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 Formulary Chapter 4: Central nervous system - Full Chapter
Notes:

Review date: June 2020

Non-formulary drugs - any drug or formulation not listed in the formulary is deemed to be non-formulary.

Paediatrics - all drugs are deemed to have the same RAG status as they have for adults unless stated otherwise.

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04.07.02  Expand sub section  Opioid analgesics
 note 

Strong opioids

Notes

All patients started on weak or strong opioids should undergo a trial with a clear upper dose limit in place. An improvement in function and quality of life is more important than pain relief as such. If there is a significant improvement in function (more than 50% pain relief) an opioid management plan should be in place and weaning encouraged at the earliest opportunity. See Faculty of Pain Medicine “Opioids Aware: A resource for patients and healthcare professionals to support prescribing of opioid medicines for pain” http://www.rcoa.ac.uk/faculty-of-pain-medicine/opioids-aware. Deprescribing of strong opioids should be encouraged whenever possible. Patients requiring high doses of opioids should be reviewed and consideration given to referring to a specialist for review. (Pan Mersey specialist recommendation).

Alternative routes should only be considered for people who are unable to take oral medicines because of medical conditions and/or disability.

There are NPSA alerts regarding high dose morphine and diamorphine and reducing dosing errors with opioid medicines.

There is Care Quality Commission guidance on prescribing of fentanyl and buprenorphine transdermal patches

For details on conversion from one drug to another please contact Pharmacy or the Medicines Management Team

Use of strong opioids in Paediatrics: Neonates and infants show an increased susceptibility to respiratory depression to strong opioids. However, this should not exclude them from adequate analgesia.

Chronic pain:

See Faculty of Pain Medicine “Opioids Aware: A resource for patients and healthcare professionals to support prescribing of opioid medicines for pain” http://www.rcoa.ac.uk/faculty-of-pain-medicine/opioids-aware

Opioids are very good analgesics for acute pain and for pain at the end of life but there is little evidence that they are helpful for long term pain.

Red Retained Traffic Light Opioid Cross-Titration

Where a patient is undergoing transition from one strong opioid to another under supervision of a pain clinic specialist using “cross-titration” (gradual reduction of dose of the opioid being stopped with simultaneous gradual increase in dose of the new opioid), prescribing of both opioids should be undertaken by the specialist until the first opioid has been stopped (RED RAG rating).

Strong opioids are morphine, oxycodone, buprenorphine, diamorphine, hydromorphone, methadone, pethidine, tapentadol, fentanyl, and do not include codeine, morphine sol’n 10mg/5ml, tramadol or dihydrocodeine.

This does not apply where the first opioid is stopped with immediate effect and the new opioid started afterwards (i.e. no simultaneous use of 2 opioid drugs). It does not apply where a patient is switched from a strong opioid to a strong opioid patch (e.g. fentanyl, buprenorphine patch), where administration of the previous strong opioid is continued intermittently and/or temporarily until the patch provides steady state pain relief as recommended in the patch Summary of Product Characteristics.

This also does not apply when one opioid is used for background analgesia and a different opioid is used intermittently for breakthrough pain.

NICE Clinical Guideline 140 Opioids in palliative care: safe and effective prescribing of strong opioids for pain in palliative care of adults recommends that:-

Patients with advanced and progressive disease who require strong opioids should be offered a choice of regular oral sustained-release or oral immediate-release morphine, with rescue doses of oral immediate release morphine for breakthrough pain

Provided there is no renal or hepatic comorbidities, a typical starting total daily dose of oral morphine of 20-30mg of oral morphine, plus 5mg oral immediate release morphine for rescue doses during the titration phase should be offered

The dose should be adjusted until a balance exists between acceptable pain control and side-effects

Fast-acting fentanyl should not be offered as first line rescue medication in patients who can take oral opioids

Transdermal patch formulations should not be routinely offered as first-line maintenance treatment for patients in whom oral opioids are suitable. In those patients unsuitable for oral opioids whose analgesic requirements are stable, consider initiating transdermal patches with the lowest acquisition cost

When calculating opioid equivalence for transdermal patches please contact Pharmacy or the Medicines Management Team

In patients for whom oral opioids are not suitable and analgesic requirements are unstable, consider initiating subcutaneous opioids with the lowest acquisition cost

Ensure that patients are informed of the side-effects which may occur when starting strong opioid treatment and treatment increase, including constipation, nausea and drowsiness.

