• NJ - New Jersey Register
• 2023
• DECEMBER
• DECEMBER 4, 2023
• RULE PROPOSALS
• LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Authorized By: Antonia Winstead, Executive Director, State Board of Medical Examiners, and Anthony Rubinaccio, Executive Director, Board of Pharmacy.

Authority: N.J.S.A. 45:9-2, 45:14-48, and 45:14-67.9.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2023-118.

Submit comments by February 2, 2024, to:

Antonia Winstead, Executive Director
Board of Medical Examiners
PO Box 183
Trenton, NJ 08625

or to:

Anthony Rubinaccio, Executive Director
Board of Pharmacy
PO Box 45013
Newark, NJ 07101

or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.

The joint proposal of the agencies follows:

Summary

The State Board of Medical Examiners (BME) and the Board of Pharmacy (BOP) are jointly proposing new rules to implement P.L. 2023, c. 2, which is codified at N.J.S.A. 45:14-67.9 (the Act). The Act authorizes pharmacists to furnish self-administered hormonal contraceptives pursuant to standardized procedures and protocols jointly developed by the BME and BOP (collectively, "the Boards") in consultation with the American College of Obstetricians and Gynecologists (ACOG), the New Jersey Pharmacists Association, and other appropriate entities. The Boards sought feedback from the ACOG, the New Jersey Pharmacists Association, and 11 other stakeholder entities, and jointly developed standardized procedures and protocols for pharmacists to furnish self-administered hormonal contraceptives (the Protocol). The Boards propose new rules to authorize pharmacists to furnish self-administered hormonal contraceptives and to incorporate the Protocol into each of the Board's respective rules as appendices.

The BME proposes new N.J.A.C. 13:35-6.28 and the BOP proposes new N.J.A.C. 13:39-14 to implement the Act.

Proposed new N.J.A.C. 13:35-6.28(a) and 13:39-14.1(a) provide that a pharmacist may furnish self-administered hormonal contraceptives in accordance with the Protocol set forth at Appendix A of the respective chapters, a standing order issued by a licensed physician pursuant to the Protocol, and the rules of the BOP. The proposed rules also provide that if the licensed physician issuing the standing order is the New Jersey Commissioner of Health, or a designee of the New Jersey Commissioner of Health, the standing order may have Statewide effect. The Boards believe that a standing order with Statewide effect will effectuate the Act's goal of expanding access to hormonal contraceptives and, as such, a standing order will be available to any New Jersey licensed pharmacist who wishes to participate in the Protocol.

Proposed new N.J.A.C. 13:35-6.28(b) and 13:39-14.7(a) require a pharmacist to take a four-hour training program on patient screening, selection of self-administered hormonal contraceptives, and patient counseling regarding self-administered hormonal contraceptives. Proposed new N.J.A.C. 13:35-6.28(b) and 13:39-14.7(b) specify that a training program that provides education only on the pharmacology of contraceptives is not sufficient to prepare the pharmacist to furnish self-administered hormonal contraceptives. The American Pharmacists Association (APhA) recommended that the Boards require the APhA's four-hour training course that is accredited by the Accreditation Council for Pharmacy Education (ACPE). The New Jersey Pharmacists Association suggested pharmacists be required to affirm the completion of one hour of ACPE-approved training. The Boards believe that a four-hour course is necessary and sufficient to train pharmacists to furnish self-administered hormonal contraceptives safely because the Protocol includes five types of hormonal contraceptives (see proposed new N.J.A.C. 13:39-14.3(a)) and pharmacists need training on each type in order to become authorized to furnish them.

Proposed new N.J.A.C. 13:35-6.28(c) and 13:39-14.7(c) provide that the Boards shall recognize a training program that is either offered at a college of pharmacy accredited by the Accreditation Council for Pharmacy Education (ACPE), offered by an ACPE-approved provider, or approved by the BOP pursuant to N.J.A.C. 13:39-3A.6 and by the BME. This proposed provision will permit pharmacists to take existing ACPE-approved courses immediately to facilitate pharmacist authorization to furnish hormonal contraceptives. Offering additional training options in pharmacy colleges or other programs approved by the Boards, should such programs be developed, will provide additional flexibility to pharmacists seeking training.

Proposed new N.J.A.C. 13:39-14.1(b) requires the pharmacist to keep a written copy of the Protocol at each location at which the pharmacist furnishes self-administered hormonal contraceptives. The final page of the Protocol must include the names of each pharmacist who may furnish self-administered hormonal contraceptives at that pharmacy practice site. The pharmacist must make a copy of the Protocol and standing order available upon the request of a representative of the BOP. The BOP believes that this requirement will facilitate the BOP's ability to enforce the provisions of proposed new Subchapter 14.

Consistent with N.J.S.A. 45:14-67.9.e, proposed new N.J.A.C. 13:39-14.1(c) states that nothing in the subchapter or the Protocol shall be construed to expand the authority of a pharmacist to prescribe any prescription medication. Also, consistent with N.J.S.A. 45:14-67.9.e, proposed new N.J.A.C. 13:39-14.1(d) states that the requirements of the subchapter and the Protocol do not apply to a pharmacist dispensing a self-administered hormonal contraceptive pursuant to an individual prescription issued by a healthcare practitioner authorized to prescribe self-administered hormonal contraceptives in the course of professional practice. Proposed new N.J.A.C. 13:39-14.1(d) also states that the requirements of the subchapter and the Protocol do not apply to a nonprescription hormonal contraceptive, but that nothing in the proposed rule prohibits any person from obtaining a nonprescription hormonal contraceptive pursuant to the Protocol.

Consistent with N.J.S.A. 45:14-67.9.b(1)i and ii, proposed new N.J.A.C. 13:39-14.2(a) sets forth the requirements for a pharmacist to be authorized to furnish self-administered hormonal contraceptives pursuant to the Protocol. The pharmacist shall complete a training program compliant with proposed new N.J.A.C. 13:39-14.7; affirm that the pharmacist will follow pertinent guidelines from the Federal Centers for Disease Control and Prevention, including the United States Medical Eligibility Criteria for Contraceptive Use (USMEC); and retain the affirmation as a medical record. To aid in the BOP's ability to enforce the requirements of the proposed new subchapter, proposed new N.J.A.C. 13:39-14.2(a) requires the pharmacist to submit the affirmation and certificate of training completion to the BOP.

Proposed new N.J.A.C. 13:39-14.2(b) prohibits a pharmacist who is authorized to furnish a self-administered hormonal contraceptive pursuant to the Protocol from delegating the furnishing of hormonal contraceptives to any other person. The Boards believe that the proposed non-delegation rule is necessary to ensure that the person engaging in patient screening and counseling and in the selection of a hormonal contraceptive is properly trained. A pharmacy intern or pharmacy technician may prepare the self-administered hormonal contraceptive for dispensing, but the steps at N.J.A.C. 13:39-14.4 and 14.5(a) through (f) shall be completed by the [page=2385] pharmacist authorized to furnish hormonal contraceptives pursuant to the Protocol.

