netFormulary South East London Joint Medicines Formulary NHS
Guy's and St Thomas' NHS Foundation Trust
Kings College Hospital NHS Foundation Trust
Lewisham and Greenwich NHS Trust
 
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 Formulary Chapter 6: Endocrine system - Full Chapter
Notes:

Where a formulary entry does not detail a medicine’s indications for use, the medicine can be assumed to be approved for all licensed indications.

Formulary approved "off-label" use is detailed separately.

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06.01  Drugs used in diabetes
06.01.01  Insulins
06.01.01.01  Short-acting insulins
Insulin Aspart  (NovoRapid®)
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Formulary  
   
Insulin Lispro 100 units/ml (Humalog®)
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Formulary  
   
Soluble insulin - human (Actrapid®, Humulin S®)
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Formulary

Approved for licensed use, and the following off-label indication:

Hyperkalaemia - Use in accordance with locally approved guidelines

 
   
Insulin 500 units in 1mL (Humulin R U-500®)
Unlicensed Drug Unlicensed
Red

Concentrated injection

Restricted use – initiation restricted to named consultants only (Dr David Hopkins, KCH)

Continuation of supply and monitoring remains the responsibility of the hospital

 
   
06.01.01.02  Intermediate- and long-acting insulins
Isophane Insulin - human sequence (Humulin I®, Insulatard®)
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Formulary  
   
Insulin Detemir (Levemir®)
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Formulary  
   
Insulin Glargine 100 units/ml (Abasaglar®)
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Formulary

First line insulin glargine 100 unit/mL product when initiating insulin glargine treatment

Insulin glargine 100 units/mL should be prescribed by brand name

Patients whose clinical condition remains stable on Lantus® should continue on their current treatment.

Blanket switching of patients between different insulin glargine preparations is not supported.

Refer to the SE London APC biosimilar glargine 100 units/mL position statement

 
Link  SE London Area Prescribing Committee biosimilar insulin glargine 100 units/mL position statement
   
Insulin Glargine 100 units/ml (Lantus®)
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Formulary

Not for initiation in new patients (use Abasaglar 100 units/mL insulin glargine biosimilar).

Insulin glargine 100 units/mL to be prescribed by brand name

Patients whose clinical condition remains stable on Lantus® should continue on their current treatment.

Blanket switching of patients between different insulin glargine preparations is not supported.

Refer to SE London APC insulin glargine 100 units/mL biosimilar position statement.

 
Link  SE London Area Prescribing Committee biosimilar insulin glargine 100 units/mL position statement
   
Insulin Glargine 300 units/ml (Toujeo®)
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Restricted Drug Restricted
Amber 2

Specialist initiation only

Restricted to patients already on long acting insulin analogues (e.g. insulin glargine or detemir) who:

  • Experience painful injections with high volumes (>60 units in a single injection) of their current 100 units/ml long acting insulin analogue and/or
  • Suffer from recurrent episodes of nocturnal hypoglycaemia

Not bioequivalent to insulin glargine 100 units/ml dose for dose. Switches to Toujeo® from other insulins require dose adjustment (see SPC and below for further information)

 
Link  SE London APC recommendation: Toujeo for type 2 diabetes in adults
Link  MHRA Apr 2015: High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error
Link  Toujeo: Guide for healthcare professionals
   
Insulin Degludec (Tresiba®)
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Restricted Drug Restricted
Amber 3

Specialist initiation only

Monitoring and continuation of care remains the responsibility of the Specialist for the first 3 months, after which care may be transferred to primary care in accordance with the Transfer of Care document

Restricted to use in children >1 year and adults with type 1 diabetes where:

  • Both insulin detemir and insulin glargine have been tried and the patient still has poorly controlled diabetes and
  • The next step would otherwise be an insulin pump and
  • Psychosocial or other factors indicate the need for longer duration insulin to facilitate continued treatment and avoid decompensation due to the mismanagement of insulin and
  • There have been frequent emergency admissions
 
Link  SE London APC Recommendation: Insulin Degludec for diabetes
Link  SE London APC: Insulin Degludec Transfer of Care Document
   
Isophane Insulin - highly purified animal (Hypurin® Bovine Isophane)
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Formulary  
   
06.01.01.02  Biphasic insulins to top
Biphasic Insulin Aspart (NovoMix® 30)
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Formulary  
   
Biphasic Insulin Lispro (Humalog® Mix)
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Formulary  
   
Biphasic Isophane Insulin (Humulin® M3)
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Formulary  
   
