Problem

Most people who take buprenorphine do so as directed by their medical providers, but some people who need buprenorphine cannot access it through the healthcare system and are forced to obtain it from friends or on the street. The current federal restrictions on prescribing buprenorphine for opioid use disorder impose barriers to accessing affordable, safe treatment.

While buprenorphine diversion is rare, it does occur. Buprenorphine is the third-most diverted prescription pain medication,

¹

U.S. Dep’t of Justice, Drug Enforcement Administration (“DEA”), NFLIS-Drug 2019 Annual Report, at 14 Table 2.1: Narcotic analgesics (2019), https://www.nflis.deadiversion.usdoj.gov/DesktopModules/ReportDownloads/Reports/NFLIS-Drug-AR2019.pdf.

but makes up only 1.35% of all illicit drugs in the United States.

²

U.S. Dep’t of Justice, Drug Enforcement Administration (“DEA”), NFLIS-Drug 2019 Annual Report, at 7 Table 1.1: National and regional estimates for the 25 most frequently identified drugs.

Buprenorphine naloxone is the most commonly prescribed formulation. Because it reduces the euphoric effect of the medication, buprenorphine naloxone is particularly effective at deterring diversion.

³

Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 114 (2019), https://www.nap.edu/catalog/25310/medications-for-opioid-use-disorder-save-lives.

Most people who receive buprenorphine follow the instructions of their medical providers. According to HHS, three-fourths of people who take buprenorphine adhere to the prescription directions.

⁴

HHS, Buprenorphine misuse decreased among U.S. adults with opioid use disorder from 2015-2019 (Oct. 15, 2021) https://www.nih.gov/news-events/news-releases/buprenorphine-misuse-decreased-among-us-adults-opioid-use-disorder-2015-2019 (“Data from a nationally representative survey indicate that in 2019, nearly three-fourths of U.S. adults reporting buprenorphine use did not misuse the medication in the past 12 months. In addition, buprenorphine misuse among people with opioid use disorder trended downward between 2015-2019, despite increases in the number of people receiving buprenorphine treatment.").

The non-prescribed use of buprenorphine is lower than the non-prescribed use of antibiotics and allergy medications.

⁵

Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 114 (2019), https://www.nap.edu/catalog/25310/medications-for-opioid-use-disorder-save-lives (“To put diversion of OUD medications in context, it is worth noting that these rates are lower than the diversion rates for other prescribed medications. For instance, prescribed antibiotics and allergy medications are diverted at rates of 25 and 21 percent, respectively.”).

Why does buprenorphine diversion occur? There is a shortage of medical providers who can prescribe buprenorphine for opioid use disorder. Today 40% of counties do not have a single healthcare provider who can prescribe buprenorphine.

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HHS, Geographic Disparities Affect Access to Buprenorphine Services for Opioid Use Disorder (2020), https://oig.hhs.gov/oei/reports/oei-12-17-0240.pdf?utm_source=newsletter&utm_medium=email&utm_campaign= newsletter_axiosvitals&stream=top (“Fully 40 percent of counties in the U.S. did not have a single health care provider with a waiver permitting them to prescribe the opioid addiction treatment drug buprenorphine in an office setting.”).

And in those areas where there are providers, the wait time for an appointment is often weeks or months. Patients, desperate to stop using heroin and fentanyl, are sometimes forced to find this medication from friends or on the street.

⁷

HHS, Nat’l Institutes of Health, Buprenorphine misuse decreased among U.S. adults with opioid use disorder from 2015-2019 (Oct. 15, 2021) https://www.nih.gov/news-events/news-releases/buprenorphine-misuse-decreased-among-us-adults-opioid-use-disorder-2015-2019 (“The study also found that people who received no drug use treatment and those who lived in rural areas were more likely to misuse the medication.”).

For these reasons, increasing access to buprenorphine treatment actually reduces its misuse - a fact that the DEA has recognized.

