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

Dalhousie University

Status: Begins enrollment this month

Conditions: Pharmacists; Menopause

Treatments: Other: Pharmacist-led menopause care

Study type: Observational

Funder types: Other

Identifiers

NCT07618039

REB 2025-7730

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Pharmacist (pharmacies) participants:

• Select community pharmacies with an appointment based system as chosen in consultation with PANS.
• Pharmacist participants must be licensed to practice direct patient care in Nova Scotia.
• Pharmacist participants must have completed the MOMENT education and training.

Patient participants:

• Resident of Nova Scotia with a provincial MSI card.

• People with the anatomical and physiological components (AFAB) that would predispose them to signs and symptoms of menopause that are associated with decreasing hormones (e.g., estrogen).

• Signs and/or symptoms of the menopause and the person is seeking care for the same, regardless of whether they are using treatments.

  • The potential participants will screen using MQ6 questions based on: 1) changes in periods; 2) presence of hot flashes; 3) vaginal dryness, pain, or sexual concerns; 4) bladder issues or incontinence; 5) new sleep difficulties; 6) new or increased anxiety, irritability, depression or low mood.

    • People with symptoms in 2, 3, or 4 indicate symptoms for which MHT may be indicated and are eligible to be included for the study.
    • People with only number 1 should talk with the pharmacist to determine if these symptoms are related to menopause and what the menstrual changes are (i.e. frequency, volume, regularity, duration, non-menstrual bleeding, bleeding outside of the reproductive age, acute or chronic bleeding). If there is evidence of other signs and symptoms of menopause on assessment, they can be included. If no other signs or symptoms related to menopause are present, people will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https://www.nshealth.ca/wheretogoforhealthcare).
    • People only with 5 can be considered as part of common ailments prescribing (existing scope within the Standards of Practice for Prescribing Drugs), if appropriate, and will be included in the study only if other signs and symptoms of menopause are present.
    • People only with number 6 will be assessed regarding their symptoms. If no other signs or symptoms related to menopause are present, people will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https://www.nshealth.ca/wheretogoforhealthcare) and options for mental health care if deemed appropriate (https://mha.nshealth.ca/en). Additionally, the pharmacist can determine if there are options within their existing scope to provide care to the patient, if appropriate, and also refer the patient to a Bloom Program pharmacy if deemed appropriate.

• Perimenopausal people who previously had symptoms of menopause and were also receiving hormonal contraceptives but warrant a transition to MHT based on clinical factors (e.g., older age, reached menopause).

Exclusion criteria

Patient participants:

• People with surgical menopause via oophorectomy.

  o Patients who have had oophorectomy experience early menopause (i.e., surgical menopause). These patients are most likely to have previously received or currently be receiving systemic treatment with MHT. If this was not the case, pharmacists will refer the patient back to their regular primary care provider, if the patient has one. If not, the pharmacist will provide the person with information on care options (e.g., https://www.nshealth.ca/wheretogoforhealthcare).

  o If the pharmacist deems that a renewal of previous MHT is appropriate, they will use their clinical discretion and follow their legal and ethical obligations as per usual when engaging in this activity.

• People with a final menstrual period (FMP) < 40 years or "early menopause" (FMP <45 years).

  o additional investigation is required to explore underlying causes related to their menstrual cessation (e.g., hypothalamic-pituitary-ovarian axis conditions or other possible causes). People in this category will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https://www.nshealth.ca/wheretogoforhealthcare). Typically, people in this situation are typically treated with hormones to around the age of 51 (i.e. typical age of menopause).

  o Note: a person that had premature or early menopause and has progressed beyond the typical age of treatment for replacement of hormones (i.e., 51), and is currently experiencing signs and symptoms via screening, can be considered for inclusion.

• Perimenopausal people who are seeking contraception prescribing.

  o Pharmacists should engage in prescribing for contraceptive management as per the Nova Scotia College of Pharmacists Standards of Practice for Prescribing Drugs.

• People who are stable on existing MHT and other therapies to manage menopausal symptoms and no changes are required.

• People who only require a renewal, adaptation, or therapeutic substitution for a menopausal treatment. These activities fall within pharmacists' existing scope.

  o Exception: people who do not have a doctor or nurse practitioner are eligible for inclusion if the pharmacist has been providing these prescribing services.

• GSM induced by testosterone therapy for gender affirming care. o Transmasculine or gender diverse individuals using testosterone therapy with GSM induced by testosterone therapy (these people should be managed in collaboration with their gender affirming care providers).

• The person cannot consent for themselves for the study due to cognitive impairment (e.g., advanced Alzheimer's disease or other dementias).

Considerations related to inclusion and exclusion criteria:

• Older age: older age is not necessarily an exclusion criteria but will have a role as "a flag" in clinical assessment.

o People AFAB who are > 10 years after their FMP or > 60 years of age are not globally initiated on systemic MHT if they have have symptoms and have never had MHT before. However, there must be a benefit-risk discussion with the person regarding the treatment options if treatment is being sought, and therapies must be individualized. Although, "second-line", there are other systemic non-MHT options available for symptom management and other treatments (e.g., localized treatments such as intravaginal hormones for GSM). Regardless of the treatment, a benefit-risk discussion is required with the person AFAB.