Fewer Opioid Treatment Programs Offer HIV Testing

“According to a study, fewer opioid treatment programs are offering onsite testing for HIV and sexually transmitted infections (STIs), despite guidelines from the Centers for Disease Control and Prevention (CDC) recommending routine HIV testing in all health care settings.

The absolute number of programs offering testing for HIV, STIs, and HCV increased from 2000 to 2011. However, the percentage of programs offering HIV testing decreased significantly, by 18%, and the percentage of those offering testing for STIs fell by 13% throughout the study. Testing for each infection did not change over time in public programs, but HIV testing dropped by 20% among for-profit programs and 11% in nonprofit programs.

http://www.pharmacytimes.com/publications/issue/2014/February2014/Fewer-Opioid-Treatment-Programs-Offer-HIV-Testing

Source: PharmacyTimes.com - February 19, 2014

Jana Burson Blog: More about IRETA’s Guidelines for Benzodiazepines in OTPs

blog1“This is a continuation of my last blog post about the IRETA (Institute for Research, Education & Training in Addictions) guidelines for management of benzodiazepine use in medication-assisted treatment of opioid addiction. You can read all of the guidelines at: http://ireta.org/sites/ireta.org/files/Best%20Practice%20Guidelines%20for%20BZDs%20in%20MAT%202013_0.pdf

Under the section of recommendations regarding addressing benzodiazepine use is found the following statement:

“Many people presenting to services have an extensive history of multiple substance dependence and all substance abuse, including benzodiazepines, should be actively addressed in treatment. People who have a history of benzodiazepine abuse should not be disallowed from receiving previously prescribed benzodiazepines, provided they are monitored carefully and have stopped the earlier abuse.”

The experts, after reviewing the best data, are saying that if a patient has abused benzos in the past, but isn’t abusing prescribed benzos now, it may be OK to continue benzos, with careful monitoring.

I don’t like this statement. It doesn’t conform to my present thoughts on the topic. I fear that the majority of patients with a history of benzodiazepine abuse or addiction will, sooner or later, revert back to problem use of the medication. That’s my anecdotal experience. Anecdotal experience is worth something, but data from clinical trials trumps anecdotal experience, and IRETA’s guidelines are based on both clinical trials and expert opinion.

So now I need to challenge my previously held views about benzos in the OTP. It’s unpleasant and uncomfortable to change a long-held view. But isn’t that what I ask of my patients? In the interest of science, I will re-consider my present opinion, but I won’t ignore the last part of the statement, which says careful monitoring needs to be done.”

 http://janaburson.wordpress.com/2014/02/02/more-about-iretas-guidelines-for-benzodiazepines-in-otps/

Source: Jana Burson - February 2, 2014

Guidance Provided for Safe Methadone Induction and Stabilization in OTP Patients By Guest Author Stewart B. Leavitt

doctor and patient jpeg winter 2014Expert opinion from ASAM stresses safety during MMT start-up   

For roughly half a century, methadone dispensed in federally certified opioid treatment programs (OTPs) in the United States has been a well-studied, effective, and relatively safe addiction therapy. Yet, there have been ongoing incidents of methadone-associated overdoses and deaths, largely due to its widespread prescription and frequent misuse as a pain reliever, but also to a lesser extent in patients attending OTPs.

When properly prescribed and used in OTPs, methadone has a favorable safety profile; however, there can be special risks of overdose and death from methadone during start up and early phases of treatment. To address these concerns, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) invited the American Society of Addiction Medicine (ASAM) to convene an expert panel to develop a consensus statement on methadone induction and stabilization, which provides recommendations for reducing risks of overdose or death related to the methadone maintenance treatment (MMT) of addiction.

Methadone Start-Up Takes Time and Caution

A distinguished panel of 10 experts in the MMT field—the “Methadone Action Group,” including Drs. Louis Baxter, Anthony Campbell, Michael DeShields, Petros Levounis, Judith Martin, Laura McNicholas, Tom Payte, Ed Salsitz, and Trusandra Taylor, along with Bonnie Wilford, MS—conducted a comprehensive literature search spanning 1979-2011. The group evaluated the resulting information and collaborated in formulating a best practices consensus document, which was subsequently reviewed and commented on by more than 100 experts in the addiction treatment field.

The final document, published in the November/December edition of ASAM’s Journal of Addiction Medicine [Baxter et al. 2013; PDF here], extensively focuses on safety during the 3 most critical phases of starting MMT: A. methadone induction (weeks 1-2); B. early stabilization (weeks 3-4); C. late stabilization (weeks 5+).

According to the medical literature examined by the expert panel, overdoses and deaths during methadone induction most commonly may occur either because 1) the initial dose is too high, 2) the dose is increased too rapidly, or 3) the prescribed methadone interacts with another drug. Therefore, the panel developed recommendations that help methadone providers avoid or minimize these risks.

When it comes to the initial methadone dosing at MMT start-up, the panel stresses the traditional advice to “start low, go slow.” Acknowledging the difficulties of accurately assessing a new patient’s opioid tolerance—and, therefore, a definitely “safe” methadone dose—the initial dose of methadone should typically range between 10 mg to 30 mg per day. An additional 5-10 mg/day is allowed if necessary to help relieve persistent withdrawal symptoms; however, the standard in the U.S. is that the total daily dose should not exceed 40 mg.

There are a number of high-risk situations to consider that may prompt low initial dosing. These include patient age >60 years, recent use of sedating drugs (e.g., benzodiazepines), alcohol abuse or dependence, concurrent physical disorders (e.g., respiratory or cardiac disease, sleep apnea, central nervous system depression, and others), or taking medications that either increase or decrease methadone metabolism.

