AT Forum Volume 25, #2 Spring 2014 Newsletter

SAMHSA Accreditation Guidelines for Opioid Treatment Programs: Final Version Out Within a Year

guidelinesThe draft accreditation guidelines for opioid treatment programs (OTPs) released last spring (see AT Forum July 19, 2013) by the Substance Abuse and Mental Health Services Administration (SAMHSA) are still going through the review process within the federal government, and will be out no later than next April, AT Forum has learned.

“We have gotten a lot of comments, and we’ve been going through every one of them,” said Robert Lubran, MS, MPA, director of the Division of Pharmacologic Therapies at SAMHSA’s Center for Substance Abuse Treatment. “We got to a point at which we thought we needed to confer with the lawyers, and we’re having a discussion about interpreting the language,” he said. The holdup has been inconsistency in the language referring to midlevel providers, Mr. Lubran told AT Forum on April 10.

The final draft will be completed within the next several months, after which the external workgroup that developed the guidelines will be convened again, said Mr. Lubran. “Hopefully there will be few changes.” After the final draft comes out, the Drug Enforcement Administration (DEA) and Office of National Drug Control Policy (ONDCP) will be asked if they would like a briefing. The DEA never commented on the draft guidelines, which means that they don’t have a problem with them.

Originally, there were some concerns that the DEA might oppose the involvement of midlevel providers—people who are not physicians—in making treatment decisions. But Mr. Lubran said the DEA doesn’t have any say on whether midlevel providers can be used, because that is a medical practice issue. He doesn’t expect that the DEA will want to be briefed, but the ONDCP has already requested a briefing, so that will take place.

“Once that all transpires we go to SAMHSA and HHS [the Department of Health and Human Services] to get the whole thing cleared,” he said.

The final guidelines will be available by the April 2015 conference of the American Association for the Treatment of Opioid Dependence (AATOD), said Mr. Lubran.

Keep in mind that the SAMHSA accreditation guidelines are just that—guidelines, which accrediting bodies such as The Joint Commission can use.

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.

Project Lazarus Brings Opioid Treatment Program to Wilkes County Along With Naloxone Kits

kitProject Lazarus, a nonprofit organization based in Moravian Falls, North Carolina, is best known nationally for its work on making the overdose-reversal medication naloxone more available. But the organization, under the guidance of CEO Fred Wells Brason II, was also instrumental in bringing the first opioid treatment program (OTP) to Wilkes County North Carolina. It started as a buprenorphine clinic, which was more palatable to physicians, and then became a full-service OTP including methadone.

The first time Mr. Brason suggested that the county needed an OTP was in 2006, and the response, he recalled, was virulently anti-methadone. “They said, ‘not in our county, and not a drug for a drug.’” But there was no treatment available for people with opioid addiction.

But Mr. Brason, a combination of optimism, determination, and diplomacy, worked out an agreement. First, he got Mountain Health Solutions, an Asheville-based OTP, now owned by CRC Health Group, to set up a satellite clinic in Wilkes County. They would provide only buprenorphine at first—something that was more acceptable by the town. “At least we had something,” he said. Then, he embarked on a two-year education program focusing on methadone. “We talked about addiction, about treatment, and did a lot of myth-busting,” he said. In addition, census in the buprenorphine clinic continued to grow—and Mr. Brason knew that patients needed the comprehensive treatment that is provided in an OTP. “We didn’t want just dispensers, we wanted someone who was an advocate” for the patients, he said.

In addition, buprenorphine is much more expensive than methadone, and since Mountain Health Solutions doesn’t accept Medicaid, it could offer treatment only to people who could afford it, he said. So eventually, what was a buprenorphine clinic became a full-scale OTP in North Wilkesboro.

The doctors in Wilkes County and other counties were among the most vocal opponents of methadone and buprenorphine—at first. In one meeting with them and Jana Burson, MD, from the OTP, one doctor said he didn’t want “those people in the waiting room with Grandma,” Mr. Brason recalled. “I replied, ‘We are meeting right now in a church—and if this were Sunday morning, those people would be here.’” By the time the meeting was over, there was more understanding, at least of buprenorphine, said Mr. Brason, with some of the physicians agreeing to get a waiver so they could provide buprenorphine treatment.

Community Education

Mr. Brason provided education to the community about the importance of medication-assisted treatment during pregnancy, dispelling myths about neonatal abstinence syndrome (facts: NAS is transient and easily treatable, while withdrawing from opioids during pregnancy is harmful to the fetus). “Slowly, after a couple more years, methadone was introduced, and now they are serving more than 400 people a day in our tiny county,” he said. The vast majority are on methadone because they cannot afford buprenorphine.

There are now churches that are financially supporting their members for treatment—paying for the OTP and medications. “The church sees them, that they are going to church, they are going to work, they are supporting their families,” he said.

Mr. Brason is a chaplain, something that gives him credibility in the conservative South—maybe more credibility than a physician or scientist. In addition, he has worked extensively with a hospice in the area. “They know me and who I am,” he said. “That makes a difference.”

It’s still an uphill battle, he said; recently a county commissioner said that methadone clinics are a scam. Brason then sat down with a reporter and got a front page article showing that methadone treatment helps reduce overdose deaths. It was a public relations victory that benefited people who desperately needed help.

“We’ve had a for-profit private detox center all along,” said Mr. Brason. “We were losing people to overdose deaths 24 hours after detox.” That is much better now, because of the presence of the OTP.

Naloxone Kits

Opioid overdose deaths as a problem separate from addiction are also an important focus for Mr. Brason, who was able to introduce naloxone to Wilkes County. Through a grant from Purdue Pharma, the Lazarus Project was able to provide naloxone kits at no charge to the OTP. Originally, when the program started in 2009, this worked by the OTP writing prescriptions for the kits for all new patients—the first weeks on methadone are the riskiest for overdose, not from methadone but from other opioids as the patients are getting used to the doses. Then the patients would go to the pharmacy to pick up their prescription for the $50 kit. However, only 25 percent of the patients were actually getting these prescriptions filled. “They didn’t want to be seen at the pharmacy, they didn’t want the stigma,” he said. So he met with the OTP and agreed on a new system, in which Project Lazarus would pay for half the cost of the kit and the OTP would pay for the other half out of the patient’s enrollment fee. (The grant was over.) The OTP would write the prescription, and then send someone to the pharmacy to pick it up, giving it directly to the patient in the OTP

Spencer Clark, MSW, ACSW, who oversees OTPs for the North Carolina Division of Mental Health, Developmental Disabilities and Substance Abuse Services, has been very interested in the naloxone kits, said Mr. Brason. “He wondered if they could do this for every OTP in the state.” So far the OTP has documented four lives saved.

Mr. Brason sends naloxone kits to organizations, including first responders like police departments, across the country. The kits include the nasal atomizers, not the actual naloxone, which must be prescribed. Eventually, he hopes that first responders will be able to use the new auto-injector. “It will be great for them, they don’t have to put it together” like the kits, which come in a box. However, because it does involve a needle, some first responders will be more comfortable with the nasal spray, he said.

