Archive for the ‘Governmental solutions to addiction’ Category

New OTP Guidelines Issued by SAMHSA

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Our nation’s Substance Abuse and Mental Health Services Administration just published new guidelines for opioid treatment programs, released in late March. SAMHSA updates the guidelines in order to re-interpret the existing federal regulations in the face of changing medical issues faced by opioid treatment programs in this country.
I can’t list all the updates in a single blog entry, but I’ll comment on those I find most interesting and relevant. If you want to read the entire SAMHSA document, you can get a free download at: http://store.samhsa.gov/product/PEP15-FEDGUIDEOTP

First of all, near the beginning of the document, it says the new guidelines reflect the responsibility that OTPs have to deliver “patient-centered, integrated, and recovery oriented standards of addiction treatment and medical care in general.”

I’ve long marveled at how, in the mental health and addiction treatment field, so many words can be used without saying much of anything. (I once heard the head of a federal government agency talk for forty-five minutes and say absolutely nothing. That is a gift.) Also, words and phrases in this field take on meaning beyond what those words traditionally mean. Innocent-looking phrases take on coded meanings.

For example, “recovery-oriented”…what does that mean? Part of what this phrase seems to mean is the same as what “harm reduction” meant in the past, except it became so controversial that we needed a new phrase.

Recovery-oriented means a patient’s recovery program may not look like what we’ve imagined in the past. Maybe the patient isn’t fully abstinent from all drugs, but if the patient is doing better than in the past, we accept that as a worthy accomplishment. Rather than black and white thinking of abstinence as the only recovery and any drug use as a full relapse failure, recovery-oriented approach means accepting any change for the better as a worthy goal.

I am fine with this. The field of medicine is harm-reduction. At least, that’s what it’s like in primary care. It may be different in surgery, where the diseased gall bladder can be cut out and the patient is permanently cured of gallstones. But much of primary care is all about keeping the patient as healthy and functional as possible, for the longest time possible, despite some non-compliance on the patient’s part. It makes sense to view the treatment of addiction in the same way.

Integrated: the bane of my existence…it means all people caring for the patient, plus the patient, TALK to one another. I’ve whined on this blog before about the difficulty of talking to my patient’s other doctors so I agree it’s a big problem but SAMHSA’s kind of preaching to the choir with that one.

It also means getting the patient’s family and/or friends involved if possible and if OK with the patient, along with other supports available in the community.

These new SAMHSA guidelines also tackled new technologies, like telemedicine.

Patients in remote locations can now communicate with care providers using new technology, sometimes called telemedicine, or e-therapy, or telehealth. This technology can make care more convenient for patients who live in remote areas, and encourage more participation in care by making it easier to access. These are worthy goals, but of course there are also risks.

Since Medicaid and Medicare services already has guidance for this type of care, the new OTP guidelines remind us of we have to do if we treat patients with Medicaid or Medicare… and want to get paid.

The new OTP guidelines make several points. They remind us that providers need to follow their own states’ laws around telemedicine, and to make sure transmissions of data during telemedicine are secure, relatively resistant to hacking. The guidelines also remind us telemedicine can’t expand a provider’s scope of practice (what the provider is allows to do, medically speaking), and that telemedicine can’t be used in situation where physical exam is necessary.

At first, I interpreted this to mean that admission to opioid treatment programs cannot be done by telemedicine, since a physical exam is required. But then I read this sentence: “…[telemedicine] may be used to support the decision making of a physician when a provider qualified to conduct physical examinations and make diagnoses is physically located with the patient.”

So can a physician assistant do the exam and relate finding to a physician who then can order the starting dose? I think that’s allowed by this sentence, at least by federal standards. State standards may vary, though.

This discussion naturally leads to another big expected change in the new guidelines. Many people working at OTPs expected these new guidelines to permit physician extenders like nurse practitioners and physician assistants to do admission history and physical exams for OTP patients, give induction orders, and do dose change orders.

This did not happen. Apparently, according to discussion at the AT Forum (http://atforum.com/2015/04/new-otp-accreditation-guidelines-will-not-allow-mid-levels/ ) SAMHSA’s lawyers put a halt to this, and said physician extenders could not do these things. The lawyers said that implementation regulations say “dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling.”

I have mixed feelings about allowing physician extenders, by which we mean nurse practitioners and physician assistants, to do admission orders. Often, patients presenting for OTP admission are complex, with both chronic pain and addiction issues, sometimes also with severe mental health disorders. I don’t think a new nurse practitioner graduate with little experience could do the job without a whole lot of special training. On the other hand, I know a physician assistant, working in the Addiction Medicine field for years, who is as good if not better than many doctors in the state. He’s competently been doing admissions and dose changes for years.

Thankfully, a sort of compromise has been proposed. Treatment programs can ask their state opioid treatment authority (SOTA) for an exemption from usual regulations, to allow a qualified physician extender to do admission orders and dose changes. Both the program’s medical director and program sponsor must give a clear reason why an extender is necessary to improve care. Then SOTA decides if allowing this particular physician extender enhances the care of patients at that treatment center.

For example, a program in a remote area may have problems finding physicians to work as many hours as the program needs. In that case, the medical director may know a physician extender who is experienced and mature, who could safely meet patients’ needs. That program could explain all of this to their SOTA and get an exemption, permission for the extender to do work ordinarily not allowed by state and federal regulations.

This seems like the best of both perspectives. Well-trained and competent physician extenders can get permission to do this work, while the state can withhold approval for an extender with little experience or training. Hopefully exemptions will be given for legitimate need, and not just because extenders are cheaper to hire than physicians.

Finally, I was pleased this version of the OTP guidelines frankly discusses the dangers of benzodiazepines: “…Benzodiazepines are highly associated with overdose fatalities when combined with opioids. Patients known to be using benzodiazepines even by prescription should be counselled as to their risk and provided with overdose prevention education and naloxone.” The guidelines go on to recommend providers consult IRETA’s best practices guidelines around how to manage the benzo issue without overreacting in either a too permissive or too restrictive manner.

Regular readers of my blog will recall I did several blog posts, in 1/26/14 and 2/2/14, about the IRETA guidelines when they were first published.

