New AATOD Policy Statement: Increasing Access to Medication to Treat Opioid Addiction

AATODEarlier this month AATOD issued a policy paper “Increasing Access to Medication to Treat Opioid Addiction – Increasing Access for the Treatment of Opioid Addiction with Medications.” AATOD noted that “this paper raises a number of questions in order to stimulate a thoughtful policy discussion given the urgency of the public health crisis of untreated opioid addiction”.

The statement provides a discussion of: the value of providing comprehensive treatment services to treat a complicated illness, current policy debates on OTPs, DATA 2000 practices, reports of medication diversion, and future policy considerations

http://www.aatod.org/wp-content/uploads/2014/07/MAT-Policy-Paper-FINAL-070214-2.pdf

Source: The American Association of the Treatment of Opioid Dependence – July 2, 2014

 

Overdose Deaths from Opioids, Heroin on the Rise

News Update 7-18-14“Overdose deaths from both prescription opioids and heroin increased in 2011, the most recent year available, according to new data from the U.S. Centers for Disease Control and Prevention.

While prescription opioid deaths followed a more than decade long trend and increased by about 2% from 2010 to 2011, to 16,917; heroin deaths jumped by about 44% in the same span of time to 4,397.

Officials with the CDC said the increase in heroin deaths may be partly due to users having less access to prescription opioids and switching to the illicit drug.

Leonard Paulozzi, a physician and researcher with the CDC, said about 75% of heroin users say they started out by using prescription opioids.

Paulozzi said doctors need to do a better of job of screening for opioid abusers by checking prescription drug monitoring programs in their states for patients who are doctor shopping and using urine screens to detect if they are using illicit drugs.”

http://www.jsonline.com/watchdog/watchdogreports/overdose-deaths-from-opioids-heroin-on-the-rise-b99302962z1-265452991.html

Source: Milwaukee Journal Sentinel – July 2, 2014

Treat Patients with Addiction During, After Hospitalization, Researchers Say

hospital sign purchasedshutterstock_33280960The results of a new study demonstrate that starting hospitalized patients who have an opioid (heroin) addiction on buprenorphine treatment in the hospital and seamlessly connecting them with an outpatient office based treatment program can greatly reduce whether they relapse after they are discharged.

Led by researchers at Boston Medical Center (BMC), the study shows the important role that providers play in offering these patients addiction treatment both while in the hospital and after – even if their primary reason for being in the hospital is not for their addiction.

In this study, 139 hospitalized individuals with opioid addiction who were not already in treatment were randomized into two groups. One group received a tapered dose treatment of buprenorphine for withdrawal and referral information about community treatment programs and the other were initiated on buprenorphine, an opioid substitute proven to treat opioid addiction, along with referral to a primary care office-based buprenorphine treatment program.

Of those in the buprenorphine maintenance group, more than one third (37 percent) reported no illicit opioid/drug use for the month after they left the hospital compared to less than one in ten (nine percent) among the control group. These patients also reported, on average, fewer days of illicit drug use and continued to use less over the following six months. This effect was evident despite the fact that these patients did not initially come to the hospital seeking treatment for their addiction.

“Unfortunately, referral to substance abuse treatment after discharge is often a secondary concern of physicians caring for hospitalized patients,” said Jane Liebschutz, MD, MPH, a physician in general internal medicine at BMC and associate professor of medicine at Boston University School of Medicine, who served as the study’s corresponding author. “However, our results show that we can have a marked impact on patient’s addiction by addressing it during their hospitalization.”

This study is published in JAMA Internal Medicine.

http://medicalxpress.com/news/2014-06-patients-addiction-hospitalization.html

Source: Boston Medical University –  June 30, 2014

Blog by Jana Burson on Split Dosing

“Split dosing, when used in reference to the medication-assisted treatment of opioid addiction, means instead of once daily dosing, the total medication dose is divided, or split, into two doses.

Methadone and buprenorphine (Suboxone, Zubsolv, etc.) are long-acting opioids.

When we use these medications for opioid addiction, we prefer to dose once per day.

Before I can order split dosing, I need to get permission from the state and federal authorities, just like I would for extra take homes doses for patient emergencies. In my state, methadone peak and trough levels are usually requested before they grant permission for split dosing. We draw the patient’s blood three hours after their dose, which is the peak. That’s the highest blood level the patient will have on that dose. On the next day, right before they take the next day’s dose, we draw another methadone blood level, called the trough, which is the lowest level the patient ever has on that dose.