Rescuing someone from an overdose should mean that person gets access to treatment, said Mr. Brason. First of all, they will—it is hoped—go to the emergency department to get checked out after the rescue. “We approach the link to treatment by tying all the services together. We get our crisis intervention teams to that person within an hour” of the rescue, he said. The crisis counselor interviews the individual to figure out the next steps.

For more information on ordering the kits ($12), go to info@projectlazarus.org. Project Lazarus has covered the shipping charges. For more general information on Project Lazarus, go to http://projectlazarus.org/.

The M.A.R.S. Peers Model at Work in Medication-Assisted Treatment for Opioid Addiction

couselingThe M.A.R.S. Project is the only federally funded program that provides peer recovery support to patients in medication-assisted treatment (MAT) for opioid addiction. Funded by the Substance Abuse and Mental Health Services Administration, M.A.R.S. is conducted in collaboration with the substance abuse division of the Albert Einstein College of Medicine in New York City, Yeshiva University, and the National Alliance for Medication-Assisted (NAMA) Recovery.

Walter Ginter, CMA, M.A.R.S. project director, talked with AT Forum recently about how peers can help patients in MAT. First of all, MAT peers can help new patients understand that recovery is a long-term commitment. “All of us come into treatment with the idea that we’re just visiting,” said Mr. Ginter. By the time most patients enter an opioid treatment program (OTP), they have already been through “a couple of detoxes, a therapeutic community,” he said. Patients are usually older than 35, and have already been told that being on methadone means “still using.” Other programs tell people with opioid addiction to go to detoxification and go to meetings, which doesn’t help—at least 80 percent of people who go through detoxification only relapse.

So when they finally get to an OTP, they’re desperate, he said. But they still don’t think they should stay, because being on methadone isn’t “real recovery.” Peers—other patients on methadone—can communicate the facts: They can say, “’I’m not using, I’m taking a medication for a brain disorder,’” and model the appropriate recovery response. This was an unexpected bonus for M.A.R.S., he said.

Trusting Peers More Than Counselors

Why do you need peers? Of course, counselors can say the same thing—that methadone is a medication for a brain disease, and does mean being in recovery. “But when they hear that from the counselor, they wonder about the motivation, because the counselor is paid to say it,” said Mr. Ginter.  The real problem is that patients haven’t learned to trust their counselors, not that counselors are giving misinformation. The same phenomenon occurs in other conditions; for example, patients who are overweight can get better nutrition support from peer groups than from doctors, who they may feel patronized by and disconnected from.

Support is key. Recovery in general has been based on mutual support, he said. “Why do people go to 12-step meetings—for support.”

Mental health peers are part of community mental health centers, and are much more allied with treatment than MAT peers, he said. Insurance companies are starting to reimburse some peers in substance use disorders, but not in MAT. At a recent meeting of mental health peers, Mr. Ginter got the clear impression that insurance companies don’t like the idea of maintenance medication. “They’re concerned about paying for methadone treatment for the rest of someone’s life,” he said.

Mr. Ginter’s M.A.R.S. program is the only one like it in the country, but some other peers have been trained there. Cheryl Blankenship Kupras, a Licensed Clinical Social Worker, worked for an OTP for 12 years in Santa Clara County, California. The OTP, a Beyond M.A.R.S. grantee, sent Ms. Blankenship Kupras, a manager, to peer training, along with two long-standing patients.

‘By the Patients and For the Patients’

It’s essential that any peer group be “by the patients and for the patients,” said Ms. Blankenship Kupras. “It can’t be an arm of the clinic,” because then patients don’t trust the peers.”

The peer who was most involved in the program “really wanted to break down the us-versus-them mentality,” she said. “Whatever was said in M.A.R.S. stayed in M.A.R.S.”

The clinic does control medication, but beyond that, the peers make sure that patients have a place to go for support that is different than mandated counseling, said Ms. Blankenship Kupras. This is particularly important because many OTP patients don’t feel welcome at 12-step meetings. “Just having another option for support is important,” she said. It’s important for the OTP to give the peers a place to meet in the building, as well.

Peer groups can also provide education to dispel myths. “Everybody was hearing rumors,” Ms. Blankenship Kupras said. “So they asked a physician from the program to come in and make a presentation.” Originally, the doctor was reluctant to do this, because she was afraid patients would ask questions about their personal treatment. As it turned out, that didn’t happen. She saw the patients in a different light, and more importantly, they saw her in a different light as well. “The presentation helped them to make a connection with the doctor in a way they hadn’t before,” she said.

Study Suggests Chronic Pain is Widespread and Undertreated in MMT Programs By Guest Author Stewart B. Leavitt

shutterstock_119720380Pain is a worldwide epidemic and more than a third of all adults, or 100 million persons, in the U. S. alone suffer from chronic pain conditions of some sort, as estimated by the U.S. Institute of Medicine (IOM 2011). Even more troubling, newly published research suggests that the prevalence of clinically significant, persistent pain among patients in methadone maintenance treatment (MMT) programs is nearly twice that  of  the general population—and most of that chronic pain is going untreated.

Survey Provides Bleak Picture of Pain in MMT

Writing recently in the journal Pain Medicine, Kelly E. Dunn, PhD, and colleagues reported on a survey of MMT patients at the Johns Hopkins Bayview Medical Center in Baltimore, Maryland (Dunn et al. 2014). Approximately 80 percent of all patients at the clinic responded to a self-report questionnaire widely used in the pain field—the Brief Pain Inventory (BPI)—which assesses severity of pain and its interference with daily activities. Additional data were gathered on patient demographics, pain location, drug use, and current treatments for pain and addiction.

Overall, the 227 survey participants were 45 years old, had been in MMT for 4.5 years on average, and roughly half were male (47%) and Caucasian (49%). Sixty percent of respondents (N=137) indicated on the BPI that they had chronic pain. Also, there were some statistically significant differences in this group compared with MMT patients not reporting such pain: Patients with chronic pain were older (mean age 46 vs. 42 years, respectively), had higher average daily methadone doses (86 mg/d vs. 71 mg/d), and had a higher rate of benzodiazepine-positive urine samples in the past 90 days (7% vs. 3%).

Chronic pain was reported in multiple body areas by roughly a third (36%) of patients with pain, but the most common locations were the back (51%) and lower extremities (59%). Average pain during the past 24 hours on a 0-to-10 scale was reported as 5.8, with worst pain averaging 7.2. Also, using a 10-point scale to rate how pain affected daily life, interference with sleep was ranked highest (6.0 on average), followed by interference with general activity, normal work, and enjoyment of life. Interference in relationships with other people was least affected by chronic pain (rated 4.1 on average).

