Only approved for use in Tees.

Chloral hydrate is not recommended in the BNF for the management of insomnia. The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Chloral Hydrate 500mg in 5mL - Unlicensed liquid for use in paediatrics only. Recommended strength in children as per NPPG/RCPCH Position Statement: Using Standardised Strengths of Unlicensed Liquid Medicines in Children.

Chloral Hydrate (Suppositories) - Unlicensed for paediatrics only - 100mg and 500mg strengths available

MHRA Drug Safety Update (Oct 2021): Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication

BNF: less suitable for prescribing

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

MR Tabs - 2mg

MR tabs licensed only for adults over 55years. Classed as Amber for children and young adults and prescribed off label. 

MR tablets are not approved on the formulary for the management of primary insomina in adults.

Circadin^® - melatonin 2 mg prolonged-release tablets - swallowed whole or crushed (if unable to swallow whole or immediate-release action required)

Shared Care Guideline: Melatonin

1 mg and 5 mg prolonged release tablets

Treatment of insomnia in children and adolescents aged 2 - 18 years with ASD and/or Smith-Magenis Syndrome (SMS) only where sleep hygiene measures have been insufficient.

Shared Care Guideline: Melatonin

MR Tabs - 2mg (Circadin(R)

AMBER SPECIALIST INITIATION

Neurology use includes Parkinson's disease on advice of a specialist/specialist nurse.

MR tabs licensed only for adults over 55years. MR tablets are not approved on the formulary for the management of primary insomina in adults.

Classed as Amber shared care for children and young adults and prescribed off label  (see separate Melatonin Shared Care entry

Circadin® - melatonin 2 mg prolonged-release tablets - swallowed whole or crushed (if unable to swallow whole or immediate-release action required)

NHS prescribing of melatonin for jet lag is not appropriate.

(N.B. only licensed for short term treatment of jet lag in adults)

Off-label used in paediatric not cost-effective instead use Circadin® - melatonin 2 mg prolonged-release tablets - swallowed whole or crushed (if unable to swallow whole or immediate-release action required)

Melatonin 5mg/5ml alcohol free and propylene glycol free oral solution (200ml) (unlicensed product)

Second line only if crushing Circadin tablets inappropriate

Shared Care Guideline: Melatonin

1mg/ml oral solution

NHS prescribing of melatonin for jet lag is not appropriate.

(N.B. only licensed for short term treatment of jet lag in adults)

Formulation contains:
 Sorbitol 140 mg/ml (may cause osmotic diarrhoea, GI discomfort);
 Propylene glycol 150.37 mg/ml (accumulation can lead to CNS depression);
 Ethanol 0.00045 mg/ml (risk of acute intoxication with accidental overdose and chronic toxicity)
Therefore, there are safety concerns in children & adolescents relative to the unlicensed preparation which does not contain these excipients

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

10mg & 25mg tablets
5mg in 5ml sugar-free elixir
25mg in 1ml injection

TEWV Rapid Tranquilisation Policy

Tablets - 10mg

Liquid - 10mg/5ml

Zolpidem: MHRA Drug Safety Alert (May 2014) – risk of drowsiness and reduced driving ability

FIRST LINE

Tablets - 3.75mg, 7.5mg

Tabs - 2mg, 5mg

Oral solution - 2mg/5ml

Rectal tubes - 2mg/ml, 4mg/ml

5mg & 10mg capsules

Chlordiazepoxide: used for acute alcohol withdrawal syndrome. See NICE guidance on the withdrawal of alcohol.

Tabs - 1mg

4mg in 1ml injection

SECOND LINE where rapid action is required and no suitable alternative or palliative care

Lorazepam: shorter acting benzodiazepines e.g lorazepam may be preferred in patients with hepatic impairment but carry greater risk of withdrawal symptoms.
Injection when used for rapid control of agitated or disturbed behaviour in patients with schizophrenia or manic episode where oral treatment is not appropriate. See TEWV Rapid Tranquilisation prescribing guidelines.

Tablets can be used for sublingual administration

TEWV Rapid Tranquilisation Policy

Safety concerns - see BNF.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Buspirone: patients must be stabilised on this prior to transfer of prescribing responsibility to GP. It is expected that they will have completed at least one month of treatment and be suitable for 28 day prescriptions.

(see also section 4.8)
Pregabalin: For those unable to tolerate SSRIs and SNRIs patients must be stabilised on this prior to transfer of prescribing responsibility to GP. It is expected that they will have completed at least one month of treatment and be suitable for 28 day prescriptions.

MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression

MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

See section 4.8

AMBER SPECIALIST INITIATION

See section 4.8

AMBER SPECIALIST INITIATION

Tabs 200mg, 400mg (Priadel) - brand of choice

Tabs - 400mg  (Camcolit) - for exisiting patients only

Tabs - 250mg (Essential Pharma) - for exisiting patients only

MR Tabs - 450mg (Liskonum)- for exisiting patients only

Lithium should be prescribed by brand name

Unsuitable for discharge to GP from TEWV

See Safety Guidance: Lithium on admission to CDDFT – intranet link (CDDFT only)

See TEWV Lithium - Shared Care Guidelines

See TEWV Lithium on admission to an acute hospital - safety guidance

For patients maintained on lithium levels above 1.0mmol/l – lithium is classed as a red drug

Oral Solution - 520mg/5ml (Priadel) - brand of choice

Oral Solution - 509mg/5ml (Li-Liquid)  - for existing patients only

See BNF for conversion of lithium citrate to lithium carbonate as the salts are not equivalent.

Lithium should be prescribed by brand name

Unsuitable for discharge to GP from TEWV

See Safety Guidance: Lithium on admission to CDDFT – intranet link (CDDFT only)

See TEWV: Lithium Shared Care Guideline

2.5mg, 5mg, 7.5mg & 10mg, 15mg & 20mg tablets
5mg, 10mg & 15mg orodispersible tablets

AMBER SPECIALIST INITIATION

Orodispersible tablets - should only be used in situations where the plain tablets are unsuitable

25mg, 100mg, 150mg 200mg & 300mg tablets
50mg, 200mg, 300mg & 400mg prolonged release tablets

AMBER SPECIALIST INITIATION

Immediate release should be used 1st line, MR preparations should be reserved for those with a clinical need e.g. poor compliance.

