Posts Tagged ‘SAMHSA’

Advice for New Prescribers

 

 

 

The medical care providers of this nation are being encouraged get training necessary to prescribe buprenorphine products (brand names Suboxone, Zubsolv, Bunavail, Sublocade, and the generics) for the treatment of opioid use disorder in their patients. We need more good prescribers, because even after twenty years into this opioid situation, only about twenty percent of patients who need treatment can get it.

I’ve written on this topic a few times in the past, but this blog entry will contain some advice directed to new prescribers of buprenorphine products. Hopefully it will help them have good experiences prescribing medication-assisted treatment.

Here are some ideas that work for me at my office:

Treat the patient with opioid use disorder with the same attitude and compassion that you would for any other patient with a potentially fatal chronic illness. If you can’t do that, then don’t treat patients with substance use disorders. Patients detect negative attitudes such as distain and dislike even when those attitudes are communicated non-verbally. For whatever reason, if you can’t put judgment aside, then work on your own issues before you attempt to treat suffering people trying to get well.

Patients will resent a physician with a bad attitude. That will contaminate the relationship with predictable results.

For example, I talked to one physician who had his waiver to prescribe buprenorphine from an office setting. I asked him why he wasn’t using his waiver to treat patients, since there were so many in our community that needed help.

He told me the visits with the first two patients went poorly. He said both these patients threatened his life and the lives of his family members. After that, he decided not to risk treating anyone with opioid use disorder.

I was shocked. I’ve never, in the thirteen years I’ve been prescribing from an office practice, had any patient threaten my life, though I’ve made some angry at me. I had to wonder what kind of bedside manner this doctor had, for his first two patients to want to kill him. That sounds like I’m blaming the doctor, and maybe I am, but his experience was so contrary to my own that I had to wonder what was going on. I suspect his patients didn’t feel respected by him.

I’ve had one patient threaten me with bodily harm, but that was at an opioid treatment program in Gastonia, NC, more than a decade ago. The patient was an avowed KKK member, tall and large, with tattoos of hate groups on his muscular arms. I might have been worried, except at the time he threatened me, he was so impaired on benzos that I could have pushed him over with a finger. I’d just told him he couldn’t dose with methadone that day, due to impairment. The next week, he greeted when we passed in the hall. I assume he had been in a blackout from his benzodiazepine ingestion the week before and didn’t remember our previous interaction.

Be clear with your patients about your expectations. At the first visit, I sit with the patient and go over a patient agreement form. I adapted it from a SAMHSA website where you can find helpful forms, tools, and ideas.

https://pcssnow.org/resources/clinical-tools/

https://www.samhsa.gov/medication-assisted-treatment/training-resources/publications

In that agreement, I outline my expectations. I have paragraphs indicating that disruptive or violent behavior won’t be tolerated and are grounds for immediate dismissal from my practice. In thirteen years, I’ve never had one patient become rowdy or disruptive. Having said that, I do realize other prescribers have had different experiences.

I ask patients to keep and be on time for appointments, and if they don’t show up and don’t call, they will be charged for the missed visit. I tell patients I won’t call in prescriptions if they miss a visit. Having said that, I’m also flexible enough to know that things do come up – cars break down, traffic jams occur, etc. In the winter, travel can be treacherous, so that’s another factor to be dealt with. All I ask is that the patients communicate problems early so we can find a reasonable solution.

Patients who miss appointments, don’t call, and won’t answer our calls to find out what’s going on will have problems at my practice. It may or may not be their fault, but if it doesn’t work out they will need to find a new provider.

My agreement also says I won’t “fire” a patient before I talk to them face-to-face. Patients tell me they’ve been dismissed by a practice by letter, for some issue or another. I think that’s cowardly, and disrespectful to the patient. If there’s a reason I feel I can no longer to continue treatment as we are, I owe it to the patient to tell them exactly what the problem is. Sometimes we can find solutions short of termination and sometimes we can’t. At least the patient will know I respect them enough to talk to them, and they will know the basis of my decision. They will also get a referral to a new provider, or at least a recommendation.

Be careful with patient selection and try to match the patient with the best level of care.

