on page 221, where an addiction counselor named Anne Giles said of the opioid overdose death epidemic: “We should be sending helicopters!”

I underlined this too.

She pointed out that if the same number of people dying from opioid overdoses were dying of Ebola, the government would be sending helicopters of medical help to rescue people and contain the epidemic, and she’s right. We ought to be sending helicopters….helicopters loaded with emergency medical personnel and treatment medication. (By the way, per most recent data from NIDA, over 49,000 people in the U.S. died from opioid overdose in 2017. That’s one-hundred and thirty-four people per day. If they were dying from Ebola…helicopters for sure.)

So I heartily recommend this book to anyone interested in this topic. Even if you aren’t interested, it’s so well-written that it will entertain you. I particularly appreciate the author’s talent at describing so many facets of this opioid epidemic and the obvious scope of her research.

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.

Continuum of Care for Opioid Use Disorder

 

 

 

 

 

 

“Continuum of care is a concept involving an integrated system of care that guides and tracks patient over time through a comprehensive array of health services spanning all levels of intensity of care.” (Evashwick, 1989)

Continuum of care isn’t a new concept. It’s a pattern of care that we use to treat patients with all sorts of chronic medical illnesses. For mild forms of a chronic illness, primary care providers manage patients’ illnesses. For more severe forms of the same illness, patients are referred to specialists, with more experience and training in that area of medicine. Ideally these shared patients flow back and forth between specialists and primary care providers as needed based on the severity of illness as it may fluctuate over time.

We ought to apply this same concept for the management of opioid use disorder. It’s a chronic illness which can have exacerbations and remissions over time, just like diabetes and asthma.

I try to follow this concept at the opioid treatment program where I work. Patients new to treatment often are ill, not only from the drug use, but also from neglected physical and mental health issues. They need more intense care. An opioid treatment program offers more structure and supervision than an office-based practice, so it’s a level of care that’s appropriate for such patients.

At the opioid treatment program, we can do daily observed dosing, to make sure patients take the dose I prescribe. We assess the adequacy of the dose by asking about withdrawal symptoms and observing withdrawal physical signs. We can monitor for side effects. We can do frequent drug screens, to provide information about the proper level of counseling needed. Counseling, both group and individual, are built into the system at opioid treatment programs.

At the other end of the spectrum, stable patients with years of recovery in medication-assisted treatment need less care. We still need to monitor for relapses, but they usually don’t need as much counseling, and no longer require observed dosing. They need the freedom that office-based practices provide.

Stable patients on methadone get more take home doses, but opioid treatment programs are their only option for treatment setting. Stable patients on methadone can’t get their treatment in primary care settings. It’s illegal for office-based physicians to prescribe methadone for the purpose of treating opioid use disorder. Primary care doctors can prescribe methadone to treat pain, but not if the patient also has opioid use disorder.

It’s different for patients on buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail). Since 2000, it’s been legal to prescribe this medication from office-based settings for patients with opioid use disorder.

But that doesn’t mean this is the right setting for all patients with opioid use disorder.

I have an advantage, since I see patients in both settings, both opioid treatment program and an office-based practice. I have the luxury of being able to treat new patients in the opioid treatment program, and after they stabilize, talk to them about transitioning to the office-based practice. If a patient encounters a rough patch, I can ask them to return to the opioid treatment program for more intense treatment until they again stabilize.

I can use the same concept as used with other chronic medical illnesses.

Sometimes a new patient can safely be treated in an office-based program. This all depends on individual patient circumstances. One patient may have a fantastic support system at home, while another may have to put up with active drug use in his home. Obviously, the latter patient needs more support from treatment staff.

Sometimes patients on buprenorphine aren’t appropriate for office-based treatment, even after months of treatment.

Unfortunately, most patients with opioid use disorder aren’t placed in a treatment setting based on their needs. Most patients end up in whatever facility they enter for the duration of their treatment, which may not be the best thing for the patients.