In the past, SAMHSA guidelines didn’t speak to the dangers of mixing benzos with MAT, leading some doctors to underestimate the dangers to MAT patients. In some areas, where benzos are prescribed appropriately, it’s not a big issue. However, in geographic areas (like the South) where benzos are commonly prescribed outside of accepted guidelines, it’s a huge problem. I often see patients prescribed benzos literally for years, despite guidelines which say benzodiazepine usefulness is limited to a few weeks to months. There’s no evidence benzodiazepines are of benefit past that, and mounting evidence indicates that they can be harmful (overdose, increased risk of falls and motor vehicle accidents, broken bones especially in the elderly, etc.)

I did find one sentence on naloxone, the medication that reduces opioid-overdose deaths, under the section on orientation to treatment. It says OTPs should provide patient education, including “Signs and symptoms of overdose, use of the naloxone antidote (prescriptions should be given to patients on entry into treatment), and when to seek emergency assistance.”
It’s not much, but it’s a start.

Use of prescription monitoring programs was mentioned repeatedly in these new guidelines. In 2007, when the last guidelines were published, many states didn’t have prescription monitoring programs. My state’s PMP was just becoming available in 2007, so it was a new and exciting tool.

Sections of the present SAMHSA guidelines strongly recommended the PMP be used upon admission to an opioid treatment program, and periodically during OTP treatment. The guidelines suggest the PMP be checked quarterly, which should be do-able.

I think SAMHSA’s new guidelines bravely addressed some of the problem areas of OTPs and gave some direction to programs about these issues. It’s not a perfect document, but it appears much thought and discussion was given to these issues.

North Carolina Prepares to Step Off a Cliff…

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The first time I saw a copy of North Carolina bill S297, it was from a prankster friend. I thought I was being punk’d. I thought someone, knowing how crazy it makes me when politicians play doctor, wrote this phony bill and said it was up for consideration in the NC legislature.

When more reputable people sent me similar notices, I found out this bill is for real.

Republican Brent Jackson presented this bill, which reads, “A woman may be prosecuted for assault under G.S. 14-33(a) for the illegal use of a narcotic drug as defined in G.S. 90-87, while pregnant, if her child is born addicted to or harmed by the narcotic drug and the addiction or harm is a result of her illegal use of a narcotic drug taken while pregnant. “

The bill goes on to say that the pregnant woman has a defense to prosecution if she is involved in a treatment program before delivery, stayed in the treatment program after delivery and – get this – completed the program.

This is not a good law.

While it may make politicians and voters feel like they are doing something to stop reckless drug-addicted women from using drugs during pregnancy, it demonstrates a lack of knowledge about what addiction is, how it is treated, and the few treatment options open to opioid-addicted pregnant women.

Here are the ways in which this law is bad, and will worsen the health of addicted women and their babies:
1. Addicted women who become pregnant will shun pre-natal care. They won’t want to take the risk of being sent to jail. While proponents of the bill say it should encourage addicted women to seek help, that’s not realistic. It’s contrary to human nature for a sick person to get medical care if that illness it a crime.

Women with addiction who become pregnant are no different from other women. They want all the best things for their baby, and especially want that baby to be healthy. Most women will have already tried desperately to stop using drugs, and are unable to do so. The inability to stop using is one of the symptoms of the disease of addiction, after all. They are loaded down with shame and guilt over using drugs while pregnant. They feel like bad people, and they feel hopeless. They do what humans do when they feel bad about themselves – they hide. They don’t go to doctors.

Fewer and later prenatal visits directly correlate with worse outcomes. Best results for the mom and babies are seen when addiction is treated as the public health problem that it is.

2. Let’s say the woman IS able to stop using drugs on her own somehow. If the woman is addicted to opioids, her pregnancy can be endangered if she stops suddenly. We know, from years of studies, that opioid withdrawal in pregnancy increases the risk for complications such as pre-term labor, miscarriage, placental abruption, and other conditions. Even if nothing catastrophic happens, the baby is more likely to be born early or have a low birth weight. Even if she’s able to stop without calamity, we know that relapse rates are consistently in the 90% range.

3. If the opioid-addicted pregnant woman came to her OB and asked for help with her addiction, what do you think would happen? I’ve seen such patients shuffled around from place to place with no one willing to take responsibility to treat this high-risk patient. Opioid treatment programs, some teaching hospitals, and one of the state-run inpatient facilities in the state, Walter B Jones in Greenville, NC, are the only places I’ve seen that are willing to take care of these women.

I had one pregnant patient who went to our local hospital emergency department to ask for help with her addiction, as soon as she found out she was pregnant. She talked to the doctor there, who called our local management entity (our equivalent of county mental health system). That LME sent a worker to interview her and the worker recommended she get an appointment with an obstetrician to get help. The ER sent her home with the names of OB’s in the area, which, by the way, she already had. On Monday morning she called them, and was told she could be seen in a few weeks, after she got approved for her pregnancy Medicaid, since she had no insurance at present.

Frustrated, she called that doctor’s office back, and explained that she had an addiction and needed help more quickly. She was directed to go to the emergency department but when she told them she’d already gone there, they recommended she go to a detox.

She went to the local detox unit in our area and they would not admit her because, you guessed it, she was pregnant and they said they weren’t equipped to treat pregnant patients. They recommended she go back to the local emergency department.

She did go to an emergency department, but had the good sense to go to Forsyth Medical Center in Winston-Salem. She was admitted to their detox unit and started on buprenorphine. Workers there arranged for her to be admitted to our opioid treatment program immediately after she was stabilized and discharged from their hospital.

She spent four days trying to negotiate the confusing network of care in our state. Some patients may not be that willing to persist after getting no help from three or four sources.

4. Women may be more likely to consider abortion as an option, even if they would like to have the baby. Think about it – if you commit a crime by becoming pregnant while addicted, what’s the quickest way to remain within the law, prevent arrest with its public humiliation? Get rid of the pregnancy. I suspect it’s easier to get an abortion than to get inpatient drug addiction treatment in this state, but I do not know this for sure.

