The Joint Commission Issues Revised Standards for Opioid Treatment Programs

Joint CommissionWorking closely with the Substance Abuse and Mental Health Services Administration (SAMHSA), The Joint Commission has revised several standards for Opioid Treatment Program (OTP) accreditation. For The Joint Commission to be allowed to accredit OTPs, accreditation standards must be in alignment with SAMHSA’s regulations and guidelines. The Joint Commission, to keep up with SAMSHA regulations and guidelines, has added some new elements of performance and some new notes.

The new revisions to standards for OTPs, which took effect March 23, cover a range of issues, including administrative discharges, neonatal abstinence syndrome, parenting support groups, child care services, and prenatal care. The first topic covered is pain—a key issue for OTPs and for patients with opioid dependence.

“Some OTP patients may have co-occurring pain that existed with their opioid addiction prior to entering treatment, and some are in treatment and in recovery from addiction, but have pain,” said  Megan Marx, associate director at The Joint Commission, in an interview with AT Forum.

The Joint Commission’s biggest concerns are 1) that patients with pain be treated for their pain, and 2) that patients’ methadone or buprenorphine dose not be lowered as a result of their being put on pain medication. “This is language that came from SAMHSA,” said Ms. Marx. “We’re saying that if you have a patient, you need to adequately treat their opioid addiction, and not change the dose just because that patient is now accessing pain treatment. You need to confer and make sure that your patient is treated adequately.”

Asked whether the OTP should treat pain in its patients, Ms. Marx responded, “That’s not for us to say.” If the best way to meet the patient’s needs is to have the pain treated by another provider in the community, that is what should happen, she said.

It is clear that The Joint Commission is not telling OTPs they need to be able to treat pain—quite the opposite. They can, but they don’t have to. “I don’t know that all OTPs are in a position where they can treat pain,” she said.

What led The Joint Commission to the pain standard was SAMHSA, which, as the agency that regulates OTPs, has great interest in the standards promulgated by The Joint Commission—and vice versa. Since 2001, SAMHSA has required OTPs to be certified by a “deemed” accrediting body—and The Joint Commission has such deeming authority. A review of The Joint Commission’s most recent renewal application for deemed status, submitted to SAMHSA two years ago, prompted the clarification and revisions to The Joint Commissions standards.

The discussion about pain has taken time, said Ms. Marx. “But it is SAMHSA that wants to make sure that all patients are assessed for pain. Where there may be challenges in treating people who have pain issues, OTPs need to be aware of their limitations.”

And there may be an oblique indication that non-opioid pain relief is something both SAMHSA and The Joint Commission want to see offered. “When we talk about treating pain, there is treating pain with medication, but also a variety of other ways,” said Ms. Marx. “We don’t want to leave those people out of the loop either.” For example, there are pain management specialists who may use physical therapy, acupuncture, and other methods.

OTPs are good at recognizing drug-seeking and the pain of withdrawal, she said. “But so much more comes with the patient who has pain,” she said. People can have pain in addition to drug addiction, she added, citing the need to evaluate short-term pain related to an injury, and chronic pain related to disease.

Case-By-Case Administrative Discharges

The Joint Commission makes it clear that OTPs cannot institute across-the-board rules for “administrative discharges.”  Some OTPs discharge patients because they can’t pay, or more often because they have tested positive for other drugs, like benzodiazepines. “It has to be on a case-by-case basis,” said Ms. Marx. And The Joint Commission checks documentation to make sure that, indeed, decisions are made on a case-by-case basis. There can be no policy that says a certain number of positive tests for benzodiazepines, for example, results in an automatic discharge.

“Ongoing multi drug use is not necessarily a reason for discharge. We all know that when people come into treatment, many are not using just heroin,” she said.

There was a reason for patients to use drugs, and that’s why they’re in treatment, Ms. Marx pointed out. “They didn’t get the way they are overnight, and they’re not going to change overnight. We don’t want patients to be taken out of programs simply because they have issues reducing their use of other substances.”

Benzodiazepine abuse is very worrying to OTPs, because of the risk—like opioids, benzodiazepine is a central nervous system depressant, and combining it with methadone could result in overdose, even death. But the way to approach benzodiazepine use is not to terminate treatment, “it’s to work with your team and your patient to come up with the best plan,” she said.

In addition, a patient who is dependent on benzodiazepines and is threatened with administrative discharge could try to stop using the benzodiazepines on their own. Withdrawal from benzodiazepines is life-threatening and is typically managed in an inpatient setting, she said.

The field is now able to use harm-reduction terminology, which is helpful in accreditation of OTPs. For example, if patients are no longer using opioids, even if they are misusing benzodiazepines, harm is being reduced. “You have to use common sense and ask whether it is safer for the patient to be in treatment, because at least they’re successful with the opioid addiction,” said Ms. Marx. She added that by staying in treatment, eventually the patient can be helped to stop using other substances as well.

Neonatal Abstinence Syndrome

If there is a risk of neonatal abstinence syndrome (NAS)—such as when a pregnant patient is taking methadone or buprenorphine—The Joint Commission now requires the OTP to help obtain comprehensive care for the baby. “This goes back to the issue of making sure that everyone has access to the best care,” Ms. Marx said. “Because OTPs deal with this on a more regular basis, they have information to share with patients about where this care can be provided. If it’s not something that the obstetrician knows about, then the OTP should be able to provide patients with the information.”

It’s helpful for the OTP to let the obstetrician know how the mother has been doing in the OTP during pregnancy, she said.

Parenting Support Groups

OTPs should also be able to provide referrals for parenting support groups—something that isn’t new, but that SAMHSA has “gotten more specific about,” said Ms. Marx. “There used to be one sentence about it in the old guidelines, and programs were confused about whether they had to offer these support groups.” While parenting support is important, especially when children have special needs, there’s no funding for it, she pointed out. She added that programs should at least be able to offer referrals, even if they don’t have to offer the actual groups.

She stressed that OTPs are not required to report parenting support problems to social services. But programs may realize, through their work with patients, that some families and children have specific needs and require prevention services. “If OTPs are aware of the fact that there are some behavioral health needs, as a responsible care provider, they need to see that there is a referral,” she said.

Child Care Services

This revised standard makes it clear that a program must either offer or provide referrals to child care services. “There was a lot of confusion about this,” said Ms. Marx. “In more remote locations, there are few services available for anything—it’s a geographic problem. This revision makes it clear that if you can’t provide a referral, you don’t have to have a day care center in the OTP.”

Prenatal Care

While some OTPs have the clinical expertise to care for pregnant patients, some do not. This standard provides for reciprocity in exchange of clinical information with the obstetrician providing care. In addition, if the patient refuses prenatal care, OTPs are now required to have the patient acknowledge in writing that she was offered the services, but refused them.

Treating pregnant patients who are not getting prenatal care is a liability issue for OTPs, which is why it’s important for them to get the signed documentation of refusal, she said. Why would a patient refuse prenatal services? Ms. Marx said for some women in treatment who plan on remaining pregnant there may be affordability or transportation issues.

“We do care about OTPs’ liability, because we want them to stay open,” she said. “We don’t want them to close, unless they’re really providing substandard care. There’s a shortage of treatment in the country. We need more treatment, not less.”

The revised standards are available at: http://www.jointcommission.org/assets/1/18/Opioid_BHC.pdf

Tennessee Law Puts Pregnant Women on Medication-Assisted Treatment for Opioid Addiction in Danger of Arrest

shutterstock_39985291As of July 1, a pregnant woman who gives birth in Tennessee to a baby who has neonatal abstinence syndrome (NAS), a transient and easily treatable condition, could be arrested for assault. Many women in opioid treatment programs (OTPs) are likely to deliver a baby with NAS, so the American Association for the Treatment of Opioid Dependence (AATOD) and the state chapter worked hard to try to convince Gov. Bill Haslam not to sign the bill; however, April 29, he signed it.