It’s rare for an office-based practice to refer their patients who are struggling to opioid treatment programs. Many office-based providers, enthusiastic about treating patients with opioid use disorder, still regard opioid treatment programs with great suspicion. It’s partly due to lack of knowledge about OTPs. It’s also partly due to that old bugaboo that blocks so much of appropriate treatment for people with substance abuse disorders: stigma. Some providers believe all sorts of outlandish things about what takes place at opioid treatment programs.

It’s painful to admit, but some providers’ opinions are formed based on the actions of poorly run opioid treatment programs. Some opioid treatment programs provide little more than daily dosing of medication. In our business, those programs are referred to derisively as “juice bars,” meaning patients get a daily dose of methadone, which looks like red juice, and little more.

These programs taint the reputation of good opioid treatment programs which offer an array of services all meant to help the patient. This is a real shame.

So, what about me? Do I refer stable buprenorphine patients at our opioid treatment program to other office-based buprenorphine practices? Well…not so often.

I know plenty of excellent office-based buprenorphine providers across the state who are diligent and painstaking about the care they deliver. And I know some providers in my area who don’t meet that standard. I’m hesitant to refer to them.

For example, one nearby provider charts extensive patient visits. These notes include everything from history of present illness, complete review of systems, and complete physical exam for each visit. Yet I was troubled about how similar each visit was, and suspected there was a whole lot of “cut and paste” going on, and that the charted care wasn’t actually being delivered.

Recently a patient transferred from this practice back to me, at the opioid treatment program, for purely financial reasons. We requested a copy of her charts, as we do for all patients who have been seeing other practitioners. This is good medical practice, even if it hasn’t been all that helpful with this particular provider in the past.

I was reading the records, and was confused. I read in the exam section of her last visit, “Abdomen consistent with eight month pregnancy.”

How had I missed this, I thought. I’m no obstetrician, but even I should pick up an advanced pregnancy on exam.

I slid my eyes back to the patient, sitting on a chair near the corner of my desk. Her abdomen looked flat.

“Um, so…are you pregnant?”

“No! Why?”

“Well you don’t look pregnant,” I added, not wishing to offend her. “It’s just that this last note says you’re eight months pregnant.”

She sighed and rolled her eyes. “The baby is seventeen months old. I guess they just never changed it in my chart.”

I looked back at each note. Sure enough, the exams for each date all read, “Abdomen consistent with eight month pregnancy.” For many months. Clearly, this was cut and paste charting. It’s not quality care, and may be illegal if the provider charged for services not delivered.

This confirmed my worst suspicions about the level of care provided at that practice, so I don’t think I will be referring patients to them.

In this country, we do have obstacles to providing a continuum of care for patients with opioid use disorders. We have some office-based practices that aren’t well-run and have little oversight. We have substandard opioid treatment programs providing little more than medication dosing, and we have undeserved stigma against opioid treatment programs that have been providing quality care for many years.

In fact, opioid use disorder may have the least organized continuum of care of all chronic diseases.

What’s the answer? Better communication and better education among medical providers.

I’m doing my part.

I go to many conferences, to learn the latest data and standards in my field. I also meet other providers at these conferences, even though by nature I’m a bit of a recluse. I’ve given talks, both to community groups and at medical meetings, to do my part to pass on what I know. I don’t enjoy public speaking, but find that once I get involved in my topic, I lose my fears.

All providers of care for people with opioid use disorders need to do this – we must meet each other, talk to each other, and learn from each other.

Here are a few wonderful opportunities to interact and learn:

ASAM conferences: the American Society of Addiction Medicine holds several conferences per year at the national level, and these are excellent for learning and meeting the leaders in the field. You can read more at their web site: www.asam.org

 

In my state of North Carolina, you can get some valuable information from the Governor’s Institute, at https://governorsinstitute.org/ and also their blog: http://www.sa4docs.org/

You can attend webinars, get clinical tools, and obtain mentoring from the Providers’ Clinical Support System MAT, at https://pcssmat.org/

If you are a provider in North Carolina and want CME hours while you teleconference with peers and mentors, you can participate in the UNC ECHO project. You can read more about that here: https://uncnews.unc.edu/2017/02/15/unc-chapel-hill-initiative-will-combat-opioid-use-disorders-overdose-deaths/

Write to me if you want to participate and I can forward you to the people that can make that happen.