⁸

HHS, Buprenorphine misuse decreased among U.S. adults with opioid use disorder from 2015-2019 (“Data from a nationally representative survey indicate that in 2019, nearly three-fourths of U.S. adults reporting buprenorphine use did not misuse the medication in the past 12 months. In addition, buprenorphine misuse among people with opioid use disorder trended downward between 2015-2019, despite increases in the number of people receiving buprenorphine treatment…[T]hese findings highlight the urgent need to expand access to buprenorphine treatment, because receipt of treatment may help reduce buprenorphine misuse…”); Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 114 (2019), https://www.nap.edu/catalog/25310/medications-for-opioid-use-disorder-save-lives (“Importantly, the rates of both misuse and diversion decline as buprenorphine availability increases.”); DEA, Economic Impact Analysis of Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder, at 19 (Jan. 2018), https://docs.house.gov/meetings/IF/IF14/20180517/108343/HMKP-115-IF14-20180517-SD004.pdf (“However, the primary reason for prescription buprenorphine (Subutex) and buprenorphine combined with naloxone (Suboxone) diversion is the failure to access legitimate addiction treatment. This finding suggests that increasing, not limiting, buprenorphine treatment may be an effective response to the diversion of buprenorphine.”).

It is not surprising then that even the small amounts of buprenorphine that are currently diverted save lives and decrease heroin and fentanyl use. Most people who use non-prescribed buprenorphine do so to manage withdrawal symptoms because they cannot otherwise access treatment.

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Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 114 (2019), https://www.nap.edu/catalog/25310/medications-for-opioid-use-disorder-save-lives (“While some individuals with OUD report misusing buprenorphine to achieve intoxication, more report using it to relieve symptoms of withdrawal.”); DEA, Economic Impact Analysis of Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder, at 19 (Jan. 2018), https://docs.house.gov/meetings/IF/IF14/20180517/108343/HMKP-115-IF14-20180517-SD004.pdf (“In another study of untreated injection drug users found that three out of four respondents said their intended use of buprenorphine or buprenorphine/naloxone was to self-medicate for addiction and/or to treat withdrawal. While buprenorphine and buprenorphine/naloxone are Schedule III narcotics with a potential for diversion and abuse, academic literature seems to indicate that the diversion is not motivated by addiction to buprenorphine, but rather as a method to treat opioid addiction problems.”); Kevin Fiscella, MD, MPH, Sarah E. Wakeman, MD, Leo Beletsky, JD, MPH, Buprenorphine Deregulation and Mainstreaming Treatment for Opioid Use Disorder: X the X Waiver, 76(3) JAMA Psychiatry 229-30 (2018), https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2719455 (“[B]uprenorphine regulation is premised on the faulty assumption that buprenorphine diversion is driven by a desire to 'get high.' Yet, buprenorphine obtained illicitly is mostly used for self-medication to relieve withdrawal symptoms rather than for euphoria. People denied treatment for OUD are at higher risk for seeking diverted buprenorphine. This suggests that regulations constraining access to buprenorphine may paradoxically contribute to a market for illicit buprenorphine among those who seek treatment.”)

People with opioid use disorder who obtain non-prescribed buprenorphine for even a handful of days experience significantly fewer overdoses and reduce their use of heroin and fentanyl.

¹⁰

Robert G. Carlson et al., Unintentional drug overdose: Is more frequent use of non-prescribed buprenorphine associated with lower risk of overdose?, 79 Int’l J. of Drug Policy, at 4 (May 2020), https://www.sciencedirect.com/science/article/abs/ pii/S0955395920300633 (“Higher mean percentage of days of non-prescribed buprenorphine use in the past six months was significantly associated with a decreased risk of an overdose in the past six months…individuals who used non-prescribed buprenorphine on more than 5.4% of days (10 days; the median) had 33% lower odds of overdose…In other words, taking buprenorphine on 2–3 days out of 184 reduced the odds of overdose by 20% compared to just 1 day, with an approximately linear trend of more use associated with even greater reduction in odds of overdose…Regarding our hypothesis that increased use of non-prescribed buprenorphine lowers risk of overdose at least in part through a corresponding decrease in the use of heroin and/or fentanyl, we found that (after adjusting for confounding) greater (log-transformed) frequency of use of non-prescribed buprenorphine is strongly associated with lower (log-transformed) frequency of use of heroin/fentanyl (beta = -0.076, 95% CI =-0.098, -0.053), and lower (log-transformed) frequency of use of heroin/fentanyl is strongly associated with lower risk of overdose.”).

