Medicine Directory - dpt

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Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 Feb 19 Page 1 of 22 Medicine Directory The purpose of the Trust Medicine Directory is to assist clinicians with evidence based, clinical and cost effective advice and information when prescribing medication for the management of mental health and behavioural conditions and medication associated side effects. For medication prescribed for the management of physical health conditions refer to local joint formulary recommendations (this also applies to medication included in this list when prescribed for physical health condition, e.g. prochlorperazine for nausea and vomiting or valproate for epilepsy). The aims of the Trust Medicine Directory are to: Promote adherence to existing prescribing guidance and advice (national and local) Raise awareness of and signpost clinicians to relevant prescribing guidelines, protocols and safety alerts to enable the safe and effective use of medicines. Ensure clinicians are aware of current information and advice in order to maximise the potential for individuals, teams and services to achieve Trust agreed cost improvement plans for prescribing. Raise awareness to specific resources and tools available to healthcare professionals which can be used to help support optimal prescribing and treatment with medication through shared decision making. The Medicine Directory is not intended to replace prescribing information contained in the BNF and / or Summary of Product Characteristics for specific medications, nor is it intended to replace advice included in locally developed joint formularies (which are inclusive of all conditions and not just mental health) The Medicine Directory is arranged in alphabetical order of medication with a list of conditions for which the medication may be prescribed. The following key is used to indicate the current status for each medication which is condition specific (i.e. evidence may support use for the management of depression but not anxiety). No approval required. Prescribe in accordance with Trust recommendations NON-APPROVED MEDICATION Approval is required by your Clinical Director or Associate Clinical Director prior to prescribing in order to agree that the medication is clinically appropriate, and to accept the impact on the prescribing budget. These medicines may be: Medicines that are not commissioned by the CCG Medicines that are commissioned but with conditional measures based on adherence to locally agreed procedures Please refer to Standard Operating Procedure MM26 and complete a Non-Approved Medication form (click here to access the SOP and form) These medicines are not recommended due to: Concerns over safety or effectiveness Insufficient evidence Cost effectiveness (more expensive compared to equivalent treatment options) Record the clinical rationale for treatment in the electronic patient record and discuss the treatment with your local pharmacist and/or peers. If prescribing is to continue, please refer to Standard Operating Procedure MM26 and complete a Non-Approved Medication form (click here to access the SOP and form) Refer to local joint formulary

Transcript of Medicine Directory - dpt

Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19

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Medicine Directory

The purpose of the Trust Medicine Directory is to assist clinicians with evidence based, clinical and cost effective advice and information when prescribing medication for the management of mental health and behavioural conditions and medication associated side effects. For medication prescribed for the management of physical health conditions refer to local joint formulary recommendations (this also applies to medication included in this list when prescribed for physical health condition, e.g. prochlorperazine for nausea and vomiting or valproate for epilepsy).

The aims of the Trust Medicine Directory are to: Promote adherence to existing prescribing guidance and advice (national and local) Raise awareness of and signpost clinicians to relevant prescribing guidelines, protocols and

safety alerts to enable the safe and effective use of medicines. Ensure clinicians are aware of current information and advice in order to maximise the potential

for individuals, teams and services to achieve Trust agreed cost improvement plans for prescribing.

Raise awareness to specific resources and tools available to healthcare professionals which can be used to help support optimal prescribing and treatment with medication through shared decision making.

The Medicine Directory is not intended to replace prescribing information contained in the BNF and / or Summary of Product Characteristics for specific medications, nor is it intended to replace advice included in locally developed joint formularies (which are inclusive of all conditions and not just mental health) The Medicine Directory is arranged in alphabetical order of medication with a list of conditions for which the medication may be prescribed. The following key is used to indicate the current status for each medication which is condition specific (i.e. evidence may support use for the management of depression but not anxiety).