500microgram, 1mg, 2mg, 3mg, 4mg & 6mg tablets
Oral solution - 1mg/ml

AMBER SPECIALIST INITIATION

Orodispersible tablets - should only be used in situations where the plain tablets are unsuitable. MHRA Alert – risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery. More details here.

See section 4.8

AMBER SPECIALIST INITIATION

Prevention and treatment of manic episodes associated with bipolar disorder

MHRA Drug Safety Update (Feb 2016): Valproate and of risk of abnormal pregnancy outcomes: new communication materials

MHRA Drug Safety Update (Jan 2015): Medicines related to valproate: risk of abnormal pregnancy outcomes 

MHRA Drug Safety Update (Nov 2013): Sodium valproate: Risk of neurodevelopmental delay in children following maternal use

MHRA Drug Safety Update (April 2017): Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures 

MHRA Drug Safety Update (April 2018): Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met 

MHRA Drug Safety Update (May 2018): Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online

MHRA Drug Safety Update (Sept 2018): Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

MHRA Drug Safety Update (April 2019): Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

MHRA Drug Safety Update (Feb 2020): Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials

MHRA Drug Safety Update (May 2020): Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here

Patient Group: Girls (of any age) and women of child bearing potential

See section 4.8 for preparations

Prevention and treatment of manic episodes associated with bipolar disorder

MHRA Drug Safety Update (Feb 2016): Valproate and of risk of abnormal pregnancy outcomes: new communication materials

MHRA Drug Safety Update (Jan 2015): Medicines related to valproate: risk of abnormal pregnancy outcomes 

MHRA Drug Safety Update (Nov 2013): Sodium valproate: Risk of neurodevelopmental delay in children following maternal use

MHRA Drug Safety Update (April 2017): Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures 

MHRA Drug Safety Update (April 2018): Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met 

MHRA Drug Safety Update (May 2018): Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online

MHRA Drug Safety Update (Sept 2018): Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

MHRA Drug Safety Update (April 2019): Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

MHRA Drug Safety Update (Feb 2020): Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials

MHRA Drug Safety Update (May 2020): Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here

Tabs E/C - 250mg, 500mg (as semi sodium valproate)

AMBER SPECIALIST INITIATION

Depakote® and Convulex® licensed alternative to sodium valproate for treatment of manic episodes.

MHRA Drug Safety Update (Feb 2016): Valproate and of risk of abnormal pregnancy outcomes: new communication materials

MHRA Drug Safety Update (Jan 2015): Medicines related to valproate: risk of abnormal pregnancy outcomes 

MHRA Drug Safety Update (Nov 2013): Sodium valproate: Risk of neurodevelopmental delay in children following maternal use

MHRA Drug Safety Update (April 2017): Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures 

MHRA Drug Safety Update (April 2018): Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met 

MHRA Drug Safety Update (May 2018): Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online

MHRA Drug Safety Update (Sept 2018): Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

MHRA Drug Safety Update (April 2019): Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

MHRA Drug Safety Update (Feb 2020): Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials

MHRA Drug Safety Update (May 2020): Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here

Patient Group: Girls (of any age) and women of child bearing potential

Tabs E/C - 250mg, 500mg (as semi sodium valproate)

Depakote® and Convulex® licensed alternative to sodium valproate for treatment of manic episodes.

MHRA Drug Safety Update (Feb 2016): Valproate and of risk of abnormal pregnancy outcomes: new communication materials

MHRA Drug Safety Update (Jan 2015): Medicines related to valproate: risk of abnormal pregnancy outcomes 

MHRA Drug Safety Update (Nov 2013): Sodium valproate: Risk of neurodevelopmental delay in children following maternal use

MHRA Drug Safety Update (April 2017): Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures 

MHRA Drug Safety Update (April 2018): Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met 

MHRA Drug Safety Update (May 2018): Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online

MHRA Drug Safety Update (Sept 2018): Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

MHRA Drug Safety Update (April 2019): Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

MHRA Drug Safety Update (Feb 2020): Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials

MHRA Drug Safety Update (May 2020): Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here

20mg in 1ml, 40mg in 2ml, 50mg in 0.5ml,
100mg in 1ml & 200mg in 1ml injections

If the transfer of care was made prior to 11/7/2019 then this drug was considered as amber specialist initiation and does not need to be referred back to establish shared care. A shared care agreement is required for any transfer from 11/7/2019 onwards.

50mg in 1ml & 100mg in 1ml injections

If the transfer of care was made prior to 11/7/2019 then this drug was considered as amber specialist initiation and does not need to be referred back to establish shared care. A shared care agreement is required for any transfer from 11/7/2019 onwards.

25mg, 37.5mg and 50mg long acting injections

Risperidone long acting only for use by specialists in TEWV in accordance with TEWV Psychosis pathway

NTAG September 2017: The Northern (NHS) Treatment Advisory Group recommends the use of
Paliperidone LAI and 3-monthly injection as per its licensed indications and as outlined in the updated Guidance on the Use of Antipsychotic Long-acting Injections in the North of England.

If the transfer of care was made prior to 11/7/2019 then this drug was considered as amber specialist initiation and does not need to be referred back to establish shared care. A shared care agreement is required for any transfer from 11/7/2019 onwards.

200mg in 1ml & 500mg in 1ml injections

If the transfer of care was made prior to 11/7/2019 then this drug was considered as amber specialist initiation and does not need to be referred back to establish shared care. A shared care agreement is required for any transfer from 11/7/2019 onwards.

400mg long acting injection

Aripiprazole LAI - TEWV shared care guidelines

50mg, 100mg & 150mg pre-filled syringe

Both monthly and three-monthly preparations of Paliperidone LAI are included in the formulary.

NTAG September 2017: The Northern (NHS) Treatment Advisory Group recommends the use of
Paliperidone LAI and 3-monthly injection as per its licensed indications and as outlined in the updated Guidance on the Use of Antipsychotic Long-acting Injections in the North of England.

Paliperidone 3 monthly injection may be considered for patients clinically stable for at least 4 months on 1 monthly paliperidone palmitate injection.

Paliperidone LAI - TEWV shared care guidelines

210 mg, 300 mg, and 405 mg, powder and solvent for prolonged release suspension for injection.