06.01.01.03  Hypodermic equipment
06.01.01.03  Needles
06.01.01.03  Lancets
06.01.02  Antidiabetic drugs
06.01.02.01  Sulphonyureas to top
Glibenclamide tabs
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Formulary  
   
Gliclazide tabs
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Formulary  
   
Glipizide tabs
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Formulary  
   
Tolbutamide tabs
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Formulary  
   
06.01.02.02  Biguanides
Metformin tabs, m/r tabs, oral solution
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Formulary Prescribing of oral solution should be restricted for patients who are unable to swallow tablets 
   
Metformin tabs
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Formulary

Approved off-label indications:

1. Gestational diabetes - use in accordance with the NICE guidance on diabetes in pregnancy

2. Polycystic ovary syndrome - Dose = 500 mg twice or three times daily

 
Link  NICE NG3: Diabetes in pregnancy: management from preconception to the postnatal period
   
06.01.02.03  Other antidiabetic drugs
06.01.02.03  Alpha glucosidase inhibitors
Acarbose tabs
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Formulary  
   
06.01.02.03  GLP-1 mimetics
Dulaglutide injection
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Formulary
Amber 3

Follow SE London APC GLP-1 guidance for criteria for use

Initiation by specialist only.

Ongoing supplies can be requested from primary care after the 3 months review using the transfer of care document (links below)

 
Link  SE London APC recommendation: Dulaglutide for Type 2 diabetes
   
Exenatide prolonged release injection (Bydureon▼®)
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Formulary
Amber 3

Follow SE London APC GLP-1 guidance for criteria for use

Initiation by specialist only.

Ongoing supplies can be requested from primary care after the 3 months review using the transfer of care document (links below)

 
   
Liraglutide injection
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Formulary
Amber 3

Follow SE London APC GLP-1 guidance for criteria for use

Initiation by specialist only.

Ongoing supplies can be requested from primary care after the 3 months review using the transfer of care document (links below)

 
   
Lixisenatide injection
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Formulary
Amber 3

Follow SE London APC GLP-1 guidance for criteria for use

Initiation by specialist only.

Ongoing supplies can be requested from primary care after the 3 months review using the transfer of care document (links below)

 
Link  SE London APC recommendation: Lixisenatide or exenatide with insulin in type 2 diabetes
   
06.01.02.03  DPP4 inhibitors (gliptins) to top
Linagliptin tabs
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Restricted Drug Restricted Reserved for use in patients with severe renal impairment (eGFR <30 mL/min) 
   
Sitagliptin tabs
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Formulary  
   
06.01.02.03  SGLT2 inhibitors
Canagliflozin tabs
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Formulary
Green
 
Link  MHRA Advice - SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis, April 2016
Link  MHRA Mar 2017: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation
Link  NICE TA315: Canagliflozin in combination therapy for treating type 2 diabetes
Link  NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
   
Dapagliflozin tabs
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Formulary
Green
 
Link  MHRA Advice - SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis, April 2016
Link  MHRA Mar 2017: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation
Link  NICE TA288: Dapagliflozin in combination therapy for treating type 2 diabetes
Link  NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
Link  NICE TA418: Dapagliflozin in triple therapy for treating type 2 diabetes
   
Empagliflozin tabs
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Formulary
Green
 
Link  MHRA Advice - SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis, April 2016
Link  MHRA Mar 2017: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation
Link  NICE TA336: Empagliflozin in combination therapy for treating type 2 diabetes
Link  NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
   
Ertugliflozin tabs
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Formulary
Green

 

 
Link  MHRA Advice - SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis, April 2016
Link  MHRA Mar 2017: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation
Link  NICE TA572: Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes
Link  NICE TA583:Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes
   
06.01.02.03  GLP1 agonists
06.01.02.03  Meglitinides
Repaglinide tabs
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Formulary  
   
06.01.02.03  SGL2 inhibitors
06.01.02.03  Other to top
06.01.02.03  Thiazolidinediones
Pioglitazone tabs
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Formulary  
Link  MHRA Advice - Insulin combined with pioglitazone: risk of cardiac failure, January 2011
Link  MHRA Advice - Pioglitazone: risk of bladder cancer, August 2011
   
06.01.02.07  Other antidiabetic drugs
06.01.03  Diabetic ketoacidosis
06.01.04  Treatment of hypoglycaemia
Glucagon injection (GlucaGen® HypoKit)
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Formulary  
   
Glucose oral gel 40%
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Formulary  
   
06.01.04  Chronic hypoglycaemia to top
Diazoxide tabs
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Formulary
Red
 
   
06.01.05  Treatment of diabetic nephropathy and neuropathy
06.01.06  Diagnostic and monitoring agents for diabetes mellitus
Flash glucose monitoring (Freestyle libre®)
Formulary
Amber 3