Not every patient will do well in an office-based setting. For example, if a patient has been using buprenorphine products illicitly by insufflation or injection, that patient probably is best treated in an opioid treatment program, where observed dosing is done.

Most patients need to be on the combination products buprenorphine/naloxone. Adverse reactions do occur with the monoproduct, but they are rare, and drug diversion is not. If a new patient needs the monoproduct, I refer them to an opioid treatment program where they can be properly observed.

If that patient has been treated in another office-based setting with medical records that support their progress and compliance on the monoproduct, my recommendation would be different. Many factors influence my treatment decisions, so I need all the information I can get to make the best decisions.

This leads me to my next recommendation: get old records. Make the effort to get records from a previous practice. Sometimes patients, to curry favor with a new prescriber, will tell tales about how awful their last prescriber was. That may be true…or there may be more to the story, so get records to get a better idea of what happened at the last practice.

Don’t falsify your own records. It’s unethical and probably illegal to bill for services you document but don’t provide. To get higher insurance reimbursements, physicians sometimes chart long review of systems and/or physical exams than were performed. This is called “up-billing.” I suspect up-billing when I see records with four pages of single-spaced type for each visit, but then notice the same four pages for each monthly visit, with no changes.

I blogged before about a patient whose records recorded an exam saying “consistent with eight-month pregnancy” for every monthly visit for over a year. Yeah…kind of suspicious…using that cut-and-paste feature, I think.

If you do telemedicine, make sure you have some sort of medical personnel on site with the patient to look for physical finding you may miss with telecommunications. I just admitted a patient to our opioid treatment program who had been on Suboxone for six months from a provider he only saw online. This patient was injecting his medication, but his prescriber couldn’t see it. His most prominent tracks were on the side of his neck, which could be hidden with a high collar. Obviously, this could have ended in disaster had the patient not realized he needed a higher level of care.

Be careful about lab schemes. If a laboratory diagnostic service is charging patients $500 for one drug screen, it’s probably a scam. In past years, these organization popped up like mushrooms in manure, saying they could do extensive lab testing for all patients, but only charge those with insurance. Uninsured would get free testing.

As it turns out, some of those companies charged outrageous fees to the insurance companies, including Medicaid and Medicare, for expensive and unnecessary testing, in get-rich-quick schemes. Here’s a link to an article that explains how this works:

https://www.healthcarefinancenews.com/news/report-urine-based-drug-tests-helping-some-doctors-soak-profits

Good providers don’t want to sully their name by associating with shady laboratory service providers. Physicians can do good point-of-care testing on site for $10 or less. Sometimes patients need more extensive testing, and this can be decided on a case-by-case basis rather than testing every patient for dozens of drugs that aren’t commonly used in the community where you practice.

Be aware of what drugs are trending in your area and make sure they are included in your drug testing protocol. In the past, heroin was rare in rural areas, but that’s changed. As I’ve discussed on this blog, heroin frequently contains fentanyl, a much more powerful opioid that’s responsible for many overdose deaths.

Ask your new patients what drugs are being used in your community. They can be great sources of information, as can local addiction medicine educational conferences, and your local law enforcement officials.

Make friends with the medical director at your local opioid treatment program. Most physician medical directors at opioid treatment programs are happy to work collaboratively with office-based providers. We share patients all the time and need to do what’s best for the patient. We don’t need to look at each other as competitors, because there are more than enough patients for everyone, unfortunately. Let’s work together to get people into treatment, and to match the patient with the right level of care.

It can be a relief for an office-based provider to know they have a facility willing to deliver a higher level of care when necessary. Sometimes the patient may need inpatient treatment, but at other times it might be an opioid treatment program, where the patient may come daily for dosing and oversight.

Again, some patients, in an effort to curry favor with a new prescriber, may talk disparagingly about another treatment facility, so don’t take a patient’s word that an opioid treatment program does an awful job.

Decades ago in my previous life as a primary care physician, I learned that the new patient who tells me how wonderful I am compared to their last terrible doctor will soon be saying the same thing to another new doctor, about how terrible I am. I know there are terrible doctors, but there are also some patients that can’t be pleased no matter how good the physician.