It’s much safer for the fetus for a woman to stay on methadone or buprenorphine during her pregnancy than to come off it, medical experts agree. That’s why AATOD and other health care advocates are concerned that out of fear of being arrested, pregnant women will try to avoid or terminate treatment, or if they are not in treatment, avoid medical care altogether.

Although the Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS), which regulates OTPs and other treatment programs, has said that it doesn’t want women in treatment in OTPs to be arrested, it has no authority over what individual prosecutors and police officers decide to do.

“It continues to trouble us that the Department of Health and TDMHSAS has no authority over prosecutors,” said a joint press statement signed by AATOD president Mark Parrino, Deb Crowley (chair and president of the Tennessee chapter of AATOD), Joycelyn Woods (executive director of the National Alliance for Medication Assisted Recovery [NAMA-R]), and Zac Talbott (director of NAMA-R of Tennessee). “Under the new law the possibility remains that individual prosecutors could attempt to bring charges against pregnant women enrolled in MAT who deliver babies that show signs of neonatal abstinence syndrome.”

The law has no specific exemption for women in medication-assisted treatment (MAT) who do not test positive for any illicit substance, something that AATOD calls “frightening.” Women in treatment with methadone will be subject to criminal proceedings simply for following the best advice of their physicians.

This is not to say that AATOD thinks any women should be arrested for using drugs—in fact, nobody can be arrested for “using” drugs. What the Tennessee law does is to take another step toward calling a fetus a “person,” and criminalizing the mother for “assault” on the fetus by using drugs.

“This law could leave open the possibility for women to be criminally prosecuted for seeking and obtaining the medical treatment for their disease that is the medically accepted standard of care and most responsible decision they could make for the healthy development of their unborn babies,” concluded AATOD.

Asked whether women in MAT will be protected from arrest, TDMHSAS communications director Michael A. Rabkin said that the law “protects these women from arrest.”  The law says that women who complete a treatment program will not be arrested. What should providers do to protect their patients? “There is nothing specific that providers need to be doing to protect them, since it is the law that protects them from arrest.

Advocates, however, urge that treatment providers can do the best thing for their patients by safeguarding their confidentiality and not reporting them or turning over their records to authorities.

We asked what the TDMHSAS is recommending in terms of whether patients should stay on methadone while pregnant. Mr. Rabkin’s response: “Obstetricians have standards of care that they follow that generally say that pregnant women should stay on methadone, but this decision is an individual decision that must be made by each pregnant woman and her doctor.”

Jack McCarthy, MD, an expert on pregnancy and methadone who is with Bi-Valley Medical Clinic in Sacramento, California, is horrified by the law. “I would call detoxing a pregnant woman ‘fetus abuse,’” he says. “Legally the fetus might be allowed protection from cruel practices such as opioid withdrawal.” McCarthy published a paper on “Intrauterine Abstinence Syndrome” two years ago. Summed up, it says that “You can kill a fetus and you can severely stress a fetus by ‘detoxing’ the mother,’” he said.

Other National News of Interest

Surge in Narcotic Prescriptions for Pregnant Women

“Doctors are prescribing opioid painkillers to pregnant women in astonishing numbers, new research shows, even though risks to the developing fetus are largely unknown.

Of 1.1 million pregnant women enrolled in Medicaid nationally, nearly 23 percent filled an opioid prescription in 2007, up from 18.5 percent in 2000, according to a study published last week in the journal Obstetrics & Gynecology. That percentage is the largest to date of opioid prescriptions among pregnant women. Medicaid covers the medical expenses for 45 percent of births in the United States.”

The lead author, Rishi J. Desai, a research fellow at Brigham and Women’s Hospital, said he had expected to “see some increase in trend, but not this magnitude.”

http://www.nytimes.com/2014/04/15/science/surge-in-prescriptions-for-opioid-painkillers-for-pregnant-women.html

Source: NewYorkTimes.com – April 15, 2014

World Health Organization (WHO) Releases Guidelines: Substance Use and Pregnancy

These recently released guidelines contain recommendations on the identification and management of substance use and substance use disorders for health care services which assist women who are pregnant, or have recently had a child, and who use alcohol or drugs or who have a substance use disorder. They have been developed in response to requests from organizations, institutions and individuals for technical guidance on the identification and management of alcohol and other substance use and substance use disorders in pregnant women, with the target of healthy outcomes for both pregnant and their fetus or infant.

http://www.who.int/substance_abuse/publications/pregnancy_guidelines/en/

Source: World Health Organization – March 2014

From the Publisher—Special Issue on Recovery From Opioid Addiction

people-sunlight

For six decades methadone maintenance has been an approved treatment for opioid addiction. People who are taking methadone are no different from those who manage their diabetes by taking insulin: they are in recovery. Yet some policymakers—and even some medical, and yes, some addiction authorities—don’t believe it. Although that may change as more and more professionals buy into the scientific fact that addiction is a brain disease, and therefore it can be treated, and people can recover from it.

The federal government, from the Substance Abuse and Mental Health Services Administration (SAMHSA) to the Office of National Drug Control Policy (ONDCP), states that medication-assisted treatment (MAT) is recovery. In this issue, we write about a comprehensive literature review funded by SAMHSA demonstrating the efficacy of MAT. And we cover an article by William L. White describing the stigma and other obstacles methadone patients face when joining 12-step groups—and the important role these groups could play in helping patients in recovery. We also interview Walter Ginter, peer, patient, and advocate, who spoke before the ONDCP in December on the topic of recovery and MAT. Mr. Ginter, a methadone patient in long-term recovery, is an articulate spokesman for methadone and for patients, helping to guide peer services across the country from his position at MARS, in New York City. We also interview Zac Talbott, based in the less-welcoming South, about his work as an advocate.

Not all of the news is good: In New Jersey, a state that strongly endorses methadone as a treatment for opioid-dependent pregnant women, a woman is facing child abuse and neglect charges simply for being in a methadone program while pregnant. The Supreme Court is due to hear the case, and legal and medical authorities are hopeful that the court will not in effect ban MAT for pregnant women. The woman was in recovery, doing the right thing for herself and her baby, yet was reported, and was held by a lower court to have committed child abuse and neglect by being on methadone while pregnant. On the bright side, the best legal and medical minds who know about MAT have filed a friend of the court brief on the mother’s behalf.

In Philadelphia, where AT Forum attended the AATOD conference last fall, recovery transformation is happening in a solid way, moving from treating addiction as an acute episode to a continuum instead, in which someone enters recovery as a person, not a patient. Roland Lamb discusses efforts to help opioid treatment programs (OTPs) provide what is needed for recovery, with more of a focus on the person than on the dosage and the monitoring. Methadone is a way to recovery—that’s why it was created—but the person taking it is the point of recovery.

Finally, a new evidence-based document from ASAM provides guidance for safe methadone induction and stabilization in OTP patients. This is the first time this vital information has been brought together in one place. Our article by Stewart Leavitt is recommended reading for everyone interested in methadone maintenance treatment.

I hope you enjoy this issue, and we look forward to your comments and feedback.

Sue Emerson
Publisher

Is Maternal Methadone Treatment Child Abuse and Neglect? New Jersey Supreme Court to Weigh In

pregnant woman jpegOne year after the New Jersey Supreme Court ruled that a pregnant woman did not commit child abuse just because she tested positive for cocaine, the state has brought a similar case to the court: that of a pregnant woman who was in methadone treatment in an opioid treatment program (OTP).