Merely 13 percent (N=18) of study participants with chronic pain reported receiving pain management treatment, and these patients were significantly more likely to be female, report less income from employment, and have a lower rate of benzodiazepine use. MMT patients being treated for pain most commonly reported back pain, and the majority of those being treated (89%) were prescribed medications; half received short-acting opioids and a third received nonopioid medications (eg., NSAIDs, gabapentin). Only 28 percent received nonpharmacologic therapies for their pain, such as physical therapy. Overall, those treatments were effective; study participants indicated that pain management provided, on average, 51 percent relief from their pain (range 0%-90%).

In sum, this study found that a substantial proportion of patients in a large MMT program reported clinically significant and persistent pain, for which only a relative handful were receiving pain management therapy. Dunn and her coauthors state, “Overall these data suggest that pain was not being adequately evaluated or treated in the majority of this sample. These findings are remarkable . . . and they illustrate what little progress has been made in the past 10 years regarding the concurrent treatment of pain and opioid use disorders.

Better and More Research is Needed

Similar to Dunn et al., in 2008, Cruciani and colleagues reported a study that found 61 percent of 390 MMT patients had experienced persistent pain for more than 6 months, and greater than a third of those patients (37%) had severe chronic pain (Cruciani et al. 2008). In an Addiction Treatment Forum interview article last year (see AT Forum, Winter 2013), it was noted that pain in patients attending MMT programs is commonplace, and a recent study of 489 patients had found that 237 (48.5%) had clinically significant chronic pain. Generally, past research surveys have reported high but varying prevalences of chronic pain among MMT patients, ranging from approximately 27 percent to 80 percent, with relatively few receiving pain care (references in Dunn et al. 2014).

While the newly reported study by Dunn and colleagues is consistent with most of the past research, it also exhibits many of the limitations in this area of scientific inquiry:

  • Dunn et al. gathered data for their study between December 2006 and January 2007, but were just reporting on results now in 2014; so, the outcomes may or may not reflect current circumstances. Unfortunately, it is not unusual in the pain research literature or government surveys for the reporting of data to come long after its collection.
  • Chronic pain was defined in the Dunn et al. study as answering “yes” to the BPI question, “Have you had pain other than everyday kinds of pain today?” And, even though locations of pain also were reported by patients and recorded by the investigators, this was a somewhat vague definition of chronic pain.This is a common problem encountered in most surveys of chronic pain, since there usually are no readily observable clinical signs or imaging evidence (eg., on X-ray, MRI) of pathology to confirm the presence, severity, or duration of pain. Pain most often is what the patient says it is, without sufficient clinical confirmation; so, it is understandable that there are wide variations in the prevalence of pain reported in different studies of pain in MMT patients, as well as in the general population.
  • There was a small, but significant, increase in benzodiazepine use among patients with pain (small differences between groups in illicit opioid and cocaine use were not statistically significant). However, considering that sleep disturbance was ranked high in persons with pain, this might account for their greater use of sedatives like benzodiazepines; additionally, Dunn et al. did not distinguish between prescribed vs. illicit use of these medications.
  • There was no assessment by Dunn et al. of which came first, pain or addiction, patients’ histories of pain or its treatment, and how MMT might have affected chronic pain. For example, although patients with pain were receiving higher average methadone doses (86 mg/day), the researchers acknowledge that persistent symptoms of opioid withdrawal in some persons were likely confused with chronic pain. Dunn and coauthors also note that some patients might have been receiving certain treatments in the MMT clinic—eg., antidepressants, cognitive behavioral therapy, biofeedback—that were intended for pain management, but not identified as such.
  • In general, the study by Dunn and colleagues surveyed a relatively small sampling of MMT patients in a single clinic setting, which cannot be assumed to represent the larger MMT population. While they present statistical data on those patients receiving pain care during MMT, their numbers were so small (N=18) that the validity of results in this group need confirmation in a larger sampling. For example, the findings that patients receiving pain care were more likely to be women, making less money from employment, and less likely to be using benzodiazepines should be cautiously considered in view of such small numbers.

Dunn et al. do not speculate as to why there is such a high prevalence of chronic pain among MMT patients, or why so few patients receive pain management for those conditions. Clearly, more and better research is needed to understand these problems and to develop strategies for providing effective pain management in the presence of the disease of addiction. At the least, there is a need for prospective studies examining large numbers of patients upon entry to MMT—or buprenorphine therapy—for addiction and during long-term follow-up to determine the progress of those with clinically diagnosed pain conditions.

Challenges and Opportunities

As Dunn and colleagues point out, patients with opioid addiction are likely being “systematically undertreated for pain.” And, while surveys have found that MMT clinic staff are interested in receiving education on treating pain in persons with substance-use disorders, there could be important barriers for MMT patients when it comes to receiving adequate pain care.

Opioid analgesics have been demonstrated as effective for relieving most types of moderate to severe pain, although their long-term use for chronic pain needs further investigation. Dunn and colleagues found that half of their respondents being treated for pain (N=9) were administered short-acting opioids, and Cruciani et al. similarly had noted that 47 percent of MMT patients with pain in their survey were receiving opioid pain relievers. Methadone itself is an excellent analgesic; however, to be effective for pain, it requires more frequent administration than the once-daily (or even split-dose) regimen provided during MMT for addiction. At the same time, many staff in MMT programs are uneducated in, or uncomfortable with, the concurrent administration of methadone and other opioids.

Often multiple types of pain treatment are necessary—spanning the medication and nondrug spectrums—which can be costly and required for extended periods of time. Yet, Dunn and her coauthors note, patients in addiction treatment have historically had limited access to insurance or other financial resources for such care. Furthermore, the pain-care field is highly fragmented, with the various specialists—eg., rheumatologists, orthopedists, neurologists, physiatrists—in high demand and short supply in most communities.

Dunn et al. conclude that their study should illustrate to health care professionals in both the substance abuse treatment and pain management fields that “patients with both disorders are not necessarily intractable hopeless cases and that they deserve the same level of attention and clinical care as chronic pain patients in the general population.” However, unless the many challenges are overcome, the plights of persons with chronic pain in methadone or buprenorphine maintenance treatment are unlikely to improve. There is an important opportunity here for the addiction treatment and pain care fields to forge alliances that can serve the mutual goal of achieving better care for patients with co-occurring pain and opioid use disorders.

References

Cruciani RA, Esteban S, Seewald RM, et al. MMTP patients with chronic pain switching to pain management clinics. A problem or an acceptable practice? Pain Med. 2008;9(3):359-364. doi: 10.1111/j.1526-4637.2006.00224.x. http://www.ncbi.nlm.nih.gov/pubmed/18366514

Dunn KE, Brooner RK, Clark MR. Severity and interference of chronic pain in methadone-maintained outpatients [Epub ahead of print April 7, 2014]. Pain Med. doi:10.1111/pme.12430. http://www.ncbi.nlm.nih.gov/pubmed/24703517

IOM (U.S. Institute of Medicine). Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. June 2011. http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx.

