Hormone Replacement Therapy (HRT) Policy

Initiation and Review

Purpose & Governance

This policy defines the framework for the safe prescribing of Hormone Replacement Therapy (HRT) at Salisbury Medical Practice. The objective is to ensure that all clinical decisions align with national standards and regional formulary guidance.

Initial Assessment and Pre-Treatment Screening

Before initiating HRT, a clinical evaluation must be conducted and documented.

Cautions and contraindications excluded:

• Do not prescribe hormone replacement therapy (HRT) in women with:
  • Current, past, or suspected breast cancer.
  • Known or suspected oestrogen-dependent cancer.
  • Undiagnosed vaginal bleeding.
  • Untreated endometrial hyperplasia.
  • Previous idiopathic or current venous thromboembolism (deep vein thrombosis or pulmonary embolism).
  • Active or recent arterial thromboembolic disease (for example, angina or myocardial infarction).
  • Acute or active liver disease.
  • Pregnancy.
  • Thrombophilic disorder.
• Prescribe HRT with caution in women with:
  • Acute porphyrias.
  • Diabetes mellitus (increased risk of heart disease).
  • Factors predisposing to venous thromboembolism.
  • History of breast nodules or fibrocystic disease — closely monitor breast status (risk of breast cancer).
  • History of endometrial hyperplasia.
  • Hypophyseal tumours.
  • Increased risk of gallbladder disease.
  • Migraine or migraine-like headaches.
  • Increased risk of breast cancer.
  • Endometriosis - seek specialist advice due to the potential risk of disease reactivation and malignant transformation.
  • Uterine fibroids - may increase in size. 

Clinical History

• Symptom Profile: Assess severity and impact of vasomotor symptoms (hot flushes, night sweats), psychological symptoms (mood changes, brain fog), genitourinary symptoms, and joint pain.
• Menstrual History: Record Last Menstrual Period (LMP) to determine menopausal status (perimenopause vs. postmenopause).
• Medical & Family History: Specific screening for venous thromboembolism (VTE), cardiovascular disease, stroke, breast cancer, and oestrogen-dependent malignancies.

Physical Examinations & Investigations

• Blood Pressure & BMI: Must be recorded baseline. Hypertension must be controlled prior to initiation.
• Routine Screening: Ensure the patient is up-to-date with national breast and cervical cancer screening programmes.
• Laboratory Tests: Routine FSH testing is not recommended in women over 45 with typical symptoms. Consider FSH testing only if atypical (e.g., age <45, suspected premature ovarian insufficiency).

Initiation of HRT

The choice of HRT regimen must be tailored to the patient’s medical history, risk profile, and personal preferences.

Regimen Selection

• Oestrogen-Only HRT: Suitable only for individuals who have undergone a hysterectomy.
• Combined HRT (Oestrogen + Progesterone): Required for individuals with an intact uterus to prevent endometrial hyperplasia and carcinoma.
  • Sequential (Cyclical) Combined: For perimenopausal individuals (regular or irregular periods). Oestrogen is taken daily; progesterone is added for 12–14 days of the cycle.
  • Continuous Combined: For postmenopausal individuals (at least 12 months since LMP). Oestrogen and progestogen are taken daily without a break.

The Mirena® IUS as Progestogen Protection

The Mirena® 52mg Intrauterine System (IUS) is highly effective as the progesterone component of combined HRT alongside systemic oestrogen.

Critical Safety Requirement (Repeat Template Documentation): To mitigate the risk of endometrial hyperplasia or malignancy arising from an expired, unprotected systemic oestrogen regimen, the patient's electronic medical record and repeat prescription template must explicitly state:

1. The exact date the Mirena® IUS was inserted.
2. The exact date the Mirena® IUS is due for change/removal.

Note: When used specifically for endometrial protection within an HRT regimen, the Mirena® system must be replaced according to local/national licensing guidelines (typically every 5 years), irrespective of its extended lifespan when used solely for contraception.

Route of Administration

• Oral: Standard choice but carries a small increased risk of VTE due to first-pass hepatic metabolism.
• Transdermal (Patches/Gels): Preferred for patients with a BMI >30, a history of migraines with aura, controlled hypertension, or an elevated risk of VTE, as transdermal delivery does not increase baseline VTE risk.
• Local/Vaginal Oestrogen: Indicated for isolated genitourinary symptoms. Can be used long-term without systemic progestogen protection.

