Cal. Code Regs. Tit. 16, § 1746.2 - Protocol for Pharmacists Furnishing Nicotine Replacement Products
(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
Click here to view image
Click here to view image
Notes
Note: Authority cited: Sections 4005, 4052(a)(10) and 4052.9, Business and Professions Code. Reference: Sections 4052(a)(10) and 4052.9, Business and Professions Code.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.