Finally, get involved with organizations that can help you. You don’t need to re-invent the wheel; as I mentioned above, help is available from several sources.

Go to the SAMHSA website mentioned above and you will find helpful resources. Or you can go to the American Society of Addiction Medicine website for information: https://www.asam.org/  You may decide to go to one of their excellent conferences.

Go to the Providers’ Clinical Support System (PCSS) website and search their educational offerings at https://pcssnow.org/ They have archived webinars, mentoring programs, and other great things available.

If you work in North Carolina, there is the UNC ECHO program, which offers live teleconferences three days per week on issues surrounding medication-assisted treatment of patients in the office setting. You can hear cases presented and listen to input from experts and other prescribers, while getting free (yes I said free) CME hours. Once involved, you can present your own difficult cases to get help with difficult patient situations. You can go to their website at: https://echo.unc.edu/ or leave me a comment with your email and I can connect you to the organization.

It can be difficult to persuade new prescribers that treating patients with opioid use disorder is rewarding and fun. I became a physician because I wanted to help people, sappy as that sounds. I didn’t feel the sense of satisfaction during the decade I worked in primary care, for whatever reason, that I now feel working in the field of Addiction Medicine.

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What’s a Doctor To Do?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Above, you will see two documents which illustrate the problem.

The second is a letter sent to North Carolina opioid treatment program (OTP) physicians from the preeminent OB/GYN group at the University of Tennessee. The first is a letter sent last month to obstetrical providers and opioid use disorder treatment providers from the Center for Substance Abuse Treatment, an arm of SAMHSA (Substance Abuse and Mental Health Services Administration).

You will note they recommend polar opposite approaches to the management of opioid use disorder in pregnant women. The obstetricians at University of Tennessee recommend that pregnant women with “chronic narcotic use” be offered the option of taper from opioids, to avoid neonatal abstinence syndrome and to avoid microcephaly.

In contrast, the letter to providers from CSAT division of SAMHSA recommends, “Pregnant women with opioid use disorder should be advised that medically supervised withdrawal from opioids is associated with high rates of relapse and is not the recommended course of treatment during pregnancy.”

That mention of microcephaly in the U of T letter baffles me. The resources cited in their letter referred to one study of head circumference in babies with neonatal abstinence syndrome (NAS). There’s no mention whether the moms are on illicit opioids or MAT. The second study looked at head circumference in babies born to moms with polysubstance use. None of the studies looked at head circumference of infants born to moms on MAT and compared them with controls. Using microcephaly as an argument against MAT is a misuse of data.

Why on earth would Tennessee obstetricians send their letter to NC opioid treatment program providers? Because, as I have ranted about so often in the past, there are no opioid treatment programs in Eastern Tennessee. Because that portion of Tennessee still has no methadone programs, patients are forced to drive across the border to get the gold standard of treatment for opioid use disorder. True, there are some buprenorphine prescribers in that area, and that’s a great thing as far as it goes, but as we know, not all patients do well with buprenorphine, and we have around six decades worth of data about methadone in pregnancy.

So not only does Tennessee refuse to allow the most evidence-based treatment for opioid use disorder to exist in that part of their state, but their physicians seek to control the actions of opioid treatment physicians in North Carolina, and ask us to adopt treatment approaches discouraged by all other expert organizations.

The study touted by Dr. Towers in their above letter was published by Bell, Towers, et al. in September 2016 issue of the American Journal of Obstetrics and Gynecology: http://www.ajog.org/article/S0002-9378(16)00477-4/abstract

After reading this study in some detail, I’m surprised by the authors’ conclusions. I find their conclusions to be based on some very thin evidence.

This study was a retrospective analysis of four groups of pregnant women with opioid use disorder. The first group consisted of incarcerated women, allowed to go through opioid withdrawal without the standard of care, buprenorphine or methadone. How this is even legal is beyond me.

The study says that jail programs in east Tennessee have “no ability to provide opiates to prevent or perform an opiate-assisted withdrawal medical withdrawal.” It went on to say that the jail doctor can treat symptoms with anti-nausea meds, clonidine, and anti-diarrheal meds. They also lack the ability to perform fetal monitoring while incarcerated.