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

Conferences/Meetings

events1American Mental Health Counselors Association (AMHCA) Annual Conference
July 10-12, 2014
Seattle, Washington
Contact: http://www.amhca.org/

 

National Association for Court Management (NACM) 2014 Annual Conference
July 13-17, 2014
Scottsdale, Arizona
Contact: http://www.nacmnet.org/conferences/index.html

 

Virginia Summer Institute for Addiction Studies
July 14-16, 2014
Williamsburg, Virginia
Contact: http://www.vsias.org/

 

C.O.R.E. (Clinical Overview of the Recovery Experience 2014 Conference
July 20-23, 2014
Amelia Island, Florida
Contact: http://core-conference.com/

 

Community Anti-Drug Coalitions of America (CADCA) Mid-Year Training Institute
July 20-24, 2014
Orlando, Florida
Contact: http://www.cadca.org/trainingevents/conference-event

 

National Association of Social Workers (NASW) 2014 Conference
July 23-26, 2014
Washington DC
Contact: http://www.socialworkers.org/

AT Forum Volume 24, #1 Winter 2014 Newsletter

From the Publisher—Special Issue on Recovery From Opioid Addiction

people-sunlight

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

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

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

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

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

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

Sue Emerson
Publisher

MAT With Methadone or Buprenorphine: Assessing the Evidence for Effectiveness

evidenceIt’s not surprising that a thorough review of the efficacy of medication-assisted treatment (MAT) with methadone or buprenorphine reveals  a high level of evidence for the positive impact of MAT in keeping patients in treatment and reducing or eliminating illicit opioid use.

What is surprising is that the stigma against MAT persists—even though evidence suggests that methadone maintenance treatment (MMT) has a positive impact on drug-related HIV risk behaviors and criminal activity—and thus could make clinic neighborhoods safer, rather than less desirable.

The research findings on MMT and buprenorphine or buprenorphine-naloxone maintenance treatment (BMT) were published in November 2013 in two peer-reviewed articles (see References) as part of the Assessing the Evidence Base (AEB) Series sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).

The Assessing the Evidence Base Series

SAMHSA sponsored the AEB Series to help guide providers’ decisions about which behavioral health services public and commercially funded plans should cover. The Affordable Care Act (ACA) greatly expands health care coverage and provides the opportunity “for federal and state agencies to work with private and nonprofit sectors to transform the American health care system” by developing a comprehensive set of community-based, recovery-oriented, and evidence-based services for people with mental and substance use disorders. The ACA doesn’t specify specific treatments, leaving the decision to federal, state, and local agencies, managed care organizations, and commercial and private insurers.

Deciding which services have verified effectiveness isn’t an easy task. To help in the decision-making process, the AEB Series provides a literature evaluation for 14 behavioral health services. For people with substance use disorders, they include, in addition to MMT and BMT, residential treatment, peer-recovery support, and intensive outpatient programs. The goal of the AEB Series is “to provide a framework for decision makers to build a modern addictions and mental health service system for the people who use these services and the people who provide them.”

The Studies

Authors of the MMT and BMT studies searched major databases and other sources to review meta-analyses, reviews, and individual studies from 1995 through 2012.

In brief, the studies found that with adequate dosing, MMT (> 60 mg) and BMT (16 mg-32 mg) caused a similar reduction in illicit opioid use, but MMT was associated with better treatment retention and BMT with a lower risk of adverse events. In pregnancy, MMT and BMT (without naltrexone) showed similar efficacy, but MMT was better than BMT in retaining pregnant women in treatment, and BMT was associated with improved maternal and fetal outcomes, compared to no MAT.

MMT and BMT showed similar occurrence rates of neonatal abstinence syndrome, “but symptoms were less severe for infants whose mothers were treated with BMT.” BMT is associated with a lower risk of adverse events, and has the advantage of greater availability (office facilities improve access and provide earlier care). MMT may be needed for patients who require high doses of opioid agonist treatment, and has the advantage of a possible positive effect on mortality, drug-related HIV risk behaviors, and criminal activity.

The authors advise that MMT “should be a covered service available to all individuals,” and that BMT “should be considered for inclusion as a covered benefit.”

Sprinkled within the two articles are qualifiers such as “possible,” “associated with,” and “suggestive.” That’s because the statistical significance shown in some large, well-designed studies tends to disappear when data from individual studies are merged. Merging changes drug dosages, length of treatment, patient characteristics of the group, and other data; these changes may make reaching statistical significance impossible.

Areas for Future Research

The authors identified several areas where additional data would be helpful. For methadone, these include the impact of MMT on secondary outcomes, the efficacy and safety tradeoffs of doses > 100 mg, and confirmation of results of interim treatment for improved outcome. (In interim treatment, patients receive methadone daily under supervision for up to 120 days, and emergency counseling, while awaiting placement in a program.)  Another research area: the use of MMT in subpopulations—racial and ethnic minority groups, and people who misuse prescription drugs.

For buprenorphine, suggested research areas include the impact of BMT on secondary outcomes, appropriate dosing to enhance outcomes, and confirmation of stepped-care results. (Stepped-care involves gradually increasing buprenorphine doses to 32 mg—higher doses “do not provide additional efficacy;” patients requiring more medication are switched—“stepped-up”—to high-dose methadone.) Other research areas: the use of BMT in subpopulations (described above), and improved induction protocols to minimize retention problems.

A box in each publication summarizes the authors’ findings for each treatment. We reproduce them below, as they appeared in print.

 

Evidence for the effectiveness of MMT: high

Evidence clearly shows that MMT has a positive impacta on:

  • Retention in treatment
  • Illicit opioid use

Evidence is less clear but suggestive that MMT has a positive impact on:

  • Mortality
  • Illicit drug use (non-opioid)
  • Drug-related HIV risk behaviorsb
  • Criminal activity

Evidence suggests that MMT has little impact on:

  • Sex-related HIV risk behaviorsc

 

a Compared with placebo, detoxification, drug-free rehabilitation, or wait-listing
b Sharing injection equipment.
c Having unprotected sexual relations.

 

Evidence for the effectiveness of BMT: high

Evidence clearly shows that BMT has a positive impact compared with placebo on:

  • Retention in treatment
  • Illicit opioid use

Evidence is mixed for its impact on:

  • Non-opioid illicit drug use

 

Regarding retention in treatment and illicit opioid use, BMT had a positive effect compared to placebo, while MMT had a positive effect compared to placebo, detoxification, drug-free protocols, or wait-listing protocols.

Closing Statements

The authors note the importance of MAT, especially considering the poor success rates of abstinence-based treatments, and recognize both MMT and BMT as important treatment options. Below are summaries of their closing statements.

Methadone: The authors point out the need for educating providers, consumers, and family members about the benefits of MMT and ways to avoid the significant adverse events that can occur (referring to respiratory depression and cardiac arrhythmias). They also note the need for education about “appropriate doses to improve efficacy” and “appropriate initiation to minimize adverse events.”

