Cal. Code Regs. tit. 16 § 1746

Current through Register 2024 Notice Reg. No. 45, November 8, 2024

Section 1746 - Emergency Contraception

(a) A pharmacist furnishing emergency contraception pursuant to Section 4052.3(a)(2) of the Business and Professions Code shall follow the protocol specified in subdivision (b) of this section.

(b) Protocol for Pharmacists Furnishing Emergency Contraception (EC).

(1) Authority: Section 4052.3(a)(2) of the California Business and Professions Code authorizes a pharmacist to furnish emergency contraception pursuant to a protocol approved by the California State Board of Pharmacy and the Medical Board of California. Use of the protocol specified in this section satisfies that requirement.

(2) Purpose: To provide timely access to emergency contraceptive medication and ensure that the patient receives adequate information to successfully complete therapy.

(3) Procedure: When a patient requests emergency contraception, the pharmacist will ask and communicate the following:

* Are you allergic to any medications?

* Timing is an essential element of the product's effectiveness. EC should be taken as soon as possible after unprotected intercourse. Treatment may be initiated up to five days (120 hours) after unprotected intercourse.

EC use will not interfere with an established or implanted pregnancy.

If more than 72 hours have elapsed since unprotected intercourse, the use of ella^TM (ulipristal) may be more effective than levonorgestrel. For other options for EC, consult with your health care provider.

Please follow up with your health care provider after the use of EC.

(4) The pharmacist shall provide a fact sheet and review any questions the patient may have regarding EC. In addition, the pharmacist shall collect the information required for a patient medication record required by Section of Title 161707.1 of Title 16 of the California Code of Regulations.

Fact Sheet: The pharmacist will provide the patient with a copy of the current EC fact sheet approved by the Board of Pharmacy as required by Business and Professions Code Section 4052.3(e).

(5) Referrals and Supplies: If emergency contraception services are not immediately available at the pharmacy or the pharmacist declines to furnish pursuant to conscience clause, the pharmacist will refer the patient to another emergency contraception provider. The pharmacist shall comply with all state mandatory reporting laws, including sexual abuse laws.

(6) The pharmacist may provide up to 12 non-spermicidal condoms to each Medi-Cal and Family PACT client who obtains emergency contraception.

(7) Advanced provision: The pharmacist may dispense emergency contraception medication for a patient in advance of the need for emergency contraception.

(8) EC Product Selection: The pharmacist will provide emergency contraception medication from the list of products specified in this protocol. This list must be kept current and maintained in the pharmacy. Along with emergency contraception products, the list will include adjunctive medications indicated for nausea and vomiting associated with taking EC containing estrogen. Patients will be provided information concerning dosing and potential adverse effects.

(9) Documentation: Each prescription authorized by a pharmacist will be documented in a patient medication record as required by law.

(10) Training: Prior to furnishing emergency contraception, pharmacists who participate in this protocol must have completed a minimum of one hour of continuing education specific to emergency contraception.

(11) Medications Used for Emergency Contraception

Dedicated Approved Products for Emergency Contraception
Brand	Dose	Ethinyl Estradiol per dose (mcg)
		One Tablet Regimens
Plan B^TM One-Step	1 tablet		0	1.5mg levonorgestrel
ella^TM	1 tablet		0	30mg ulipristal
Levonorgestrel	1 tablet		0	1.5mg levonorgestrel

		Two Tablet Regimens
Next Choice^TM	2 tablets at once (1.5mg total dose) or 1 tablet (0.75mg) followed by 1 tablet (0.75mg) 12 hours later		0	Each tablet is 0.75 mg levonorgestrel

Levonorgestrel	2 tablets at once (1.5mg total dose) or 1 tablet (0.75mg) followed by 1 tablet (0.75mg) 12 hours later		0	Each tablet is 0.75 mg levonorgestrel

*Oral Contraceptive Pills*

*Brand*	*Tablets per Dose*	*Ethinyl Estradiol*	*Levonorgestrel*
	**(two doses 12 hours apart^)***	*per dose (mcg)*	per dose (mg)^*
Alesse	5 pink tablets	100	0.50
Aviane	5 orange tablets	100	0.50
Levlen	4 light-orange tablets	120	0.60
Levlite	5 pink tablets	100	0.50
Levora	4 white tablets	120	0.60
Lo/Ovral	4 white tablets	120	0.50
Low-Ogestrel	4 white tablets	120	0.60
Nordette	4 light-orange tablets	120	0.60
Ogestrel	2 white tablets	100	0.50
Ovral	2 white tablets	100	0.50
Tri-Levlen	4 yellow tablets	100	0.50
Triphasil	4 yellow tablets	120	0.50
Trivora	4 pink tablets	120	0.50
Ovrette	20 yellow tablets	0	0.75

^* The progestin in Ovral, Lo/Ovral, and Ovrette is norgestrel, which contains two isomers, only one of which (levonorgestrel) is bioactive; the amount of norgestrel in each dose is twice the amount of levonorgestrel.
In addition to the products specified in this paragraph, generic equivalent products may be furnished. Estrogen containing regimens are not preferred and should be used only when the other options are not available.

(12) Anti-nausea Treatment Options for use with Emergency Contraception

Non-Prescription Drugs	Dose	Timing of Administration
Meclizine hydrochloride (Dramamine II, Bonine)	One or two 25 mg tablets	1 hour before first EC dose; Repeat if needed in 24 hours

Diphenhydramine hydrochloride (Benadryl)	One or two 25 mg tablets or capsules	1 hour before first EC dose; repeat as needed every 4-6 hours

Dimenhydrinate (Dramamine)	One or two 50 mg tablets or 4-8 teaspoons liquid	30 minutes to 1 hour before first EC dose; repeat as needed every 4-6 hours

Cyclizine hydrochloride (Marezine)	One 50 mg tablet	30 minutes before first EC dose; repeat as needed every 4-6 hours

Cal. Code Regs. Tit. 16, § 1746

1. New section filed 11-2-2004; operative 12-2-2004 (Register 2004, No. 45). For prior history, see Register 80, No. 8.
2. Change without regulatory effect amending subsections (a) and (b)(1) and amending NOTE filed 12-18-2007 pursuant to section 100, title 1, California Code of Regulations (Register 2007, No. 51).
3. Amendment filed 3-13-2013; operative 7-1-2013 (Register 2013, No. 11).

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4052 and 4052.3, Business and Professions Code.

1. New section filed 11-2-2004; operative 12-2-2004 (Register 2004, No. 45). For prior history, see Register 80, No. 8.
2. Change without regulatory effect amending subsections (a) and (b)(1) and amending Note filed 12-18-2007 pursuant to section 100, title 1, California Code of Regulations (Register 2007, No. 51).
3. Amendment filed 3-13-2013; operative 7-1-2013 (Register 2013, No. 11).