5. The bill lacks knowledge of addiction as a chronic illness. When farmers become politicians and think they can play doctor, we get these nonsense laws. Since addiction is a chronic illness, the treatment won’t have a “completion.” It makes as much sense as saying a diabetic who gets pregnant won’t be prosecuted for eating sugar if she “completes” the treatment for her diabetes.

It reminds me of my patient in primary care who got angry when I told him he would have to keep taking his blood pressure pills in order for them to work. He thought blood pressure pills should cure the disease. He told me he was taking his business elsewhere, to a better doctor who would prescribe something to cure his hypertension, not just keep taking a pill every day to treat it. He could not grasp the concept of a chronic illness.

6. Second, I hate this term “narcotic.” It’s become more of a legal term than medical. In the doctor world, narcotic means anything that could put someone to sleep. “Narco” in Greek, means sleep, thus the association with sleep and sedation. So I went to GS 90-87 to see what the state’s definition is for this word. Turns out they mean cocaine and opioids.
Sleeping pills and benzodiazepines are not mentioned, and neither is marijuana or methamphetamine. Will these drugs also be illegal in pregnancy?

7. These types of laws attempting to punish “bad” women who use drugs while pregnant are unevenly enforced. You won’t see an affluent opioid-addicted pregnant woman incarcerated under this law, but you may see poor or minority women incarcerated. They have fewer resources to avoid prosecution and less voice to speak out against bad laws like these. One only need look at other states with similar laws to see this is true. Just look at the first person to be jailed in Tennessee after their harsh new law was passed last year.

Plus, these laws are not upheld by higher courts. In Ferguson versus City of Charleston, the Supreme Court held that it was an illegal search when hospital workers sent urine samples for drug tests without consent from the mothers.

If North Carolina passes this bill, we will be the second state, after Tennessee, to pass laws making drug use during pregnancy a crime. Do we really want to model ourselves after Tennessee, with all of their mess?

8. If politicians want to take action to prevent harm to babies, they should focus on nicotine. We know smoking in pregnancy is very harmful to the fetus and newborn, and far more women smoke than use drugs. You can read a summary of current knowledge at this CDC site: http://www.cdc.gov/reproductivehealth/tobaccousepregnancy/
Why does the NC legislature treat smoking during pregnancy as a public health issue? Why not criminalize smoking while pregnant, since we know much more about the harm caused by cigarettes? I could ask the same question about alcohol as well.
Of course I know the answer to my own question. Alcohol and cigarettes are legal, and have much less stigma than other drugs, even though both kill more people per year than all other drugs combined.

Can’t we please let common sense and medical science drive the bus on this issue? Even if you are mad at pregnant women who use drugs and have a desire to punish them, please refrain from doing so, if only for the sake of the babies, who WILL suffer if this law passes.

Policies that inflict criminal penalties on pregnant women with the treatable disease of addiction cause harm to everyone. Hospitals have higher costs when a mom with no prenatal care arrives on their door step ready to deliver, with much higher rates of perinatal complications. Taxpayers end up paying the high costs of incarceration for these women. But most of all, the babies and their moms are harmed.

The “Protect Our Infants Act”

Rate of neonatal abstinence syndrome per 1,000 live births, by mother's county of residence

Rate of neonatal abstinence syndrome per 1,000 live births, by mother’s county of residence

(This map can be seen at:http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6405a4.htm )

I just read an interesting news piece about new legislature named “Protecting Our Infants Act.” This bill was sponsored last year by Rep. Katherine Clark of Massachusetts, but died during the session. Then she got support from other congressmen, including Rep. Steve Stivers from Ohio (who happens to represent the area of the country where I was raised, in Southeastern Ohio), and Sen. Bob Casey of Pennsylvania. When Majority leader Senator McConnell got onboard as a sponsor of the bill this year, it gained momentum, and is now in a congressional committee, waiting to be sent to the house or Senate.

When I first heard about this new bill, and that Senator McConnell was backing it, I worried it might be something weird and unscientific that would send us backward in time. But after reading the bill online for myself, I’m in favor of it: https://www.congress.gov/bill/113th-congress/senate-bill/2722/text

This bill asks the Secretary of Health and Human Services to collect and evaluate all of the best evidence-based information available about how to prevent and treat babies born dependent on opioids. The bill’s actual wording is that the secretary of HHS “shall conduct a study and develop recommendations for preventing and treating prenatal opioid abuse and neonatal abstinence syndrome, soliciting input from nongovernmental entities, including organizations representing patients, health care providers, hospitals, other treatment facilities and other entities, as appropriate.”

The bill asks for Health and Human Services to identify and also report on any gaps in our knowledge, where more research is needed. The bill also requests an evaluation of medical use of opioids during pregnancy, and an assessment regarding access to treatment for opioid-addicted pregnant women and post-partum women. The bill asks for an evaluation of the risk factors for opioid addiction, and the barriers to treatment.

According to the bill, the Secretary of Health and Human Services will collect all this information and post it on a website, available healthcare providers in the U.S., in no less than one year after the bill (hopefully) passes.

Our present Secretary of Health and Human services is Sylvia Mathews Burwell, who replaced Kathleen Sibelius last summer. I didn’t know much about her, so I went to the website for HHS, and found a blog post of hers, addressing our epidemic of opioid addiction: http://www.hhs.gov/blog/2015/03/26/its-time-act-reduce-opioid-related-injuries-deaths.html

I really like what I read. In her blog post, she emphasizes three areas which need attention: wider distribution of naloxone to prevent opioid overdose deaths, better prescribing practices by doctors, and…“using medication-assisted treatment to slowly move people out of opioid addiction.”

What a relief. She supports MAT. I mean, one would hope and expect such support for evidence-based treatments, but as my readers know, sometimes politicians take strong positions on matters about which they know little (oh yes I’m talking about Tennessee).

If the Secretary does a good job, this is a golden opportunity to promote evidence-based treatment of opioid addiction in pregnancy: MAT.

I also think some politicians could learn things they didn’t expect.

Is it possible that with such a prominent seal of approval, both methadone and buprenorphine treatment of opioid addiction will move out of the dark ages? Perhaps politicians will say, “Oh I now see I don’t know what I’m talking about when I limit access to treatment at methadone and buprenorphine programs! How foolish of me!”