Of the 108 women in group 1, two suffered intrauterine fetal death, one at 34 weeks and one at 18 weeks. The authors don’t say what the expected rate of fetal death would be, and I don’t know either. Apparently the authors didn’t consider these two deaths to be outside the range of normal.

Group 2 consisted of 23 pregnant women with opioid use disorder who were sent to inpatient opioid detoxification followed by long-term follow-up behavioral health programs. These women did well, with only 17% relapsing while in treatment. This group had a 17% rate of neonatal abstinence syndrome in the newborns.

I guess that means all of the four women who relapsed had babies with NAS. That’s 100%, much higher than the 50% rate nationwide. That seems odd to me.

Group 3 did the worst. These 77 women had inpatient detoxification but then did not have the long-term treatment that group 2 were given. Of the infants born to these women, 22% needed admission to the neonatal intensive care unit. Of these 77 women, 74% relapsed, and NAS was present in 70% of those infants. Again, this gives a NAS rate of 95%, which is a great deal higher than most other studies of NAS in babies born to moms using opioids of any kind. Even with methadone, studies give estimates of 50% to 80% at the highest.

Group 4 consisted of 93 women on buprenorphine prescribed by office-based physicians who agreed to taper the women’s doses during pregnancy. The rate of relapse in this group was noted to be 22%, and 17% of all the babies had NAS. Again, this gives a relatively higher NAS rate than has been found in other studies. In this Bell study, NAS occurred in 76% of the women who relapsed, up from 50% of women on buprenorphine in the MOTHER trial who were not tapered.

A little sentence in the articles table of demographics and outcomes gives the clue to why their NAS rates were so high. The way this study determined relapse was by drug screen at the time of admission to the hospital for delivery, or an admission by the pregnant woman, or positive meconium screen, or treatment of NAS in the newborn.

I think relapses could have gone undetected very easily, so that only the women with a relapse close enough to the time of delivery were detected to have used opioids.

Other problems with this study have been pointed out by much smarter people than me. Dr. Hendree Jones, author of the landmark MOTHER trial comparing methadone and buprenorphine during pregnancy, commented in the Journal of Addiction Medicine in the March/April 2017 issue: Her conclusions after a review of the Bell article plus a handful of other similar studies is: “Evidence of fetal safety to support the equivalence of medically assisted withdrawal to opioid agonist pharmacotherapy is insufficient.”

Of course, pregnant patients have one big concern: “What can I do to keep my baby from having withdrawal?” and that’s what they focus on. They are willing to do anything, including coming off methadone or buprenorphine or other opioids, if it will keep their baby from withdrawal. As Doctor Jones cogently points out in the above referenced article, there’s lack of data to show medically-supervised withdrawal from opioids results in less risk of NAS.

In other words, if prevention of NAS is our only goal, there’s not enough evidence to show that reducing opioids during pregnancy will achieve this. In part, that’s due to the high risk of relapse in the mother, and in part due to other factors.

This is the state of the situation right now. Things could change in the future. We do need new studies, done with closer attention to fetal monitoring and drug testing throughout pregnancy to help us determine the ideal treatment of pregnant women with opioid use disorder.

But for right now, maintenance on buprenorphine or methadone is still the treatment of choice.

It’s not only SAMHSA that’s recommending MAT as the treatment of choice for pregnant patients with opioid use disorder. Even the American College of Obstetrics & Gynecology (ACOG), the professional organization of OB/GYNs in the U.S., in a position statement from 2012, says:

  • “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.”
  • “Medically supervised tapered doses of opioids during pregnancy often result in relapse to former use.”
  • “The rationale for opioid-assisted therapy during pregnancy is to prevent complications of illicit opioid use and narcotic withdrawal, encourage prenatal care and drug treatment, reduce criminal activity, and avoid risks to the patient of associating with a drug culture.”

The World Health Organization says, in its guidelines from 2014:

  • “Pregnant women dependent on opioids should be encouraged to use opioid maintenance treatment whenever available rather than to attempt opioid detoxification. Opioid maintenance treatment in this context refers to either methadone maintenance treatment or buprenorphine maintenance treatment.”