Approved for use in the patient groups as listed in the Area Prescribing Committee Position Statement (link below)

 
Link  APC Position Statement: Flash Glucose Monitoring systems
Link  Flash Glucose initiation letter
Link  Flash Glucose Monitoring in South East London - Guidance and Pathway
Link  Flash Glucose patient prescriber agreement and transfer of prescribing
Link  Flash Glucose 6-9 month review letter
Link  Flash Glucose Community Pharmacy Information Sheet
Link  Flash Glucose Competencies and Resources
Link  Flash Glucose Patient FAQ
Link  Flash Glucose Primary Care information Sheet
Link  South East London Flash Glucose - safe disposal arrangements
   
06.01.06  Blood glucose monitoring
Advantage II®
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Formulary NOT TO BE USED BY PATIENTS UNDERGOING CAPD 
   
BM-Accutest®
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Formulary Glucose monitoring 
   
Glucostix®
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Formulary  
   
MediSense® Optium H
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Formulary For blood glucose monitoring on wards and outpatient departments 
   
Multistix 8 SG®
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Formulary  
   
StatStrip®
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Formulary For blood glucose and ketone monitoring within GSTFT 
   
06.01.06  Urinalysis
Albustix®
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Formulary

Protein detection

 
   
Combur Test® 7
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Formulary Blood, leucocytes, nitrate, glucose, protein, ketone and pH detection 
   
Diastix®
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Formulary Glucose detection 
   
Ketostix®
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Formulary Ketones detection 
   
Uristix®
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Formulary Glucose and protein detection 
   
06.01.06  Blood glucose meters for adults with type 2 diabetes to top
06.01.06  Blood glucose meters for children and adults with type 1 diabetes
06.01.06  Blood glucose meters for patients on continuous insulin infusion pump
06.01.06  Blood glucose meters for patients with dexterity problems
06.01.06  Talking blood glucose meters
06.02  Thyroid and Antithyroid drugs to top
06.02.01  Thyroid hormones
Levothyroxine tabs, oral solution
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Formulary  
   
Liothyronine injection
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Formulary
Red
High Cost Medicine

 
   
Liothyronine tabs (resistant depression - off-label)
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Formulary
Red

Approved for:

Monotherapy or combination therapy for the treatment of resistant depression

Consultant psychiatrist initiation only where no other options have worked.

See APC Position Statement (link below) for further details.

 
Link  SE London APC Position Statement: Liothyronine monotherapy or combination therapy for the treatment of resistant depression
   
Liothyronine tabs (thyroid replacement prior to radioiodine)
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Formulary
Red

Approved for:

Temporary thyroid replacement therapy after thyroidectomy and prior to radioiodine therapy.

Hospital only prescribing

See APC Position Statement (link below) for further details.

 
Link  SE London APC Recommendation: Liothyronine tablets for temporary thyroid replacement therapy after thyroidectomy and prior to radioiodine therapy
   
06.02.02  Antithyroid drugs
Aqueous Iodine oral solution (Lugol's)
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Formulary  
   
Carbimazole tabs
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Formulary Refer to BNF for CSM advice on neutropenia and agranulocytosis 
Link  MHRA Feb 19: Carbimazole: increased risk of congenital malformations; strengthened advice on contraception
Link  MHRA Feb 19: Carbimazole: risk of acute pancreatitis
   
Propylthiouracil tabs
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Methylthioninium chloride injection 0.5%, 1%, 2% (methylene blue)
Unlicensed Drug Unlicensed
Red

Diagnostic agent used for staining parathyroid glands.

Maximal staining of glands occurs if infused intravenously for 1 hour prior to operation

Dose: 5 mg/kg actual body weight in 250 mL dextrose/saline

 
Link  MHRA Apr 2009: Methylthioninium chloride (methylene blue): update on central nervous system (CNS) toxicity with serotonergic antidepressants
   
Methylthioninium chloride injection 2% (methylene blue)
Unlicensed Drug Unlicensed
Red

For testing intragastric balloon insertions and as a dye for patients with polyps undergoing colonoscopies (Endoscopy/Day Surgery)

For checking bladder patency secondary to injury during C-sections and checking fallopian tube patency (Birth Centre Theatres)

 
Link  MHRA Apr 2009: Methylthioninium chloride (methylene blue): update on central nervous system (CNS) toxicity with serotonergic antidepressants
   
Potassium Iodate tabs
Unlicensed Drug Unlicensed

Protection of thyroid function during radioactive iodine therapy

Dose: 130 mg daily

 
   
06.03  Corticosteroids
06.03.01  Replacement therapy
Fludrocortisone tabs
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Formulary

Approved for licensed indication(s) and for the treatment of Postural Orthostatic Tachycardia Syndrome (POTS)/Inappropriate Sinus Tachycardia (IST) - see information regarding fludrocortisone within the SE London APC recommendation for midodrine in POTS/IST (link below). 