Is it possible that someday in the future I’m going to call a certain obstetrician in my area about the methadone dose of a patient we both treat, and he will say, as he’s said before, “It’s wrong to treat pregnant patients with methadone. You need to get them off that stuff!”

And I will say…please go to the Health and Human Services website, to read what the experts say, since you won’t believe me. And he will read. And he will change his mind. He will begin to encourage all his opioid-addicted patients to seek effective, evidence-based treatment… And the health of the whole community will improve as we come to agree on evidence-based solutions to medical problems.

So my first train of thought was a happy engine, chugging along with optimism and relief. Then came the caboose of negativity.

Why do doctors need to have the Secretary of Health and Human Services research this issue for them? For prevention, yes, that’s a public health issue and more research would be valuable. But to find out how to treat a medical issue?? If doctors have a question about how to deal with a medical issue, we have sources that summarize and review best data to date. We go to a reliable source, to the experts in the field. For the topic of opioid addiction in pregnancy, one would ask obstetricians and addiction medicine doctors.

Oh wait. The American College of Obstetrics and Gynecology, along with the American Society of Addiction Medicine, already have published a position paper of best practices in this area. It is titled, “Opioid Abuse, Dependence, and Addiction in Pregnancy.” They didn’t hide their report in a dark cave. They published it. They posted it on the internet:

In fact, if you Google “pregnancy and opioid addiction,” one of the first options is ACOG’s paper: http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Health-Care-for-Underserved-Women/Opioid-Abuse-Dependence-and-Addiction-in-Pregnancy
And for those people who are deeply puzzled by how to treat opioid addiction in pregnancy, this is the summary sentence of the report, published in 2012: “The current standard of care for pregnant women with opioid dependence is referral for opioid-assisted therapy with methadone, but emerging evidence suggests that buprenorphine also should be considered.”

That wasn’t so hard, was it?

Then I Googled “american academy of pediatrics and neonatal abstinence syndrome,” because I figure who knows kids better than pediatricians, and my first choice was a state of the art review article from 2014 describing NAS and its treatment in detail.

After considering the “Protecting our Infants Act,” I have several observations. First, it’s not terribly hard to find state of the art information about the treatment of opioid addiction in pregnancy, and the treatment of neonatal abstinence syndrome, if the healthcare worker really wants to find it. But if the healthcare worker can’t or won’t accept these answers due to ideology, a report from the Secretary of HHS may carry more weight than the science that’s already available.

I also believe we have a whole lot more to learn in this field. This new Act’s best feature is the mandate to assess areas where we need more research, and to investigate barriers to treatment, because there are many. For example, Eastern Tennessee has one of the highest rates of NAS in all the country, yet that state denied a certificate of need for a methadone clinic to be established to serve that area. I do believe that history will judge those politicians harshly.

I hope the bill passes. It would be interesting to see what the Act’s current sponsor, Senator Mitch McConnell, would think about the DHH report.

North Carolina Pregnancy & Opioid Exposure Project

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Imagine being in a room filled with more than four hundred people: social workers, nurses, substance abuse counselors, and doctors specializing in obstetrics, pediatrics, and addiction medicine. Every one of them are there to learn how to care for pregnant women using opioids or addicted to opioids.

This actually happened earlier this month at the POEP conference in Greensboro, NC. (POEP stands for Pregnancy & Opioid Exposure Project. You can learn more about this organization at their website: http://www.ncpoep.org )

This organization, funded through a federal block grant through the NC Department of Mental Health, is run by the UNC School of Social Work. The organization has managed to bring together many of the people in our state who take care of pregnant women with opioid addiction. The goal of POEP is to disseminate information, resources, and technical assistance regarding all aspects of opioid exposure in pregnancy. The organization was formed in 2012 in response to concerns about the problem of pregnant women being exposed to opioids.

This organization is talking about all opioid use in pregnancy, not only about addiction in pregnancy. Some pregnancy women are prescribed opioids for the treatment of pain. These women may have physical dependence on opioids, though they may not have the mental obsession and compulsion to take opioids. However, the same problems can be seen in the newborn whatever the reason the woman takes opioids, so there is overlap in the problems faced.

This conference had renowned speakers; Marjorie Meyer, an expert in maternal-fetal medicine from Vermont, was the keynote speaker. This doctor participated in the MOTHER trials, and also set up an innovative treatment method in Vermont for mothers addicted to opioids. She has written about her data, and contributed greatly to our knowledge about buprenorphine in pregnancy (see my blog post of February 28, 2015).

Dr. Hendree Jones, lead author of the MOTHER study, did an excellent session on myths about medication-assisted treatment in pregnancy. She’s also a world-renowned leader in the field of addiction in women.

Dr. Stephen Kandall was there, and spoke about the challenges of advocating for women with addiction, with some historical perspective. He wrote an outstanding book, “Substance and Shadow: Women and Addiction in the United States,” which is one of my all-time favorites. It’s one of the best books about females and addiction. This conference was the first time I met Dr. Kandall, and I got all creepy-gush-y, and dithered about how much I loved his book. I can be such a nerd at times, but he was very polite and gracious.

There were many sessions going on at the same time, so it was impossible to go to all of the sessions that I wanted to attend. Other speakers talked about how best to coordinate care for pregnant women when they go to the hospital to deliver their babies, how to work with the court system if the pregnant woman has legal problems, and how to work with female patients on opioids about family planning.

I was honored to be one of the four-doctor panel that was organized to answer audience questions about medication-assisted treatment with buprenorphine and methadone during pregnancy. We got some great questions, like how to deal with co-occurring benzodiazepine use during pregnancy. Our session was only forty-five minutes long, and we probably could have spent a few hours answering all their questions. I was also impressed by the thoughtful opinions and recommendations from the other three doctors, all leaders in our state.

This conference was a great experience. I felt like many of the attendees got a better view of what opioid-dependent pregnant women need, and where and how to direct them for the best care. I’m pleased people in our state cared enough to start the difficult work of informing families and care providers about the problem of opioid use and addiction during pregnancy.

