For information on prescribing of unlicensed medicines and off-label use of medicines in this chapter, see TEWV Guidelines on unlicensed and off-label use of medicines
TEWV: Safe transfer of prescribing guidance
MHRA Drug Safety Alert (Feb 2015): Drugs and driving: blood concentration limits set for certain drugs
Guidelines
County Durham and Darlington APC - Opioid Prescribing for Persistent (Non-Cancer) Pain in Adults
County Durham and Darlington APC - Key Messages: For Pain Management Scenarios
County Durham and Darlington APC - Pharmacological Treatment of Neuropathic Pain
NICE NG41: Spinal injury: assessment and initial management
NICE NG42: Motor neurone disease: assessment and management
NICE NG62: Cerebral palsy in under 25s: assessment and management
NICE NG71: Parkinson’s disease in adults
NICE NG92: Stop smoking interventions and services
NICE NG116: Post-traumatic stress disorder
NICE CG100: Alcohol-use disorders: diagnosis and management of physical complications
CD&D APC Patient Decision Aids Resource available at: http://medicines.necsu.nhs.uk/guidelines/durham-darlington/
CD&D APC “Do Not Prescribe List” and “Grey List – drugs prescribed under limited circumstances” available at: http://medicines.necsu.nhs.uk/guidelines/durham-darlington/
NHS England Guidance on “Conditions for which over the counter items should not routinely be prescribed” available at: https://www.england.nhs.uk/medicines/conditions-for-which-over-the-counter-items-should-not-routinely-be-prescribed/
Please refer to NICE guidelines NICE TA77
All hypnotics should be prescribed for short periods of time only.
Switching from one drug to another should only occur if the patient experiences side effects that are specifically related to the medicines.
Patients who have not responded to one of these hypnotics should not be prescribed any of the others.
Use in the elderly is discouraged.
First choice
Zopiclone
Temazepam
Alternatives
Zolpidem: MHRA Drug Safety Alert (May 2014) – risk of drowsiness and reduced driving ability
Promethazine
CSM Advice:
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.
Shared Care Guideline: Melatonin
CDDFT Intranet: Melatonin – available here
Zolpidem: MHRA Drug Safety Alert (May 2014) – risk of drowsiness and reduced driving ability
10mg & 25mg tablets
5mg in 5ml sugar-free elixir
25mg in 1ml injection
Chloral hydrate is not recommended in the BNF for the management of insomnia.
NTAG June 2017: The Northern (NHS) Treatment Advisory Group only 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.
4.5mg and 18mg film-coated tablets
NTAG Nov 2018: recommends the use of Pitolisant only in narcoleptic patients with residual severe daytime sleepiness who have an Epworth score of 14 or over if they have already tried modafinil and dexamfetamine or methylphenidate, and where therapy will make a substantial difference to their quality life.
Prescription of this medication will be limited to Sleep Centres with adequate expertise in managing narcolepsy and using this medication:
The James Cook University Hospital, Department of Sleep Medicine and
Royal Victoria Infirmary
See NICE NG10 - Violence and aggression: short-term management in mental health, health and community settings
See NICE guidelines for the management of Anxiety Disorders
If a person with generalised anxiety disorder (GAD) chooses drug treatment, offer a selective serotonin reuptake inhibitor (SSRI) (see section 4.3)
Consider offering sertraline first as it is the most cost-effective, but is unlicensed for GAD.
Do not offer a benzodiazepine for the treatment of GAD except as a short-term measure during crises. Follow the advice in the ‘British national formulary’ on the use of a benzodiazepine in this context: should not be used as an anxiolytic for more than 4 weeks without being reviewed.
Use in the elderly is discouraged.
First choice
Diazepam
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.
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.
Refer to NICE guidance for schizophrenia CG 178
See also: NICE NG11 - Challenging behaviour and learning disabilities: prevention and interventions for people with learning disabilities whose behaviour challenges
The choice of antipsychotic should take into account the relative side-effect profile and the views of the user.