This January, experts in addiction treatment and maternal and fetal health filed a friend of the court brief before the New Jersey Supreme Court, urging it to overturn a lower court ruling in which a pregnant woman in a methadone treatment program was charged with child abuse and found guilty.

In the cocaine case, on February 6, 2013, the New Jersey Supreme Court unanimously held that the state’s child protection laws don’t give child welfare authorities control over pregnant women, and that positive drug test results alone on pregnant women and newborns do not establish neglect. That case involved positive test results for cocaine. The Supreme Court held that those positive test results did not by themselves show maternal neglect.

Here’s the situation now: The state wants to call it child abuse if a woman takes prescribed methadone while pregnant. This is despite the fact that the state has a robust system in which methadone is recommended for pregnant women.

The case involves a woman—YN—who was dependent on opioid pain relievers when she learned she was pregnant. Her medical providers recommended that she obtain methadone treatment and other care, which she did, and she subsequently gave birth to a healthy baby. The baby was successfully treated for neonatal abstinence syndrome (NAS), a predictable treatable and transitory, possible side effect of maternal methadone treatment.

But because of the NAS, YN was reported to the Division of Child Protection and Permanency (DCPP, formerly the Division of Youth and Family Services), and was judged by the lower court to have abused or neglected her child. In effect, the lower court is rewriting the law by applying child abuse statutes to pregnant women and their fetuses, according to the friend of the court brief.

Advocates hope that the Supreme Court will rule, as it did last year, in favor of the mother. Lawrence S. Lustberg, of Gibbons P.C., co-counsel for the amici, said that “the New Jersey Supreme Court has been a national leader in recognizing that when cases raise scientific, medical, or other technical issues, the evaluation of these issues must be informed by existing scientific knowledge, including expert testimony.” He added, “This case should not be an exception, yet, the decision in the lower court was reached without the input of a single medical expert and without considering the established science addressing the value of methadone treatment to maternal, fetal, and child health, and other key health and social welfare issues in the case.”

“As a matter of medicine and health care, it is simply nonsensical to regard methadone treatment as a form of child abuse,” said Robert Newman, MD, one of the experts represented in the brief. “Decades of research unequivocally demonstrate the benefits of treating a pregnant woman’s addiction to opioids with methadone, an extraordinarily well-studied medication whose benefits to the mother as well as the baby unquestionably outweigh the treatable and transitory side effects that are sometimes seen in the newborns.” He noted that “It is not recommended that women simply stop using opiates during pregnancy” and that “methadone and other related treatments are acknowledged by national and international governmental, academic, and clinic authorities to be the best choice for maternal, fetal, and child health, reducing risks of miscarriage, stillbirth, and premature birth.”

The bottom line: YN was in recovery. But unless the lower court’s ruling is reversed, New Jersey will effectively be the first state in the country to ban pregnant women from receiving methadone treatment, said Lynn Paltrow, Executive Director of National Advocates for Pregnant Women (NAPW) and co-counsel representing the experts. Not only do the DCPP’s actions “fly in the face of the recommendations of the World Health Organization and the U.S. government, but New Jersey itself, which, through collaborations between the New Jersey Department of Mental Health and Addiction Services and DCPP, provides methadone treatment to pregnant women and families in the child welfare system.”

The Legal Action Center signed on to the amicus brief and strongly supports the NAPW.  “It is wrong, counterproductive, and dangerous to charge a pregnant woman with child abuse simply because she is in a methadone maintenance program,” Sally Friedman, legal director for the Legal Action Center, told AT Forum. “Singling out pregnant women receiving methadone maintenance treatment also can violate anti-discrimination laws.” Ms. Friedman added that child welfare authorities “need to act on the basis of medical evidence, not myths.” The best way for OTPs to make sure that their patients aren’t reported is to educate, added Ms. Friedman.

The mother, YN, is represented by Clara S. Licata and T. Gary Mitchell.

For the friend of the court brief filed January 9, go to http://advocatesforpregnantwomen.org/briefs/DYFS%20v.%20YN%20-%20Amended%20Supplemental%20Brief%20and%20Appendices.pdf

Experts Challenge Decision That Would Make New Jersey the First State to Effectively Outlaw Methadone Treatment for Pregnant Women

Pg8_law“This week, 76 organizations and experts in maternal, fetal, and child health, addiction treatment, and health advocacy filed an amicus curiae (friend of the court) brief before the New Jersey Supreme Court, urging it to overturn a lower court ruling making the state’s civil child abuse law applicable to women who received medically prescribed methadone treatment while pregnant.

At the center of the case is a woman, identified by the court as Y.N., who had been struggling with a dependency on opioid painkillers. When she found out she was pregnant, she followed medical advice and obtained care that included methadone treatment. She gave birth to a healthy baby who was successfully treated for symptoms of neonatal abstinence syndrome (NAS). NAS is a side effect of methadone treatment and other medications, such as those commonly prescribed to treat depression. Y.N. was reported to the Division of Child Protection and Permanency (DCPP, formerly the Division of Youth and Family Services), and was judged to have abused or neglected her child because she agreed with her physician’s recommendation and followed the prescribed course of methadone treatment while pregnant.

Lawrence S. Lustberg of Gibbons P.C., co-counsel for the amici, explains that “the New Jersey Supreme Court has been a national leader in recognizing that when cases raise scientific, medical, or other technical issues, the evaluation of these issues must be informed by existing scientific knowledge, including expert testimony.” He added, “This case should not be an exception, yet, the decision in the lower court was reached without the input of a single medical expert and without considering the established science addressing the value of methadone treatment to maternal, fetal, and child health, and other key health and social welfare issues in the case.”

Dr. Robert Newman, one of the experts represented in the brief and a nationally and internationally recognized authority on methadone treatment, said, “As a matter of medicine and health care, it is simply nonsensical to regard methadone treatment as a form of child abuse.” He explained, “Decades of research unequivocally demonstrate the benefits of treating a pregnant woman’s addiction to opioids with methadone, an extraordinarily well-studied medication whose benefits to the mother as well as the baby unquestionably outweigh the treatable and transitory side effects that are sometimes seen in the newborns.” He noted that “It is not recommended that women simply stop using opiates during pregnancy” and that “methadone and other related treatments are acknowledged by national and international governmental, academic and clinic authorities to be the best choice for maternal, fetal, and child health, reducing risks of miscarriage, stillbirth, and premature birth.”

The experts’ brief addresses the fact that the lower court did not consider health measures that can be taken after birth to reduce symptoms of NAS, including keeping the new mother and baby together and encouraging breast feeding. The brief also notes that there is nothing in the lower court’s decision that limits its ruling to pregnant women who receive methadone treatment and could be applied to any pregnant woman, including those who experience health conditions such as epilepsy, depression, and blood clots that require medication that have potential adverse effects in the newborn.

Lynn Paltrow, Executive Director of National Advocates for Pregnant Women and co-counsel representing the experts, explained that, “unless the lower court decision is reversed, New Jersey would become the only state in the U.S. to effectively ban pregnant women from receiving methadone treatment.” She added, “DCPP’s position and the lower court’s decision is inexplicable and irrational. They not only fly in the face of the recommendations of the World Health Organization and the U.S. government, but New Jersey itself, which, through collaborations between the New Jersey Department of Mental Health and Addiction Services and DCPP, provides methadone treatment to pregnant women and families in the child welfare system.”

