| Formulary Chapter 4: Central nervous system - Full Chapter
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| Notes: |
This chapter of the formulary is under continual development, please let the team know if you have any comments about the contents: mlcsu.lscformulary@nhs.net.
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| Details... |
| 04.08.01 |
Control of epilepsy |
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Brivaracetam (Briviact®)
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Formulary
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Tablets - all strengths
Oral solution
Category 3 - It is usually unecessary to ensure that patients are maintained on a specific manufacturer's product as therapeutic equivalence can be assumed
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 MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers’ products
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Cannabidiol (Epidyolex®)
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Formulary
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Oral solution
100mg/mL
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NICE TA873: Cannabidiol for treating seizures caused by tuberous sclerosis complex
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Fenfluramine  (Fintepla®)
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Formulary
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Oral solution 2.2 mg/mL
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NICE TA808: Fenfluramine for treating seizures associated with Dravet syndrome
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Piracetam (Nootropil®)
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Formulary
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Tablets 800mg, 1200mg
Oral Solution 33%
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| 04.08.01 |
Partial seizures with or without secondary generalisation |
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| 04.08.01 |
Generalised seizures |
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| 04.08.01 |
Carbamazepine and Oxcarbazepine |
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Carbamazepine (Tegretol®)
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Formulary
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Tablets 100mg, 200mg, 400mg
M/R tablets (Tegretol® Retard) 200mg, 400mg
Chewable tablets (Tegretol® Chewtabs) 100mg, 200mg
Liquid 100mg/5mL
Suppositories 125mg, 250mg
Note: 125mg suppositories are approximately equivalent in therapeutic effect to 100mg tablets (plasma concentration monitoring is recommended
Category 1 - Doctors are advised to ensure that their patient is maintained on a specific manufacturer's product
Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.
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Eslicarbazepine (Zebinix®)
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Formulary
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Tablets 800mg
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
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Oxcarbazepine (Trileptal®)
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Formulary
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Tablets 150mg, 300mg
Liquid 30mg/5mL
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
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| 04.08.01 |
Ethosuximide |
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Ethosuximide
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Formulary
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Capsules 250mg
Liquid 250mg/5mL
Category 3 - It is usually unecessary to ensure that patients are maintained on a specific manufacturer's product as therapeutic equivalence can be assumed
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| 04.08.01 |
Gabapentin and pregabalin |
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Gabapentin
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Formulary
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Capsules 100mg, 300mg, 400mg
Category 3 - It is usually unecessary to ensure that patients are maintained on a specific manufacturer's product as therapeutic equivalence can be assumed
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MHRA: Gabapentin (Neurontin): risk of severe respiratory depression
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Pregabalin
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Formulary
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Capsules 25mg, 50mg, 75mg, 100mg, 150mg, 300mg
Category 3 - It is usually unecessary to ensure that patients are maintained on a specific manufacturer's product as therapeutic equivalence can be assumed
A decision has been made and ratified by UHMB Drug & Therapeutics Committee and Morecambe Bay Area Prescribing Committee that generic pregabalin will be dispensed for all licensed and unlicensed indications
**under review**
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MHRA: Pregabalin (Lyrica): findings of safety study on risks during pregnancy
MHRA: Pregabalin (Lyrica): reports of severe respiratory depression
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| 04.08.01 |
Lacosamide |
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Lacosamide
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Formulary
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Tablets 50mg, 100mg, 150mg, 200mg
Oral solution 50mg/5ml
Category 3 - It is usually unecessary to ensure that patients are maintained on a specific manufacturer's product as therapeutic equivalence can be assumed
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Lacosamide
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Formulary
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200mg/20ml solution for infusion - vials
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| 04.08.01 |
Lamotrigine |
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Lamotrigine
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Formulary
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Tablets 25mg 50mg, 100mg
Dispersible tablets 5mg, 25mg, 100mg
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
CSM advice: blood disorders - see BNF
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| 04.08.01 |
Levetiracetam |
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Levetiracetam
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Formulary
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Tablets 250mg, 500mg, 1g
Liquid 100mg/mL
Category 3 - It is usually unecessary to ensure that patients are maintained on a specific manufacturer's product as therapeutic equivalence can be assumed
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| 04.08.01 |
Perampanel |
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| 04.08.01 |
Phenobarbital and other barbiturates |
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Phenobarbital
(phenobarbitone)
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 Restricted
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Tablets 15mg, 30mg
Liquid 15mg/5mL
Stocked for patients admitted on this but not recommended for initiation
Category 1 - Doctors are advised to ensure that their patient is maintained on a specific manufacturer's product
Liquid 50mg/5mL (alcohol free) for paediatric use only
**under review**
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Primidone
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Restricted
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Tablets 250mg
Stocked for patients admitted on this but not recommended for initiation
Category 1 - Doctors are advised to ensure that their patient is maintained on a specific manufacturer's product
**under review**
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| 04.08.01 |
Phenytoin |
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Phenytoin
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Formulary
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Capsules (Flynn Pharma®) 25mg, 50mg, 100mg (as phenytoin sodium)
Liquid (Epanutin®)30mg/5mL
Category 1 - Doctors are advised to ensure that the patient is maintained on a specific manufacturer's product
Phenytoin suspension 90mg in 15mL is approximately equivalent in therapeutic effect to capsules or tablets containing phenytoin sodium 100mg
**under review**
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| 04.08.01 |
