Cal. Code Regs. Tit. 16, § 1746.3 - Protocol for Pharmacists Furnishing Opioid Antagonists

A pharmacist furnishing an opioid antagonist for overdose reversal pursuant to section 4052.01 of the Business and Professions Code shall satisfy the requirements of this section.

(a) As used in this section:
(1) "Opioid" means naturally derived opiates as well as synthetic and semi-synthetic opioids.
(2) "Recipient" means the person to whom an opioid antagonist is furnished.
(b) Training. Prior to furnishing an opioid antagonist, pharmacists who use this protocol must have successfully completed a minimum of one hour of an approved continuing education program or equivalent curriculum-based training program, completed in a Board recognized school of pharmacy, specific to the use of opioid antagonists for overdose reversal.
(c) Protocol for Pharmacists Furnishing Opioid Antagonists. Before providing an opioid antagonist, the pharmacist shall:
(1) Provide the recipient training in opioid overdose prevention, recognition, response, and administration of the opioid antagonist furnished.
(2) When an opioid antagonist is furnished:
(A) The pharmacist shall provide the recipient with appropriate counseling and information on the product furnished, including dosing, effectiveness, adverse effects, storage conditions, shelf-life, and safety. The recipient is not permitted to waive the required consultation.
(B) The pharmacist shall provide the recipient with any informational resources on hand and/or referrals to appropriate resources if the recipient indicates interest in addiction treatment, recovery services, or medication disposal resources at this time.
(C) The pharmacist shall answer any questions the recipient may have regarding the opioid antagonist furnished.
(3) Product Selection: A pharmacist shall advise the recipient on how to choose the route of administration based on the formulation available, how well it can likely be administered, the setting, and local context. A pharmacist may also recommend optional items when appropriate, including alcohol pads, rescue breathing masks, and rubber gloves.
(4) Labeling: A pharmacist shall label the opioid antagonist consistent with law and regulations.
(5) Notifications:

At the request of the patient, a pharmacist shall notify the identified primary care provider, if any, of the product furnished or enter appropriate information in a shared patient record system as permitted by the primary care provider. If the patient does not have or does not identify a primary care provider, the pharmacist shall provide the patient a written record of the drug furnished along with a recommendation for the patient to consult with an appropriate health care provider of the patient's choice.

Notes

Cal. Code Regs. Tit. 16, § 1746.3

Note: Authority cited: Sections 4005 and 4052.01, Business and Professions Code. Reference: Section 4052.01, Business and Professions Code.

Note: Authority cited: Section 4052.01, Business and Professions Code. Reference: Section 4052.01, Business and Professions Code.

1. New section filed 4-10-2015 as a deemed emergency exempt from OAL review pursuant to Business and Professions Code section 4052.01(e); operative 4-10-2015 (Register 2015, No. 15). A Certificate of Compliance must be transmitted to OAL by 10-7-2015, pursuant to Business and Professions Code section 4052.01(e), or emergency language will be repealed by operation of law on the following day.
2. New section refiled 9-29-2015 as a deemed emergency exempt from OAL review pursuant to Business and Professions Code section 4052.01(e); operative 10-8-2015 pursuant to Government Code section 11346.1(d) (Register 2015, No. 40). A Certificate of Compliance must be transmitted to OAL by 4-5-2016, pursuant to Business and Professions Code section 4052.01(e), or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 9-29-2015 order, including further amendment of section, transmitted to OAL 12-15-2015 and filed 1-27-2016; amendments effective 1/27/2016 pursuant to Government Code section 11343.4(b)(3) (Register 2016, No. 5).
4. Amendment of subsection (c)(6) filed 1-27-2020; operative 4/1/2020 (Register 2020, No. 5).
5. Amendment of section heading, section and NOTE filed 9-17-2024; operative 9/17/2024 pursuant to Government Code section 11343.4(b)(3) (Register 2024, No. 38).

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