POEP has a great website that I’ll recommend to the pregnant women I treat, and I’ll also recommend it to their obstetricians. That site has clear information not only for families, but also for care providers. Here are the fourteen important points for infant care providers, taken directly from the POEP website:

“Key Messages for Infant Care Providers Working with Families of an Opioid-Exposed Newborn
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1. Parents should be counseled as early as possible (preferably well before delivery) about the need for close monitoring of an opioid-exposed infant.[2]
2. Parents should be encouraged to disclose any maternal opioid use that occurred during pregnancy and should be treated in a nonjudgmental manner.[3]
3. Hospital care of the newborn should be family-centered, meaning that the parents should be a driver in the care plan.
4. Parents should receive education about how opioid-exposed infants are monitored and how neonatal abstinence syndrome (NAS) is treated at their delivery hospital.
5. There are various approaches to monitoring for neonatal abstinence syndrome in opioid-exposed infants, such as the use of the Finnegan Scoring tool.[2],[3]
6. Monitoring for the onset of NAS may mean the infant will be monitored in the hospital for up to 5 days.
7. Infants at risk of NAS may be monitored in the mother’s room, in the newborn nursery, special care nursery or neonatal intensive care, depending on hospital protocols and resources.
8. There are various approaches to the management of NAS including non-pharmacologic interventions and pharmacologic therapy, depending on the needs of the infant. Approaches include:
• Non-pharmacologic management of NAS: environmental controls emphasizing quiet zones, low lighting, and gentle handling. Loose swaddling, as well as holding and slow rocking of infant may be helpful. The use of a pacifier for excessive sucking is also helpful.[2],[6],[7]
• Pharmacologic management of NAS: the use of a variety of medication to ease the withdrawal symptoms of the infant. Common medications include opioids (dilute tincture of opium, morphine, or methadone) and phenobarbital.[2],[6],[7]
9. Breastfeeding is encouraged for women in medication assisted treatment, unless there are medical reasons to avoid it. Reasons to avoid breastfeeding include an HIV infection or specific medication for which breastfeeding is not safe.[2],[3]
10. Infants experiencing NAS may have difficulty establishing breastfeeding or bottle-feeding. Women may need additional encouragement and lactation consultation to support breastfeeding.[2],[3]
11. Whenever possible, having the newborn room-in with the mother while in the hospital is encouraged. Benefits include opportunity to initiate breastfeeding, bonding and decreased need for treatment of NAS.[1]
12. Some infants will experience NAS as a result of maternal opiate use through a treatment program (such as a methadone maintenance program) or by prescription (such as buprenorphine for an opioid use disorder or prescription narcotics for pain management). The opioid exposure alone in situations where the mother was adherent to a prescribed treatment plan would not constitute an appropriate reason for referral to Child Protective Services. See structured intake 1407 http://info.dhhs.state.nc.us/olm/manuals/dss/csm-60/man/
13. Not all infants at risk of NAS are identified in the hospital, particularly in situations where maternal use of opioids has not been disclosed. This may be due to women not disclosing legal or illegal use of opioids.[2]
14. Withdrawal symptoms from opioids may appear in the infant after discharge to home. It is important for providers working with the infant and the family in the community (pediatricians, CC4C, Early Intervention) to be aware of signs and symptoms of NAS. If the infant displays any of these signs or symptoms, the family should be encouraged to seek pediatric care promptly.[2]”

North Carolina has a great start in addressing the problem of opioid-exposed newborns. The organizers of POEP can stand as an example of how other states can begin to address this challenging situation. Neighboring states (you know I’m talking about Tennessee!) have walked in the opposite direction, preferring to view opioid use during pregnancy as a crime rather than the medical problem that it is. That’s sad, because an aggressive attitude of judgment is correlated with poorer outcomes for both mother and infant.

Congratulations to the organizers of the POEP conference. Hopefully it was the first of many more to come.

The Broken System

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I’m feeling discouraged this week, due to a recent vivid display of my state’s broken mental health/substance abuse treatment system.

Details of this encounter have been changed to protect identities.

One of our former opioid treatment program patients returned to us, asking to be admitted again to methadone maintenance. In previous admissions, this patient struggled with repeated bouts of benzodiazepine addiction and had several near overdoses. He also had months at a time when he did relatively well, with little benzo use. I felt we were helping him – to some degree – until late last summer, when his condition worsened after his son died from an overdose. He was distraught and using all types of drugs in order to push away the pain of his loss. I became worried he would die of an overdose if we didn’t do something different. We really wanted him to go to inpatient care, because he’d become too sick for outpatient, medication-assisted treatment. He rejected this option and left treatment.

He was back last week, asking for help. He admitted to using a wide variety of drugs, including benzos, illicit methadone, cocaine, alcohol, and marijuana. He knew he was still grieving for his son, and he too had come to fear that he would die from his addiction. He was now ready to go to an inpatient residential treatment center. Even though we don’t offer that service, he came to us when he couldn’t find help anywhere else.

He’d already gone to our local hospital emergency department two days prior, asking for help, but he said he was turned away with no evaluation and no medication. Our patient told us the emergency department personnel told him he could be put on a waiting list for an inpatient program, and that it could take weeks for a bed to open up for him. Our patient left the emergency department feeling like personnel there didn’t care about what happened to him. He suspected they judged him as a bad person, not a sick person. He got no further referrals for treatment and wasn’t even offered clonidine, a blood pressure medication that can help with some of the opioid withdrawals.

Granted, our patient may be leaving out part of the story, or too sick to remember accurately. I know better than to take every patient report as completely accurate, but what this patient said had the ring of truth to it, and I tend to believe he gave an accurate account of his emergency department experience.

After this disappointment, he came to our program, saying he knew we did care about what happened to him. For the next five or more hours, our OTP counselor tried to get help for this patient.

First, she called our local management entity, or LME. This is a weird, non-descriptive term for local governmental agencies in North Carolina that contract with other mental organizations to provide care for any patient with substance abuse and/or mental health issues. LMEs are the safety net…but the net is broken.

The counselor called the LME and they offered to send a mobile crisis team. This is a grand term implying quick, on-site help for resolution of crises facing the service recipient. Service recipient is the new term for patient, by the way.