It is essential to medically assess patients at intake and closely monitor their response to therapy. It may take several weeks before an optimal methadone dose can be safely achieved, during which time symptoms of withdrawal may persist to some degree, especially late in the day or during the night.

The ASAM panel states that the first day’s methadone dose may be increased “every five or more days in increments of 5 mg or less” [note that this dose increase is at the low end of what previous guidance has recommended]. Because methadone levels accumulate gradually before reaching a steady state, whereby opioid withdrawal is prevented throughout a 24-hour period, patients should be carefully assessed and they often need more time for full effects to be realized rather than more daily methadone during the induction period.

The first 2 weeks of MMT are a critical period from a safety standpoint, and the ASAM expert panel discusses the many subtle factors that may influence a patient’s therapeutic response to methadone and also affect clinical impressions of overmedication. For example, individual patient differences in metabolism may alter the duration of methadone effects; furthermore, in some cases, overmedication may be marked by unexpected feelings of excess energy, with or without euphoria.

Beyond the first 2 weeks—during early and late stabilization—the objective is to achieve a methadone maintenance dose allowing the patient to live a better life free of withdrawal symptoms, drug intoxication or excessive sedation, or troublesome drug craving. Various factors may upset this process—e.g., changes in physical health, psychological distress, continued substance abuse, etc.—so ongoing patient assessments and methadone dose adjustments may be necessary in some cases for an extended period of time. The ASAM expert panel does not comment on what optimal methadone dosing eventually might be, other than to note that “some patients require doses larger than 120 mg/day” for blocking euphoric effects of self-administered (e.g., illicit) opioids.

This new evidence-based document from ASAM is the first time all of this vital information has been so extensively brought together in one place; so, it is recommended and important reading for all persons involved or interested in MMT. At the same time, the principles and best practices described are not entirely new; indeed, this topic was previously discussed, although more briefly, in past AT Forum articles [see Special Report 2003 and ATF fall 2006]. Additionally, in 2007, a methadone induction instruction handout for patients and significant others was made available to AT Forum readers by Tom Payte, MD (who also is one of the Methadone Action Group panel members) [PDF here].

Education and Preparedness Are Essential

Methadone overdose can have a deceptive and slow onset, and the ASAM panel stresses the importance of patient and family education beginning with intake into MMT. Involvement of family [or significant others, and presumably with patient consent] can be a critical safety measure by helping to ensure that they understand the lengthy process of methadone induction and stabilization, as well as the signs/symptoms of overmedication and overdose to watch for along the way. Being able to recognize therapeutic risks and potential problems, and knowing appropriate actions to take if problems do occur, are essential for OTP staff, patients, and patients’ families.

Unfortunately, in the ASAM document there is only a single mention of naloxone, which is an effective and safe antidote for methadone overdose. It states, “Opioid treatment programs should establish protocols for emergency response to and management of patient overdoses, including onsite availability of naloxone and any necessary support and education for families.”

Indeed, there appears to be growing interest in the U.S. (and in other countries) in making naloxone more widely available to patients, their families, and others for helping to reverse opioid overdose in an emergency—whether involving prescribed or illicit opioid agents. For example, Washington State has an aggressive program of naloxone distribution [see StopOverdose.org] and the ASAM expert panel references an “Opioid Overdose Prevention Toolkit” from SAMHSA [PDF here]  that discusses how to identify overdose and the use of lifesaving naloxone. Methadone overdose in MMT—what to know; how to prevent it; what to do if it happens (including naloxone) —was the theme of a past edition of AT Forum [Summer 2007 PDF].

In sum, careful management of methadone induction and stabilization, coupled with patient/family education and increased clinical vigilance by staff, can be lifesaving measures during MMT. According to Louis Baxter, MD—ASAM immediate Past-President and chair of the expert panel—in a press release [PDF here], “The use of methadone to treat addiction has saved countless lives in the last 50 years, but it also has an increased risk of toxicity and adverse events for the patient during the medication’s induction and stabilization phases. The protocols designed by the ASAM expert panel could dramatically decrease these negative outcomes if all clinicians prescribing methadone would follow them.”

References

Baxter LE, Campbell A, DeShields M, Levounis P, Martin JA, McNicholas L, Payte JT, Salsitz EA, Taylor T, Wilford BB. Safe Methadone Induction and Stabilization: Report of an Expert Panel. J Addiction Med. 2013(Nov/Dec);7(6):377-386. PDF available at: http://www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policy-statements/2013/11/26/safe-methadone-induction-and-stabilization. Access checked 1/29/2014.

Leavitt SB. Methadone Dosing & Safety. AT Forum [special report]. 2003 (September). PDF available at: http://www.atforum.com/SiteRoot/pages/addiction_resources/DosingandSafetyWP.pdf. Accessed 1/27/2014.

Methadone Overdose in MMT. AT Forum. 2007(Summer);16(3). PDF available at: http://atforum.com/pdf/Summer07_news.pdf. Access checked 1/29/2014.

Payte JT. Methadone induction instructions to patients and significant others. CMG Induction Handout v7; 2007. PDF available at: http://atforum.com/pdf/PayteSafetyInstructions.pdf. Accessed 1/29/2014.

Safely starting methadone in MMT. AT Forum. 2006(Fall);15(4). PDF available at: http://atforum.com/SiteRoot/pages/current_pastissues/2006Fall.pdf Accessed 1/27/2014.

