Why Aren’t More Physicians Prescribing Buprenorphine?

According to recent surveys, an estimated 1.9 million Americans meet the criteria for opioid use disorder based on their use of prescription painkillers in the past year, 212,000 people aged 12 or older used heroin for the first time within the past 12 months, and 435,000 people used heroin in the past month.

“The fundamental issue with people who have opioid use disorders and addictive disorders generally is that they are uncomfortable,” said Stuart Gitlow, M.D., immediate past president of the American Society of Addiction Medicine and executive director of the Annenberg Physician Training Program in Addictions. “When they use their drug of choice, they use it to get comfortable. The downside with opioids and narcotics is that there are significant side effects—especially rebound withdrawal—that leave them even more uncomfortable than before. So they end up chasing the euphoric effect.”

There are three FDA-approved medications to treat opioid use disorder: methadone, extended-release naltrexone, and buprenorphine.

Originally formulated as an injectable medication for pain relief, buprenorphine was approved for treatment of opioid addiction under the Drug Addiction Treatment Act of 2000 (DATA 2000).

Buprenorphine is a partial agonist, binding to the critical mu-opioid receptors in the brain (where analgesics and narcotics work) but not fully activating the receptors—so that the drug satisfies cravings without the euphoria that drives drug-seeking behavior.

Think of a lock and key, John Renner, M.D., vice chair of the APA Council on Addiction Psychiatry and president of the American Academy of Addiction Psychiatry, told Psychiatric News: “The drug is the key. If you stick heroin in the lock, it turns the lock all the way and can kill a person. But with buprenorphine, the lock gets turned only partially—no matter how high the dose, you will never get to a level that can be fatal.”

Petros Levounis, M.D., chair of the Department of Psychiatry at Rutgers New Jersey Medical School, noted another critical benefit of the drug: it can be dispensed in sublingual form in a physician’s office, unlike methadone, which requires patients to seek out treatment in a qualified methadone treatment center.

“Buprenorphine is the first line of treatment for opioid use disorder, unless there is a specific contraindication, such as an allergic reaction, or patients have done very well on methadone or other treatments,” Levounis said.

Patients most likely to benefit from the treatment include those receiving treatment for pain who have become addicted to opiate painkillers and those who are addicted to heroin, Levounis and Renner explained. (There’s significant overlap between these groups, they noted. As prescriptions of opiate painkillers have been restricted, many patients who are addicted to opiates have sought out heroin on the street.)

DATA 2000 required that in order to prescribe or dispense buprenorphine, physicians must complete eight hours of training and apply for a waiver from Substance Abuse and Mental Health Services Administration (SAMHSA). APA provides waiver-eligible training through an online course and live courses at APA meetings (see sidebar).

With this waiver, physicians are permitted to treat up to 30 patients in settings other than an opioid treatment program such as a methadone clinic; after one year, they can apply to receive a waiver to treat up to no more than 100 patients at a time. In contrast, physicians do not need to obtain a waiver to administer monthly injections of naltrexone, but patients must go to certified treatment centers to receive methadone for the treatment of symptoms of opiate withdrawal. (Physicians who prescribe methadone as a painkiller are able to do so without obtaining a waiver.)

According to SAMHSA statistics obtained at the end of February, there are 31,862 physicians who have a waiver to prescribe buprenorphine. Of that number, 21,581 (67.7 percent) are certified to treat 30 patients, and 10,281 (32.3 percent) are certified to treat 100 patients. However, according to SAMHSA, 40 percent of the physicians who have a waiver do not prescribe buprenorphine at all.

Why are so many certified physicians staying away from prescribing buprenorphine? Gitlow told Psychiatric News he thinks this may be because physicians are reluctant to have people with addictive disorders frequenting their office practice. (The latter is not a trivial problem; Gitlow said he has had to move his practice twice owing to complaints from the surrounding community or other professional tenants in an office building about the appearance of people with addictive disorders at the practice.) Levounis suggested that other physicians do not use their prescribing certification because they fear being audited by the Drug Enforcement Administration (DEA).

Renner told Psychiatric News that patient limits were incorporated into DATA 2000 out of concern for quality of care, but he acknowledged that the resulting limitation in treatment access is among several factors that have contributed to some diversion of the drug. The Department of Health and Human Services is developing a proposed rule aimed at expanding treatment access. Modifications to the patient limits are expected to be included in the rule, which is likely to be released for public comment in the near future.

APA does not advocate for removing the patient caps entirely, Renner explained, due to concern that such action could lead to large-volume buprenorphine prescribing practices with diminished clinical quality. Rather, along with the American Academy of Addiction Psychiatry and the American Osteopathic Academy of Addiction Medicine, APA has advocated for an incremental increase in the patient caps along with efforts to expand the number of providers (see sidebar).

Ideally, experts say buprenorphine should be prescribed as part of a total addiction treatment plan including participation in 12-step recovery and/or psychotherapy.

“There is little question in my mind that patients who participate in 12-step or psychotherapy do better,” Levounis said. “But if a patient doesn’t want to go to AA or see a therapist, the medication is strong enough that it can give a reasonable chance of success.”

Renner added, “I like to think of buprenorphine as a pharmacological platform that takes away withdrawal. It does not resolve whatever problems led an individual to seek out drugs in the first place, but what does change is that the patient’s life is not dominated by drug-seeking. The pharmacological platform makes recovery possible.” ■