WASHINGTON — A new report from the National Academies of Sciences is calling for expanded use of medications to help patients with opioid use disorder (OUD) and to end barriers that limit access to these drugs so as to help curb the US opioid epidemic.

The report, entitled "Medications for Opioid Use Disorder Save Lives," argues for a shift in the way the medical community views OUD.

On a media conference call, the report's authors framed OUD as being akin to common chronic conditions for which medications are frequently used. They gave as an example high cholesterol, for which statins are used.

The report seeks to build a case for greater use of treatments approved by the US Food and Drug Administration (FDA) — methadone, buprenorphine, and naltrexone.

In 2017, only about 20% of the individuals in the United States who required treatment for OUD received it, meaning that 80%, or about 1.7 million, did not, the authors note.

The need is particularly acute among individuals who have been incarcerated. Only 1 in 20 OUD patients in prison receive treatment, the authors report. Moreover, some treatment sites ban OUD medications, they note.

"That makes no scientific sense," said Alan Leshner, PhD, chair of the committee that produced the report. "Why would we want to withdraw treatment from people in any setting? We certainly wouldn't do that with blood pressure medications or diabetes medications or statins. Why would we single out these medications [for OUD]?"

The report seeks to replace the term "medication-assisted treatment" for OUD with the term "medication-based treatment." That change is meant to emphasize a more central role for OUD medications and to highlight their role in addressing the changes in the brain that result from repeated opioid use.

Denial of Treatment "Unethical"

Leshner said there is a misconception that OUD treatment must include behavioral interventions.

"There are people who do need those interventions, but there also are people who do just fine only receiving these FDA-approved medications," he said.

"Behavioral interventions can be very useful in helping engage people in treatment, in helping to retain them in treatment. However, they are not essential," he added.

In the view of the committee, withholding or failing to offer FDA-approved drugs to patients is an "unethical" denial of appropriate medical treatment, whether in a clinic or prison, said Leshner, who earlier served as director of the National Institute on Drug Abuse (NIDA).

In the criminal justice system, OUD treatments are sometimes withheld or are provided only on a limited basis for medically supervised withdrawal. Those who do receive medication for OUD often are unable to continue receiving medical care after their release, which leads to discontinuation of OUD treatments and the associated risks for overdose and death.

"In every situation where it's been studied, medication-based treatment is effective and saves lives," Leshner said. "There is no scientific evidence that justifies withholding medications from patients in any setting or denying access to social services, like housing or income support, to individuals who are on medications."

The report calls for an "all hands on deck" strategy to address the nation's OUD crisis. About 47,000 people in the United States died in 2017 as a result of opioid overdoses.

Excess regulation is preventing many people from obtaining methadone or buprenorphine, despite a "wealth of evidence" that supports use of these OUD drugs, the authors note.

Restrictions Not Supported by Evidence

Research shows that individuals with OUD are less likely to die when they receive long-term treatment with methadone or buprenorphine than when they go untreated, the report says.

The authors also note that studies of extended-release naltrexone (Vivitrol, Alkermes) have not had sufficient power or duration of follow-up to detect a mortality benefit.

Extended-release naltrexone can be prescribed by any licensed healthcare provider, the report says. It works by blocking the euphoric and sedative effects of opioid drugs. It's not considered likely to be abused or sold. With buprenorphine and methadone, which activate opioid receptors, there is a risk for diversion.

In the United States, methadone can be dispensed only by treatment programs that are certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) and that are registered with the Drug Enforcement Administration (DEA), the report says. In the United States, many patients who receive methadone are required to visit treatment programs daily, which impedes their ability to hold jobs.

"Regulations with little to no evidence base — and which vary by state — often restrict take-home medication privileges, require supervised medication consumption, and mandate the frequency of urine testing and counseling," the report says.

In Great Britain, Canada, and Australia, methadone can be prescribed in primary care clinics, and prescriptions can be filled in community pharmacies, the report says.

Pilot studies have suggested that allowing methadone to be prescribed in primary care offices might improve access in the United States. "Calls are increasing to allow methadone to be prescribed for OUD in a wider range of medical settings," the report says.

To prescribe buprenorphine, healthcare providers in the United States must undergo additional training and obtain a waiver from the DEA.

Only 2% to 3% of physicians in the United States have waivers to provide buprenorphine, the authors report.

"These policies are not supported by evidence, nor are such strict regulations imposed upon access to life-saving medications for other chronic diseases," they write.

Physician Fear

Recent federal laws that allow nurse practitioners and physician assistants to prescribe buprenorphine have led to "modestly increased" access. "Despite this progress, most providers who are waivered to prescribe buprenorphine maintain patient panels well below the regulated patient limits," the authors write.

Concerns about diversion of the drug and potential difficulties with the DEA are among the reasons that many physicians avoid prescribing the drug, the report says.

It also notes that "there have been calls to eliminate prescribing limits on the grounds that there is no evidence base for limiting access to this medication."

Scott Steiger, MD, who is a member of the committee, contrasted limits on prescribing OUD treatments to the relatively easy access to prescription painkillers, which put many people on the path to addiction. He deemed this situation to be "kind of backwards."

As a physician who has treated patients for OUD, Steiger said he wished this field were like surgery, so that he "could just do a quick fix and send people on their way."

Many people erroneously regard rehabilitation and detoxification programs as the equivalent of surgery for OUD, said Steiger, who is an associate clinical professor at the University of California, San Francisco.

"That's just not a rational approach for a chronic disease, and it's not supported by the data, as our report shows," he said.

Leshner emphasized that physicians should help patients with OUD to accept responsibility for their healthcare, just as physicians do for patients with other conditions.

"We always recommend medical management, particularly for chronic disorders. So take diabetes, blood pressure, even high cholesterol. We want people to monitor their issue, we want them to account for their compliance," Leshner said. "Medical management should be the norm."

Impact on the Brain

In the report, Leshner and colleagues argue for combating stigma that surrounds addiction and that depicts it as a moral failing. The authors propose that greater emphasis be placed on the way repeated exposure to opioids changes the brain.

Published research suggests the brain's dopamine response becomes more "sensitized," or magnified, after repeated exposure to opioids. In some people, repeated exposure may also dampen the influence of brain circuits related to executive function and decision making, making those persons more likely to abuse opioids.

"Moreover, these changes to the brain continue even after an individual discontinues opioid use and no longer has symptoms of acute withdrawal, making long-term recovery more difficult," the authors note.

Leshner's committee carried out its study of OUD medications between October 2018 and March 2019. Its work included a comprehensive literature review and a public workshop. The study was sponsored by SAMHSA, the NIDA, and the National Institutes of Health.

The core message of the report is its endorsement of broader use of OUD medications, said Leshner. "They all are effective and save lives," he said.

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