The court is expected to hear oral arguments this term. The group of expert amici included the American College of Obstetricians and Gynecologists, American Psychiatric Association, American Public Health Association, American Society of Addiction Medicine, Medical Society of New Jersey, New Jersey Psychiatric Association, New Jersey Obstetrical and Gynecological Society, National Council on Alcoholism and Drug Dependence, and National Council on Alcoholism and Drug Dependence-NJ. A full list of amici is available here:http://bit.ly/K7vhNo.

In 2013, more than 50 national and international experts published an open letter urging that media coverage of prenatal exposure to opioids be based on science, not stigma and misinformation. This letter is available at: http://bit.ly/1eIdeaz.

http://advocatesforpregnantwomen.org/blog/2014/01/experts_to_new_jersey_supreme.php

Source: National Advocates for Pregnant Women – January 9, 2013

 

 

Jana Burson Blog Inspired at AATOD – Supplemental Study of the MOTHER Trial

 

baby“Yesterday at the AATOD conference, I heard a lecture by one of the main authors of the MOTHER (Maternal Opioid Treatment: Human Experimental Research) trial, Dr. Karol Kaltenbach. I’ve posted blogs about this trial (see Dec 16, 2010, March 23, 2013), which randomized opioid-addicted pregnant women to treatment with either methadone or buprenorphine. The goal was to compare outcomes of the babies born to moms maintained on methadone versus buprenorphine.

From the MOTHER study we learned that babies born to moms on buprenorphine have about the same risk of withdrawal, called neonatal abstinence syndrome (NAS), as babies born to moms on methadone. In both groups, fifty percent of the babies had NAS severe enough to need medication to treat opioid withdrawal. The babies were scored on the Finnegan scale, which grades the babies on many signs of withdrawal to indicate when treatment is needed.

Now for the exciting part: a supplemental study of these children is being completed. This data hasn’t yet been published, but Dr. Kaltenbach says it will show that kids of moms on methadone and buprenorphine were compared and assessed at three months, six months, twelve, twenty-four, and thirty-six months. A standardized scoring system for infant development called the Bayley Scale was used to study these children, and the groups were compared to scores for normal children.

Dr. Kaltenbach says there are no differences between the babies born to methadone versus buprenorphine, and better yet – both groups showed scores in the normal ranges on this scale. The scale measured things like language and motor skills, cognitive abilities, and conceptual and social skills.”

http://janaburson.wordpress.com/2013/11/14/inspired-at-aatod/

Source: Jana Burson – November 14, 2013

 

Methadone vs. Buprenorphine: How Do OTPs and Patients Make the Choice?

choicesOpioid treatment programs (OTPs) have always been able to dispense buprenorphine on the same basis as methadone, but now they can dispense take-home buprenorphine more liberally than take-home methadone. This has given rise to many questions about how new patients should be selected for which medication—the appeal of take-homes is clear, but that doesn’t necessarily mean everyone who wants buprenorphine from an OTP should get it. Still, there is very little information available about how to select which patients for which medication. AT Forum talked to top experts in the country about this question.

There aren’t formal selection criteria developed for OTPs, explained Melinda Campopiano, MD, medical officer for the Center for Substance Abuse Treatment (CSAT) at the federal Substance Abuse and Mental Health Services Administration (SAMHSA). Dr. Campopiano said physicians should apply exclusionary criteria for each medication, but aside from that, the decision is “supposed to be made by a physician, based on individual circumstances.”

It’s clear, said Dr. Campopiano, that more is involved than simply patient choice. “How healthy is the patient medically and psychiatrically? How stable is their life? Can they keep take-home medication safely?”

Andrew J. Saxon, MD, professor in the Department of Psychiatry & Behavioral Sciences and director of the Addiction Psychiatry Residency Program at the University of Washington, prefaced his answers to our questions by saying there are no good data that would help predict which patients might do best on which medication. “My responses involve my own opinion,” he said. He is trying to “piece together the data we do have to lead us at least to some reasonably rational decisions.”

Dr. Saxon noted that the situation is no different from any other area of psychiatry—“We have lots of antidepressants and antipsychotics, but no data to tell us which patient will respond best to which” drug.

That said, methadone has the advantage of retaining patients better in treatment, said Dr. Saxon. “This advantage is very important because so many patients drop out of maintenance treatment, and almost all relapse and significantly raise their risk for mortality.”

The advantage of buprenorphine is a better safety profile, allowing the dose to be raised very quickly to therapeutic levels, said Dr. Saxon, who was the source recommended by the National Institute on Drug Abuse for this article.

If what people want is a formula that gives cookie-cutter recommendations for one drug over the other that can apply in all cases—that isn’t going to happen, said Dr. Campopiano. “You can’t use a formula to tell you what medication to give for blood pressure. You might try one, and if that doesn’t work, try another.” It’s important to rely on science, she said.

One of the big challenges with medication-assisted treatment—and all treatment—for addiction is that the field is short on physicians, unlike other medical treatment fields. This creates a struggle when it comes to answering questions about different medications. A choice between buprenorphine and methadone is, after all, a medical decision.  

The decision to treat with buprenorphine or methadone is based on a combination of factors, said Laura Murray, MD, medical director for Addiction Services for NHS Human Services. Dr. Murray oversees medication-assisted treatment with methadone and buprenorphine in multiple OTPs in Philadelphia and surrounding counties. “In our treatment programs, the process begins with a thorough intake assessment to first determine the appropriate level of care, whether that be inpatient treatment or treatment in the OTP setting,” said Dr. Murray. After review and collaboration with the intake specialist, the final decision for the appropriate form of medication is made by the physician, she said.

Patient Preference

A history of patient reliability, patient choice, and a history of response or lack of response to buprenorphine or methadone would guide Peter L. Tenore, MD, medical director of the division of substance abuse at Albert Einstein College of Medicine in New York City. However, patient preference is not as important as the patient’s responsibility in taking medications correctly.

Dr. Tenore stressed that a patient’s desire to have take-homes is not alone a valid criterion for dispensing buprenorphine instead of methadone. Patient responsibility—to take medications correctly and to prevent diversion—and patient history of or a response or nonresponse to buprenorphine—are the important issues, he said.

“Patient preference guides me a lot,” said Dr. Saxon. “We have a qualitative study showing that patients who prefer methadone but get buprenorphine instead are not well satisfied and don’t stay on it,” he said. “Since we don’t have good data to guide us in making a choice between medications, why not give the patient what the patient wants, unless there are reasons not to?” He added that one reason not to would be that the patient hasn’t done well on that medication before.

Individual preference is a major factor in the decision between methadone and buprenorphine, agreed Dr. Murray. “If an individual presents requesting buprenorphine treatment, we make every attempt to accommodate their preference,” she said. “When a person struggling with addiction has reached the point of accepting the need for help, denying their preferred treatment can be antagonistic and harmful in establishing a therapeutic relationship from the outset.”

However, Dr. Murray noted that the program is “very clear from the beginning that the final decision rests with the program physician after a complete examination and an assessment of appropriateness for treatment,” she said. If patient preference cannot be accommodated, the program works with the patient to help him or her “in a mutual understanding regarding the appropriate treatment and the reasons for the denial.”

Patient preference should be taken into consideration, because patients do better when OTPs “meet them where they’re at,” said Susan F. Neshin, MD, medical director of JSAS Healthcare, an OTP based in Neptune, New Jersey.

Take-homes

If patients’ main reasons for wanting buprenorphine are take-homes, they need to realize that there are more stringent requirements for these privileges.

The more liberal take-home policy for buprenorphine is often attractive for people who are holding down full-time jobs or for mothers with child-care issues, said Dr. Murray. “However, we are very aware of diversion issues and as such we attempt to make an assessment regarding the type of program and the level of structure best suited to the individual, based on their presentation and history.”

