California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1746.2 - Protocol for Pharmacists Furnishing Nicotine Replacement Products

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A pharmacist
				furnishing nicotine replacement products pursuant to Section
				4052.9
				of the Business and Professions Code shall follow the protocol specified in
				subdivision (b) of this section.
(b) Protocol for Pharmacists Furnishing
				Nicotine Replacement Products
(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:
(A) Review the
				patient's current tobacco use and past quit attempts.
(B) Ask the patient the following screening
				questions:
(i) Are you pregnant or plan to
				become pregnant? (If yes do not furnish and refer to an appropriate health care
				provider)
(ii) Have you had a heart
				attack within the last 2 weeks? (If yes, furnish with caution and refer to an
				appropriate health care provider)
(iii) Do you have any history of heart
				palpitations, irregular heartbeats, or have you been diagnosed with a serious
				arrhythmia? (If yes, furnish with caution and refer to an appropriate health
				care provider)
(iv) Do you
				currently experience frequent chest pain or have you been diagnosed with
				unstable angina? (If yes, furnish with caution and refer to an appropriate
				health care provider)
(v) Do you
				have any history of allergic rhinitis (e.g., nasal allergies)? (If yes, avoid
				nasal spray)
(vi) Have you been
				diagnosed with temporal mandibular joint (TMJ) dysfunction? (If yes, avoid
				nicotine gum)
These screening questions shall be made available in
				  alternate languages for patients whose primary language is not
				  English.
(C) When
				a nicotine replacement product is furnished:
(i) The pharmacist shall review the
				instructions for use with every patient using a nicotine replacement
				product.
(ii) Pharmacists should
				recommend the patient seek additional assistance for behavior change, including
				but not limited to the California Smokers' Helpline (1-800-NO-BUTTS), web-based
				programs (e.g., http://smokefree.gov), apps, and local cessation
				programs.
(D) The
				pharmacist shall answer any questions the patient may have regarding smoking
				cessation therapy and/or nicotine replacement products.
(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
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