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Non-formulary and Unlicensed Medicines
Non-formulary prescribing in BNSSG
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If a medicine is not included within the Joint Formulary, it is considered non-formulary.
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The aim is for the Joint Formulary to cover 90% of prescribing, however, it is recognised that there are occasions when it is clinically necessary for a non-formulary medicine to be prescribed.
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Non-formulary medicines should be prescribed only when formulary choices are not suitable or have been exhausted.
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Non-formulary prescribing should not be used to bypass usual NHS commissioned pathways.
Managing non-formulary requests in primary care
Non-formulary requests in primary care should be managed using the principles above.
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Clinical and prescribing responsibility for non-formulary medicines can only be transferred to primary care with agreement of the GP.
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A GP would be under no compulsion to prescribe any non-formulary medication. It is reasonable for GPs to request that any non-formulary prescribing is maintained by the specialist recommending use.
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Requests to prescribe should demonstrate why formulary choices are not suitable and the rationale for use.
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Clinical need, suitability for prescribing within primary care, GP clinical competence to prescribe and cost should all be considered by the GP when deciding whether to prescribe.
Each ICS partner has mechanisms for the appropriate prescribing of non-formulary medicines.
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For information about the process for prescribing of non-formulary medicines in secondary care, mental health or community services, please contact your individual organisation’s Pharmacy Department, Specialist Pharmacist or Medicines Optimisation Team.
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For advice regarding non-formulary prescribing in primary care, please email the Joint Formulary Pharmacists via BNSSG.formulary@nhs.net
Unlicensed medicines and off-label use
New uses are sometimes found for older, established medicines that are outside the manufacturer’s original product licence e.g. metformin or finasteride for polycystic ovary syndrome. Clinicians may prescribe a medicine outside the terms of its product licence but will need to be aware of the quality of evidence to support its unlicensed or ‘off label’ use. Some older medicines are therefore listed in Red or Amber categories to highlight unlicensed indications, for which the prescriber will bear sole responsibility. Many paediatric preparations are unlicensed but are not listed specifically because their use in most situations will be familiar to prescribers.