News You Can Use

 

 

 

 

 

 

 

 

 

 

 

 

 

Tidbits From the latest issue of Journal of Addiction Medicine

Don’t Forget the Family

I finished reading the latest issue of the Journal of Addiction Medicine this weekend, and as usual there’s much good stuff in it. One article that captured my interest was about family involvement in substance use disorder treatment.

Family members of patients with substance use disorder can powerfully influence the course of treatment of their loved ones.

I’ve known about the studies that support this for years, yet I must admit I haven’t gone out of my way to involve family members unless my patients request this.

The journal article reminded me we have research that shows family members can help prevent substance use disorder, can halt the development of these disorders, and can affect the prognosis once a substance use disorder is established. This article, by Ventura et al., reminds readers that involving family members in evidence-based interventions can improve health outcomes for the entire family.

That is, not only do these interventions improve the health of the person affected with substance use disorder, but also improve the health of all family members. Family members of affected patients show decreased healthcare expenditures as the patient’s treatment outcome improves.

It’s not fair to blame family members for actions which may worsen the substance use disorder of the affected person. They aren’t professionals. They are trying their best to deal with the insanity brought into the home with substance use disorders. They may not know the best way to support their affected loved one. Instead of judging these family members for their actions, better outcomes are seen when we educate them, and help them get care for themselves.

It’s tough to include families. Sometimes, our patients refuse us to include family in their treatment, and that is their right, and must be honored. Sometimes family members have their own substance use disorder that needs treatment. It’s also time consuming to involve family members, and many treatment professionals already feel their time is stretched. Some families are hostile to medication-assisted treatment of opioid use disorder. Explaining the reason why MAT is not just “substituting one drug for another” takes time and patience.

But if we can overcome these obstacles, involving the family in treatment can make a substantial difference in the lives of all family members, and not just the affected person.

 

Ondansetron for opioid withdrawal:

An article by Chu et al. described a study that looked to see if ondansetron (often known better under its brand name Zofran) could lessen withdrawal in patients on chronic opioid therapy. Because of previous studies that show some symptoms of opioid withdrawal may be mediated through the serotonin system, the authors hypothesized that ondansetron, as a serotonin receptor antagonist, could reduce opioid withdrawal.

This was a small study, with only 33 subjects, who participated in this double-blind, randomized crossover study. The subjects all had chronic back pain, and were changed from whatever opioid they were on to sustained-release morphine prior to the study. Then precipitated withdrawal was induced in these subjects with intravenous naloxone. Subjects’ withdrawals were treated with either placebo or ondansetron, and then both objective signs and subjective symptoms were measured.

The study showed no difference in withdrawal symptoms when ondansetron was given, compared to placebo.

That’s disappointing, but important to know.

The Disease of Addiction, Explained

 

 

The New England Journal of Medicine published an excellent review article explaining the neuroscience of addiction in their January 28, 2016 issue. It was written by three heavy-hitters in the addiction field: Dr. Nora Volkow, the director of NIDA, Dr. George Koob, the director of NIAAA; and Dr. Thomas McLellan, founder of the Treatment Research Institute.

