4729-5-39 Dispensing of naloxone.

(A) A pharmacist or pharmacy intern under the direct supervision of a pharmacist may dispense naloxone without a prescription to either of the following in accordance with an approved protocol specified in paragraph (B) of this rule:

(1) An individual who there is reason to believe is experiencing or at risk of experiencing an opioid-related overdose;

(2) A family member, friend, or other person in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid-related overdose .

(B) To be considered an approved protocol pursuant to section 4729.44 of the Revised Code, the physician-established protocol for the dispensing of naloxone by a pharmacist or pharmacy intern under the direct supervision of a pharmacist shall include, but is not limited to, the following:

(1) A description of the clinical pharmacology of naloxone.

(2) Indications for use of naloxone as rescue therapy, including criteria for identifying persons eligible to receive naloxone under the protocol.

(3) Precautions and contraindications concerning dispensing naloxone.

(4) Assessment and follow-up actions by the pharmacist or pharmacy intern.

(5) Naloxone products authorized to be dispensed, including all of the following information:

(a) Name of product;

(b) Dose;

(c) Route of administration and required delivery device; and

(d) Directions for use.

(6) Any patient instructions in addition to the counseling specified in paragraphs (C) and (D) of this rule.

(C) A pharmacist or pharmacy intern under the direct supervision of a pharmacist who dispenses naloxone pursuant to this rule shall instruct the individual to whom naloxone is dispensed verbally or in writing to summon emergency services as soon as practicable either before or after administering naloxone.

(D) A pharmacist , pharmacy intern under the direct supervision of a pharmacist , or a pharmacist's designee that is appropriately trained shall personally provide in-person training and written educational materials to the individual to whom naloxone is dispensed, appropriate to the dosage form of naloxone dispensed, including, but not limited to, all of the following:

(1) Risk factors of opioid overdose;

(2) Strategies to prevent opioid overdose;

(3) Signs of opioid overdose;

(4) Steps in responding to an overdose;

(5) Information on naloxone;

(6) Procedures for administering naloxone;

(7) Proper storage and expiration of naloxone product dispensed; and

(8) Information on where to obtain a referral for substance abuse treatment.

(E) If training conducted pursuant to paragraph (D) of this rule is offered by a pharmacist's designee, the pharmacist shall not be required to counsel a patient or caregiver pursuant to rule 4729-5-22 of the Administrative Code if the patient or caregiver refuses the offer of counseling or does not respond to the written offer to counsel. In this situation, when counseling is refused, the pharmacist or their designee shall ensure that such refusal is documented in the presence of the patient or the patient's caregiver.

(F) The pharmacy's responsible person shall ensure that all pharmacists and pharmacy interns that dispense naloxone pursuant to this rule are appropriately trained on the use of naloxone and can meet the training requirements listed in paragraphs (C) and (D) of this rule.

(G) The terminal distributor and the pharmacy's responsible person shall ensure that all pharmacist designees are appropriately trained on the use of naloxone and can meet the training requirements listed in paragraph (D) of this rule.

(H) A pharmacist may document the dispensing of naloxone by the pharmacist or a pharmacy intern supervised by the pharmacist on a prescription form. The form may be assigned a number for record-keeping purposes.

(I) Paragraph (L) of this rule does not apply to institutional pharmacies that provide naloxone to inpatients or patients upon discharge.

(J) A licensed terminal distributor of dangerous drugs may make occasional sales of naloxone at wholesale pursuant to rule 4729-9-10 of the Administrative Code to a state or local law enforcement agency if the terminal distributor is any of the following:

(1) A pharmacy;

(2) A board of health of a city or general health district;

(3) An authority having the duties of a board of health under section 3709.05 of the Revised Code; or

(4) A health department operated by such a board or authority.

(K) All physician-established protocols shall be signed and dated by the physician prior to implementation and maintained by the pharmacy's responsible person. The protocol shall be made readily available to the dispensing pharmacist or pharmacy intern under the direct supervision of a pharmacist.

(L) Any pharmacy that dispenses naloxone pursuant to this rule, shall notify the board, in a manner prescribed by the board, within thirty days of establishing an approved protocol. A pharmacy that no longer dispenses naloxone pursuant to this rule shall notify the board, in a manner prescribed by the board, within thirty days of discontinuation.

Cite as Ohio Admin. Code 4729-5-39

Effective: 6/6/2016
Five Year Review (FYR) Dates: 10/16/2020
Promulgated Under: 119.03
Statutory Authority: 4729.44, 4729.26
Rule Amplifies: 4729.44
Prior Effective Dates: 7/17/2015 (Emer.), 10/16/2015