by Laurel Sindewald and Anne Giles
Wait lists for medication-assisted treatment (MAT) for opioid addictions treatment can be months long, especially in rural areas. While opioid addiction is considered an epidemic in the U.S, patients struggle to access and then to pay for medications known to support opioid addictions recovery.
Buprenorphine is a partial opioid agonist used in maintenance therapy for opioid use disorders. As is methadone, buprenorphine is an evidence-based treatment for opioid use disorder. Buprenorphine has been shown repeatedly to improve treatment outcomes more than behavior therapies (Clark et al., 2015; Bart, 2012) and more than abstinence-based treatment.
Yet federal and state governments have intervened to impose a number of strict regulations, effectively limiting patient access to buprenorphine, beginning with the federal Drug Addiction Treatment Act of 2000 (DATA 2000):
- DATA 2000 mandates that only physicians may prescribe buprenorphine. This is unusual, because nurse practitioners, as well as physicians, are typically given clearance to prescribe a number of schedule II opiates, including Oxycodone. Source
- Physicians are required to complete DATA 2000 Certification. The government usually allows doctors discretion in determining what techniques and medications require what training. Source
- DATA 2000 imposed 30-patient limits on physicians prescribing buprenorphine. Due to the Office of National Drug Control Policy Reauthorization Act of 2006, physicians must apply, after one year, to raise their patient limit to 100. Patient limits were imposed to reduce diversion of medication for street sale. However, the abuse potential for buprenorphine has been found to be less than that of full opioid agonists such as heroin or oxycodone. Diversion for illicit use has been limited in the US, and has typically been used therapeutically when diverted. There are no patient limits for prescription of other opiates, including oxycodone. Source
- On July 8, 2016, Substance Abuse and Mental Health Services Administration (SAMHSA) and the US Department of Health and Human Services (HHS) published new regulations for MAT in the Federal Register, allowing doctors to prescribe up to 275 patients at a time. In order to do so, doctors must have credentials in addiction medicine or addiction psychiatry from a specialty medical board or professional society, or work in a qualified practice setting providing comprehensive MAT treatment. These regulations will be effective on August 7, 2016.
- Some states, including Virginia, require physicians to refer patients to counseling in order to prescribe buprenorphine. Counseling has not been shown to improve treatment outcomes for MAT patients. Source from 2016 / Source from 2015 / Source from 2011
- While the Mental Health Parity and Addiction Equity Act of 2008 requires health insurers to cover behavioral health services, this does not extend to MAT. Not all insurance plans cover buprenorphine, and in some cases doctors insist on payment in cash. If a patient has no insurance, the requirement to comply with counseling adds an extra expense that may be prohibitive.
- Some states set limits on how long patients may be treated with buprenorphine. The SAMHSA guidelines for treatment with buprenorphine state that some patients may require many years, or even life-long maintenance.
- Some states set age restrictions on who can receive buprenorphine. In Virginia, no one under the age of 16 is allowed to take the medication. This is clearly not because people under 16 never develop substance use disorders. The 2014 SAMHSA National Survey on Drug Use and Health reports that 1.3 million adolescents aged 12-17 had substance use disorders. This means 5% of adolescents, or 1 in 20, met the criteria for a substance use disorder in 2014. 168,000 of these adolescents were addicted to pain relievers, and 18,000 were addicted to heroin.
Opioids produce tolerance in people over time, which means their bodies no longer respond to the drug as strongly as before. As tolerance develops, people take higher and higher doses of opioids to get increasingly lessened effects. If people with opioid use disorders are abstinent, their tolerance drops. This means if they relapse, they may try to take the kinds of high doses they had been used to, and so are likely to overdose and die.
As only a partial agonist, buprenorphine and methadone do not produce highs in patients who have, already, developed tolerance to opioids. Rather, these medications are designed to stabilize opioid levels while patients rebuild their lives, staving off withdrawal symptoms as well as cravings, and reducing the risk of lethal overdose.
“[T]he treatment delivery strategies that are often used and that can produce excellent patient outcomes (eg, frequent clinic visits, observed dosing, provision of intensive psychosocial services, limited take-home doses) may simultaneously decrease treatment availability, practicality, acceptability, enrollment, and retention for some patients. Alternatively, treatment paradigms that may be most convenient for patients and physicians (eg, infrequent clinic visits, reduced oversight, and providing longer-duration supplies of medication) may increase the risk of medication diversion and abuse and undermine treatment outcomes. This paradox poses significant barriers to the widespread therapeutic delivery of effective medications to opioid-dependent patients, particularly in rural areas with few services and significant unmet need for treatment.”
– Stacey C. Sigmon, Ph.D., Access to Treatment for Opioid Dependence in Rural America, 2014
When talking about MAT, we must be clear about our values and objectives. Above all, MAT is a non-punitive approach to opioid addiction recovery. Abstinence may be wished for, but in the meantime, treatment providers are hoping to reduce disease risk, crime, and death. Lessons from the AIDS epidemic may be helpful in understanding and implementing best practices quickly.
A recent pilot study indicates that buprenorphine dosing while patients are waiting for comprehensive addictions treatment significantly reduced illicit opioid use, including intravenous use, compared to patients on wait lists who did not receive buprenorphine. Even without additional addictions treatment, buprenorphine seems to be effective. The authors suggest that their findings could be especially useful for treating people with opioid use disorders in rural areas where treatment is hard to access due to limited transportation.
Latest science indicates that incarceration and punishment are ineffective, even harmful. Yet this did not prevent drug courts from lobbying against Human Health Services’s efforts to increase patient limits to 200. Fortunately, their efforts were not successful, and we may see patient limits increased in the near future.
The question remains whether patient limits should be imposed at all. In other areas of medicine, we trust doctors to limit their patient load to what they can effectively handle. We still trust doctors to prescribe painkillers, like hydrocodone and oxycodone, without restriction of dose or patients. Not that we should begin imposing arbitrary restrictions on other aspects of medicine. It is simply time for government to recognize addiction as an illness requiring treatment, not punishment, and that sometimes treatment includes medications such as buprenorphine.
With millions of Americans addicted to opiates and close to a million still left without treatment, a 200 patient limit may not go far enough to ensure people get the treatment they need. Meanwhile, people are dying while they wait.
Updated 12/28/16
Image: iStock
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The content of this post is for informational purposes only and is not a substitute for medical or professional advice. Consult a qualified health care professional for personalized medical and professional advice.
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