 “A patient appropriate for buprenorphine treatment should have relative stability in many important life areas,” said Dr. Neshin, citing employment, housing, relationships, physical and mental health, and support systems. “Patients whose lives are more chaotic need the structure of methadone treatment,” which means coming to the clinic more often.

Array of Services

OTPs offer a broad array of services, and many patients benefit from this. However, many patients are unwilling to commit to the daily attendance and stringent requirements of OTPs. “The stronger their own support systems and commitment to recovery, the less they need the structure of OTPs,” said Dr. Neshin.

It’s not possible to compare office-based treatment with buprenorphine and treatment in the OTP setting (with either buprenorphine or methadone), because of the extra services offered by an OTP. Dr. Tenore demands and arranges for additional services for patients on buprenorphine, as well as for those on methadone.

Treatment in an OTP and office-based treatment are “probably not comparable,” agreed Dr. Saxon, adding that no study has even been done comparing the two settings. “Right now we suspect that patients who make it to office-based treatment are probably different from those who end up in OTPs, with OTP patients being generally sicker and  poorer. But I’m not sure we have adequate data to support that.” And, he stressed, dropout rates from office-based treatment are very high.

In general, patients with a high opioid tolerance and chronicity of use in general should be guided to methadone treatment, said Dr. Neshin. But she added that many patients with apparent high tolerances can comfortably reach an adequate buprenorphine dose.

Previous Failures

For people who have a history of instability on buprenorphine, chances are it won’t be efficacious when tried again, unless there are significant changes in the patient’s circumstances, Dr. Neshin noted.

But clinicians should look beyond a history of failure with either buprenorphine or methadone to the reason for that failure, said Dr. Tenore. Usually, he said, the reason for the failure is that the dose was too low.

Previous failures can make a difference in which medication is chosen, but should never be used alone as a deciding factor, said Dr. Murray. She agreed that the reasons for failure are important. In addition, she said, a past failure with a specific treatment “can lead to a positive outcome in a future attempt, because the individual has learned something from the failed attempt.”

Specific Drug of Abuse

All of our sources agreed that whether patients were addicted to heroin or prescription opioids is not relevant in deciding between methadone and buprenorphine.

But if the patient used opioids intravenously, the structure of an OTP is preferred, regardless of the medication delivered. These patients are more likely to have higher addiction severity scores, noted Dr. Neshin.

Typically, patients with longer addiction histories and longer periods of instability in their lives should be referred for methadone treatment in an OTP, Dr. Neshin said. And while age isn’t an important factor, “immaturity” usually requires the structure of an OTP, she added.

Dr. Murray agreed completely on maturity of the patient playing a role in choice of treatment. While both methadone and buprenorphine patients should be at least 18 years of age, it’s important to determine whether the patient can be compliant with treatment requirements. Younger patients benefit from the more structured environment of methadone maintenance treatment, according to Dr. Murray. “Lifestyle and support systems are important factors in determining the appropriate treatment,” she said, adding again that the more structured environment of methadone maintenance treatment “may be more appropriate for a person without support systems and with an unstable living environment.” 

OTP vs. Office-based

Often, the question of methadone vs. buprenorphine is interpreted as one of OTP vs. office-based treatment. That came up frequently in our interviews, because methadone is still associated with OTPs, and buprenorphine with office-based treatment.

But it’s important to realize that buprenorphine can be given in either setting, and that the fact that patients are allowed buprenorphine take-homes under federal guidelines doesn’t mean that an OTP will make the clinical decision that patients should have take-homes. In other words, methadone always must be dispensed in an OTP (with very rare exceptions), while buprenorphine can be dispensed in an OTP or by an office-based practitioner.

In deciding between an office-based model and an OTP when giving buprenorphine, IV drug users should be steered toward an OTP unless the office-based practitioner is “conscientious about all the necessary medical testing that needs to be done,” said Dr. Neshin, citing in particular HIV and hepatitis testing.

At NHS, all addiction treatment, whether with methadone or buprenorphine, includes multiple ancillary services, said Dr. Murray. “We believe that for most people, medication-assisted treatment does not work alone.”

Among the ancillary services that should be offered in addition to medication: group and individual therapy, family therapy, case-management services, services for specialized groups such as seniors and pregnant women, enhanced recovery services, peer specialist supports, and on-site psychiatric services—these are all offered by NHS. While some office-based providers give referrals for counseling elsewhere, many are not in a position to provide these ancillary services, said Dr. Murray. And it’s often the OTPs who have to pick up the pieces when the services aren’t provided. “We sometimes treat patients who have failed treatment in an office-based treatment setting because they needed a higher level of care or other services to support their recovery, and these were not made available to them.” 

Pregnancy

Pregnancy status is less relevant as a patient-selection criterion than it used to be, now that enough studies have been done using buprenorphine during pregnancy, said Dr. Neshin. “However, I have had many women who started out on buprenorphine and had to switch to methadone during pregnancy due to inability to reach an adequate buprenorphine dose as the pregnancy progressed,” she said.

There are differences of opinion about this issue, with CSAT’s Dr. Campopiano saying that not enough studies have been done to make clinicians comfortable prescribing buprenorphine during pregnancy, and Dr. Tenore of Albert Einstein saying he would absolutely not prescribe it, citing U.S. Food and Drug Administration (FDA) guidelines.

Dr. Murray conceded that recent studies do suggest positive outcomes with buprenorphine treatment, but she said that methadone maintenance “is still the standard of care, and would be our preferred treatment at this time for a pregnant woman seeking treatment.”

fundingCost

There are huge differences in cost between methadone, which is very inexpensive, and buprenorphine. In New Jersey, for example, if a patient has Medicaid and little money, it is often less expensive to be on office-based buprenorphine than on methadone, Dr. Neshin explained. Many OTPs in New Jersey either do not accept Medicaid or limit the number of Medicaid patients they can treat, and many Medicaid patients have to pay the standard weekly clinic fee. Since Medicaid covers the cost of a buprenorphine prescription, patients may have to pay only a monthly fee to an office-based physician. On the other hand, patients without prescription coverage often cannot afford buprenorphine treatment, as even the cost of generic buprenorphine can be prohibitive.

At NHS, cost is irrelevant, since the only out-of-pocket expense is a “very minimal co-pay for buprenorphine prescriptions,” said Dr. Murray. She explained that patients already in treatment with buprenorphine often are admitted to NHS because they can’t afford the cost of an office visit with their office-based provider.

Switching Medications

Some patients want to “graduate” from methadone to buprenorphine, mainly because they are unable to attend the OTP as frequently as methadone treatment requires, said Dr. Neshin, who has transferred many patients for this and other reasons. Typically, the transfer is done with “minimal discomfort,” and patients usually stabilize within days.

Sometimes the transfer is from buprenorphine to methadone—for example, if a patient isn’t doing well in office-based treatment and continues abusing drugs, a referral to medication-assisted treatment in an OTP—or in some cases, to inpatient treatment—should be made, said Dr. Neshin.

If issues of cost are ignored, said the University of Washington’s Dr. Saxon, “it makes sense to start with buprenorphine with a back-up plan to switch promptly to methadone if the response to buprenorphine is not good.” He added that it’s important for patients to know that it’s “easy to switch from buprenorphine to methadone, but it can be quite challenging to switch from methadone to buprenorphine.”

