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 Formulary Chapter 4: Central nervous system - Full Chapter
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04.08.01  Expand sub section  Control of epilepsy
 note 
    • Epilepsy can be described as idiopathic (or primary) generalised epilepsy (tonic-clonic convulsions, typical absences, myoclonic and atonic seizures), or focal (partial) epilepsy with or without secondary generalisation.
    • Anti-epileptic drugs (AED) therapy should be initiated on the recommendation of a specialist once the diagnosis has been confirmed.
    • Whenever possible treatment should involve a single AED. A second drug for a single seizure type should be considered only when the first choice drug is ineffective despite adequate plasma concentrations. The first drug should then be withdrawn slowly.
    • Patients taking phenytoin, carbamazepine, phenobarbital or primidone should be stabilised on one particular brand or generic and this should be quoted on all prescriptions and correspondence. See MHRA guidance on substitution of brands of all antiepileptic drugs.
    • Therapeutic monitoring is not routinely recommended but may be useful for monitoring in special situations or in selected patients. Plasma concentration measurements for sodium valproate do not correlate well with therapeutic effect and thus may not be useful.
    • Long term use of carbamazepine, phenytoin, primidone and sodium valproate is associated with decreased bone mineral density. Monitoring is necessary see Leicestershire Guidance - Antiepileptics and Bone Mineral Density
    • Please be aware of MHRA advice on Valproate. Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. No woman or girl should stop taking valproate without first discussing it with their doctor.
    • Care should be taken when prescribing all AEDs for women and girls of reproductive age due to a possible increased risk of birth defects. Referral to a specialist is necessary if considering pregnancy. Levetiracetam and lamotrigine are considered to have a lower teratogenic risk. Folic acid 5 mg per day should be prescribed before any possibility of pregnancy.
    • Hormonal contraception may affect or be affected by AEDs.

 

Lamotrigine
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Formulary First line for focal (partial) epilepsy and alternative to sodium valproate for idiopathic generalised epilepsy; may exacerbate myoclonic seizures.
Lamotrigine is generally well tolerated but use has been associated with serious blood disorders and skin reactions. Initiate slowly.
 
   
Sodium Valproate
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Formulary

First line for all types of idiopathic generalised epilepsy.
Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. Please use resources below to ensure effective counselling and selection of patients. 

No woman or girl should stop taking valproate without first discussing it with their doctor.

 
Link  Drug Safety Update: Valproate medicines (Epilim▼, Depakote▼)
Link  MHRA Guidance: Valproate use by women and girls
Link  Leicestershire Guidance: Valproate Advice Following MHRA Alert 24th April 2018
Link  Resources to Use: Booklet for Healthcare Professionals
Link  Resources to Use: Card to give to patients
Link  Resources to Use: Consultation Checklist
Link  Resources to Use: Guide to give to patients
Link  Topiramate and Valproate Flow Chart
   
Levetiracetam
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Formulary Alternative in focal partial epilepsy and idiopathic generalised epilepsy. Levetiracetam has a different mode of action to lamotrigine and carbamazepine.

Intravenous preparation is classified as Red on the Leicestershire traffic lights. 
   
Everolimus (Votubia)
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Formulary
Red
NHS England
BlueTeq

Refractory focal onset seizures associated with tuberous sclerosis complex (ages 2 years and above) as per NHSE Clinical Commissioning Policy

Blueteq prior approval required before initiation
Implementation Date: September 2019

 
Link  NHSE Clinical Commissioning Policy: Everolimus for refractory focal onset seizures associated with tuberous sclerosis complex (ages 2 years and above)
   
Carbamazepine
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Formulary Alternative for focal (partial) epilepsy and useful if rapid titration is required but is generally less well tolerated. 
   
Ethosuximide
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Formulary Alternative to sodium valproate for typical absence seizures. 
   
Phenytoin
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Restricted Drug Restricted 3rd line drug due to long term side effects.
Also indicated in the management of seizure activity following brain injury. 
   
Clobazam
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Restricted Drug Restricted  
   
Clonazepam
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Restricted Drug Restricted  
   
Gabapentin
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Restricted Drug Restricted

As of 1st April 2019, gabapentin will become a schedule 3 controlled drug. Gabapentin will be subject to the prescribing requirements for CDs, but not to the safe storage and register requirements.  