The mobile crisis management team consisted of a young woman with a bad attitude and little idea how to talk to patients who were sick and suffering. After an assessment of about forty-five minutes, which necessarily consisted of questions that we had already asked her, this mobile crisis management worker told our patient that he was in opioid withdrawal, and it was likely to get worse instead of better.

At this epiphany of the obvious, our patient thrust his face towards the worker and said sarcastically, “Ya think??” It was obvious our patient did not regard this revelation as particularly helpful. It was also obvious he had offended the worker, who angrily started to pack up her belongings. She said the only thing she had to recommend was going to the emergency room. When our patient informed her he had already gone there two days ago and no help had been forthcoming, the mobile crisis worker said that if he didn’t want to take her advice, she couldn’t make him. She said she could put on the list for a bed at an inpatient program, but it could take weeks for a bed to open. Then she left.

So…I was not at all impressed with the mobile crisis management team.

Our tenacious OTP counselor flew into action again, and called our favorite inpatient treatment program directly. This is a state-run program that’s also an opioid treatment program, named Walter B Jones ADATC (alcohol, drug addiction treatment center). It’s affectionately called “Walter B” by us. It’s the only inpatient program in the state that I know of that will admit patients with opioid addiction and keep them on their maintenance meds or start them on maintenance meds.

I felt that starting the patient on methadone as an inpatient, while benzodiazepine withdrawal was being managed, would be much safer. His mental health status could also be addressed, or at least begin to be addressed. A few weeks as an inpatient won’t fix everything, but it is a start, and the best option we could think of.

Walter B said they wouldn’t have a bed for at least a week, and that they needed an EKG and various labs prior to admission. This is because they don’t want to admit a medically unstable patient. Our patient would still have to go back to the hospital emergency department for the EKG and labs, since our OTP doesn’t have the capacity to do those. But our local emergency department sometimes refuses to do lab tests for inpatient admissions. I don’t know why, but I’m guessing it’s because most of these patients have no insurance, and the hospital assumes they’ll get stuck with the bill.

Next, our OTP counselor called a local detox facility. This facility does not “believe” in methadone maintenance and doesn’t even use buprenorphine to ease opioid withdrawal symptoms. But they do administer phenobarbital to help with benzodiazepine withdrawal, and they could perform the labs this patient needed for admission to Walter B. It wasn’t an ideal solution either, but an option.

No one answered the phone at this detox facility. The counselor left several voice mail messages, but didn’t get any calls back.

Frustrated but by no means willing to give up, our tenacious counselor called Project Lazarus. This is a program in Wilkes County that has received accolades for its work at preventing opioid addiction, overdose deaths, and promoting evidence-based treatments for opioid addicts. People who work at Project Lazarus have connections. They tend to know everybody in the treatment field, so they are often a valuable resource for us. One of their employees did know someone at the detox, and was able to call them through a back channel. That person finally called our counselor back.

Finally, a plan emerged. Our patient would go to this private detox that day or the next, where he could get the labs Walter B wanted. In a perfect world, our patient would leave the detox on the day a bed opens at Walter B. However, if that can’t be worked out, I will admit our patient to methadone as a stop-gap until the inpatient bed opens up. After treatment at Walter B., our OTP will accept him back into treatment and continue efforts to stabilize him.

This isn’t the best plan and it isn’t the safest plan. It’s piecemeal at best, and the plan could still fall through.

Ideally, our LME would contract with an agency that could do all of this for the patient. Ideally, detox beds could be offered on the same day the patient asks for help, with a seamless transition to inpatient treatment to continue patient stabilization. Inpatient treatment programs would offer patients medication-assisted treatment of opioid addiction or abstinence-based treatment and the patient could participate in the choice. Instead, most inpatient facilities don’t even mention the possibility of medication-assisted treatment, so there is no informed consent about which type of treatment is given.

If it took a dedicated and savvy counselor five hours and multiple phone calls to work out a plan for this patient, how would he have been able to access care on his own? Indeed, he did try to access care on his own, and failed to get timely help.

I wish all of the people who recommend inpatient abstinence-based treatment of patients with opioid addiction should be made to try to navigate our present labyrinth of care. This wasn’t even a non-insured person; he had Medicaid, and we still couldn’t find a bed for him.

I know our state has little money with which to treat mentally ill and addicted patients. Budgets for mental health and substance abuse treatments have been cut to the bone and then deeper. The public expects a safety net to appear without having to pay for it. The state-funded facilities do miraculous things with the little money that they have. But no one should have the misperception that our system of care is anything but broken.

Expanding Access to Buprenorphine

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My last blog post stimulated some lively debate, and I thought this topic deserved further discussion. However, I would like to ask commenters to talk about the issue and please refrain from mentioning specific names of previous commenters. Please and make your points in a thoughtful and respectful manner. Thanks for your cooperation.

Given our present epidemic of opioid addiction and opioid overdose deaths, authorities are considering lifting the 100-patient limit for physicians who prescribe buprenorphine from office-based settings. Some people in the addiction treatment field oppose expanding access to buprenorphine in the office setting, saying some of these patients don’t get the counseling that they need, but only medication. They say there aren’t enough regulations to prevent shady physicians from opening buprenorphine mills.

Experts on both sides of the debate make good points. It’s a tough topic, but let’s explore the issues further.

1. “You don’t provide enough counseling.”

Weirdly, this used to be a main complaint against OTPs, but now OTP personnel are directing the same complaint toward office-based buprenorphine physicians.

Is there any data to help us decide how much counseling is enough for opioid-addicted patients who are started on medication, either buprenorphine or methadone?

The POATS trial gives some information on this topic. (Weiss et al, 2010, http://ctndisseminationlibrary.org/protocols/ctn0030.htm )

POATS showed that opioid-addicted patients maintained on buprenorphine/naloxone were likely to reduce illicit opioid use during treatment with the medication, but most relapsed after being tapered off the medication at twelve weeks. So this part of the study supported keeping patients on medication longer, just like the older data with methadone for heroin users. No surprises so far.

Now comes the interesting part: POATS showed similar outcomes for patients getting standard medical management versus standard medical management plus fairly intense counseling. The group with added counseling didn’t do any better than the standard medical management group.