SAMHSA (Substance Abuse and Mental Health Services Administration). Opioid Overdose Prevention Toolkit. Rockville, MD: HHS Publication No. (SMA) 13-4742; 2013. PDF available at: http://store.samhsa.gov/shin/content//SMA13-4742/Overdose_Toolkit_2014_Jan.pdf. Access checked 1/29/2014.

StopOverdose.org. University of Washington Alcohol & Drug Abuse Institute. 2013. Website at: http://www.stopoverdose.org/pharmacy.htm. Access checked 1/29/2014.

————————————————————————————
Stewart B. Leavitt, MA, PhD, is a former editor of Addiction Treatment Forum and most recently was director/editor of Pain Treatment Topics.

The Joint Commission: Revised Requirements for Opioid Treatment Programs (OTPs)

Joint CommissionOn January 15 the Joint Commission issued for prepublication revised requirements for opioid treatment programs that will become effective March 23. The requirements address four areas:

  • Care, Treatment, and Services
  • Information Management
  • Medication Management
  • Rights and Responsibilities of the Individual

The prepublication requirements can be accessed at:

http://www.jointcommission.org/assets/1/18/Opioid_BHC.pdf

Source: The Joint Commission – January 15, 2014

Open Access Journal Article: Advancing Service Integration in Opioid Treatment Programs for the Care and Treatment of Hepatitis C Infection

liverABSTRACT

It is estimated that approximately 200 million people globally are infected with the hepatitis C virus and that roughly half of these people live in Asia. Without treatment, it is estimated that roughly twenty percent of those infected with hepatitis C virus progress to chronic liver disease, then subsequently, end-stage liver disease. Thus, access to hepatitis C testing and subsequent care and treatment of chronic hepatitis C infection are essential to address the global burden of disease.

In the United States, the Center for Disease Control and Prevention estimates that 60% of new cases of hepatitis infection are due to injection drug use. Opioid Treatment Programs (OTP’s) dispense methadone and buprenorphine under specific federal regulations to injection drug users diagnosed with opioid dependence. OTPs are developing comprehensive care and treatment model programs that integrate general medical and infectious disease-related medical care with substance abuse and mental health services. Integrating hepatitis care services and treatment in the substance abuse treatment settings fosters access to care for patients with hepatitis C infection, many who otherwise would not receive needed care and treatment.

This may serve as a national model for highly cost-efficient healthcare that has a measurable outcome of improved public health with reduced hepatitis C prevalence.

http://www.scirp.org/journal/PaperInformation.aspx?PaperID=42589#.Uul-AJtALzZ

Source: International Journal of Clinical Medicine – January 2014

Dr. Westley Clark on Overdose – Prevention of Prescription Drug Abuse Can Start With Education about the Risk of Overdose Death

ClarkOn January 16, the ATTC Network hosted a free webinar, “SAMHSA’s Opioid Overdose Prevention Toolkit & Prescription Drug Abuse,” led by the Director of the Center for Substance Abuse Treatment at SAMHSA, Dr. H. Westley Clark.

In addition to an overview of the toolkit itself, Clark’s presentation included epidemiological details about the current overdose epidemic, federal-level efforts to address overdose, and the importance of access to evidence-based treatment (including medications).

The recorded webinar is available online for on-demand viewing.  You can also download the slides for an overview of the talk.

Here are two salient points:

  • The exchange of prescription pain relievers is happening at a person-to-person level.
  • Prevention of prescription drug abuse can start with education about the risk of overdose death. 

The risk of death from an overdose, said Clark, is a good jumping off place for a larger conversation about substance use.  Not only is pill-popping not harmless, it can actually kill you or someone you love. “We can use overdose as a starting point to get people to be aware of some of the consequences of the misuse of prescription opioids or heroin, for that matter,” he said. “We’ve got friends and relatives who are handing people very powerful drugs with the assumption that if they can take it, then anybody can take it.  And that is not the case.”

Emphasizing the long-term consequences of a behavior–like the possibility of becoming addicted as a result of recreational painkiller use–doesn’t always get through to people.  But the possibility of dying from a drug overdose today or tomorrow?  No kindly neighbor wants to bear responsibility for that.

The Institute for Research, Education & Training in Addictions (IRETA) blog also provides a list of currently available and forthcoming resources to help individuals and communities prevent prescription drug abuse and overdose.

http://iretablog.org/author/iretablog/

Source:  Institute for Research, Education & Training in Addictions – January 27, 2014

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

 

 

New Toolkit Will Combat Opioid Overdose

SAMHSA Opioid Overdose Toolkit

“The Substance Abuse and Mental Health Services Administration (SAMHSA) has developed an Opioid Overdose Toolkit to educate first responders, physicians, patients, family members, and community members on ways to prevent opioid overdose, as well as how to use a drug called naloxone to prevent overdose-related deaths.

Inside the toolkit are five separate booklets, each designed for a specific audience:

  • Patients can learn how to minimize the risk of opioid overdose.
  • Prescribers can understand the risks of opioid overdose, as well as clinically sound strategies for prescribing opioids and educating and monitoring patients.
  • First Responders will find five steps to use in responding to an overdose, including how to use naloxone and provide other life-saving assistance.
  • Community Members can view facts about opioid overdose that can help local governments, community organizations and private citizens develop policies and practices to prevent overdoses and deaths.
  • Survivors and Family Members can gain information and support through the information provided in this booklet.”

