California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1746.1 - Protocol for Pharmacists Furnishing Self-Administered Hormonal Contraception

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A pharmacist
				furnishing self-administered hormonal contraception pursuant to Section
				4052.3
				of the Business and Professions Code shall follow the protocol specified in
				subdivision (b) of this section.
(b) Protocol for Pharmacists Furnishing
				Self-Administered Hormonal Contraception
(1)
				Authority: Section
				4052.3(a)(1)
				of the California Business and Professions Code authorizes a pharmacist to
				furnish self-administered hormonal contraceptives 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 self-administered hormonal contraception medication
				and to ensure that the patient receives adequate information to successfully
				comply with therapy.
(3) Definition
				of Self-Administered Hormonal Contraception: Hormonal contraception products
				with the following routes of administration are considered self-administered:
(A) Oral;
(B) Transdermal;
(C) Vaginal;
(D) Depot Injection.
(4) Procedure: When a patient requests
				self-administered hormonal contraception, the pharmacist shall complete the
				following steps:
(A) Ask the patient to use
				and complete the self-screening tool;
(B) Review the self-screening answers and
				clarify responses if needed;
(C)
				Measure and record the patient's seated blood pressure if combined hormonal
				contraceptives are requested or recommended;
(D) Before furnishing self-administered
				hormonal contraception, the pharmacist shall ensure that the patient is
				appropriately trained in administration of the requested or recommended
				contraceptive medication.
(E) When
				a self-administered hormonal contraceptive is furnished, the patient shall be
				provided with appropriate counseling and information on the product furnished,
				including:
1. Dosage;
2. Effectiveness;
3. Potential side effects;
4. Safety;
5. The importance of receiving recommended
				preventative health screenings;
6.
				That self-administered hormonal contraception does not protect against sexually
				transmitted infections (STIs).
(5) Self-Screening Tool: The pharmacist shall
				provide the patient with a self-screening tool containing the list of questions
				specified in this protocol. The patient shall complete the self-screening tool,
				and the pharmacist shall use the answers to screen for all Category 3 and 4
				conditions and characteristics for self-administered hormonal contraception
				from the current United States Medical Eligibility Criteria for Contraceptive
				Use (USMEC) developed by the federal Centers for Disease Control and Prevention
				(CDC). The patient shall complete the self-screening tool annually, or whenever
				the patient indicates a major health change.
A copy of the most recently completed self-screening tool
				  shall be securely stored within the originating pharmacy or health care
				  facility for a period of at least three years from the date of dispense.
This self-screening tool should be made available in
				  alternate languages for patients whose primary language is not
				  English.
(6) Fact Sheets:
(A) The pharmacist should provide the patient
				with a copy of a current, consumer-friendly, comprehensive birth control guide
				such as that created by the Food and Drug Administration (FDA). Examples of
				appropriate guides are available on the Board of Pharmacy's website.
(B) The pharmacist shall provide the patient
				with the FDA-required patient product information leaflet included in all
				self-administered hormonal contraception products, as required by Business and
				Professions Code Section
				4052.3(c).
				The pharmacist shall answer any questions the patient may have regarding
				self-administered hormonal contraception.
(C) The pharmacist should provide the patient
				with a copy of an administration-specific factsheet. Examples of appropriate
				factsheets are available on the Board of Pharmacy's
				website.
(7) Follow-Up
				Care: Upon furnishing a self-administered hormonal contraceptive, or if it is
				determined that use of a self-administered hormonal contraceptive is not
				recommended, the pharmacist shall refer the patient for appropriate follow-up
				care to the patient's primary care provider or, if the patient does not have a
				primary care provider, to nearby clinics. A patient who is determined not to be
				an appropriate candidate for self-administered hormonal contraception shall be
				advised of the potential risk and referred to an appropriate health care
				provider for further evaluation.