However, the standard medical management consisted of an hour-long first visit with the doctor, and a fifteen- to twenty- minute visit per week for the first four weeks, then every two weeks.
This may be more than an average buprenorphine doctor provides in real life. It’s a little more than I do for my office-based patients. My first visit with new patients is one hour, and usually I see them back in one week for a twenty-minute visit. But then, if they are doing well, I see them every two weeks, until the patient is established in counseling. After that, if all is going well, I cut down to monthly visits. I conclude that the average buprenorphine doctor may have to increase visit frequency to get the results seen in the POAT study.

The group with enhanced counseling treatment got 45 minutes with a counselor twice per week for the first four weeks, then twice per month. At present, patients of OTPs must have two counseling sessions per month, even at the beginning of treatment. Opioid clinic opponents say twice per month isn’t even close to enough counselling, and use this point as a reason to say opioid treatment programs deliver bad care.

The POAT study was relatively short. Twelve weeks may not be long enough to detect an improvement in patients getting enhanced counseling. We know life changes usually don’t happen quickly. Maybe it is unfair to say the counseling didn’t help, because the patients weren’t followed long enough.

Now let’s look at interim methadone. Interim methadone was proposed as an alternative to long waiting lists for patients to enter an opioid treatment program. People were concerned about the welfare of opioid addicts who wanted help, but had to wait for a treatment slot to open. Interim methadone is a short-term, simplified treatment where methadone medication is started for the opioid addict, until the patient can be admitted to an OTP. With interim methadone, some counseling given, but only for emergency situations. Drug screening is still done, but is more limited than for OTP patients. These interim patients can transition to a traditional opioid treatment program when a slot opens for them.

It appears that starting just methadone, with limited other services, still helps the patients. Studies show these patients are less likely to continue to use heroin, are less likely to commit crimes, and more likely to enter a full-service OTP when admission is offered. [1]

Would “interim buprenorphine” work as well? I don’t think there are any studies to give us data, but it seems logical that it would.

2. “Just apply to be an OTP”

Government officials have said that if office-based physicians wish to see more than one hundred buprenorphine patients, the physician should apply to become an opioid treatment center.

When I first read this suggestion, I laughed, because it sounded so silly to me. Well-intentioned though this statement might be, it starkly exposed a lack of knowledge of the average physician’s economic circumstances.

I don’t know many doctors like me who have the necessary capital to do this. Some professionals in the field estimate it takes starting capital of around a quarter of a million dollars. I’ve seen one OTP fold due to inadequate financial support and management, and another escape closure by a narrow margin. These days, it takes deep pockets to afford the eighteen to twenty-four month process to establish an OTP. Getting the certificate of need alone can take years. (Just look at Crossroad’s struggles to get a CON in Eastern Tennessee, an area with arguably more opioid addiction per capita than most other states!)

OTP sites must be approved by multiple agencies: the DEA, CSAT, SOTA, and local authorities to name a few. The pharmacy has to meet strict regulations, as do personnel. If you want to accept Medicaid, that’s another avalanche of regulation and paperwork.

I’m not saying it’s impossible for a physician to open an OTP, but I am saying that it would cost so much that most doctors who treat opioid addiction wouldn’t consider it. I could be wrong – maybe my colleagues are making a whole lot more than me…

3. “In it for the money.”

Experts in the field who work for opioid treatment programs oppose expansion of office-based treatment, saying doctors charge exorbitant fees for their patients. Sadly, in some cases, they are right. But many office-based doctors charge reasonable fees. If we allowed doctor to treat more than one hundred opioid-addicted patients at one time with buprenorphine, wouldn’t that reduce demand for services? And when demand decreases, shouldn’t cost of treatment drop too?

For example, let’s take a community where one buprenorphine doctor is price gouging, and charging $500 per month for only one doctor’s visit. The second buprenorphine doctor charges $250 per month for the same service plus addiction counseling. Both are at their one- hundred patient limit. If both were allowed to increase the number of their patients, wouldn’t the second, more reasonably-priced doctor get some of the more expensive doctor’s business?

Conversely, some advocates for office-based treatment say that opioid treatment programs are upset because they have lost money in recent years. They accuse organizations like AATOD of wanting to limit further expansion of office-based programs because it cuts into their business. With more access, more patients would abandon OTPs for these less restrictive programs

DATA 2000 changed the landscape of opioid addiction treatment. OTPs aren’t the only option for patients seeking treatment for their opioid addiction.

My point is, both OTPs and buprenorphine doctors can accuse the other group of being in it for the money. But as I pointed out in my last blog…no medical treatment in this country is free.

4. “My medication is better than your medication.”

Patients entering opioid addiction treatment often ask me, “Which is better, buprenorphine or methadone?” I say, “Both.” Each has its advantages, and I’ve discussed this in previous blog entries. Briefly, buprenorphine is safer, since there is a ceiling on its opioid effects, but it’s more expensive. Patients on buprenorphine also seem to leave treatment prematurely more often than methadone patients. This isn’t a good thing, since the majority of these patients relapse back to illicit opioid use.

Methadone, as a full opioid agonist, may be more difficult to taper off of, and maybe fewer patients leave treatment prematurely because of that feature. Methadone has been around for fifty years now, with a proven track record. It works, and it’s dirt cheap. Methadone does have more medication interactions, but those can usually be managed if all the patient’s doctors communicate with each other.

Buprenorphine isn’t strong enough for all opioid addicts. Because it’s a partial agonist, there’s a ceiling on its opioid effect. This property means it’s much safer than methadone, but it doesn’t work for everyone.

Buprenorphine is safer than methadone, which to me is its best quality. I’ve started hundreds of patients on buprenorphine and never had an induction death. Sadly, I cannot say the same of methadone. I am not saying overdose death is impossible with buprenorphine…I’m saying it’s much less likely, and that’s worth a lot to me.

Buprenorphine’s superior safety profile is one reason it was approved for use in an office setting. Methadone is riskier to prescribe from an office, because misuse and diversion is more likely to be fatal with this drug. That’s why buprenorphine has fewer restrictions on it. Neither medication is good or bad; the difference between the medications is pharmacologic, not moral.

Next week, I’ll describe my OTP, where we provide methadone, buprenorphine under the OTP license, and buprenorphine under my office-based license, all on the same premises. I think we’ve created a continuum of care that’s able to meet the needs of patients as their recovery evolves.