The booklets are available for download at:
http://store.samhsa.gov/product/SMA13-4742?utm_source=social&utm_medium=blog&utm_term=OC&utm_campaign=opioid

Source: SAMHSA – August 28, 2013

New York: New York’s Problem with Prescription Drugs

“An analysis, released by the New York City Department of Health in May, reported that between 2005 and 2011 the opioid analgesic overdose fatality rate increased by 65 percent despite the fact that during the same period overall drug overdose deaths decreased by 22 percent. As the drug-of-choice has changed, so too has the image of the traditional drug dealer and addict. Increasingly, those using and abusing these drugs are white middle-class citizens.

According to the same report released by the NYC Department of Health, 56 percent of opioid analgesic overdose fatalities occurred in middle or high income neighborhoods. These are also the neighborhoods where the largest increase in overdose fatality rates were observed. From 2005 to 2011 overdose fatality rates increased in middle income neighborhoods 115 percent while high income neighborhood experienced a 110 percent increase.

The results of the analysis also show that a vast majority of overdose victims are white. The fatality rate for whites was four and a half time higher that the fatality rate for blacks and three times higher than the rate for latinos.

Additionally, contrary to popular belief, the victims of overdose are not just young recreational drug users. In New York City the largest share of overdose fatalities occur in the age range from 45 to 54 years old, accounting for 27 percent of New York City’s opioid overdose fatalities. This is a troubling fact that makes clear the line between prescription misuse and the path to prescription opiate addiction.”

http://digitaljournal.com/article/357369

Source: DigitalJournal.com – September 4, 2013

ASAM: States and Insurance Companies Limit MAT in Face of Opioid Abuse Epidemic and ODs

ASAM logoMedication-assisted treatment (MAT) is being thwarted by state governments and insurance companies, the American Society of Addiction Medicine (ASAM) warned in a scathing report released June 20. The report, which details practices by governments, Medicaid, and insurance companies, shows that by restricting the use of methadone, buprenorphine, and naltrexone, policymakers are doing nothing to stave off the opioid addiction and overdose epidemic. And they may even be adding to it by denying patients MAT, according to the report, which was prepared by the consulting and research firm Avisa Group and the Treatment Research Institute (TRI).

The main point of the report is that the medications work only when used as long-term, maintenance treatment. There is very little evidence that short-term treatment is effective. Yet, short-term, curtailed, or no MAT is what many politicians and insurance companies are calling for

“I wonder how many governors are actively intervening to dictate the nature, amount, and duration of cancer treatment or hypertension medications that are available,” said A. Thomas McLellan, PhD, CEO of TRI, in an interview with AT Forum after the report was released. “I wonder how many state insurance authorities would get away with restricting the amount, duration, and coverage for cancer, pain, asthma, hypertension care.” Treatment of addiction needs to be governed by the same rules of clinical science that govern the rest of medical care, Dr. McLellan said. “At the end of the day this is a medical illness. It is that simple. If you can say a sentence about diabetes treatment and its coverage, and then replace the word diabetes with addiction and have the sentence still make sense, you are probably on the right track.”

Medicaid

medicaidIn 31 states, methadone maintenance treatment in OTPs is covered by fee-for-service (FFS) Medicaid. In some states, additional funding comes from the federal Substance Abuse Prevention and Treatment (SAPT) block grant and state funds. In three states, methadone treatment is funded only through the SAPT block grant or state or county funds, with no Medicaid coverage. Medicaid does not cover methadone maintenance at all in 17 states. States having no public funding for methadone maintenance, according to the report, are:

    • Arkansas
    • Colorado
    • Idaho
    • Indiana
    • Iowa
    • Kansas
    • Kentucky
    • Louisiana
    • Mississippi
    • Montana
    • North Dakota
    • Oklahoma
    • South Carolina
    • South Dakota
    • Tennessee
    • West Virginia

Although addiction is a chronic disease, with opioid addiction best treated with medications and behavioral interventions, not only are the medications underutilized, but their use is deliberately being foiled for reasons related to cost and stigma.

“These reports show that we could be saving lives and effectively treating the disease of addiction if state governments and insurance companies remove roadblocks to the use of these medications,” said Stuart Gitlow, MD, president of ASAM. “Treatment professionals need every evidence-based tool available to end suffering from this chronic disease.

The report on effectiveness of opioid medications looked at 642 different studies evaluating the three medications—the only medications approved by the Food and Drug Administration for the treatment of opioid addiction. The report also shows that the medications are cost-effective, roughly comparable to diabetes medications.

Restrictions by Payers

A major part of the report is a survey of state Medicaid and other insurer restrictions.  “We really learned something there,” said Dr. McLellan. “I thought there were frank restrictions on MAT, but that is not the case.” Instead of explicit, written restrictions, there are non-quantitative treatment limitations, to use the language of the parity law. Insurance companies make it very difficult for patients to get the right amount of medication, and to access MAT in general.

The report found that insurance company representatives did not want to discuss opioid treatment medications, and that while every state covers at least one opioid addiction medication on the Medicaid formulary, restrictions vary and often amount to a complete denial of access, with coverage limits and onerous utilization review common by states. The situation is similar for private insurance companies, which have utilization management techniques that can be contradictory and arbitrary, and often limit quantities and dosages.

The situation is similar for private insurance companies. They have utilization management techniques, which can be contradictory and arbitrary, and often limit quantities and dosages.

These limitations are in direct opposition to recommendations by medical associations and the Substance Abuse and Mental Health Services Administration (SAMHSA), according to ASAM. Not only do these limitations have no therapeutic goal, but they can risk patient safety and lead to suffering and death.