Refer to TEWV policies:
Guidance for safe transfer of prescribing (TEWV website)
HDAT - High Dose Antipsychotic Treatment (TEWV intranet only)
TEWV website: Hyperprolactinaemia guidance
Prescribing antipsychotics in the elderly
The balance of risks and benefits should be considered. See Pharmacological management guidelines for Behavioural & Psychological Symptoms of Dementia (available via TEWV intranet only)
Tabs - 500microgram, 1.5mg, 5mg, 10mg, 20mg
Oral Liquid - 2mg/ml
Haloperidol: Injection for rapid control of agitated or disturbed behaviour in patients with schizophrenia or manic episode where oral treatment is not appropriate.
Link to TEWV Rapid Tranquilisation prescribing guidelines
See NICE NG10 - Violence and aggression: short-term management in mental health, health and community settings
Tabs - 1mg, 5mg
Oral Solution - 5mg/5ml
For initiation by specialists only
Trifluoperazine: 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.
Tablets - 200mg & 400mg
Oral solution - 200mg in 5ml sugar-free
Sulpiride: 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.
Tabs - 2mg, 10mg, 25mg
Zuclopenthixol: 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.
For initiation by specialists only
50mg in 1ml injection
For short term use by specialists in TEWV
Tabs - 500microgram, 1mg, 2mg, 3mg, 4mg, 6mg
Orodispersible tabs - 500micrograms, 1mg, 2mg, 3mg, 4mg
Orodispersible tablets should only be prescribed for patients who are unable to swallow solid dose form.
MHRA Alert – risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery. More details here.
Tabs - 5mg, 10mg, 15mg
Orodispersible Tabs - 10mg, 15mg
Oral Solution - 1mg/ml
Orodispersible tablets should only be prescribed for patients who are unable to swallow solid dose forms
Enhanced efficacy above 15mg per day has not been demonstrated for any indication. However, some individuals may benefit from higher doses; such cases should be considered in conjunction with secondary care.
Approved for use in accordance with the following NICE TAs
Tabs - 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg
Orodispersible Tabs - 5mg, 10mg, 20mg
Orodispersible tablets should only be prescribed for patients who are unable to swallow solid dose forms
Tabs - 25mg, 100mg, 150mg, 200mg, 300mg
M/R Tabs - 50mg, 150mg, 200mg, 300mg, 400mg
Quetiapine immediate release should be used 1st line, MR preparations should be reserved for those with a clinical need e.g. poor compliance
1st choice in treatment-resistant schizophrenia.
TEWV: Clozapine treatment guidance
TEWV: Clozapine treatment for psychosis in Parkinson’s disease
MHRA Drug Safety Alert (Oct 2017): Clozapine: reminder of potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus
Refer to NICE Guideline Bipolar Disorder CG185
Antipsychotics drugs can be useful in acute episodes of mania and hypomania.
Tabs 200mg, 400mg (Priadel) - brand of choice
Tabs - 250mg, 400mg (Camcolit) - 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 TEWV policy Safe Lithium Treatment Shared Care Guidelines (TEWV intranet only)
See Safety Guidance: Lithium on admission to CDDFT – intranet link (CDDFT only)
See Lithium Shared Care Guideline
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
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
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
1mg per ml liquid
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
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 (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
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 (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
Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here
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
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
Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here
Refer to NICE guidance for schizophrenia CG 178
Consider offering depot/long-acting injectable antipsychotics when:
− service users would prefer this after an acute episode
− avoiding covert non-adherence to medication is a clinical priority
20mg in 1ml, 40mg in 2ml, 50mg in 0.5ml,
100mg in 1ml & 200mg in 1ml injections
12.5mg in 0.5ml, 25mg in 1ml,
50mg in 0.5ml & 100mg in 1ml injections
No new patients to be started on Fluphenazine Decanoate as of Sept 2017 as being discontinued from 2018.
25mg, 37.5mg and 50mg long acting injections
Risperidone long acting only for use by specialists in TEWV in accordance with TEWV Psychosis pathway
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.
