Formulary Chapter 4: Central nervous system - Full Chapter
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Chapter Links... |
MHRA Drug Safety Alert (Feb 2015): Drugs and driving: blood concentration limits set for certain drugs |
NENC Palliative and End of Life Care Symptom Control Guidelines |
NICE NG62: Cerebral palsy in under 25s: assessment and management |
TEWV - Medicines Optimisation – Interactive Guide |
TEWV Guidelines |
TEWV Safe Transfer of Prescribing Guidance |
Details... |
04.08.01 |
Control of epilepsy |
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The MHRA recommend that patients on certain antiepileptic drugs remain on the same brand where possible. In order to help decide which anti-epileptics may or may not be switched the MHRA have classified anti-epileptics in to 3 categories.
Category 1 - the patient should be maintained on a specific manufacturer’s product (carbamazepine, phenobarbital and phenytoin)
Category 2 - the need for continued supply of a particular manufacturer’s product should be based on clinical judgement and consultation with patient and/or carer, taking into account factors such as seizure frequency and treatment history (clobazam, clonazepam, eslicarbazepine acetate, lamotrigine, oxcarbazepine, perampanel, retigabine, rufinamide, sodium valproate, topiramate, and zonisamide).
Category 3 - usually unnecessary to ensure that patients are maintained on a specific manufacturer’s product unless there are specific reasons such as patient anxiety and risk of confusion or dosing errors (acetazolamide, brivaracetam, ethosuximide, gabapentin, lacosamide, levetiracetam, pregabalin, stiripentol, and vigabatrin). |
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Acetazolamide (Category 3)
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Formulary
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Brivaracetam (Category 3)
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Formulary
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- Approved for use as adjunctive therapy in patients with severe/intractable partial onset seizures e.g. a sezuire frequency of 1 per week following failure of first-line adjunctive therapy. Response must be assessed within 3-6 months before transferring prescribing to primary or stopping treatment, as appropriate.
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Cannabidiol (Epidyolex®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 100mg/1mL oral solution
- Approved for use in combination with clobazam for treating seizuires associated with Dravet syndrome in people aged 2 years and older
- Approved for use in combination with clobazam for treating seizures associated with Lennox-Gastaut syndrome
- Approved as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over - in line with NICE TA873.
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NICE TA614: Cannabidiol with clobazam for treating seizures associated with Dravet syndrome
NICE TA615: Cannabidiol with clobazam for treating seizures associated with Lennox–Gastaut syndrome
NICE TA873: Cannabidiol for treating seizures caused by tuberous sclerosis complex
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Carbamazepine (Category 1)
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Formulary
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- Carbamazepine 200mg and 400mg MR tablets (Tegretol® retard) are available on consultant request for those in whom conventional carbamazepine has been shown to be unsuitable
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Carbamazepine Suppositories
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Formulary
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Clobazam (Category 2)
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Formulary
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Clonazepam (Catergory 2)
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Formulary
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- Clonazepam 500microgram in 5ml sugar-free oral solution is also approved
unlicensed
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Eslicarbazepine (Category 2)
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Formulary
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- Approved for use by specialists only in those patients for whom intolerance of carbamazepine is a major concern and when use of this agent is more cost effective than alternatives available.
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Ethosuximide
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Formulary
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Fenfluramine (Fintepla®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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Oral solution: 2.2mg/mL
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NICE TA808: Fenfluramine for treating seizures associated with Dravet syndrome
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Gabapentin (Category 3)
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Formulary
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- Note: gabapentin 250mg in 5ml is also approved
unlicensed.
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MHRA Drug Safety Alert (Oct 2017): Gabapentin (Neurontin): risk of severe respiratory depression
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Lacosamide (Category 3)
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Formulary
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- Only approved on advice from consultant neurologists, in patients that are refractory to treatment with other drugs.