They close with: Because of MMT’s relative efficacy, efforts should be made to increase access to MMT for all individuals who struggle with opioid use disorders. Directors of state mental health and substance abuse agencies and community health organizations should look for methods to increase access to MMT, and purchasers of health care services should cover appropriately monitored MMT.”

Buprenorphine: Noting the key advantage of buprenorphine—its availability—and the “limited access to and more restrictive safety profile of MMT,” the authors consider BMT an important treatment for opioid dependence. “Policy makers have reason to promote access to BMT for patients in substance use treatment who may wish to choose BMT as a potentially safer alternative to MMT.

They close with: “Administrators of substance use treatment programs, community health centers, and managed care organizations and other purchasers of health care services, such as Medicare, Medicaid, and commercial insurance carriers, should give careful consideration to BMT as a covered benefit.”

#     #     #

References

Fullerton CA, Kim M, Thomas CP, et al. Medication-assisted treatment with methadone: assessing the evidence. Psychiatric Services in Advance. November 18, 2013; doi: 10.1176/appi.ps.201300235.

Thomas CP, Fullerton CA, Kim M, et al. Medication-assisted treatment with buprenorphine: Assessing the Evidence. Psychiatric Services in Advance. November 18, 2013; doi: 10.1176/appi.ps.201300256.

Dougherty RH, Lyman DR, George P, Ghose SS, Daniels AS, Delphin-Rittmon ME.

Assessing the Evidence Base for Behavioral Health Services: Introduction to the Series.

Psychiatric Services. 2014; doi: 10.1176/appi.ps.201300214

http://ps.psychiatryonline.org/article.aspx?articleID=1759202

Walter Ginter on the Importance of Peers in Recovery With Medication-Assisted Treatment

walterStigma is a common theme among people seeking recovery from the disease of opioid addiction, but it’s particularly poignant for people in medication-assisted treatment (MAT), because stigma can itself prevent recovery from taking place. People who don’t understand MAT—and that’s a big group, including many employers, politicians, and even friends and family members—don’t believe methadone or buprenorphine treatment means being in recovery. But it does. And that’s the message that Walter Ginter, CMA, project director of Medication- Assisted Recovery Services (MARS), and the country’s foremost patient advocate, brings to patients. On December 9, he brought this message to the first White House drug policy conference.

Sponsored by the Office of National Drug Control Policy (ONDCP), the conference included a panel that focused on stigma and drug addiction. Michael Botticelli, deputy director of the ONDCP, and himself in recovery, invited Mr. Ginter to participate. “He called me himself to ask me to be on that panel, and afterwards I got a nice handwritten note from him thanking me for participating,” said Mr. Ginter.  Mr. Botticelli, formerly the official in charge of substance use disorder services for Massachusetts, is a strong supporter of MAT. “This direction and focus that we are seeing from the Obama Administration is encouraging,” continued Mr. Ginter “It would strengthen that effort to see Mr. Botticelli promoted and the recovery community is hopeful that he will fill the opening as director of the ONDCP.”

 Stigma Impedes Recovery

The main stigma patients face in terms of methadone comes from believing what people who know nothing about MAT tell them. They learn to believe the myth that methadone is a substitute drug, and that they aren’t really in recovery. What peer recovery support services can do for patients is to help them eliminate feelings of stigma by helping them understand that they are in treatment with a medication, just like someone with any other disease. “If people come into treatment with the idea that methadone is just substituting one addiction for another,” said Mr. Ginter, “that attitude makes them feel as if recovery isn’t an option, for them. This discouraging prospect sets the stage for a less than optimal outcome. They ask themselves what difference does it make if they use a little benzodiazepines or smoke a little pot, if recovery isn’t an option anyway? That is how stigma stops patients from achieving recovery.”

 Peers Believe Peers

Peers—other people who are in MAT—can help support patients’ recovery in a way that nobody else—not a physician and not other people who are not taking methadone—can. “In the recovery community, you always hear people say they ‘support all pathways to recovery,’” said Mr. Ginter, “but often this is just lip service and not really an endorsement, with too many anti-MAT people weighing in and adding to the stigma. A lot of people support it and understand it’s evidence based practice, but still they don’t accept it as a legitimate pathway.”

At the MARS project, patients learn from peers that methadone and buprenorphine are “not substitute drugs, they’re medications,” said Mr. Ginter. “And suddenly, that person is a candidate for recovery. Before that, they never had a choice.”

When people are given the option of being in recovery, they choose it. Once they realize that taking methadone or buprenorphine is not the same as using, they stop using other drugs and alcohol. Yes, they were in treatment, but neither the opioid treatment program nor the physician could convince them that they were in recovery—it took another person in MAT to do that. “Peers believe things from other peers that they would not believe from anyone else,” said Mr. Ginter.

 Feeling Good

One of the magical things about erasing stigma is this: Once people start to feel good about themselves, the community starts to look at them differently. That’s why one exercise patients can use is to write down three nice things that happen each day.“ At the end of a few weeks, people start to feel better,” said Mr. Ginter. “For us to do well in recovery, we have to feel good about ourselves.”

Calling addiction a brain disease—which it is—takes away a lot of guilt, said Mr. Ginter. That internal feeling of guilt is magnified by stigma coming from the outside world.

In some ways, stigma from the outside world isn’t getting any better. “There are these nice dissertations out there about your rights, but if you’re in jail because you got picked up outside your methadone clinic, you can’t tell the cop he’s wrong,” said Mr. Ginter. It would help if drug courts and parole officers saw more patients for whom treatment is working, and not just those for whom it isn’t, he added.

Finally, fear of stigma keeps people from even saying that they are on buprenorphine or methadone. Thousands of people are doing well in treatment—not just the few, like Mr. Ginter, who publicly identify themselves.

As an anecdote illustrating this, Mr. Ginter related that visitors from overseas at the MARS booth at the AATOD conference last fall were amazed that two of the people working at their display booth were patients. “They couldn’t believe that peer recovery support services were provided by ‘real’ methadone patients,” he said.

 Other Participants

The ONDCP half-day meeting also featured panels on public health approaches to drug policy, being “smart on crime” instead of “tough on crime,” with an emphasis on drug courts using MAT, and a screening of The Anonymous People. Mr. Ginter related that the drug court speaker, magistrate Alby Zweig from Denver, was shocked to hear that many of his colleagues require participants to stop using methadone or buprenorphine before they can be admitted.

Note: MARS is a project of the National Alliance of Medication-Assisted (NAMA) Recovery. NAMA chapters are small groups of individuals who organize around advocacy to teach patients about their rights and to support them in their rights. Patient advocates are not the same as peer recovery support.

For more information, go to www.marsproject.org.

Interview: Zac Talbott on Being a Patient and Certified Advocate for Medication-Assisted Treatment

Zac 2-9-14Patients and other individuals who are advocates are a growing force in medication-assisted treatment (MAT) for opioid dependence, providing information and support to patients as well as assistance to opioid treatment programs (OTPs). Advocates also are an essential link between patients and OTPs. They are not as well known as they should be, there aren’t enough of them, and they are in dire need of funding.

