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/pdf/2009FallNews.pdf
Accessed February 20, 2012.

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