Little Support from Insurance

Mady Chalk, PhD, of TRI, conducted the survey of commercial insurance plans for the report. “I was surprised at the extent of the comments that we got,” Dr. Chalk told AT Forum. “One was ‘How did you get my name and my email address?’ Another was ‘I sent this up the chain, and my CEO says I can’t respond.’” Most of the data for the commercial report was culled from secondary sources.

Public insurance—Medicaid—officials also did not want to discuss the restrictions on MAT. The National Association of Medicaid Directors refused to write a letter of support for the survey (which would have encouraged state Medicaid directors to respond), said Dr. Chalk. “They said they couldn’t support it because it would mean that the Medicaid directors would have to change their practices, and ‘we can’t put them in that position.’” Dr. Chalk was surprised at the extent of the resistance to even examining policies related to MAT. “Of course it might mean you would have to change some practices,” she said.

A number of insurance companies use “step therapy,” also known as “fail-first,” in which patients have to fail on a certain dose before it can be increased. “They can have a requirement that you have to start with 8 milligrams of buprenorphine, and if that doesn’t work then you can move up to 16,” said Dr. Chalk. One state said that in order for Medicaid to pay for Vivitrol, the patient would have to fail first at two attempts of residential treatment and fail two attempts at buprenorphine, she said.

Another general practice of many insurance companies is to allow patients to have a prescription for buprenorphine, for example, for six months, and then require a renewal of the prior authorization, said Dr. Chalk. But there’s a catch—“they say if you’re not at the moment in “active treatment”—which they don’t define—then no renewal.”

OTPs as Silos

Ironically, the price objections by payers to buprenorphine and extended-release naltrexone are not there for methadone, which is very inexpensive as a medication. But since it can only be given in OTPs, they don’t know how to deal with the modality.

Addiction treatment is often criticized as being a separate “silo” from medical care, but OTPs are like silos within silos, according to the report. Even though the report treats methadone, buprenorphine, and naltrexone equally, methadone is unique. Methadone tablets cannot be prescribed for opioid dependence on an outpatient basis; they can only be provided in OTPs, which have their own accreditation and licensing systems. Anyone closely involved with regulation and reimbursement of OTPs is unlikely to be familiar with other reimbursement systems, the report noted. In many cases, OTPs are not familiar with Medicaid, even when Medicaid covers some of the costs of treatment. Likewise, Medicaid staff who are not involved with OTPs or methadone know little about that system—even if their agency pays for treatment.

“We found virtually no commercial insurance coverage for methadone in OTPs,” said Dr. Chalk. Many insurance companies don’t want to reveal publicly that they cover addiction treatment because they are worried about “adverse selection,” a phenomenon in which people with a certain disease sign up for the insurance company that covers its treatment. However, if all of the insurance companies had coverage and benefits for addiction treatment, adverse selection would not be such an issue, said Dr. Chalk. Because of adverse selection concerns, access to medications is likely to continue to be a problem, even when health care reform is implemented.

“It is essential that there be greater transparency on the part of commercial plans and Medicaid agencies, so that consumers and treatment programs and clinicians are able to understand what their access is to medications,” said Dr. Chalk.

For the full report, go to: http://www.asam.org/docs/advocacy/Implications-for-Opioid-Addiction-Treatment

Philadelphia Releases Benzodiazepine Draft Guidelines for MAT

benzo2benzo 1Important guidelines to help opioid treatment programs (OTPs) determine how to handle benzodiazepine use by their patients have been developed by the Institute for Research, Education and Training in the Addictions (IRETA) for the Philadelphia Department of Behavioral Health and Intellectual disAbility Services (DBHIDS). Roland Lamb, MA, director of the DBHIDS Office of Addiction Services, talked with AT Forum about what the draft guidelines mean to OTPs who are struggling with ways to manage patients who use benzodiazepines while in medication-assisted treatment (MAT).

Although the guidelines were prepared under contract with DBHIDS for use by Philadelphia-area MAT providers, Mr. Lamb said they can be used by anyone—and he hopes they will be, when finalized. “This is a collaboration that went beyond Philadelphia,” he said. Partners were the Community Care Behavioral Health (CCBH) and the University of Pittsburgh in Allegheny County, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Pennsylvania Department of Drug and Alcohol Programs, he said. “We need to make sure the focus is on the disease of addiction and not just on managing medications. Methadone maintenance is so overregulated that it can become medication-focused, as opposed to treating people for their addiction.”

Treating Addiction

And while methadone maintenance is focused on opioid addiction, OTPs and all MAT providers must recognize that they are treating addiction per se, he said. “Once you have stabilized a person on methadone, you still need to pay attention to other issues.” Those other issues could include misuse of alcohol or other drugs, such as benzodiazepines

The concern for OTPs and patients is that benzodiazepines, in combination with methadone, buprenorphine, or any central nervous system (CNS) depressant, could result in respiratory depression and death. “There has been extensive writing about the synergistic effects,” he said.

But it’s not only about risk. Helping patients recover from addiction means counseling and a personal transformation away from seeking relief from drugs and alcohol.

“I believe that OTPs are failing their population if they don’t address addiction,” said Mr. Lamb. “It’s not just benzodiazepines, it’s everything.”

Lower Starting Dose, Inpatient Detox

One of the recommendations is for people on benzodiazepines to be inducted on a lower starting dose of methadone, but another is that all patients need an adequate starting dose. There seems to be a conflict between those two recommendations, but Mr. Lamb said that there isn’t. “What it really means is that you would need a longer lead time to get up to the optimal dose,” he said. “What you don’t want is to continue to follow through to the maximum dosage level, which could be 30 or 40 milligrams, at the onset of treatment,” he said.

