Increasing Access to Buprenorphine (Suboxone)

Drug overdose is now the leading cause of accidental death in the U.S., with over 60% of those overdose deaths involving an opioid, including heroin or pharmaceutical pain killer.

While the mortality related to opioid use disorder has reached epidemic levels, rates of individuals seeking treatment are also on the rise. One evidence-based resource in the fight against opioid use disorder and its numerous health consequences is the partial opioid agonist known as buprenorphine (often prescribed as a formulation that is combined with naloxone, called “Suboxone”)

WHAT PROBLEM DOES THIS STUDY ADDRESS?

Beginning with its approval in 2002 by the United States Food and Drug Administration (FDA), physicians that complete a certification course or had board certification in addiction medicine or addiction psychiatry could prescribe the medication. This initial certification (or X license) only allows the physician to treat up to 30 patients at a time (hereafter called 30-patient physicians).

This cap was put into place, in part, due to concerns about the possibility that the medication could be sold by patients to others to be used outside of medical supervision or for non-medical reasons (i.e., diversion). Capping physicians’ caseloads, many thought, would make medical supervision easier, and minimize the amount of buprenorphine that could potentially be misused or diverted.

Beginning in 2006, physicians were eligible to prescribe for 100 patients if they had the initial waiver for at least 1 year and were currently using medication-assisted treatment with buprenorphine in their practice (hereafter called 100-patient physicians).

Furthermore, some eligible physicians prescribe buprenorphine in a private outpatient office; others are staff at a substance use disorder (SUD) treatment program, or more specifically at a program that specializes in the treatment of opioid use disorder. This study by Stein et al. examined whether the availability of waivered physicians and SUD treatment programs is associated with the amount of buprenorphine prescribed.

HOW WAS THIS STUDY CONDUCTED?

Authors used data from three large, national datasets:

First, they obtained the amount of buprenorphine dispensed during 2004 to 2011 from the Drug Enforcement Agency’s Automation of Reports and Consolidated Orders System.
Second, they obtained the number, and type of waivered physicians (eligible to treatment 30 vs. 100 patients), from the Substance Abuse and Mental Health Services Administration (SAMHSA) Buprenorphine Waiver Notification System.
Third, they identified all general substance use disorder (SUD) treatment programs and opioid-specific SUD treatment programs (i.e., methadone clinics), and whether they were staffed to prescribe buprenorphine, from the SAMHSA National Survey of Substance Abuse Treatment Services (N-SSATS).
Fourth, they categorized physicians/programs according to whether they were located in rural or urban areas as determined by Rural-Urban Continuum Codes from the Area Resource File.

The primary independent variable was number of waivered physicians and buprenorphine-providing programs per 10,000 state residents (i.e., per capita). The primary outcome was amount of buprenorphine dispensed per capita by state each year. Analyses controlled for differences in state population, and several other state-level factors that authors did not specify explicitly.

WHAT DID THIS STUDY FIND?

Overall, the number of waivered physicians increased substantially from 3,293 in 2004 to 20,410 in 2011.

Programs treating patients with buprenorphine also increased substantially between 2004 and 2011: From 246 to 1241, respectively, for substance use disorder (SUD) programs and from 71 to 348, respectively, for opioid-specific programs. Rates of waivered physicians in urban areas were greater than those in rural areas, though this difference declined somewhat over time (suggesting increased access in rural areas). Authors did not examine whether these differences were statistically significant.

The opposite pattern was observed for SUD and opioid-specific programs, where urban programs increased relative to rural programs. Regarding impact of provider availability, the 100-patient physicians appear to have the greatest impact on the amount of buprenorphine dispensed.

There was a significant association between the 100-patient physicians and buprenorphine dispensed for 2007-2011 in urban areas and 2008-2011 in rural areas. Specifically in 2011, each additional 100-patient physician was associated with 400 more grams of buprenorphine in urban areas and 500 more grams of buprenorphine in rural areas. The association between the 30-patient physicians and more buprenorphine dispensed was significant only for select years in rural areas.

Substance use disorder (SUD) and opioid-specific treatment program prescribing was not associated with buprenorphine prescribing. Below is a graph of the number of theoretical additional patients with access to buprenorphine provided by each additional physician or program in 2011, broken down by urban and rural areas. The calculation is based on a maximum buprenorphine dose (24 mg/day), and assumes a patient is in treatment for the entire year in the analysis (8.8 gram per year). In other words, the number of additional patients treated could be higher than these totals; these are conservative estimates.