Summing Up

Overall, the determination to treat with methadone or buprenorphine is multifactorial. Methadone maintenance in an OTP provides greater structure because the individual has to visit every day for dosing, or to attend group sessions and counseling. Patients who want take-home buprenorphine are expected to be reasonably compliant with treatment and safety precautions. Patients who have untreated or unstable psychiatric comorbidities, or are currently abusing or dependent on sedative-hypnotic drugs or alcohol (in addition to opioids) may be recommended for methadone treatment in an OTP instead of treatment with buprenorphine.

Another View: Healthy Moms on Methadone Can Safely Breast-Feed By John McCarthy

“I am responding to The Sacramento Bee’s article on how Sacramento Child Protective Services handled the case of a baby who died of a drug overdose (“CPS lapse cited in death,” The Public Eye, Sept. 1). This report seems to imply that routine breastfeeding by mothers on steady and controlled doses of methadone might expose their babies to the possibility of an overdose. It is physiologically impossible for a baby nursed from birth by a mother on stable daily doses of methadone to overdose.”

http://www.sacbee.com/2013/09/14/5734760/another-view-healthy-moms-on-methadone.html

Source: The Sacramento Bee – September 14, 2013

POLL QUESTION: Should Methadone Programs Include Birth Control?

question boxUniversity of Maine researcher Marie Hayes says she has been criticized for her opinion that methadone programs should incorporate birth control for addicted women.

“That sounds like you’re saying, ‘These defective people shouldn’t reproduce,’ so I’ve been attacked by social workers for that position [who say] ‘Why can’t they have a family like everyone else?’ And the answer is they can, as soon as they get their health back.”

She did not suggest that methadone programs should incorporate sterilization.”

As of July 25, there 656 total votes and 83.24% voted yes.

http://bangordailynews.com/2013/07/16/health/should-methadone-programs-include-birth-control/

Source: BangorDailyNews.com – July 16, 2013

Neonatal Abstinence Syndrome Linked to Exorbitant Costs

baby“A single hospital’s costs to treat neonatal abstinence syndrome in infants born to opioid-dependent mothers who received opioid replacement therapy during pregnancy totaled more than $4 million during a 3-year period, a new study shows.

The average length of stay for infants in the study ranged from 15.1 days in year 2 to 16.2 days in year 3, Dr. Roussos-Ross reported. The average total charge per infant and per hospitalization ranged from $19,535 in year 2 to $28,592 in year 3. Hospital costs per year for treating these neonates were $1.1 million in the first year, nearly $1.5 million in the second, and $1.8 million in the third year, according to the data presented.”

http://www.medscape.com/viewarticle/803656

Source: Medscape.com – May 6, 2013

Genes Found That May Protect Infants Born to Addicted Mothers

“Genes tied to addiction in adults may help guide doctors to better treatments for infants born withdrawing from narcotics, according to researchers who identified the genetic link.

Babies exposed in the womb to opioid drugs who have certain variations to two genes had less severe withdrawal symptoms than those without the variants, according to a study in the Journal of the American Medical Association. The babies left the hospital sooner and needed fewer treatments, researchers said. The study, the first to look at the link between genetics and opioid withdrawal in infants, may help researchers find more effective way to treat these babies, said Jonathan Davis, senior study author and chief of newborn medicine at Floating Hospital for Children at Tufts Medical Center in Boston.”

http://www.businessweek.com/news/2013-04-30/genes-found-that-may-protect-infants-born-to-addicted-mothers

Source: BusinessWeek.com – April 30, 2013

Blog: Obstetricians Behaving Badly

baby“Dealing with uninformed obstetricians is getting old. Overall, about four percent of opioid addicts are pregnant, according to past data. At one of the opioid treatment programs where I’m medical director, the percentage is a bit higher at five or six percent, but it seems like many more. Maybe it seems like more because of the unpleasantness I encounter when I contact these patients’ obstetricians, to coordinate care with them. Aside from a few pleasant exceptions, I dread calling these OB’s.”

http://janaburson.wordpress.com/2013/03/23/obstetricians-behaving-badly/

Source:   Jana Burson - March 22, 2013

Tennessee – Safe Harbor Bill to Protect Infants Wins Passage in Senate Health and Welfare Committee

”Legislation which aims to improve health outcomes for infants born to drug-addicted mothers won passage in the Senate Health and Welfare Committee on Wednesday.  

Senate Bill 459, sponsored by Senator Ken Yager (R-Harriman), encourages pregnant women who misuse prescription opioids to access early prenatal care and drug rehabilitation. In exchange, they would be given a safe harbor from having their parental rights terminated through a petition filed by the Department of Children’s Services due to prenatal drug abuse. The safe harbor only applies if the mother meets certain requirements set out in the bill to protect the health of the fetus.”

http://www.chattanoogan.com/2013/2/28/245492/Safe-Harbor-Bill-To-Protect-Infants.aspx

Source: Chatanoogan.com – February 28, 2013

Drug Addiction: It’s Different—and Riskier—for Women

When it comes to drug addiction, gender does make a difference.

Women start using substances and become addicted differently from men. Their addiction progresses faster, they find it harder to quit, they recover differently from men, and they relapse for different reasons.

These gender differences have a substantial impact on treatment for substance abuse. But when women’s specific needs are understood and addressed from the outset, better treatment engagement and successful outcomes often follow.

Women and Addiction: The Biopsychosociocultural Framework

The Substance Abuse and Mental Health Administration TIP 51, Substance Abuse Treatment: Addressing the Specific Needs of Women, proposes approaching substance abuse treatment for women from the perspective of “the biopsychosociocultural framework.”

Differences between women and men in genetics, physiology, anatomy, and sociocultural expectations and experiences lay the foundation for women’s unique health concerns related to substance-use disorders (SUDs). The biopsychosociocultural framework encompasses the impact of gender and culture and the contexts of a woman’s life, including her social and economic environment, and her relationships with family and support systems.

Risk Factors for Substance Use in Women

Some factors are associated more strongly with initiation of illicit drug use in women than with progression to abuse. They include risk-taking (as a personality trait), depression, obsessiveness, anxiety, and difficulty controlling behavior (as indicated by temper tantrums or tearfulness).

Genetics and environment both play a role in some risk factors. Parents who abuse substances may pass along a genetic susceptibility. They may also fail to adequately protect their children from abuse by others, and may be of little help to them emotionally. And they may unintentionally pass along the message that it’s okay to use substances to cope with problems.

Among other risk factors:

  • Divorce, never having been married, and widowhood (the incidence of SUDs in married women is only 4%)
  • Sexual or physical abuse or domestic violence in childhood or adulthood
  • A history of having adult responsibilities as a child: caring for younger children, performing household duties, emotionally supporting their parents
  • Unemployment or underemployment; low income; low education level
  • A partner who abuses alcohol or drugs (some women continue using substances in order to maintain the relationship, a situation that also occurs in some same-sex relationships)
  • Sexual orientation: lesbians have higher rates of SUDs than heterosexual women; younger lesbians and bisexual women are most likely to abuse prescription drugs

Protective Factors

Factors that help protect a woman against substance use, abuse, and dependence include a good marriage, a supportive partner, parental warmth during her childhood, religious affiliation and beliefs, and deep personal devotion.

Research Results: Characteristics of Women with OUDs

Women face a higher risk of co-occurring mental and physical disorders. A UCLA study examined gender differences in 578 men and women with opioid-use disorders (OUDs), drawn from the National Epidemiologic Survey on Alcohol and Related Conditions. The study found that “women were about twice as likely as men to have either a mood or anxiety disorder.” Women were also “more likely to have paranoid disorder, and men, more likely to have antisocial personality disorder.” Another study, the National Survey on Drug Use and Health, found higher rates of “serious psychological distress” and “cigarette use” related to non-medical use of prescription opioids among women, but not among men. In contrast, “serious psychological distress” was a significant predictor of abuse/dependence for both sexes.

