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 Formulary Chapter 6: Endocrine system - Full Chapter
06.06.02  Expand sub section  Bisphosphonates and other drugs affecting bone metabolism
06.06.02  Expand sub section  Bisphosphonates
Alendronic Acid
(once weekly)
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Green

70mg tablets are once weekly.

First line for osteoporosis.

 
Link  MHRA: Bisphosphonates: atypical femoral fractures
Link  MHRA: Bisphosphonates: osteonecrosis of the jaw
Link  MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
 
Disodium Pamidronate
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Red

Intravenous infusion 30mg/10mL, 60mg/10mL, 90mg/10mL

First line for osteolytic lesions and bone pain

Treatment option for hypercalcaemia of malignancy

Paget's disease

 
Link  MHRA: Bisphosphonates: atypical femoral fractures
Link  MHRA: Bisphosphonates: osteonecrosis of the jaw
Link  MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
Link  MHRA: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
 
Ibandronic Acid injection (Bonviva®)
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Red

Injection 3mg/3mL pre-filled syringe

 
Link  MHRA: Bisphosphonates: atypical femoral fractures
Link  MHRA: Bisphosphonates: osteonecrosis of the jaw
Link  MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
 
Ibandronic Acid Tablets
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Amber 0

Alternative monthly bisphosphonate when alendronic acid is not appropriate.

 
Link  MHRA: Bisphosphonates: atypical femoral fractures
Link  MHRA: Bisphosphonates: osteonecrosis of the jaw
Link  MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
 
Ibandronic Acid Tablets (Bondronat®)
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Amber 0

(Bondronat®) Tablets 50mg: Oral alternative bisphosphonate for patients with breast cancer

 
Link  LSCMMG: Ibandronic acid tablets
Link  MHRA: Bisphosphonates: atypical femoral fractures
Link  MHRA: Bisphosphonates: osteonecrosis of the jaw
Link  MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
 
Risedronate
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Green

Second line for osteoporosis.

Alternative weekly preparation when alendronic acid is not appropriate.

 
Link  MHRA: Bisphosphonates: atypical femoral fractures
Link  MHRA: Bisphosphonates: osteonecrosis of the jaw
Link  MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
 
Sodium Clodronate
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Amber 0

Capsules 400mg

Tablets 800mg

Oral alternative for patients with multiple myeloma

 
Link  MHRA: Bisphosphonates: atypical femoral fractures
Link  MHRA: Bisphosphonates: osteonecrosis of the jaw
Link  MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
 
Zoledronic Acid
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Formulary
Red

(Aclasta®) Specialist use in osteoporosis

Second choice treatment in Paget's disease

(Zometa ®) Second line for osteolytic lesions and bone pain treatment option for hypercalcaemia of malignancy

 
Link  MHRA: Bisphosphonates: atypical femoral fractures
Link  MHRA: Bisphosphonates: osteonecrosis of the jaw
Link  MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
Link  MHRA: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
 
Alendronic Acid with colecalciferol (Fosavance)
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Do Not Prescribe
 
 
06.06.02  Expand sub section  Denosumab
06.06.02  Expand sub section  Strontium renelate
 ....
Key
Restricted Drug Restricted Drug
Unlicensed Drug Unlicensed
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Link to adult BNF
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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
ICB
ICB
Green Low Carbon

Low carbon footprint

Amber Medium Carbon

Medium carbon footprint

Red High carbon footprint

High carbon footprint

Status Description

Green

Green: Appropriate for initiation and ongoing prescribing in both primary and secondary care. Generally, little or no routine drug monitoring is required.  

Green Restricted

Green (Restricted): Appropriate for initiation and ongoing prescribing in both primary and secondary care provided: Additional criteria specific to the medicine or device are met, or The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway. Generally, little or no routine drug monitoring is required.   

Red

Red medicines: Medicine is supplied by the hospital for the duration of the treatment course. Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP. Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this. Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care.  

Amber 0

Amber level 0: Suitable for prescribing in primary care following recommendation or initiation by a specialist. Little or no specific monitoring required. Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care. Brief prescribing document or information sheet may be required. Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information. When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe.  

Amber 1

Amber level 1 (with shared care): Suitable for prescribing in primary care following recommendation or initiation by a specialist. Minimal monitoring required. Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care. Full prior agreement about patient’s on-going care must be reached under the shared care agreement. Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care.  

Amber 2

Amber level 2 (with shared care and enhanced service): Initiated by specialist and transferred to primary care following a successful initiation period. Significant monitoring required on an on-going basis. Full prior agreement about patient’s on-going care must be reached under the shared care agreement. Suitable for enhanced service. These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements).  

Do Not Prescribe

Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria. Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need.  

Grey

Grey medicines: Medicines which have not yet been reviewed or are under the review process. GPs and specialists are recommended not to prescribe these drugs. This category includes drugs where funding has not yet been agreed.   

Multiple

Refer to local guidance and local commissioning arrangements  

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