At our program, it’s not one program versus another. Difference patients need different things, and the same patient may need different things at different points in recovery.

1. Schwartz et al, “A Randomized Control Trial of Interim Methadone,” Archives of General Psychiatry, 2006

Office-based Opioid Addiction Treatment: Raising the One-hundred Patient Limit

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The hearts of addiction medicine doctors nationwide are aflutter at rumors that the limit on office-based buprenorphine patients may be raised or lifted. As it is now, the DATA 2000 law says each doctor who prescribes buprenorphine from an office setting for the treatment of opioid addiction can have no more than one hundred patients at any one time.

DATA 2000 was a big deal. Until it passed, it was illegal for any doctor to prescribe any opioid to treat opioid addiction, unless they worked at a specially licensed opioid treatment program. In other words, doctors in an office setting had to refer opioid-addicted patients to opioid treatment centers for medication-assisted treatment. And the only medication available was methadone.

Then DATA 2000 allowed Schedule 3 opioids to be prescribed from physicians’ offices for the purpose of treating opioid addiction, as long as these medications were FDA-approved for this purpose. Thus far, buprenorphine is the only medication that meets the DATA 2000 requirements.

But the law had other limitations. For example, each physician had to get a special DEA number to prescribe buprenorphine. And as above, no physician could have any more than one hundred patients on buprenorphine at any one time.

My office gets multiple calls each week from people seeking treatment for opioid addiction in an office setting. These callers say they’ve already been to the websites that list doctors. (http://buprenorphine.samhsa.gov and http://suboxone.com . They’ve made multiple calls and discovered these doctors aren’t taking new patients because they’re already at their one hundred patient limit. This is happening all over the country; patients want treatment but can’t get it. For many such people, opioid treatment centers are geographically impractical, so that’s not an option either.

Since addiction is a devastating and potentially fatal disease, government officials feel pressure to do something to help our nation’s opioid addiction problem. Lifting the one- hundred patient limit has been suggested as one option to improve the situation. This would seem to be the best, easiest, and quickest way to get more people into treatment. At least, most Addiction Medicine doctors like me think it makes sense.

Not everyone agrees.

Opposition has come from some unexpected sources. I went to an opioid addiction treatment conference in a neighboring state lately and heard the president of AATOD (American Association for the Treatment of Opioid Dependence), Mark Parrino, MPA, speak against lifting the limit.

First let me say I admire Mr. Parrino immensely. He has been and continues to be a huge advocate for this field. He’s done more good in the field of opioid addiction treatment than most people I can think of, and has been doing this good work long before I ever even entered the field.

But that doesn’t mean I agree with him on everything.

When he spoke at the conference, he said he was opposed to expanded buprenorphine treatment in the office-based setting because patients don’t get the counseling that they need, so it really isn’t medication-assisted treatment, it’s just medication assistance. He says opioid treatment programs provide on-site counseling, drug testing, and other services that can help patients, and that most office-based programs don’t offer such comprehensive services. He also said diversion of buprenorphine from office-based practices is a huge problem, and that much of the black market use is actually abuse of the medication. He raised the uncomfortable issue of price gouging by some unscrupulous buprenorphine doctors who charge large fees and deliver little care.

You can read a statement on the AATOD website that fully describes their opposition – or at least call for caution – regarding raising the one hundred patient office based treatment limit:
http://www.aatod.org/policies/policy-statements/increasing-access-to-medication-to-treat-opioid-addiction-increasing-access-for-the-treatment-of-opioid-addiction-with-medications/

I don’t completely disagree with the points Mr. Parrino made at the conference, but I do think the same arguments can be made against OTPs if one were inclined to do so.

What about opioid treatment programs that pay lip service to the counseling needs of the patients? What about OTPs that hire people to be counselors with little or no experience in the counseling field? Just as Mr. Parrino can point to the worst examples of office-based buprenorphine treatment, I can point to OTPs who aren’t doing a great job. How can an OTP counselor provide Motivational Interviewing as a therapeutic technique if that counselor has never even heard of MI? Yet I’ve seen these problems at opioid treatment programs.

Don’t paint all office-based practices with the same brush. Many of us want to provide good treatment with adequate counseling. For example, my office has a therapist who is a Licensed Professional Counselor with a Master’s in Addiction Counseling. He does a great job, and as an added bonus has great legs. (He’s my fiancé, before you assume I’m sexually harassing him at the workplace).

Alternatively, if the patient prefers to do only 12-step meetings, I’m OK with that, so long as they provide me with a list of meetings they’ve attended each month. Or if they’re already working with a therapist, it’s OK with me if they want to continue, as long as they agree to allow me to speak with their therapist about issues directly relating to the treatment of their addiction.

Diversion of buprenorphine to the black market is a big problem. Not all office-based buprenorphine doctors are as careful as we should be. We will never be able to get rid of all diversion of any controlled substance that we prescribe, but all buprenorphine doctors should be doing drug screens and have diversion controls in place to limit the problem.

Not as much methadone is diverted, but only because of the very strict regulations on methadone take- home doses at the OTP. Many patients – and OTP personnel – feel present regulations on methadone take- home doses are overly strict and limit flexibility of treatment for patients who are doing well. Is the answer then to regulate take -home doses of buprenorphine as closely as methadone?

What about the predatory doctors who prescribe buprenorphine just for a quick buck, sensing they can charge exorbitant fees from desperate opioid addicts? I can’t say anything in their favor. They embarrass me. As with many things in life, the actions of a few give the rest of us a bad reputation. But I do think these doctors are in the minority.

And don’t believe everything you are told about office-based practices; I’m sometimes told by patients that I’m in it “for the money” though I charge the same for an office visit for a buprenorphine patient as I would for any other medical ailment. Some patients feel like their treatment should be free, but the U.S system of medical care is not usually free for any disease.

In short, though I recognize there’s some truth in many of Mr. Parrino’s statements, I still think most buprenorphine doctors try very hard to do things right so that they provide good care for opioid addicts who can’t or won’t go to an opioid treatment program. Expanding access by raising the one-hundred patient limit will allow more people to get addiction treatment.

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