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.

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5 responses to this post.

  1. Posted by Alan Wartenberg MD on April 27, 2015 at 4:44 pm

    Agree with most of Dr. Burson’s thoughts on this matter (as I usually do) with the exception of the statement about evidence-based use of benzodiazepines only being for a few months. This is simply NOT the case in a large number of patients. There are many papers on long-term use of benzodiazepines indicating that they continue to be effective in reducing symptoms of anxiety in patients with anxiety disorders for decades. However, everyone in the field would prefer patients be on psychotherapy, SSRI or SNRI antidepressants for these indications, but another reality is that such therapies are neither available to all, or effective in all, and the antidepressants often are either ineffective as well, or not tolerated.

    Most drug approvals are based on short-term studies, so many drugs only have a label indication for some short period of time (6 months is typical). This does NOT mean they don’t work after that time, just that nobody has presented the studies that would prove that they do. Such studies are difficult and expensive, and once the indication is obtained by a pharmaceutical company, they have little interest in funding such long-term studies. The dangers of benzodiazepines have virtually ONLY been in those taking larger doses than prescribed, or in cases where MMTPs are raising doses without thinking about the benzodiazepines, or benzo prescribers raising doses without thinking about the methadone.

    Reply

    • Thank you, Dr. Wartenberg. I am delighted someone of your stature reads my blog. You are truly a leader in the field of Addiction Medicine. As you say, we probably agree on most things… but I don’t agree with you about the benzo issue.

      I like the IRETA guidelines on benzodiazepine use by OTP patients. I think they were careful to review what literature there is and come up with recommendations based on the best data. For all I know, you may have been one of the experts who participated in those guidelines.
      Maybe not, because on page 22 of the IRETA guidelines we read: “…Long-term maintenance of benzodiazepines is rarely indicated and should be avoided. “

      OTP patients on benzos have been found to have worse treatment outcomes. Is that because they are on benzos, or because they are sicker overall? I don’t think we know for sure.

      Even for patients with no addiction issues, we have troublesome data regarding long-term use of benzos.

      Last fall a large Canadian study showed benzo use for more than three month was associated with a greater than 50% increase in the risk for Alzheimer’s in elderly patients. (Gage et al, BMJ 2014) Other studies came to the same conclusions; Wu et al,2009 in the American Journal of Geriatric Psychiatry also found benzodiazepine use was associated with an increased risk of dementia. Benzo exposure has been associated with an increased risk of hip fracture (Chang et al 2008) We’ve also seen benzodiazepine use be associated with premature death and increased incidence of cancer. (Weich et al, BMJ, 2014, Kripke et al, BMJ, 2012)

      As you know, being associated with isn’t the same as causing. Benzodiazepine use could be a marker of sicker people, though some of those studies controlled for degree of illness. At any rate, I think we’ve accumulated enough data to give pause when prescribing benzodiazepine to anyone for more than three months.
      And if you have data showing benzos continue to be effective for anxiety when used continuously for more than three months, please send it to me.
      having said all of that, I do see the occasional patient who seems to function better on benzos than off them, but I think that’s pretty rare. Here is the South, we have oodles of overprescribing for benzodiazepines.

      Reply

  2. Posted by neil goldberg on April 28, 2015 at 7:55 pm

    Hi Jana,One of the disappointing things at the ASAM conference (for me) was when a former SAMSA exec said he didn’t think they should increase the number of patients we could treat outpatient with suboxone because there was too much diversion. I think the patients response is outstanding, at least where I am in Charlotte. Marijuana seems very scary and treatment for addiction/withdrawal symptoms not good at all. Designer drugs even more scary. If anything, treatment of opiates may be the the best of what’s out there.Anyway, enjoyed your Blog as always.Hello from Hickory,Best,Neil Goldberg, M.D.

    Reply

  3. Posted by Lindsay on March 28, 2016 at 12:26 am

    Can you provider greater information on initiating the exemption process for a qualified physician extender who is working in OTP with experience. I have been unable to find any process outlined on SAMHSA site.

    Reply

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