North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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Formulary Chapter 6: Endocrine system - Full Chapter

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NTAG Endocrine System Recommendations

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06.04.01.01

Oestrogens and Hormone Replacement Therapy HRT

Oestrogen conjugated tablets 625microgram and 1.2mg (Premarin^®)

Formulary

Estradiol patches/gel/spray
(Oestrogen only patches/gel)

Formulary

Twice weekly matrix patches releasing approximately 25, 37.5 (Estradot® only), 50, 75 & 100 microgram/24 hours (Estradot®,Evorel®, Estraderm® MX);
Weekly matrix patches releasing approximately 25, 50, 75 & 100 microgram/24 hours (Femseven®);
Once weekly matrix patches releasing approx. 50 & 100 microgram estradiol/24 hours (Progynova TS®)
Estradiol 0.1% gel (Sandrena®)
Estradiol 0.06% gel (Oestrogel®)
- Approved for use in gender dysphoria therapy
- Approved for use as hormone replacement therapy
Estradiol 1.53mg/spray transdermal spray (Lenzetto®)
- Approved as an alternative to patches and gels for patients who have issues with absorption, find patch adhesive irritating or the gel messy

Estradiol tablets
(Oestrogen only tablets)

Formulary

1mg and 2mg tablets

Ethinylestradiol
(Oestrogen only tablets)

Formulary

Note: ethinylestradiol 2microgram tablets are unlicensed.

Continuous combined HRT patch (Evorel® Conti)

Formulary

Combined cyclical HRT tablet (Elleste Duet^®)

Formulary

Pack of 16 x 1mg estradiol tablets + 12 x 1mg estradiol and 1mg norethisterone tablets

Combined cyclical HRT tablet (Femoston^®)

Formulary

Femoston® 1/10 Tablets:
- Pack of 14 x 1mg estradiol tablets + 14 tablets containing estradiol 1mg and dydrogesterone 10mg

Femoston® 2/10 Tablets:
- Pack of 14 x 2mg estradiol tablets + 14 tablets containing estradiol 2mg and dydrogesterone 10mg

Continuous combined HRT tablets (Elleste-duet Conti, Kliofem, Kliovance, Femosten Conti, Premique-low dose)

Formulary

Estradiol vaginal tablet

Formulary

10mg vaginal tablet
- Vagifem® 10mg vaginal tablets
- Vagirux® 10mg vaginal tablets (alternative)

Sequential combined cyclical HRT patch (Evorel® Sequi)

Formulary

Tibolone

Formulary

British Menopause Society update on HRT supply

MHRA Drug Safety Update (Aug 2019): Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping.

NENC ICB - Management of the Menopause

NICE NG23: Menopause: diagnosis and management

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Hormone replacement therapy

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Ethinylestradiol

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Raloxifene

Raloxifene Hydrochloride

Formulary

For use on the advice of specialists in the prevention and treatment of osteoporosis where alternative treatments are inappropriate.

NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women (Not Approved)

NICE TA161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women

06.04.01.01

Oestrogen only tablets

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Oestrogens and progestogen sequential combined therapy

06.04.01.01

Continuous combined therapy

06.04.01.01

Gonadomimetic

06.04.01.01

Selective oestrogen modulator

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Key

	Restricted Drug
	Unlicensed
	Link to adult BNF
	Link to children's BNF
	Link to SPCs
	Cytotoxic Drug
	Controlled Drug

	High Cost Medicine
	NHS England
	Homecare
	ICB
	Low carbon footprint
	Medium carbon footprint
	High carbon footprint

Status	Description
	Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.
	Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic. The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible. SCGs are available or are being developed for most of the drugs listed as AMBER.
	Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria. These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary. In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary. If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days.
	Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care.