Review Schedule and Monitoring 

Three-Month Review (Post-Initiation)

A review should take place 3 months after starting HRT or after any significant dose/regimen adjustment.

• Efficacy: Assess control of menopausal symptoms.
• Adherence & Tolerability: Monitor side effects (e.g., irregular bleeding, mood changes).
• Safety Check: Re-measure blood pressure and review bleeding patterns.
• Action: Titrate the dose or adjust the route/progestogen type if adverse effects persist or symptom control is inadequate.

Annual Review

All patients stabilized on HRT must be reviewed at least once every 12 months.

• Risk-Benefit re-assessment: Evaluate whether the benefits of symptom relief continue to outweigh potential risks (e.g., age-related increases in cardiovascular or breast cancer risk).
• Device audit: For patients utilizing a Mirena® IUS for endometrial protection, cross-reference the repeat template documentation to verify the device remains within its approved lifespan. Please refer to the unopposed Oestrogen protocol if you discover an out-of-date coil. 
• Bleeding patterns: Investigate any unexpected or unscheduled bleeding (e.g., postmenopausal bleeding, or new-onset heavy/prolonged bleeding on a continuous regimen) via urgent referral or pelvic ultrasound.
• Discussion of duration: There is no arbitrary limit on the duration of HRT. The decision to continue should be an informed, shared choice made annually based on the patient's ongoing symptoms and health status.

Licensed Preparations Only

Salisbury Medical Practice operates a Licensed Dose Policy for HRT. Clinicians must only initiate or repeat prescriptions for HRT preparations that hold a valid UK marketing authorization (MHRA license) and are prescribed within the explicit licensed dose limits set by the manufacturer. BMS guidelines are that to do otherwise, requires training as a BMS specialist.

SMP does not have this additional role as a permanent member of staff. Prescriptions must adhere to the traffic-light designations specified in the BSW ICB Joint Formulary (e.g., Green status for standard oral and transdermal therapies and Amber for specific specialist-initiated treatments like testosterone).

Rejection of Off-License Prescriptions

In accordance with BSW ICB prescribing directives and Wessex LMC advisory guidelines regarding clinical safety and liability boundaries, SMP declines to prescribe off-license HRT regimens.
This restriction applies to supra-physiological doses. Requests to prescribe oestrogen doses exceeding maximum licensed product boundaries even if recommended by private or tertiary clinics. Responsibility for this prescription falls with the prescriber not the specialist. Should an individual wish to seek this, ongoing prescriptions and monitoring would need to be continued by the initiating specialist.

Clinical Rationale (NICE/BMS): Prescribing supra-physiological or off-license doses of oestrogen without established safety data substantially escalates the risk of endometrial hyperplasia and uterine malignancy. The practice maintains a duty of care to protect patients from long-term adverse events.

Private-to-NHS Shared Care Transfer Requests

In line with BMA recommendations SMP does not accept shared care with private providers. There is no guarantee of ongoing specialist input leaving the practice responsible for specialist only medication.

Issue Refusal Notification

Patient and provider communication:

• Send a practice notification to the patient and the recommending specialist.
• State clearly that Salisbury Medical Practice declines the prescription transfer due to safety bounds, in alignment with published guidance.

Offer Licensed NHS Alternative

• Clinical Harm Reduction: Invite the patient for a consultation to initiate a safe, equivalent, fully licensed alternative regimen within the boundaries of NHS BSW ICB guidance.

Local Management of Testosterone Prescribing

In alignment with the BSW formulary guidelines topical testosterone only if the following criteria re met:

• It is initiated strictly after a trial of appropriate, optimized systemic licensed HRT has failed to resolve low libido (NICE NG23).
• Initiation follows a documented recommendation from a British Menopause Society (BMS) accredited specialist.
• Baseline and regular ongoing monitoring of Total Testosterone, Sex Hormone Binding Globulin (SHBG), and the calculated Free Androgen Index (FAI) are maintained within standard female physiological ranges to avoid masculinizing effects.