This article should lay to rest any debate about whether addiction is a disease of the brain.

http://www.nejm.org/doi/pdf/10.1056/NEJMra1511480

Updates

 

Prisoner death from drug withdrawal:

In my blog entry on October 20, 2015, I discussed the horrible death from drug withdrawal suffered by David Stojcevski in the Macomb County, Michigan, jail. I’ve been scouring the internet looking for updates on the lawsuit the family has filed against the county, but haven’t found anything. However, I’m pleased to find many news stories about this awful incident, which helps to keep the issue of medical treatment of prisoners in the news. This is something we must change. Incarcerated people should not be allowed to die from drug withdrawal!

http://www.newsjs.com/ca/cops-arresting-man-in-murder-probe-leave-him-locked-on-bus-with-passengers/diV1CbLR9C6B0bMHAlNf4Wk68k_mM&authuser=0/

Bad legislation:

On April 12, 2015, I blogged about NC bill S297, which is legislature intended to make drug use by a pregnant woman a criminal act. Regrettably, this sorry and misguided piece of legislation was passed on its first reading in the NC senate. It’s now been referred to the Committee on Rules and Operations of the Senate. If you live in NC, when you vote, remember that Republican Brent Jackson presented this bill, which I believe will keep pregnant women from seeking medical care during pregnancy if they have the disease of addiction. This bill is not good for society, pregnant women, and especially not good for fetuses.

Probuphine:

I’ve written a few blog entries (September 2, 2011; March 30, 2013; May 21, 2013; and November 7, 2015), about Probuphine, implantable small rods that deliver buprenorphine into a patient’s bloodstream over six months.

In January of 2016, an advisory committee to the FDA voted to recommend Probuphine for approval by the FDA for the treatment of opioid addiction. The FDA is expected to hold its vote at the end of this month. You will recall that despite a similar recommendation last year, the FDA did not approve this implant, stating more study was needed, especially on patients who were stable at lower dose of buprenorphine.

This time, Titan Pharmaceuticals is seeking approval in patients who are stable on 8mg of the sublingual buprenorphine or less per day.

Of the minority of people on the advisory panel who voted no to the recommendation, concerns were expressed about identifying appropriate patients for this medication, and risks of both implantation and removal of the rods.

I’m still not clear if there will be changes to the rules for implantation and removal of the Probuphine rods. For a buprenorphine prescriber to be able to offer Probuphine, she would have to take a training class for the procedures for implantation and removal. This requires time away from work, to meet an uncertain demand for this product. Not all doctors who prescribe buprenorphine will want do this procedure anyway.

If I want to do this procedure in my office, how to I get the implants? Do I have to buy them, and wait for the patient to pay me back? Do I write a prescription and have the patient pick them up at the pharmacy? Will insurance cover the medication and the procedure? If yes, how long would I have to wait for payment from these companies? I’ve been able to stay in business at my private office by keeping overhead pared to a minimum, so if Probuphine requires an investment by me, I may decide it’s not worth my time and effort.

Hepatitis C treatment

As described in my July 3, 2015 blog entry, the CDC recently reported a surge in the numbers of U.S. citizens who have contracted Hepatitis C. Now another drug has entered the market to treat Hep C, but remains extremely expensive. Earlier this year, Merck pharmaceutical company launched a new Hep C drug called Zepatier. It’s an oral drug that costs an estimated $54,000 for a twelve week course, compared to $80,000 for a similar course of Harvoni. However, early reports say Zepatier cure rates may not be as high as Harvoni’s, so we await more information.

Many health insurance systems can’t afford to pay this much money for treatment of their insured, and so many people infected with Hep C have found their insurer refuses to pay for this new treatment that cures Hep C in most patients. Without insurance, few people could shoulder that expense themselves.

So we have another treatment option, and a little bit less expensive. Let’s hope this trend continues.

ALKS 5461

In my blog post from January 17.2015, I reported a new drug on the horizon that was hoped to be a novel treatment for resistant depression. This medication, known as ALKS 5461, contains buprenorphine (just like Suboxone, Subutex) and samidorphan, a new opioid receptor blocker. The medication was theorized to treat depression by the buprenorphine’s antagonistic action on the kappa receptors, and the samidorphan would serve to block the effect of buprenorphine on opioid receptors, so that the patient would not develop an opioid dependency.

