Formulary Chapter 4: Central nervous system - Full Chapter
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Chapter Links... |
MHRA Drug Safety Alert (Feb 2015): Drugs and driving: blood concentration limits set for certain drugs |
NENC Palliative and End of Life Care Symptom Control Guidelines |
NICE NG62: Cerebral palsy in under 25s: assessment and management |
TEWV - Medicines Optimisation – Interactive Guide |
TEWV Guidelines |
TEWV Safe Transfer of Prescribing Guidance |
Details... |
04.07 |
Analgesics |
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04.07.01 |
Non-opioid analgesics and compound analgesic preparations |
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Paracetamol
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First Choice
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- Paracetamol 500mg tablets / soluble tablets
- Paracetamol 1gram injection for IV infusion
- NoTGhdNC: approved for limited short-term use where oral and rectal routes cannot be used and NSAIDs are not appropriate in paediatric areas only, the 50ml formulation should be stocked.
- Paracetamol suppositories
- Licensed preparations include 60mg,125mg, 250mg, and 500mg suppositories are available in primary care.
- unlicensed preparations include 15mg, 30mg, 60mg, 120mg, 240mg, and 500mg. These are used in NUTH.
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Naproxen tablets
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Formulary
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Ibuprofen
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Alternatives
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MHRA Drug Safety Update (June 2015): High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk
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Aspirin
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Alternatives
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Diclofenac
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Alternatives
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- Oral diclofenac is restricted to short-term use for post operative pain.
- If long-term use is required diclofenac is only approved for 4th line treatment (see below):
- Ibuprofen low dose – first line treatment.
- Naproxen low dose – second line treatment.
- Naproxen high dose – third line treatment.
- Diclofenac – fourth line treatment.
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MHRA Drug Safety Update (Dec 2007): NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
MHRA Drug Safety Update (Jan 2015): Cox-2 selective inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs): Cardiovascular safety.
MHRA Drug Safety Update (June 2013): Diclofenac: new contraindications and warnings
MHRA Drug Safety Update (Oct 2012): Non-steroidal anti-inflammatory drugs (NSAIDs): cardiovascular risks
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04.07.01 |
Compound analgesic preparations |
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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. |
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04.07.02 |
Opioid analgesics |
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NENC ICB DOES NOT support the routine long-term prescribing (greater than 3 months) of opioids or the use of high dose opioids (higher than 120 mg/day of oral morphine equivalent) for non-cancer, persistent pain in adults. |
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Codeine
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Formulary
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First line
Second line
The following codeine preparations are unlicensed and approved for use:
- 30 mg suppositories.
- codeine 2mg, 3mg, 6mg, 15mg;
- codeine 30mg in 1ml injection
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MHRA Drug Safety Update (Dec 2014): Codeine for analgesia: restricted use in children because of reports of morphine toxicity
MHRA Drug Safety Update (Dec 2014): Codeine: very rare risk of side-effects in breastfed babies
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Morphine
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Formulary
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- Tablets - 10mg, 20mg, 50mg (Sevredol®)
- MR capsules - 10mg, 30mg, 60mg, 100mg, 200mg (Zomorph®)
- MR tablets - 5mg, 10mg, 15mg, 30mg, 60mg, 100mg, 200mg (MST®)
- Oral solution - 10mg in 5ml
- Injection - 10mg/ml, 15mg/ml, 20mg/ml, 30mg/ml
- Zomorph® is the preferred M/R formulation.
- Note: the following preparations are also approved for use:
- morphine 5mg in 1ml injection unlicensed
- 10mg in 1ml preservative free injection unlicensed
- 2mg in 5ml epidural unlicensed
- 100 micrograms/1 ml oral solution. For use in neonates. unlicensed
- 50mg in 50ml PCA injection
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Alfentanil
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Formulary
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- Palliative care use
- 500micrograms in 1ml [ST&S], 1mg in 2ml, 5mg in 10ml & 5mg in 1ml injection ampouless - approved for initiation by specialists in palliative care
- All non-palliative care indications
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Diamorphine
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Formulary
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- Unlicensed intranasal diamorphine is approved for use in children for the relief of severe pain due to clinically suspected limb fractures, burns and significant fingertip injuries. Appropriate risk assessments are to be conducted by each organisation in order to determine formulation of choice (e.g. ampoules or intranasal spray).
- Note: intranasal diamorhine
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Ketamine
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Formulary
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Tramadol
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Alternatives
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- 50mg capsules, 50mg dispersible tablets & 100mg/2ml injection
- Only approved for use as a second-line weak opioid analgesic 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.