Other studies have found that women are much more likely than men to have co-occurring mental disorders, often three or more, including anxiety disorders, major depression, eating disorders, and post-traumatic stress disorder (PTSD). Typically, PTSD follows trauma, sexual abuse, or violence—events that unfortunately are all too common in women with OUD. Physical disorders in women include gynecological infections, high blood pressure, amenorrhea (absence of menstrual periods) and pneumonia.

In a symposium report, Florence Haseltine, PhD, MD, noted that women tend to take illicit drugs to relieve stress; men, to get a high; women, for self-medication; men, as an adventure.

She added that women with OUDs are more likely to

  • Self-medicate, especially using drugs to manage negative moods
  • Need help for emotional problems, and at a younger age
  • Have attempted suicide

Others have observed that, in addition, women with OUDs tend to use more prescription drugs (and use prescription drugs that can be abused), obtain prescription opioids free from family or friends (men are more likely to buy them), and have partners who use illicit drugs.

Relationships and family history are key factors in women’s—but not men’s—initiation and continued illicit use of opioids and other substances. Women are more likely than men to have a family background of dysfunction and alcohol dependency, and to be brought into and maintained in drug use by a partner or family member. It almost seems that when women start to abuse substances, they already have three strikes against them.

Women are more likely to borrow needles and equipment from the person they inject drugs with. They’re also likely to inject immediately after that person—putting themselves at added risk of HIV and hepatitis infections. Intravenous drug use accounts for up to half the cases of HIV infection among women in the U.S., twice as many as sexual transmission.

But, importantly, women can temporarily change their pattern of substance use to meet caregiver responsibilities involving the family, such as pregnancy.

Looking Back When In Methadone Maintenance Treatment

In gender-specific focus groups in a methadone maintenance clinic at UCLA, comments from participants older than 50 years revealed clear differences between men and women in their views of their previous life in addiction. Women talked about the impact on their families, and their regrets about “. . . not being the mother I should have been.” And their remorse: “I almost lost my family.”  Men typically expressed surprise at still being alive, and previous fears about incarceration.

Pregnancy

If a woman’s menstrual periods stop when she is using opioids, she may assume at first that the early signs of pregnancy are symptoms of withdrawal or underdosing. This often delays her pregnancy diagnosis and prenatal care.

But, as TIP 51 points out, “Women are socialized to assume more caregiver roles and to focus attention on others.” Indeed, once a woman is told she is pregnant, she typically casts aside her vulnerability and regains her traditional role of caregiver. She is likely to accept medical care for herself and her unborn child, and to stop or substantially curtail her use of illicit drugs, alcohol, and cigarettes, throughout her pregnancy.

*     *     *

This article is the first in a series on the special challenges that make coping with addiction especially difficult for women. Future topics include the barriers women face in seeking and accepting treatment, and the best approaches to treatment for women in medication-assisted treatment programs. Programs need to address the special needs of women by offering auxiliary or wraparound services, or both—such as child care and prenatal services, and workshops on woman-focused topics.

Resources

Center for Substance Abuse Treatment. Substance Abuse Treatment: Addressing the Specific Needs of Women. Treatment Improvement Protocol (TIP) Series 51. HHS Publication No. (SMA) 09-4426. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2009.

Becker JB, Hu M. Sex differences in drug use. Frontiers in Endocrinology. 2008;29:36-47.

Haseltine FP. Symposium Report: Gender differences in addiction and recovery. J Womens Health Gend Based Med. 2000;9(6).

Hamilton AB, Grella CE. Gender differences among older heroin users. J Women Aging. 2009;21(2):111-124.

Grella CE, Karno MP, Warda US, et al. Gender and comorbidity among individuals with opioid use disorders in the NESARC study. Addict Behav. 2009;34(6-7):498-504.

Grella CE, Lovinger K. Gender differences in physical and mental health outcomes among an aging cohort of individuals with a history of heroin dependence. Addict Behav. 2012;37(3):306-312.

Subramaniam GA. Clinical characteristics of treatment-seeking prescription opioid versus heroin using adolescents with opioid use disorder. Drug Alcohol Depend. 2009;101(1-2):13-19.

Back SE, Payne RL, Simpson AN, Brady KT. Gender and prescription opioids: Findings from the National Survey on Drug Use and Health. Addict Behav. 2010;35(11)1001-1007.

Benzodiazepine & MAT Conference Videos Available From IRETA

On February 9, 2012 the Philadelphia Department of Behavioral Health and Intellectual Disability Services, the Institute for Research, Education, and Training in Addictions (IRETA), and Community Care Behavioral Health hosted a kickoff conference in Philadelphia that will lead to working guidelines for the management of benzodiazepines in medication-assisted treatment.

Recorded presentations from the conference are now available to view online. Experts in the field discuss local rates of concurrent use, the perspective of primary care, pregnancy, patient education, co-occurring disorders, and more. A total of 18 videos are available to view including: 

  • Jane C. Maxwell, PhD: Epidemiology, Morbidity and Mortality for Benzodiazepine Use
  •  James Schuster, MD, MBA: Rates of Benzodiazepine Use in Medication-Assisted Treatment
  •  Laura F. McNicholas, MD, PhD: Clinical Management of the Benzodiazepine-dependent Patient
  •  Karol Kaltenbach, PhD: Benzodiazepines and the Pregnant Patient: Special Challenges
  •  Peter R. Cohen, MD: Guidelines for Treating OMT Patients with Benzodiazepines

http://www.youtube.com/playlist?list=PLiML4AFpuB72QBVMT6bR2maChRvT5MXsr

Source: Institute for Research, Education, and Training in Addictions – November 2012

New Infographic From NIDA – Maternal Opiate Use and Newborns Suffering From Opiate Withdrawal Are On The Rise in The U.S.

Use of opiates during pregnancy can result in a drug withdrawal syndrome in newborns called neonatal abstinence syndrome (NAS). A new study to determine the extent, context, and costs of NAS found that incidence of NAS is rising in the US. The proportion of babies born with NAS tripled from 2000 to 2009, when an estimated 13,539 infants were born with NAS —equivalent to one baby suffering from opiate withdrawal born every hour.

The number of delivering mothers using or dependent on opiates rose even more—nearly five-fold—from 2000 to 2009, to an estimated 23,009. In 2009, newborns with NAS stayed in the hospital an average of 16.4 days (compared to 3.3. days for other newborns), costing hospitals an estimated $720 million; the majority of these charges (77.6%) were paid by state Medicaid programs, reflecting the greater tendency of opiate-abusing mothers to be from lower-income communities. The rising frequency (and costs) of drug withdrawal in newborns points to the need for measures to reduce antenatal exposure to opiates.

The full text description can be accessed at: http://www.drugabuse.gov/related-topics/trends-statistics/infographics/maternal-opiate-use-newborns-suffering-opiate-withdrawal-are-rise-in-us

Source: National Institute on Drug Abuse

Methadone Dosing During Pregnancy: Does Anyone Have a Clue? John J. McCarthy, MD, Guest Author


Methadone treatment of the pregnant, opioid-addicted mother is routinely cited in research studies as causing a neonatal abstinence syndrome (NAS). But this is an oversimplification of the effects on the fetus of the mother’s drug use before, and sometimes during, methadone treatment.

