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The Ohio Board of Pharmacy (“BOP”) recently posted notices of Ohio Administrative Code rule changes related to record keeping and the sale and distribution of certain ephedrine-containing products.

BOP Amended Rules:

The following rules were amended by the BOP:

• Outpatient Pharmacies Definitions | Rule 4729:5-5-01
  • This amended rule saw no substantive changes to the previous definitions.
• Record Keeping | Rule 4729:5-5-04
  • This amended rule now requires pharmacies utilizing a computerized system to dispense dangerous drugs to electronically document positive identification. If not or they have a waiver, they shall maintain hard copy identification.
  • This amended rule expands the requirements for what to do if a pharmacy utilizing a computerized system experiences a power outage to include the utilization of hardcopy records and manual signatures to capture positive identification.
  • This amended rule now contains carveouts for pharmacies utilizing computerized systems to dispense dangerous drugs. A pharmacy can obtain a waiver of the requirement for electronic positive identification:
    • If a request for waiver reflects public interest;
    • With approval remaining in effect until a new computer system for dispensing dangerous drugs is obtained or there’s board determination;
    • Where any denial of waiver will receive a written explanation; and
    • And when determining waiver approval, the board considers at least: the cost viability of the identification system, the average amount of drugs, the results from a 4729:5-3-03 inspection, and a review of past disciplinary actions.
  • This amended rule now allows pharmacies utilizing computerized systems to dispense dangerous drugs to use hardcopy records and manual signatures for compounding and dispensing compounded drugs and ancillary services under 4729:5-5-02.1 of the OAC.
• Licensure | Rule 4729:5-14-02
  • This amended rule now requires that EMS organizations that possess dangerous drugs be headquartered at the location where records and drugs for distribution to satellite locations are maintained.
• Record Keeping | Rule 4729:5-14-04
  • This amended rule now requires records of receipt to include the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt. An invoice from a drug distributor licensed in accordance with OAC 4729:6 containing the required information can be used to meet this requirement.
  • This amended rule now requires records of disposal of dangerous drugs from inventory, except controlled substances, to include the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and the positive identification of the EMS personnel that performed the disposal.
  • Under this amended rule, records for the disposal of controlled substance drugs shall include the positive identification of the two EMS personnel who disposed of the drugs in accordance with OAC 4729:5-14-03.
  • Under this amended rule, an EMS organization conducting an annual inventory of all controlled substances in accordance with OAC 4729:5-3-07 may now include an EMS utilizing a 1:1 exchange system with a hospital acting as its responsible DEA registrant.
  • This amended rule now requires records of transfer or sale conducted in accordance with OAC 4729:5-3-09 to include the name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

BOP Rescinded and/or New Rules:

BOP new rule for Protocols and Verbal Orders for Drug Administration | 4729:5-14-05

• Under this new rule, an EMS professional certified and acting within the scope of their can directly administer a dangerous drug, including controlled substances, outside the physical presence of a medical director or authorizing prescriber in accordance with:
  • A protocol or standing order issued and adopted by one or more medical directors of the EMS organization; or
  • A verbal order that is:
    • Issued in accordance with a policy of the organization; and
    • Provided by a medical director or an authorizing prescriber in response to a request by the EMS professional with respect to a specific patient in any of the following circumstances:
      • In the case of a mass casualty incident; or
      • To ensure the proper care and treatment of a specific patient.
    • An EMS organization may administer an initial dose of buprenorphine, or another medication for opioid use disorder approved by the board, to a patient in accordance with a protocol approved by the organization's medical director. Such a protocol shall ensure that the EMS organization is able to provide a direct linkage to a program or prescriber who will continue the patient's therapy.
    • A controlled substance administered in accordance with paragraph (C) of this rule is exempted from reporting to the drug database established in ORC 4729.75.

BOP rescinded OAC rules 4729:9-3-02, 4729:9-3-03, 4729:9-3-04, 4729:9-3-05, 4729:9-3-06, 4729:9-3-07, 4729:9-3-08, replacing them with new OAC rule 4729:9-3-01 (sale or distribution of ephedrine-containing products), which does all of the following:

