Rule 4729:1-3-02 | Immunization administration.
(A) A course in the administration of immunizations developed pursuant to division (B)(1) of section 4729.41 of the Revised Code shall meet the following requirements:
(1) The instructor shall be a licensed health care professional and have the appropriate education and experience to teach a course in the administration of immunizations.
(2) The content must meet the standards established for such courses by the centers for disease control and prevention in the public health service of the United States department of health and human services.
(3) The course shall be conducted by an accreditation council for pharmacy education (ACPE) accredited provider.
(4) The course must be a minimum of five hours in length and include the following:
(a) A review of immunology that includes a discussion of the body's immune system reaction to immunizations.
(b) A review of each immunization recommended by the committee on immunization practices of centers for disease control and prevention in the United States department of health and human services (8/5/2022) that includes the following:
(i) Disease states associated with the immunization;
(ii) Type or nature of activity of the immunization;
(iii) Administration schedules;
(iv) Routes of administration;
(v) Injection sites;
(vi) Dosages;
(vii) Monitoring and treatment of the patient for adverse reactions, including the use of diphenhydramine and epinephrine;
(viii) Patient populations;
(ix) Precautions and contraindications; and
(x) Proper storage requirements for the immunization.
(c) A review of sterile technique in injectable dosage preparation and administration.
(d) A minimum of one hour of instruction and physical participation in administration techniques.
(e) A review of the proper disposal procedures for contaminated needles and immunizations.
(f) A review of the proper procedures for accidental needle sticks.
(5) The course must provide a method to evaluate the successful comprehension of the content.
(6) The course must provide a method to demonstrate the participant has successfully completed the course.
(B) Courses on immunization administration may be reviewed by the state board of pharmacy. A training course that fails to comply with the requirements set forth in this rule shall be considered in violation of this rule.
(C) Failure to adhere to the standard of care for administration of an immunization shall be considered a violation of this rule and may subject a pharmacist to discipline in accordance with rule 4729:1-4-01 of the Administrative Code.
(D) Pursuant to section 4729.41 of the Revised Code, a physician-established protocol for the administration of immunizations shall include the following:
(1) For each immunization authorized:
(a) Name and strength;
(b) Precautions and contraindications;
(c) Intended audience or patient population;
(d) Dosage;
(e) Administration schedules;
(f) Routes of administration; and
(g) Injection sites.
(2) The length of time the pharmacist or pharmacy intern under the direct supervision of a pharmacist must observe an individual for adverse effects, which shall be based on appropriate standards of care established by the physician. The location of the observation shall be in the general vicinity of the administering pharmacist or pharmacy intern to allow for on-going evaluation.
(3) A method to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions, and accidental needle sticks.
(4) A method to notify an individual's primary care provider or the applicable board of health within thirty days after administering an immunization, except for influenza immunizations administered to individuals eighteen years of age and older.
(5) The locations that a pharmacist or pharmacy intern under the direct supervision of a pharmacist may engage in the administration of immunizations.
(E) All physician-established protocols must be signed and dated by the physician prior to implementation and maintained by the terminal distributor of dangerous drugs. The protocols shall be renewed by a physician on a biennial basis.
(1) A physician may sign one protocol for multiple locations licensed as terminal distributors of dangerous drugs.
(2) Each location licensed as a terminal distributor of dangerous drugs shall maintain a copy of the protocol on-site for inspection by an agent, inspector or employee of the state board of pharmacy.
(F) Upon the request of the state board of pharmacy, a pharmacist or terminal distributor of dangerous drugs shall immediately provide the protocols for immunizations. The state board of pharmacy, after review, may approve the protocol or return it to the pharmacist or terminal distributor for revision without approval. If a protocol has been returned for revision without approval, it may not be implemented until the board has granted approval.
(G) A pharmacist may administer the following immunizations in accordance with section 4729.41 of the Revised Code and this rule:
(1) In the case of an individual who is seven years of age or older but not more than thirteen years of age, administer to the individual an immunization of any of the following:
(a) Influenza;
(b) COVID-19;
(c) Any other disease, but only pursuant to a prescription.
(2) In the case of an individual who is thirteen years of age or older, administer to the individual and immunization for any disease, including an immunization for influenza or COVID-19.
(H) A pharmacist shall obtain informed consent pursuant to rule 4729:5-5-04 of the Administrative Code to administer an immunization.
(I) Immunization records shall be maintained in accordance with rule 4729:5-5-04 of the Administrative Code.
(J) A pharmacist shall comply with the vaccine information statement requirements of the National Vaccine Childhood Injury Act, 42 USC Section 300aa-26 (12/14/1993).
(K) For each immunization administered to an individual by a pharmacist, other than an immunization for influenza administered to an individual eighteen years of age or older, the pharmacist shall notify the individual's primary care provider or, if the individual has no primary care provider, the board of health of the health district in which the individual resides or the authority having the duties of a board of health for that district under section 3709.05 of the Revised Code. The notice shall be given not later than thirty days after the immunization is administered. Notification shall be conducted using one of the following methods that is capable of confirming delivery of the required notification:
(1) Electronic mail;
(2) Interoperable electronic medical records system;
(3) Facsimile;
(4) Electronic prescribing system;
(5) Electronic pharmacy record system;
(6) Documented verbal communication;
(7) Reporting to the state's immunization registry; or
(8) Any other method of notification that might reasonably be expected to allow for the confirmed transmission of the required notification.
(L) A pharmacist administering immunizations in accordance with this rule shall receive and maintain certification to perform basic life-support procedures by successfully completing a basic life-support training course certified by the American red cross, American heart association or other training course approved by the board. Certification shall be obtained and maintained through courses that are conducted in-person or, at a minimum, offer an in-person or electronic hands-on training component.
(M) A pharmacist who completed a course in the administration of immunizations that complied with the training requirements in effect immediately prior to the adoption of this rule shall be deemed in compliance with division (B)(1) of section 4729.41 of the Revised Code.
(N) A pharmacist shall maintain the following records on file at the location(s) where the pharmacist administers immunizations in accordance with this rule:
(1) Proof of successful completion of a training course specified in paragraph (A) of this rule; and
(2) Proof of maintenance of certification to perform basic life-support procedures in accordance with paragraph (M) of this rule.
(O) As part of engaging in the administration of immunizations or supervising an individual authorized to administer immunizations, a pharmacist may administer epinephrine or diphenhydramine, or both, to individuals in emergency situations resulting from adverse reactions to the immunizations administered by the pharmacist or other authorized individuals under the supervision of the pharmacist.
Last updated June 1, 2023 at 8:29 AM
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