Ensure that laxative treatment is prescribed regularly at an effective dose, in all patients initiating strong opioids and ensure that patients are aware that treatments for constipation take time to work

Patients should be advised that nausea may occur, but that this is likely to pass

Prescribe and optimise anti-emetic treatment if nausea persists before considering switching opioid treatment

Specialist advice should be sought if there are any complications e.g. moderate to severe renal or hepatic impairment, inadequate pain control despite optimising first-line maintenance treatment, initiating subcutaneous opioids, uncontrolled breakthrough pain or uncontrolled drowsiness

 

Codeine
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Formulary
Green

Codeine use in children and adolescents under 18 years of age

MHRA has recommended restricting codeine use in children. It should only be used in children over 12 years old and only if other pain killers such as paracetamol or ibuprofen are not sufficient. Codeine presents well-known safety and efficacy problems related to genetic variability in biotransformation. Codeine is a prodrug that is converted into its active metabolite morphine. The efficacy of a prodrug depends on the amount of active metabolite formed. Variable expressions of the enzymes involved in the biotransformation of prodrugs can lead to substantial inter-individual and inter-ethnic differences in the conversion rate and the plasma concentration of the active metabolite. As a consequence, the analgesic effect is (very) low or absent in neonates and young children. Furthermore, the percentage of poor metabolizers can vary in ethnic groups, resulting in ineffectiveness in large numbers of patients, including children. Conversely, individuals who metabolize codeine quickly and extensively are at risk of severe opioid toxicity, given the high and uncontrolled conversion of codeine into morphine.Black Initiated Traffic Light Children under 12 yearsRed Triangle Pan Mersey APC: CODINE: USE IN CHILDREN, November 2017


Codeine use in Adults

Codeine is a prodrug that is converted into its active metabolite morphine. The efficacy of a prodrug depends on the amount of active metabolite formed. Variable expressions of the enzymes involved in the biotransformation of prodrugs can lead to substantial inter-individual and inter-ethnic differences in the conversion rate and the plasma concentration of the active metabolite. Furthermore, the percentage of poor metabolizers can vary in ethnic groups, resulting in ineffectiveness in large numbers of patients. Conversely, individuals who metabolize codeine quickly and extensively are at risk of severe opioid toxicity, given the high and uncontrolled conversion of codeine into morphine.
Tablets 15mg, 30mg, 60mg
Linctus 15mg/5ml (3 mg per 1 ml)
Linctus, sugar free 15mg/5ml (3 mg per 1 ml)
Oral liquid 25mg/5ml (5 mg per 1 ml)
Injection
CD Schedule 2
60mg/ml
Red Retained Traffic Light Paediatrics

 

 
   
Morphine
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Formulary
Green
Red Triangle Take care when prescribing and dispensing
Morphine modified release capsules are avialable as both 12 hourly and 24 hourly dosage forms. All modified release morphine preparations should be prescribed by brand name to avoid confusion.
Patients requiring high doses of morphine(> 60mg BD) should be reviewed and consideration given to referring to a pain specialist for review.
Hyperlink NPSA: High dose morphine and diamorphine injections, 25 May 2006
Oral solution 100micrograms/ml (special order medicine)
10mg/5ml (2 mg per 1 ml)
100mg/5ml (20 mg per 1 ml) CD Schedule 2
Tablets
CD Schedule 2
10mg, 20mg, 50mg
Modified-release tablets
CD Schedule 2
12-hourly 5mg, 10mg, 15mg, 30mg, 60mg, 100mg, 200mg
Modified-release capsules
CD Schedule 2
12-hourly 10mg, 30mg, 60mg, 100mg, 200mg
24-hourly 30 mg, 60 mg, 90 mg, 120 mg, 150 mg, 200 mg
Modified-release granules
CD Schedule 2
12-hourly 20mg, 30mg, 60mg, 100mg, 200mg
Suppositories
CD Schedule 2
10 mg, 15 mg, 30 mg
Solution for injection
CD Schedule 2
1mg/ml, 10mg/ml, 15mg/ml, 20mg/ml, 30mg/ml
Amber Retained Traffic Light Paediatrics
Amber Recommended Traffic Light Paediatric palliative care
 
