The aim of this policy is to set out how the practice will safely and effectively support individuals who seek shared care for transgender medicine having consulted a specialist in gender medicine. The objective of the policy is to set out how we will provide safe and effective care which adheres to the Equality Act.

Recent years has seen very significant increases in the number of persons accessing NHS gender services, resulting in higher waiting times for treatment. A number of individuals have turned to the independent sector to seek advice. In some cases, our patients have then requested that we develop shared care protocol with their specialist. These arrangements would include clinical review, investigations, prescribing and administration of parenteral medicines by the practice.

To complicate the governance and safety, it is noted that there is no specialist register for transgender medicine, and as yet, no credentialing for this expertise.

There is not as yet a local NHS standard for shared transgender care, although there are attempts to develop this. In the absence of this as a gold standard, the practice will adopt the following principles:

• The practice will not prescribe ‘bridging’ medication – medicines being prescribed without the patient first being assessed by a transgender specialist or service.
• Where the practice is asked to provide shared care by an independent specialist, the practice will examine the governance around the specialist. We would normally limit shared care arrangements to specialists on the UK GMC specialist register in a related specialty, such as sexual health, endocrinology, psychiatry, urology, or gynaecology. Where the specialist is not on the specialist register, the practice will use its judgement to decide if the advice being provided meets our standards for safe shared care. Where the specialist is not registered and working in the UK, the practice reserves the right to decide if the arrangements are safe for shared care.
• The practice standard for shared care will be that set out by the National gender Identity Clinical Network for Scotland (www.ngicns.scot.nhs.uk/endocrine-treatment)
• Where the practice agrees to shared care, patients should be provided with a copy of this guidance and hey should be asked to share this with the specialist. Where the practice has contacted us directly, the practice will write to the specialist setting out our shared care arrangements so that they can ensure that any additional monitoring that they consider necessary, is carried out by the specialist service.
• It should be noted that shared care takes place in the context of an ongoing review process with the transgender specialist. Where the care starts in the independent sector and the patient is seeking or waiting for the NHS service review, the practice will facilitate the referral and subject to the provisions above, deliver shared care with the proviso that the patient provides us with the scheduled dates of review by the independent specialist. Without ongoing review, shared care and prescribing cannot continue. Given the need for safety, and the potential financial implications for individual patients, the patient must agree to this at the outset of treatment through a shared care agreement which can be found in appendix C. This should be signed and kept in the patient’s docman record.

Appendix A – Feminising Endocrine Treatment

This section relates to patients originally assigned male at birth, identifying as trans women, trans feminine or non-binary.

Baseline assessment: Responsibility of Gender Specialist

• Medical, family and sexual histories; particular concerns are hypertension, thromboembolic disease, migraine, breast disease, liver disease and prostate disease. Patients with significant co-morbidities should be referred for an endocrinological opinion at a service local to the patient.
• Assess cardiovascular risk status (BNF or www.qrisk.org).
• Glucose, U and E, and lipid profile (preferably fasting).
• LFT
• Prolactin.
• Consider PSA if age is greater than 50yrs or symptomatic.
• Consider HIV, Hepatitis B core Antibody, Hepatitis C Antibody, and sexual health screen. Consider Hepatitis A and B and HPV vaccination if sexual history indicates higher risk.
• BMI on its own should not be a contraindication of hormone treatment. However, people with higher BMI/BMI deemed within the unhealthy range should be counselled re additional risks of taking hormones, offered weight-loss assistance and informed in clear terms that BMI limits for surgery exist and surgery may not be possible for patients with a high BMI.

Monitoring of patients on established hormonal therapy: Responsibility of Primary Care

• Hormone blood tests as below on a 3-4 monthly basis for the first year (this would usually be undertaken by the specialist gender service until patient is on a stable medication regime) and 12 monthly thereafter.
• Monitor cardiovascular risk including blood pressure, height, weight and lipid profile annually if risk factors present.
• LFT annually.
• Serum estradiol (aiming for levels not higher than 600pmol/L; if greater than 600pmol/L seek advice from GIC).
• Prolactin (if greater than 1000mU/L seek advice from endocrinology).
• If on spironolactone: U+E annually.
• Maintain awareness of prostatic disease and institute appropriate investigations should lower urinary tract symptoms occur. PSA monitoring is not required.
• Breast cancer screening as for natal female guidelines.
• DEXA scanning is only recommended for patients who cannot take estrogen or testosterone and who have been on a GnRH analogue treatment alone for more than 12 months. Refer to local Board guidance on management of osteoporosis.
• Patients migrating to Scotland on established, stable hormone therapy should be allowed to continue without re-undergoing assessment, but in the case of any concerns, referral to GIC or endocrinology should take place.
• Exclusion from cervical screening recall should be actioned using the ‘no cervix’ code.