- Note: modified release tramadol is not approved or recommended.
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Buprenorphine
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Alternatives
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- 200microgram sublingual tablets
- 300microgram in 1ml injection
- Buprenorphine patches (Preferred brand - Butec®) are approved for use in palliative care when fentanyl 12 microgram/hr transdermal patches exceed the patient’s analgesic requirements.
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Fentanyl
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Alternatives
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- 12, 25, 50, 75 & 100 microgram/hour transdermal patches
- Prescribe by brand. Mezolar® has replaced Matrifen® as the first choice brand. Patients who currently use Matrifen® can continue to do so if managing well.
- Fentanyl sublingual tablets (Abstral®) NoTGhdNC only for patients experiencing incident pain during radiotherapy, restricted to palliative care use only
- Fentanyl sublingual tablets (Abstral®) CD&TV for breakthrough / rescue pain relief in palliative care
- nasal spray
- approved for use in children during diamorphine shortage with appropriate local governance arrangements
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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
Transdermal fentanyl – MHRA Drug Safety Update (July 2014): Transdermal fentanyl “patches”: reminder of potential life threatening harm from accidental exposure, especially in children
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Hydromorphone
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Alternatives
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Methadone
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Alternatives
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The following preparations are approved:
- 5mg tablets;
- 5mg in 5ml mixture DTF & 5mg in 5ml sugar free solution
- 20mg in 1ml concentrated oral solution (unlicensed)
- 10mg in 1ml injection
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Oxycodone
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Alternatives
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- Approved only for use in patients who are intolerant of morphine.
- Note: Oxycodone 50mg in 1ml injection is also approved for use, but is restricted to controlled circumstances in palliative patients following risk assessment by individual organisations.
- Approved for use as part of Enhanced Recovery After Surgery (ERAS) as part of multi-modal enhanced recovery pathway following hip and knee surgery
- The OxyPro® branded generic is preferred (most cost effective option).
- The oral solution should be used instead of immediate release tablets.
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Pethidine
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Alternatives
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Tapentadol
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Alternatives
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- Approved for use by chronic pain specialist in adults with severe pain who have been screened for a neuropathic element to their pain and are uncontrolled or experiencing GI side effects on existing therapy.
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MHRA Drug Safety Update (Jan 2019): Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines
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Dihydrocodeine
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Alternatives
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- 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).
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04.07.02 |
Weak opioids |
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04.07.02 |
Strong opioids |
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04.07.02 |
Breakthrough pain |
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04.07.02 |
Injectable |
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04.07.02 |
Other |
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04.07.03 |
Neuropathic pain |
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Prescribing of gabapentinoids to treat persistent non-neuropathic pain is NOT routinely recommended
Note: 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. |
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Amitriptyline
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First Choice
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Gabapentin
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Second Choice
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- For use in the treatment of neuropathic pain
- Gabapentin is also approved for hospital use as an adjunct to other treatment in the management of peri/post-operative pain. unlicensed
- GPs should not be asked to prescribe gabapentin for this unlicensed indication.
- Approved for intractable itch with severe burns
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MHRA Drug Safety Alert (Oct 2017): Gabapentin (Neurontin): risk of severe respiratory depression
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Pregabalin
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Second Choice
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- Pregabalin is restricted to use in the management neuropathic pain as a second choice where treatment with gabapentin has been unsuccessful or not tolerated.
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MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy
MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression
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Nortriptyline
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Formulary
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Carbamazepine
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Alternatives
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- Restricted use in treatment of trigeminal neuralgia only.
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Duloxetine
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Alternatives
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- 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.
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Phenytoin
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Alternatives
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04.07.03 |
Trigeminal neuralgia |
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04.07.03 |
Postherpetic neuralgia |
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Capsaicin
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Formulary
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- Qutenza® cutaneous patch approved for the treatment of neuropathic pain as fourth line agent for neuropathic pain and in line with the attached regionally agreed pathway.
- 0.075% cream (Axsain®) approved for post hepatic neuralgia and peripheral diabetic neuropathy
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NTAG - Treatment Appraisal Decision Summary - Capsaicin (Qutenza)
NTAG Pathway for the use of Qutenza (Capsaicin 8%) in the Neuropathic Pain Patient Group
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Lidocaine 5% medicated plasters (700mg lidocaine/plaster)
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Formulary
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- For use in the treatment of post-herpetic neuralgia only, on the advice of pain specialists and subject to an appropriate trial of efficacy in each individual patient.