TEWV Olanzapine LA Prescribing Administration guidelines

Tabs - 10mg, 25mg, 50mg

Oral Solution - 25mg/5ml, 50mg/5ml

For use unlicensed for neuropathic pain

Tablets - 10mgs, 25mg

Tabs - 70mg,

Oral Solution - 70mg/5ml

Tabs - 10mg, 25mg

Caps - 50mg

Tabs - 10mg, 25mg

Trimipramine prescribing is not recommended.  For existing patients prescribed Trimipramine this TEWV guidance applies.

NHS England (November 2017) advises that primary care prescribers should not initiate trimipramine for new patients. NHS England also supports the deprescribing of trimipramine.
If a tricyclic antidepressant is required there are more cost-effective alternatives.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Caps - 50mg, 100mg

Tabs - 150mg

Liquid - 50mg/5ml

Dosulepin prescribing is not recommended.  For existing patients prescribed dosulepin this TEWV guidance applies.

NICE guidance for depression (CG90, October 2009) states that patients should not be initiated on dosulepin as the cardiac risks and toxicity in overdose outweigh potential benefits; additionally, PrescQIPP (Bulletin 126, April 2016) advise that dosulepin should not be prescribed for unlicensed indications. NHS England (November 2017) supports the deprescribing of dosulepin.
Patients prescribed dosulepin should be reviewed for suitability for swapping to a safer suitable alternative. Dosulepin should not be stopped abruptly unless serious side effects have occurred; gradual tapering is recommended to help prevent discontinuation symptoms

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

10mg, 25mg and 50mg capsules 

To be used as per TEWV depression & anxiety guidelines

Tabs - 150mg, 300mg

Initiation to be recommended by secondary care

15mg tablets

Initiation to be recommended by secondary care

Indicated when there is no response to other antidepressant groups

See TEWV policies:

Depression pathway handy hints when prescribing antidepressants

Depression Medication Pathway for Adults

CYP Depression Pathway - guidance for pharmacological management

BNF: less suitable for prescribing

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

BNF: less suitable for prescribing

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Tabs - 10mg, 20mg, 40mg

Oral Drops - 40mg/ml

Citalopram: See MHRA guidance regarding dose related QT prolongation and TEWV guidance on dose reduction and ECG monitoring

MHRA Drug Safety Update (July 2016): Citalopram: suspected drug interaction with cocaine; prescribers should consider enquiring about illicit drug use

MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

Caps - 20mg

Liquid - 20mg/5ml

MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

Tabs - 50mg, 100mg

50mg/5ml oral solution - Recommended strength in children as per NPPG/RCPCH Position Statement: Using Standardised Strengths of Unlicensed Liquid Medicines in Children.

MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

Escitalopram: See MHRA guidance regarding dose related QT prolongation and TEWV guidance on dose reduction and ECG monitoring

MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

10mg, 20mg and 30mg tablets

Only for existing patients and patients moving into the area already stabilised on paroxetine.

MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

Caps - 30mg, 60mg

Caps - 90mg and 120mg are not approved on the basis that not cost effective.

Tabs - 25mg

Recommended for the treatment of depression only following an adequate trial of at least three alternative antidepressant drugs at maximally tolerated doses.  See NTAG recommendation.

MHRA Drug safety Update (Nov’ 2014): risk of liver toxicity – reminder to test LFTs before and during treatment

Tabs - 15mg, 30mg, 45mg

Orodispersible Tabs - 15mg, 30mg, 45mg 

1st line intervention for depression in those requiring sedation.

See TEWV policies:

Depression pathway handy hints when prescribing antidepressants

Depression Medication Pathway for Adults

CYP Depression Pathway - guidance for pharmacological management

Orodispersible tablets should only be prescribed for patients who are unable to swallow solid dose forms

Tabs - 37.5mg, 75mg 

When prescribed in doses less than 225mg per day.
Immediate release should be used 1st line, MR preparations should be reserved for those with a clinical need e.g. poor compliance. The reason should be stated in GP communications when transferring prescribing.
In low doses is as expensive as an SRRI.
See TEWV Depression Pathway Medication Guidelines Primary and Secondary Care Monotherapies

When prescribed in doses above 225mg per day (Amber Specialist initiation drug)

Must be recommended by a specialist and arrangements for 6-monthly monitoring of blood pressure agreed with GP.
Immediate release should be used 1st line, MR preparations should be reserved for those with a clinical need e.g. poor compliance. The reason should be stated in GP communications when transferring prescribing.

MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

4mg tablets

AMBER SPECIALIST INITIATION

5mg, 10mg & 20mg film-coated tablets

For use as 3^rd line treatment option for the management of depression as per NICE TA367

See TEWV policies:

Depression pathway handy hints when prescribing antidepressants

Depression Medication Pathway for Adults

CYP Depression Pathway - guidance for pharmacological management

MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

120mg capsules

MHRA Drug Safety Update (March 2014): theoretical interaction with antiretroviral HIV medicines  

NICE CG189: Obesity: identification, assessment and management of overweight and obesity in children, young people and adults

Tablets - 50mg

Tablets - 15mg

Tablets - 5mg

500 microgram capsules,1.5mg, 5mg & 10mg tablets
5mgin 5ml, 1mg in 1ml & 2mg in 1ml oral liquid
5mg in 1ml & 20mg in 2ml injection

MHRA Drug Safety Update (Dec 2021): Haloperidol (Haldol): reminder of risks when used in elderly patients for the acute treatment of delirium

5mg tablets; 5mg in 5ml syrup
12.5mg in 1ml injection
3mg tablets (buccal) (Buccastem®)

6mg tablets^u, 25mg tablets
25mg in 1ml injection - For use in palliative care

25mg tablets can be halved or quartered
6mg tablets are unlicensed and should only be used in palliative care

Tablets - 10mg

Suspension - 5mg/5ml

MHRA Drug Safety Alert (May 2014): indication now restricted to nausea and vomiting

MHRA Drug Safety Update (Dec 2019): Domperidone for nausea and vomiting: lack of efficacy in children; reminder of contraindications in adults and adolescents

Tablets - 10mg

Oral Solution - 5mg/5ml

Caution in elderly, young adults and children

Do not use in people under 20 years

MHRA Drug Safety Update Alert (Aug 2013) Metoclopramide– restricted dose and duration

4mg & 8mg tablets
4mg in 5ml sugar-free solution
4mg in 2ml & 8mg in 4ml injections
16mg suppositories

MHRA Drug Safety Alert (Jul 2013): Ondansetron for intravenous use: dose-dependent QT interval prolongation

MHRA Drug Safety Update (Jan 2020): Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy

250 microgram in 5ml injection, 500 microgram capsules
- for 2nd line of treatment for chemotherapy induced nausea vomiting only

Only injection available STHFT

1 mg film-coated tablets

1 mg/ml concentrate for solution for injection or infusion

3.1 mg/24 hours transdermal patch

Nausea and vomiting induced by cytotoxic chemotherapy or radiotherapy.