No approval required. Prescribe in accordance with Trust recommendations

NON-APPROVED MEDICATION Approval is required by your Clinical Director or Associate Clinical Director prior to prescribing in order to agree that the medication is clinically appropriate, and to accept the impact on the prescribing budget. These medicines may be:

Medicines that are not commissioned by the CCG

Medicines that are commissioned but with conditional measures based on adherence to locally agreed procedures

Please refer to Standard Operating Procedure MM26 and complete a Non-Approved Medication form (click here to access the SOP and form)

These medicines are not recommended due to:

Concerns over safety or effectiveness

Insufficient evidence

Cost effectiveness (more expensive compared to equivalent treatment options)

Record the clinical rationale for treatment in the electronic patient record and discuss the treatment with your local pharmacist and/or peers. If prescribing is to continue, please refer to Standard Operating Procedure MM26 and complete a Non-Approved Medication form (click here to access the SOP and form)

Refer to local joint formulary

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Prescribing Off-Licence and Unlicensed Medicines Clinicians should always prescribe licensed medicines for licensed indications in preference to the ‘off-licence’ use of medicines (which includes indication, dose and method of administration) or unlicensed medicines. However, the Trust recognizes that prescribing of ‘off-licence’ (‘off-label’) or unlicensed medication, is occasionally necessary in order to offer and provide the optimum treatment for an individual, and in these circumstances Trust Standard Operating Procedure MM06 ‘Prescribing Unlicensed and Off-Label Medication’ must be adhered to. Trust categorisation of ‘off-label’ and ‘unlicensed prescribing’ is summarised below;

Level 1 (L1)

'Off-label' prescribing of a licensed drug where use is recognised in prescribing guidelines issued by The National Institute for Health and Care Excellence (NICE) and / or robust evidence of efficacy is available and reflected in the Trust Medicine Directory

Level 2 (L2)

'Off-label' prescribing of a licensed drug where supporting evidence is weak.

Off-label indication for medication not included in Trust Medicine Directory (unless highlighting that prescribing is not recommended due to lack of evidence to support efficacy and / or safety profile)

As of December 2017 it is recommended that clinicians seek a second opinion using the non-approved medicines process when prescribing level 2 off label items

Level 3 (L3)

Prescribing of an Unlicensed drug (Medication without UK Marketing authorisation or Central European Licence)

As of December 2017 it is recommended that clinicians seek a second opinion using the non-approved medicines process when prescribing level 3 unlicensed medicines

Keeping the Medicine Directory Up To Date The Medication Directory will be reviewed and updated by the Trust Drugs and Therapeutics Committee (DTC) on a monthly basis. This will be completed in collaboration with Medicine Optimisation Teams and Formulary Interface Groups (FIGs) within the local Clinical Commissioning Groups (CCGs). Please contact the Medicines Optimisation Team if you would like further information about this process.

New Medications The definition of a ‘new drug’ is a newly launched treatment or a ‘new indication and / or formulation’ of an existing treatment. At the time of launch, new medicines will be included in the Medicine Directory as ‘Non-approved drugs’ and the stage of evaluation stated (i.e. “Awaiting commissioning decision from CCG Clinical Policy Committee”). Following a commissioning decision the non-approved status will be updated to reflect this.

Generic and Brand Prescribing Prescribing medicines generically rather than by brand name can improve cost-effectiveness and is encouraged. However, there are some circumstances in which brand-name prescribing is preferred in order to support the safe and clinically effective delivery of treatment with medication. These include:

Where there is a difference in bioavailability between brands of the same medicine, particularly if the medicine has a narrow therapeutic index

Where modified release preparations are not interchangeable

Where there are important differences in formulation between brands of the same medicine

Where products contain multiple ingredients and brand name prescribing aids identification

Where administration devices (e.g. inhaler or self-injection) have different instructions for use and patient familiarity with the same product is important

Where different preparations of the same medicine have different licensed indications

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Even where there is only one brand available, products should still be prescribed generically unless one of the reasons listed above applies. The reason for this is so that if / when a generic version becomes available, prescribing practice will not have to change and financial savings from generic prescribing will be maximised. Occasionally there will be a requirement to prescribe a branded generic version of a medicine to realise financial savings.

The following symbol in the Medicine Directory indicates that medication should be prescribed by brand in order to support treatment efficacy and / or patient safety.