Proposed new N.J.A.C. 13:39-14.2(c) requires a pharmacist authorized to furnish hormonal contraceptives to comply with the pharmacist's mandatory child abuse reporting obligations pursuant to N.J.S.A. 9:6-8.10, including, but not limited to, reports of sexual offenses at N.J.S.A. 2C:14-1 et seq. N.J.S.A. 9:6-8.10 requires "any person having reasonable cause to believe that a child has been subjected to child abuse, including sexual abuse" to report to the Division of Child Protection and Permanency. The Boards believe it is important to remind pharmacists furnishing hormonal contraceptives of this obligation.

Proposed new N.J.A.C. 13:39-14.3(a) sets forth the self-administered hormonal contraceptives that a pharmacist may furnish pursuant to the Protocol. The self-administered hormonal contraceptives available pursuant to the Protocol are the combined oral contraceptive pill, progestin-only contraceptive pill, patch, ring, and injectable hormonal contraceptive. The Act defines "self-administered hormonal contraceptive" as "any oral, transdermal, or vaginal contraceptive product, including, but not limited to, birth control pills, vaginal rings, and diaphragms." N.J.S.A. 45:14-67.9.d. The Boards determined that diaphragms are not eligible to be furnished by a pharmacist pursuant to the Protocol because fitting a diaphragm requires a clinical exam. Diaphragms are also a barrier method of birth control, rather than a hormonal method.

Proposed new N.J.A.C. 13:39-14.3(b) clarifies that a pharmacist may not furnish any other self-administered hormonal contraceptives, and that the injectable hormonal contraceptives furnished pursuant to the Protocol must be self-administered by the patient and cannot be administered by the pharmacist. Proposed new N.J.A.C. 13:39-14.3(c) provides that if the Federal Food and Drug Administration confers nonprescription status to any contraceptive authorized pursuant to the Protocol, a consumer shall not be required to obtain that nonprescription contraceptive through the Protocol, but may obtain it through the Protocol if the consumer chooses to do so.

Proposed new N.J.A.C. 13:39-14.4 sets forth the procedures for screening patients and selecting a hormonal contraceptive. Proposed new N.J.A.C. 13:39-14.4(a) sets forth the steps for screening a patient. Proposed new N.J.A.C. 13:39-14.4(a)1 requires the pharmacist to have the patient complete a Health Screening Questionnaire prepared by the New Jersey Department of Health, in the recipient's primary language, whenever possible. Proposed new N.J.A.C. 13:39-14.4(a)2 requires the pharmacist to review the Health Screening Questionnaire with the patient and clarify responses, if needed. Responses to the Health Screening Questionnaire are necessary for the pharmacist to use the USMEC to identify whether the patient has any contraindications to using the hormonal contraceptives available pursuant to the Protocol.

Proposed new N.J.A.C. 13:39-14.4(a)3 requires the pharmacist to measure and record the patient's seated blood pressure because hypertension is a contraindication to certain hormonal contraceptives, according to the USMEC. Hypertension is not a contraindication to progestin-only oral contraceptive pills, so the pharmacist is not required to measure and record blood pressure if the patient requests progestin-only oral contraceptives. The pharmacist may retake the seated blood pressure if the first reading exceeds the level for eligibility according to the USMEC. If the pharmacist uses a device other than a stethoscope and manual blood pressure cuff to measure seated blood pressure, the pharmacist shall have a valid certificate of calibration for the device to ensure the accuracy of the blood pressure reading.

Proposed new N.J.A.C. 13:39-14.4(a)4 requires the pharmacist to complete the Algorithm for Self-Administered Hormonal Contraceptive Pills, Patches, and Rings set forth at proposed new Appendix B or, if an injectable hormonal contraceptive is under consideration, the Algorithm for Self-Administered Injectable Hormonal Contraceptives set forth at proposed new Appendix C (collectively, "the Algorithms"). The pharmacist must assess the patient's health and history using the latest version of the USMEC. The Algorithms are decision-making flow charts to aid the pharmacist in using the USMEC criteria to select a hormonal contraceptive.

Proposed new N.J.A.C. 13:39-14.4(b) requires a pharmacist to provide patient privacy during screening and counseling consistent with the Federal Health Insurance Portability and Accountability Act (HIPAA), 45 CFR Parts 160 and 164, Subparts A and E, and other applicable law. The Boards believe that HIPAA provides the appropriate framework for privacy in this context.

Consistent with N.J.S.A. 45:14-67.9.b(4), proposed new N.J.A.C. 13:39-14.4(c) requires the pharmacist to make clinical decisions that are free from any financial influence imposed by insurance providers, contraceptive product manufacturers, and other parties having a financial interest in the disbursement or non-disbursement of self-administered hormonal contraceptives.

Proposed new N.J.A.C. 13:39-14.4(d) provides that a pharmacist may furnish a self-administered hormonal contraceptive pursuant to the Protocol only if the patient's intended use is contraception. The Boards believe that a patient seeking self-administered hormonal contraceptives for other reasons, such as to address irregular or painful menstruation, should consult a health care provider. Proposed new N.J.A.C. 13:39-14.4(d) also provides that a pharmacist may furnish self-administered hormonal contraceptives only if the patient has begun menstruating because hormonal contraceptives should not be initiated prior to that time.

Proposed new N.J.A.C. 13:39-14.5 sets forth the procedures for patient counseling and furnishing self-administered hormonal contraceptives. Proposed new N.J.A.C. 13:39-14.5(a) sets forth the procedures for the pharmacist to follow if the pharmacist concludes, based on proposed new N.J.A.C. 13:39-14.4, that a hormonal contraceptive is indicated for the patient. Proposed new N.J.A.C. 13:39-14.5(a)1 requires the pharmacist to ensure that the patient is appropriately instructed in the administration of the self-administered hormonal contraceptive, which could be a pill, patch, ring, or injectable.

Proposed new N.J.A.C. 13:39-14.5(a)2 requires the pharmacist to provide the patient with counseling that includes the information specified at proposed new N.J.A.C. 13:39-14.5(a)2i through v, including 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; the package insert for the product furnished; the importance of receiving recommended preventative health screenings and following up with the patient's primary care provider or a medical clinic; a statement 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 any other information relevant to the hormonal contraceptive furnished. If medroxyprogesterone acetate is furnished, the pharmacist must counsel the patient that using it for more than two years is not recommended because, according to its label, patients that use it risk loss of significant bone mineral density. The Boards believe patients need this information to use a hormonal contraceptive safely and effectively, and to make informed decisions regarding their health.

Proposed new N.J.A.C. 13:39-14.5(a)3 requires the pharmacist to 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 at proposed new Appendix D to provide the written record. A pharmacist may customize the template by adding to it, but may not remove any elements from the template. At a minimum, the written record provided to the patient must include the information specified at proposed new N.J.A.C. 13:39-14.5(a)3i through vi. The Boards believe this written record is necessary to facilitate the patient's ability to keep track of the patient's medication and refill status, as well as the sharing of information with other health care providers.

Consistent with N.J.S.A. 45:14-67.9.b(6), proposed new N.J.A.C. 13:39-14.5(a)4 requires the pharmacist to 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, to provide the patient with specific and appropriate information about such other forms of contraception, based on the results of the Health Screening Questionnaire.

[page=2386] Consistent with N.J.S.A. 45:14-67.9.b(7), proposed new N.J.A.C. 13:39-14.5(a)5 requires that at each patient encounter, 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. Proposed new N.J.A.C. 13:39-14.5(a)5 requires the referral to provide both preventive and contraceptive care to ensure that the referral is able to meet the patient's needs. The Pharmacist Visit Summary and Referral template set forth at proposed new Appendix D may be used. A pharmacist may customize the template by adding to it, but may not remove any elements from the template.

Proposed new N.J.A.C. 13:39-14.5(b) states that if the patient is eligible to receive a self-administered hormonal contraceptive, 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. The Boards believe that a three-month supply is appropriate to facilitate the consistent use of the hormonal contraceptive and is consistent with the duration of one self-administered injection.

Proposed new N.J.A.C. 13:39-14.5(c) states that, 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. The proposed new rule further states that measuring blood pressure is not necessary if the patient is taking progestin-only oral contraceptive pills. Monitoring blood pressure is not necessary for the use of progestin-only oral contraceptive pills, but is recommended for the use of other hormonal contraceptives. After three months, the pharmacist may authorize refills for up to nine months if there are no changes to the patient's eligibility for the hormonal contraceptive.

Proposed new N.J.A.C. 13:39-14.5(d) addresses a patient's request for a refill after 12 months. At that time, the pharmacist must repeat the procedures at proposed new N.J.A.C. 13:39-14.4. The patient must complete the Health Screening Questionnaire at least every 12 months. Pursuant to proposed new N.J.A.C. 13:39-14.5(d)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. Pursuant to proposed new N.J.A.C. 13:39-14.5(d)2, if there is a change in the formulation or method of contraceptive, 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. As with the initiation of a self-administered hormonal contraceptive at proposed new N.J.A.C. 13:39-14.5(c), in the event of a change in formulation or method, 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, although rechecking blood pressure is not necessary if the patient is taking progestin-only oral contraceptive pills.

Proposed new N.J.A.C. 13:39-14.5(e) establishes that a pharmacist cannot continue to furnish medroxyprogesterone acetate after two years without a prescription. If a patient has used it for one year and nine months, the pharmacist shall refer the patient to a health care provider to obtain a prescription. According to its label, use of medroxyprogesterone acetate is not recommended for more than two years, unless other options are considered inadequate. The Boards believe that determining whether other options are inadequate is a clinical decision that should be made by a health care provider with prescriptive authority.

Proposed new N.J.A.C. 13:39-14.5(f) sets forth procedures for when the pharmacist determines that the hormonal contraceptives available pursuant to the Protocol are contraindicated for the patient. In that event, the pharmacist shall not furnish hormonal contraceptives to the patient and must offer to provide the patient with the same counseling and provide the same referral as required at proposed new N.J.A.C. 13:39-14.5(a)4 and 5. The Pharmacist Visit Summary and Referral form, found at proposed new Appendix D, must include the reason the pharmacist did not furnish a self-administered hormonal contraceptive to the patient.

Proposed new N.J.A.C. 13:39-14.5(g) provides that 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.

Proposed new N.J.A.C. 13:39-14.6 addresses recordkeeping requirements. Proposed new N.J.A.C. 13:39-14.6(a)1 requires the pharmacist to keep a written or electronic record for any patient screened and for any self-administered hormonal contraceptive furnished pursuant to the Protocol. The record must include, without limitation, any completed Health Screening Questionnaire, Pharmacist Visit Summary and Referral form (found at proposed new Appendix D), and the information required pursuant to N.J.A.C. 13:39-7.6. Proposed new N.J.A.C. 13:39-14.6(a)2 requires the pharmacist to keep documentation of the pharmacist's successful completion of a training program, the affirmation required pursuant to proposed new N.J.A.C. 13:39-14.2(a), and the copy of the Protocol with the names of pharmacists who may furnish self-administered hormonal contraceptives pursuant to the standing order at that pharmacy practice site as required at proposed new N.J.A.C. 13:39-14.2(b).

Proposed new N.J.A.C. 13:39-14.6(b) requires all records required pursuant to Subchapter 14 to be kept for not less than seven years. Proposed new N.J.A.C. 13:39-14.6(c), (d), and (e) address the availability of records and storage and confidentiality requirements for records. The length of time and other requirements for records are consistent with the requirements for pharmacist collaborative practice records at N.J.A.C. 13:39-13.4(e) and vaccine records at N.J.A.C. 13:39-4.21(p). The Boards believe that applying the same requirements to records required pursuant to this subchapter is appropriate because the pharmacist's hormonal contraceptive records are clinical records.

Proposed new N.J.A.C. 13:39-14 Appendix A sets forth the Protocol. The Protocol is an appendix to proposed new N.J.A.C. 13:35-6.28 and proposed new N.J.A.C. 13:39-14. The Protocol does not set forth any requirements that are not included in proposed new Subchapter 14. A pharmacist furnishing hormonal contraceptives pursuant to the Protocol must comply with the provisions at proposed new Subchapter 14.

Proposed new N.J.A.C. 13:39-14 Appendix B sets forth the Algorithm for Self-Administered Hormonal Contraceptive Pills, Patches, and Rings addressed at proposed new N.J.A.C. 13:39-14.4(a)4. Proposed new N.J.A.C. 13:39-14 Appendix C sets forth the Algorithm for Self-Administered Injectable Hormonal Contraceptives addressed at proposed N.J.A.C. 13:39-14.4(a)4. Proposed new N.J.A.C. 13:39-14 Appendix D sets forth the Pharmacist Visit Summary and Referral template addressed at proposed new N.J.A.C. 13:39-14.5(a)3 and 5 and (f)2.

The Boards have provided a 60-day comment period for this notice of proposal; therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Boards believe that the proposed new rules will have a positive social impact on licensees and consumers by increasing access to hormonal contraceptives and reducing unintended pregnancy. The proposed new rules will provide a way for licensees to expand their practice should they choose to do so. The proposed new rules do not require licensees to become authorized to furnish hormonal contraceptives. The Boards believe that the training required for pharmacists and the screening and counseling required by the Protocol will protect the health, safety, and welfare of New Jersey consumers.

In New Jersey, the rate of unintended pregnancy is approximately 28 percent. See Pregnancy Risk Assessment Monitoring System, Unintended Pregnancies Among Mothers in New Jersey, available at http://www.nj.gov/health/fhs/maternalchild/documents/Unintended%20Pregnancy.pdf#:~:text=Almost%20one%20out%20of%20every%20three%20births,%2828.4%25%29%20in%20New%20Jersey%20are%20considered%20unintended, and Pregnancy Intention, New Jersey PRAMS 2012-2015, available at http://www.nj.gov/health/fhs/maternalchild/documents/NJ%20Pregnancy%20Intention%20Topic%20Report%202012-2015.pdf. Unintended pregnancy is associated with an increased risk of negative health outcomes for the pregnant person and the infant. See U.S. Centers for Disease Control and Prevention, Unintended Pregnancy, available at http://www.cdc.gov/reproductivehealth/contraception/unintendedpregnancy/#print; Pregnancy Risk Assessment Monitoring System, Unintended Pregnancies Among Mothers in New Jersey, available at [page=2387] http://www.nj.gov/health/fhs/maternalchild/documents/Unintended%20Pregnancy.pdf#:~:text=Almost%20one%20out%20of%20every%20three%20births,%2828.4%25%29%20in%20New%20Jersey%20are%20considered%20unintended. In 2015, 22 percent of unintended pregnancies in New Jersey received late or no prenatal care. See Pregnancy Risk Assessment Monitoring System, Pregnancy Intention, New Jersey PRAMS 2012-2015, available at http://www.nj.gov/health/fhs/maternalchild/documents/NJ%20Pregnancy%20Intention%20Topic%20Report%202012-2015.pdf. Infants born to persons who do not receive prenatal care are three times more likely to have a low birth weight and five times more likely to die than those born to people who received prenatal care. See U.S. Department of Health and Human Services, Office on Women's Health, Prenatal care, available at http://www.womenshealth.gov/a-z-topics/prenatal-care.

According to ACOG, "the human cost of unintended pregnancy is high: women must either carry an unplanned pregnancy to term and keep the baby or make a decision for adoption, or choose to undergo abortion. Women and their families may struggle with this challenge for medical, ethical, social, legal, and financial reasons." The benefits of contraception "are widely recognized and include improved health and well-being, reduced global maternal mortality, health benefits of pregnancy spacing for maternal and child health, female engagement in the workforce, and economic self-sufficiency for women." See ACOG, Access to Contraception Committee Opinion, available at http://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/01/access-to-contraception.

By reducing barriers to accessing hormonal contraceptives, the proposed new rules will help prevent unintended pregnancies. New Jersey consumers will need to take fewer steps to obtain hormonal contraceptives because a visit to a health care provider will not be necessary. Moreover, additional locations to access hormonal contraceptives will be available.

Economic Impact

The Boards anticipate that the proposed new rules will have a positive economic impact. A pharmacist's participation in furnishing hormonal contraceptives pursuant to the Protocol is voluntary. Pharmacists who choose to become authorized to furnish self-administered hormonal contraceptives will pay a fee for the training program. Once authorized, the pharmacist will be able to expand the number of patients to whom the pharmacist dispenses contraceptives, which will offset the fee for the training program. The hormonal contraceptives training program can be used towards the pharmacist's fulfillment of the existing continuing education requirement at N.J.A.C. 13:39-3A.1.

In addition, by reducing barriers to accessing contraceptives, the proposed new rules will help prevent unintended pregnancies and their associated health care costs and reduce barriers to consumers pursuing education and participating in the workforce.

Federal Standards Statement

There are no Federal laws or standards applicable to the proposed new rules, which are governed by N.J.S.A. 45:14-67.9.

Jobs Impact

The Boards believe that the proposed new rules may increase jobs in the State if pharmacies experience an increased demand for the services of pharmacists. The Boards do not anticipate that the rulemaking will have any other impact on jobs.

Agriculture Industry Impact

The Boards do not anticipate that the proposed new rules will have any impact on the agriculture industry in the State because the proposed new rules concern hormonal contraceptives.

Regulatory Flexibility Analysis

Any licensee, registrant, and/or permit holder that is a "business which is resident in this State, independently owned and operated and not dominant in its field, and which employs fewer than 100 full-time employees" constitutes a "small business" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq. (RFA). To the extent a licensee qualifies as a "small business" under the RFA, the following analysis applies pursuant to N.J.S.A. 52:14B-19.

The proposed new rules impose recordkeeping and compliance requirements on pharmacists who choose to furnish hormonal contraceptives pursuant to the Protocol as detailed in the Summary; the proposed new rules do not impose registration or other reporting obligations. Pharmacists who choose to furnish hormonal contraceptives pursuant to the Protocol will be required to take a training program that may have a fee; no additional professional services will be needed to comply with the proposed new rules. The proposed new rules may have a positive economic impact on small businesses for the reasons stated in the Economic Impact above. The Boards believe that the proposed new rules protect the health, safety, and welfare of patients by expanding options for accessing hormonal contraceptives, while protecting patient safety by ensuring that participating pharmacists are appropriately trained. Accordingly, the rules should be uniformly applied to all licensees and no differing compliance requirements for any licensees are imposed based upon the size of the business.

Housing Affordability Impact Analysis

The proposed new rules will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed new rules concern hormonal contraceptives.

Smart Growth Development Impact Analysis

The proposed new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers pursuant to the State Development and Redevelopment Plan in New Jersey because the proposed new rules concern hormonal contraceptives.

Racial and Ethnic Community Criminal Justice and Public Safety Impact

The Boards have evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.

Full text of proposed new rules follows:

CHAPTER 35

BOARD OF MEDICAL EXAMINERS

SUBCHAPTER 6. GENERAL RULES OF PRACTICE

13:35-6.28 Furnishing of self-administered hormonal contraceptives by pharmacists

(a) A pharmacist shall be authorized to furnish self-administered hormonal contraceptives to a patient, in accordance with standardized procedures and protocols jointly developed and approved by the Board and the Board of Pharmacy as set forth at N.J.A.C. 13:39-6.28 Appendix (Protocol), a standing order issued by a licensed physician pursuant to the Protocol, and the rules of the Board of Pharmacy. If the licensed physician issuing the standing order is the New Jersey Commissioner of Health or a designee of the New Jersey Commissioner of Health, the standing order may have Statewide effect.

(b) In order to be authorized to furnish self-administered hormonal contraceptives pursuant to the Protocol, a pharmacist must successfully complete a training program meeting the requirements at (c) below that is at least four hours and that trains the pharmacist to screen patients to determine eligibility for the self-administered hormonal contraceptives authorized at N.J.A.C. 13:39-14.3, to select a self-administered hormonal contraceptive, and to counsel patients. A training program that provides education only on the pharmacology of contraceptives is not sufficient to satisfy the requirements of this subsection.

(c) The Board shall recognize training programs that meet the requirements at (b) above and are:

1. Offered at a college of pharmacy accredited by the Accreditation Council for Pharmacy Education;

2. Offered by an Accreditation Council for Pharmacy Education-approved provider; and

[page=2388] 3. Of comparable scope and rigor to courses accredited by the Accreditation Council for Pharmacy Education and be approved by the Board of Pharmacy pursuant to N.J.A.C. 13:39-3A.6 and by the Board.

APPENDIX

Pharmacist Hormonal Contraceptives Protocol

Background

On January 13, 2023, Governor Phil Murphy signed into law P.L. 2023, c. 2 (codified at N.J.S.A. 45:14-67.9), which states:

"Notwithstanding any other law to the contrary, a pharmacist shall be authorized to furnish self-administered hormonal contraceptives to a patient, in accordance with standardized procedures and protocols to be jointly developed and approved by the Board of Pharmacy and the State Board of Medical Examiners, in consultation with the American Congress of Obstetricians and Gynecologists, the New Jersey Pharmacists Association, and other appropriate entities, and in accordance with the 'Administrative Procedure Act,' P.L.1968, c.410 (C.52:14B-1 et seq.) and the provisions of this subsection."

This protocol ("Protocol") was developed jointly by the State Board of Medical Examiners and the Board of Pharmacy after consulting with professional associations and other appropriate entities. It was approved by the State Board of Medical Examiners on _____, 2024 and by the Board of Pharmacy on _______, 2024.

Pursuant to this Protocol, the Commissioner of the New Jersey Department of Health (or the Commissioner's designee) issued a statewide standing order authorizing New Jersey licensed pharmacists to furnish self-administered hormonal contraceptives to patients without an individual prescription. The State Board of Medical Examiners regulations implementing the Protocol are found at N.J.A.C. 13:35-6.28. The Board of Pharmacy regulations implementing the Protocol are found at N.J.A.C. 13:39-14.1 through 14.7.

A pharmacist who furnishes self-administered hormonal contraceptives pursuant to a standing order must follow this Protocol and the regulations of the Board of Pharmacy. Copies of all documents and templates referenced in this Protocol are available on the Board of Pharmacy's website at http://www.njconsumeraffairs.gov/phar/Pages/default.aspx.

Pharmacist Authorization

In order for a pharmacist to be authorized to furnish self-administered hormonal contraceptives pursuant to this Protocol, the pharmacist shall:

1. Complete a training program compliant with N.J.A.C. 13:39-14.7;

2. Affirm, in writing, that the pharmacist has completed a training program compliant with N.J.A.C. 13:39-14.7 and will follow pertinent guidelines offered by the Federal Centers for Disease Control and Prevention, including the United States Medical Eligibility Criteria for Contraceptive Use. This written affirmation shall be retained by the pharmacist as a medical record pursuant to N.J.A.C. 13:39-14.6; and

3. Submit to the Board:

i. The pharmacist's written affirmation from 2 above; and

ii. A certificate of completion of the training course required by 1 above.

A pharmacist must keep a written copy of this Protocol and the standing order under which the pharmacist furnishes hormonal contraceptives at each pharmacy practice site at which the pharmacist furnishes self-administered hormonal contraceptives. This Protocol must include the names of each pharmacist authorized pursuant to N.J.A.C. 13:39-14 to furnish self-administered hormonal contraceptives at the pharmacy practice site on the final page. The pharmacist must make a copy of the Protocol and the standing order available upon the request of a representative of the Board of Pharmacy.

A pharmacist who is authorized to furnish a self-administered hormonal contraceptive pursuant to this protocol is prohibited from delegating the furnishing of hormonal contraceptives to any other person. A pharmacy intern or pharmacy technician may prepare the self-administered hormonal contraceptive for dispensing, but the steps at N.J.A.C. 13:39-14.4 and 14.5(a) through (f) must be completed by the pharmacist authorized to furnish a hormonal contraceptive under this Protocol.

A pharmacist authorized to furnish hormonal contraceptives pursuant to this subchapter shall comply with mandatory child abuse reporting obligations at N.J.S.A. 9:6-8.10, including but not limited to, reports of sexual offenses at N.J.S.A. 2C:14-1 et seq.

Hormonal Contraceptives Authorized Pursuant to this Protocol

Pharmacists may furnish the following self-administered hormonal contraceptives pursuant to this Protocol:

1. Combined oral contraceptive pill;

2. Progestin-only oral contraceptive pill;

3. Patch;

4. Ring; and

5. Injectable hormonal contraceptive.

A pharmacist may not furnish any other self-administered hormonal contraceptives pursuant to the Protocol. An injectable hormonal contraceptive furnished pursuant to the Protocol must be self-administered and cannot be administered by the pharmacist.

Procedures for Hormonal Contraceptive Screening and Selection

(a) When an individual requests a pharmacist to furnish a self-administered hormonal contraceptive, the pharmacist shall:

1. Have the patient complete the Health Screening Questionnaire prepared by the New Jersey Department of Health. Upon request and whenever possible, the Health Screening Questionnaire shall be provided in the recipient's primary spoken language. If the patient does not complete the Health Screening Questionnaire, the pharmacist shall not furnish a self-administered hormonal contraceptive pursuant to the Protocol;

2. Review the Health Screening Questionnaire with the patient and clarify responses, if needed;

3. Measure and record the patient's seated blood pressure, unless progestin-only oral contraceptive pills are requested by the patient. Seated blood pressure may be retaken if the first reading exceeds the level for eligibility according to the United States Medical Eligibility Criteria for Contraceptive Use (USMEC) prepared by the Federal Centers for Disease Control and Prevention (CDC). If the pharmacist uses a device other than a stethoscope and manual blood pressure cuff to take seated blood pressure, the pharmacist shall have a valid certificate of calibration for the device; and

4. Complete the Algorithm for Self-administered Hormonal Contraceptive Pills, Patches, and Rings or, if an injectable hormonal contraceptive is under consideration, the Algorithm for Self-administered Injectable Hormonal Contraceptives. As part of that process, the pharmacist must assess the health and history of the patient using the latest version of the USMEC. Pharmacists may use the Summary Chart of the USMEC, which is color-coded to match the Health Screening Questionnaire.

(b) The pharmacist must provide patient privacy during health screening and counseling consistent with the Federal Health Insurance Portability and Accountability Act, 45 C.F.R. Part 160 and Subparts A and E of Part 164, as may be amended and supplemented, and other applicable law.

(c) A pharmacist may furnish a self-administered hormonal contraceptive pursuant to this Protocol only if the patient's intended use is contraception and only if the patient has begun menstruating.

Procedures for Patient Counseling and Furnishing Hormonal Contraceptives

(a) If the pharmacist concludes based on "Procedures for Hormonal Contraceptive Screening and Selection" above 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 appropriate counseling and the following information:

i. An information sheet for the product furnished that includes, without limitation, 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 [page=2389] (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 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); and

vi. Any recommended follow-up.

4. Offer to provide counseling to the patient about other forms of contraception, including contraception not included in "Hormonal Contraceptives Authorized Pursuant to this Protocol" above, 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 preventive and contraceptive care. The Pharmacist Visit Summary and Referral template 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 refills for up to nine months, for a total of twelve 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, provided that measuring seated blood pressure is not necessary if the patient is taking progestin-only oral contraceptive pills.

(d) If, after twelve months, the patient requests a refill, the pharmacist shall repeat the procedures in "Procedures for Hormonal Contraceptive Screening and Selection" above. The patient shall complete the Health Screening Questionnaire at least once every twelve 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 twelve 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 twelve 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 healthcare 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 must not furnish one.

1. The pharmacist must offer to provide counseling to the patient about other forms of contraception, including contraception not included in "Hormonal Contraceptives Authorized Pursuant to this Protocol" above, 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 preventive and contraceptive care. The Pharmacist Visit Summary and Referral template 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 per this Protocol, the name and National Provider Identifier number of the physician issuing the standing order is entered in the patient profile as the prescriber.

Recordkeeping

The pharmacist must keep the following records for seven years according to the requirements at N.J.A.C. 13:39-14.6(b) through (e):

1. A written or electronic record for any patient screened and for any self-administered hormonal contraceptive that is furnished pursuant to the Protocol, including, without limitation, any completed Health Screening Questionnaire, Pharmacist Visit Summary and Referral form, and all of the information required at N.J.A.C. 13:39-7.6; and

2. Documentation of the pharmacist's successful completion of the self-administered hormonal contraceptive training program, the affirmation required in N.J.A.C. 13:39-14.2(a) and a copy of the Protocol with the names of pharmacists who may furnish self-administered hormonal contraceptives pursuant to the standing order at the pharmacy practice site as required at N.J.A.C. 13:39-14.2(b).

Pharmacists Authorized to Furnish Self-Administered Hormonal Contraceptives

Pharmacy Name: __________________________________________

Pharmacy Practice Site Address: ______________________________

Pharmacy Permit Number: __________________________________

Pharmacy Phone Number ___________________________________

By signing below, the pharmacist affirms that the pharmacist has completed a training program compliant with N.J.A.C. 13:39-14.7, will follow pertinent guidelines offered by the Federal Centers for Disease Control and Prevention, including the United States Medical Eligibility Criteria for Contraceptive Use, and is authorized to furnish self-administered hormonal contraceptives pursuant to the New Jersey Pharmacist Hormonal Contraceptives Protocol. This form will be retained as a medical record for seven years.

CHAPTER 39

STATE BOARD OF PHARMACY

SUBCHAPTER 14. SELF-ADMINISTERED HORMONAL CONTRACEPTIVES

13:39-14.1 Protocol for pharmacists furnishing self-administered hormonal contraceptives

(a) A pharmacist shall be authorized to furnish self-administered hormonal contraceptives to a patient, in accordance with standardized procedures and protocols jointly developed and approved by the Board and the State Board of Medical Examiners as set forth at N.J.A.C. 13:39 Appendix A (Protocol), a standing order issued by a licensed physician pursuant to the Protocol, and the rules in this chapter. If the licensed physician issuing the standing order is the New Jersey Commissioner of the Department of Health, or a designee, the standing order may have Statewide effect.

(b) A pharmacist must keep a written copy of the Protocol and the standing order under which the pharmacist furnishes hormonal contraceptives at each pharmacy practice site at which the pharmacist furnishes self-administered hormonal contraceptives. The final page of the Protocol must include the names of each pharmacist authorized pursuant to this subchapter to furnish self-administered hormonal contraceptives at the pharmacy practice site. The pharmacist must make a copy of the Protocol and the standing order available upon the request of a representative of the Board.

(c) Nothing in this subchapter or the Protocol shall be construed to expand the authority of a pharmacist to prescribe any prescription medication.

(d) The requirements of this subchapter and the Protocol do not apply to a pharmacist dispensing a self-administered hormonal contraceptive pursuant to an individual prescription issued by a healthcare practitioner authorized to prescribe self-administered hormonal contraceptives in the course of professional practice or to a nonprescription hormonal contraceptive; provided, however, that nothing in this subchapter shall prohibit any person from obtaining a nonprescription hormonal contraceptive pursuant to the Protocol.

13:39-14.2 Authorization of pharmacists to furnish self-administered hormonal contraceptives

(a) In order for a pharmacist to be authorized to furnish self-administered hormonal contraceptives pursuant to the Protocol, the pharmacist shall:

1. Complete a training program compliant with N.J.A.C. 13:39-14.7;

2. Affirm, in writing, that the pharmacist has completed a training program compliant with N.J.A.C. 13:39-14.7, and will follow pertinent guidelines offered by the Federal Centers for Disease Control and Prevention, including the United States Medical Eligibility Criteria for Contraceptive Use. This written affirmation shall be retained by the pharmacist as a medical record pursuant to N.J.A.C. 13:39-14.6; and

3. Submit to the Board:

i. The pharmacist's written affirmation as required at (a)2 above; and

ii. A certificate of completion of the training course required pursuant to (a)1 above.

(b) A pharmacist who is authorized to furnish a self-administered hormonal contraceptive pursuant to the Protocol is prohibited from delegating the furnishing of hormonal contraceptives to any other person. A pharmacy intern or pharmacy technician may prepare the self-administered hormonal contraceptive for dispensing, but the steps at N.J.A.C. 13:39-14.4 and 14.5(a) through (f) shall be completed by the pharmacist authorized to furnish a hormonal contraceptive pursuant to the Protocol.

(c) A pharmacist authorized to furnish hormonal contraception pursuant to this subchapter shall comply with mandatory child abuse reporting obligations at N.J.S.A. 9:6-8.10, including, but not limited to, reports of sexual offenses at N.J.S.A. 2C:14-1 et seq.

13:39-14.3 Hormonal contraceptives authorized pursuant to the Protocol

(a) Pharmacists may furnish the following self-administered hormonal contraceptives pursuant to the Protocol:

1. Combined oral contraceptive pill;

2. Progestin-only oral contraceptive pill;

3. Patch;

4. Ring; and

5. Injectable hormonal contraceptive.

(b) A pharmacist may not furnish any other self-administered hormonal contraceptives pursuant to the Protocol. An injectable hormonal contraceptive furnished pursuant to the Protocol must be self-administered by the patient and cannot be administered by the pharmacist.

(c) In the event the Federal Food and Drug Administration confers nonprescription status to any contraceptive authorized to be furnished pursuant to the Protocol, a consumer shall not be required to obtain that nonprescription contraceptive through the Protocol, but may obtain it through the Protocol if the consumer chooses to do so.

13:39-14.4 Procedures for hormonal contraceptive screening and selection

(a) When an individual requests a pharmacist to furnish a self-administered hormonal contraceptive, the pharmacist shall:

1. Have the patient complete the Health Screening Questionnaire prepared by the New Jersey Department of Health. Upon request and whenever possible, the Health Screening Questionnaire shall be provided in the recipient's primary spoken language. If the patient does not complete the Health Screening Questionnaire, the pharmacist shall not furnish a self-administered hormonal contraceptive pursuant to the Protocol;

2. Review the Health Screening Questionnaire with the patient and clarify responses, if needed;

3. Measure and record the patient's seated blood pressure, unless progestin-only oral contraceptive pills are requested by the patient. Seated blood pressure may be retaken if the first reading exceeds the level for eligibility according to the United States Medical Eligibility Criteria for Contraceptive Use (USMEC) prepared by the Federal Centers for Disease Control and Prevention (CDC). If the pharmacist uses a device other than a stethoscope and manual blood pressure cuff to measure seated blood pressure, the pharmacist shall have a valid certificate of calibration for the device; and

4. Complete the Algorithm for Self-Administered Hormonal Contraceptive Pills, Patches, and Rings set forth at N.J.A.C. 13:39-14 Appendix B or, if an injectable hormonal contraceptive is under consideration, the Algorithm for Self-Administered Injectable Hormonal Contraceptives set forth at N.J.A.C. 13:39-14 Appendix C. As part of that process, the pharmacist must assess the health and history of the patient using the latest version of the USMEC. Pharmacists may use the Summary Chart of the USMEC, which is color-coded to match the Health Screening Questionnaire.

(b) The pharmacist must provide patient privacy during health screening and counseling consistent with the Federal Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164, Subparts A and E, and other applicable law.

(c) The pharmacist must make clinical decisions that are free from any financial influence imposed by insurance providers, contraceptive product manufacturers, and other parties having a financial interest in the disbursement or non-disbursement of self-administered hormonal contraceptives.

(d) A pharmacist may furnish a self-administered hormonal contraceptive pursuant to the Protocol only if the patient's intended use is contraception and only if the patient has begun menstruating.

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:

[page=2391] 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); and

vi. Any recommended follow-up.

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 preventive 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 preventive 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.

13:39-14.6 Recordkeeping

(a) The pharmacist must keep the following records:

1. A written or electronic record for any patient screened and for any self-administered hormonal contraceptive that is furnished pursuant to the Protocol, including, without limitation, any completed Health Screening Questionnaire, Pharmacist Visit Summary and Referral form, and all of the information required at N.J.A.C. 13:39-7.6; and

2. Documentation of the pharmacist's successful completion of the self-administered hormonal contraceptive training program, the affirmation required at N.J.A.C. 13:39-14.2(a) and a copy of the Protocol with the names of pharmacists who may furnish self-administered hormonal contraceptives pursuant to the standing order at the pharmacy practice site, as required at N.J.A.C. 13:39-14.2(b).

(b) All records required pursuant to the Protocol shall be maintained in either hard copy or electronic form for a period of not less than seven years and shall be supplied to the Board upon request.

(c) All records shall be made available to persons authorized to inspect them pursuant to State and Federal statutes and regulations. The oldest six years of information shall be maintained in such a manner, so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day.

(d) Records not currently in use need not be stored in the pharmacy, but the storage facilities shall be secure.

(e) Patient records shall be kept confidential.

[page=2392] 13:39-14.7 Hormonal contraceptive training

(a) In order to be authorized to furnish self-administered hormonal contraceptives pursuant to the Protocol, a pharmacist must successfully complete a training program recognized pursuant to (c) below that is at least four hours and trains the pharmacist to:

1. Screen patients to determine eligibility for the self-administered hormonal contraceptives authorized at N.J.A.C. 13:39-14.3;

2. Select a self-administered hormonal contraceptive; and

3. Counsel patients.

(b) A training program that provides education only on the pharmacology of contraceptives is not sufficient to satisfy the requirements of this section.

(c) The Board shall recognize training programs that meet the requirements at (a) above and are:

1. Offered at a college of pharmacy accredited by the Accreditation Council for Pharmacy Education;

2. Offered by an Accreditation Council for Pharmacy Education-approved provider; and

3. Of comparable scope and rigor to courses accredited by the Accreditation Council for Pharmacy Education and be approved by the Board pursuant to N.J.A.C. 13:39-3A.6 and by the State Board of Medical Examiners.

APPENDIX A

Pharmacist Hormonal Contraceptives Protocol

Background

On January 13, 2023, Governor Phil Murphy signed into law P.L. 2023, c. 2 (codified at N.J.S.A. 45:14-67.9), which states:

"Notwithstanding any other law to the contrary, a pharmacist shall be authorized to furnish self-administered hormonal contraceptives to a patient, in accordance with standardized procedures and protocols to be jointly developed and approved by the Board of Pharmacy and the State Board of Medical Examiners, in consultation with the American Congress of Obstetricians and Gynecologists, the New Jersey Pharmacists Association, and other appropriate entities, and in accordance with the 'Administrative Procedure Act,' P.L.1968, c.410 (C.52:14B-1 et seq.) and the provisions of this subsection."

This protocol ("Protocol") was developed jointly by the State Board of Medical Examiners and the Board of Pharmacy after consulting with professional associations and other appropriate entities. It was approved by the State Board of Medical Examiners on _____, 2024 and by the Board of Pharmacy on _______, 2024.

Pursuant to this Protocol, the Commissioner of the New Jersey Department of Health (or the Commissioner's designee) issued a statewide standing order authorizing New Jersey licensed pharmacists to furnish self-administered hormonal contraceptives to patients without an individual prescription. The State Board of Medical Examiners regulations implementing the Protocol are found at N.J.A.C. 13:35-6.28. The Board of Pharmacy regulations implementing the Protocol are found at N.J.A.C. 13:39-14.1 through 14.7.

A pharmacist who furnishes self-administered hormonal contraceptives pursuant to a standing order must follow this Protocol and the regulations of the Board of Pharmacy. Copies of all documents and templates referenced in this Protocol are available on the Board of Pharmacy's website at http://www.njconsumeraffairs.gov/phar/Pages/default.aspx.

Pharmacist Authorization

In order for a pharmacist to be authorized to furnish self-administered hormonal contraceptives pursuant to this Protocol, the pharmacist shall:

1. Complete a training program compliant with N.J.A.C. 13:39-14.7;

2. Affirm, in writing, that the pharmacist has completed a training program compliant with N.J.A.C. 13:39-14.7 and will follow pertinent guidelines offered by the Federal Centers for Disease Control and Prevention, including the United States Medical Eligibility Criteria for Contraceptive Use. This written affirmation shall be retained by the pharmacist as a medical record pursuant to N.J.A.C. 13:39-14.6; and

3. Submit to the Board:

i. The pharmacist's written affirmation from 2 above; and

ii. A certificate of completion of the training course required by 1 above.

A pharmacist must keep a written copy of this Protocol and the standing order under which the pharmacist furnishes hormonal contraceptives at each pharmacy practice site at which the pharmacist furnishes self-administered hormonal contraceptives. This Protocol must include the names of each pharmacist authorized pursuant to N.J.A.C. 13:39-14 to furnish self-administered hormonal contraceptives at the pharmacy practice site on the final page. The pharmacist must make a copy of the Protocol and the standing order available upon the request of a representative of the Board of Pharmacy.

A pharmacist who is authorized to furnish a self-administered hormonal contraceptive pursuant to this protocol is prohibited from delegating the furnishing of hormonal contraceptives to any other person. A pharmacy intern or pharmacy technician may prepare the self-administered hormonal contraceptive for dispensing, but the steps at N.J.A.C. 13:39-14.4 and 14.5(a) through (f) must be completed by the pharmacist authorized to furnish a hormonal contraceptive pursuant to this Protocol.

A pharmacist authorized to furnish hormonal contraceptives pursuant to this subchapter shall comply with mandatory child abuse reporting obligations at N.J.S.A. 9:6-8.10, including but not limited to, reports of sexual offenses at N.J.S.A. 2C:14-1 et seq.