Unfortunately, ALKS 5461 failed to show benefit in two phase III clinical trials, leading Alkermes stock to fall when this data was announced in January of 2016. Despite these results, Alkermes is reported to be continuing research into this potential new medication for depression.

Treatment of Pain in Patients with Addiction

 

 

 

 

Recently I was discussing the finer points of management of pain with a colleague, and it occurred to me I hadn’t done a recent post on the management of pain in opioid addicts.

I think about pain in two categories: acute and chronic. While there are some conditions that defy this handy concept, most types of pain fall into one of the two types.

This post will address only about acute pain; I will do another post about chronic pain in future posts.

To reiterate, I’m not talking about pain from chronic conditions like arthritis, chronic back pain, pelvic pain, fibromyalgia, and the like. In contrast, acute pain examples include broken bones, surgery, physical trauma from an accident, and other conditions that begin suddenly, and resolve over a period of weeks to months.

Just because a person has the disease of opioid addiction does NOT mean she needs to suffer through acutely painful conditions without the blessed relief opioids can bring. Obviously, any time a person with opioid addiction is given a bottle of opioids, pain or no, we worry about the risk of relapse. And we know relapse can be serious, even life-threatening. However, safeguards can be put into place to defend against a relapse.

Acute severe pain is more difficult to manage if the patient is taking buprenorphine than methadone, but pain relief can still be achieved.

Many patients in recovery from opioid addiction are surprised to discover that mild to moderate acute pain can often be treated with non-opioid pain medication like anti-inflammatories such as ibuprofen or acetaminophen. While in active addiction, many of my patients never even tried such measures, and are happy to find that they can be effective. Other options like massage, heat, ice, or elevation can also help.

But moderate to severe acute pain usually requires opioid pain medications.

For patients on methadone, the standard approach is to continue the methadone at the patient’s usual dose, and add short-acting opioids. Best results for the patient are seen when the opioid treatment program doctor communicates with the doctor treating the condition causing the acute pain.

When I collaborate with other doctors, I tell them to prescribe whatever they would prescribe for any other patient, except my patients will probably need about fifteen to twenty percent higher dose, to make up for their existing tolerance to opioids.

I don’t worry about a relapse while the patient is in the hospital. While hospitalized, the patient’s response to opioid medication can be controlled and adjusted. It would be difficult for the patient to abuse the opioids they are being given while hospitalized.

The greater risk occurs after the patient leaves the hospital. I suggest the patient give their bottle to a dependable non-addict who can dispense one dose at a time, or at least one day’s dose at a time. So long as someone else controls the opioid medication, my patient will be safer. I also recommend prescribing smaller amounts of opioids with more frequent follow-up, but that’s not always possible.

With buprenorphine, it gets tricky. Some patients on buprenorphine get pain relief from short-acting opioid prescribed in addition to the usual buprenorphine daily dose, but I’ve had plenty of patients tell me they could not get pain relief from opioids until after buprenorphine was stopped for several days. To be on the safe side, if a patient has a surgery scheduled, I’ll ask my patient to stop dosing the day prior to the surgery, and stay off buprenorphine until after the pain resolves enough to get by without short-acting opioids.

For patients who were more fragile in their recovery, I’ve used an approach that I learned from other doctors at addiction medicine conferences: I reduce the usual maintenance dose of buprenorphine down to 2 mg sublingual daily, starting the day before surgery. Theoretically, this low dose of buprenorphine prevents euphoria from short-acting opioids, while not blocking the analgesic (anti-pain) effect of these opioids.

For a planned surgery, I prefer to work out details of pain control with the other doctor prior to the surgery. Duh. I hate getting post-operative calls from the nurses of surgeons telling me I am expected to manage the patient’s pain, since the patient has addiction and Dr. Surgeon does not “believe” in prescribing opioids for opioid addicts.

Oh no. That does not work for me at all.

I’m not a surgeon, so I don’t know how long patients usually need opioids after this type of surgery. I also won’t know when the degree of pain may indicate some complication from surgery. Not to mention that I wasn’t the one who got paid for doing the surgery, and was not consulted pre-operatively.