Medication

Patients will usually attend regular GIC appointments for review while hormone dosages are adjusted. The GIC will liaise closely with the patient’s Primary Care Provider until a stable hormonal regimen is established. Estrogen doses are gradually increased e.g. 1-2mg oral estradiol increased by 1-2 mg increments until therapeutic range and clinical efficacy appropriate.

• Monitor estradiol level at clinic visits (3-4 monthly during first year, then annually) and increase dose of estradiol aiming to achieve estradiol levels in range 200-600pmol/L.
• Androgen suppression is recommended for all patients who do not suppress androgen levels with estrogen alone. This occurs in approximately 1 in 3 patients after 3-6 months.
• Should androgen suppression not occur, anti-androgen therapy can be offered.

Typical medication regimes may include:

• Transdermal estradiol patches (initially 40-50mcg changed twice weekly but increase to up to 160-200mcg changed twice weekly) recommended for use in patients over 40 and in patients with cardiovascular risk factors, high BMI, liver disease or patient preference

Or

• Oral estradiol 1mg to 6mg daily

Or

• Estradiol gel 1-3mg daily
• Estradiol level in the range 200-600pmol/L is appropriate.
• If there are availability issues, it is acceptable to switch to other equivalent prescriptions.

Generic prescribing is recommended.

Progesterone (or synthetic progestogens) is of no proven benefit in this patient group and is not recommended.

Androgen suppression

• Leuprorelin/Triptorelin 3.75mg 4 weekly or 11.25mg 12 weekly by IM injection*

Or

• Goserelin 3.6mg implant subcutaneously 4 weekly or 10.8 mg implant 12 weekly*

Or

• Cyproterone Acetate (25-100 mg daily: 6 monthly checks of LFTs are necessary as serious hepatotoxicity has been reported)
• Finasteride 5mg daily and Spironolactone (50 -100mg daily) are not recommended as they are less effective in androgen suppression although may help with hirsutism (NB ensure normal renal function with spironolactone and monitor for possible hyperkalaemia).

*If prescribing GnRH analogues a short term prescription of Cyproterone Acetate 100mg daily for 10 days only may be useful at the time of first GnRH administration to prevent the effects of a short-lived increase in testosterone levels.

Surgery

Individual guidance regarding cessation and restarting of hormone therapy should always be sought from the surgical team. For gender related surgery, surgeons currently recommend  that estrogen therapy should be ceased 6 weeks prior to surgery, and resumed 3 weeks after surgery if there are no complications. The surgeon will usually communicate directly with GPs before and after surgery. Androgen suppression is not required after orchidectomy.

Gender related surgery could include: Orchidectomy, penectomy, vaginoplasty, clitoroplasty, labiaplasty, breast augmentation, facial feminisation surgery and tracheal shave. It should be noted that there are strict cut-offs with regard to BMI for surgery as set by the surgical providers, and commencement of hormones does not mean that a patient has a BMI which is suitable for surgery.

Post operative care

The estrogen dose should continue to be monitored post operatively with circulating estradiol levels maintained below 600pmol/L.

Where bloods are being monitored in primary care these will be shared with the patient who must then share these with the specialist in a timely way. The specialist can then inform the patient and practice about changes to medications or monitoring.

Appendix B – Masculinising Endocrine Treatment

This section relates to patients originally assigned female at birth, identifying as men, trans masculine or non-binary.

Baseline assessment by Gender Specialist Service

• Medical, family, sexual histories and menstrual histories are taken; particular concerns are hypertension, breast disease, heavy menstrual bleeding and haematological disease. Patients with significant co-morbidities should be referred for an endocrinological opinion at a local service.
• Assess cardiovascular risk (BNF or www.qrisk.org).
• FBC, LFT, glucose and lipid profile (preferably fasting).
• Consider hormonal profile if history of irregular menses (LH, FSH, estradiol, testosterone, prolactin).
• Consider HIV, Hepatitis B core Antibody, Hepatitis C Antibody, and sexual health screen.
• Consider Hepatitis A and B vaccination if sexual history indicates higher risk. Consider HPV vaccination if at risk and missed school vaccination programme.
• BMI on its own should not be a contraindication for hormone treatment. However, people with high BMI/BMI deemed within the unhealthy range should be should be counselled re the additional risk of taking hormones with a higher BMI, offered weight-loss assistance and clearly informed that strict BMI limits for surgery exist and surgery may not be possible for patients with a high BMI.