Patches restricted to patients unable to swallow.

300 microgram oral/sublingual tablets
1mg/72 hour patches
- for the management of excessive secretions where tablets are unsuitable

80mg & 125mg capsules
- for the prevention of chemotherapy induced nausea and vomiting (CINV) in high risk patients in accordance with North of England Cancer Network: CINV Guidelines in adult oncology and haematology patients

1mg caps

2.5mg/ml injection

For post surgery nausea & vomiting

Tablets - 8mg, 16mg

Meniere's disease

500mg plain & soluble tablets^OTC
120mg & 250mg in 5ml suspensions (sugar-free)^OTC
60mg, 125mg, 250mg & 500mg suppositories

See section 10.1.1

NICE ES23: COVID-19 rapid evidence summary: acute use of non-steroidal anti-inflammatory drugs (NSAIDs) for people with or at risk of COVID-19

NICE ES25: COVID-19 rapid evidence summary: Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) for people with or at risk of COVID-19

30mg tablets

County Durham & Tees Valley APC do not support the prescribing of nefopam 30mg tablets in primary care unless on the recommendation of specialist pain services.

County Durham & Tees Valley APC Position Statement on Nefopam

Nefopam should not be prescribed in primary care unless on the recommendation of specialist pain. It should
only be considered 5th line to manage central nociceptive pain after amitriptyline, gabapentin, duloxetine or
pregabalin have proven to be either ineffective not tolerated. In such extreme cases nefopam should be initially
trialled for no more than 2 weeks, reviewed regularly and discontinued if ineffective, or if unacceptable adverse
effects develop.

It should for used only for patient who are unable to tolerate opioids or where opioids are contra-indicated.

Key Messages:
• don’t initiate nefopam for acute or chronic pain in primary care
• don’t continue nefopam post-discharge following secondary care acute initiation
• only continue nefopam in line with recommendations of the specialist pain service
• review existing patients

Adverse effects are common, nefopam is toxic in overdose and has abuse potential through its psychostimulant-like effects. Nefopam is very expensive.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

The NHS Regional Drug and Therapeutics Centre bulletin (January 2008) states that co-proxamol should not be prescribed under any circumstances to new patients; existing patients should be converted to alternative analgesics.
Co-proxamol has an unfavourable adverse-events profile, particularly toxicity in accidental and intentional overdose.
The MHRA Drug Safety Update (January 2011) further confirms the cardiac risks associated with co-proxamol.

NHS England (November 2017) supports the deprescribing of co-proxamol.  Studies suggest co-proxamol is no more effective than standard doses of paracetamol taken alone

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Poor evidence base.
This preparation does not allow for effective dose titration and the advantages of using a compound
formulation have not been substantiated. There is no instance where this product is appropriate to use from a safety or efficacy point of view, over existing treatments.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

NHS England (November 2017) supports the deprescribing of combination tramadol/paracetamol preparations.
Paracetamol and tramadol combination products are more expensive than the products with the individual components PrescQIPP CIC also issued a bulletin which did not identify any significant advantages over individual products, however it does recognise that some people may prefer to take one product instead of two

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Intrathecal Analgesia

NHS England – Not routinely commissioned

200 microgram sublingual tablets
300 micrograms in 1ml injection
5 microgram/hour, 10 microgram/hour, 20 microgram/hour transdermal patch (BuTrans®)
35microgram, 52.5microgram, 70microgram/hour transdermal patch over 96 hours

Prescribe by brand

The preferred brand of choice for weekly buprenorphine patches within North Durham and DDES is Butec(R) patches.

72 hour transdermal patches (e.g. Hapoctasin and Penotrix) are non-formulary.

North of England Cancer Network Palliative and End of Life Care Pathway

Tablets - 15mg, 30mg

Syrup - 25mg/5ml

30mg in 1ml injection^u  & 60mg in 1ml injection

Codeine is the preferred weak opioid analgesic.

MHRA Drug Safety Alert (Nov 2003): significant restrictions in paediatrics and breast feeding mothers

Interim CDDFT advice available via CDDFT intranet

5mg, 10mg, 30mg, 100mg & 500mg injections

Diamorphine 500 microgram in 0.5ml sodium chloride 0.9% intrathecal pre-filled syringes (unlicensed)

Drug protocol: diamorphine for pain relief during labour (CDDFT intranet access only)

North of England Cancer Network Palliative and End of Life Care Pathway

Tablets - 30mg

Note: the use of dihydrocodeine 30mg tablets & 10mg in 5ml oral solution is no longer recommended for regular use. Codeine is the preferred weak opioid analgesic.

Dihydrocodeine is only approved for use in breast feeding mothers immediately postdelivery/ c-section where adequate pain relief has not been achieved using paracetamol and NSAIDs. Patients requiring contunation of dihydrocodeine following discharge (post delivery/c-section) can have dihydrocodeine prescribed in primary care (for short-term use only).

Dipipanone hydrochloride/Cyclizine hydrochloride 10mg/30mg tab

Not a cost-effective use of resources

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Patches - 12microgram/hour, 25microgram/hour, 50microgram/hour, 75microgram/hour, 100microgram/hour

Prescribe by brand

The preferred brand of choice within North Durham and DDES is Mezolar Matrix(R) patches.

Transdermal fentanyl – MHRA Drug Safety Update (July 2014) – reminder of potential life threatening harm from accidental exposure, especially in children

MHRA Drug Safety Update (Oct 2018): Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children

MHRA Drug Safety Update (Sep 2020): Transdermal fentanyl patches for non-cancer pain: do not use in opioid-naive patients

Refer to palliative care guidelines for advice on swapping to/from patches: North of England Cancer Network Palliative and End of Life Care Pathway

CD&D Grey List: Novel Fentanyl preparations should not be prescribed as these have been rejected by NTAG

100, 200, 300, 400, 600, 800 microgram tablets to replace the use of Actiq lonzenge.