 
Link  SE London APC Recommendation: Midodrine for the treatment of Postural Orthostatic Tachycardia Syndrome (POTS)/Inappropriate Sinus Tachycardia (IST)
   
06.03.02  Glucocorticoid therapy to top
Betamethasone soluble tabs, injection
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Formulary  
   
Betamethasone tabs
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Formulary  
   
Cortisone tabs
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Formulary  
   
Dexamethasone injection (palliative care)
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Formulary
Amber 1

GPs may be asked to prescribe dexamethasone injections as part of palliative care in the community setting

Palliative care recommendation only

 
   
Dexamethasone tabs, oral solution, injection
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Formulary  
   
Hydrocortisone MR tabs (Plenadren®)
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Formulary
Red

Consultant specialists only

Restricted to patients with primary adrenal insufficiency (AI) who have experienced at least two hospital admissions in the last 12 months due to unstable AI.

Use in secondary AI is not currently recommended

 
Link  SE London APC recommendation: Plenadren for primary adrenal insufficiency in adults
   
Hydrocortisone sodium succinate injection (Solu-Cortef)
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Formulary

 
   
Hydrocortisone sodium succinate injection (Solu-Cortef - off-label intrathecal use in haemato-oncology)
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Formulary
Red

Approved off-label use:

  • Intrathecal use in haemato-oncology chemotherapy regimens
  • Solu-Cortef brand must be used
  • Internal Trust guidance and protocols should be strictly followed
 
   
Hydrocortisone tabs
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Formulary

 
   
Methylprednisolone acetate depot injection (Depo-Medrone®)
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Formulary  
   
Methylprednisolone sodium succinate injection (Solu-Medrone®)
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Formulary  
Link  MHRA Oct 17: Methylprednisolone injectable medicine containing lactose (Solu-Medrone 40 mg): do not use in patients with cows’ milk allergy
   
Methylprednisolone tabs
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Formulary  
   
Prednisolone tabs, soluble tabs
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Formulary Prednisolone enteric coated tablets are non-formulary 
   
Triamcinolone acetonide injection (Kenalog® - asthma)
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Restricted Drug Restricted
Red

Specialist asthma clinic at GSTFT only

For treatment of severe asthma

Restricted to use in patients requiring continuous use of oral steroids where response to oral treatment has been insufficient

 
   
Methylprednisolone sodium succinate injection (Solu-Medrone® - intratympanic use [off-label])
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Formulary
Red

Approved off-label indication:

Intratympanic injection for sudden sensorineural hearing loss or Meniere’s disease

Dose = 40mg, with a maximum of 3 injections 1 week apart

Consultant ENT specialist use only

 
   
Prasterone caps (DHEA)
Unlicensed Drug Unlicensed Treatment of adrenal insufficiency Dose: 25-50 mg daily 
   
06.04  Sex hormones
06.04.01  Female sex hormones and their modulators
06.04.01.01  Oestrogens and HRT
Cyclo-Progynova® tabs (estradiol valerate and norgestrel)
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Formulary  
   
Duavive® MR tabs (Conjugated oestrogens and bazedoxifene)
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Restricted Drug Restricted
Amber 2

Secondary care initiation only

Restricted to use (as per product licence) where progestin containing therapy is not appropriate

 
Link  APC recommendation: Duavive for oestrogen deficiency in the menopause
   
Estraderm ® patches (estradiol)
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Formulary  
   
Estradiol 0.06% gel (Oestrogel)
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Formulary
Green

For oestrogen deficiency symptoms in postmenopausal women who have experienced adverse reactions to HRT patches, e.g. skin irritation

First choice topical oestrogen gel for HRT

See APC recommendation for further information 

 
Link  APC recommendation: Estradiol gels - for oestrogen deficiency symptoms in postmenopausal women
   
Estradiol 0.5mg gel (Sandrena®)
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Formulary
Green

For oestrogen deficiency symptoms in postmenopausal women who have experienced adverse reactions to HRT patches, e.g. skin irritation

Second choice topical oestrogen gel for HRT

See APC recommendation for further information

 
Link  APC recommendation: Estradiol gels - for oestrogen deficiency symptoms in postmenopausal women
   
Estradiol tabs
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Formulary  
   
Evorel® Conti patches (estradiol and norethisterone)
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Formulary  
   
