MSDC Submits Comments on Pharmacist Prescribing Proposed Regs June 25, 2023

Today, MSDC President Dr. Susanne Bathgate submitted comments to DC Health on proposed regulations allowing pharmacists to prescribe hormonal birth control.

The proposed regulations permit DC pharmacists to prescribe self-administered hormonal birth control after completing a health assessment form. Visits with a medical provider are not required for the prescription, but a person must visit a medical provider to receive a refill.

MSDC submitted questions asking for clarification on the assessment, medical visit requirements, and more. MSDC stressed support for wider, more easily available birth control but cautioned over pharmacists going beyond their scope of medical training. The full comments are below.

Comments on the proposed regulations were due June 26. DC Health will review comments and issue revised proposed regulations in the future.

June 23, 2023

District of Columbia Department of Health
Attn: Phillip Husband, General Counsel
899 North Capitol Street NE, 6th Floor
Washington, DC

The Medical Society of DC is the largest medical organization representing metropolitan Washington physicians in the District. We advocate on behalf of all 12,000 plus licensed physicians in the District and seek to make the District “the best place to practice medicine”.

MSDC is responding to the “Notice of Proposed Rulemaking” N130656 in the May 26, 2023, District Register. The proposed regulations would give authority to certain pharmacists to prescribe and dispense self-administered hormonal contraceptives under specific conditions. MSDC’s comments and questions on the regulations are below.

MSDC believes in the importance of readily available birth control and contraception and supports making it easier to obtain a mutual goal. In addition, we support efforts like those at the federal level to make progestin-only birth control pills available over the counter. What differentiates that effort from these proposed regulations is that in the case of combined hormonal birth control, medical expertise and availability may be needed for prescription, follow up and management of adverse events that is absent in these proposed regulations.

Please see below for the following comments and questions as sought by the department:

Section 6517.1.b – the definition of protocol includes the phrase, “provides rules for certified pharmacists to determine if a prescription… is medically appropriate using the information provided by the patient in the self-screening questionnaire.” Determination of medical appropriateness is based on a questionnaire without a medical history available. It will be essential for this questionnaire to be thorough, to ensure the person seeking birth control can accurately document medical conditions that medical professionals would flag as problematic for hormonal birth control.

Section 6517.1.d – The questionnaire to be used by the “certified pharmacist” will be developed by the Boards of Pharmacy and Medicine. According to the DC Health website, four physician positions are vacant. There is a realistic scenario where the questionnaire could be completed by two entities where physicians are a minority of those serving, or where there will be no reproductive health specialists like a gynecologist. How would DC Health address this concern in these regulations? Would the department be amenable to ensuring subsequent regulation drafts require the body creating the questionnaire have a majority of physicians?

Section 6517.8 – The regulations do not specify the “appropriate counseling” that a patient is to be given. What counts as appropriate in a non-medical setting? A pharmacist – even PharmD – has fewer educational and clinical training requirements as physicians or other medical providers who can prescribe hormonal birth control now. How will “appropriate counseling” be determined based on this?

Section 6517.9 – The regulations state a pharmacist must refer the person receiving the prescription to a primary care provider or “reproductive health provider.” Is the Department concerned that this language is so vague as to allow a pharmacist to send a person to any type of provider to receive care? If the person does not have an established relationship with a primary care provider, how would a pharmacist refer the person and on what basis? This is especially important if the person seeking the prescription has underlying medical health issues that may interact poorly with hormonal birth control.

Section 6517.10 – The requirement to see a provider prior to a prescription is for a refill, not for the initial prescription. Even with the low risk of health issues, a patient’s medical history is important for hormonal birth control. We want to reiterate our question in Section 6517.1.b

General questions:

● If a patient suffers an adverse reaction to the prescription due to an underlying health condition, does the District’s medical malpractice laws allow for the pharmacist to be held accountable?

● Why do the regulations not cite or rely on medical information from the American Medical Association or American College of Obstetricians and Gynecologists when developing materials for pharmacists?

MSDC wants to work with the Department to ensure birth control is easily access in a medically safe way. Our questions seek to help us determine how we can help with this goal. We look forward to seeing how the department answers our questions and concerns. If you have any questions, please contact Robert Hay Jr., Executive Vice President, at 202-355-9401 or hay@msdc.org to contact me. Thank you for your assistance with this matter.

Sincerely,
Susanne Bathgate, MD, FACOG
President, Medical Society of the District of Columbia