AMBER SPECIALIST RECOMMENDATIOM

For breakthrough / rescue pain relief in palliative care patients (patients with life-limiting illness requiring specialist palliative care team member review) who have:

1. Intolerance of morphine / oxycodone

2. Renal impairment which necessitates strong opioid choice other than morphine /oxycodone

3. Dysphagia

NHS England (November 2017) advises that primary care prescribers should not initiate immediate-release fentanyl preparations for new patients. NHS England also supports the deprescribing of immediate-release fentanyl preparations. More cost-effective preparations are available.
NHS England recommendations for immediate-release fentanyl do not apply to patients undergoing palliative care treatment arranged with a suitable specialist.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Sublingual tablets, buccal tablets, lozenges, nasal sprays

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

NHS England (November 2017) advises that primary care prescribers should not initiate immediate-release fentanyl preparations for new patients. NHS England also supports the deprescribing of immediate-release fentanyl preparations. More cost-effective preparations are available.

NHS England recommendations for immediate-release fentanyl do not apply to patients undergoing palliative care treatment arranged with a suitable specialist

1mg/1ml liquid and 5mg tablets available.

Use in pain management should be under the advice of palliative care
 Concentrated liquid and injection can be ordered if required

Tablets - 10mg, 20mg, 50mg (Sevredol),

MR capsules - 10mg, 30mg, 60mg, 100mg, 200mg (Zomorph)

MR tablets - 10mg, 15mg, 30mg, 60mg, 100mg, 200mg (MST)

10mg in 5ml Liquid                                                              

Injection - 10mg/ml, 15mg/ml, 20mg/ml, 30mg/ml

Zomorph is the preferred modified release preparation in County Durham and Darlington

Drug protocol: neonatal morphine sulphate for ventilation (CDDFT intranet access only)

North of England Cancer Network Palliative and End of Life Care Pathway

Oxycodone and naloxone combination product is used to treat severe pain and can also be used second line in restless legs syndrome. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.
PrescQIPP have issued a bulletin and did not identify a benefit of oxycodone and naloxone in a single product over other analgesia (with laxatives if necessary).
Due to the significant cost of the oxycodone and naloxone combination product and the unclear role of the combination product in therapy compared with individual products, this combination product is considered by NHSE as less suitable for prescribign.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Capsules - 5mg, 10mg, 20mg,

Liquid - 5mg/5ml

MR Tablets - 5mg, 10mg, 15mg, 20mg, 40mg, 60mg80mg, 120mg

Oral solution should be used instead of immediate release tablets.

Prescribe by brand

See CQC - safer use oxycodone

Oxycodone only to be used in patients who are intolerant of morphine.

Oxycodone should be prescribed by brand to avoid confusion between different preparations – Longtec® is currently the local formulary modified release preparation of choice.

North of England Cancer Network Palliative and End of Life Care Pathway

BNF: less suitable for prescribing

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

50mg in 1ml & 100mg in 2ml injections

Drug protocol: pethidine for pain relief during labour (CDDFT intranet access only)

50mg, 100mg, 150mg, 200mg and 250mg m/r tablets
50mg and 75mg immediate release tablets

AMBER SPECIALIST INITIATION

3rd line treatment for the relief of severe chronic pain in adults which can be adequately managed only with opioid analgesics AND in whom morphine and oxycodone has failed to provide adequate pain relief or is not tolerated.

For chronic pain team use and inpatient acute pain team use only.

County Durham and Tees Valley APC Dose Reduction Guidance for Primary Care Practitioners

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

MHRA Drug Safety Update (Jan 2019): Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines

Capsules - 50mg

50mg dispersible tablets
100mg in 2ml injection

Tramadol - only recommended for use in patients where treatment with possible alternatives such as paracetamol, NSAIDs, and codeine is insufficiently effective, not tolerated or considered unsuitable for other reasons. Modified release tramadol is not recommended.

See CDDFT Tramadol Schedule 3 CD prescribing memo – intranet link (CDDFT only)

50mg/50ml injection

For PCA use only.

100microgram/ml oral solution (unlicensed)

For use in neonates only.

See section 4.3

See section 4.8.1

Also approved for hospital use as an adjunct to other treatment in the management of peri/post-operative pain. GPs should not be asked to prescribe gabapentin for this unlicensed indication.

MHRA Drug Safety Alert (Oct 2017): Gabapentin (Neurontin): risk of severe respiratory depression 

See section 4.8.1

Restricted to use in the management neuropathic pain as a second choice where treatment with gabapentin has been unsuccessful or not tolerated.

The preferred brand of choice within North Durham and DDES is Alzain(R) where licensing allows.

MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression

MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy

See section 4.8.1

30mg & 60mg capsules 30mg & 60mg capsules

For third-line use (after drugs such as the tricyclic antidepressants and gabapentin) in the treatment of neuropathic pain on the advice of pain specialists.

See section 4.8.1

179 mg cutaneous patch

NTAG June 2017: The Northern (NHS) Treatment Advisory Group recommends use of
Qutenza® as a fourth line agent for neuropathic pain and in line with the regionally agreed pathway.

5% medicated plasters (700mg lidocaine/plaster)

AMBER SPECIALIST INITIATION

Lidocaine patches are only licensed for the treatment of postherpatic neuralgia (PHN).
In addition, they are approved locally for use in the following:
• the treatment of multiple rib fractures on the advice of pain specialists only, in line with the procedure for pain management and rehabilitation following multiple rib fractures - RED drug
• palliative care – please note that prescribers in primary care can initiate prescribing in palliative care patients.

NHS England (November 2017) advises that primary care prescribers should not initiate lidocaine plasters for new patients, and supports the deprescribing of lidocaine plasters for existing patients; this does not apply to patients still experiencing post-herpetic neuralgia having been treated in accordance with NICE Guidance for neuropathic pain in adults (CG173, February 2017). In exceptional clinical need, lidocaine plasters may be prescribed in co-operation with a suitable specialist.

NICE CG173 recommends offering initial treatment with amitriptyline, duloxetine, gabapentin or pregabalin, offering one of the remaining three drugs if the initial treatment is not effective or not tolerated; consider capsaicin cream for patients with localised neuropathic pain who wish to avoid, or cannot tolerate, oral treatments.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

167mg capsules

Unlicensed for use management of pain.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

10mg, 25mg, 50mg, 75mg and 100mg film coated tablets

10mg/mL oral solution 

AMBER SPECIALIST RECOMMENDATION

Brivaracetam has been approved as third line treatment option for use as adjuvant therapy in patients with focal onset seizures. Not currently indicated in generalised epilpesy syndromes. 