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Co Durham & Tees Valley APC – Advice on prescribing Lidocaine Patches in Primary Care
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04.07.03 |
Chronic facial pain |
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04.07.04 |
Antimigraine drugs |
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04.07.04.01 |
Treatment of the acute migraine attack |
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Rizatriptan
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Formulary
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04.07.04.01 |
Analgesics |
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Paracetamol
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Formulary
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Ibuprofen
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Formulary
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MHRA Drug Safety Update (June 2015): High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk
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Naproxen tablets
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Formulary
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Aspirin
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Formulary
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Diclofenac
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Formulary
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MHRA Drug Safety Update (Dec 2007): NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
MHRA Drug Safety Update (Jan 2015): Cox-2 selective inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs): Cardiovascular safety.
MHRA Drug Safety Update (June 2013): Diclofenac: new contraindications and warnings
MHRA Drug Safety Update (Oct 2012): Non-steroidal anti-inflammatory drugs (NSAIDs): cardiovascular risks
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04.07.04.01 |
5HT1 agonists |
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Sumatriptan
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First Choice
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Zolmitriptan 2.5mg tablets
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Alternatives
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Frovatriptan
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Alternatives
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04.07.04.01 |
Ergot alkaloids |
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04.07.04.01 |
Anti-emetics |
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Metoclopramide
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Formulary
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- Used to help promote absorption of analgesics.
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MHRA Drug Safety Update Alert (Aug 2013): Metoclopramide: risk of neurological adverse effects
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04.07.04.01 |
Other drugs for migrane |
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04.07.04.02 |
Prophylaxis of migraine |
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Pizotifen
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Formulary
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Metoprolol
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Formulary
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Propranolol
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Formulary
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Topiramate
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Formulary
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- MHRA Drug Safety Update (July 2022): Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure
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Clonidine
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Formulary
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- Clonidine is not generally recommended for migraine prophylaxis; may aggravate depression/cause insomnia.
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Eptinezumab (Vyepti®)
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Formulary
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- 100mg/1ml concentrate for solution for infusion
- Approved for the prevention of chronic migraine in adults in line with NICE only if
- they have 4 or more migraine days a month
- at least 3 preventative drug treatments have failed
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NICE TA871: Eptinezumab for preventing migraine
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Erenumab (Aimovig®)
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Formulary
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- 70mg/1ml and 140mg/1ml solution for injection (pre-filled pens)
- Approved for the prevention of chronic migraine in adults in line with NICE only if
- they have 4 or more migraine days a month
- at least 3 preventative drug treatments have failed
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NICE TA682: Erenumab for preventing migraine in adults
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Fremanezumab (Ajovy®)
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Formulary
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- 225mg/1.5ml solution for injection (Pre-filled pens/syringes)
- Approved for the prevention of chronic migraine in adults in line with NICE only if
- they have 4 or more migraine days a month
- at least 3 preventative drug treatments have failed
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NICE TA764: Fremanezumab for preventing migraine
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Galcanezumab (Emgality®)
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Formulary
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- 120mg/1ml injection
- Approved for the prevention of chronic migraine in adults in line with NICE only if
- they have 4 or more migraine days a month
- at least 3 preventative drug treatments have failed
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NICE TA659: Galcanezumab for preventing migraine
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Rimegepant (Vydura®)
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Formulary
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- 75mg oral lyophilisates
- Approved for preventing migraine in line with NICE
- First three month's supply from secondary care followed by 12 week review and then transfer to primary care with a 4 week prescription to allow for handover
- Approved for treating migraine in line with NICE
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NICE TA906: Rimegepant for preventing migraine
NICE TA919: Rimegepant for treating migraine
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Botulinum Toxin Type A
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Formulary
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- Only approved for use in accordance with NICE guidance.
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NICE TA260: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine
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Amitriptyline
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Unlicensed
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Imipramine
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Unlicensed
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Sodium valproate
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Unlicensed
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- Note: sodium valproate 500mg & 1000mg MR granules (Episenta®) are also approved for use in those who have difficulty swallowing sodium valproate tablets. MR granules may be more convenient to use than large volumes of liquid formulations.
Black Triangle in Females
Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP)
For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:
MHRA Drug Safety Updates (valproate)
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Valproate medicines: Pregnancy Prevention Programme materials
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04.07.04.03 |
Cluster headache |
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Lithium carbonate
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Unlicensed
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- Lithium should be prescribed by brand name.
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Lithium Shared Care Guideline (Amber)
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Lithium citrate
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Unlicensed
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- Lithium should be prescribed by brand name.
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Lithium Shared Care Guideline (Amber)
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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Description |
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Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment.
In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.
For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
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Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
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Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
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Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
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NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status. |
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