In January, Zac Talbott, a patient who is the director of the Tennessee Statewide and Northwestern Georgia chapter of the National Alliance for Medication Assisted Recovery (NAMA Recovery), shared his experiences with addiction, treatment, recovery, and patient advocacy with AT Forum.

 Getting Started in Advocacy: The CMA

Patients and others who want to be advocates need to first have a good knowledge of advocacy and the various issues surrounding MAT. Taking the CMA (Certified Medication Assisted Treatment Advocate) course and obtaining certification gives both patients and health care professionals the basic grounding for advocacy. Certification is essential to being a credible advocate. “There are patients out there who often are well-meaning, who claim to be advocates, but who can do harm,” he said. “A lot of folks without training do not realize that advocates have a code of ethics, and one of the main ethical guidelines is confidentiality. It goes to the heart of our professional credibility. There has never once been a case of a patient’s confidentiality being violated by a CMA working with NAMA-R.”

The second crucial skill that CMAs have is knowing how to communicate with OTPs on behalf of a patient. “You can make things worse for the patient you’re trying to help if you come off like an attack dog. Patients and OTPs agree on more than 90 percent of the issues, and that should always remain the primary focus. It’s also important to remember that the job of a patient advocate is to advocate for what the patient wants. We can’t take off and start a crusade without that patient wanting us to,” he said.

NAMA-R developed the CMA training course with no funding, which was a tremendous challenge. However, the course has been strongly supported by the American Association for the Treatment of Opioid Dependence (AATOD), and the federal Center for Substance Abuse Treatment (CSAT).

 Volunteering and Funding

Some NAMA-R chapters could do significantly more if their expenses were paid. Members are committed people who largely volunteer their time and give of themselves without any compensation.

NAMA Recovery chapters do need funding. NAMA-R is a 501c3 non-profit organization, so donations are tax-deductible. All other industrialized countries fund organizations like NAMA-R, said Mr. Talbott. “The United States is the exception. This leaves NAMA-R dependent on donations from patients, for-profit OTPs, and the pharmaceutical industry.”

In Tennessee—and in many other states—Medicaid won’t currently pay for MAT with methadone. “It’s all cash down here,” he said. The fee for patients is $300 to $400 a month—frequently all the money a patient has.

Mr. Talbott hopes NAMA Recovery can partner with OTPs for funding and support. “We had a wonderful meeting with Chief Operating Officer Jerry Rhodes and the regional managers of CRC Health Group during the AATOD Conference in Philadelphia this past November,” he said. “They recognize that advocacy is extremely important.”

 Insurance and the ACA

Whether the Affordable Care Act (ACA) will help fund MAT is still unclear, said Mr. Talbott. “It’s supposed to, but insurance companies are good at finding loopholes.” Implementation and enforcement are still problematic.

In Tennessee, for example, the state is making it impossible for new OTPs to open, which means that facilities are opening up across the state border. “Programs in other states are treating the patients that Tennessee isn’t,” said Mr. Talbott. If Tennessee Medicaid were to say that patients had to be treated in a Tennessee facility, that might make it more attractive for programs to open in Tennessee.

Even though his organization is in Tennessee, most of Mr. Talbott’s calls come from outside the state—just because there are so many patients, especially in nearby southern states, who need help. NAMA-R has always had difficulty recruiting individuals willing to make a commitment to advocacy and start a chapter. Stigma, prejudice, and just plain fear have been barriers in southeastern states.

 From Pain Medication to Heroin

Mr. Talbott’s addiction started—as with many people—with a prescription for hydrocodone for a chronic painful condition. Most people feel sick when they take opioids, but Mr. Talbott is part of the 10 percent of the population that is susceptible to addiction. “I loved them,” he said of opioids. His addiction sent him to buying pills from a pill mill and eventually to the street, where he also bought heroin. “This was in the late 90s,” he recalled. “Within eight years I went from a couple of prescribed hydrocodone a day to 25 prescribed 30-milligram doses of oxycodone.” He became an intravenous drug user within four years of initially starting the pills.

“The opposite of the stereotypical drug user,” Mr. Talbott had two college degrees when he first became addicted to opioids, and came from a well-known and well-respected family—“church folks,” he explained.

 Recovery

Then, there was treatment. “I went for all the wrong reasons—I didn’t go because I was seeking recovery,” Mr. Talbott said of his treatment in an OTP. “People who are drug users think that there’s no withdrawal, and that you might even get a little buzz.” But six months after entering the OTP and starting methadone, he found that he was in recovery—by accident. “I had no craving. I stopped using the needle. I was thinking about my life again—by accident. The person I was prior to the addiction quickly started to re-emerge. That’s the beauty of methadone.”

After that, it took Mr. Talbott a year to focus on recovery and life. “There’s so much you need to do, straightening out your credit, fixing everything you did when that disease is active.” When his addiction was at its height, he was in the middle of his masters’ in clinical social work. Ultimately, the addiction took over and he left the program. But even before his addiction, he had always wanted to be in a helping profession—a mental health counselor, an Episcopal priest, or a lawyer. “I wanted to help people,” he said. “Once I was in recovery, that part of me came back quickly.”

He found NAMA Recovery because his counselor recommended it as an alternative to driving to the clinic for four group meetings during his induction period in treatment. “I had to drive more than two hours one way to the OTP because I was so rural. So my counselor said to go to the website—methadone.org—print out, read, and bring in one of the Education Series to discuss ‘and that will count as one of your groups.’” Ultimately, he wrote to the NAMA-R chapter coordinator and said a NAMA Recovery chapter was needed in Tennessee.

NAMA Recovery’s main goal is advocacy, and that is where Mr.Talbott saw his life heading. “It’s a natural fit,” he said. “To be a MAT advocate is to advocate for the patient in treatment, but we’re not patient advocates only or specifically. ‘The patient comes first,’ as Rokki [Roxanne Baker, NAMA-R president] often says.”

 Partnership With OTPs

Patient advocates can have a lot of power, not only on behalf of patients, but on behalf of providers. When onerous restrictions are imposed by states, especially states that don’t have an AATOD chapter, providers call NAMA Recovery. “We are more than just patient advocates, we are MAT advocates,” said Mr. Talbott. “We advocate for the entire modality.”

About a third of the calls he gets—Tennessee joined AATOD just last fall—are from OTPs, said Mr. Talbott. “Sometimes patients and providers don’t have the best relationship. Some OTPs view advocates as whistleblowers and troublemakers, and sometimes the OTPs get defensive as soon as advocates call them. Several of us are trying to stress to OTPs and patients that we’re all on the same team.”

Technically, the provider advocacy organization is AATOD. But when there is an issue that draws both patient and provider complaints, Mr. Talbott reaches out to consult with AATOD president Mark Parrino or the state chapter of AATOD. “We can strategize together,” he said. Sometimes the approach involves filing a complaint with the Department of Justice or SAMHSA’s CSAT, which regulates OTPs. Often, OTPs haven’t even heard of NAMA Recovery, and sometimes haven’t heard of AATOD either, he said.