Category 3 in epilepsy treatment - it is usually unnecessary to ensure the patient is maintained on a specific manufacturers product unless there are specific concerns.

Epidyolex®100 mg/ml oral solution

Approved for use in accordance with the following NICE TAs:

• 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 

Commissioner: NHS England

Tablets - 100mg, 200mg, 400mg

MR Tablets - 200mg, 400mg

Liquid - 100mg/5ml

AMBER SPECIALIST RECOMMENDATION

Category 1 in epilepsy treatment - ensure patient is maintained on specific manufacturers product.

Film coated tablets

Approved for use in accordance with the following NICE TAs:

• NICE TA753: Cenobamate for treating focal onset seizures in epilepsy 

AMBER SPECIALIST INITIATION DRUG.

Tablets - 10mg

1mg/ml and 2mg/ml oral suspension

AMBER SPECIALIST RECOMMENDATION

Only prescribable on NHS for epilepsy. Must be endorsed SLS

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

Tablets - 500microgram, 2mg

AMBER SPECIALIST RECOMMENDATION

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

800mg tablets

AMBER SPECIALIST RECOMMENDATION

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.

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

Capsules - 250mg

Syrup - 250mg/5ml

AMBER SPECIALIST RECOMMENDATION

Category 3 in epilepsy treatment - it is usually unnecessary to ensure the patient is maintained on a specific manufacturers product unless there are specific concerns.

Capsules - 100mg, 300mg, 400mg

Tablets - 600mg

Oral Solution - 250mg/5ml

AMBER SPECIALIST RECOMMENDATION

Also licensed for neuropathic pain

MHRA Drug Safety Alert (Oct 2017): Gabapentin (Neurontin): risk of severe respiratory depression 

Category 3 in epilepsy treatment - it is usually unnecessary to ensure the patient is maintained on a specific manufacturers product unless there are specific concerns.

50mg, 100mg, 150mg & 200mg tablets
10mg per ml syrup, 10mg per ml intravenous infusion

AMBER SPECIALIST RECOMMENDATION
- on advice from consultant neurologists, in patients that are refractory to treatment with other drugs

Category 3 in epilepsy treatment - it is usually unnecessary to ensure the patient is maintained on a specific manufacturers product unless there are specific concerns.

Tablets - 25mg, 50mg, 100mg, 200mg

Dispersible Tablets - 2mg (only Chewable), 5mg, 25mg, 100mg

AMBER SPECIALIST RECOMMENDATION

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

Tablets 250mg, 500mg, 750mg and 1g
Sugar Free solution 100mg/ml

AMBER SPECIALIST RECOMMENDATION

Category 3 in epilepsy treatment - it is usually unnecessary to ensure the patient is maintained on a specific manufacturers product unless there are specific concerns.

Medium Chain Triglyceride oil

Indication = resistant epilepsy as part of a ketogenic diet.

150mg, 300mg & 600mg tablets

60mg/ml, 250ml oral suspension - N.B. double the cost of tablets so only use when patient is unable to swallow tablets.

AMBER SPECIALIST RECOMMENDATION

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

2mg, 4mg, 6mg, 8mg, 10mg, 12mg tablets.

0.5 mg/ml oral suspension

AMBER SPECIALIST INITIATION

NTAG June 2021: The NHS North East Treatment Advisory Group recommends perampanel for the treatment partial-onset seizures (POS) with or without secondarily
generalised seizures in patients from 4 years of age and older, and primary
generalised tonic-clonic (PGTC) seizures in patients from 7 years of age
and older with idiopathic generalised epilepsy (IGE) in-line with the
product license only when other treatment options recommended by NICE
have been tried or fully considered.

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

15mg, 30mg & 60mg tablets; 15mg in 5ml elixir;

50mg in 5ml suspension (alcohol free) - Recommended strength in children as per NPPG/RCPCH Position Statement: Using Standardised Strengths of Unlicensed Liquid Medicines in Children.

AMBER SPECIALIST RECOMMENDATION

15mg in 1ml, 30mg in 1ml & 200mg in 1ml injections - usually a RED drug.

Category 1 in epilepsy treatment - ensure patient is maintained on specific manufacturers product.

Capsules - 25mg, 50mg, 100mg, 300mg,

Chewable Tablets - 50mg

Suspension - 30mg/5ml

AMBER SPECIALIST RECOMMENDATION

Phenytoin: different preparations may vary in bioavailability; always prescribe by brand name. Therapeutic drug monitoring required.

Suspension contains phenytoin base - care need when changing to or from capsules

Category 1 in epilepsy treatment - ensure patient is maintained on specific manufacturers product.

AMBER SPECIALIST RECOMMENDATION

Capsules - 25mg50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg

AMBER SPECIALIST RECOMMENDATION

Also licensed for neuropathic pain

The preferred brand of choice within North Durham and DDES is Alzain(R) where licensing allows.

Category 3 in epilepsy treatment - it is usually unnecessary to ensure the patient is maintained on a specific manufacturers product unless there are specific concerns.

MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression

MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy

AMBER SPECIALIST RECOMMENDATION

Category 1 in epilepsy treatment - ensure patient is maintained on specific manufacturers product.

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

Tablets e/c - 200mg, 500mg,

Tablets MR - 200mg, 300mg, 500mg,

Oral Solution - 200mg/5ml,

Tablets (crushable) - 100mg

Capsules MR - 150mg

Sachets MR - 100mg and 250mg (Epilim Chronosphere)

AMBER SPECIALIST RECOMMENDATION

MHRA Drug Safety Update (Feb 2016): Valproate and of risk of abnormal pregnancy outcomes: new communication materials

MHRA Drug SafetyAlert (Jan2015): Medicines related to valproate: risk of abnormal pregnancy outcomes

MHRA Drug Safety Alert (Nov 2013): Sodium Valproate - special reminder on risk of neurodevelopmental delay in children following maternal use. 