   
Tramadol
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Formulary
Green
Red Triangle Take care when prescribing and dispensing
Tramadol modified release capsules are avialable as both 12 hourly and 24 hourly dosage forms. All modified release tramadol preparations should be prescribed by brand name to avoid confusion.
Capsules
CD Schedule 3
50mg
Amber Initiated Traffic Light Children under 12 years will remain under the care of the paediatric specialist pain team.
Orodispersible tablets
CD Schedule 3
50mg
Amber Initiated Traffic Light Children under 12 years will remain under the care of the paediatric specialist pain team.
Oral drops
CD Schedule 3
100mg/1ml (100 mg per 1 ml)
Amber Initiated Traffic Light Children under 12 years will remain under the care of the paediatric specialist pain team.
Modified-release tablets
CD Schedule 3
12-hourly 50mg, 100mg, 150mg, 200mg
24-hourly 100 mg, 150 mg, 200 mg, 300 mg, 400 mg
Amber Initiated Traffic Light Children under 12 years will remain under the care of the paediatric specialist pain team.
Modified-release capsules
CD Schedule 3
12-hourly 50 mg, 100 mg, 150 mg, 200 mg
Amber Initiated Traffic Light Children under 12 years will remain under the care of the paediatric specialist pain team.
Solution for injection
CD Schedule 3
50mg/ml
Red Recommended Traffic Light Paediatrics
 
   
Dihydrocodeine Tartrate
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Formulary
Green
Tablets, 30 mg
Oral solution, 10 mg/5ml

Weak opioid – oral preparation 
   
Oxycodone
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Formulary
Green
Red Triangle Take care when prescribing and dispensing
Oxycodone modified release tablets are available as both 12 hourly and 24 hourly dosage forms. All modified release oxycodone preparations should be prescribed by brand name to avoid confusion.
Patients requiring high doses of oxycodone(> 30mg BD) should be reviewed and consideration given to referring to a pain specialist for review.
CD CQC Safer use of oral oxycodone medicines
Capsule
CD Schedule 2
5mg, 10mg, 20mg
Modified-release tablet
CD Schedule 2
12-hourly 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg, 120mg
Oral solution
CD Schedule 2
5mg/5ml (1 mg per 1 ml)
10mg/ml (10 mg per 1 ml)
Solution for injection
CD Schedule 2
10mg/ml, 50mg/ml
Amber Retained Traffic Light Paediatrics
Amber Recommended Traffic Light Paediatric palliative care
 
   
Buprenorphine
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Formulary
Green
Red Triangle Take care when prescribing and dispensing
Buprenorphine transdermal patches tablets are avialable as 72-hourly, 96-hourly and 7-day dosage form. All transdermal patch preparations should be prescribed by brand name to avoid confusion.
CD CQC: Safer use of fentanyl and buprenorphine transdermal patches
Sublingual tablets
CD Schedule 3
200microgram, 400microgram
Amber Initiated Traffic Light Paediatrics. Patient will remain under the care of the paediatric specialist pain team.
Transdermal patch
CD Schedule 3
72-hourly 35microgam/hr, 52.5microgram/hr, 70microgram/hour
96-hourly 35microgam/hr, 52.5microgram/hr, 70microgram/hour
7-day 5microgram/hr, 10microgram/hr, 15microgram/hr, 20microgram/hr
Amber Initiated Traffic Light Paediatrics. Patient will remain under the care of the paediatric specialist pain team.
 