“The way to go is moving away from patient advocacy specifically and toward MAT advocacy as a modality,” said Mr. Talbott. And patients who are certified advocates can be of immense help to OTPs, whether they are testifying before the legislature or making a complaint to the Department of Justice. Patients and providers aren’t always going to agree, but ultimately they’re fighting the same battles and striving for the same goals.

Recovery Transformation in Philadelphia OTPs: Person-centered, not Patient-centered

RecoveryOver a decade ago, Philadelphia’s public health system moved toward recovery for mental health and addiction services. On the mental health side, there had been a belief that recovery wasn’t possible, especially for people with serious mental illness. On the addiction side, recovery was already in wide parlance, but the system was set up to treat the disorder as if it was acute, with no long-term or continuous follow-up care, resulting in relapses. Now, Philadelphia has taken great steps to bring along its providers in adopting a recovery-based framework. We caught up with Roland Lamb, director of addiction services for the Philadelphia Department of Behavioral Health and Intellectual disAbility Services (DBHIdS) to get an update on the recovery transformation as it affects patients in medication-assisted treatment (MAT).

“The good news is that we have moved towards more of a person-centered perspective in MAT,” Mr. Lamb said. In other words, providers are learning to look at people as people, not patients.

“We have the richest environment for MAT, with all levels of care,” he told AT Forum. He added that not only is there outpatient methadone, but there is medication-assisted treatment in all levels of care, and there are efforts to reach out to the 144 physicians in the system who are certified to dispense buprenorphine, and to provide access to those they are seeing to all of the treatment resources in Philadelphia.

The Medication ‘Culture’

But, because of the oversight and stigma, it has been a struggle to get providers to focus on the fact that people are people first, and not patients to be “dosed and monitored,” Mr. Lamb said. “The bad news is that we still have to work to overcome the stigma-driven culture of managing the medication, instead of treating addiction and focusing on recovery.”

This medication “culture” isn’t completely the fault of the opioid treatment programs (OTPs), Mr. Lamb noted. “It’s the most regulated form of treatment—in health care—that there is,” he conceded. The preoccupation with regulations, one drug after another, and the diagnosis, is at the cost of focusing on treating the addiction and supporting recovery and other needs. “People lose sight of managing the addiction.” Yes, methadone maintenance is part of recovery, but the medication isn’t the only part of it. “This treatment was created to help people get into recovery, but recovery is more than the medication alone.”

Buprenorphine—the medication—is not on the DBHIDS formulary, said Mr. Lamb. “But we do pay for all the services that surround it—the physical exams, counseling, and the drug screens.”

But whether those in care are taking methadone or buprenorphine, the focus has to be on the individual, said Mr. Lamb. “We are making sure that our providers have what they need—good assessment instruments, evidence-based practices, and psychiatric supports.”

There is a high prevalence of co-occurring mental illness in the MAT population, said Mr. Lamb. “We know a lot of what has happened with those co-occurring illnesses to those in care, who in many cases are self-medicating the very illnesses that they need help with.”

The DHBIdS meets with MAT providers every two months. These include inpatient and outpatient MAT providers, and the state licensing authority and the Drug Enforcement Administration are present as well.

No Involuntary Discharges

One of the key patient-centered initiatives in Philadelphia is this: “We say we don’t want involuntary discharging going on,” said Mr. Lamb, noting that “noncompliance” in addiction treatment is no worse than it is in treatment for high blood pressure or type II diabetes, and that terminating treatment is no solution. The reason for discharge may be violence, or threats of violence, for example, but many times this behavior is a result of untreated mental illness, said Mr. Lamb. Other reasons for discharge are drug dealing on the premises, or, of course, noncompliance with the treatment plan, but aren’t they some of the very reasons treatment is needed?

“We see ourselves as being in a partnership in terms of trying to overcome these issues,” said Mr. Lamb. The person in recovery, the providers, the regulators, and the payers all need to be at the recovery table to make this work.

Another point about person-centered care: OTPs should treat people based upon their need. For example, Pennsylvania requires two and a half hours a month of counseling—but patients should get more if they need it, said Mr. Lamb. “The issue for us is that we want to see counseling based upon the needs of the person.” That’s why the DBHIdS pays based on how much counseling is given. “We track the counseling separately.”

Training in CBT, Other Modalities

“The real challenge for us is to get staff to rethink what they’re doing,” said Mr. Lamb. “We’ve been doing it one staffer at a time.” Staffers are getting training in cognitive behavioral therapy (CBT), dialectal behavioral therapy (DBT), trauma, and the sanctuary model, he said. “All of these are evidence-based practices that we’ve been paying our providers to get trained in.”

There are 11 providers operating 13 OTPs in Philadelphia, treating a total of 5,000 patients a day. “When you think about it, that’s approximately 400 people coming in every day,” said Mr. Lamb. “It would be better if we could have smaller numbers of people in each facility, and more facilities.” He noted that community complaints about traffic would then go down. Of course, for that to happen, there would have to be community cooperation in siting clinics. “There is still so much stigma,” said Mr. Lamb, noting that this comes from the “outside” community and from the drug-addiction treatment community itself.

“Through a recovery focus we have a chance to change the usual ‘down with methadone’ discussion to a discussion about solutions for long-term opioid dependence and long-term recovery,” Mr. Lamb said. This is especially important now, with the burgeoning cohort of people becoming addicted via the non-medical use of prescription opioids, and their conversion to heroin. We need to do a better job of reaching out to, engaging, and retraining this population if we are going to impact the growing number of overdose deaths we are seeing, said Mr. Lamb. “We also need to evolve the recovery focus to one of wellness, and the need for those who are actively recovering to take better care of their health.”

Patients in Methadone Maintenance Treatment Face Obstacles and Stigma When Joining 12-Step Groups

recovery winter 2014 jpegIt’s ironic—and disappointing—that patients in methadone maintenance treatment (MMT) who join mainstream addiction recovery groups face considerable stigma and daunting obstacles from professionals and from other patients, rather than the helping hand they might reasonably hope for and expect.

This became evident in the first in-depth survey detailing the experiences and perceptions of MMT patients in Narcotics Anonymous (NA), Alcoholics Anonymous (AA), and other support groups. Although most of the 323 MMT patients surveyed participated in support groups and found them helpful, patients’ rates of taking part in socializing, speaking at meetings, and other functions were much lower, because of negative experiences.

Key interfering factors include restrictions on MMT patients at 12-step meetings, and obstacles that spring from stigma and professional attitudes.  Yet more MMT patients take part in 12-step programs than might be expected, given the problems encountered.

The OTP Survey

The survey took place at Partners in Drug Abuse Rehabilitation and Counseling (PIDARC), an opioid treatment program (OTP) in Washington, DC. Founded in 1971 as a private, not-for-profit facility, PIDARC today has more than 650 patients and 24 counselors, nurses, physicians, and support personnel. Most patients are poor and African American, and report long-term involvement with the criminal justice system. Many have a history of addiction treatment failures and current medical problems.

