SAMHSA Panel: No Mandatory ECG Testing for OTP Patients


 A panel convened by the Substance Abuse and Mental Health Services Administration (SAMHSA) has stopped short of recommending mandatory
electrocardiograms (ECGs) on patients treated with methadone in opioid treatment programs (OTPs). In “QT Interval Screening in Methadone Maintenance Treatment: Report of a SAMHSA Expert Panel,” published November 3 in the Journal of Addictive Diseases, the panel described the process that resulted in the inability to recommend ECG screening for all OTP patients.

The panel, convened initially in 2007, was charged with coming up with recommendations for addressing cardiac risk—specifically, an arrhythmia that can lead
to a dangerous condition known as torsade de pointes (TdP).  An erroneous report by this panel on cardiac effects was published—and later retracted—in the prestigious Annals of Internal Medicine (see related links). Finally, the case has been closed: no required baseline ECGs on OTP patients. There was no consensus
—five panel members voted to recommend baseline ECGs, and four voted against.

The story began six years ago when the Food and Drug Administration (FDA) issued an alert relating to methadone and cardiac arrhythmias, followed by a warning label. At higher doses, methadone may prolong the QT interval.

It’s important to note that the presence of QT prolongation does not necessarily lead to TdP, and that TdP can also occur in people who have normal QT intervals. It is also important to know that many medications are related to QT prolongation, alone and in combination with others.

Nobody knows how many OTP patients have suffered methadone-related arrhythmias. “It’s hard to put a finger on it; we really don’t have that much data,” said Anthony Campbell, DO, medical officer with the division of pharmacologic therapies at SAMHSA’s Center for Substance Abuse Treatment (CSAT). “The only way you can capture this is if you have a Holter monitor on the patient at the time of event.”

Panel Recommendations

The recommendations from the panel: Patients with significant risk factors for QT prolongation should have a baseline ECG at admission, and again within 30 days, the panel agreed. These risk factors include a history of cardiac arrhythmia or prolonged QT interval; symptoms suggestive of arrhythmia, such as episodes of syncope, dizzy spells, palpitations, or seizures; medication history; family history of premature death; or any other historical information suggestive of a possible cardiac arrhythmia.

Nothing in the recommendations has the force of law or regulation behind it. These are recommendations only. “Opioid treatment programs and other providers are encouraged to consider these conclusions to the extent that they are practically or financially capable of doing so,” the article concludes. “Nothing in this report is intended to create a legal standard of care for any opioid treatment program or to interfere with clinical judgment in the practice of medicine.”

Not a ‘Major Danger’

OTPs have been divided by this issue. “When we went to the initial meeting the deck was stacked,” said Brian A. McCarroll, DO, of BioMed Behavioral Healthcare in Sterling Heights, Michigan, one of the panel members who voted against requiring ECGs of all patients within 30 days of admission. “It didn’t matter what the clinical evidence was, they wanted something to come out that said this is a major danger with methadone. And it’s not.” Dr. McCarroll is a diplomate of the American Board of Addiction Medicine.

While screening ECGs should not be mandatory for all new OTP patients, complete cardiac histories should be, he said. “If someone has a history of dizzy spells that could be a sign of an arrhythmia, it would be prudent to do an ECG.”

Prevalence of Prolonged QT Interval

The panel concluded that 2 percent of OTP patients have a very prolonged QT interval. If so, of the 250,000 people currently enrolled in OTPs, 5,000 would need “interventions for cardiac risk reduction,” and an additional 40,000 to 60,000 would have a lesser risk but may need an intervention, the article states.

One of the factors the panel considered in coming up with its recommendations was “compelling evidence that the majority of physicians who direct treatment in opioid treatment programs are not fully aware of methadone’s association with adverse cardiac events,” the article stated. In one survey, only 41 percent of 692 physicians in OTPs were aware of methadone’s QT-prolonging properties, and only 24 percent were aware of the possible risk for TdP.

