Marlene Busko

October 05, 2015

DENVER — A proposal that would require physicians to meet minimal competency standards before prescribing methadone has been rejected here at the American Academy of Family Physicians (AAFP) 2015 Congress of Delegates.

"Methadone has some idiosyncrasies about how you dose it and how certain people might respond to it," said incoming AAFP president Wanda Filer, MD, from York, Pennsylvania. The resolution was developed to increase physicians' understanding of methadone, "so they know exactly what they're doing, as we all should with all of our medication prescribing," she explained.

There is concern about the extensive use of methadone, not only in addiction management, but also pain management, said a delegate from New York, the chapter that brought the resolution forward.

An unintended consequence of the increase in opioid prescriptions to manage pain has been the "dramatic rise in overdose deaths, with a rate paralleling the rate of prescribing," according to the AAFP. Although methadone accounts for a small percentage of the opioid prescriptions in the United States, it is implicated in about one-third of the deaths from opioid overdose.

Resolution 502 proposed that the AAFP "advocate that the US Food and Drug Administration (FDA) develop a risk evaluation and mitigation strategy (REMS) to establish minimal competency for those who elect to prescribe methadone for pain."

Resolution to Regulate

After testimony was presented at a hearing, the reference committee on advocacy, chaired by Sterling Ransone, MD, from Virginia, reported that it "recognized legitimate and unique concerns about the safety of prescribing methadone for pain."

Nevertheless, the committee concluded that a specific policy for methadone is not needed, noting that "minimum competency standards are appropriately set by state licensing boards." In addition, it pointed out that the AAFP already has a "policy on pain management and opioid abuse."

We really have to educate people how to prescribe methadone.

Not everyone agreed that this is enough. There is a risk evaluation and mitigation strategy for opioids, but "it's not specific about methadone," Jose David, MD, from Albany, New York, told Medscape Medical News. "We really have to educate people how to prescribe methadone."

Dr David, along with several other New York delegates, testified at the hearing in favor of resolution 502.

"Companies are creating long-acting opiates with a drug-deterrent molecule. If you chew the drug or crush it and mix it with water, it gels, so you can't snort or inject it," said Dr David. Methadone, however, doesn't have a protective mechanism to prevent overdose.

A second New York delegate testified that each day he treats patients who have overdosed on opioids. "Methadone is going to be the number 1 drug causing drug overdose very soon because it is so cheap," he said.

A third explained that formulary issues are a huge driver of methadone prescribing. Our first question should be, "What is best for the patient?" And "when the system gets in the way of what's best for the patient, we should advocate to fix the system," he said. The second question should be, "How do we make sure that AAFP members, who choose methadone because it is best for the patient, are better trained?"

The resolution was supported with some caveats by a delegate from Washington testifying at the hearing. When "our Medicaid program removed oxycodone from the formulary because of cost, we saw many people prescribing methadone who really were not well enough versed in it, and the rate of opioid overdose death, with methadone in particular, went way up," he said. This issue "is clearly important, but whether this proposal is the right avenue is certainly debatable."

Methadone is the major killer in the opiates; that's why it is being singled out.

The New York delegate involved in the development of this proposal said that "a camel is a horse designed by a committee; this is a camel." Nevertheless, this is a small step in the right direction, he maintained. "Methadone is the major killer in the opiates; that's why it is being singled out."

Other delegates supported the objective of the resolution, but disagreed with the means to attain it.

One delegate acknowledged that there is a problem with the safe use of methadone for pain management, but pointed out that this resolution "is perhaps not the right solution."

Carol Blackwood, MD, from White River Junction in Vermont, testified that she is against this resolution because, by making it more difficult to prescribe methadone, prescribers will merely switch to another narcotic. "Education in the prescribing all of narcotics is much more important than making prescribing one of them too onerous," she said.

Another delegate pointed out that physicians can easily learn about the unique aspects of methadone and ways to prescribe it safely by reading the 2006 drug alert issued by the FDA.

The Texas chapter is concerned that the FDA would create "a more circuitous process" for prescribing methadone, said a delegate from that state. "We advocate instead a voluntary CME process" to learn about prescribing methadone, he continued. "I am not aware of any evidence that proves that mandatory CME alters prescribing habits," he added.

A delegate from Illinois was more categorical. "I'm in opposition to any restrictions in family medicine in caring for our patients," he said.

In rejecting the proposal, Dr Ransone and the committee members pointed out that a member of the AAFP sits on a Centers for Disease Control and Prevention advisory body that is looking at developing guidelines for primary care prescribers of methadone.


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