Research and Development The Trust’s overarching research and development aims are to maximise the participation of people using its services in clinical research, innovation and improvement projects by increasing the Trust’s participation in the National Institute for Health Research portfolio studies which are open to recruitment, other high quality research and clinical trials.

In order to raise awareness, where the organisation is actively involved in a research project that involves prescribing medication, information will be included in the Directory. Clinicians should contact the Research and Development Department or the Primary Investigator for more information.

Cost Improvement Plans

The Medicines Optimisation Team proactively works with prescribers and teams to minimize the routine costs associated with prescribing on a daily basis without compromising the safety and efficacy of treatment. Advice on optimising prescribed medication and minimising associated costs is included in the Directory under individual drugs where applicable. Cost Comparison Charts for the most commonly used medications are available here

Further information and advice about safe and effective prescribing can be obtained by:

Visiting the Trust Medicines Optimisation Team’s intranet site: http://daisy.exe.nhs.uk/quality-safety/medicines-optimisation.aspx

Visiting the Devon Partnership Trust’s internet site for prescribers and professionals: http://www.devonpartnership.nhs.uk/For-prescribers-and-professionals.513.0.html

Telephoning or emailing the Trust Medicines Optimisation Team:

– Direct Dial 01392 675674 – Email address [email protected]

Calling the Trust Medicines Helpline (for staff and people who use our services)

Visiting the Choice and Medication Website (For staff and people who use our services)

If any supporting document links do not work, please inform the Medicines Optimisation Team: [email protected]

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MEDICATION

(Approved name)

Indication and Prescribing Recommendations

Prescribing Support Documents Prescribing guideline

Clinical Protocol

Shared Care

Safety Briefing

AGOMELATINE ▼ DEPRESSION Acquisition cost of agomelatine is considerably higher than currently available antidepressant therapies. Link to full statement: https://nww.devonpctinfo.nhs.uk/EPC/post/2010/01/Agomelatine-(Valdoxan)-in-the-treatment-for-depression.aspx

PG03

Suicide & depression

AMISULPRIDE SCHIZOPHRENIA

PG10 CP10

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - evidence base weak

PG14

ATLAS Randomised Controlled Trial (RCT) for late-onset schizophrenia-like psychosis comparing amisulpride vs placebo Primary Investigator: Dr Richard McCollum

AMITRIPTYLINE DEPRESSION PG03 Suicide &

depression

L1 PTSD (POST-TRAUMATIC STRESS DISORDER) Prescribe in accordance with NICE CG26

PG11

L2 INSOMNIA

Not recommended - safety concerns Should not be used to treat insomnia (although insomnia may improve in response to adequate treatment of a depressive episode). Low dose amitriptyline is sometimes used to treat insomnia but where there is no relevant co-morbidity (e.g. neuropathic pain) it should not be used as tolerance is quickly developed to the sedating effects and the relative side effects are unfavourable compared to the preferred hypnotics above.

PG02

ANTICOAGULATION Refer to local Joint formularies for recommended prescribing options

Link to NPSA alert: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=61777&p=3 CP02

VENOUS THROMBOEMBOLISM (VTE) Prevention and treatment

CP14 CP17

ARIPIPRAZOLE SCHIZOPHRENIA PG10

CP10

ACUTE HYPOMANIA Considered 3rd line where other treatment ineffective or not tolerated (NB ONLY commissioned in South Devon)

PG13

CP10

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OBSESSIVE COMPLUSIVE DISORDER (OCD) May have some efficacy augmenting SSRIs

PG25

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - evidence base weak

PG14

Personality disorders – not recommended, evidence base weak PG26

ARIPIPRAZOLE IM

RAPID TRANQUILLISATION CP11

ARIPIPRAZOLE LONG ACTING INJECTION ▼

SCHIZOPHRENIA (WHEN STABLE ON ORAL ARIPIPRAZOLE) Commissioned with condition that prescribing is in accordance with PG10 and PG23 Process for Non-approved medicines MM26 applies.