Then we compare the peak to the trough. If the peak is more than twice the trough level, the patient is probably a fast metabolizer who will feel better taking part of their dose in the morning and part in the evening.”

http://janaburson.wordpress.com/2014/07/06/split-dosing/ 

Source: JanaBurson.com – July 6, 2014

How Heroin Baggies are Marketed Like iPhones

“Nine years ago, when Graham MacIndoe was living in New York City and addicted to heroin, he started collecting the small glassine bags that held the drugs he bought. MacIndoe was a commercial photographer, and even in the grip of a years-long addiction that would ultimately leave him broke, imprisoned on Riker’s Island, and facing deportation, he became interested in the baggies on a visual level.

“There was just something about the design, the typography, the branding,” MacIndoe tells Quartz. “And just being around the drug trade myself, the promises that were in the bags—of good times and money, and this elusive lifestyle that you thought drugs would bring you.

MacIndoe found that marketing in the underground economy mirrored the corporate one in other ways. Special offers often accompanied a new drug’s introduction. Popular brands quickly attracted imitators, who adopted the visual look of the packaging but filled it with a lower-quality product. A kind of built-in obsolescence was common too, with suppliers “cutting” (i.e., adulterating) initially potent brands to maximize profits—a pressure to upgrade that MacIndoe compares to Apple’s strategy with the iPhone. “They’re giving you a product that seems really great at the time,” he says, “and then after a little while you realize you’ve got to move on, because they’re telling you something else is better—and they’re making it better intentionally so you’ll move on to a different brand.”

http://qz.com/229470/how-heroin-baggies-are-marketed-like-iphones/

Source: Quartz – July 7, 2014

Feds Seek Ways to Expand Use of Addiction Drug

White House“The government’s top drug abuse experts are struggling to find ways to expand use of a medicine that is considered the best therapy for treating heroin and painkiller addiction.

Sen. Carl Levin of Michigan on Wednesday pressed officials from the White House, the National Institute of Drug Abuse and other agencies to increase access to buprenorphine, a medication which helps control drug cravings and withdrawal symptoms. It remains underused a decade after its launch.

“As long as we have too few doctors certified to prescribe bupe, we will be missing a major weapon in the fight against the ravages of addiction,” Levin told the forum, which also included patients and non-government medical experts.”

http://bostonherald.com/business/business_markets/2014/06/feds_seek_ways_to_expand_use_of_addiction_drug

Source: BostonHerald.com – June 18, 2014

Across The US, An Explosion of Addiction

heroin and injection“Over the last 18 months, The Cincinnati Enquirer has used a team of reporters to cover the heroin problem locally. We joined with Gannett papers in Arizona, Delaware and Vermont for this series on heroin nationally.”

Part IThe Resurgence Of The Deadly Drug Has Sparked A Flurry Of Action From Governors’ Mansions And Statehouses Across New England And The Midwest To Small-Town Police Stations From Northern Kentucky To Wisconsin

Part II – Heroin’s Hidden Journey – Nearly All Heroin Fueling A U.S. Resurgence Enters Over the 1,933-Mile Mexico Border

Part III – Heroin addicts left trapped; families, heartbroken

Part IV – Scanning the battlefield in war on heroin

Part V – In Vermont, on the front lines of war on heroin

Source: USAToday.com – June 12, 2014

Heroin Users Are 90 Percent White, Living Outside Urban Areas

“The image of the heroin user is changing, according to researchers who say the great majority are now white men and women who mostly live outside the cities.

Their study published in JAMA Psychiatry, tracked data from almost 2,800 heroin users and found that first-time users are now generally older than those who began taking the drug in the 1960s. About 90 percent are white, according to the study, and 75 percent now live in non-urban areas.

The research also confirmed a link between the rise of opioid abuse and the growing use of heroin that had been noted in earlier studies. Heroin use has jumped 80 percent to 669,000 users from 2007 to 2012, according to the National Survey on Drug Use and Health, after being relatively stable since 2000.”

http://washpost.bloomberg.com/Story?docId=1376-N6AV3H6S972C01-71HUL1EQ4U5J4QKSAPSPOBBT5I

See related article  - Opioids leading to new class of heroin abusers, study finds at: http://www.jsonline.com/news/health/opioids-leading-to-new-class-of-heroin-abusers-study-finds-b99278535z1-260996001.html

Source: WashingtonPost.com – May 29, 2014

Drugs for Treating Heroin Users: A New Abuse Problem in the Making?

