Federal rules on opioid addiction are hindering effective treatment

The U.S. has, at best, a tenuous grip on the opioid epidemic. Fentanyl has rapidly become both widely available and increasingly potent. More and more Americans are facing addiction crises and are looking for help.

Now more than ever, we need to support doctors working at opioid treatment programs (OTPs) in using their experience and industry best practices to prescribe life-saving medications. 

OTPs are specially licensed facilities which, unlike other treatment options, can offer methadone in addition to other opioid treatments and various services such as counseling and health screenings. 

These OTPs can provide more support to addiction patients than out-of-office treatment options can. But because they provide methadone, OTPs must abide by specific federal Substance Abuse and Mental Health Services Administration (SAMHSA) regulations.

Designed specifically to curb abuse of methadone, the SAMHSA guidelines are unfortunately hindering some treatment options that individuals with opioid use disorder can get from OTPs. And here’s why: The guidelines state that OTPs must administer and dispense all opioid addiction treatment medications “in accordance with the manufacturer’s labeling.”

This regulation is designed to limit any abuse of methadone, but it also applies to other, less potentially dangerous opioid treatments such as buprenorphine. If doctors at OTPs want to prescribe Suboxone, for example (a common brand of buprenorphine), they must do so in accordance with the label on Suboxone, which states that the two milligram drug must be administered whole, and cannot be cut, chewed or swallowed. 

The issue is, of course, that treating patients is never a one-size-fits-all solution, especially when it comes to treating opioid addiction. To safely take buprenorphine, patients need to have cleared out from their system a certain amount of the opioids they’ve been taking. A person taking oxycodone needs to wait a different length of time than a person taking heroin or fentanyl. Other factors play a part as well, including the amount taken and length of time someone has been taking it for.

If taken too soon, a large dose of buprenorphine would send patients into even more severe withdrawal than usual.  

One way to handle this is by giving very small doses of buprenorphine while the original opioid is still in an individual’s system in large quantities — doses small enough that they do not precipitate severe withdrawal. This practice is called “microdosing,” and it allows buprenorphine to be given much sooner while minimizing withdrawal symptoms.

Yet because of SAMHSA’s regulations, OTP facilities cannot lawfully administer buprenorphine at lower doses than 2 mg and therefore cannot use this method. Patients are thus forced to endure moderate to severe withdrawal, which can take several days, before they can take buprenorphine at all. Many patients simply can’t make it that long through moderate withdrawal symptoms.  

At a time when the opioid epidemic is fatal to hundreds of patients a day, the policies of SAMHSA have inadvertently created barriers to treatment. There are dozens of studies that support letting patients microdose buprenorphine and tapering their way to a full dose. Starting with a lower dose lessens withdrawal symptoms and can be the difference between success and failure for a patient.

Regulators need to update their standards to be in line with the current standard of medicine. But obviously, creating change at the federal level is never a fast process. Another simple option is for manufacturers to update their product labeling. By simply eliminating the instructions that say not to cut buprenorphine, they would allow doctors in OTP settings greater flexibility in treating their patients. An immediate change from buprenorphine manufacturers could save thousands of lives. 

Opioid treatment programs are key tools to ensuring the success in the fight against the opioid epidemic. The future could be even brighter if more options were possible.

Dr. Erika Steinbrenner is a Chicago-based doctor of medicine and psychiatry working more than six years in medication-assisted addiction treatment.