(8) Notifications: The pharmacist shall
				notify the patient's primary care provider of any drug(s) 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 drug(s)
				or device(s) furnished and advise the patient to consult an appropriate health
				care professional of the patient's choice.
(9) Referrals and Supplies: If
				self-administered hormonal contraception services are not immediately available
				or the pharmacist declines to furnish pursuant to a conscience clause, the
				pharmacist shall refer the patient to another appropriate health care provider.
The pharmacist shall comply with all state mandatory
				  reporting laws, including sexual abuse laws.
(10) Product Selection: The pharmacist, in
				consultation with the patient, may select any hormonal contraceptive listed in
				the current version of the USMEC for individuals identified as Category 1 or 2,
				based on the information reported in the self-screening tool and the blood
				pressure (if recorded by the pharmacist). The USMEC 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.
(11)
				Documentation: Each self-administered hormonal contraceptive 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.
(12) Training:
				Prior to furnishing self-administered hormonal contraception, pharmacists who
				participate in this protocol must have completed a minimum of one hour of a
				board-approved continuing education program specific to self-administered
				hormonal contraception, application of the USMEC, and other CDC guidance on
				contraception. An equivalent, curriculum-based training program completed on or
				after the year 2014 in an accredited California school of pharmacy is also
				sufficient training to participate in this protocol.
(13) Patient Privacy: All pharmacists
				furnishing self-administered hormonal contraception in a pharmacy or health
				care facility shall operate under the pharmacy or facility's policies and
				procedures to ensure that patient confidentiality and privacy are
				maintained.
(14) Self-Screening
				Tool Questions
HORMONAL CONTRACEPTION SELF-SCREENING TOOL
				  QUESTIONS
1
What was the first date of your last menstrual
						  period?
/ /
2a
Have you ever taken birth control pills, or used a birth
						  control patch, ring, or shot/injection? (If no, go to question 3)
Yes []
No []
2b
Did you ever experience a bad reaction to using hormonal
						  birth control?
Yes []
No []
2c
Are you currently using birth control pills, or a birth
						  control patch, ring, or shot/injection?
Yes []
No []
3
Have you ever been told by a medical professional not to
						  take hormones?
Yes []
No []
4
Do you smoke cigarettes?
Yes []
No []
5
Do you think you might be pregnant now?
Yes []
No []
6
Have you given birth within the past 6 weeks?
Yes []
No []
7
Are you currently breastfeeding an infant who is less
						  than 1 month of age?
Yes []
No []
8
Do you have diabetes?
Yes []
No []
9
Do you get migraine headaches, or headaches so bad that
						  you feel sick to your stomach, you lose the ability to see, it makes it hard to
						  be in light, or it involves numbness?
Yes []
No []
10
Do you have high blood pressure, hypertension, or high
						  cholesterol?
Yes []
No []
11
Have you ever had a heart attack or stroke, or been told
						  you had any heart disease?
Yes []
No []
12
Have you ever had a blood clot in your leg or in your
						  lung?
Yes []
No []
13
Have you ever been told by a medical professional that
						  you are at a high risk of developing a blood clot in your leg or in your
						  lung?
Yes []
No []
14
Have you had bariatric surgery or stomach reduction
						  surgery?
Yes []
No []
15
Have you had recent major surgery or are you planning to
						  have surgery in the next 4 weeks?
Yes []
No []
16
Do you have or have you ever had breast cancer?
Yes []
No []
17
Do you have or have you ever had hepatitis, liver
						  disease, liver cancer, or gall bladder disease, or do you have jaundice (yellow
						  skin or eyes)?
Yes []
No []
18
Do you have lupus, rheumatoid arthritis, or any blood
						  disorders?
Yes []
No []
19a
Do you take medication for seizures, tuberculosis (TB),
						  fungal infections, or human immunodeficiency virus (HIV)?
Yes []
No []
19b
If yes, list them here:
20a
Do you have any other medical problems or take regular
						  medication?
Yes []
No []
20b
If yes, list them here: