# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 40 — Pharmacists Prescribing Contraceptives

**Authority:** Health-Occupations Article, §§12-101, 12-102(b), 12-205(a), and 12-511, Annotated Code of Maryland

**Administrative History:** Effective date: July 2, 2018 (45:13 Md. R. 668)

#### Regulation .01 Scope.

*COMAR 10.34.40.01*

This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice.

#### Regulation .02 Definitions.

*COMAR 10.34.40.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Board” means the Maryland Board of Pharmacy.

  (2) “Contraceptives” means contraceptive medications and self-administered contraceptive devices approved by the U.S. Food and Drug Administration.

  (3) “Pharmacist” means an individual who practices pharmacy under the Health Occupations Article, §12-101, Annotated Code of Maryland.

  (4) “Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland.

  (5) “Practicing pharmacy” has the same meaning stated in Health Occupations Article, §12-101(x), Annotated Code of Maryland.

  (6) “Primary care practitioner” means a licensed health care practitioner who:

    (a) Provides an individual’s primary care services; and

    (b) Is the primary coordinator of health care services for the individual.

  (7) “Reproductive health care practitioner” means a licensed health care practitioner who provides an individual’s reproductive health services.

  (8) “Visit summary” means:

    (a) A written record of either the contraceptives dispensed or a brief explanation as to why contraceptives were not prescribed;

    (b) Written information about the importance of seeing the patient’s primary care practitioner or reproductive health care practitioner to obtain recommended tests and screenings; and

    (c) A copy of the patient’s completed Self-Screening Risk Assessment Questionnaire.

#### Regulation .03 Requirements to Prescribe Contraceptives.

*COMAR 10.34.40.03*

A. Board Responsibilities. The Board shall develop and adopt the following items, in consultation with stakeholders to be determined by the Board:

  (1) A self-screening risk assessment questionnaire that a patient shall complete before a pharmacist may prescribe contraceptives for a patient;

  (2) A standard procedure contraceptive algorithm which the pharmacist shall use to perform a patient assessment for purposes of determining:

    (a) Whether to prescribe contraceptives; and

    (b) Which contraceptive options to prescribe;

  (3) A notification form to be submitted by a pharmacist before prescribing contraceptives; and

  (4) Other forms and procedures for:

    (a) The prescription of contraceptives; and

    (b) Referral to a primary care or reproductive health care practitioner for treatment.

B. Notification.

  (1) Except as provided in §B(2) of this regulation, at least 15 days before prescribing contraceptives, a pharmacist shall submit to the Board a notification form, which includes an attestation of completion of a Board-approved training program.

  (2) A pharmacist who has undergone training for prescribing contraceptives as part of the pharmacist’s formal educational program:

    (a) Is exempt from completing a Board-approved training program; and

    (b) At least 15 days before prescribing contraceptives, shall submit to the Board a notification form, which includes an attestation of the pharmacist’s formal education program.

  (3) A pharmacist may not prescribe contraceptives until the pharmacist receives a written confirmation from the Board accepting the pharmacist’s notification form.

C. Pharmacist Responsibilities.

  (1) For each new patient requesting contraceptive services, and at a minimum of every 12 months for each returning patient, a participating pharmacist shall:

    (a) Obtain the completed Board-approved self-screening risk assessment questionnaire from the patient; and

    (b) Utilize and follow the Board-approved standard procedure contraceptive algorithm to:

      (i) Perform the patient assessment;

      (ii) Determine whether to prescribe contraceptives; and

      (iii) Determine which contraceptive options to prescribe.

  (2) Upon completion of all requirements established by the Board and after review of all relevant information, a pharmacist may prescribe contraceptives, if deemed clinically appropriate.

  (3) If contraceptives are prescribed, the pharmacist shall:

    (a) Refer the patient:

      (i) For additional care to their primary care practitioner or reproductive health care practitioner; or

      (ii) If the patient does not have a primary care practitioner or a reproductive health care practitioner, to a family planning provider or a licensed clinician who provides reproductive health care services;

    (b) Provide the patient with a visit summary; and

    (c) Document the encounter and maintain records pursuant to Regulation .05 of this chapter.

  (4) Upon completion of all requirements established by the Board and after review of all relevant information, if the pharmacist does not prescribe contraceptives, the pharmacist will provide a visit summary to the patient which provides the basis for the decision not to prescribe contraceptives.

  (5) A pharmacist may not prescribe contraceptives before January 1, 2019.

#### Regulation .04 Training Program Requirements.

*COMAR 10.34.40.04*

At a minimum, a Board-approved training program shall contain the following elements:

A. An overview of contraceptive medications and self-administered contraceptive devices;

B. An overview of the self-screening risk assessment questionnaire;

C. An overview of the standard procedure contraceptive algorithm; and

D. An overview of the U.S. Medical Eligibility Criteria for Contraceptive Use and other Center for Disease Control guidance on contraception.

#### Regulation .05 Record Keeping.

*COMAR 10.34.40.05*

For a minimum of 5 years, a pharmacy whose pharmacists prescribe contraceptives shall maintain documentation, in electronic or other form, which includes:

A. The type of contraceptive prescribed, and dosage, if applicable, or the basis for not prescribing a contraceptive;

B. The name, address, and date of birth of the patient;

C. The name of the pharmacist who prescribed the contraceptive or determined a contraceptive would not be prescribed;

D. The date the contraceptive was prescribed or that the patient was advised that a  contraceptive would not be prescribed;

E. A copy of the patient’s visit summary;

F. A copy of the patient’s self screening risk assessment questionnaire; and

G. The name and address of the:

  (1) Patient’s primary care practitioner or reproductive health care practitioner, if provided by the patient; or

  (2) Family planning provider or licensed clinician who provides reproductive health care services referred by the pharmacist, if the patient does not have a primary care practitioner or reproductive health care practitioner.

#### Regulation .06 Continuing Education Requirement.

*COMAR 10.34.40.06*

A pharmacist who prescribes contraceptives in Maryland shall earn 1 hour of Board-approved continuing pharmaceutical education related to contraception before the pharmacist’s license renewal date.