“Evidence is mounting that certain drugs used to treat heroin users are themselves being sold on the streets – and may even be a ‘gateway’ to heroin or opioid use. As some experts herald their value for treating addiction, others ask if the ‘cure’ is making things worse.

More than a decade ago, the FDA partnered with a British company to develop Suboxone, a new treatment for addiction to opioids. But that effort has had highs and lows, experts say. Lifesaving to some opioid abusers, Suboxone and generic drugs like it have not helped others to whom they have been prescribed – in part, these experts say, because of poor oversight of how the opioids are dispensed and used.

Those drugs have also ended up where the U.S .government hoped they wouldn’t: on the street, where they are sold in the same illicit subculture in which heroin and prescription painkillers are peddled.”

http://www.csmonitor.com/USA/Society/2014/0530/Drugs-for-treating-heroin-users-a-new-abuse-problem-in-the-making

Source: Christian Science Monitor – May 30, 2014

To Beat Heroin Addiction, A Turn To Coaches

“Recommendations out this week from a task force on opiate abuse include more peer support and home-based counseling. Health insurers and state Medicaid leaders say they will look at funding for recovery coaches, but there is no plan to do so right now.

Across the country, there’s growing interest in using recovery coaches to help heroin users stop, says Robert Lubran, director of the division of pharmacologic therapies at the federal Substance Abuse and Mental Health Services Administration. At least one state, New York, is paying for coaches to help treat addiction through its Medicaid program.

“This is an evolving field,” Lubran says. “[We are] learning more and more about the best ways to treat addiction and certainly the use of peer counselors, or peer coaches, has become more and more widespread.”

http://commonhealth.wbur.org/2014/06/heroin-recovery-coaches

Source: WBUR’s CommonHealth Reform and Community – June 13, 2014

Opioid Prevention Programs Could Reduce Deaths from Overdose

hospital sign purchasedshutterstock_33280960“Researchers at the University of Cincinnati  School of Medicine conducted a study that analyzed 19 published studies evaluating the effectiveness of Opioid Overdose Prevention Programs (OOPPs) in terms of recognition, prevention, and risk factors for opioid overdoses. Fourteen of the studies analyzed featured follow-up data on over 9,000 people enrolled in an OOPP, of which half had experienced an overdose and 80% witnessed one.

The research found that eleven of the OOPP studies reported a 100% survival rate when administering naloxone, and the others featured at least an 83% rate. The percentages were determined out of nearly 2,000 naloxone administrations.

However, the researchers believe further studies must be conducted to ensure the strength of knowledge of overdose prevention and risk factors for those who are enrolled in OOPPs. Their findings are promising, but there is limited research and data on OOPPs and that’s really the only way more can be determined about overdose prevention efforts.”

http://www.scienceworldreport.com/articles/15166/20140603/opioid-prevention-programs-reduce-deaths-overdose.htm

The article Development and Implementation of an Opioid Overdose Prevention Program Within a Preexisting Substance Use Disorders Treatment Center which was published in the Journal of Addiction Medicine.

Also see article from Medscape ‘Project Lazarus’ Making Headway on Opioid Overdoses available at: http://www.medscape.com/viewarticle/826865. Free registration required.

Source: ScienceWorldReport.com – June 3, 2014

Blog by Jana Burson – Naloxone

“Naloxone is the opioid buzz-kill drug… and it’s also the opioid overdose life saver.

People die from opioid overdoses because the brain gets saturated with opioids. The part of the brain that tells us to breathe during sleep, the medulla, also gets saturated, and eventually shuts off. This usually occurs gradually. The respiratory rate slows over one to three hours, until all respirations stop. Then tissues of essential organs like the brain and heart die from lack of oxygen.