The Journal of Groups in Addiction and Recovery published the PIDARC article last November. The lead author is William L. White, MA, a prolific writer and a pioneer in the addiction treatment field. Two of the survey’s coauthors, Howard A. Hoffman, MD, and Brian Crissman, are affiliated with PIDARC.

Enrollees’ Characteristics

Volunteers who were at the OTP at a randomly selected time were enrolled in the survey. Characteristics of the 323:

  • 55% male
  • Average age, 53 years; range, 21 to 79 years
  • Average time in continuous MMT: 2 ¾ years
  • Average percentage of days in the past year abstinent from use of alcohol and non-prescribed drugs: about 70%
  • Primary support affiliation: NA, 68%; other (usually church or PIDARC group), 11%; AA, 7%

Participation in Mainstream Groups

PIDARC doesn’t hold 12-step meetings, but a nonclinical staff person, an NA member, strongly encourages involvement in NA meetings.

Most patients (66 percent) took part in NA/AA programs, and most (about 75 percent) found the programs helpful. Yet most didn’t participate in activities:

Activities of MMT Patients
Who Joined Outside 12-Step Programs

Characteristic  Percent Participating
Have a home group 50
Have a sponsor 26
Sponsor others 13
Attend 12-step social events 23
Take active part in step work 21

 

Patients enjoyed the social aspects of NA and AA. Some liked AA because it “provided more structure and had a stronger spiritual base than NA.” Others identified with NA’s drug-focused fellowship; many never had problems with alcohol.

Problems Encountered

One-fourth of participants encountered a serious problem being an MMT patient within NA or AA. An extreme example: At an NA meeting, a patient who mentioned being in MMT was asked to leave and not return.

Problems MMT Patients Encountered in NA/AA

Problem Approximate Percent
Recipient of negative comments
about methadone use
45
Pressured to stop taking methadone 35
Pressured to reduce their dose 25
Denied the right to speak at a meeting 15
Denied the right to be a sponsor or chair a meeting 10

 

Cautioning against generalizing about patients’ negative experiences, the authors pointed out the considerable variation in “the attitudes of NA and AA groups towards medication-assisted treatment [MAT] of addiction in general and methadone maintenance treatment for opioid addiction in particular.”

Don’t Ask, Don’t Tell

It’s hardly surprising that only 34 percent of patients surveyed disclosed their MMT status at NA or AA meetings, and only about 25 percent did so to their sponsor.

A Lost Opportunity

For patients seeking long-term recovery, “12-Step fellowships and other recovery mutual aid groups may provide a source of critical support,” the authors believe. So lack of support is a squandered opportunity to welcome fellow patients into the recovery circle.

Patients need that support, given their long-term outlook. The common idealized view is that MMT is lifelong therapy, but the fact is that most patients do leave treatment, and they do so without support.

To bring reality home, the authors compiled a list of seven “stark realities” that challenge the idealized views of the optimal time in medication-assisted treatment:

  • 80%-100% of surveyed patients expect to end MMT at some point
  • One-year retention rates in MMT are less than 50%
  • Few patients end treatment in a planned manner (11%, in one study)
  • Post-treatment monitoring, support, and early re-intervention are not standard practices
  • Most discharged patients eventually return to illicit opioid use
  • Patients who end MMT face a significantly increased risk of infectious disease and death
  • Most MMT patients who choose to taper don’t successfully complete the process as planned

The authors note that these realities underscore “the more specific role participation in recovery mutual aid groups could potentially play in long-term recovery from opioid addiction.”

12-step approaches to MMT have a history of encountering obstacles. According to the authors, “The stigma and discrimination MMT patients face when seeking participation within mainstream recovery mutual aid groups are, in part, expressions of the larger professional and cultural stigma attached to MMT in the United States.”

In 1991, MMT patients’ negative experiences in support groups led to the creation of Methadone Anonymous (MA), but, according to the authors, MA “is not widely available in the U.S. at the present time.”

What OTPs Can Do

The authors said that because MMT is a substance-specific treatment, but addiction is not a substance-specific disorder, OTPs and other groups need to address patients’ complex patterns of concurrent and sequential drug use. “Increasing patient participation in recovery mutual aid groups may prove helpful in addressing patterns of multiple drug dependencies.”

The authors suggested ways for OTPs to help patients establish links with other mutual aid groups:

  • Develop relationships with NA service committees
  • Host NA meetings
  • Coach OTP patients about taking part in NA/AA
  • Establish protocols for linking with mutual aid groups
  • Co-host programs on MAT and recovery with mutual aid groups
  • Encourage development of local MA meetings and other recovery-support meetings for patients in medication-assisted recovery

In closing, the authors emphasize that support groups may be able to reach out to MMT patients if they falter during the crucial period when they face the “stark realities” of life after they leave the OTP “on current doses of methadone without planned tapering and support for the transition to recovery maintenance without medication support.” They note again that “the risk of relapse is great under these circumstances and remains a lifelong risk; 12-Step fellowships and other recovery mutual aid groups may provide a source of critical support for patients seeking stable long-term recovery during and following discharge from OTPs.”

Reference

White WL, Campbell MD, Shea C, Hoffman HA, Crissman B, DuPont RL. Co-participation in 12-Step Mutual Aid Groups and Methadone Maintenance Treatment: A Survey of 322 Patients. J Groups Addict Recovery.  2013;8(4):294-308. Published online Nov. 8, 2013. doi 10.1080/1556035X.2013.836872.

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

Events

eventsNAADAC 2014 Advocacy in Action Conference
March 2-4, 2014
Alexandria, Virginia
Contact: http://naadac.org/advocacyconference

 

American Academy of Pain Medicine (AAPM) 30th Annual Meeting
March 6-9, 2014
Phoenix, Arizona
Contact: http://www.painmed.org/annualmeeting/main.aspx


American Counseling Association (ACA) Annual Conference and Expo
March 27-30, 2014
Honolulu, Hawaii
Contact: http://www.counseling.org/conference/hawaii-aca-2014

 

American Psychiatric Association (APA) 167th Annual Meeting
May 3-7, 2014
New York, New York
Contact: http://annualmeeting.psychiatry.org/

 

National Council for Behavioral Health 43rd National Mental Health and Addictions Conference
May 5-7, 2014
Washington, DC
Contact: http://www.thenationalcouncil.org/cs/conference

 

20th Annual National Treatment Accountability for Safer Communities (TASC) Conference on Drugs Crime and Reentry
May 7-9, 2014
Birmingham, Alabama
Contact: http://www.nationaltasc.org/2013conference/2014-conference1/

 

National Association of Addiction Treatment Providers (NAATP) Annual Conference
May 17-20, 2014
Charlotte, North Carolina
Contact: https://www.naatp.org/

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