In countries that have removed restrictions on prescribing buprenorphine for opioid use disorder, heroin use has decreased.

¹¹

Congressional Research Svc. (“CRS”), Buprenorphine and the Opioid Crisis: A Primer for Congress, at 15 (2018), https://fas.org/sgp/crs/misc/R45279.pdf (“In France, all registered medical doctors have been allowed to prescribe buprenorphine without any special education or licensing since 1995...Results from studies on this model show that allowing physicians to prescribe without much regulation led to a rapid increase in the number of opioid-dependent users receiving buprenorphine treatment in primary care...Studies have also reported a significant nation-wide decrease in heroin use following the introduction of buprenorphine in 1995.").

According to the bipartisan U.S. Commission on Combating Synthetic Opioid Trafficking use of diverted medications is less risky than the use of illegally sourced opioids.

¹²

U.S. Commission on Combating Synthetic Opioid Trafficking, Final Report, at p. 50 (Feb. 2022) https://bit.ly/3ycCKVt (“Research shows that people use diverted buprenorphine and methadone to manage withdrawal and to abstain from use of heroin. Use of diverted-medication therapies to manage withdrawal or abstinence signals the need to expand their access. All things being equal, use of diverted medications by people with OUD is less risky than use of illegally sourced opioids.").

For these reasons, the U.S. Surgeon General has stated, “[d]ecades of research have shown that the benefits of [medication-assisted treatment] greatly outweigh the risks associated with diversion.”

¹³

U.S. Surgeon General, Facing Addiction in America: The U.S. Surgeon General’s Report on Alcohol, Drugs, and Health, at 4-22 (2016), https://www.ncbi.nlm.nih.gov/books/NBK424857/

And, according to the National Academy of Sciences, Engineering and Medicine, concerns about buprenorphine diversion are driven by stigma and are not supported by evidence.

¹⁴

Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 113 (2019), https://www.nap.edu/catalog/25310/medications-for-opioid-use-disorder-save-lives (“Concerns about the misuse and diversion of medications for OUD also contribute to the insufficient numbers of providers willing to prescribe them. Evidence suggests that these concerns emanate from stigma and misunderstanding about the motivations for using diverted medication…Providers’ concerns about the diversion of medication are inconsistent with available data, particularly in the context of medications that are formulated with deterrent properties, such as buprenorphine/naloxone.”).

Solution

The Mainstreaming Addiction Treatment Act will ensure that people who need buprenorphine can access it through the healthcare system, not on the street. The bill will allow medical providers with a standard controlled medication license from the DEA to prescribe buprenorphine for opioid use disorder in the normal course of their medical practices.

The U.S. Drug Enforcement Administration has stated that expanding access to buprenorphine treatment will reduce diversion.

¹⁵

DEA, Economic Impact Analysis of Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder, at 19 (Jan. 2018), https://docs.house.gov/meetings/IF/IF14/20180517/108343/HMKP-115-IF14-20180517-SD004.pdf (“However, the primary reason for prescription buprenorphine (Subutex) and buprenorphine combined with naloxone (Suboxone) diversion is the failure to access legitimate addiction treatment. This finding suggests that increasing, not limiting, buprenorphine treatment may be an effective response to the diversion of buprenorphine.”).

Indeed, rates of diversion decline as more people with opioid use disorder can access buprenorphine through their primary care doctors.

¹⁶

Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 113 (2019), https://www.nap.edu/catalog/25310/medications-for-opioid-use-disorder-save-lives (“Importantly, the rates of both misuse and diversion decline as buprenorphine availability increases.”).