If naloxone can be given during this process, the opioids are tossed off brain receptors, and the medulla fires urgent orders for the body to resume breathing. The patient wakes up, so long as irreversible damage hasn’t yet been done to the brain and heart. In some cases, the patient goes into full precipitated opioid withdrawal, but usually the naloxone doesn’t reverse all of the opioids on board, just enough to save the patient’s life.”

http://janaburson.wordpress.com/2014/06/15/naloxone/

Source: Jana Burson – June 15, 2014

Top 5 Percent of Opioid Prescribers Write 40 Percent of US Narcotic Prescriptions

doctor and prescription bottle“Forty percent of U.S. narcotic prescriptions in 2011-2012 were written by only five percent of opioid prescribers, according to a study Express Scripts  presented today at Academy Health’s annual research meeting.

The study identifies prescribers who prescribe opioids at a much higher rate than peers who are in the same specialty, treat patients of similar age, and practice in the same geographic region.

According to the analysis, high prescribers wrote an average of 3.5 times more opioid prescriptions — 4.6 prescriptions per patient compared to 1.3 in their peer group. Opioid cost per patient per day of therapy was nearly 5 times higher, on average, for patients treated by high prescribers.

Internal medicine and family practice are among the specialties with the highest prevalence of high prescribers, even after accounting for the volume of prescribers in these two specialties.”

http://www.marketwatch.com/story/top-5-percent-of-opioid-prescribers-write-40-percent-of-us-narcotic-prescriptions-2014-06-09

Source: MarketWatch.com – June 9, 2014

Death by Prescription Painkiller – First Major Review Provides Evidence of Sharp Increase in Deaths from Painkillers in US and Canada and Leading Causes

The number of deaths involving commonly prescribed painkillers is higher than the number of deaths by overdose from heroin and cocaine combined, according to researchers at McGill University. In a first-of-its-kind review of existing research, the McGill team has put the spotlight on a major public health problem: the dramatic increase in deaths due to prescribed painkillers, which were involved in more than 16,000 deaths in 2010 in the U.S. alone. Currently, the US and Canada rank #1 and #2 in per capita opioid consumption.

In an effort to identify and summarize available evidence, Nicholas King, of the Biomedical Ethics Unit in the Faculty of Medicine and his team conducted a systematic review of existing literature, comprehensively surveying the scientific literature and including only reports with quantitative evidence.

“We also wanted to find out why thousands of people in the U.S and Canada are dying from prescription painkillers every year, and why these rates have climbed steadily during the past two decades,” says King. “We found evidence for at least 17 different determinants of increasing opioid-related mortality, mainly, dramatically increased prescription and sales of opioids; increased use of strong, long-acting opioids like Oxycontin and methadone; combined use of opioids and other (licit and illicit) drugs and alcohol; and social and demographic factors.”

“We found little evidence that Internet sales of pharmaceuticals and errors by doctors and patients–factors commonly cited in the media — have played a significant role,” Prof. King adds.

The findings point to a complicated “epidemic” in which physicians, users, the health care system, and the social environment all play a role, according to the researchers.

The results of this research are published in the American Journal of Public Health.

Source: McGill University – June 17, 2014

Pope Francis Opposes Marijuana Legalization, Questions Methadone

Pope Francis said he opposed efforts to legalize marijuana and questioned the use of substitute drugs like methadone to treat heroin addicts.

“Substitute drugs, moreover, aren’t a sufficient therapy, but rather a hidden way to surrender,” Francis said. “I want to emphasize what I’ve said in other occasions. No to every type of drug. Simply no to every type of drug.”

http://www.bloomberg.com/news/2014-06-20/pope-francis-opposes-marijuana-legalization-questions-methadone.html

Source: – Bloomberg News.com – June 20, 2014

News From the States

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

Providing Buprenorphine in an Opioid Treatment Program: Challenges and Opportunities

shutterstock_3917107When the federal government said in December of 2012 that opioid treatment programs (OTPs) can dispense take-home doses of buprenorphine with fewer restrictions than are placed on take-home doses for methadone—in particular, no waiting period (http://atforum.com/news/2013/02/otps-can-now-dispense-buprenorphine-take-homes-with-no-waiting-periods/), there was an expectation that patients and treatment providers would be interested in buprenorphine. But there was also a concern that the high cost of buprenorphine compared to methadone would be an obstacle. In addition, states have their own rules that may be stricter than the federal government’s.

It turns out that more than a year later, most OTPs are still not dispensing buprenorphine on a widespread basis, and the main reasons are cost and insurance reimbursement. “I just completed a survey among the State Opioid Treatment Authorities, to find out what they think the impediments are to the use of buprenorphine in their state,” Mark Parrino, MPA, President of the American Association for the Treatment of Opioid Dependence (AATOD), told AT Forum in April. “It would seem that the biggest singular impediment is the lack of insurance reimbursement in OTPs.