Monitoring (Specialist Gender Service OR Primary Care)

On a 3-4 monthly basis for the first year and 12 monthly thereafter.

• Cardiovascular risk assessment, including blood pressure, height, weight and lipid profile annually.
• FBC (Hb and haematocrit).
• For parenteral treatment monitor testosterone trough level (Ideal 9-15 nmol/L), if more than 20nmol/L discuss with GIC).
• For transdermal preparations monitor testosterone level (should be within normal male range; beware taking blood from the arm to which testosterone is applied)
• Cervical screening should continue as for female guidelines if cervical tissue is present, however, sensitive discussion of this should take into account the patient’s dysphoria.
• Breast screening should also follow female guidelines if mastectomy has not been performed.
• Monitoring for osteoporosis if high risk for osteoporotic fracture or prolonged periods of hypogonadism. DEXA scanning is only routinely recommended for gender patients who cannot take estrogen or testosterone and who have been on a GnRH analogue treatment alone for more than 12 months. Refer to local guidance on management of osteoporosis.

Medication

Patients will usually attend regular GIC appointments for review while hormone dosages are adjusted. The GIC will liaise closely with the patient’s Primary Care Provider until a stable  hormonal regimen is established. Testosterone is introduced gradually and slowly titrated to avoid adverse reactions e.g. affective changes, amongst others.

Initiation phase (GIC)

Gradual introduction of testosterone:

• Transdermal testosterone 1% (eg Testogel or Testim sachets) 50mg on alternate days for 2 months, increasing to 50mg-100mg daily thereafter
• Transdermal testosterone pump dispensers:
  • Tostran 2%; 10mg/press. 20mg per day for 2 months, increasing to 40- 60mg daily thereafter, ie 2 presses increasing to 4-6 presses.
  • Testogel 16.2mg/g; 20.25mg/press. 20.25mg per per day for 2 months, increasing to 40.5 mg daily thereafter, ie 1 press increasing to 2 presses

Or

• Sustanon or testosterone enantate, 125mg three weekly for 2-3 months, increase to 250mg 3 weekly if well tolerated and testosterone levels subtherapeutic
• After 6 months patients either continue on the treatment they are on or can be offered the maintenance treatments below.
• Note that topical DHT for clitoral growth is not recommended. Please note that administration differs by topical testosterone product, please see Summary of Product Characteristics for detailed administration information when prescribing (links below).

Tostran 2% gel product information: www.medicines.org.uk/emc/product/332

Testogel 16.2mg/g gel product information: www.medicines.org.uk/emc/product/8919/smpc

Testim 50mg gel product information: www.medicines.org.uk/emc/product/6614

GnRH analogues can be prescribed for cessation of menses. These should be stopped once patient is established on testosterone, typically after 6 months.

• Goserelin 3.6mg implant subcutaneously 4 weekly or 10.8 mg implant 12 weekly

Or

• Leuprorelin/Triptorelin 3.75mg 4 weekly or 11.25mg 12 weekly by IM injection.

Maintenance treatments

• Testosterone undecanoate (Nebido) 1000mg intramuscular injections 10-14 weekly

Or

• Testosterone (Sustanon or Enantate) intramuscular injections 125-250 mg 2-3 weekly

Or

• Transdermal testosterone (Testogel, Testim, Tostran) 40-100mg daily.
• Sustanon results in very large variation of serum testosterone levels over the 3 week cycle of administration, and is therefore less preferred to longer acting injectable treatment.
• If there are availability issues, it is acceptable to switch to other prescriptions of the closest equivalent dose. Generic prescribing is recommended. Testosterone oral preparations are not recommended

Surgery

Individual guidance regarding cessation and restarting of hormone therapy should always be sought from the surgical team.

Gender related surgery could include:

Chest reconstruction, mastectomy, yysterectomy, salpingo-oophorectomy, vaginectomy, metoidioplasty, phalloplasty, urethroplasty, scrotoplasty, testicular prostheses.

It should be noted that there are strict cut-offs with regard to BMI for surgery, and commencement of hormones does not mean that a patient has a BMI which is suitable for surgery.

Post operative care

The testosterone dose should continue to be monitored post operatively aiming for circulating concentrations as described above under ‘monitoring’.

Where bloods are being monitored in primary care these will be shared with the patient who must then share these with the specialist in a timely way. The specialist can then inform the patient and practice about changes to medications or monitoring.

Appendix C