N.J. Admin. Code § 13:39-14.5

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:39-14.5 - Procedures for patient counseling and furnishing hormonal contraceptives

(a) If the pharmacist concludes, based on N.J.A.C. 13:39-14.4, that a self-administered hormonal contraceptive is indicated for the patient, the pharmacist may furnish one. The pharmacist shall:

1. Ensure that the patient is appropriately instructed in the administration of the self-administered hormonal contraceptive.

2. Provide the patient with counseling that includes the following information:

i. An information sheet for the product furnished that includes when and how to take or use the hormonal contraceptive, when the contraceptive becomes effective, what to do if the patient misses a dose or the contraceptive patch or ring dislodges, possible side effects (including the risks, if any, of long-term use), and when to seek medical attention;

ii. The package insert for the product furnished;

iii. The importance of receiving recommended preventative health screenings and following up with the patient's primary care provider or a medical clinic;

iv. That the self-administered hormonal contraceptive does not protect against sexually transmitted infections or HIV, and that the use of a condom does provide protection against sexually transmitted infections and HIV; and

v. Any other information relevant to the hormonal contraceptive furnished; if medroxyprogesterone acetate is furnished, counsel the patient that using it for more than two years is not recommended because of a risk of loss of significant bone mineral density.

3. Provide the patient with a written record of the self-administered hormonal contraceptive furnished. The pharmacist may use the Pharmacist Visit Summary and Referral template set forth at N.J.A.C. 13:39-14 Appendix D and available at http://www.njconsumeraffairs.gov/phar/Pages/default.aspx to provide the written record and may customize the template by adding to it, but may not remove any elements from the template. At a minimum, the written record provided by the pharmacist to the patient must include:

i. The patient's name and date of birth;

ii. The name, address, permit number, and telephone number of the pharmacy practice site, and the name, license number, and signature of the pharmacist;

iii. The date of the visit and the date on which the self-administered hormonal contraceptive was furnished;

iv. The name and strength (if applicable) of the contraceptive that was furnished;

v. The quantity furnished and how many refills were authorized (if any);

vi. Any recommended follow-up; and

vii. A statement that information on reproductive rights, health care coverage and services, and other resources can be found at the New Jersey Reproductive Health Information Hub, http://www.nj.gov/health/reproductivehealth/.

4. Offer to provide counseling to the patient about other forms of contraception, including contraception not included at N.J.A.C. 13:39-14.3(a), that have been approved by the Federal Food and Drug Administration, and, if the patient accepts the offer for counseling, the pharmacist must provide the patient with specific and appropriate information about such other forms of contraception, based on the results of the Health Screening Questionnaire.

5. At each patient encounter, provide the patient with a referral to the patient's primary care provider, or, if the patient does not have a primary care provider, to an appropriate and nearby medical clinic that provides primary and contraceptive care. The Pharmacist Visit Summary and Referral template set forth at N.J.A.C. 13:39-14 Appendix D and available at http://www.njconsumeraffairs.gov/phar/Pages/default.aspx may be used. A pharmacist may customize the template by adding to it, but may not remove any elements from the template.

(b) If the patient is eligible to receive a self-administered hormonal contraceptive from the pharmacist, the pharmacist may furnish an initial supply of up to three months at one time, with a refill for up to nine months, for a total of 12 months.

(c) At three months, the pharmacist shall recheck the patient's blood pressure and ask if there are any changes to the patient's responses to the Health Screening Questionnaire to verify the patient's continued eligibility for the hormonal contraceptive, provided that measuring seated blood pressure is not necessary if the patient is taking progestin-only oral contraceptive pills.

(d) If, after 12 months, the patient requests a refill, the pharmacist shall repeat the procedures at N.J.A.C. 13:39-14.4. The patient shall complete the Health Screening Questionnaire at least once every 12 months.

1. If there is no change in the formulation or method of contraceptive furnished to the patient, the pharmacist may authorize refills for a supply of up to 12 months.

2. If there is a change in the formulation or method of hormonal contraceptive furnished to the patient, then the pharmacist may furnish an initial supply of up to three months at one time, with refills for up to nine months, for a total of 12 months. At three months, the pharmacist shall recheck the patient's blood pressure and ask if there are any changes to the patient's responses to the Health Screening Questionnaire, provided that rechecking seated blood pressure is not necessary if the patient is taking progestin-only oral contraceptive pills.

(e) A pharmacist shall not continue to furnish medroxyprogesterone acetate after two years without a prescription from a health care provider. If a patient has used medroxyprogesterone acetate for one year and nine months, the pharmacist shall refer the patient to a health care provider to obtain a prescription.

(f) If the evaluation indicates that hormonal contraceptives are contraindicated for the patient, the pharmacist shall not furnish one.

1. The pharmacist shall offer to provide counseling to the patient about other forms of contraception, including contraception not included at N.J.A.C. 13:39-14.3(a), that have been approved by the Federal Food and Drug Administration, and, if the patient accepts the offer for counseling, the pharmacist must provide the patient with specific and appropriate information about such other forms of contraception, based on the results of the Health Screening Questionnaire.

2. The pharmacist must provide the patient with a referral to the patient's primary care provider, or, if the patient does not have a primary care provider, to an appropriate and nearby medical clinic that provides primary and contraceptive care. The Pharmacist Visit Summary and Referral template set forth at N.J.A.C. 13:39-14 Appendix D and available at http://www.njconsumeraffairs.gov/phar/Pages/default.aspx may be used. A pharmacist may customize the template by adding to it, but may not remove any elements from the template. The referral must include the reason the pharmacist did not furnish a self-administered hormonal contraceptive to the patient.

(g) The dispensing of the self-administered hormonal contraceptive furnished pursuant to a standing order shall be processed in the same manner that a prescription drug or device is dispensed, pursuant to the applicable statutes and rules for the dispensing of prescription drugs and devices. When furnishing self-administered hormonal contraceptives pursuant to the Protocol, the name and National Provider Identifier number of the licensed physician issuing the standing order is entered in the patient profile as the prescriber.

N.J. Admin. Code § 13:39-14.5

Adopted by 56 N.J.R. 906(a) effective 5/20/2024