There are limits to what we really know about the effects of opioid abuse on the developing fetus. Even more complicated are the effects of additional use of nicotine, alcohol, stimulants, and benzodiazepines. We know something about the effects of cycles of opioid intoxication and withdrawal on the health of the fetus and newborn, but we can’t routinely identify or measure these effects.  We can only wonder if maternal addiction can truly be “without harm”—leaving only methadone withdrawal as the cause of the newborn’s ill health.

Despite all this uncertainty, methadone has become identified as “the cause” of NAS. Here’s how this chain of events typically unfolds. The mother arrives at a hospital on methadone. The baby has NAS. The doctors know nothing about what the baby has been exposed to during the pregnancy, beyond some vague drug abuse history before methadone treatment—but not what drugs, what amount, or for how long. And if doctors see a sick baby, they look for a cause: there is methadone.

It is almost as if addiction never happened. Despite exaggerated claims about how potentially deadly methadone withdrawal is,* in an ongoing study in our pregnancy program the majority of newborns experience NAS that is so mild it does not require treatment. Uncomplicated opioid withdrawal that is more severe is very treatable; only medical neglect would endanger the life of the neonate! What really was life-threatening was fetal withdrawal in the pre-methadone era, for it did result in fetal and neonatal death.*

But opioid withdrawal, when complicated by the harmful effects of poly-drug addiction and repeated episodes of withdrawal on the fetus, might not be easily treated.  It is more complicated than simple methadone withdrawal.

As for how we reduce risks for the neonatal illness called NAS, I suggest the following:  1.) treat the maternal addiction, and stop the fetal exposure to drugs and drug withdrawal; 2.) stabilize the disordered maternal and fetal brain chemistry, using the dose of methadone that will keep the mother and fetus out of withdrawal; and 3.) treat the more severe cases of NAS after birth, if needed, when the newborn’s symptoms are easy to monitor. There is evidence that avoiding neonatal intensive care units and encouraging rooming-in, with frequent skin-to-skin contact between mother and newborn, starting at birth, along with breastfeeding, can reduce NAS symptoms.*

In reality, risks aren’t always reduced by such evidence-based practices, however. We have mothers put through withdrawal during pregnancy “to prevent NAS.”* This practice shifts the burden of withdrawal onto the fetus, where we can’t see what’s happening, because our limited tools of fetal monitoring show us almost nothing of actual fetal withdrawal physiology. Because maternal withdrawal is linked to fetal withdrawal, the fetus can develop an intrauterine abstinence syndrome (IAS).* Maternal/fetal opioid withdrawal can cause restriction of placental blood flow and fetal hypoxia (reduced levels of oxygen in the brain), and fetal brain damage.  Some authors have also encouraged mothers to stay on low doses of methadone and endure withdrawal “to protect the fetus.”* I would ask  what the fetus is being protected from when it is suffering withdrawal in utero; how making the mother sick helps the pregnancy; and how fetal withdrawal helps the baby.

In summary, we have no consensus on the goals of methadone treatment in pregnancy.

Part of the confusion relates to the question of whether giving the mother high doses of methadone worsens NAS. A recent meta-analysis of 67 studies found this not to be the case.* The fetus is not exposed to the maternal dose; it is exposed to the maternal plasma level. We know that plasma levels vary significantly, depending on genetics. And pregnant women metabolize methadone more quickly, necessitating dose increases—but these increases do not necessarily increase fetal exposure to methadone.

One mother in our pregnancy program required 270 mg/day of methadone, in four divided doses. Her plasma level, before the morning dose one week before delivery, was undetectable. After birth, the baby required no treatment for NAS. We don’t know how many physicians are willing to prescribe these high, split doses to keep the mother and fetus out of withdrawal. We don’t know whether programs use maternal plasma methadone levels to monitor changes in maternal metabolism and fetal exposure.

In pregnancy, split doses of methadone protect the fetus from exposure to daily cycles of peaks and troughs, which have been shown to have negative physiologic effects on the fetus.* Even high doses, when given as single daily doses, can result in fetal withdrawal distress before the next day’s dose. That may be why high doses, at times, seem to cause more cases of NAS: The fetus may be sensitized to daily episodes of withdrawal.* Some mothers, like our patient who received 270 mg daily, are ultra-rapid metabolizers; the methadone exposure for their fetuses is far more consistent and physiologic when dosing is four times a day.

While the MOTHER study showed that hospitalization stays were shorter and NAS less severe for the newborns when the mother was on buprenorphine, compared to methadone, this doesn’t answer the question about induction on buprenorphine, which itself raises medical concerns. Maternal treatment with buprenorphine is complicated by buprenorphine’s narcotic antagonist properties, which require mother and fetus to be in withdrawal before the first dose is given. If they are not, buprenorphine may cause acute withdrawal, a threat to the safety of the pregnancy. Methadone inductions are far safer for the fetus.

The MOTHER study did not use split doses of methadone, introducing a potential bias in the methadone arm. Furthermore, the study used comparatively low doses of methadone, averaging 79 mg/day. If the goal of treatment is to use doses high enough to keep the mother and fetus out of withdrawal, our experience is that the average daily dose must be much higher. The average in our ongoing study is 140 mg/day, always split, given two to four times a day. With this approach, only 28 percent of our current cohort of babies (N=53) have required treatment for NAS. The MOTHER study found about a 50 percent treatment rate for both methadone and buprenorphine.

As far as buprenorphine’s having a less severe withdrawal, a Norwegian study found a treatment rate of 67 percent in neonates undergoing buprenorphine withdrawal.* And a study from Finland reported “severe” NAS with a 57 percent rate of morphine treatment, as well as a high number of sudden infant  deaths, in buprenorphine-exposed neonates!* These ”real world” studies  must temper  conclusions about any proposed superiority of buprenorphine over methadone. The etiology of NAS is likely more complicated than a simple choice of one medication or others.

The low treatment rate and relative mildness of NAS in the majority of our babies certainly is not conclusive evidence for the use of our protocol. Ours is one approach that has good theoretical support, and seems to be associated with reduced risk of NAS. It may not be widely used, but we have no true idea of current practices.

Dr. McCarthy, a specialist in addiction medicine, is the Executive/Medical Director of the Bi-Valley Medical Clinic in Sacramento, CA. He is a diplomate of the American Board of Psychiatry and Neurology and the American Board of Addiction Medicine, and an assistant professor of psychiatry at the University of California, Davis. His research publications have focused on opioid addiction in pregnancy.

Dr. McCarthy and AT Forum would deeply appreciate feedback from you, our readers, about your program’s current practices and guidelines for mothers taking methadone during pregnancy.
Please take our survey.

For a list of Dr. McCarthy’s publications and presentations, go to:

http://www.bivalley.com/articles.html

*References

1.  Jones HE, Kaltenbach K, Heil SH, et al. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010;363:2320–2331. DOI: 10.1056/NEJMoa1005359.

2.  Zuspan FP, Gumpel JA, Mejia-Zelaya A, et al. Fetal stress from methadone withdrawal.  Am J Obstet Gynecol. 1975;122(1):43-46. PMID 1130446.

3.  Hodgson ZG, Abrahams, RR. A rooming-in program to mitigate the need to treat for opiate withdrawal in the newborn. J Obstet Gynaecol Can. 2012;34(5):475–481. PMID 22555142.

4.  Dashe JS, Jackson GL, Olscher DA, et al.  Opioid detoxification in pregnancy. Obstet Gynecol. 1998;92(5):854-858. PMID 9794682.

5.  McCarthy JJ. Intrauterine abstinence syndrome (IAS) during buprenorphine inductions and methadone tapers: can we assure the safety of the fetus? J Matern Fetal Neonatal Med. 2012;25(2):109–112. PMID 21867403.

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