Evorel® patches (estradiol)
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Formulary  
   
Evorel® Sequi patches
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Formulary Combination of estradiol only and estradiol and progesterone patches (sequential use) 
   
Femoston® tabs (estradiol with dydrogesterone)
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Formulary  
   
FemSeven® patches (estradiol)
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Formulary  
   
Hormonin® tabs (estradiol)
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Formulary  
   
Kliofem® tabs (estradiol and norethisterone)
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Formulary  
   
Kliovance® tabs (estradiol and norethisterone)
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Formulary  
   
Premarin® tabs (conjugated oestrogens)
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Formulary  
   
Tibolone tabs
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Formulary  
   
Trisequens® tabs (estradiol and norethisterone)
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Formulary  
   
Femoston Conti® tabs (estradiol with dydrogesterone)
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Formulary  
   
Estradiol implants 25mg and 50mg
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Unlicensed Drug Unlicensed

Approved for use in:

  • HRT for estrogen deficiency symptoms in postmenopausal women
  • Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis

Dose: 25-100 mg subcutaneously, every 4-8 months

 
   
06.04.01.01  Ethinylestradiol
Ethinylestradiol tabs
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Formulary  
   
06.04.01.01  Raloxifene to top
Raloxifene tabs
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Formulary  
Link  NICE TA160: Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women
Link  NICE TA161: Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women
   
06.04.01.01  Oestrogen only tablets
06.04.01.01  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 to top
06.04.01.02  Progestogens
Medroxyprogesterone acetate tabs
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Formulary  
   
Norethisterone tabs
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Formulary  
   
Progesterone (micronised) oral caps (Utrogestan®)
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Formulary

 
   
Progesterone pessaries (Cyclogest®)
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Formulary  
   
Ulipristal tabs (Esmya®)
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Formulary
Red

Approved for ONE treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids. See SEL APC recommendation (link below) for more detailed prescribing advice.

Liver function monitoring is to be carried out in all women treated with ulipristal (see MHRA link below and product SPC for more information)

 
Link  Aug 18 - MHRA Alert: Esmya (ulipristal acetate) and risk of serious liver injury: new restrictions to use and requirements for liver function monitoring before, during, and after treatment
Link  SE London APC Recommendation: Ulipristal acetate 5mg tablets (Esmya®) for the pre-operative treatment of moderate to severe symptoms of uterine fibroids
   
Ulipristal tabs (Esmya®)
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Formulary
Amber 2

Approved for intermittent treatment of moderate to severe uterine fibroids in women of reproductive age - who are not eligible for surgery. See SEL APC recommendation (link below) for more detailed prescribing advice.

First treatment course (i.e. 3 month supply) to come from hospital.

Liver function monitoring is to be carried out in all women treated with ulipristal (see MHRA link below and product SPC for more information)

 
Link  
Link  Aug 18 - MHRA Alert: Esmya (ulipristal acetate) and risk of serious liver injury: new restrictions to use and requirements for liver function monitoring before, during, and after treatment
Link  SE London APC Recommendation: Ulipristal acetate 5mg tablets (Esmya®) for the intermittent treatment of moderate to severe uterine fibroids in women of reproductive age
   
Progesterone pessaries (Cyclogest®)
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Formulary

Approved off-label indication:

Assisted conception Dose: 400 mg twice daily

 
   
06.04.02  Male sex hormones and antagonists
Testosterone gel  (Tostran®, Testogel®)
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Formulary
Amber 1

Intitiation by specialist only

Male hypogonadism due to androgen deficiency (confirmed by clinical features and biochemical tests)

 
   
Testosterone gel  (Tostran®, Testogel® - off-label menopausal women)
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Formulary
Amber 2

Approved off-label indication: For use in women with decreased libido in the menopause

See SEL APC recommendation for more detailed information including dosage (link below) as well as supporting patient information leaflet 

 
Link  Patient information leaflet: Testosterone gel or sachets for the treatment of low sex drive in the menopause
Link  SE London APC Recommendation: Testosterone in topical gel formulation for use in women with decreased libido in the menopause (Tostran™ 2% gel and Testogel™ 50mg in 5 grams)
   
Testosterone salts injection (Sustanon 250®)
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Formulary
Amber 1

 
   
Testosterone undecanoate caps (Restandol Testocaps®)
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Formulary
Amber 1
 
   
Testosterone undecanoate injection (Nebido®)
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Formulary
Amber 1
 
   
Testosterone implant
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Unlicensed Drug Unlicensed
Red
Imported product - not licensed in the UK 
   