“California and New York are states with the largest number of certified OTPs; however, California Medicaid does not provide any reimbursement for buprenorphine use in OTPs. At the present time, New York State does not have a current Medicaid reimbursement mechanism for buprenorphine use in their OTPs, although it did have such a reimbursement before the state converted to a new system called APGs [Ambulatory Patient Groups]. I understand that state officials and treatment providers, as organized through COMPA [Committee of Methadone Program Administrators of New York State, Inc.] are working to correct the problem.“

Other states have legislative restrictions for the use of public funds to use buprenorphine in OTPs. Idaho provides a case in point. North Dakota has just released its administrative/licensing regulations for OTPs, and the use of buprenorphine will be required in newly sited OTPs.

Here’s the problem. If buprenorphine is picked up in a pharmacy, the pharmacy benefit covers it. But if it’s dispensed by an OTP, there is no separate reimbursement for the medication—the cost has to come out of the fee the OTP gets for overall treatment. The cost of methadone is far less than the cost of buprenorphine, depending on the formulation.

Private insurance generally doesn’t cover OTP treatment services, in general, so the bulk of the payment falls on Medicaid or on self-pay patients. While there are 49 states that now allow OTPs, only 33 of them allow Medicaid to pay for such treatment, said Mr. Parrino. In the other states, patients have to make out-of-pocket payments. We have also learned that commercial insurance is providing coverage for OTP services but there are a number of restrictions when it comes to paying a claim.

“It’s a state-by-state fight,” he said. “There is no federal fix for this. There are states that have buprenorphine-only OTPs. Ohio provides an illustration where three buprenorphine-only OTPs were approved in 2013. Other states have reported this as well.”

Of course, the federal Centers for Medicare and Medicaid Services (CMS) would not block states that wanted to reimburse OTPs for dispensing buprenorphine, but CMS has historically not intervened if a state refuses to do so.

In some states, there are still regulatory, bureaucratic barriers that need to be fixed. For example, in many states, before the reimbursement issue can even be addressed, language changes are needed that would allow buprenorphine to be dispensed in an OTP.

In self-pay states, adding the cost of buprenorphine to what patients are already paying would be prohibitive, said Mr. Parrino. In spite of this, some treatment systems such as CRC have indicated that 10 percent of their patient population is currently utilizing buprenorphine through their network of OTPs.

When the rule allowing buprenorphine dispensing was published, Mr. Parrino immediately suggested to states that they look into actions that would encourage the use of buprenorphine. However, he doesn’t think there is necessarily great interest in patients switching from methadone to buprenorphine. “I haven’t heard of any groundswell of patients in an OTP saying ‘Please put me on buprenorphine so I can qualify for take-homes,’” he said.

There’s a lot that isn’t known, especially about the physicians who are prescribing buprenorphine from their offices. “We don’t know how many physicians are monitoring and tracking their patients,” said Mr. Parrino, noting that such monitoring and tracking is done by OTPs through federal and state regulations. But intuitively, he said, it makes some sense that a patient would rather go to an office-based treatment—regardless of whether the medication were methadone (which isn’t allowed to be dispensed or prescribed from an office), or buprenorphine—than to an OTP. “If I’m a patient who can pay for care, do I want to go to an OTP where there’s counseling requirements and toxicology testing, or to a physician where there aren’t any treatment requirements?” he asked rhetorically. “On the other hand, I have been informed that some patients do want such services and access such care through OTPs. It is also important to keep in mind that a number of physicians who have DATA 2000 practices are providing excellent care to patients as well as providing a comprehensive array of services at or through their offices. We just do not have credible data to indicate who is doing what.”

There are approximately 325,000 patients in OTPs at the present time. While it’s not clear how many patients are in ongoing treatment with buprenorphine from office-based physicians, AATOD estimates the number to be between 400,000 and 500,000.The number is based on prescriptions being written, but not necessarily unique patients, said Mr. Parrino.

In Vermont, where more OTPs are opening up, there is a current perceived advantage of having patients medicated on site, even with buprenorphine, because of diversion related issues.