Retigaine |
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| 04.08.01 |
Rufinamide |
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Rufinamide (Inovelon®)
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Formulary
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Tablets 100mg, 200mg
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
Consultant neurologist initiation only
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| 04.08.01 |
Rufinamide |
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| 04.08.01 |
Tiagabine |
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Tiagabine (Gabitril®)
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Formulary
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Tablets 5mg, 10mg, 15mg
Category 3 - It is usually unecessary to ensure that patients are maintained on a specific manufacturer's product as therapeutic equivalence can be assumed
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| 04.08.01 |
Topiramate |
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Topiramate
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Formulary
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Tablets 25mg,50mg, 100mg, 200mg
Sprinkle capsules 15mg, 25mg
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.
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
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.
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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
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| 04.08.01 |
Valproate |
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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
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Sodium Valproate (Epilim®)
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Formulary
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Crushable tablets 100mg
e/c tablets 200mg, 500mg
Liquid 200mg/5mL
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.
Counselling: hepatic & blood disorders - see BNF
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
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
**Under review**
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Sodium Valproate (Epilim® Chrono)
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Formulary
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m/r tablets 200mg, 300mg, 500mg
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.
Counselling: hepatic & blood disorders - see BNF
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
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
**Under review**
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Sodium Valproate (Epilim® Intravenous)
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Formulary
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Injection 400mg with 4mL water for injections
Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.
Counselling: hepatic & blood disorders - see BNF
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
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
**Under review**
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Sodium Valproate (Episenta®)
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Formulary
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m/r capsules 150mg, 300mg
m/r granules 50mg, 100mg, 250mg, 500mg,750mg,1g
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.
Counselling: hepatic & blood disorders - see BNF
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
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
**Under review**
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| 04.08.01 |
Vigabatrin |
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Vigabatrin (Sabril®)
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Formulary
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Tablets 500mg
Powder sachet 500mg
Category 3 - It is usually unecessary to ensure that patients are maintained on a specific manufacturer's product as therapeutic equivalence can be assumed
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| 04.08.01 |
Zonisamide |
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Zonisamide (Zonegran®)
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Formulary
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Capsules 25mg, 50mg, 100mg
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
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| 04.08.01 |
Benzodiazepines |
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Clobazam
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Formulary
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Tablets 10mg
Category 2 - Clinical judgement should be used when deciding whether to switch between different manufacturer's products
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| 04.08.01 |
Other Drugs |
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Cenobamate (Ontozry®)
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Formulary
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Tablets 12.5mg*, 25mg* (*initiation pack) 50mg, 100mg, 150mg, 200mg
Cenobamate is recommended as an option for treating focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least 2 antiseizure medicines. It is recommended only if:
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it is used as an add-on treatment, after at least 1 other add-on treatment has not controlled seizures, and
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treatment is started in a tertiary epilepsy service.
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NICE TA753: Cenobamate for treating focal onset seizures in epilepsy
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Perampanel (Fycompa®)
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Formulary
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Tablets f/c 2mg,4mg, 6mg, 8mg, 10mg, 12mg
Suspension 500micrograms/1mL
Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products
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NICE NG217: Epilepsies in children, young people and adults
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Stiripentol (Diacomit® )
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Formulary
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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
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Key |
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Restricted Drug |
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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
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Scottish Medicines Consortium |
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Cytotoxic Drug |
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Controlled Drug |
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High Cost Medicine |
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Cancer Drugs Fund |
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NHS England |
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Homecare |
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ICB |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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| Status |
Description |
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Green:
Appropriate for initiation and ongoing prescribing in both primary and secondary care.
Generally, little or no routine drug monitoring is required. |
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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.
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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. |
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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. |
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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. |
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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). |
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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. |
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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.
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Refer to local guidance and local commissioning arrangements |
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