Dispensing and administration of emergency opioid antagonist without a

Transcription

1 Dispensing and administration of emergency opioid antagonist without a prescription. (a) A pharmacist may dispense an FDA-approved emergency opioid antagonist and the necessary medical supplies needed to administer an emergency opioid antagonist to a patient, bystander, first responder agency or school nurse without a prescription in accordance with written protocol approved by the board. (b) Any pharmacist dispensing an emergency opioid antagonist pursuant to this regulation must maintain a current, signed copy of the written protocol approved by the board. (c) The board-established protocol for the dispensing of an emergency opioid antagonist by a pharmacist shall include, but is not limited to, the following: (1) A description of the clinical pharmacology of emergency opioid antagonists; (2) Indications for use of emergency opioid antagonists as rescue therapy, including criteria for identifying persons eligible to receive an emergency opioid antagonist under the protocol; (3) Precautions and contraindications concerning dispensing an emergency opioid antagonist; (4) Assessment and follow-up actions by the pharmacist; (5) Procedures for documenting dispensation of an emergency opioid antagonist; and (6) Any emergency opioid antagonists authorized to be dispensed, including the following information: (A) Name of product; (B) Dose; (C) Route of administration and required delivery device; and

2 Page 2 (D) Directions for use. (d) Any pharmacist who dispenses an emergency opioid antagonist pursuant to this regulation shall instruct the individual to whom an emergency opioid antagonist is dispensed to summon emergency medical services as soon as practicable either before or after administering the emergency opioid antagonist. (e) Each pharmacist dispensing an emergency opioid antagonist pursuant to this regulation shall provide in-person counseling, training and written educational materials to the individual to whom the emergency opioid antagonist is dispensed, appropriate to the dosage form dispensed, including 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 emergency opioid antagonists; (6) Procedures for administering an emergency opioid antagonist; (7) Proper storage, disposal and expiration of the emergency opioid antagonist dispensed; (8) Information on where to obtain a referral for substance use disorder treatment; and (9) For any first responder agency or school nurse, the requirements to keep inventory records and report any administration of the emergency opioid antagonist to the appropriate healthcare provider pursuant to this regulation. (f) If a patient or bystander refuses counseling, the pharmacist shall not dispense the emergency opioid antagonist.

3 Page 3 (g) Each pharmacist dispensing an emergency opioid antagonist to a first responder agency or school nurse pursuant to this regulation shall ensure that such first responder agency or school nurse is provided with written education and training materials that meet the requirements listed in paragraphs (d) and (e). (h) Each emergency opioid antagonist dispensed by a pharmacist shall be labeled in accordance with the pharmacy practice act and any rules and regulations promulgated thereunder. (i) Each pharmacist shall document the dispensation of any emergency opioid antagonist pursuant to this regulation in a written or electronic prescription record for the individual or first responder agency to whom the emergency opioid antagonist is dispensed. The pharmacist shall record themselves or the protocol healthcare practitioner as the prescriber. The prescription record shall be maintained such that the required information is readily retrievable during the pharmacy s normal operating hours, and shall be securely stored within the pharmacy for a period of five years. (j) Any of the following individuals or facilities licensed or registered with the board of pharmacy or the board of healing arts may make sales of emergency opioid antagonists at wholesale to a first responder agency or school nurse: (A) A pharmacist; (B) a physician medical director; or (C) a pharmacy.

4 Page 4 (k) All board-established protocols shall be signed and dated by the physician and the pharmacist prior to implementation, and shall be maintained by the pharmacist. The protocol shall be made readily available to the pharmacist-in-charge, the board, and the board s designee. (l) Each pharmacist that dispenses emergency opioid antagonists pursuant to this regulation, shall notify the board, in a manner prescribed by the board, within five days of establishing an approved protocol. Any pharmacist that no longer dispenses emergency opioid antagonists pursuant to the protocol shall notify the board, in a manner prescribed by the board, within thirty days of discontinuation. (m) Each first responder, scientist and technician operating under a first responder agency administering an emergency opioid antagonist shall: (1) Summon emergency medical services as soon as practicable either before or after administering the emergency opioid antagonist; (2) immediately provide information related to the administration to any responding emergency medical services personnel, any emergency room personnel, or any treating physician; and (3) notify the physician medical director for the first responder agency within 24 hours of administration. (n) Each first responder agency that is dispensed an emergency opioid antagonist shall ensure that any first responder, scientist or technician operating under such first responder agency is appropriately trained on the use of emergency opioid antagonists, and can meet the training requirements listed in paragraphs (d) and (e), and the board-established protocol.

5 Page 5 (Authorized by 2017 HB 2217, sec. 1; implementing 2017 HB 2217, sec. 1; effective April 16, 2004; amended April 18, 2008; effective T-.)