A new statement from the American Society of Addiction Medicine earlier this year, titled, “Substance Use, Misuse, and Use Disorders During and Following Pregnancy, with an Emphasis on Opioids” said:

  • “For pregnant women with opioid use disorder, opioid agonist pharmacotherapy is the standard of care; the ASAM National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use recommends that pregnant women who are physically dependent on opioids receive treatment using methadone or buprenorphine monoproduct rather than withdrawal management to abstinence.

So the experts agree. Medication-assisted treatment is the gold standard for pregnant women with opioid use disorder.

Why are some OB/GYNs in Tennessee and other areas recommending the opposite, based on evidence that most of us consider preliminary at best, and flimsy at worst?

I don’t know for sure, but I think these physicians suffer from the same biases as other non-medical people. I would like for these physicians to base their actions on the best scientific data, but that’s not happening in some areas. I believe these doctors, with the best of intentions, have been swayed by the political climates of their areas. Rather than challenge long-held beliefs about medication-assisted therapies that have been based on ideology rather than fact, they have stayed inside the comfort zone of believing pregnant women shouldn’t be on methadone or buprenorphine.

This leaves addiction medicine physicians in the middle. We know what the standard of care is, but our patients are told we are wrong, and that they should taper off maintenance medication, or not start it in the first place.

I’ve tried, one OB at a time, to educate gently about what I see as the standard of care. I’ve sent studies and position papers and other data to the OBs with whom I share patients. I’ve blogged about the negative experiences I’ve had. In short, many of these obstetricians say something to the effect of: “Who are you to tell me how to care for this pregnant patient?” After all, I’m not an obstetrician. But I do read, and I do keep my fund of knowledge up to date in the field of addiction medicine, which overlaps with obstetrics at times.

I’m terribly frustrated by the situation, and I know my colleagues at other opioid treatment programs feel the same way. I’m fortunate that there is one group of OBs who are somewhat supportive of my pregnant patients on MAT, and I appreciate that. But often these pregnant ladies using opioids are already going to one of the anti-MAT OBs, and that creates real problems.

If it’s difficult for physicians, just think how the pregnant patients feel. They are given polar opposite recommendations by their OB and their physician at the OTP. They sought help in order to do the best thing for their babies, wanting to be good mothers. In most situations, they have tried desperately to quit opioid on their own, and couldn’t. Now the OB is telling them they must taper off their medication during pregnancy, and the OTP physician is recommending they stay on it, even recommending they increase their dose if needed.

At a difficult time in their lives, these mothers-to-be aren’t sure if they are doing the right thing by being in treatment with MAT or not. They second guess themselves, and their families also recommend, with the best of intentions, that they follow the OB’s directions.

I think this won’t change unless professional organizations like ACOG reach out more directly to obstetricians in the field. Perhaps SAMHSA can organize educational lectures, given by obstetricians who know the data and know the best practice recommendations. Perhaps state medical societies or state medical boards can contact these obstetricians with statements of best practices, if more are needed. With WHO, ACOG, SAMHSA, and ASAM all recommending MAT for opioid-dependent pregnant women, you wouldn’t think further statements of best practice would be needed…yet they are.

All I know is that I don’t seem to be making any headway at all. I need help, and my patients need help.

 

 

 

National Prescription Drug Action Plan

Yesterday, government officials proclaimed the formation of collaborative plan to address this nation’s problem with prescription opioid abuse and addiction. Speakers included Mr. Gil Kerlikowske, the director of the ONDCP (Office of National Drug Control Policy), Dr. Howard Koh, from the department of Health and Human Services (DHHS), Dr. Margaret Hamburg from the Food and Drug Administration ( FDA), and Ms. Michele Leonhart, administrator of the Drug Enforcement Administration (DEA).

 Speakers recited pertinent statistics regarding the state of opioid addiction and abuse in the U.S.  It’s now the faster growing public health problem in our country. Around 28,000 citizens died from unintentional drug overdose in 2007, the latest year for which data is available.  More people in the U.S. now die of unintentional drug overdose than gunshot wounds. In seventeen states and Washington D.C., unintentional overdose deaths outnumber deaths from motor vehicle accidents.