Hormonal Contraceptives Authorized Pursuant to this Protocol

Pharmacists may furnish the following self-administered hormonal contraceptives pursuant to this Protocol:

1. Combined oral contraceptive pill;

2. Progestin-only oral contraceptive pill;

3. Patch;

4. Ring; and

5. Injectable hormonal contraceptive.

A pharmacist may not furnish any other self-administered hormonal contraceptives pursuant to the Protocol. An injectable hormonal contraceptive furnished pursuant to the Protocol must be self-administered and cannot be administered by the pharmacist.

Procedures for Hormonal Contraceptive Screening and Selection

(a) When an individual requests a pharmacist to furnish a self-administered hormonal contraceptive, the pharmacist shall:

1. Have the patient complete the Health Screening Questionnaire prepared by the New Jersey Department of Health. Upon request and whenever possible, the Health Screening Questionnaire shall be provided in the recipient's primary spoken language. If the patient does not complete the Health Screening Questionnaire, the pharmacist shall not furnish a self-administered hormonal contraceptive pursuant to the Protocol;

2. Review the Health Screening Questionnaire with the patient and clarify responses, if needed;

3. Measure and record the patient's seated blood pressure, unless progestin-only oral contraceptive pills are requested by the patient. Seated blood pressure may be retaken if the first reading exceeds the level for eligibility according to the United States Medical Eligibility Criteria for Contraceptive Use (USMEC) prepared by the Federal Centers for Disease Control and Prevention (CDC). If the pharmacist uses a device other than a stethoscope and manual blood pressure cuff to take seated blood pressure, the pharmacist shall have a valid certificate of calibration for the device; and

4. Complete the Algorithm for Self-Administered Hormonal Contraceptive Pills, Patches, and Rings or, if an injectable hormonal contraceptive is under consideration, the Algorithm for Self-administered Injectable Hormonal Contraceptives. As part of that process, the pharmacist must assess the health and history of the patient using the latest version of the USMEC. Pharmacists may use the Summary Chart of the USMEC, which is color-coded to match the Health Screening Questionnaire.

(b) The pharmacist must provide patient privacy during health screening and counseling consistent with the Federal Health Insurance Portability and Accountability Act, 45 C.F.R. Part 160 and Subparts A and E of Part 164, as may be amended and supplemented, and other applicable law.

[page=2393] (c) A pharmacist may furnish a self-administered hormonal contraceptive pursuant to this Protocol only if the patient's intended use is contraception and only if the patient has begun menstruating.

Procedures for Patient Counseling and Furnishing Hormonal Contraceptives

(a) If the pharmacist concludes based on "Procedures for Hormonal Contraceptive Screening and Selection" above 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 appropriate counseling and the following information:

i. An information sheet for the product furnished that includes, without limitation, 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 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); and

vi. Any recommended follow-up.

4. Offer to provide counseling to the patient about other forms of contraception, including contraception not included in "Hormonal Contraceptives Authorized Pursuant to this Protocol" above, 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 preventive and contraceptive care. The Pharmacist Visit Summary and Referral template 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 refills for up to nine months, for a total of twelve 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, provided that measuring seated blood pressure is not necessary if the patient is taking progestin-only oral contraceptive pills.

(d) If, after twelve months, the patient requests a refill, the pharmacist shall repeat the procedures in "Procedures for Hormonal Contraceptive Screening and Selection" above. The patient shall complete the Health Screening Questionnaire at least once every twelve 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 twelve 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 twelve 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 healthcare 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 must not furnish one.

1. The pharmacist must offer to provide counseling to the patient about other forms of contraception, including contraception not included in "Hormonal Contraceptives Authorized Pursuant to this Protocol" above, 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 preventive and contraceptive care. The Pharmacist Visit Summary and Referral template 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 per this Protocol, the name and National Provider Identifier number of the physician issuing the standing order is entered in the patient profile as the prescriber.

Recordkeeping

The pharmacist must keep the following records for seven years according to the requirements at N.J.A.C. 13:39-14.6(b) through (e):

1. A written or electronic record for any patient screened and for any self-administered hormonal contraceptive that is furnished under the Protocol, including, without limitation, any completed Health Screening Questionnaire, Pharmacist Visit Summary and Referral form, and all of the information required at N.J.A.C. 13:39-7.6; and

2. Documentation of the pharmacist's successful completion of the self-administered hormonal contraceptive training program, the affirmation required at N.J.A.C. 13:39-14.2(a) and a copy of the Protocol with the names of pharmacists who may furnish self-administered hormonal contraceptives under the standing order at the pharmacy practice site as required at N.J.A.C. 13:39-14.2(b).

[page=2394] Pharmacists Authorized to Furnish Self-Administered Hormonal Contraceptives

Pharmacy Name: __________________________________________

Pharmacy Practice Site Address: ______________________________

Pharmacy Permit Number: __________________________________

Pharmacy Phone Number ___________________________________

By signing below, the pharmacist affirms that the pharmacist has completed a training program compliant with N.J.A.C. 13:39-14.7, will follow pertinent guidelines offered by the Federal Centers for Disease Control and Prevention, including the United States Medical Eligibility Criteria for Contraceptive Use, and is authorized to furnish self-administered hormonal contraceptives pursuant to the New Jersey Pharmacist Hormonal Contraceptives Protocol. This form will be retained as a medical record for seven years.

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APPENDIX D

Pharmacist Visit Summary and Referral Template

Attention: You may customize this template by adding to it; however, you must retain all elements in this template.

Patient Name:________________ Date of birth:____/____/________

Date of visit: ___/___/___

Date hormonal contraceptive furnished (if applicable): ___/___/____

Please review this form with your primary care provider. If you do not have a primary care provider, you may follow up at _____________________ (insert name, address, and phone number of an appropriate and nearby medical clinic that provides preventive and contraceptive care).

Recommended follow-up:

__________________________________________________________

Self-administered hormonal contraceptive furnished:

__________________________________________________________

Strength (if applicable): _____________ Quantity furnished: ______ Refills authorized: ______

OR

______ Pharmacist is not able to furnish a self-administered hormonal contraceptive to you because:

□ Pregnancy cannot be ruled out.

(Notes:_________________________________________________)

□ You may have a health condition than requires further evaluation.

(Notes:_________________________________________________)

□ You take medication(s) or supplements that may interfere with contraceptives.

(Notes:_________________________________________________)

□ Your blood pressure reading is _______/_____ (higher than 140/90) and you are not eligible for progestin-only pills because ______________________________________.

□ Other (e.g., intended use is not contraception)

(Notes:_________________________________________________)

Each requires additional evaluation by another healthcare provider. Please share this information with your provider.

Pharmacist Name _________________________________________

Pharmacist Signature ______________________________________

Pharmacist License Number ________________________________

Pharmacy Name __________________________________________

Pharmacy Practice Site Permit Number ________________________

Pharmacy Practice Site Address ______________________________

Pharmacy Practice Site Phone Number _________________________