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 Formulary Chapter 6: Endocrine system - Full Chapter
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06.04.01.02  Expand sub section  Progestogens
Norethisterone 5mg tablets
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First Choice
Green
 
Levonorgestrel (Mirena®)
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Formulary
Green
  • Levonorgestrel 52mg in a T-shaped intra-uterine system. 
  • For idiopathic menorrhagia. Especially in women requiring (reversible) contraception. Also used for protection with endometrial hyperplasia during oestrogen replacement therapy. Lasts for up to 5 years - for use in accordance with agreed guidelines.
 
 
Medroxyprogesterone Acetate
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Formulary
Green

Approved Medroxyprogesterone formulations include:

  • 2.5mg, 5mg, and 10mg tablets (sometimes used as a progestogen component of HRT).
  • 100mg & 200mg tablets (for use in malignant disease see section 8.3.2).
  • 50mg in ml injection - see sections 7.3.2.2 for use of  medroxyprogesterone acetate injection in contraception.
 
 
Micronised progesterone (Utrogestan®)
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Formulary
  • 100mg oral capsules Green
  • Approved for:
    • adjunctive use with estrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT)
    • Perimenopause (off-label)
    • Premature ovarian insufficiency (off-label)
    • Adolescents undergoing pubertal induction following chemotherapy (off-label)


 
 
Progesterone
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Formulary
  • Approved formulations include:
    • 200mg & 400mg pessaries (Cyclogest®) Green
    • 25mg SC/IM injection (Lubion®) Red
      • Approved for luteal support in patients who have had a previous failed biochemical pregnancy in a froxen embryo transfer (FET) cycle
  • CD&TV Red for Luteal Phase support following IVF.
    • Full course to be supplied by hospital
  • CD&TV  Green plus to support the pregnancies of women who have a history of miscarriage or premature labour as per NICE NG25: Preterm labour and birth.
 
 
Ulipristal (Esmya®)
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Restricted Drug Restricted
Red
  • 5mg tablets

    • Approved for the pre-operative treatment of uterine fibroids for one 3 month course, as per its product licence.
    • Approved for the medical treatment of uterine fibroids in women unsuitable for surgery, up to a maximum of four 3 month intermittent courses, as per its product licence and reviewed regularly.
    • Contraindicated in women with underlying liver disorders.  
    • Requirements for liver function monitoring before, during, and after treatment
 
Link  MHRA Drug Safety Update (Feb 2021): Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury
 
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Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
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Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

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.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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