 The plan has four main points. First, both patients and prescribers of controlled substances will be provided with better education about these potentially dangerous medications. The drug manufacturers will be asked to develop educational products for both patients and providers for education, which will be reviewed by the FDA before approved for release. The medications included will likely include sustained-release oxycodone, oxymorphone, hydromorphone, and methadone. Fentanyl patches will also be included. The ONDCP is seeking to introduce legislation that will change the Controlled Substances Act in order to make training mandatory for doctors who prescribe long-acting opioids.

 Second, the national government will push the few remaining states that don’t have function prescription monitoring programs to put them in place, and to be able to share data with adjacent states.

 Third, the government will support more medication “take back” days in communities across the U.S. Citizens will be encouraged to bring old medication to community sites in order for proper disposal. Previous take back days have been very successful, with tons of pills collected and disposed. This will reduce the number of prescription opioid pills available for diversion. Surveys reveal that round 70% of the pills obtained by people misusing prescription medication for the first time are obtained from friends and family members, often without permission, from old prescription bottles.

 Fourth, state and federal agencies plan to crack down further on rogue doctors and clinics that are “pill mills.” This will require participation from state medical boards, law enforcement, and the DEA.

 At the end of this presentation, Karen Perry, founder of NOPE, told the story of her son, a bright young college student who died of an unintentional drug overdose. She described how his death affected her and his siblings. Her face was etched with the grief that can only come from such a profound loss

 The goal of this plan is to achieve a 15% reduction in prescription opioid misuse in this country by at within the next five years.

 I’m so pleased to see this announcement. Back in 2001, when I first started treating prescription opioid addiction, I was amazed at the numbers of people seeking treatment for this disorder. Studies since then have shown the situation has gotten much worse.

 There will be problems with this plan. Many doctors will not be happy they must have mandatory training in order to be able to prescribe some controlled substances (probably schedule II). Some will stand up on their hind legs and protest this new regulation, if it is passed by congress. But after seeing the prescribing habits of some of my brethren and sistren, it’s obvious we need this. We don’t get much education about appropriate prescribing of opioids, recognizing addiction, and referral for treatment. I’ve blogged before about this (see February 10th’s entry)

 I’ve been blathering on to anyone who will listen about the need for prescription monitoring plans (see prior blog entries for March 6, 8, and 31), so I’m delighted more attention is being paid to this. But I still worry about how states will communicate with each other. For example, my practice is close to South Carolina, yet that state has denied me access to their database. The only allow access to doctors licensed in South Carolina. I use the prescription monitoring program in my state both at the two Opioid Treatment Programs where I work and in my own office, where I see Suboxone patients. I’ve been using it since 2007.

I support the pill “take back” programs. While such events probably won’t do much for those with established addiction, they can help reduce the number of new users and experimental users. Remember, opioid overdose deaths don’t just happen to addicts. Youngsters experimenting with opioids can die from overdoses. In fact, new users dabbling with these pills, because they think they’re safer than “street” drugs, may be more likely to die because they don’t have any tolerance to opioids.

 We need good judgment and balance when shutting down pill mills. How can the DEA tell a pill mill from a legitimate pain treatment practice? I believe this is best done by other doctors. In this state, the medical board does investigations, which I feel is more appropriate than having investigations done by law enforcement. Law enforcement personnel just don’t have the training to tell the difference between appropriate care and careless prescribing with disregard for patients. Let other doctors do that. Granted, a few places will be so obvious that little investigation is needed.

 We don’t want the opioid pendulum to swing to the opposite side again, and become completely opioiphobic. These pain medications are addictive, but are also godsends in the right setting and used in the right way. Let’s take care not to throw out the good with the bad. The best people to set policy in this area are well-trained doctors who approach this issue with common sense and balance.

 Coming as late as it does in this epidemic, I could be negative and say the government has had an epiphany of the obvious. But I do know it takes time for all of these agencies to come together in a cooperative manner and form a plan of action. I’m just thankful that action is finally being taken.