Costs of ECGs

“There were some people who said requiring screening is wrong because OTP patients can’t afford the cost of going to a cardiologist,” said Robert Lubran, MA, MPH, director of CSAT’s Division of Pharmacologic Therapies. “We took the opposing view, which is that it’s
important for patient care and patient safety that the medical staff be aware of this potential problem, and that it’s really incumbent on them to help the patients access needed services.” According to Mr. Lubran, ECGs cost about $100.

If OTPs themselves don’t offer ECGs—and Mr. Lubran acknowledges that many can’t—then it’s “incumbent on the OTP to help the patient find an affordable medical service.” Some OTPs are going to become medical health homes, which means that they will be able to offer affordable ECGs, he said. “And as we’re moving toward health care reform, everybody is supposed to have access to primary medical care. This is another step. We are suggesting that programs understand the consequences of not screening.”

Another argument against requiring ECGs, said Mr. Lubran, was that patients who couldn’t afford them would then be denied treatment. “One side said it was better to get people into treatment, and the other said it was better to get the ECG baseline done at admission.” He has also heard the argument that programs will discharge patients or reduce their dose if they appear to have cardiac risks. “We have never made any recommendation that suggests the answer is discharging patients,” he said. “We don’t want programs to take the easy way out and discharge patients instead of doing a reasonable assessment and treating them as the standard of care provides.”

CSAT was to meet in late January to discuss the issue further. Mr. Lubran admitted that there is still controversy about whether QT prolongation contributes to deaths. But there’s enough data to warrant a cardiac risk assessment on each patient. “Whether that includes an ECG or not is up to the OTP,” he said. “Nobody is being required to do this by the federal government.”

Resources:

Krantz MJ, Martin J, Stimmel B, Mehta D, Haigney, MC. QTc interval screening in methadone treatment. Ann Intern Med. 2009;150(6):387-395.
http://www.annals.org/content/150/6/387.full?HITS=10&hits=10&RESULT=&maxtoshow=.
Accessed February 20, 2012.

QTc Interval Screening – AATOD Policy and Guidance Statement. March 30, 2009. American Society for the Treatment of Opioid Dependence, Inc. New York, New York. http://www.aatod.org/qtc.html.  Accessed February 20, 2012.

Mandatory QTc Screening for Methadone Patients – OTPs Respond to Published Guidelines. ATForum. 2009 #2 (Spring); vol 18. http://atforum.com/newsletters/2009spring.php#QTc.
Accessed February 20, 2012.

For a link to the abstract, go to http://www.ncbi.nlm.nih.gov/pubmed/22026519.
Accessed February 20, 2012.

Comments

  1. If you don’t do an ekg and the patient dies, what have you accomplished? A dead addict never recovers. Ekg’s could be done at the clinic and only takes about five minutes. Interpretive Ekg machines are not that expensive (around $1300.00) Isn’t it worth five minutes to potentially save a life?

  2. Unfortunately there is issue with the EkG’s that are done at many OTP’s and the battles that this test causes MANY MMT patients to have to fight in order to receive adequate treatment for their Chronic Disease of Opioid Addiction is in itself, DANGEROUS to the patient.
    Many patients who have undergone EkG testing at their Opioid Treatment Program or Clinic are told that their stable/therapeutic dose level must be decreased due to the results of the EkG only to go outside of the Treatment Facility for a second opinion and find that their numbers are extremely the opposite and in fact very GOOD indicating NO Issue of QT Prolongation.

    The only time an EkG is effective or possibly needed is as it says in the article, when cardiac issues present and are prevalent at time of patient intake. At this time a baseline EkG is done to use as a needed guide. Or the patient later on in their MMT develops symptoms that raise a flag. And even in these cases I believe that the EkG should be done OUTSIDE of the OTP/Clinic by a neutral medical doctor/facility. NOT in the OTP itself. It leaves too much to question with the results as WE, the Patient and MMT Advocates have seen over the years and also room for error. And most troublesome to myself and many others is the issue of the EkG to be used in way of dose capping patients and calling it anything BUT what it is as Dose Capping is illegal period.

