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 Formulary Chapter 6: Endocrine system - Full Chapter
Notes:

Review date: September 2019

Non-formulary drugs: Any drug or formulation not listed in the formulary is deemed to be non-formulary.

Off-label use: Drugs are included in the formulary for their licensed indications – where inclusion of off-label use is considered to be included in the formulary this is specifically stated in the formulary entry for the drug N.B. also see Paediatrics note below.

Paediatrics: Drugs are included in the formulary for paediatric use for their BNF for Children recommended indications (indicated by symbol View childrens BNF) which may be off-label, unless otherwise stated. All drugs are deemed to have the same RAG status as they have for adults unless stated otherwise.

NHS England Specialised Commissioning
Drugs carrying the NHS England logo are commissioned by them. Links to key documents, national programmes of care, and clinical reference groups are found below.

NHSE NHS England Specialised Commissioning: Key documents

NHSE NHS England Specialised Commissioning: National programmes of care and clinical reference groups

Medications which are indicated for medically assisted reproduction, including ovulation induction (e.g. clomifene, letrozole and tamoxifen) and assisted reproduction, such as In Vitro Fertilisation or Ex Vitro Fertilisation (e.g. gonadotrophins) are restricted to use by specialist secondary care physicians, and are categorised as RED drugs for these purposes.

 Details...
06.06.02  Expand sub section  Bisphosphonates and other drugs affecting bone metabolism
 note 

Patients should have a dental check-up (and any necessary remedial work should be performed) before bisphosphonate treatment, or as soon as possible after starting treatment.

During bisphosphonate treatment patients should maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms.

See MHRA Drug Safety Updates:

Review continued bisphosphonate therapy for osteoporosis with patient after 3 years treatment, in light of lack of consistent evidence of further benefit after this time, as per NICE guidance NG56.

06.06.02  Expand sub section  Bisphosphonates
Alendronic Acid
View adult BNF View SPC online View childrens BNF
First Choice
Green

Tablets (as sodium alendronate) 10mg

Effervescent tablets 70mg

Oral solution, sugar-free, alendronic acid (as sodium alendronate) 70mg/100mL (4×100mL)

Amber Recommended  Paediatrics

 
Risedronate tablets
View adult BNF View SPC online View childrens BNF
First Choice
Green

5mg, 30mg, 35mg

Amber Recommended  Paediatrics

 
Disodium Etidronate tablets
View adult BNF View SPC online
Second Choice
Green

200mg

Paediatrics: no BNFc entry - seek specialist advice

 
   
Ibandronic acid tablets
View adult BNF View SPC online
Formulary
Green

50mg, 150mg For post-menopausal osteoporosis

Amber Patient Retained  for other indications

Paediatrics: no BNFc entry - seek specialist advice

 
   
Ibandronic acid injection
View adult BNF View SPC online
Formulary
Red

1mg/mL, 3mL prefilled syringe Concentrate for intravenous infusion, 1mg/mL, 2mL vial, 6mL vial

Paediatrics: no BNFc entry - seek specialist advice

 
   
Sodium Clodronate
View adult BNF View SPC online View childrens BNF
Formulary
Red
400mg capsules
520mg tablets
800mg tablets 
   
Zoledronic Acid (Aclasta®)
View adult BNF View SPC online
Formulary
Red

Intravenous infusion, 50micrograms/mL, 100mL bottle Licensed for: Treatment of Paget's disease of bone; Treatment of postmenopausal osteoporosis and osteoporosis in men (including corticosteroid-induced osteoporosis)

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Zoledronic Acid (Zometa®)
View adult BNF View SPC online
Formulary
Red

Concentrate for intravenous infusion, 800micrograms/mL, 5mL (4mg) vial Solution for intravenous infusion, 40micrograms/mL, 100mL (4mg) bottle Licensed for: Reduction of bone damage in advanced malignancies involving bone; Hypercalcaemia of malignancy

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Pamidronate disodium
View adult BNF View SPC online View childrens BNF
Formulary
Red
Concentrate for intravenous infusion:
3mg/mL, 5mL vial, 10mL vial
6mg/mL, 10mL vial
9mg/mL, 10mL vial
15mg/mL, 1mL vial, 2mL vial, 4mL vial, 6mL vial

Intravenous infusion, powder for reconstitution, 15mg vial, 30mg vial, 90mg vial (all with diluent) 
   
06.06.02  Expand sub section  Denosumab
06.06.02  Expand sub section  Strontium renelate
 ....
Key
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 children's 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

Green

Medicines considered suitable for non-specialist prescribing in primary or secondary care.  

Amber Recommended

Requires specialist assessment to enable patient selection.  Amber Recommended medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Following specialist assessment, the medicine is suitable for prescribing in Primary Care.  

Amber Initiated

Amber Initiated. Requires specialist initiation of prescribing. Prescribing to be continued by the specialist until stabilisation of the dose is achieved and the patient has been reviewed. Amber Initiated medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable   

Amber Retained

Amber Patient Retained. Requires specialist initiation of prescribing. Prescribing to be continued by specialist until stabilisation of the dose is achieved and the patient had been reviewed. Patient remains under the care of specialist (ie not discharged) as occasional specialist input may be required. Amber Patient Retained medicines must meet criteria: (1)Requires specialist assessment to enable patient selection (2)Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable (4) May require occasional specialist input indefinitely and therefore the patient should not be discharged from specialist care   

Amber

Medicines recommended or initiated by specialists in primary or secondary care. Non-specialist prescribing in primary care may follow according the RAG criteria. In process of being superceded by Amber Recommended, Amber Initiated and Amber Patient Retained.  

Purple

Shared Care. Medicines are considered suitable for Primary Care prescribing and/or management, following specialist initiation of therapy, with on-going communication between the Primary Care prescriber and specialist, within the framework of a Shared Care Agreement. Medicines designated as requiring Shared Care require on-going input from both Specialist and Primary Care clinicians and patients should not be discharged from Specialist care. Where prescribing and monitoring are required under shared care, it is implicit that the responsibility for both of these tasks rests with the prescriber. A Shared Care Agreement will always be available for Shared Care medicines and this document will include a Shared Care Agreement pro-forma which will be completed by all involved clinicians. This pro-forma will record agreement to take on defined aspects of care e.g. monitoring and/or on-going prescribing for the individual patients. A policy detailing clinician responsibilities in Shared Care Agreements must be referred to in all cases of Shared Care. All drugs to be included in this category must meet Shared Care criteria 1 to 3: SC1 Requires specialist assessment to enable patient selection and also initiation, stabilisation and review of treatment and the patient`s condition. SC2 Prescribing and/or management of the drug in Primary Care with specialist support and input, within the framework of the Shared Care Agreement is safe and convenient and that there is an appropriate mechanism for individual patient access in Primary Care. SC3 Requires specific long-term monitoring (blood test or other measurement) for adverse effects and / or efficacy of the drug to be completed in Primary Care, and requires on-going specialist support for the dose changes or management of adverse effects. Monitoring is required on a regular basis (typically four times a year). Implicit in any shared care agreement is the understanding that participation is at the discretion of the Primary Care prescriber subject to their clinical confidence.   

Red

Primary care prescribing of these medicines is NOT recommended. These treatments should be initiated by specialists only; ongoing prescribing is retained within secondary care.   

Black

Not recommended for use. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist.   

Grey

Not recommended for use at this time. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist. Further guidance will be issued when more information or evidence is made available.  

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