   
Hydromorphone
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Formulary
Green















note Patients requiring high doses of Hydromorphone(> 8mg BD) should be reviewed and consideration given to referring to a pain specialist for review.
Capsules
CD Schedule 2
1.3mg, 2.6mg
Amber Initiated Traffic Light Paediatrics. Patient will remain under the care of the paediatric specialist pain team.
Modified release capsules
CD Schedule 2
2mg, 4mg, 8mg,16mg, 24mg
Amber Initiated Traffic Light Paediatrics. Patient will remain under the care of the paediatric specialist pain team.
 
   
Pethidine
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Formulary
Green












Tablets
CD Schedule 2
50mg
Injection
CD Schedule 2
10mg/ml, 50mg/ml
Red Retained Traffic Light Paediatrics
 
   
Diamorphine HCl
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Formulary
Green

Injection, 5 mg, 10 mg, 30 mg, 100 mg, 500 mg

Amber Patient Retained Paediatrics

Amber Recommended  Paediatrics, palliative care


 Opioid – parenteral preparation

 
Controlled Drug Schedule 2
Link  NPSA: High dose morphine and diamorphine injections, 25 May 2006
   
Fentanyl
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Formulary
Green

Patches, 12 micrograms/hr, 25 micrograms/hr, 37.5 micrograms/hr, 50 micrograms/hr, 75 micrograms/hr, 100 micrograms/hr
Amber Initiated Paediatrics

Patients requiring high doses of fentanyl (>25mcg/hr) should be reviewed and consideration given to referring to a pain specialist for review.

2nd line - Strong opioid – alternative route
 

 
Controlled Drug Schedule 2
Link  Pan Mersey APC: TRANSDERMAL OPIOID ANALGESIC PATCHES ENSURING SAFETY, March 2016
Link  Pan Meraey APC: FENTANYL transdermal patch - brand choice, January 2017
Link  CQC: Safer use of fentanyl and buprenorphine transdermal patches
   
Buprenorphine
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Formulary
Amber Recommended

Injection, 300 mcg/ml

Opioid – parenteral preparation

Amber InitiatedPaediatrics

 
Controlled Drug Schedule 3
   
Fentanyl
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Formulary
Amber Recommended

(as citrate) sublingual tablets, 100 micrograms, 133 micrograms, 200 micrograms, 267 micrograms, 300 micrograms, 400 micrograms, 533 micrograms, 600 micrograms, 800 micrograms
(as citrate) buccal tablets, 100 micrograms, 200 micrograms, 400 micrograms, 600 micrograms, 800 micrograms
(as citrate) lozenge with oromucosal appliactor 200 micrograms, 400 micrograms, 600 micrograms, 800 micrograms, 1.2 mg, 1.6 mg
(as citrate) nasal spray, 50 micrograms, 100 micrograms/metered spray, 200 micrograms/metered spray, 400 micrograms/metered spray

2nd line strong opioid – alternative route. For use in palliative care breakthrough pain only.

 
Controlled Drug Schedule 2
   
Methadone
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Formulary
Amber Recommended

Injection 10 mg/ml

Opioid – parenteral preparation

Amber Initiated  Paediatrics: palliative care

 

 
Controlled Drug Schedule 2
   
Oxycodone with naloxone
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Formulary
Amber Recommended

Tablets M/R 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg

Restricted use: see Pan Mersey statement - link below

GREY for restless legs syndrome

No BNFc entry – seek specialist advice

 
Controlled Drug Schedule 2
Link  CQC Safer use of oral oxycodone medicines
Link  OXYCODONE with NALOXONE modified release tablets (Targinact®) for Pain, Pan Mersey APC policy statement
   
Tapentadol
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Formulary
Amber Initiated

Tablets M/R, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg

Strong opioid – oral preparation, modified release

Red Retained Traffic Light  when used in cross titration

BLACKTablets, 50 mg, 75 mg immediate release, Oral solution 20 mg per 1 ml 

 

No BNFc entry – seek specialist advice

 
Controlled Drug Schedule 2
Link  TAPENTADOL prolonged release tablets (Palexia® SR) Pan Mersey APC Policy Statement
Link  TAPENTADOL immediate release tablets (Palexia®) Pan Mersey APC Policy Statement
   