New Jersey

We talked with Ed Higgins, MA, executive director and CEO of JSAS Healthcare Services, an OTP based in Neptune, New Jersey, and the only non-profit OTP in two contiguous counties. The insurance reimbursement problem is a reality, he said. When buprenorphine first came on the market, as Suboxone and Subutex, OTPs made sure it would be covered by Medicaid. And it is—but only as a pharmacy benefit. “I’m not a pharmacy,” said Mr. Higgins. “A Medicaid Rx card won’t work here.” The retail price for a 1-week supply of only 8 milligrams a day of buprenorphine is $50.

So at JSAS, all three physicians are waivered to prescribe buprenorphine. Two of them are American Society of Addiction Medicine (ASAM) physicians. They see patients and write a prescription for buprenorphine, most of which is not reimbursed, said Mr. Higgins. “We can’t bill extra for the induction,” he added. “It’s just a regular Medicaid office visit, and we’re working on 1985 rates.” Only one of our ASAM physicians is currently accepting self-pay patients.

Patients can get buprenorphine from other waived physicians, of course, but Mr. Higgins describes this as the “Wild West,” where patients are charged as much as $350 to $500 for the induction.

Mr. Higgins agrees that the cost of buprenorphine is prohibitive for self-pay patients. And he is curious about the “hundreds of thousands” of patients who enroll in the private-practice model of buprenorphine treatment each year. “This begs for a follow-up study,” he said. “How many of those patients stay in treatment?” There are also questions about dosing: the limit was supposed to be 16 milligrams a day, but there are some patients who require 24 milligrams—although not in his clinic—said Mr. Higgins. “That’s the reality in the private sector.” Some managed care companies are now mandating that patients on buprenorphine be given at least one counseling session a month, he said, while others have no counseling requirement.

Finally, Mr. Higgins said that there are patients who feel better on methadone. But they can’t have the freedom of going to private practitioners, and also be on methadone.

Fewer than 5 percent of the patients at JSAS are on buprenorphine, said Mr. Higgins. “In the world I’d like to live in, we would look at a patient, especially a younger patient, and say, ‘We have some choices for you.’” The OTP could recommend buprenorphine first, and if it doesn’t work, then easily convert to methadone. The problem is that the prices are still too high. There are now five generic forms of buprenorphine, and Mr. Higgins would like to see the manufacturers get together and lower the prices dramatically. “I’m not talking about 10 percent,” he said.

Now, however, the choices just come down to finance. “I can give you 80 milligrams of methadone, and my lowest cost for that is 36 cents. Or you can get a prescription for    16 milligrams of buprenorphine, which is a therapeutic dose, and your weekly cost is going to be approximately $100.”

JSAS gets $120 per month per patient from Medicaid.

 

 

 

New Methadone Safety Guidelines Published for Opioid Addiction and Chronic Pain Management

shutterstock_114229831In recent years the safety of methadone has been questioned by data indicating a large rise in the number of methadone-associated overdose deaths occurring at the same time as a marked increase in methadone use to treat chronic pain.

Between 2008 and 2011, several medical groups issued methadone safety guidelines to address the increased mortality. Published in BMJ Supportive & Palliative Care, Annals of Internal Medicine, and Journal of Addictive Diseases, these guidelines focused on preventing cardiac arrhythmias. None addressed other methadone safety issues; nor did they grade the strength of their recommendations or the quality of the evidence.

The American Pain Society and the College on Problems of Drug Dependence, in collaboration with the Heart Rhythm Society, commissioned a 16-member interdisciplinary expert panel to address these shortcomings. The panel’s careful review of the evidence led to specific guidelines for methadone use for treating opioid addiction in licensed opioid treatment programs, and for treating chronic pain in primary care or specialty settings. The Journal of Pain published the guidelines in April.

The new guidelines focus on promoting patient safety and mitigating avoidable harms. They include patient risk assessment, patient education and counseling, selective use of electrocardiography, dose initiation and titration, diligent monitoring and follow-up, and medication interactions.

Zeroing in on the risk of respiratory depression, a major cause of methadone-associated deaths, the panel stressed safety issues—low initial methadone doses, careful titration, and the use of alternative opioids for selected patients. Panelists concluded that the safe use of methadone “requires clinical skills and knowledge to mitigate potential risks, including serious risks related to overdose and cardiac arrhythmias.”

Methadone-Associated Deaths: Overdoses or Arrhythmias?