The two recommendations are consistent when looked at together, because the main point is to ultimately get the patient up to the optimal dose. “In induction, they are in limbo, and will be struggling mightily to manage their addiction and perhaps find other means to do that,” he said. Some ways to bring patients up to optimal dosage and minimize the withdrawal symptoms that come with the very early days of induction for some is to provide a split dose during the day, to minimize the valleys, he said.

Another recommendation for patients who are using benzodiazepines is to taper their benzodiazepine use and then induct them into MAT. Sometimes, the best way to do this is inpatient detoxification, the guidelines state.

“It’s problematic that people think MAT is only done in an outpatient methadone program,” said Mr. Lamb. Philadelphia has established MAT across all levels of care. “We have people in residential treatment who receive MAT, as well as people who are in outpatient programs,” he said. “When a person isn’t responding to the outpatient milieu, you need to address the severity of the addiction.” And for OTPs, it may mean assessing the person as needing inpatient treatment. “‘If you didn’t have methadone, what level of care would this person be receiving?’ is a good question to ask,” he said.

Key Recommendations

The key recommendations of the IRETA report clearly state that use of benzodiazepines or other CNS depressants is not a contraindication for methadone or buprenorphine treatment—patients should not automatically be discharged from treatment because they are using benzodiazepines, either by obtaining prescriptions from other physicians or by buying them.

From the Recommendations:

  • CNS depressant use is not an absolute contraindication for the use of either methadone or buprenorphine in MAT, but is a reason for caution because of potential respiratory depression. Serious overdose and death may occur if MAT is administered in conjunction with benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol.
  • Individuals who use benzodiazepines, even if used as a part of long-term therapy, should be considered at risk for adverse drug reactions including overdose and death.
  • Many people presenting to services have an extensive history of multiple substance dependence and all substance abuse, including benzodiazepines, should be actively addressed in treatment.
  •  MAT should not generally be discontinued for persistent benzodiazepine abuse, but requires the implementation of risk management strategies.
  • Clinicians should ensure that every step of decision-making is clearly documented.

There wasn’t always unanimous agreement among the participants in the development process for the guidelines, said Mr. Lamb. “We narrowed down the guidelines to what we had consensus around.”

Risk Management vs. Addiction Treatment

At the core of the consensus process was reconciling risk management with treatment of addiction, two goals that can be at odds with one another. But is there really any conflict? If the goal is recovery, then treatment of addiction should include dealing with craving and the problems of patients who are suddenly living without getting high.

There is a desperate need for this information, said Mr. Lamb. “We had a number of providers who were struggling with how to manage the use of benzodiazepines.” That’s the reason for the guidelines, and also the reason for a physician’s town hall sponsored by DBHIDS at the November conference of the American Association for the Treatment of Opioid Dependence (AATOD), to be held in Philadelphia.

“Some people have a legitimate need for an anti-anxiety drug,” said Mr. Lamb. “However, there has to be a limit to how far a provider goes, if there is no cooperation from the patient.”

Some patients start abusing benzodiazepines when they enter MAT because they are no longer able to feel euphoria from opioids, according to Mr. Lamb. “Part of the disease of addiction is the preoccupation with feeling good or feeling better,” he said, referring to euphoria and to minimizing withdrawal symptoms. Others come into treatment managing collateral emotional pain and psychic confusion, he said. “We’ve often found that the need to self-medicate is strong.” That’s why getting a patient stable on methadone is only the first step, he said. “That’s when the hard part begins.”

The early stages of treatment, when patients are no longer experiencing “feeling better” from opioids, are when other drugs, such as cocaine, alcohol, marijuana, or benzodiazepines, get introduced, said Mr. Lamb. “Chemistry is a way of life in our population, always finding new combinations to feel good and to feel better.” A new patient on methadone, once stable, won’t feel any signs of withdrawal, so the need to “feel better” will be gone. “But with this population there is always the need to alter one’s consciousness.” And there may also be depression and anxiety or legitimate mental illnesses, which methadone will not treat, and which require medication. But that doesn’t necessarily mean medications are always the answer.

When opioid-dependent patients begin MAT, they may also be going to other physicians who are prescribing medications for anxiety. “Hopefully the doctors are talking to each other, communicating in the best interest of the patient,” said Mr. Lamb. But the patient may want just the opposite. “Those in care are interested in keeping those two doctors separate, not wanting them to collaborate, because that will interfere with their goals.”

For the draft guidelines, go to: http://ireta.org/sites/ireta.org/files/BZD%20and%20MAT%20FINAL%20REPORT%20Dec%202012%20marked%20draft.pdf

No Evidence to Support QTc-Interval Screening in Methadone Maintenance Treatment: Cochrane Review

EKG“Methadone represents today the gold standard of efficacy for the pharmacological treatment of opioid dependence,” states the newly published (June 20) Cochrane Review on QTc interval screening for cardiac risk in methadone treatment. The review goes on to say that “methadone, like many other medications, has been implicated in the prolongation of the [QTc] interval of the electrocardiogram (ECG), which is considered a marker for arrhythmias such as torsade de pointes (TdP).” It further notes that the recommendations and consensus statements regarding QTc screening developed for patients receiving methadone maintenance treatment (MMT) have been questioned

At times, that questioning has been contentious (see issues of the AT Forum newsletter: Spring 2009, Summer 2009, and Winter 2012 ).

