| Formulary Chapter 4: Central nervous system - Full Chapter
|
| 04.01.01 |
Zaleplon, Zolpidem and Zopiclone |
|
|
| 04.01.01 |
Chloral and derivatives |
|
|
| 04.01.01 |
Clomethiazole (Chlormethiazole) |
|
|
Sodium Oxybate 500mg/1ml oral solution (Xyrem®)
|
Formulary
|
- Approved for the treatment of narcolepsy with cataplexy in children age 7 years and above only in accordance with NHS England clinical commissioning policy.
- The Northern (NHS) Treatment Advisory Group recommends the use of sodium oxybate in adult patients who have received and benefited from treatment with sodium oxybate as commissioned by NHS England. i.e. continuing treatment for those >19 years old.
- The Northern (NHS) Treatment Advisory Group also recommends sodium oxybate for use in adults who have not received it as a child as per the RMOC criteria, noting that may sometimes be used in combination with other agents.
- The following criteria for use in adults who have not received sodium oxybate as child apply:
- Patients presenting with narcolepsy with cataplexy according to International Classification of sleep disorders 3 (ICSD) criteria for Narcolepsy Type 1 AND
- Patients ≥ 19 years old AND
- Where patients have co-morbidities, which are also affecting sleep, these should be managed and adequately treated (for example moderate to severe obstructive sleep apnoea or restless legs syndrome) AND
- Failure to respond to non-pharmacological treatments consisting of behavioural and environmental adaptations, for example planned naps AND
- Inadequate response (within 3 months) to, or intolerable adverse effects from, or contra-indicated use of, more than one stimulant for narcolepsy, and more than one anticataplectic agent AND
- Assessed as being able to benefit from sodium oxybate via a specialist sleep centre.
- Sodium oxybate is generally considered as a final treatment option for patient
|
Key |
|
|
|
|
Cytotoxic Drug
|
|
|
Controlled Drug
|
|
High Cost Medicine
|
|
NHS England |
|
Homecare |
|
CCG |
|
Traffic Light Status Information
| Status |
Description |
|
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. |
|
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. |
|
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. |
|
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. |
|
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. |
|
UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
|
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. |
|
|