The panel noted factors that make it difficult to identify the cause of methadone-associated deaths, among them prescribed vs. illicit methadone use, concurrent use of other medications or substances, and uncertainty about links between increased methadone prescribing and a rise in the death rate. In the vast majority of cases, the panel could not determine whether death was due to “respiratory depression related to overdose, or to other factors, such as arrhythmia.”

The characteristics of methadone present special challenges. Methadone has a long and variable half-life, and can interact with many medications. It is difficult to adjust methadone dosages safely when switching patients from a different opioid.  Methadone is associated with a prolonged QTc interval, “which may predispose patients to the ventricular arrhythmia known as torsades de pointes [TdP].” Also, “the proportion of methadone-associated deaths related to arrhythmia is likely to be small relative to the proportion related to accidental overdose,” the panelists found.

The panel gave each recommendation a separate grade for the strength of the recommendation and the quality of the evidence. This Addiction Treatment Forum article includes only the strong recommendations. The published guidelines include additional recommendations and practice advice. The table below describes the grading system.

 

Strength of Recommendation Quality of Evidence
Strong: The panel believes that the potential benefits of following the recommendation “clearly outweigh potential harms and burdens” (or vice versa); most clinicians and patients would choose to follow a strong recommendation.
Weak: Benefits outweigh potential harms and burdens (or vice versa), “but the balance of benefits to harms is smaller or evidence is weaker.” Clinical circumstances or patient preferences could affect the decision.
The type, number, size, and quality of studies, strengths of associations, and comparative consistency of results determine the quality of the evidence that supports a recommendation.

High: A low probability exists that new evidence would affect the recommendation.
Low: A high probability exists that new evidence would affect the recommendation.

 

Because of a lack of published evidence-based studies on methadone safety, panelists were obliged to base their recommendations on what they had—evidence they considered to be of generally low quality. Panelists reviewed more than 3,700 abstracts and 168 primary studies, solicited input from more than 20 external peer reviewers, and eliminated the lowest-ranked recommendations. All of the approved recommendations received unanimous or near-unanimous consensus. In contrast, as the authors point out, two of guidelines published earlier “were not fully endorsed by a professional society or government entity, and the third was endorsed by the Substance Abuse and Mental Health Services Administration.”

The following provides highlights of this panel’s recommendations for adult patients.

Patient Assessment and Selection – When considering methadone treatment, perform an individualized medical and behavioral risk-and-benefits evaluation (low-quality evidence).

Patient Education and Counseling - Before prescribing methadone, educate and counsel patients about the indications for treatment, goals of therapy, availability of other therapies, ongoing management, and other factors (low-quality evidence).

Baseline Electrocardiograms - On the controversial key topic of baseline ECGs, the panel has two strong recommendations, both based on low-quality evidence.

  • Obtain an ECG before starting methadone in patients with risk factors for QTc interval prolongation, any previous ECG showing a QTc > 450 ms, or a history suggesting previous ventricular arrhythmia. In patients without new risk factors for QTc interval prolongation, an ECG within the previous 3 months with a QTc < 450 ms can serve as the baseline study.

In contrast, some previous guidelines required a baseline ECG screening for all patients.

  • The panel recommends against methadone use in patients with a baseline QTc interval  > 500 ms.

Some previous guidelines allowed methadone use in selected patients in this category.

Panelists provided a lengthy discussion of ECGs and risk factors for TdP and for QTc interval prolongation.

Initiating Methadone Therapy - The panel offers two strong recommendations:

  • Start with low doses, based on treatment indication and the patient’s previous opioid exposure; titrate slowly; and monitor for sedation (moderate-quality evidence). The panel’s emphasis on low initial dosing and careful titration echoes previous guidelines. It  prioritizes patient safety and takes into consideration methadone’s long, variable half-life—usually assumed to be about one day, but, according to some reports, occasionally as long as 120 hours. The panel stresses the need to withhold the dose temporarily if patients show evidence of sedation, and to restart treatment cautiously.
  • When restarting methadone, consider patients who have not taken opioids for 1 to 2 weeks to be opioid-naïve (low-quality evidence).

