(1) Authority: section 4052.9(a) of the California Business and Professions Code authorizes a pharmacist to furnish nicotine replacement products approved by the federal Food and Drug Administration for use by prescription only in accordance with a protocol approved by the California State Board of Pharmacy and the Medical Board of California. Use of the protocol in this section satisfies that requirement.

(2) Purpose: To provide timely access to nicotine replacement products and to ensure that the patient receives information to appropriately initiate smoking cessation medication therapy.

(3) Explanation of Products Covered: Prescription nicotine replacement products approved by the federal Food and Drug Administration and provided by a pharmacist for smoking cessation are covered under this protocol. Pharmacists may continue to provide over-the-counter smoking cessation products without use of this protocol.

(4) Procedure: When a patient requests nicotine replacement therapy or other smoking cessation medication, or when a pharmacist in his or her professional judgment decides to initiate smoking cessation treatment and counseling, the pharmacist shall complete the following steps:

(5) Product Selection: The pharmacist, in consultation with the patient, may select any nicotine replacement product (alone or in combination) from the list of therapies specified in this protocol in the Table “Nicotine Replacement Therapy Medications for Smoking Cessation.” This list shall be kept current and maintained in the pharmacy or health care facility, and shall be available on the Board of Pharmacy's website.

Generic equivalent products may be furnished.

(6) Notifications: The pharmacist shall notify the patient's primary care provider of any prescription drug(s) and/or device(s) furnished to the patient, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, or is unable to provide contact information for his or her primary care provider, the pharmacist shall provide the patient with a written record of the prescription drug(s) and/or device(s) furnished and advise the patient to consult an appropriate health care provider of the patient's choice.

(7) Documentation: Each nicotine replacement product provided for smoking cessation and furnished by a pharmacist pursuant to this protocol shall be documented in a patient medication record and securely stored within the originating pharmacy or health care facility for a period of at least three years from the date of dispense. A patient medication record shall be maintained in an automated data processing or manual record mode such that the required information under title 16, sections 1717 and 1707.1 of the California Code of Regulations is readily retrievable during the pharmacy or facility's normal operating hours.

(8) Training: Prior to furnishing prescription nicotine replacement products, pharmacists who participate in this protocol must have completed a minimum of two hours of an approved continuing education program specific to smoking cessation therapy and nicotine replacement therapy, or an equivalent curriculum-based training program completed within the last two years in an accredited California school of pharmacy.

Additionally, pharmacists who participate in this protocol must complete ongoing continuing education focused on smoking cessation therapy from an approved provider once every two years.

(9) Patient Privacy: All pharmacists furnishing nicotine replacement products in a pharmacy or health care facility shall operate under the pharmacy's or facility's policies and procedures to ensure that patient confidentiality and privacy are maintained.

(10) Nicotine Replacement Therapy Medications for Smoking Cessation