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Effective Dec 1, Pharmacies, Prescribers, and Wholesalers Must Report Gabapentin to Ohio Automated Rx Reporting System

Beginning December 1, 2016, the State of Ohio Board of Pharmacy requires pharmacies, prescribers, and wholesalers to report the dispensing, personal furnishing, and wholesale sale of all products containing gabapentin (brand names: Neurontin, Gralise, Horizant) to the Ohio Automated Rx Reporting System (OARRS). Gabapentin has not been reclassified as a controlled substance, but it is being added to the Board’s list of drugs reportable to OARRS following increased reports of misuse, abuse, and concomitant abuse of gabapentin nationwide.1

No new requirement to review an OARRS report prior to dispensing gabapentin

Unlike the rules requiring pharmacists and prescribers to request and review an OARRS report prior to dispensing, prescribing, or personally furnishing controlled substances, there is no requirement to request and review an OARRS report prior to dispensing, prescribing, or personally furnishing gabapentin. Pharmacists and prescribers are expected to use professional judgment to determine the need to request an OARRS report prior to dispensing, prescribing or personally furnishing gabapentin.

Changes to prior exemptions to reporting

Pharmacies or prescribers that were previously exempt from OARRS reporting requirements because they did not dispense or personally furnish controlled substances do not need to reapply for a reporting exemption if they do not dispense or personally furnish gabapentin. However, pharmacies and prescribers that were previously exempt from OARRS reporting requirements, but do dispense or personally furnish gabapentin, must begin reporting such dispensing or personal furnishing to OARRS effective December 1, 2016.

More information on reporting to OARRS can be found in the Ohio PMP Handbook, available under the Pharmacies & Prescribers section on the OARRS website.


DEA Controlled Substance and Legend Drug Diversion; A Law Enforcement and Regulatory Perspective, September, 2015.

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Eric J. Plinke, Dinsmore Law, Health Care Lawyer, Corporate Attorney
Partner

Eric Plinke is a Partner in the Corporate Department and Health Law Practice Group, and he routinely advises corporate and individual clients regarding a wide-range of health care industry legal issues. He has counseled clients in practice formation and acquisition, hospital and joint venture transactions, hospital and medical practice affiliations, contract review and preparation, compliance programs, HIPAA regulations, scope of practice issues, telemedicine and Stark law and Anti-kickback statutes, as well as significant experience counseling in ambulatory surgery centers and other joint...

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Sarah C. Persinger PharmD RPh, managed care lawyer & pharmacy benefits management attorney at Dinsmore Law Firm
Associate

Sarah is a member of our Health Care Practice Group. She holds a Doctor of Pharmacy degree and is a registered pharmacist with extensive pharmacy practice experience and a working knowledge of regulatory affairs. She has managed health system pharmacy compliance with Ohio State Board of Pharmacy, DEA, and CMS regulations, the federal 340B Drug Discount Program, USP 797 and FDA Sterile Compounding requirements, and Joint Commission and HFAP Accreditation standards. 

Sarah has a strong working knowledge of specialty pharmacy, managed care and pharmacy benefits management, HIPAA and healthcare information security, and trade association industry relations, as well as work experience in the retail, hospital, and long-term care pharmacy practice settings. 

Her experience enables her to provide comprehensive and strategic legal and compliance counsel to a wide variety of healthcare clients who operate in a complex and quickly-evolving regulatory environment. Sarah also provides legal services and advice throughout the lifecycle of complex healthcare transactions, and leverages her previous experience practicing pharmacy and managing health system pharmacy compliance, along with relationships she has developed with staff, members, and executive leaders of the Board of Pharmacy, to assist clients with obtaining licensure and navigating the board’s administrative hearing process.

Sarah has served as an adjunct professor at Ohio Northern University and visiting lecturer at Cedarville University, teaching about the legal and regulatory environment of the pharmaceutical industry and the profession of pharmacy.

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Daniel S. Zinsmaster, Dinsmore Law Firm, Health Care Lawyer
Partner

Dan provides trusted counsel and advocacy to health care clients on a variety of matters, such as corporate compliance, provider credentialing, administrative proceedings and litigation.  He also advises clients on practice formation and acquisition, as well as contract review and preparation.  In recent years, Dan has helped health care companies and providers navigate through fraud and abuse investigations, antitrust reviews, and other white collar criminal matters.  He is a frequent author and lecturer on telehealth and telemedicine issues.

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