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 Formulary Chapter 6: Endocrine system - Full Chapter
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06.06.02  Expand sub section  Bisphosphonates and other drugs affecting bone metabolism
06.06.02  Expand sub section  Bisphosphonates
Alendronic Acid
(osteoporosis)
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First Choice
Green
  • Approved alendronic acid formulations include:
    • 10mg tablets (taken daily)
    • 70mg tablets (taken once weekly) – preferred
    • 70mg effervescent tablets (Binosto®) - for use only in patients with documented swallowing difficulties

  • Alendronic acid is approved for the primary prevention of osteoporosis in postmenopausal women in line with NICE
  • Approved for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis primary in line with NICE.
  • Approved for the treatment of osteoporosis in line with NICE
 
Disodium Pamidronate 30mg injection
(hypercalcaemia)
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Formulary
Red
 
 
Ibandronic Acid
(osteoporosis)
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Alternatives

  • Ibandronic acid 50mg tablets are approved for use in the reduction of bone damage in patients with metastatic breast cancer. Not approved for use in the treatment of patients with other forms of cancer (e.g. prostate). Green plus  

  • Ibandronic acid 150mg tablets are approved for the treatment of osteoporosis in line with NICE Green

  • Ibandronic acid 3mg in 3ml injection is approved for use where oral bisphosphonates are not appropriate (not tolerated, contra-indicated because of upper gastro-intestinal problems or insufficiently effective) Red

 
Link  NICE TA464 Bisphosphonates for treating osteoporosis
 
Risedronate
(Osteoporosis/Paget's)
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Alternatives
Green
  • Approved risedronate formulations include:
    • 5mg tablets (taken daily);
    • 35mg tablets (taken once weekly for osteoporosis) -preferred.

  • Risedronate is approved for the primary prevention of osteoporosis in line with NICE, and for for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis in line with NICE. 
  • Risedronate 30mg tablets are also approved for Paget’s disease.
  • Approved for the treatment of osteoporosis in line with NICE
 
Link  NICE TA464 Bisphosphonates for treating osteoporosis
 
Sodium Clodronate
(Hypercalcaemia)
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Alternatives
Green plus
  • 520mg and 800mg tablets
 
 
Zoledronic Acid 4mg injection
(Hypercalcaemia/breast cancer)
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Alternatives
Red
  • Approved for use in treating hypercalcaemia of malignancy and the prevention of skeletal events in patients with metastatic breast cancer.
  • Approved for the adjuvant treatment of post-menopausal  women with early breast cancer (subject to agreement with the CCGs and provider trusts regarding the extra activity). 
  • Not approved for preventing skeletal events in patients with prostate cancer.
  • To avoid confusion it is recommended that this product is prescribed by brand name i.e. Zometa®
 
 
Zoledronic Acid 5mg injection
(Osteoporosis/Paget's)
View adult BNF View SPC online View childrens BNF
Alternatives
Red
  • Prescribe by brand name
  • Approved for the treatment of osteoporosis in line with NICE
 
Link  NICE TA464 Bisphosphonates for treating osteoporosis
 
06.06.02  Expand sub section  Denosumab
06.06.02  Expand sub section  Strontium renelate
06.06.02  Expand sub section  Romosozumab to top
 ....
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
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
ICB
Green Low Carbon

Low carbon footprint

Amber Medium Carbon

Medium carbon footprint

Red High carbon footprint

High carbon footprint

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. 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.   

Green plus

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.  

Green

Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.  

Black

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.  

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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