MHRA Drug Safety Alert (April 2017): Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures 

MHRA Drug Safety Update (April 2018): Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met 

MHRA Drug Safety Update (May 2018): Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online

MHRA Drug Safety Update (Sept 2018): Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

MHRA Drug Safety Update (April 2019): Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

MHRA Drug Safety Update (Feb 2020): Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials

MHRA Drug Safety Update (May 2020): Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

Patient Group: Girls (of any age) and women of child bearing potential

100mg crushable tablets, 200mg & 500mg e/c tablets 200mg, 300mg & 500mg m/r tablets (Epilim Chrono).
150mg & 300mg m/r capsules

500mg & 1000mg m/r granules (Episenta) - for use in those who have difficulty swallowing sodium valproate tablets. May be more convenient to use than large volumes of liquid formulations
200mg in 5ml sugar-free liquid

Unlicensed Indication

MHRA Drug Safety Alert (April 2017): Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures 

MHRA Drug Safety Update (April 2018): Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met 

MHRA Drug Safety Update (May 2018): Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online

MHRA Drug Safety Update (Sept 2018): Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

MHRA Drug Safety Update (April 2019): Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

MHRA Drug Safety Update (Feb 2020): Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials

MHRA Drug Safety Update (May 2020): Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here

AMBER SPECIALIST RECOMMENDATION

Category 3 in epilepsy treatment - it is usually unnecessary to ensure the patient is maintained on a specific manufacturers product unless there are specific concerns.

Tablets - 25mg, 50mg, 100mg, 200mg

Capsules (Sprinkle) - 15mg, 25mg, 50mg

AMBER SPECIALIST RECOMMENDATION

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/: Topiramate hard capsules are expensive and should not be prescribed. For those patients unable to swallow topiramate tablets “sprinkle capsules” may be considered. 

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

Tablets - 500mg

Powder (Sugar free) - 500mg/Sachet

AMBER SPECIALIST INITIATION

Category 3 in epilepsy treatment - it is usually unnecessary to ensure the patient is maintained on a specific manufacturers product unless there are specific concerns.

25mg, 50mg and 100mg capsules

100mg/5ml oral suspension (licensed)

50mg/5ml oral suspension (unlicensed)

AMBER SPECIALIST RECOMMENDATION

For specialist use only in patients that are refractory to treatment with other drugs

Prescribing zonisamide 100mg/5ml oral suspension (licensed) instead of zonisamide 50mg/5ml oral suspension (unlicensed) is best practice (CAUTION: change in strength).

Category 2 in epilepsy treatment  - the need for continued supply of a particular manufacturers produce should be based on clinical judgment and consultation with the patient taking into account factors such as seizure frequency and treatment history.

Rectal Solution - 4mg/ml

Oromucosal Solution - 5mg/ml

Pre-filled syringes - 0.5ml, 1ml, 1.5ml, 2ml (Buccolam)

Other unlicensed formulations are available - check dose

1mg & 2.5mg tablets; 4mg in 1ml injection

Rectal liquid ^u

Drug protocol: neonatal IV and oral phenobarbital (CDDFT intranet access only)

250mg in 5ml injection

Capsules - 62.5mg, 125mg, 250mg

Dispersible Tablets - 62.5mg, 125mg

MR Capsules - 125mg

benserazide + levodopa

AMBER SPECIALIST RECOMMENDATION

Tablets - 62.5mg, 110mg, 125mg, 275mg

MR Tablets - 125mg, 250mg

carbidopa + levodopa

AMBER SPECIALIST RECOMMENDATION

Tablets containing:
50mg levodopa/12.5mg carbidopa/200mg entacapone
75mg levodopa/18.75mg carbidopa/200mg entacapone
100mg levodopa/25mg carbidopa/200mg entacapone
125mg levodopa/31.25mg carbidopa/200mg entacapone
150mg levodopa/37.5mg carbidopa/200mg entacapone
200mg levodopa/50mg carbidopa/200mg entacapone

AMBER SPECIALIST RECOMMENDATION

Patients should be initiated on entacapone and co-careldopa separately and switched to Stavelo if necessary to aid compliance.

Tablets - 1mg, 2mg

Ergot-Derived Dopamine Receptor Agonists (Pergolide, Cabergoline, Bromocriptine) (Neurology) Shared Care Guideline

Tablets - 1mg

Ergot-Derived Dopamine Receptor Agonists (Pergolide, Cabergoline, Bromocriptine) (Neurology) Shared Care Guideline

Tablets (as Base) - 88microgram, 180microgram, 350microgram, 700microgram

Care should be taken when prescribing as confusion can occur beween strength of salt and drug

Tablets - 250microgram, 500microgram, 1mg, 2mg, 5mg

Tablets MR - 2mg, 4mg, 8mg

AMBER SPECIALIST RECOMMENDATION

Patches - 1mg/24hours, 2mg/24hours, 3mg/24hours, 4mg/24hours6mg/24hours, 8mg/24hours

AMBER SPECIALIST RECOMMENDATION

Tablets - 5mg, 10mg

Oral Liquid - 10mg/5ml

AMBER SPECIALIST RECOMMENDATION

1mg tablets

AMBER SPECIALIST RECOMMENDATION

50mg and 100mg tablets

For treatment of Parkinson’s disease as an adjunct to levodopa alone or in combination with other antiparkinsonian drugs.

AMBER SPECIALIST RECOMMENDATION

Tablets - 200mg

AMBER SPECIALIST RECOMMENDATION

50mg capsules

For the treatment of Parkinson’s disease – second or third line - used in patients who have tried and failed on entacapone.

AMBER SPECIALIST RECOMMENDATION

100mg tablets

Initiated by specialist only
Only in patients who have failed on entacapone

Tolcapone (Neurology) Shared Care Guideline

20mg in 2ml & 50mg in 5ml injections & 30mg in 3ml
pre-filled multiple dose pen injection device
5mg in 1ml pre-filled syringe

Apomorphine shared care: Apomorphine Shared Care Guidelines

MHRA Drug Safety Update (April 2016): Apomorphine with domperidone: minimising risk of cardiac side effects

2.5mg tablets

Ergot-Derived Dopamine Receptor Agonists (Pergolide, Cabergoline, Bromocriptine) (Neurology) Shared Care Guideline

Not a cost effective use of NHS resources. NHS Commissioning Board: Duodopa policy statement DC43

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

100mg capsules; 50mg in 5ml syrup-
For use on the advice of neurologists

Tablets (as Base) - 88microgram, 180microgram, 350microgram

For treatment of restless legs.

Tablets - 250microgram, 500microgram, 2mg

For the treatment of restless legs.