I’m happy to collaborate with the surgeon, and of course prefer to do this prior to the surgery. I tell the surgeon I prescribe methadone/buprenorphine to treat addiction, not pain, and that the usual maintenance dose of either will not help with acute pain. I give the doctor some guidance regarding my patients’ opioid tolerance. I tell her our opioid treatment program will watch our shared patient more closely for signs of relapse, and that the counselor will work with the patient to get a dependable non-addict to handle the bottle of pills. I tell the surgeon that we are happy to do pill counts when needed, for additional accountability.

My patients tell me they hate to tell a surgeon or other new doctor about being in medication-assisted recovery. They say when they tell a new doctor about being prescribed methadone or buprenorphine, they sometimes detect a change in attitude, like judgment, increased brusqueness, or even hostility. They fear they will not be believed if they report pain.

I can’t blame them for being worried, because even when I call other physicians, I sometimes detect a bit of insolence from the physician on the other end of the phone. I often feel my legitimacy as a physician is being questioned, even though, ironically, I have more data to support what I do now as a doctor than I ever had as a primary care physician. I often sense a real reluctance for surgeons and other doctors to go along with what I’m recommending, and that’s a shame, because I have evidence-based information they can use.

My goal when talking with another physician is primarily to make sure my patient gets appropriate care including pain control. It’s a bonus if I can educate that doctor about medication-assisted treatment, and try to give them a better understanding of addiction and recovery.

Split Dosing of Methadone May Reduce NAS

I just read a new article (McCarthy et al, Journal of Addiction Medicine, Vol. 9, (2), pp105-110, March/April 2015) on methadone dosing during pregnancy. This study’s data showed reduced incidence of withdrawal in babies born to moms on divided doses of methadone compared to once-daily dosing. This data also showed reduced incidence of withdrawal in these moms on higher total doses of methadone compared to what we have seen in the past with lower maternal doses.

Current practice is to adjust the maternal dose of methadone according to how she feels. If she has withdrawal signs and symptoms, we increase her dose. We assume that if the mother’s at an adequate dose, the fetus should be doing OK too. We know reduced dosing of methadone during pregnancy is not recommended due to higher relapse rates in the mom, and worse fetal and maternal outcomes. Additionally, past studies showed no clear relationship between the maternal methadone dose and the likelihood of neonatal abstinence syndrome (NAS). In other words, increased maternal dose doesn’t increase the incidence or severity of withdrawal in the newborn.

However, we also have past studies which showed a significant decrease in fetal heart rates and fetal movement during times of peak methadone levels (several hours after dosing), compared to fetal heart rates and movement during times of trough blood levels (end of the 24-hour dosing cycle). Those studies showed more normal fetal heart rates and movement after splitting the total dose into equal doses, which is called split dosing. Due to this data, many opioid treatment program doctors have been trying to split the mom’s total methadone dose into two halves, a morning and evening dose.

The authors of this new study decided to build on past data and look at more than once-daily dosing of methadone during pregnancy. They also increased the total dose of methadone to treat any maternal report of withdrawal.

The study is a bit complicated. It was a retrospective chart review done in an eight-hundred patient opioid addiction treatment program in California from June 2008 until January 2013. The study followed sixty-two pregnant patients who were 83% white, 13% Hispanic, 2% African American, and 2% Asian. Of these sixty-two patients, 71% used primarily prescription opioids and 29% used mainly heroin. Some of these patients were already pregnant when they enrolled in treatment and some (32%) became pregnant after starting treatment with methadone. Sixty-six percent of these patients were smokers.

All the patients were moved to twice-daily dosing within several weeks of entry into treatment. Subsequent increases and further dividing of maternal dose was determined by maternal report of opioid withdrawal, and on methadone trough blood levels. All efforts were made to maintain maternal blood level in the “therapeutic range.” Most women dosed three or four times per day by the last trimester, and the average maternal dose at delivery was 152mg per day.
The highest dose in this study was seen in a pregnant patient who was a fast metabolizer of methadone. She required a total dose of 415mg, which was split into six doses. Interestingly, her infant did not need treatment for NAS.