ABILIFY MAINTENA®

PG10

PG23 13-010

ASENAPINE BIPOLAR DISORDER Not currently approved due to high acquisition cost and lack of evidence of superiority over existing agents Process for Non-approved medicines MM26 applies.

PG13 CP10

ATOMOXETINE ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Children and Young People

PG16 √

CAMHS

ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Specialist Adult ADHD Service PG17

BARBITURATES INSOMNIA Safer treatment alternatives now available

PG02

ANXIETY SPECTRUM DISORDERS Safer treatment alternatives now available

PG11

BENPERIDOL L2 SCHIZOPHRENIA

ANTISOCIAL SEXUAL BEHAVIOUR PG10

BISPHOSPHONATES EATING DISORDERS / ANOREXIA NERVOSA Refer to local Joint formularies for recommended prescribing options

PG24

BUPROPION (Children and Adolescents)

L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Use in accordance with NICE guidance (CG 72)

BUPRENORPHINE (Schedule 2 Controlled Drug)

OPIOID MISUSE - DETOX AND RECOVERY (NICE TA 114) PG20

BUPRENORPHINE OPIOID MISUSE Buprenorphine prolonged-release injection may be an option where there is a risk of

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prolonged-release injection (Buvidal)

diversion of opioid substitution medicines or concerns about the safety of medicines stored at home. It is currently non approved owing to the higher drug acquisition cost of buprenorphine prolonged-release injection compared with other treatments for opioid dependence.

BUSPIRONE GAD (GENERALISED ANXIETY DISORDER) In accordance with NICE Guidelines: evidence for buspirone in GAD equivocal. It should only be used when other treatments have proved ineffective.

PG11

CARBAMAZEPINE BIPOLAR DISORDER PG13

L1 ALCOHOL WITHDRAWAL PG19

L1 BENZODIAZEPINE WITHDRAWAL PG20

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - evidence base weak

PG14

OTHER INDICATIONS Refer to local Joint-formularies

CARIPRAZINE SCHIZOPHRENIA DPT Drugs & Therapeutics Committee reviewed in Sept 18. Process for Non-approved medicines MM26 applies. For transfer to primary care prescribing follow the CCG individual patient funding request process application form here: https://www.newdevonccg.nhs.uk/permanent-link/?rid=119423

PG10

CALCIUM AND VITAMIN D

NUTRITION / EATING DISORDERS Correction of vitamin and mineral deficiency (oral) Prevention of osteoporosis

PG24

CHLORPROMAZINE

SCHIZOPHRENIA PG10

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - safety concerns

PG14

CHLORPROMAZINE INTRAMUSCULAR

RAPID TRANQUILLISATION Not recommended - safety concerns CP11

CHLORAL HYDRATE INSOMNIA Not recommended - safety concerns Insufficient clinical data to support superiority over available hypnotics to justify use. Toxic in overdose

PG02

CHLORDIAZEPOXIDE ALCOHOL DETOXIFICATION PG19

CITALOPRAM DEPRESSION PG03

Suicide &

depression

PANIC DISORDER PG11

SOCIAL ANXIETY DISORDER (if other SSRIs ineffective or not tolerated)

PG11

OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25

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L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - insufficient evidence

PG14

CLOMETHIAZOLE ALCOHOL DETOXIFICATION Benzodiazepines preferred and safer alternative

PG19

INSOMNIA

PG02

CLOMIPRAMINE DEPRESSION PG03 Suicide &

depression

L1 PANIC DISORDER PG11

OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25

CLONIDINE

L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Children and Adolescents Use in accordance with NICE guidance CG72

PG16

CLONAZEPAM L1 ANXIETY Review all prescriptions on discharge for appropriateness and where on-going treatment is recommended clear rationale must be communicated to the GP, including a proposed treatment plan of when to review, reduce and/or discontinue treatment.

L1 ACUTE MANIA / HYPOMANIA

CLOZAPINE (Clozaril®) SCHIZOPHRENIA Offer clozapine to people with schizophrenia whose illness has not responded adequately to treatment despite the sequential use of adequate doses of at least two different antipsychotic drugs. At least one of the drugs should be a non-clozapine SGA.