Tablets - 50mg

Oral Solution - 50mg/5ml

AMBER SPECIALIST RECOMMENDATION

Tablets - 5mg

Oral solution - 2.5mg/5ml, 5mg/5ml

AMBER SPECIALIST RECOMMENDATION

2mg & 5mg tablets
5mg in 5ml syrup

AMBER SPECIALIST RECOMMENDATION

Tablets - 25mg

AMBER SPECIALIST RECOMMENDATION

See section 4.2.1

Unlicensed indication

MHRA Drug Safety Update (Dec 2021): Haloperidol (Haldol): reminder of risks when used in elderly patients for the acute treatment of delirium

50mg tablets and 5mg/1ml oral suspension

Shared care: Riluzole for MND (ALS presentation), Riluzole shared care agreement & guidelines

NICE TA20

Botulinum Toxin Type A products should normally be prescribed by brand name.

NICE Guidance: NICE TA260

50 units, 100 units or 200 units powder for solution for injection

Warning: Units are not equivalent to Dysport units

Approved for use in accordance with the following NICE TAs:

• NICE TA605: Xeomin (botulinum neurotoxin type A) for treating chronic sialorrhoea

Tablets - 333mg

Note in North Yorkshire naltrexone, acamprosate & disulfiram are considered AMBER Specialist Initiation: according to service specification for prescribing by those practices who are commissioned by NYCC for alcohol dependence.

Tablets - 200mg

Note in North Yorkshire naltrexone, acamprosate & disulfiram are considered AMBER Specialist Initiation: according to service specification for prescribing by those practices who are commissioned by NYCC for alcohol dependence.

Tablets - 18mg

Requires prescribing in accordance with NICE guidance: http://www.nice.org.uk/guidance/ta325. For patients who:

• Who have a high drinking risk level (defined as alcohol consumption of more than 60 g per day for men and more than 40 g per day for women, according to the World Health Organization's drinking risk levels) without physical withdrawal symptoms and

• Who do not require immediate detoxification.

The marketing authorisation states that nalmefene should:

• Only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption and
• Be initiated only in patients who continue to have a high drinking risk level 2 weeks after initial assessment

Link to Nalmefene primary care bulletin

5mg & 10mg capsules

When used for alcohol dependence.

Note in North Yorkshire naltrexone, acamprosate & disulfiram are considered AMBER Specialist Initiation: according to service specification for prescribing by those practices who are commissioned by NYCC for alcohol dependence.

Tablets - 150mg

Prescribe according to Smoking Cessation policy

In County Durham prescribe according to recommendation from Stop Smoking Service provider.

MHRA Drug Safety Update (Nov 2020): Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs

In County Durham: 

• GP Practices should continue NOT to prescribe NRT.
• NRT is provided to patients by a Stop Smoking Service provider NRT voucher

In Tees Valley:

• Follow local Tees Smoking Cessation policy

Tablets - 500micrograms, 1mg

Prescribe according to Smoking Cessation policy

In County Durham prescribe according to recommendation from Stop Smoking Service provider.

NICE TA123

NTAG April 2016: The Northern (NHS) Treatment Advisory Group does not recommend the use of e-Voke® as a stop smoking aid on the NHS.

MHRA Drug Safety Update (Jan 2020): E-cigarette use or vaping: reporting suspected adverse reactions, including lung injury

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

0.45 mg Inhaler

NTAG February 2020: The Northern (NHS) Treatment Advisory Group does not recommend the use of Voke® Inhaler as a stop smoking aid on the NHS or for prescribing by GPs. The group was concerned about the lack of any data showing the benefits of using the Voke® inhaler. Further data is required evaluating the use of Voke® as a stop smoking aid and comparing its use to other nicotine replacement therapies that are currently used within the NHS.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Sublingual tablets - 400micrograms, 2mg, 8mg

Indication = Opioid Dependence

NICE TA114

TEWV Methadone Buprenorphine In-Patient Prescribing Guideline

Note in North Yorkshire buprenorphine, buprenorphine/naloxone & methadone are considered AMBER Shared Care: according to service specification for prescribing by those practices who are commissioned by NYCC for ppioid dependence.

Oral Solution - 1mg/ml

Sugar Free Oral Solution - 1mg/ml

Indication = Opioid Dependence

NICE TA114

TEWV Methadone Buprenorphine In-Patient Prescribing Guideline

Note in North Yorkshire buprenorphine, buprenorphine/naloxone & methadone are considered AMBER Shared Care: according to service specification for prescribing by those practices who are commissioned by NYCC for ppioid dependence.

2mg/500microgram sublingual tablets containing, buprenorphine 2 mg, & naloxone 500 micrograms
8mg/2mg tablets sublingual tablets containing buprenorphine 8 mg & naloxone 2 mg

Note in North Yorkshire buprenorphine, buprenorphine/naloxone & methadone are considered AMBER Shared Care: according to service specification for prescribing by those practices who are commissioned by NYCC for ppioid dependence.

50mg tablets

NICE TA115

0.2mg film coated tablets

2mg and 8mg oral lyophilisate (Espranor)

The FSG and APC came to this recommendation not to approve addition to the formulary because:
• Concerns were expressed around patient safety implications including potential variation in bioavailability, confusion arising from multiple dosage forms of buprenorphine and the impact on community pharmacy supervised services 
• Risk of dispensing errors in community pharmacies from having Espranor and SL forms both available when 2mg and 8mg strengths both available – people may not realise the products and dose are different.

Buvidal® 8mg, 16mg, 24mg, 32 mg, 64mg, and 128mg prolonged-release solution for injection

NTAG September 2021: Recommended as alternative option for the management of opioid dependence after oral methadone and/or oral buprenorphine.

The Northern (NHS) Treatment Advisory Group supports the introduction of long-acting injectable formulations of buprenorphine by Substance Misuse Service Providers (SMSPs) (i.e. as additions to the local area formularies as RED drugs) as alternative option for the management of opioid dependence after oral methadone and/or oral buprenorphine. APCs will need to consider the products for inclusion, e.g. one product, a limited range or all available potential products.

Long-acting injectable formulations of buprenorphine may be an option in the following circumstances:

• where there is a risk of diversion of opioid substitution medicines or concerns about the safety of medicines stored at home
• for service users who have difficulties adhering to daily supervised opioid substitution medication
• for service users in custodial settings, where the risk of diversion and time needed for supervised consumption currently leads to challenges in supplying supervised medicines safely