See TEWV policies:
Depression Pathway Medication Guidelines Primary and Secondary Care Monotherapies
Depression Pathway - Handy Hints When Prescribing Antidepressants
Additional guidance for prescribing in the elderly is available.
NICE CG28: Depression in children and young people: Identification and management in primary, community and secondary care
Recommended for 2nd line treatment.
First Choice Antidepressant
Trazodone
Other Indications
Amitriptyline
See TEWV Depression Pathway Medication Guidelines Primary and Secondary Care Monotherapies
Tabs - 10mg, 25mg, 50mg
Oral Solution - 25mg/5ml, 50mg/5ml
For use unlicensed for neuropathic pain
Caps - 50mg
Tabs - 10mg, 25mg
Trimipramine prescribing is not recommended. For existing patients prescribed dosulepin this TEWV guidance applies.
Dosulepin prescribing is not recommended. For existing patients prescribed dosulepin this TEWV guidance applies.
15mg tablets
Initiation to be recommended by secondary care
Indicated when there is no response to other antidepressant groups
SSRIs are considered 1st line intervention for depression in those requiring activation.
See TEWV Depression Pathway Medication Guidelines Primary and Secondary Care Monotherapies
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
Escitalopram: initiation to be recommended by secondary care
Escitalopram: See MHRA guidance regarding dose related QT prolongation and TEWV guidance on dose reduction and ECG monitoring
Caps - 30mg, 60mg
For use in diabetic neuropathy where other treatments are unsuitable or inadequate and initiated by a specialist
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 Depression Pathway Medication Guidelines Primary and Secondary Care Monotherapies
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 (Green+)
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.
Initiation to be recommended by secondary care
Indicated when there is no response to other antidepressant groups
5mg, 10mg & 20mg film-coated tablets
For use as 3rd line treatment option for the management of depression as per NICE TA367
See TEWV Depression Pathway Medication Guidelines Primary and Secondary Care Monotherapies
NG86: Attention deficit hyperactivity disorder: diagnosis and management
TEWV Children and Young People’s Service ADHD Prescribing Guideline
TEWV Adults ADHD Prescribing Guideline
Caps - 10mg, 18mg, 25mg, 40mg, 60mg or 80mg hard capsules
Capsules- 30mg, 50mg, and 70mg
TEWV: Lisdexamfetamine Shared Care Guideline
Lisdexamfetamine – approved with the following restrictions
Second or third line option when response to previous methylphenidate treatment is considered clinically inadequate and where any of the following apply:
· a liquid preparation is required
· response to dexamfetamine established but control would be improved with a long acting preparation
· covert administration has been deemed in the person’s best interests (mental capacity or children act)
Tabs - 5mg, 10mg, 20mg
MR Tabs - 18mg, 27mg, 36mg, 54mg (Concerta XL, Delmosart, Xenidate XL, Xaggitin XL, Matoride XL)
MR Caps - 5mg, 10mg, 20mg, 30mg, 40mg, 50mg, 60mg (Medikinet XL)
Unlicensed in adults, but NICE recommend that following a decision to start drug treatment in adults, methylphenidate should normally be tried first.
TEWV: Methylphenidate Shared Care Guideline
Guanfacine to be used to be used Treatment of Attention Deficit Hyperactivity Disorder in children and adolescents 6-17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective AND in those whom Atomoxetine is not suitable, not tolerated or has been shown to be ineffective.
Only for use in accordance with NICE guidelines
120mg capsules
MHRA Drug Safety Update (March 2014): theoretical interaction with antiretroviral HIV medicines
Naltrexone hydrochloride/bupropion hydrochloride 8mg/90mg tablets
Not approved as per NICE TA494
18mg/3ml solution for injection in a prefilled pen
NTAG September 2017: The Northern (NHS) Treatment Advisory Group does not recommend the use
of liraglutide (Saxenda®) for the treatment of obesity.