06.04.02  Anti-androgens
Cyproterone acetate tabs
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Formulary
Amber 2
 
   
Finasteride tabs
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Formulary  
Link  NICE CG97: Lower urinary tract symptoms
   
06.04.03  Anabolic steroids
Nandrolone injection
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Formulary  
   
06.04.04  Gender dysphoria to top
06.05  Hypothalamic and pituitary hormones and anti-oestrogens
06.05.01  Hypothalamic and anterior pituitary hormones and anti-oestrogens
06.05.01  Anti-oestrogens
Clomifene tabs
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Formulary
Amber 2
 
   
06.05.01  Anterior pituitary hormones
Chorionic gonadotrophin injection
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Formulary
Red
 
   
Follitropin alfa injection
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Formulary
Red

Biosimilar products available, to be prescribed by brand name.

Contact pharmacy department for advice on brand for routine prescribing if unsure

Note: 1st choice product at KCH is the Ovaleap brand ®

 
   
Follitropin beta injection
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Formulary
Red
 
   
Human menopausal gonadotrophins (menotrophin)
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Formulary
Red
 
   
Pegvisomant injection
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Formulary
Red
High Cost Medicine
BlueTeq

Use under specialist supervision only

Third line, as per criteria in NHSE policy 16050/P

 
Link  NHSE 16050/P: Pegvisomant for acromegaly as a third - line treatment (adults)
   
Somatropin injection
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Formulary
Amber 3
High Cost Medicine

Initiation by specialist only

 
Link  NICE TA188: Human growth hormone (somatropin) for the treatment of growth failure in children (review)
Link  NICE TA64: Growth hormone deficiency (adults) - human growth hormone
Link  SE London APC Shared Care Agreement: Somatropin in paediatrics
   
Tetracosactide injection, depot injection
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Formulary
Red
 
   
Thyrotropin alfa injection
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Formulary
Red
 
   
Arginine injection
Unlicensed Drug Unlicensed Assessment of growth disorders; hyperammonaemia; metabolic alkalosis 
   
Corticotrophin releasing hormone injection
Unlicensed Drug Unlicensed Test for adrenal insufficiency 
   
06.05.01  Hypothalmic hormones to top
Gonadorelin injection
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Formulary
Red
 
   
Protirelin injection
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Formulary
Red
 
   
Sermorelin injection
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Formulary
Red
 
   
06.05.02  Posterior pituitary hormones and antagonists
06.05.02  Posterior pituitary hormones
Desmopressin nasal spray (licensed use)
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Formulary

To be used as per licensed indications only (see SPC)

Following MHRA safety advice, desmopressin nasal spray must not be prescribed for primary nocturnal enuresis

 

 
Link  MHRA Sept 2007: Desmopressin nasal spray: removal of nocturnal enuresis indication
   
Desmopressin injection (kidney biopsy -off-label)
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Formulary
Red

Approved for all licensed indications and the following off-label indication:

Administered before a kidney biopsy to reduce the risk of bleeding

 
   
Terlipressin injection
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Formulary
Red

Approved off-label indication:

Hepatorenal syndrome

For initiation on specialist advice only

 
   
Terlipressin injection
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Formulary
Red
 
   
Vasopressin injection (argipressin)
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Formulary
Red
 
   
Vasopressin injection (argipressin)
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Formulary
Red

Approved off-label indication:

For use as a vasopressor

Dose = 0.6 to 2.4 units per hour

For initiation on consultant advice only Use in accordance with critical care guideline at GSTFT

 
   
06.05.02  Antidiuretic hormone antagonists
Tolvaptan tabs (Jinarc® - polycystic kidney disease)
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Restricted Drug Restricted
Red
High Cost Medicine
For autosomal dominant polycystic kidney disease as per NICE TA358 
Link  NICE TA358:Tolvaptan for treating autosomal dominant polycystic kidney disease
   
Tolvaptan tabs (Samsca® - SIADH in cancer chemotherapy patients)
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Restricted Drug Restricted
Red
High Cost Medicine
For SIADH in cancer patients requiring chemotherapy as per criteria in NHSE 16051/P 
Link  NHSE 16051/P: Tolvaptan for SIADH in patients requiring cancer chemotherapy
   
Tolvaptan tabs (Samsca® - SIADH in non-cancer patients)
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Restricted Drug Restricted
Red
High Cost Medicine
Treatment of non-cancer related SIADH, with the following restrictions:
  • Initiation under the advice of endocrinology only
  • Ongoing clinical review from endocrinology
  • Patients with plasma sodium < 130mmol/L
  • Maximum treatment duration should be no more than 28 days
  • All supplies from the hospital only 
  •    
    Demeclocycline caps
    View adult BNF
    Unlicensed Drug Unlicensed  
       
