PROPOSAL
Maryland Register
Issue Date: February 16, 2018
Volume 45 • Issue 4 • Pages 212—213
Title 10
MARYLAND DEPARTMENT OF HEALTH
Subtitle 34 BOARD OF PHARMACY
10.34.40 Pharmacists Prescribing Contraceptives
Authority: Health Occupations Article, §§12-101, 12-102(b), 12-205(a), and 12-511, Annotated Code of Maryland
Notice of Proposed Action
[18-042-P]
The Secretary of Health proposes to adopt new Regulations .01—.06 under a new chapter, COMAR 10.34.40 Pharmacists Prescribing Contraceptives. This action was considered by the Board of Pharmacy at an open meeting held on October 18, 2017, notice of which was given by publication on the Board’s website, http://health.maryland.gov/pharmacy/Pages/index.aspx, from September 21, 2017 — October 18, 2017, pursuant to General Provisions Article, §3-302(c), Annotated Code of Maryland.
Statement of Purpose
The purpose of this action is to authorize a pharmacist who meets the requirements of State Board of Pharmacy regulations to prescribe and dispense specified contraceptives.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 19, 2018. A public hearing has not been scheduled.
.01 Scope.
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.
.02 Definitions.
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.
.03 Requirements to Prescribe Contraceptives.
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.
.04 Training Program Requirements.
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.
.05 Record Keeping.
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.
.06 Continuing Education Requirement.
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.
ROBERT R. NEALL
Secretary of Health