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Lamotrigine (Category 2)
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Formulary
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Levetiracetam (Category 3)
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Formulary
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- Injection is also approved for use in palliative care
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Oxcarbazepine (Category 2)
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Formulary
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Perampanel (Category 2)
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Formulary
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- NETAG approved for partial (focal) seizure epilepsy only when other treatment options recommended by NICE have been tried or fully considered.
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NTAG - Perampanel (Fycompa®) for epilepsy
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Phenobarbital (Category 1)
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Formulary
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- 15mg/5ml oral solution
- not suitable for use in children
- 50mg/5ml alcohol free oral solution e.g. Rosement (unlicensed)
- to be used for all children (<18yrs) who require a liquid preparation.
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Phenobarbital INJECTION
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Formulary
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Phenytoin (Category 1)
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Formulary
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- Note: phenytoin 30mg in 5ml suspension (base) – 90mg (15ml) is equivalent to one 100mg phenytoin sodium capsule 250mg in 5ml injection (sodium salt).
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Piracetam
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Formulary
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Pregabalin (Category 3)
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Formulary
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- Approved for specialist advice in the management of treatment resistant epilepsy.
- Also approved as a second line agent for General Anxiety Disorder. Although treatment can be given 2-3 times daily, it is more cost effective to give as a twice daily dose.
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MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy
MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression
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Primidone
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Formulary
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Rufinamide (Category 2)
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Formulary
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- Approved for limited use as a second or third-line treatment in patients with Lennox-Gastaut syndrome and related encephalopathies.
- Should only be used on the advice of paediatric neurologists and other neurologists specialising in the treatment of epilepsy.
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Sodium Valproate (Category 2)
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Formulary
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- Note: sodium valproate 500mg & 1000mg MR granules (Episenta®) - for possible use in those who have difficulty swallowing sodium valproate tablets. May be more convenient to use than large volumes of liquid formulations.
- Valproate▼ must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP)
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▼ BLACK TRIANGLE IN FEMALES
Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP)
For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:
MHRA Drug Safety Updates (valproate)
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Valproate medicines: Pregnancy Prevention Programme materials
Local Shared Care guideline in TEWV to support Valproate Pregnancy Prevention Programme
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Sodium Valproate▼ Injection
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Formulary
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Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP)
For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:
MHRA Drug Safety Updates (valproate)
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Stiripentol (Category 3)
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Formulary
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- For use as adjunctive therapy of refractory generalised tonicclonic seizures in children with severe myoclonic epilepsy in infancy.
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Tiagabine
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Formulary
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Topiramate (Category 2)
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Formulary
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Vigabatrin (Category 3)
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Formulary
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North of Tyne, Gateshead and North Cumbria - Vigabatrin Shared Care Guideline
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Zonisamide (Category 2)
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Formulary
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- For use only in patients that are refractory to treatment with other drugs on the recommendation of a specialist
- Use in children is
unlicensed.
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Partial seizures with or without secondary generalisation |
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Generalised seizures |
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Carbamazepine and Oxcarbazepine |
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Ethosuximide |
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Gabapentin and pregabalin |
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Lacosamide |
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Lamotrigine |
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Levetiracetam |
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Perampanel |
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Phenobarbital and other barbiturates |
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Phenytoin |
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Retigaine |
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Rufinamide |
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Rufinamide |
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Tiagabine |
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Topiramate |
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Valproate |
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Vigabatrin |
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Zonisamide |
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Benzodiazepines |
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Other Drugs |
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Cenobamate (Ontozry®)
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Formulary
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- 12.5mg, 25mg, 50mg, 100mg, 150mg and 200mg tablets
- Approved for treating focal onset seizure in epilepsy in line with NICE
- Patients will be stabilised by the epilepsy specialist prior to transfer to the GP for continuation. This will usually be after 3 months of treatment.
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NICE TA753: Cenobamate for treating focal onset seizures in epilepsy
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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Description |
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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. |
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Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
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Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
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Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
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NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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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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