500 microgram capsules,1.5mg, 5mg & 10mg tablets
1mg in 1ml & 2mg in 1ml oral liquid
5mg in 1ml & 20mg in 2ml inject
5mg tablets; 5mg in 5ml syrup
12.5mg in 1ml injection
3mg tablets (buccal) (Buccastem®)
Tablets - 10mg
Suspension - 5mg/5ml
MHRA Drug Safety Alert (May 2014): indication now restricted to nausea and vomiting
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
250 microgram in 5ml injection, 500 microgram capsules
- for 2nd line of treatment for chemotherapy induced nausea vomiting only
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
County Durham and Darlington APC - Opioid Prescribing for Persistent (Non-Cancer) Pain in Adults
County Durham and Darlington APC - Key Messages: For Pain Management Scenarios
County Durham and Darlington APC - Pharmacological Treatment of Neuropathic Pain
Paediatric Analgesia: Quick Reference Guide (CDDFT intranet access only)
Paediatric Analgesia Protocol (CDDFT intranet access only)
Effervescent / soluble tablets not generally recommended except in acute treatment of migraine.
CD&D APC Grey List: Short courses of analgesics for acute common ailments can be purchased by
the patient under self-care with community pharmacist support. Continue to prescribe for children and when required for chronic conditions although patients should be reminded that these medications are also available to purchase. Prescribing short courses of pain relief for acute conditions costs the NHS more than the equivalent products purchased over the counter (prescription fees, GP consultation time
etc.)
500mg plain & soluble tabletsOTC
120mg & 250mg in 5ml suspensions (sugar-free)OTC
1g injection for IV infusion
60mg, 125mg, 250mg & 500mg suppositories
See CDDFT drug protocol for IV paracetamol
1mg capsules
Nabilone: approved for very limited use in the treatment of chronic pain (unlicensed indication) that has not responded to other treatments. Treatment must be initiated by pain consultants and reviewed after about one month. Treatment to be stopped immediately in non-responders.
While Co-codamol 8/500 is commonly used, no advantages over paracetamol have been substantiated. The low dose of codeine may be enough to cause opioid side-effects (in particular, constipation) and can complicate the treatment of overdose, yet may not provide significant additional relief of pain. Use is therefore discouraged.
County Durham and Darlington APC - Opioid Prescribing for Persistent (Non-Cancer) Pain in Adults
County Durham and Darlington APC - Key Messages: For Pain Management Scenarios
200 microgram sublingual tablets
300 micrograms in 1ml injection
5 & 10 microgram/hour transdermal patch (BuTrans®)
35microgram, 52.5microgram, 70microgram/hour transdermal patch over 96 hours
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.
Tablets - 15mg, 30mg
Syrup - 25mg/5ml
30mg in 1ml injectionu & 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
Drug protocol: diamorphine for pain relief during labour (CDDFT intranet access only)
Dipipanone hydrochloride/Cyclizine hydrochloride 10mg/30mg tab
Patches - 12microgram/hour, 25microgram/hour, 50microgram/hour, 75microgram/hour, 100microgram/hour
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
CD&D APC Grey List: Novel Fentanyl preparations should not be prescribed as these have been rejected by NTAG
Tablets - 10mg, 20mg, 50mg (Sevredol),
MR capsules - 10mg, 30mg, 60mg, 10mg, 200mg (Zomorph)
10mg in 5ml Liquid
Injection - 10mg/ml, 15mg/ml, 20mg/ml, 30mg/ml
Zomorph is the preferred modified release preparation
Drug protocol: neonatal morphine sulphate for ventilation (CDDFT intranet access only)
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.
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.
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
CD&D APC Grey List: Tapentadol – Third 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.
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)
See NICE CG173: Neuropathic pain and County Durham and Darlington APC - Pharmacological Treatment of Neuropathic Pain
First Choice:
Amitriptyline
Second Choice:
Gabapentin
Pregabalin
Alternatives:
Carbamazepine
Duloxetine
Phenytoin
Tramadol
N.B. Other drugs such as Ketamine (see section 15.1.1) may also be advised by pain/palliative care specialists in the management of neuropathic pain.
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.
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.
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)
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 chronic neuropathic pain on the advice of pain specialists only, subject to an appropriate trial of efficacy in each individual patient and as part of a directed management plan
• 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
• palliative care – please note that prescribers in primary care can initiate prescribing in palliative care patients.