    06.06  Drugs affecting bone metabolism
    06.06.01  Calcitonin and parathyroid hormone to top
    Calcitonin (salmon) / Salcatonin nasal spray, injection
    View adult BNF View SPC online
    Formulary
    Red
     
       
    Teriparatide injection
    View adult BNF View SPC online
    Formulary
    Red
    High Cost Medicine
     
    Link  NICE TA161: Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women
       
    Teriparatide injection
    View adult BNF View SPC online
    Formulary
    Red

    Approved for treating osteoporosis in men (adults) as per NHSE policy criteria (see link below)

     
    Link  Interim Clinical Commissioning Policy Statement: Teriparatide for Osteoporosis in Men (Adults) (170064P)
       
    06.06.02  Bisphosphonates and other drugs affecting bone metabolism
     note  For pain relief in men with hormone-refractory prostate cancer, refer to NICE clinical guideline 175
    06.06.02  Bisphosphonates
    Alendronic acid tabs
    View adult BNF View SPC online
    First Choice FIRST-LINE ORAL BISPHOSPHONATE 
    Disodium etidronate tabs
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    Formulary  
       
    Disodium pamidronate injection
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    Formulary
    Red

    Approved for licensed use, and the following off-label indication:

    Non-malignant hypercalcaemia - follow local guidelines

     
    Link  MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
       
    Ibandronic acid injection
    View adult BNF View SPC online
    Restricted Drug Restricted
    Red

    CONSULTANT SPECIALISTS ONLY

    Treatment of osteoporosis in postmenopausal women at increased risk of fracture, who do not tolerate oral bisphosphonates

     
    Link  MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
       
    Risedronate tabs
    View adult BNF View SPC online
    Formulary  
       
    Risedronate, calcium carbonate and colecalciferol tabs
    View adult BNF View SPC online
    Formulary  
       
    Sodium clodronate caps, tabs
    View adult BNF View SPC online
    Formulary
    Red
     
       
    Zoledronic acid injection 4mg
    View adult BNF View SPC online
    Restricted Drug Restricted
    Red
    RESTICTED USE – ONCOLOGY, HAEMATOLOGY & UROLOGY ONLY 
    Link  MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
       
    Zoledronic acid injection 5mg
    View adult BNF View SPC online
    Restricted Drug Restricted
    Red
    CONSULTANT SPECIALISTS ONLY
  • Paget’s disease of the bone
  • Osteoporosis in post-menopausal women and men at increased risk of fracture
  • Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture 
  • Link  MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
       
    Zoledronic acid injection 4mg
    View adult BNF View SPC online
    Restricted Drug Restricted
    Red

    Approved off-label indication:

    Improved outcomes in early stage post-menopausal breast cancer

    Dose = 4mg infusion every 6 months after completion of adjuvant chemotherapy - maximum 5 years treatment

    Consultant oncologists only

     
    Link  MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
       
    06.06.02  Denosumab
    Denosumab (Prolia®)
    View adult BNF View SPC online
    Formulary
    Amber 3

    Approved as per NICE Technology Appraisal 204 (prevention of osteoporotic fractures in postmenopausal women):

    Consultant specialist initiation only - use in accordance with local guideline

    GPs may be asked to continue the prescribing in post-menopausal women with a ceatinine clearance > 35mL/min under the local shared care agreement in Lambeth and Southwark

     
    Link  NICE TA204: Osteoporotic fractures - denosumab
    Link  MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
       
    Denosumab (Prolia®)
    View adult BNF View SPC online
    Formulary
    Red

    Approved for:

    Secondary prevention of osteoporotic fragility fractures in male patients with osteoporosis and a creatinine clearance <30mL/min

    Consultant Specialists only - use in accordance with local guideline

    Hospital prescribing only

     
    Link  MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
       
    Denosumab (XGEVA®)
    View adult BNF View SPC online
    Formulary
    Red

    Approved as per NICE technology appraisal guidance (links below)

     
    Link  MHRA Jun 2018: Denosumab (Xgeva▼) for advanced malignancies involving bone - study data show new primary malignancies reported more frequently compared to zoledronate
    Link  MHRA Jun 2018: Denosumab (Xgeva▼) for giant cell tumour of bone - risk of clinically significant hypercalcaemia following discontinuation
    Link  NICE TA265: Bone metastases from solid tumours - denosumab
    Link  MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
       
    06.06.02  Strontium renelate
    06.07  Other endocrine drugs to top
    06.07.01  Bromocriptine and other dopaminergic drugs
    Bromocriptine tabs
    View adult BNF View SPC online
    Formulary  
       
