| Formulary Chapter 4: Central nervous system - Full Chapter
|
| 04.07.04.02 |
Prophylaxis of migraine |
|
|
Sodium valproate
|
Formulary
|
See section 4.8.1
Unlicensed indication
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**
|
Topiramate
(prophylaxis of migraine)
|
Formulary
|
Tablets 25mg, 50mg, 100mg, 200mg
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.
|
Zonisamide
|
Formulary
|
Capsules, 25mg. 50mg, 100mg
Approved for use in patients when at least 3 prior prophylactic treatments have failed and erenumab, galcanezumab and fremanezumab are being considered
|
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 and local commissioning arrangements |
|
|
(Vyepti®)