Tablets - 50mgOTC
Injection - (Auto-injector) 12mg/ml (6mg/0.5ml syringe)
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
Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here
10mg, 25mg & 50mg tablets
25mg in 5ml sugar free oral solution
Unlicensed Indication
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
Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here
200mg & 400mg m/r tablets (5.4 & 10.8 mmol Li+) = Priadel = brand of choice
250mg tablets (6.8 mmol Li+)
Lithium should be prescribed by brand name. Approved for use in the treatment of cluster headaches.
Refer to NICE guidance CG 137. The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care.
Control of epilepsy
All green plus drugs in this section should be recommended by a specialist and are suitable for transfer to primary care.
See Commission on Human Medicines advice on branded / manufacturer based prescribing here.
MHRA Antiepileptic drugs: new advice on switching between different manufacturer’s products for a particular drug. More details here.
Category 1 in epilepsy treatment - ensure patient is maintained on specific manufacturers product.
Category 2 in epilepsy treatment - 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.
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 (Nov 2017): Antiepileptic drugs: updated advice on switching between different manufacturers’ products - In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
MHRA Drug Safety Update (Dec 2018): Valproate medicines: are you acting in compliance with the pregnancy prevention measures?
See also CDDFT intranet site for CDDFT information.
Drug protocol: PAEDIATRIC Management of Convulsive Status Epilepticus – available here (CDDFT intranet access only)
MHRA Drug Safety Alert (Nov 2017): Antiepileptic drugs: updated advice on switching between different manufacturers’ products - In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
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.
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.
10mg, 25mg, 50mg, 75mg and 100mg film coated tablets
10mg/mL oral solution
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.
Tablets - 100mg, 200mg, 400mg
MR Tablets - 200mg, 400mg
Liquid - 100mg/5ml
Category 1 in epilepsy treatment - ensure patient is maintained on specific manufacturers product.
Tablets - 10mg
1mg/ml and 2mg/ml oral suspension
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
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
- 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
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
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
- 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
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
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.
150mg, 300mg & 600mg tablets
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.
- NETAG approved for partial (focal) seizure epilepsy 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; 20mg in 1ml suspension (alcohol free)
15mg in 1ml, 30mg in 1ml & 200mg in 1ml injections
Category 1 in epilepsy treatment - ensure patient is maintained on specific manufacturers product.
Capsules - 25mg, 50mg, 100mg, 300mg,
Chewable Tablets - 50mg
Suspension - 30mg/5ml
Phenytoin: different preparations may vary in bioavailability; always prescribe by brand name. Therapeutic drug monitoring required.
Drug protocol: phenytoin loading in adults, children and neonates (CDDFT intranet access only)
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.
Capsules - 25mg50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg
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.
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
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
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
Local Shared Care guideline to support Valproate Pregnancy Prevention Programme available here
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
CD&D APC 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
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
- for specialist use only in patients that are refractory to treatment with other drugs - use in children is unlicensed.
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.
Oromucosal Solution - 5mg/ml
Pre-filled syringes - 0.5ml, 1ml, 1.5ml, 2ml (Buccolam)
Other unlicensed formulations are available - check dose
Drug protocol: neonatal IV and oral phenobarbital (CDDFT intranet access only)
All green plus drugs in this section should be recommended by a specialist and are suitable for transfer to primary care.
NICE CG186: Multiple sclerosis: management of multiple sclerosis in primary and secondary care
Capsules - 62.5mg, 125mg, 250mg
Dispersible Tablets - 62.5mg, 125mg
MR Capsules - 125mg
benserazide + levodopa
Tablets - 62.5mg, 110mg, 125mg, 275mg
MR Tablets - 125mg, 250mg
carbidopa + levodopa
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
Patients should be initiated on entacapone and co-careldopa separately and switched to Stavelo if necessary to aid compliance.