These findings offer insights into the potential benefits of changing recovery-related health policies. They suggest that adding physicians waivered to prescribe buprenorphine to 100 patients at a time would offer the greatest increase in patients’ access to medication-assisted treatment with buprenorphine.

Importantly, for 2017 President Barack Obama’s budget includes $920 million earmarked to help states expand access to opioid use disorder treatment (see here). These data indicate that using these added financial resources to increase the number of 100-patient waivered physicians (e.g., with outreach and education to office-based physicians) might improve patient access to medication-assisted treatment with buprenorphine.

WHY IS THIS STUDY IMPORTANT

Results from this study can help inform decisions by policy makers in at least two ways:

First, this study may inform policies on who is able to obtain buprenorphine prescription privileges and the steps needed to obtain it.
Second, when developing and implementing policies intended to expand access to medication-assisted treatment with buprenorphine, this study may inform optimal ways to invest limited financial resources.

From the finding that 100-patient physicians were associated with increases in the amount of buprenorphine dispensed, it follows that more 100-patient physicians will increase access to medication-assisted treatment with buprenorphine.

Also, while many studies show receiving buprenorphine is associated with better short-term abstinence, a recent study, also showed medication-assisted treatment with buprenorphine is associated with abstinence over the long term.

Increased access to medication-assisted treatment for individuals with opioid use disorder may be followed by increased rates of remission, and reduced opioid use disorder-related negative consequences (e.g., overdose deaths; risk of contracting Hepatitis C through sharing needles).

LIMITATIONS

As the study authors point out, these data cannot tell us whether increased dispensing of buprenorphine actually translates into more individuals getting care.
Similarly, they cannot tell us whether increased dispensing translates into increased rates of opioid use disorder remission and recovery.
Also, although not a limitation of the study per se, the data were collected from 2004 to 2011. Spurred by the onset of the opioid overdose epidemic, the willingness of addiction programs to offer medication-assisted treatment for opioid use disorder may be on the rise. For example, according to the SAMHSA National Survey of Substance Abuse Treatment Services (N-SSATS; see here) for patients with a range of substance use problems (including but not limited to those with opioid use disorder), receipt of medication-assisted treatment has increased each 2-year period between 2003 and 2013; increasing from 20% to 30% of those in treatment. During the same time period, while only 5% of addiction programs offered buprenorphine in 2003, 22% offered it in 2013. Therefore, it is possible that treatment programs may offer greater access to buprenorphine now compared to 2011 – the last year of data analyzed for this study.

NEXT STEPS

As mentioned earlier, one potentially fruitful next step would be to investigate whether an increase in 100-patient physicians is associated with an actual increase in the number of patients that engage with buprenorphine treatment.

In addition, many policy and law makers are advocating for raising the buprenorphine patient cap, or the removal of the cap altogether (see here). The impact of these policy changes, if and when they occur, should be examined empirically.

BOTTOM LINE

For individuals & families seeking recovery: Medication-assisted treatment with buprenorphine may be an important piece of a comprehensive treatment approach to recovery from opioid use disorder. However, access to physicians and programs that can prescribe buprenorphine may differ depending on the state in which you live, and whether you are in an urban or rural area. Consult the SAMHSA treatment locator to find buprenorphine providers to which you have the most convenient access.
For scientists: With the increased political and financial attention being paid to the opioid overdose epidemic, research is needed now more than ever to develop and/or evaluate strategies to increase access to treatment and improve outcomes. This timely study serves as one example of how science can be used effectively to inform recovery-related public health policy and service delivery.
For policy makers: Strongly consider policies that reduce physician barriers to prescribing buprenorphine. As policies are put in place to increase buprenorphine access, however, it will also be important to address the risks of increased availability of buprenorphine. For example, all buprenorphine patients should have convenient access to naloxone, a drug that reverses opioid overdoses. See this summary for strategies to increase the impact of naloxone, such as prescribing the medication not only to patients, but to friends and families as well.
For treatment professionals and treatment systems: There are many strong feelings around the provision of buprenorphine for patients with opioid use disorder. Though not without risks, research has shown buprenorphine to be beneficial for many patients with opioid use disorder. The Association of Addiction Medicine and the World Health Organization consider medication- assisted treatment with buprenorphine to be an evidence-based best practice for individuals with opioid use disorder. This study suggests that having a prescriber on staff waivered to treat 100 patients might increase access for those who are interested. In turn, this is likely to prevent other severe health-related harms including overdose deaths.