(A) To be considered an approved protocol pursuant to division (B)(3) of section 4729.41 of the Revised Code, the physician-established protocol for the administration of immunizations must include at least the following:
(a) Name and strength;
(b) Precautions and contraindications;
(c) Intended audience or patient population;
(d) Appropriate dosage;
(e) Appropriate administration schedules;
(f) Appropriate routes of administration;
(g) Appropriate 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 physician or the applicable board of health within thirty days after administering medication, 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.
(B) All physician-established protocols must be signed and dated by the physician prior to implementation and maintained by the administering pharmacist. The pharmacist must renew the protocol annually with the physician.
(C) Upon the request of the state board of pharmacy, a pharmacist shall immediately provide the protocols for immunizations pursuant to division (B)(3) of section 4729.41 of the Revised Code and rule 4729-5-38 of the Administrative Code. The state board of pharmacy, after review, may approve the protocol or return it to the pharmacist for revision without approval. If a protocol has been returned for revision without approval, it may not be implemented until the board has approved it. The state board of pharmacy may review the protocols with the state medical board and the board of nursing, as appropriate.
Five Year Review (FYR) Dates: 07/15/2015 and 10/05/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26, 4729.41
Rule Amplifies: 4729.41
Prior Effective Dates: 7/1/01, 10/19/07, 6/21/09, 1/1/11