MOving Forward With MENopause Treatment Through Pharmacists' Expanded Roles in Hormone Health

Summary

The MOMENT project centres pharmacists as key partners for people assigned female at birth (AFAB) in improving menopause care. Menopause is a major life event, which half of our population will experience. For many, the mental and physical symptoms of menopause can impact quality of life, relationships, and workplace productivity. There are significant inequities in menopause health care and knowledge gaps for health care providers and the public with menopause being poorly understood. Menopausal Hormone Therapy (MHT) and related treatments are under-utilized and symptom control for people AFAB is often suboptimal. Since the publication of the Women's Health Initiative (WHI) study of postmenopausal women in 2002, menopausal care changed and misinformation about the risks versus benefits of MHT continue to create fear in those AFAB and health care providers. Guideline-concordant care includes MHT as first-line therapies for symptoms and there is increasing interest to improve the care of menopausal people. When MHT is not appropriate, there are other non-hormonal options that are available.

What do pharmacists already legally do in Nova Scotia for hormone therapies and other treatments commonly used for menopausal management for those assigned female at birth?

* Hormones and non-hormonal therapies: Pharmacists receive prescriptions for and dispense MHT and other therapies related to menopausal symptoms, and as per the Standards of Practice, assess appropriateness of all prescriptions for patients, which includes, but is not limited to, assessing indications, contraindications, dosing and intervals, drug interactions (drug-drug, drug-disease, drug-food, etc.), and providing education on the medication, including but not limited to its proper use and storage, expectations of side effects and benefits, how to monitor progress, and when to follow-up and seek help. Pharmacists have a relationship and responsibility to patients for shared decision making. This requires that they know the benefits (e.g., symptom reduction, health outcome reduction or improvement) and risks (e.g., adverse effects, contraindications, drug interactions) of hormones, and in the specific patient context.
* Pharmacists can prescribe MHT and other non-hormonal therapies with a diagnosis as set out in collaboration with another health care professional (e.g., physicians, nurse practitioners) as per the existing legal framework in Nova Scotia.
* Pharmacists provide ongoing care and monitoring throughout a patient's medication journey.
* Pharmacists engage in prescribing renewals and therapeutic substitutions. They assume the prescribing responsibility when deciding to lengthen the time a patient can receive the prescription after it was initially prescribed by another prescriber, and when changing, adapting, or substituting medications as clinically indicated.
* Pharmacists prescribe hormones for contraception.
* Pharmacists can also prescribe non-MHT medications for other conditions related to menopause (e.g., insomnia) and recommend nonpharmacological interventions (e.g., cognitive behavioural therapy for insomnia, CBTi) as this is already part of the scope of practice.

What is the project proposing? This project will focus on initiation of treatments for menopausal symptoms (e.g., MHT and other guideline-concordant treatments) for AFAB participants as a part of menopause signs' and symptoms' management and adds initiation to other participant pharmacist prescribing responsibilities as described above.

The Pharmacy Association of Nova Scotia will facilitate communications to pharmacies and pharmacists, to request participation in the project. This will go to community pharmacies that have a practice setting that includes dedicated time for appointment-based prescribing services. For brevity, the investigators refer to these as appointment-based pharmacies (ABPs). The additional prescribing responsibilities will be facilitated through the existing legal framework in Nova Scotia. This means that it would be considered "Prescribing in Accordance with an Approved Research or Pilot Protocol" according to the existing regulatory framework within the Nova Scotia Pharmacy Regulator.

The project includes mixed methods with quantitative and qualitative approaches. The main sources of data will be anonymized data capture by pharmacist participants, surveys of both pharmacist participants and patient participants, and interviews of both groups of participants (i.e., pharmacist participants and patient participants).

Initiating treatments for menopause based on the current scope of practice is a natural progression of the scope of pharmacists' practice. It provides the opportunity to improve the health of those with menopausal signs and symptoms. The project can explore feasibility of an additional MHT prescriber in the health system and whether scale and spread should be explored further.

Conditions

• Menopause
• Pharmacists

Interventions

OTHER

Pharmacist-led menopause care

There are two groups in the study: 1\) pharmacists, and 2) people AFAB experiencing signs and symptoms of the menopause transition and menopause attributable to declining hormone levels (e.g., estrogen, progesterone). Pharmacists will be employed at a community pharmacy that has a practice setting that includes appointment based pharmacy services. These will be recruited with the assistance of the Pharmacy Association of Nova Scotia (PANS). 10 pharmacies will be selected based on factors such as knowledge regarding capacity, other existing health system variables, and geographical services and needs based on existing research and knowledge of service priorities. Pharmacists will provide services within scope and those approved for the study based on approval from the Nova Scotia Pharmacy Regulator.

Sponsors & Collaborators

• Dalhousie University

  lead OTHER

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2027-07-01

Completion

2027-12-31