    Not to mention that the article and much of the research on this issue states that only 3% of MMT patients experience QT Prolongation and that many of that 3% entered into their treatment with pre-existing heart conditions. And the dose level of above 100mgs was significantly above 100mgs….some patients on doses of 400mgs+.
    Using a baseline and saying that patients above 100mgs are at risk is tenuous and very vague to say the least.

    So the issue is the NECESSITY of this procedure is non-existent as a MANDATORY test for all OTP Patients.

    I myself have been an MMT Patient for 11 years now and have yet to experience any symptom of cardiac issue or QT Prolongation and my dose is over 100mgs. Yet when it was known at my last physcial that I had insurance I was told that I HAD to have an EkG bc I was on a dose above 100mgs. When my “doctor’ started asking ab symptoms of QT Prolongation or Cardiac concern, I was honest and answered NO to each. So in other words because I had insurance was the reason for my ‘needing’ an EkG bc I also refused to decrease my dose to 100mgs at my clinic doctors behest as I have been stable for many years and very successful in my treatment on MM.

    So this is a good thing for many reasons that it is NOT Mandatory. But at the same time, many clinic doctors use their ability to require an EkG in an abusive way and when it is NOT called for. A dose of higher then 100mgs is NOT reason or grounds for an EkG or suspect of QT Interval Prologation.

    And in response to Tonya…..I get the ‘better safe then sorry’ point of view. But we don’t do procedures that are not medically needed in other situations of Treatment for Diseases and say it’s Mandatory. So why now? Why with Methadone Patients?

    For some on the outside it’s easy to speak on the issue in passing or without much conviction or read just an article or 2 with no real research or understanding of the issue. But as I said, I am an MMT Patient, my husband is an MMT patient and many of my friends and those I consider family are in Recovery on MMT and this is something that I am very passionate about as MMT is the most effective modality of treatment for those of us who suffer with this debilitating and often fatal disease.
    Those who want to point the finger at MMT for any reason at all without true foundation are the ones who are dangerous and detrimental to our treatment.

    This all started with regard to wanting to ‘pin the fault’ on Methadone. But that isn’t the case nor is it a sufficient reason for a Mandate of such potential danger ITSELF to be made.

    I am THANKFUL for Governing Organizations such as SAMHSA who are able to keep their focus as it should be and put the patients and treatment first and foremost. They have the ability to ‘weed through the crap’ when it comes to these issues.

    And I am also thankful for Organizations like AATOD, CSAT, MMTSA many many others who are working for our treatment as well!

    And as a Member of NAMA Recovery – National Alliance for Medication Assisted Recovery and the Director of NAMA Recovery of West Virginia I am never surprised by the issues that arise, but I am often saddened by them.

    This is another case in point of WHY as MMT Patients and MAT Patients we must always be aware of our RIGHTS and be our own best Advocates. As a Methadone Patient Advocate I will always work to educate and spread awareness….and to fight against the Stigma that is often perpetuated and born of these types of issues.

    In closing….I am so thankful that the Mandate was denied! And I as well as many other patients, advocates, volunteers etc will continue to fight on behalf of our Treatment and Patients like myself and to make sure that the EkG is not used for ‘the wrong reasons’.

    Thanks to ATForum for all you do! Your website is my absolute favorite for amazing information, education and more!

    Truly Sincere,

    Abby Coulter
    Director ~ MPA
    NAMA Recovery of West Virginia
    http://www.facebook.com/NAMARecoveryTNWV
    WVDirector@methadone.org

    Founder~Director
    Peer Support Specialist
    ‘Methadone Maintenance Treatment Support & Awareness’ – MMTSA
    mmtsaorg@gmail.com
    http://www.facebook.com/MethadoneMaintenanceTreatment

  3. Peter Klimon Szabo says:

    I am a long time VA methadone patient that has recently been forced to reduce my dosage because of a 30sec EKG. All followup tests (which were intensive) clearly showed I have no heart ailments but they insisted on reducing my dose to sub 90mg from 160mg. I want to thank Abby Coulter for the eye-opening response and education. It is very troubling to see the mad rush to force patients to accept medication levels that clearly are too low for patients that have been on long term methadone treatment.

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