N.Y. Comp. Codes R. & Regs. tit. 8 § 60.14

Current through Register Vol. 46, No. 36, September 4, 2024

Section 60.14 - Non-patient specific orders to dispense self-administered hormonal contraceptives

(a) As used in this section, self-administered hormonal contraceptives means self-administered oral hormonal contraceptive medications or devices approved by the federal Food and Drug Administration to prevent pregnancy by using hormones to regulate or prevent ovulation, and includes oral hormonal contraceptives, hormonal contraceptive vaginal rings and hormonal contraceptive patches.

(b) A licensed physician may issue a written non-patient specific order and protocol for a licensed pharmacist to dispense self-administered hormonal contraceptives to patients in New York State, provided that the requirements of this section are met.

(c) Order and protocol.

(1) The non-patient specific order shall include, at a minimum, the following:

(i) the name, license number and signature of the licensed physician who issues the non-patient specific order and protocol;

(ii) the name and dose of the specific drug(s) or the name of specific medical device to be dispensed;

(iii) a protocol for dispensing the self-administered hormonal contraceptives or a specific reference to a separate written protocol for dispensing the self-administered hormonal contraceptives, which shall meet the requirements of paragraph (2) of subdivision (c) of this section;

(iv) the period of time that the order is effective, including the beginning and ending dates;

(v) a description of the group(s) of persons who may receive the dispensed self-administered hormonal contraceptives; and

(vi) the name and license number of each licensed pharmacist authorized to execute the non-patient specific order and protocol or the name and address of the New York State licensed pharmacy that employs or contracts with the licensed pharmacist(s) to execute the non-patient specific order and protocol.

(2) The written protocol, incorporated into the order prescribed in paragraph (1) of subdivision (c) of this section shall, at a minimum, require the licensed pharmacist to:

(i) provide the patient with a self-screening risk assessment questionnaire, developed by the commissioner of health in consultation with the commissioner, to be reviewed by the pharmacist to identify any known risk factors and assist the patient's selection of an appropriate self-administered hormonal contraceptive;

(ii) provide the patient with a fact sheet, developed by the commissioner of health, that includes but is not limited to, the clinical considerations and recommendations for use of the self-administered hormonal contraceptive, the appropriate method for using such self-administered hormonal contraceptive, information on the importance of follow-up health care, health care referral information, and the ability of the patient to opt out of practitioner reporting requirements;

(iii) notify the patient's primary health care practitioner, unless the patient opts out of such notification, within seventy-two hours of dispensing a self-administered hormonal contraceptive, that such self-administered hormonal contraceptive has been dispensed. Such notification may occur via electronic transmission or facsimile. If the patient does not have a primary health care practitioner or is unable to provide contact information for their primary health care practitioner, the pharmacist shall provide the patient with a written record of the self-administered hormonal contraceptives dispensed and advise the patient to consult an appropriate health care practitioner;

(iv) offer or provide in writing, the names and addresses of hospitals or other health providers that offer follow-up care, which shall be identified in the protocol; and

(vi) document the pharmacy services provided as described in this paragraph and maintain the documentation in accordance with sections 29.2(a)(3), 63.6(b)(7), and 63.6(b)(8) of this Title.

N.Y. Comp. Codes R. & Regs. Tit. 8 § 60.14

Adopted New York State Register March 27, 2024/Volume XLVI, Issue 13, eff. 3/27/2024, exp. 6/9/2024 (Emergency)

Amended New York State Register June 26, 2024/Volume XLVI, Issue 26, eff. 6/10/2024, exp. 8/8/2024 (Emergency)

Adopted New York State Register July 31, 2024/Volume XLVI, Issue 31, eff. 7/31/2024