The outcomes of the study were unusual in several ways.

Of the fourteen hundred urine drug screens collected on these pregnant patients, 88.4% were negative for illicit drugs. The mean gestational age was 38 weeks, and only 18% of the babies were born before 37 weeks gestation.

But here is the most noteworthy finding: only 29% of the babies had neonatal abstinence syndrome (NAS) that was severe enough to need treatment. As in other studies, this study showed no correlation between maternal dose and the incidence of NAS.

In the past, the incidence of neonatal withdrawal syndrome has been estimated at 60-80%, though the MOTHER study of 2010 (Jones et. al) found 50% of infants born to both moms on methadone and moms on buprenorphine had withdrawal that was severe enough to need treatment. (That study also found infants born to moms on buprenorphine stayed in the hospital half as long as babies born to moms on methadone, and also had much less severe NAS.)

In this present study, the babies conceived during methadone treatment were not significantly more likely to have NAS than the babies born to moms who conceived prior to entering medication-assisted treatment with methadone.

Male infants were a little more likely to need treatment for NAS than the females.

The authors concluded that divided methadone dosing and adequate methadone dosing during pregnancy increased maternal recovery and resulted in less stress on developing fetuses. The authors postulate there was less sensitization to repeated episodes of intrauterine withdrawal, which ultimately resulted in much lower rates of neonatal abstinence syndrome.

The authors also identified some limitations of their study, and recommended further investigation.

Over the last few years, doctors in North Carolina have been trying to do split dosing on pregnant women when possible. To do this, the woman must be stable enough to manage the second half of the dose, given as a take home. If there’s an addicted male partner at home, that second dose may fall into the wrong hands, and the pregnant patient can get shorted part of her dose. That’s not a good thing during pregnancy, so it’s all about balancing risks with benefits.

This is an intriguing study, but it’s probably too soon to change what we are doing in OTPs. I know I’d like to hear how ASAM experts interpret this information.

The information in this study was gleaned from a retrospective review of patients, which may not be as good a study as a prospective double-blind study, if such could be conducted.

I’m impressed with the 66% smoking rate. I estimate that around 95% of pregnant patients at the OTPs where I work are addicted to nicotine. But I live in a tobacco state, and the study, done in California, has fewer smokers. I think that might be a significant difference, because we know NAS is more like to occur in smokers. Did that play a role in the lower NAS incidence found in this study?

Did the authors of this study take any extra measures to ensure their pregnant patients were living in a safe environment, conducive to recovery? Are the authors sure their pregnant patients were able to consume all of their take home doses? Were any doses diverted, willingly or unwillingly, to other people? Sometimes female patients live with partners who are also addicted, and the patients may be tempted or coerced into giving a dose to a partner in opioid withdrawal. If this happened it could change conclusions of this study.

I suspect the average maternal dose in this study was higher than at most opioid treatment programs in my area. As the authors concluded, this likely improved the mothers’ health and outcomes. This study had a very low rate of positive drug screens, so these patients appear to have been doing exceptionally well in treatment. So is it possible that there could be less withdrawal in babies born to moms on higher doses? That seems counterintuitive, but the authors do suggest that could be why they had low NAS incidence.

The pregnant women in this study got more counseling and support from their OTP than may be provided in other OTPs. The patients in this study had a weekly meeting with a pregnancy counselor, weekly group meeting for education and support facilitated by the clinic physician, psychiatric assessment, and monthly supportive psychotherapy. They got weekly urine drug screens, so there was close accountability. They also had methadone trough blood levels drawn when needed.

The study presents intriguing data. We need more information, more studies to see if higher and divided methadone doses will provide better outcomes with less NAS, as was seen in this study.