Current treatment of choice within Devon is the branded generic Clozaril®. If treatment is prescribed generically as ‘clozapine’, Clozaril® will be dispensed. In circumstances where, to optimised treatment, clozapine suspension is appropriate refer to CLOZAPINE (Denzapine®) entry

PG10 CP19

Personality disorders – not recommended due to poor evidence base PG26

Molecular Genetics of Adverse Drug Reactions The purpose of this research is to (a) identify patients with different types of adverse drug reactions; (b) using DNA obtained from blood or urine samples from these patients, identify genetic factors which predispose to adverse reactions. The net effect of our research will be the development of genetic tests which can help in

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predicting individual susceptibility to adverse reactions. People who have a ‘red result’ whilst taking clozapine could be eligible for inclusion in this study. Please contact the PI if anyone on your caseload has a red result whilst taking clozapine.

Primary Investigator: Dr Giovanni Salvi

CLOZAPINE (Denzapine®)

In circumstances where, to optimise treatment, clozapine suspension is appropriate, this should be prescribed as ‘Denzapine® (in accordance with CP19)

PG10 CP19

CLOZAPINE (Zaponex® Orodispersible tablets)

12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg Zaponex® Orodispersible tablets are available from 1 July 2019 and are monitored via the Zaponex Treatment Access System. Currently this is non approved and not stocked by supplying pharmacies – please contact medicines optimisation team if planning to start this product.

CYPROTERONE ACETATE

L2 GENDER DYSPHORIA For male to female non-orchiectiomised patients PG12

DEXAMFETAMINE (Schedule 2 Controlled Drug)

ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) CAMHS

PG16

L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Specialist Adult ADHD Service

PG17

DIABETES Refer to local Joint formularies and Trust Clinical Protocol Link to NPSA alert:

CP04

DIAZEPAM INSOMNIA PG02

GAD (GENERALISED ANXIETY DISORDER) Short term (up to 4 weeks) for immediate management of anxiety symptoms if distressing or disabling (NICE CG113)

PG11

PANIC DISORDER Benzodiazepines associated with a poorer outcome (NICE CG113)

PG11

SOCIAL ANXIETY DISORDER Short term (up to 4 weeks) for immediate management of anxiety symptoms if distressing or disabling

PG11

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

ALCOHOL DETOXIFICATION PG19

L1 BENZODIAZEPINE DETOXIFICATION PG20

DONEPEZIL MILD TO MODERATE ALZHEIMERS DISEASE PG15

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

DOSULEPIN ALL INDICATIONS NHS England has stated that Dosulepin should not be newly initiated and where

PG03

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appropriate its use should be reviewed. Not recommended - safety concerns

DOXEPIN SCHIZOPHRENIA (no longer routinely prescribed)

PG10

DULOXETINE DEPRESSION (Not commissioned / non-formulary for depression) Process for Non-approved medicines MM26 applies.

PG03

Suicide &

depression

GAD (GENERALISED ANXIETY DISORDER) (Not commissioned / non-formulary for GAD) evidence for duloxetine in GAD was unconvincing and did not support its inclusion in the GAD guideline Process for Non-approved medicines MM26 applies.

PG11

ESCITALOPRAM GENERALISED ANXIETY DISORDER PG11

Suicide & depression

OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25

DEPRESSION PG03

SOCIAL ANXIETY DISORDER (NICE CG159) Process for Non-approved medicines MM26 applies.

PG11

ALL OTHER INDICATIONS Insufficient clinical data to support superiority over existing SSRI antidepressants to justify significant increase in prescribing costs associated with this medication. (Improved cost-effectiveness compared with existing treatment not demonstrated). Process for Non-approved medicines MM26 applies.