Cochrane investigators undertook a review study “to evaluate the efficacy and acceptability of QTc screening” to prevent cardiac-related morbidity and mortality in MMT. The authors performed an extensive search of MEDLINE, EMBASE, other databases, and electronic sources of ongoing trials, and identified 872 pertinent records.

Their finding: “No evidence has been found to support the use of the electrocardiogram (ECG) for preventing cardiac arrhythmias in methadone-treated opioid dependents.”

Gold Standards

Just as methadone is considered the gold standard in treating opioid dependence, Cochrane reviews are internationally recognized as the gold standard in evidence-based medical information. Using predefined criteria, Cochrane researchers conduct meticulous statistical data analyses to determine the efficacy of medical interventions. Cochrane Reviews are published by The Cochrane Collaboration, an independent nonprofit organization with 28,000 volunteers in more than 100 countries.

Existing Screening Recommendations

Screening guidelines recommended several years ago by an Expert Panel (Krantz, 2009) were a pretreatment ECG for all patients being considered for methadone treatment, to measure the QTc interval; a follow-up ECG within 30 days and annually; and additional ECGs if the daily methadone dosage exceeds 100 mg, or if unexplained syncope (loss of consciousness) or seizures occur.

A different Expert Panel (Martin, 2011) recommended instead a baseline ECG at the time of admission and within 30 days only for patients with significant risk factors for QT prolongation, and additional ECGs annually, or whenever the daily dose exceeds 120 mg.

Untoward Consequences of ECG Screening

The Cochrane study points out that the procedures involved in ECG screening may be “too demanding and stressful,” and “may expose patients to health consequences of untreated opioid addiction, including increased mortality risk.”

Untoward health consequences can occur when unnecessary evaluations and false-positive findings result in delays for additional studies and other treatments. In the meantime, some patients’ opioid addiction goes untreated, with potentially fatal outcomes—a factor that “does not seem to have been appropriately ruled out” by those drafting the screening guidelines, according to the authors.

Key Points in the Review

  • QTc prolongation is “not a safety concern per se,” but a “sharply imperfect” surrogate marker for the risk of TdP. A QTc longer than 500 milliseconds—considered the threshold of increased danger—is found in about 2 percent to 16 percent of MMT patients. But the prolongation isn’t necessarily due to methadone; liver disease, low potassium levels, and therapy with a variety of drugs also prolong QTc in MMT patients.
  • Estimated mortality for TdP is about 10 percent to 17 percent. But the “supposed involvement of methadone in TdP-related mortality” is thought to be only 6 deaths per 10,000 patient-years. Studies typically do not rule out other known risk factors, such as heart disease and various medications, so the true figure is probably lower. In contrast, mortality of untreated heroin dependence is estimated to be far higher: 100 to 300 per 10,000 person-years. Methadone maintenance, with an annual mortality rate of 0.1 percent, reduces by 2 to 11 times the mortality risk of people with opioid dependence.
  • The benefits of methadone treatment include increased retention in treatment, and a reduction in opioid use, HIV transmission, and mortality.
  •  Other treatments for opioid dependence with substantially lower risk of cardiac complications, such as buprenorphine, are available, but “their pharmacological profile, efficacy and acceptability by patients do not allow them to be thought of as an easy alternative to methadone.”
  •  “Undue focus on QTc prolongation,” which may not be an appropriate way to screen for TdP, may decrease patient safety by diverting attention from other risk factors.
  •  Planning and performing ECG screenings isn’t easy; most physicians and many cardiologists cannot correctly calculate a QTc and identify a long QTc.

Unable to find any study that fulfilled methodological criteria for their review, The Cochrane authors said “it is not possible to draw any conclusions about the effectiveness of ECG-based screening strategies for preventing cardiac morbidity/mortality in methadone-treated opioid addicts.” Their recommendation: “Research efforts should focus on strengthening the evidence about the effectiveness of widespread implementation of such strategies and clarifying associated benefits and harms.”

In summing up, the authors note the lack of scientific evidence supporting ECG-based screening, and point out that “many examples of screening tests that were believed to be efficacious and recommended until rigorous evaluation showed their disadvantages are reported in the literature.” So, this appears to be another case of recommendations and guidelines being enacted “without the scientific rigour applied to other areas of medicine.”

The Cochrane study, with a complete description of study methods and results, is available for purchase through the Wiley Online Library at http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008939.pub2/abstract

Resources

Krantz MJ, Martin J, Stimmel B, Mehta D, Haigney MC. QTc interval screening in methadone treatment. Ann Intern Med. 2009;150(6):387-395. doi:10.7326/0003-4819-150-6-200903170-00103. http://www.tandfonline.com/doi/abs/10.1080/10550887.2011.610710#.UdL01zssnj4

Martin JA, Campbell A, Killip T, et al. QT interval screening in methadone maintenance treatment: report of a SAMHSA expert panel. J Addict Dis. 2011; Oct;30(4):283-306. doi: 10.1080/10550887.2011.610710. http://www.tandfonline.com/doi/pdf/10.1080/10550887.2011.610710

New ASAM Reports Show Increasing Restrictions on Addiction Medications by State Governments and Insurance Companies

ASAM logoState governments and insurance companies are increasingly restricting the use of effective, FDA-approved medications that could help reverse the epidemic of opioid addiction and overdose deaths, according to the most comprehensive reports on opioid addiction medications released June 20 by the American Society of Addiction Medicine (ASAM).