Tablets (as Base) - 88microgram, 180microgram, 350microgram, 700microgram
Tablets - 250microgram, 500microgram, 1mg, 2mg, 5mg
Tablets MR - 2mg, 4mg, 8mg
Patches - 1mg/24hours, 2mg/24hours, 3mg/24hours, 4mg/24hours6mg/24hours, 8mg/24hours
500mg capsules
For the treatment of Parkinson’s disease – second or third line - used in patients who have tried and failed on entacapone.
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
100mg capsules; 50mg in 5ml syrup-
For use on the advice of neurologists
Botulinum Toxin Type A products should normally be prescribed by brand name.
NICE Guidance: NICE TA260
See TEWV prescribing guidance for drug misuse
Unless used in accordance with Local Protocol – naltrexone, acamprosate & disulfiram prescribing should be retained within the commissioned service within County Durham
Tablets - 18mg
Requires prescribing in accordance with NICE guidance: http://www.nice.org.uk/guidance/ta325. For patients who:
The marketing authorisation states that nalmefene should:
From 1st April 2017, a revised NRT formulary will only allow the County Durham Stop Smoking Service to issue a single NRT product to each client rather than combination therapy.
However even providing one NRT product plus ongoing support from the Service will still double clients chances of quitting compared to no support.
Evidence shows that adding in a second NRT product can further increase the chances of quitting. Therefore the Service will advise that clients can purchase small packs of a second NRT product (such as chewing gum, lozenges which typically cost £5-£6 for a pack of 20) or choose to purchase an unlicensed nicotine containing product such as an e-cigarette.
GP practices should continue NOT to prescribe NRT or licensed e-cigarettes.
NRT Formulary Choices of the County Durham Stop Smoking Service from 1st April 2017
16 Hour Patch
Nicorette 25mg Invisi patch (x7)
Nicorette 15mg Invisi patch (x7)
Nicorette 10mg Invisi patch (x7)
24 Hour Patch
NiQuitin CQ 21mg Patch (x7)
NiQuitin CQ 14mg Patch (x7)
NiQuitin CQ 7mg Patch (x7)
Nicotinell TTS 30 (21mg) Patch (x7)
Nicotinell TTS 20 (14mg) Patch (x7)
Nicotinell TTS 10 (7mg) Patch (x7)
Nasal Spray
Nicorette 500microgram Nasal Spray (10ml - 1 bottle)
Mouth Spray
Nicorette QuickMist 1mg/spray (13.2ml - 1 bottle)
Nicorette QuickMist 1mg/spray (26.4ml - 1 bottle)
Inhalator
Nicorette 15mg Inhalator (x20)
Nicorette 15mg Inhalator (x36)
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.
2mg/500microgram sublingual tablets containing, buprenorphine 2 mg, & naloxone 500 micrograms
8mg/2mg tablets sublingual tablets containing buprenorphine 8 mg & naloxone 2 mg
See NICE guidance Dementia: Supporting people with dementia and their carers in health and social care NICE NG 97
Only specialists in the care of patients with dementia should initiate treatment.
Treatment should be reviewed regularly and only be continued when it is considered to be having a worthwhile effect.
Carers views on the patient’s condition should be sought.
Each product has been classified as Green + which in this case means:
First line
Donepezil
Tablets - 5mg, 10mg
Orodispersible Tablets - 5mg, 10mg
Orodispersible tablets - should only be used in situations where the plain tablets are unsuitable
Tablets - 8mg, 12mg
Oral solution - 4mg/ml
MR Capsules - 8mg, 16mg, 24mg
MR capsules only to be used when a once a day dose is essential or patient has tried standard release galantamine and is intolerant.
Letter was sent to healthcare professionals for:
Galantamine hydrobromide (Reminyl): risk of serious skin reactions (Dec 2015)
Capsules - 1.5mg, 3mg, 4.5mg, 6mg
Oral solution - 2mg/ml
Patches - 4.6mg / 24hours; 9.5mg/24hours
Patches should only be used when other formulations inappropriate
Tablets - 10mg 20mg
Oral Solution - 5mg / actuation (10mg/ml)
Option for managing moderate Alzheimer’s Disease in people who cannot take AChE inhibitors