In the midst of an acknowledged opioid epidemic and public health crisis for treatment resources and options, the Ohio General Assembly has approved Senate Bill 319 (S.B. 319) which contains provisions which are expected to aid in the response to this crisis. However, one provision of this new law will in all likelihood reduce access to Suboxone clinics operating in the State of Ohio. S.B. 319 does this by establishing State of Ohio Board of Pharmacy (Pharmacy Board) licensure requirements for locations providing Suboxone treatment to patients suffering from opioid and heroin abuse and dependence even if such locations do not store, possess, or distribute any medications. S.B. 319 is awaiting Governor Kasich’s signature.
The Pharmacy Board’s Suboxone licensure requirements from S.B. 319 are substantive and comparable to those adopted for pain management clinics in 2011 from House Bill 93. Consequently, it is anticipated that many Suboxone facilities currently in operation will encounter difficulty meeting these licensure requirements, and may no longer be able to continue operation.
These new Ohio standards, which will likely decrease access to Suboxone treatment, appear to run contrary to the trend at the federal level. There, recent legal changes have focused on increasing access to Suboxone treatment, as demonstrated by the passage of the Comprehensive Addiction and Recovery Act in July 2016, and recent regulation by the U.S. Department of Health and Human Services which, among other things, increased the patient limit for certain qualified physicians who have received special DEA registrations under the Drug Addiction Treatment Act of 2000.
Among the new Ohio licensure requirements, S.B. 319 limits who may own or operate a location providing Suboxone treatment, imposes Pharmacy Board documentation and disclosure requirements, and establishes employment standards and restrictions similar to the pain management clinic regulations. Additionally, the new law grants the Pharmacy Board rule-making authority to adopt regulations which may create additional regulatory barriers for Suboxone providers. Operation of a Suboxone clinic (meaning a location which has more than 30 patients receiving such medication) without such license or in violation of the requirements may subject such persons to fines of up to $5,000 per each day of violation from the Pharmacy Board, professional license sanction and exposure to criminal penalties.
Significantly, S.B. 319 does contain exemptions from its licensure requirements which may lessen any unintended negative impact on access to treatment for locations that are:
- Owned or operated, in whole or in part, by a hospital;
- Accredited facilities that only conduct clinical research and use controlled substances in such studies;
- Opioid treatment program that are already subject to certification by the U.S. Substance and Mental Health Services Administration (SAMHSA) and licensed by the Pharmacy Board as terminal distributors; or
- Programs or facilities that are licensed or certified by the Ohio Department of Mental Health and Addiction Services.
While S.B. 319 contains provisions which will undoubtedly aid in Ohio’s fight against the opioid epidemic, the new Suboxone licensure requirements raise concern of unintended consequences in that the number of Suboxone facilities may be reduced. If that happens, patients will have fewer treatment options, continuity of care or treatment itself will be interrupted or terminated and patient care may be compromised at a critical time.