Dihydrocodeine Tartrate
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Formulary
Red
Injection 50 mg/ml

Opioid – parenteral preparation 
Controlled Drug Schedule 2
   
Morphine
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Formulary
Red

Solution for infusion 1mg/ml, 2mg/ml

 
Controlled Drug Schedule 2
   
Fentanyl
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Formulary
Red
Injection, 50 micrograms/ml

Opioid – parenteral preparation 
Controlled Drug Schedule 2
   
Alfentanil
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Formulary
Red

Injection 500 micrograms/ml, 5 mg/ml
Amber Recommended Only when recommended by the palliative care team
 

Amber Recommended Paediatrics - Only when recommended by the palliative care team

Opioid – parenteral preparation

 
Controlled Drug Schedule 2
   
Tramadol + dexketoprofen (Skudexa®)
View adult BNF View SPC online View childrens BNF
Formulary
Black

Tablets tramadol 75mg + dexketoprofen 25mg

 
Link  PAN MERSEY AREA PRESCRIBING COMMITTEE PRESCRIBING POLICY STATEMENT: ORAL COMBINATION PRODUCTS
   
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Green

Medicines considered suitable for non-specialist prescribing in primary or secondary care.  

Amber Recommended

Amber Recommended  

Amber Initiated

Amber Initiated. Requires specialist initiation of prescribing. Prescribing to be continued by the specialist until stabilisation of the dose and the patient’s condition is achieved and the patient has been reviewed. Amber Initiated medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable   

Amber Retained

Amber Patient Retained. Requires specialist initiation of prescribing. Prescribing to be continued by specialist until stabilisation of the dose and the patient’s condition is achieved and the patient had been reviewed. Patient remains under the care of specialist (ie not discharged) as occasional specialist input may be required. Amber Patient Retained medicines must meet criteria: (1)Requires specialist assessment to enable patient selection (2)Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable (4) May require occasional specialist input indefinitely and therefore the patient should not be discharged from specialist care   

Amber

Medicines recommended or initiated by specialists in primary or secondary care. Non-specialist prescribing in primary care may follow according the RAG criteria. In process of being superceded by Amber Recommended, Amber Initiated and Amber Patient Retained.  

Purple

Shared Care. Medicines are considered suitable for Primary Care prescribing and/or management, following specialist initiation of therapy, with on-going communication between the Primary Care prescriber and specialist, within the framework of a Shared Care Agreement. Medicines designated as requiring Shared Care require on-going input from both Specialist and Primary Care clinicians and patients should not be discharged from Specialist care. Where prescribing and monitoring are required under shared care, it is implicit that the responsibility for both of these tasks rests with the prescriber. A Shared Care Agreement will always be available for Shared Care medicines and this document will include a Shared Care Agreement pro-forma which will be completed by all involved clinicians. This pro-forma will record agreement to take on defined aspects of care e.g. monitoring and/or on-going prescribing for the individual patients. A policy detailing clinician responsibilities in Shared Care Agreements must be referred to in all cases of Shared Care. All drugs to be included in this category must meet Shared Care criteria 1 to 3: SC1 Requires specialist assessment to enable patient selection and also initiation, stabilisation and review of treatment and the patient`s condition. SC2 Prescribing and/or management of the drug in Primary Care with specialist support and input, within the framework of the Shared Care Agreement is safe and convenient and that there is an appropriate mechanism for individual patient access in Primary Care. SC3 Requires specific long-term monitoring (blood test or other measurement) for adverse effects and / or efficacy of the drug to be completed in Primary Care, and requires on-going specialist support for the dose changes or management of adverse effects. Monitoring is required on a regular basis (typically four times a year). Implicit in any shared care agreement is the understanding that participation is at the discretion of the Primary Care prescriber subject to their clinical confidence.   

Red

Primary care prescribing of these medicines is NOT recommended. These treatments should be initiated by specialists only; ongoing prescribing is retained within secondary care.   

Black

Not recommended for use. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist.   

Grey

Not recommended for use at this time. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist. Further guidance will be issued when more information or evidence is made available.  

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