• This new rule excepts the following products containing ephedrine, its salts, its isomers, or the salts of its isomers from classification as a schedule V controlled substance:
  • All products that contain the isomer known as pseudoephedrine or its salts, but do not also contain any of the isomer known as ephedrine or its salts;
  • "Breathe Easy" herb tea;
  • "Bronkaid Dual Action" caplets;
  • "Hydrosal" hemorrhoidal ointment;
  • "Primatene Dual Action Formula" tablets;
  • "Primatene" tablets;
  • "SnoreStop" tablets;
  • Drug products listed in division (K)(1) of ORC 3719.44.
• Now, under this new rule, except for the excepted products listed above or if the ephedrine product is a food product or dietary supplement excepted under (K)(1) of ORC 3719.44, any person who manufactures, sells, dispenses, imports or exports products containing ephedrine must:
  • Hold a category III license in accordance with ORC 4729.52 or ORC 4729.54;
  • Comply with all applicable security and storage requirements in accordance with ORC Chapters 3719 and 4729 and OAC Chapter 4729;
  • Conduct an inventory of all products containing ephedrine under OAC 4729:5-3-07 or 4729:6-3-06; and
  • Maintain all records required in accordance with ORC Chapters 3719 and 4729 and OAC Chapter 4729.
• This new rule provides petition guidelines for any person engaged in the legitimate manufacture or wholesale sale of a drug product containing ephedrine who would like to request it be excepted from schedule V classification.
• This new rule provides the following factors the board will consider when determining whether an over-the-counter drug containing a schedule V substance is manufactured and distributed for legitimate use:
  • Size and manner of packaging
  • Distribution, advertising, and promotion of the product
  • Labeling and naming
  • Potential, duration, scope, and significance of inappropriate use/abuse
  • Other relevant factors

BOP also rescinded OAC rule 4729:5-14-03 and replaced it with OAC rule 4729:5-14-03 (security and control of dangerous drugs), which does the following:

• This new rule holds the person named on the terminal distributor of dangerous drugs license responsible for the security and control of dangerous drugs. They may delegate daily tasks to EMS organization personnel with appropriate certification/licensure and must comply with the requirements set forth in OAC 4729:5-2-01.
• This new rule requires a licensed EMS organization to provide effective control and procedures to deter and detect theft and diversion of dangerous drugs.
• Under this new rule, all dangerous drugs maintained in an ambulance or EMS vehicle shall be secured in a tamper-evident manner, if not physically secured within the ambulance or other vehicle, to deter and detect unauthorized access. The excepted products are:
  • Solutions labeled for irrigation use;
  • Dextrose solutions;
  • Saline solutions;
  • Lactated ringers;
  • Sterile water; and
  • Naloxone hydrochloride or other overdose reversal drugs under ORC 4729-8-01.
• This new rule provides that all dangerous drugs maintained at the licensed terminal distributor of dangerous drugs location be physically secured, and except as provided in paragraph (E) of this rule, only the following may access any controlled substances maintained by the EMS organization:
  • A paramedic or emergency medical technician-paramedic certified in accordance with ORC 4765
  • An advanced emergency medical technician or emergency medical technician-intermediate certified in accordance with ORC 4765; and
  • Licensed prescribers, nurses, or pharmacists who are employed or affiliated with the EMS organization.
• Under this new rule, other EMS organization personnel may only have access to controlled substances under the direct supervision of those listed above.
• This new rule provides for the proper storage condition of all areas where dangerous drugs and devices are stored. Refrigerators and freezers used for storage shall comply with the following:
  • Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:
    • Temperature logs with, at a minimum, daily observations; or
    • A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.
  • The terminal distributor shall develop and implement policies and procedures to respond to any out-of-range individual temperature readings or excursions to ensure the integrity of stored drugs.
  • The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.
• This new rule provides storage and distribution guidelines for ensuring a dangerous drug that was stored improperly, expired, damaged tampered, or otherwise adulterated is not administered to patients.
• This new rule also provides disposal guidelines for non-controlled dangerous drugs.
• Under this new rule, controlled substances must be returned to the institutional pharmacy or facility that is owned or operated by a hospital acting as the EMS organization’s responsible DEA registrant unless the EMS organization is itself DEA registered.
• This new rule provides disposal of controlled substances are controlled by OAC 4729:5-03-01 by individuals listed in this rule except if there is an unused portion of a controlled substance resulting from administration to a patient from a licensee’s stock or emergency supply. This unused portion may be destroyed using an on-site method that renders the drug unavailable and unusable and must be conducted by two licensed/certified healthcare personnel, one of whom meets the qualifications in this rule.
• Under this rule, if there is a recall of oxygen by the manufacturer, all portable oxygen tanks affected by the recall shall be handled in accordance with the manufacturer’s recall instructions.

• If you would like more information on any of these rules changes, please contact Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com.