 
   
Oxcarbazepine
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Restricted Drug Restricted  
   
Phenobarbital
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Restricted Drug Restricted  
Link  Leicestershire statement on the prescription of phenobarbital liquid
   
Piracetam
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Restricted Drug Restricted  
   
Primidone
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Restricted Drug Restricted  
   
Tiagabine
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Restricted Drug Restricted  
   
Topiramate
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Restricted Drug Restricted

Please ensure that female patients under 50 years of age receive the necessary counselling as per LMSG flow chart

 
Link  Simple Amber: Topiramate
Link  Topiramate and Valproate Flow Chart
   
Pregabalin
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Formulary

As of 1st April 2019, pregabalin will become a schedule 3 controlled drug. Pregabalin will be subject to the prescribing requirements for CDs, but not to the safe storage and register requirements.

Green Traffic Light when prescribed in line with neuropathic pain guidelines.


Amber Traffic Light simple amber when used for refractory epilepsy or generalised anxiety disorder

 
Link  Leicestershire Guidance: Neuropathic pain
Link  MHRA Advice: Pregabalin, gabapentin and risk of abuse and dependence: new scheduling requirements from 1 April
   
Lacosamide
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Restricted Drug Restricted
Amber Simple
 
Link  Leicestershire Evaluation: Lacosamide in Epilepsy
   
Rufinamide
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Restricted Drug Restricted
Amber Simple
 
   
Zonisamide
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Restricted Drug Restricted
Amber Simple
 
   
Brivaracetam
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Restricted Drug Restricted
Amber Simple

Specialist initiation only. Third line alternative

 
Link  Leicestershire Evaluations: Brivaracetam in Epilepsy
   
Eslicarbazepine
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Restricted Drug Restricted
Amber Simple
 
Link  Leicestershire Evaluation: Eslicarbazepine in Epilepsy
   
Perampanel
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Restricted Drug Restricted
Amber Simple
 
Link  Leicestershire Evaluation: Perampanel in Epilepsy
   
Retigabine
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Restricted Drug Restricted
Red

Retigabine is due to be withdrawn in 2017. Existing patients to have therapy reviewed by a specialist and no new patients to start therapy with retigabine.

The MHRA have restricted retigabine to last-line use, after reports of pigment changes in ocular tissue, skin, lips or nails.

 
Link  Leicestershire Evaluation: Retigabine in Epilepsy
   
 ....
 Non Formulary Items
Cannabis oil and cannabis extracts

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Non Formulary
Black

This applies to all cannabis extracts, cannabis oil and cannabinols or cannabinol derivatives. Not reviewed in Leicestershire

Epidiolex is not currently available in LLR - pending TAS review in March/April 2019

Link  Home Office: Drug Licensing Factsheet- Cannabis, CBD and other cannabinoids
 
Sodium valproate M/R capsules  (Episenta®)

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Non Formulary
Black
Link  Leicestershire Evaluation: Sodium Valproate Episenta® in Epilepsy
 
  
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
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Scottish Medicines Consortium
High Cost Medicine
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Cancer Drugs Fund
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Traffic Light Status Information

Status Description

Black

Drugs not recommended for use in the Leicestershire Health Community because of lack of evidence of clinical effectiveness, cost prioritization or concerns over safety. All new drugs will be black until they have been through the appropriate approval process - then they will appear as a specific entry   

Red

Drugs which should be prescribed only by hospital specialists (clinical review by specialist as appropriate and annually as a minimum).  

Amber SCA

Drugs which would initially be prescribed by a hospital specialist and then by a GP where full agreement to share the care of each specific patient has been reached under a LMSG Shared Care Agreement (SCA). Specific patient monitoring or intervention required.   

Amber Simple

Drugs suitable to be initiated and prescribed in primary care only after specialist assessment and recommendation. A shared care agreement is not required.  

Green Conditional

Drugs for which GPs are able to take full responsibility for prescribing and monitoring subject to specified conditions e.g. prescribing in line with agreed LMSG guidance or able to demonstrate suitable competence see comments under individual entries.   

Green

Drugs for which GPs would normally take full responsibility for prescribing and monitoring. Drugs included in this list have been specifically considered by LMSG.   

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