Ohio Board of Pharmacy releases proposed rules on pain management and office-based opioid treatment clinics

The State of Ohio Board of Pharmacy recently issued a number of proposed rule sets for public comment. Notably included were new rules on the operation of office-based opioid treatment (OBOT) clinics and rules governing the operation of pain management clinics. Both groups of rules amplify and expand on existing Ohio law. The proposed rules introduce numerous new operational and treatment-specific definitions, reorganize the contents of the existing rules, and impose new record-keeping and storage requirements on both types of treatment facilities. 

The proposed record keeping rules require the “positive identification” of facility personnel involved with prescribing, administering and disposing of controlled substances. Use of positive identification must be documented and maintained in the clinic’s records. The proposed rules have specific requirements on the physical and electronic storage of records and the conversion of paper records to an electronic format. 

In response to the increase in thefts involving controlled substances, prescription pads and similar items, the proposed rules impose new physical security rules for drugs and, particularly, DEA order forms and prescription blanks. The rules specify which individuals may have access to these materials and the supervision required for access. 

Owners and operators of OBOT clinics and pain management clinics are encouraged to review the proposed rules and their impact on pharmacy and clinic operations and submit comments to the Board of Pharmacy. Comments on the proposed rules will be accepted until March 26, 2018.