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

There are two groups in the study:

1) pharmacist participants, and 2) AFAB participants experiencing signs and symptoms of the menopause transition and menopause attributable to declining hormone levels (e.g., estrogen, progesterone).

Pharmacist participants:

Pharmacist participants will be employed at a community pharmacy that has a practice setting that includes appointment based pharmacy services. AFAB participants seeking care for menopause-related symptoms may be eligible.

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.