“These reports show that we could be saving lives and effectively treating the disease of addiction if state governments and insurance companies remove roadblocks to the use of these medications,” said Stuart Gitlow, MD, President of ASAM. “Treatment professionals need every evidence-based tool available to end suffering from this chronic disease. State lawmakers and insurance company administrators would never deny needed medication to people suffering from other chronic diseases, like diabetes and hypertension. But it happens every day to people with addiction.”

Strong evidence of effectiveness

The report on effectiveness of opioid medications, conducted by the Treatment Research Institute, examined 642 unique studies that evaluated buprenorphine, methadone, oral naltrexone and injectable naltrexone. The report found that these medications show substantive evidence of effectiveness and safety. They’re shown to decrease the frequency and quantity of drug use, withdrawal and craving, infectious diseases, criminal behavior and overdose, and to improve social functioning.

The medications show clear evidence of effectiveness only when used as long-term treatment, much like insulin for diabetes. There is very little indication of short-term benefit.

These medications also are cost-effective, with costs for maintenance medications to treat opioid addiction roughly comparable to costs for diabetes medications.

Complex, arbitrary restrictions

The reports on state Medicaid and insurance company restrictions were conducted through surveys by The AVISA Group and the Treatment Research Institute. The researchers reported that insurance company managers were reluctant to respond to questions about opioid medication restrictions.

The state Medicaid coverage report showed that while every state covers at least one FDA-approved opioid addiction medication, restrictions vary widely from state to state and often create de facto denial of access. Coverage limits for lifetime benefits and daily dosages are common. Restrictive prior authorizations add another level of obstacles. Information about restrictions and compliance regarding these medications is very difficult to obtain from state agencies. Many states require other treatments to fail first before addiction medications are covered.

Similarly, private insurance companies’ restrictions on opioid addiction medications are complex, contradictory and often arbitrary. Insurance companies widely use utilization management techniques like prior authorization that impedes the use of addiction medications, and they also limit coverage on quantities of medication.

Dosage and quantity restrictions on opioid addiction medications by insurance companies and state Medicaid programs contravene recommendations from professional medical associations and the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA). These restrictions may risk patient safety and lead to suffering and death with no clear therapeutic objective. With no single national practice guideline on use of pharmacotherapies for opioid addiction, states and payers are filling in a much-needed gap.

Denial of access ‘unethical’

“The fact that patients are frequently denied access to the full spectrum of treatment options for addiction is unethical and would constitute malpractice in other medical specialties and chronic disease treatment,” said Thomas McLellan, a report author who is CEO of the Treatment Research Institute and former Deputy Director of the White House Office of National Drug Control Policy. “Treatment of addiction must be raised to the same medical and ethical standards as treatment for other chronic diseases. This needs to be acknowledged by the treatment community, medical specialties, insurance companies and all levels of government.”

According to the reports, none of the medications by themselves can be considered effective treatments for opioid dependence. All medications are designed for use as part of comprehensive treatment strategies that usually include counseling, social supports and behavioral change strategies. But research shows they can be vital treatment components that raise treatment success rates.

“Medical science supports the use of addiction medications to effectively treat the disease of addiction,” Dr. Gitlow said. “This science must be the basis of state policies, insurance coverage and national standards for the treatment of addiction. We want to work with public and private payers to identify models of patient access that can be shared broadly. Restrictions by states and insurance companies make no sense when opioid addiction and overdose deaths have grown into a national epidemic.”

The full report is available at: http://www.asam.org/docs/advocacy/Implications-for-Opioid-Addiction-Treatment

http://www.asam.org/docs/default-source/pressreleases/effective-rx-thwarted-for-deadly-opioid-epidemic-2013-06-20.pdf?sfvrsn=2

Source: American Society of Addiction Medicine – June 20, 2013

New Drug-Drug Interactions in Opioid Therapy App for iPhones, iPad and Android Devices Now Available

A new tool is available that reviews the current evidence on the likelihood of drug−drug interactions between either methadone or buprenorphine and 120 commonly prescribed drugs. It is available as a website and an app for both Apple and Android devices.

The tool was created using content from the 7th Edition of ‘Drug–Drug Interactions in Opioid Therapy edited by Elinore McCance-Katz who was recently appointed Chief Medical Officer of the Substance Abuse and Mental Health Services Administration (SAMHSA). It was also peer reviewed by the European Opiate Addiction Treatment Association (Europad).

The tool is available at www.opioiddruginteractions.com.  You can use the tool online or click on the link to download the app on the Apple App Store or Google Play Store.

Source: OpioidDrugInteractions.com – April 2013

Q & A – Trends in Prescription Drug Abuse: ‘Bridging Medications’

Question: Outside of approved traditional opioid maintenance programs, I’ve heard that some drug addicts are using prescription drugs for “bridging.” What is this practice, and which prescription drugs may be involved?

Response from Michael G. O’Neil, PharmD: “The epidemic of unintended prescription drug overdoses continues to spread across the United States. The medications being abused and misused in these tragic events are often opioids and benzodiazepines.

A lesser known phenomenon involves use of other prescription medications to minimize physiologic withdrawal until individuals can obtain their next “chemical high” with their drug of choice. This practice is commonly referred to as “bridging.” Traditionally, the term “bridging” has been used in medication-assisted addiction treatment centers while stabilizing patients. Unfortunately, this terminology has gained a new meaning at the street level. Recognizing bridging behaviors may help clinicians identify patients with the disease of addiction or potential medication adverse effects.”

http://www.medscape.com/viewarticle/804740

Source: Medscape.com – May 28, 2013

Site last updated March 28, 2014 @ 7:50 am