Monitoring and Follow-up ECGs

Three strong recommendations for follow-up ECGs, all with low-quality evidence:

  • Base follow-up ECGs on baseline ECG findings, methadone dose changes, and other risk factors for QTc interval prolongation.
  • Switch patients with a QTc interval ≥ 500 ms to a different opioid, or immediately lower the methadone dose; evaluate and correct reversible causes of QTc interval prolongation; repeat the ECG after lowering the methadone dose.
  • In patients with a QTc interval ≥ 450 ms but < 500 ms, consider switching to an alternative opioid or lowering the methadone dose (otherwise, discuss with the patient the potential risks of continuing methadone therapy); evaluate and correct reversible causes of QTc interval prolongation; repeat the ECG after lowering the methadone dose.

Adverse Events – Two recommendations:

  • Monitor patients for common opioid adverse effects and toxicities; consider adverse-effects management to be part of routine therapy (moderate-quality evidence).
  • The panel recommends discussing adverse events with patients—either face-to-face or by phone—within 3 to 5 days after starting methadone and within 3 to 5 days after each dose increase (low-quality evidence).

Urine Drug Testing – Two recommendations, both low-quality evidence:

  • Obtain urine drug screens before starting methadone treatment for opioid addiction and again at regular intervals.
  • Consider urine drug testing in all patients, regardless of risk status, before starting therapy and at regular intervals; the panel recommends such testing for patients who are prescribed methadone for chronic pain and have risk factors for drug abuse (low-quality evidence).

Medication Interactions - Use methadone with care in patients taking other medications that may have additive side effects or pharmacologic interactions with methadone (low-quality evidence).

Methadone Treatment During Pregnancy – Monitor neonates whose mothers received methadone; if neonatal abstinence syndrome occurs, provide appropriate treatment (moderate-quality evidence).

Need for Additional Research

Two related articles appear in the same issue of The Journal of Pain. One discusses in more detail methadone overdose and cardiac arrhythmia potential; the second highlights research gaps related to methadone safety. These gaps include lack of enough evidence to evaluate the comparative mortality associated with of methadone treatment versus treatment with other opioids, and to determine the effectiveness of ECG monitoring and other risk-mitigation steps.

A clear need exists for additional randomized clinical trials and large, well-controlled observational studies to provide additional data. This would allow the expert panel to update the guidelines and provide additional recommendations. The panel plans an update by 2018; earlier, if critical new evidence becomes available.

The article is available online at: http://www.jpain.org/article/S1526-5900(14)00522-7/fulltext

Links to Resources Mentioned in This Article                        

Chou R, Cruciani RA, Fiellin DA, et al. Methadone safety: A clinical practice guideline from the American Pain Society and College on Problems of Drug Dependence, in collaboration with the Heart Rhythm Society. J Pain. 2014;15(4):321-337. http://www.jpain.org/article/S1526-5900(14)00522-7/abstract.  Accessed June 3, 2014.

Chou R, Weimer M, Dana T. Methadone overdose and cardiac arrhythmia potential: Findings from a review of the evidence for an American Pain Society and College on Problems of Drug Dependence clinical practice guideline.  J Pain. 2014;15(4):338-365. http://www.ncbi.nlm.nih.gov/pubmed/24685459?dopt=Abstract. Accessed June 3, 2014.

Krantz MJ, Martin J, Stimmel B, Mehta D, Haigney MD. QTc interval screening in methadone treatment. Ann Intern Med. 2009;150(6):387-395. doi:10.7326/0003-4819-150-6-200903170-00103. http://annals.org/article.aspx?articleid=744382. Accessed June 3, 2014.

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. http://www.tandfonline.com/doi/pdf/10.1080/10550887.2011.610710. Accessed June 3, 2014.

Shaiova L, Berger A, Blinderman CD, et al. Consensus guideline on parenteral methadone use in pain and palliative care. Palliat Support Care. 2008;6:165-176. http://journals.cambridge.org/action/displayFulltext?type=1&fid=1885936&jid=PAX&volumeId=6&issueId=02&aid=1885928&bodyId=&membershipNumber=&societyETOCSession=. Accessed June 3, 2014.

Weimer MB, Chou R. Research gaps on methadone harms and comparative harms: Findings from a review of the evidence for an American Pain Society and College on Problems of Drug Dependence clinical practice guideline.  J Pain. 2014;15(4):366-376. doi:10.1016/j.jpain.2014.01.496. PMID:24685460. http://www.ncbi.nlm.nih.gov/pubmed/24685460. Accessed June 3, 2014.

Click here to access additional related resources.

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.

Site last updated July 17, 2014 @ 5:55 pm