Ohio: Summary of Important Pharmacy-Related Rules, Regulations, Statutes, and Practices That Apply to Practice of Pharmacy

BOARD OF PHARMACY

• Must meet at least once a year, usually every month for 3 days.

• 9 members:

  • 8 licensed pharmacists.

  • 1 public member who must be at least 60 y/o.

  • All members appointed by governor.

  • Maximum of 2 terms of 4 years each.

• Drug Database (OARRS) (Ohio Automated Rx Reporting System)

  • This is the state’s PMP (Prescription Monitoring Program).

  • This is a mechanism for creating a database of controlled drug prescriptions dispensed and distributions.

  • To oversee abuse of controlled drugs.

  • Under purview of Board.

  • All prescriptions for C-IIs, C-IIIs, C-IVs, C-Vs, carisoprodol, and tramadol products must be reported. (Actually tramadol became a controlled substance in Ohio in August, 2014.)

  • All nonresident pharmacies must report.

  • All in state pharmacies must report.

  • Wholesalers licensed to distribute dangerous drugs must report.

  • All in-state prescribers must report (except veterinarians).

  • Daily reports from pharmacies (drugs dispensed or “zero report”).

  • Wholesalers must report on days 1–15 monthly.

  • See Board’s website for reporting procedures.

CONTROLLED SUBSTANCES

• Manufacturers must obtain license from state Board of Pharmacy (Board). Renewal annual (last day of June each year).

• Pharmacies, distributors, and wholesalers must obtain license from Board. Renewal annual (last day of June each year).

• Licenses can be denied to individuals who have been convicted of a drug-related abuse situation in the last 5 years, or to any individual who is drug dependant.

• Pharmacists may dispense controlled substances pursuant to a valid prescription.

• Prescription orders must be maintained in pharmacy for 3 years.

• C-II prescriptions must be written.

• Emergency oral prescriptions for C-IIs are allowed as long as federal guidelines are maintained. (See the Federal Law Chapter in this publication).

• No refills for C-IIs.

• C-IIIs, C-IVs, and C-Vs—5 refills within 6 months of writing prescription order.

• Authorized prescribers, who have a DEA registration may:

  • Prescribe C-IIs, C-IIIs, C-IVs, and C-Vs.

  • Dispense C-IIs, C-IIIs, C-IVs, and C-Vs directly to patients.

• Clinical nurse specialists, certified nurse midwives, or certified nurse practitioners may prescribe. Nurse practitioners may prescribe C-II opiates, sedatives, hypnotics, and stimulants, but NOT from convenience clinics.

• Licensed physician assistants (PAs) may prescribe (may not dispense) if they have authority from the physician’s collaborating authority agreement. May prescribe C-II opiates, sedatives, hypnotics, and stimulants.

• Prescribers must maintain records of prescriptions and controlled drugs dispensed. Records must be kept for 2 years.

• See statutes for list of examples within each Schedule.

• Board may change a drug’s Schedule; add a drug to a schedule; delete a drug from a Schedule.

• Methadone may be used for narcotic addiction; must be dispensed at a licensed facility.

Partial Dispensing of C-IIs

• For terminal patients or those in LTCFs (long-term care facility):

  • Licensed pharmacist must confirm patient’s status or location.

  • Licensed pharmacist must document and record:

    • Dispensing data.

    • Quantity dispensed.

    • Remaining # authorized for dispensing.

    • Prescription #.

    • Initials of licensed pharmacist.

  • The total amount must be provided (dispensed) at least 60 days from ...