The State of Ohio Board of Pharmacy (SOBP) is proposing to expand monitoring and tracking of the more than 500 wholesale pharmaceutical distributors doing business in the state – these are the companies that buy drugs from manufactures and resell them to some 20,000 Ohio pharmacies, doctors, clinics, and hospitals that, in turn, sell and dispense and administer directly to patients.
Wholesalers often have substantial information about the overall flow of drugs, and large spikes in their shipments hint at problematic activity that could be illegal. The intent of the proposed regulations is to give law enforcement and regulatory officials a better, more consistent, and accurate understanding of these kinds of shipments and give them tools to ensure compliance.
- Suspicious Orders Reporting – More Uniform, Detailed, and Timely: Orders that wholesalers believe to be suspicious must be reported to the federal Drug Enforcement Administration (DEA). Instead of waiting on the federal government to act, Ohio is creating new requirements with detailed definitions and uniform, electronic reporting formats, to make sure officials are alerted to emerging problems before they get out of control.
- Due Diligence – Requiring Wholesalers to Better Research Their Customers: Wholesalers will be required to obtain more detailed, precise information on those to whom they sell opiates and other controlled substances, including conducting site-visits and reviewing drug utilization reports so that they have deeper data sets to use when evaluating if an order is suspicious or not.
- Shipping Controls – Holding Suspicious Orders until All Questions are Answered: No wholesaler will be permitted to ship any order that is deemed to be suspicious under the new requirements. Wholesalers will be responsible for reviewing all suspicious orders to determine if orders are reasonable prior to sale. Orders that are not deemed reasonable based upon the required review criteria are prohibited from being sold.
- Developing Additional Enforcement Penalties for Violations: New enforcement penalties will be created to address violations for failing to comply with these new rules.
In order to effectively use its current and new data in enforcement activities, the SOBP is developing data analytics tools to monitor wholesale drug sales with the help of experts in the field. These new capabilities will be an important compliment to existing and new regulatory authority in order to help safeguard Ohioans from the opiate epidemic.
View the Business Impact Analysis and rules.
Comments on the proposed rules will be accepted until close of business on Wednesday, March 21. Please send all comments to Ali.Simon@pharmacy.ohio.gov and CSIPublicComments@governor.ohio.gov.