Lancashire and South Cumbria Formulary

It should be used as a fourth line adjunctive therapy, usually in a combination with one or more of the following medicines; sodium valproate (unlicensed), topiramate or lamotrigine.

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

04.08.01

Rufinamide

04.08.01

Tiagabine

Formulary

Tablets 5mg, 10mg, 15mg

Epilepsy.

Only to be considered in line with NICE as a third line add-on treatment option in people with focal seizures.

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

04.08.01

Topiramate

Formulary

Tablets 25mg,50mg, 100mg, 200mg
Sprinkle capsules 15mg, 25mg, 50mg

Epilepsy.

Topiramate oral suspension - Restricted for paediatric use only, when sprinkle capsules are unsuitable. Prescribers should be cautious when selecting the strength of suspension as multiple strengths are available.

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

MHRA: Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme

MHRA: Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure

04.08.01

Valproate

In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:

Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued

Sodium Valproate

(Epilim^®)

Formulary

Crushable tablets 100mg
e/c tablets 200mg, 500mg
Liquid 200mg/5mL

Episenta® capsules (prolonged release sodium valproate) are also available for use, and are especially helpful for those patients with swallowing difficulties.
They are given once daily as capsules or sachets which can be opened and put on soft food if required, without chewing. Like other valproate preparations when used for epilepsy, they should be prescribed by brand name.

Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued

National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf

MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met

https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met?utm_source=eshot&utm_medium=email&utm_campaign=DSUApril2018Split2

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

MHRA: Valproate use in men: as a precaution, men and their partners should use effective contraception

Sodium Valproate Intravenous

Formulary

Injection 400mg with 4mL water for injections

400mg/4ml solution ampoules

Epilepsy.

Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.

Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued

National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf

MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

MHRA: Valproate use in men: as a precaution, men and their partners should use effective contraception

MHRA Drug Safety Update April 2019: Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

04.08.01

Vigabatrin

Formulary

Tablets 500mg
Powder sachet 500mg

Epilepsy.

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

04.08.01

Zonisamide

Formulary

Capsules 25mg, 50mg, 100mg

Epilepsy.

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

04.08.01

Benzodiazepines

Clobazam

Formulary

Tablets 10mg

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

MHRA: Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression

04.08.01

Other Drugs

Cenobamate

(Ontozry^®)

Formulary

Tablets 12.5mg*, 25mg* (*initiation pack) 50mg, 100mg, 150mg, 200mg

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

NICE TA753: Cenobamate for treating focal onset seizures in epilepsy

Stiripentol (Diacomit^® )

Formulary

Capsules 250mg, 500mg

Powder for oral suspension in sachet 250mg, 500mg

RED RAG (for all ages) for continuation of treatment of patients who have previously received the drug during childhood under the NHSE standard contract for paediatric neurosciences - neurology. Not to be newly initiated in adults

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

....

Key

	Restricted Drug
	Unlicensed
	Link to adult BNF
	Link to children's BNF
	Link to SPCs
	Scottish Medicines Consortium
	Cytotoxic Drug
	Controlled Drug

	High Cost Medicine
	Cancer Drugs Fund
	NHS England
	Homecare
	ICB
	Low carbon footprint
	Medium carbon footprint
	High carbon footprint

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