Ohio's Recent Rule Changes to Administration of Immunizations, Outpatient Pharmacy Delivery, and Mobile Response Services
Client AlertThe Ohio Board of Pharmacy (“BOP”) and Ohio Department of Mental Health and Addiction Services (“OMHAS”) recently posted notices of Ohio Administrative Code rule changes related to the administration of immunizations (BOP), outpatient pharmacy delivery services (BOP), and mobile response and stabilization services (OMHAS).
BOP Rules
The hearing for the rules summarized below will be held on February 18, 2025.
Immunization Administration | Rule 4729:1-3-02
- Under the amended rule, “physician” was replaced with “prescriber” throughout. The rule defines prescriber to mean a physician or a certified nurse-midwife, clinical nurse specialist, or certified nurse practitioner.
- The rule adds new language permitting a pharmacist to administer to someone 5 years of age or older an immunization for any disease, including influenza or COVID-19. Previously, the rule permitted a pharmacist to administer immunizations for influenza, COVID-19, or any other disease (pursuant to a prescription) to anyone between 7 and 13 years of age. For individuals 13 years of age or older, a pharmacy can administer an immunization for any disease.
- Additionally, the rule adds new language requiring the pharmacist, when administering immunizations to minors, to inform the minor’s parent or legal guardian of the importance of well child visits with a pediatrician or other primary care provider.
Immunization Administration by Pharmacy Interns | Rule 4729:2-3-03
- This amended rule adds new language requiring a pharmacist intern, when administering immunizations to minors, to inform the minor’s parent or legal guardian of the importance of well child visits with a pediatrician or other primary care provider.
Immunization Administration | Rule 4729:3-3-06
- Under the amended rule, a certified/registered pharmacy technician who is working under the direct supervision of a pharmacist may administer to someone 5 years of age or older an immunization for any disease, including an immunization for influenza or COVID-19. Previously, the rule permitted a pharmacist technician to administer immunizations for influenza, COVID-19, or any other disease (pursuant to a prescription) to an individual between 7 and 13 years of age.
- Under the amended rule, for each immunization administered by a certified/registered pharmacy technician to someone who is younger than 18 years of age, the pharmacy technician must inform the minor's parent or legal guardian of the importance of well child visits with a pediatrician or other primary care provider.
Outpatient Pharmacy Delivery Services | Rule 4729:5-5-26
- Under the new rule, an outpatient pharmacy licensed as a terminal distributor of dangerous drugs (TDDD) that delivers dispensed drugs and devices in this state must comply with the following provisions, among others. The pharmacy must:
- Contact the patient or patient's caregiver for consent prior to any billing or delivery of a drug or device, except if the patient has provided general consent for delivery services. Consent may be provided in writing, electronically, or verbally.
- In accordance with the patient's communication preferences, make available to the patient or patients’ caregiver the date shipped, method of delivery (e.g., mail, courier, drone, etc.), and expected arrival.
- Take all appropriate measures to ensure temperature-sensitive drugs will be maintained within the temperature ranges recommended by the manufacturer until the delivery has been completed.
- The pharmacy must also comply with the record-keeping requirements imposed by the Board for all delivered drugs and devices. Records must include:
- Patient name;
- Patient address;
- Prescription number of drug or device being delivered;
- Name (brand name or generic) and dosage of each drug or device being delivered; and
- Name of the pharmacy delivery agent who performed, or attempted to perform, the delivery.
- Additionally, except for deliveries performed by the USPS or common carrier, an outpatient pharmacy that utilizes a third-party to deliver drugs and devices must enter into a contract with the third-party to ensure (1) that the required records are provided to the contracting pharmacy, and (2) that the third-party entity agrees to cooperate with all investigations regarding the theft or significant loss of drugs and devices.
OMHAS Rule
The hearing for this rule will be held on February 13, 2025.
Mobile Response and Stabilization Service | Rule 5122-29-14
- This new rule defines mobile response and stabilization services (MRSS), which are structured intervention and support services designed to promptly address an emotional or behavioral crisis situation with a young person. MRSS provide immediate de-escalation, rapid community-based assessment, and stabilization services to help the young person remain with their family in their home and/or community.
- MRSS consist of three phases: screening/triage, mobile response, and stabilization. The initial response by an MRSS provider is expected to occur within 60 minutes from the time the initial call ends, followed by 72 hours of de-escalation services.
- To be certified for MRSS, a community behavioral health services provider must be certified in one of the following services: (1) general services; (2) SUD case management services; (3) peer recovery services; (4) community psychiatric supportive treatment; or (5) therapeutic behavioral services and psychosocial rehabilitation.
If you would like more information on any of these rules changes, please contact Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Associate Jordan Burdick at jaburdick@bmdllc.com.