    Cabergoline tabs (licensed use, and use in breast pain)
    View adult BNF View SPC online
    Formulary
    Amber 2

    Licensed for the following indications:

    • Inhibition or suppression of physiological lactation after delivery
    • Treatment of hyperprolactinaemic disorders

    Approved for following off-label indication:

    • Breast pain
    • Dose = 500 micrograms weekly, or as divided doses on separate days, increased if necessary

    USE ON SPECIALIST ADVICE

     
       
    06.07.02  Drugs affecting gonadotrophins
    Cetrorelix injection
    View adult BNF View SPC online
    Restricted Drug Restricted
    Red

    INITIATION BY CONSULTANT SPECIALIST ONLY

    For the prevention of irreversible premature ovarian failure in women of child bearing age who are at risk due to the use of cyclophosphamide in the treatment of systemic lupus erythematosus, systemic vasculitis and anti-GBM disease

    Use in accordance with local guideline at KCH

     
       
    Danazol caps
    View adult BNF View SPC online
    Formulary  
       
    06.07.02  Gonadorelin analogues
    Buserelin injection, nasal spray (Suprecur® - gynaecology)
    View adult BNF View SPC online
    Formulary
    Red
    Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins 
       
    Goserelin implant (gynaecology indications)
    View adult BNF View SPC online
    Formulary
    Amber 1

    Initiation on recommendation of consultant specialist only

    Hospital use = one month implant (3.6mg) only

     
       
    Leuprorelin acetate pro-longed release injection (gynaecology indications)
    View adult BNF View SPC online
    Formulary
    Amber 1

    Initiation on recommendation of consultant specialist only

    Hospital use = one month implant (3.75mg) only

     
       
    Nafarelin nasal spray
    View adult BNF View SPC online
    Formulary
    Red
    Use in controlled ovarian stimulation programmes prior to in-vitro fertilisation 
       
    Triptorelin SR injection (gynaecology indications)
    View adult BNF View SPC online
    Formulary
    Amber 1

    Initiation on recommendation of consultant specialist only

    Hospital use = one month implant (3mg) only

     
       
    06.07.02  Breast pain (mastalgia)
    06.07.03  Metyrapone to top
    Metyrapone caps
    View adult BNF View SPC online
    Formulary
    Red
    SPECIALIST SUPERVISION ONLY 
       
    06.07.04  Somatomedins
     ....
     Non Formulary Items
    Dutasteride  (Avodart®)

    View adult BNF View SPC online
    Non Formulary
    Grey
     
    Dutasteride & tamsulosin  (Combodart®)

    View adult BNF View SPC online
    Non Formulary
    Grey
    Link  SE London APC recommendation: Combodart for benign prostatic hyperplasia (not approved)
     
    Ibandronic acid tabs

    View adult BNF View SPC online
    Non Formulary
    Grey

    Not approved for use in SE London (all indications)

     
    Unlicensed thyroid extracts

    Non Formulary
    Grey

    Including: Armour thyroid, ERFA Thyroid, Nature-Thyroid

    Not approved for use in SE London - See APC Position Statement (link below)

    Link  SE London APC Position Statement: Unlicensed thyroid extracts (not recommended for prescribing)
     
      
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    note Notes
    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
    Display tracking information
    click to search medicines.org.uk
    Link to adult BNF
    click to search medicines.org.uk
    Link to SPCs
    SMC
    Scottish Medicines Consortium
    Cytotoxic Drug
    Cytotoxic Drug
    CD
    Controlled Drug
    High Cost Medicine
    High Cost Medicine
    Cancer Drugs Fund
    Cancer Drugs Fund
    NHSE
    NHS England
    Homecare
    Homecare
    CCG
    CCG

    Traffic Light Status Information

    Status Description

    Red

    Specialist or hospital prescribing only. The responsibility for prescribing, monitoring, dose adjustment and review should remain with the specialist or hospital. In very exceptional circumstances a specialist may discuss individual patient need for a RED drug to be prescribed by a GP and the GP should consider informing the Medicines Management team before a decision is made to prescribe for individual patients.   

    Amber 1

    Treatment can be initiated in primary care after a recommendation from an appropriate specialist  

    Amber 2

    Specialist initiation followed by maintenance prescribing in primary care  

    Amber 3

    Specialist initiation with ongoing monitoring required. After dose stabilisation GPs can be requested to take over prescribing responsibilities using the approved APC shared care documentation  

    Green

    Specialist and non-specialist initiation  

    Grey

    Not recommended for prescribing  

    netFormulary