PG11

ESTRADIOL L1 GENDER DYSPHORIA For male to female non-orchiectiomised patients Transdermal (i.e. estradiol valerate patch / estradiol gel) or oral formulation

PG12

FLUOXETINE BULIMIA NERVOSA

DEPRESSION PG03

L1 PANIC DISORDER Only consider if licensed treatment intolerable of ineffective. Keep initial doses very low (2.5-5mg)

PG11

OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25

L1 PTSD (POST-TRAUMATIC STRESS DISORDER) Only consider if licensed treatment intolerable or ineffective

PG11

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FLUPENTIXOL SCHIZOPHRENIA PG10

FLUPENTIXOL DECANOATE IM

SCHIZOPHRENIA F55 Antipsychotic Long Acting Depot Prescription and Administration Record (Community Use)

PG10 13-010

FLUVOXAMINE DEPRESSION No longer routinely prescribed (poorly tolerated and increased likelihood of drug interactions)

PG03

OBSESSIVE COMPLUSIVE DISORDER (OCD) No longer routinely prescribed (poorly tolerated and increased likelihood of drug interactions)

PG25

GABAPENTIN L2 PANIC DISORDER Not recommended - insufficient evidence

PG11

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - insufficient evidence

PG14

GALANTAMINE

MILD TO MODERATE ALZHEIMERS DISEASE PG15

Where clinically appropriate and safe to do so, switch to equivalent treatment option with lower acquisition cost (e.g. donepezil) (NICE TA 217)

For FP10 prescribing, where a galantamine modified release formulation is indicated, prescribe generically as ‘galantamine MR capsules’ OR Luventa ® XL The CCG are recommending that GPs pre scribe this product as a branded generic (Luventa ® XL) as this will result in a cost saving of £48,000 across the health care community.

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - insufficient evidence PG14

GUANFACINE CAMHS and ADULT ADHD Rejected by Devon Clinical Policy Committee 2016. Agreed to be non-approved via CAMHS process

PG16

HALOPERIDOL SCHIZOPHRNENIA PG10 CP10

HALOPERIDOL IM RAPID TRANQUILLISATION

CP10 CP11

HALOPERIDOL DECANOATE IM

SCHIZOPHRENIA F55 Antipsychotic Long Acting Depot Prescription and Administration Record (Community Use)

PG10 CP10 13-010

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HALDOL DECANOATE ®

HYOSCINE HYDROBROMIDE

L1 HYPERSALIVATION secondary to treatment with clozapine CP19

HOMEOPATHY No commissioned by Local Clinical Commissioning Groups

IMIPRAMINE DEPRESSION (No longer routinely prescribed)

PG03

L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Children and adolescents Not recommended - safety concerns

ISOCARBOXAZID DEPRESSION (No longer routinely prescribed)

PG03

LAMOTRIGINE BIPOLAR DISORER (PREVENTION OF DEPRESSIVE EPISODES) PG13

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - insufficient evidence

PG14

LEVOMEPROMAZINE SCHIZOPHRENIA (No longer routinely prescribed)

LISDEXAMFETAMINE ▼

(Schedule 2 Controlled Drug) ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER)

CAMHS Approved by CCG Clinical Policy Committee (June 2014). Formulary status agreed at CCG Formulary Interface Groups September 2014; Specialist initiated in accordance with shared care guidelines.

PG16

ADULT Submitted to CPC Dec 15 for review for appropriateness in Adult ADHD Decision at Dec DTC to include as “non-approved drug” pending CPC decision

PG17

LIOTHYRONINE (AUGMENTATION)

L1

DEPRESSION (AUGMENTATION)

Prescribe in accordance with British Association of Psychopharmacology (BAP)

Strategy not supported by NICE CG90. NHS England has advised no new patients should be started on Liothyronine. MM26 Non Approved Process Applies

PG03

LITHIUM BIPOLAR DISORDER (Treatment and prophylaxis of bipolar depression and hypomania / mania)

Link to NPSA alert: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=65426&p=2

PG13 CP05

YES South Devon only

UNIPOLAR DEPRESSION PG03

LOFEPRAMINE DEPRESSION PG03

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LOFEXIDINE OPIOID DETOXIFICATION PG20

LOPRAZOLAM INSOMNIA Not recommended - Cost Insufficient clinical data to support superiority over available hypnotics and more expensive than zopiclone

PG02

LORAZEPAM ANXIETY

L1 MANIA / HYPOMANIA PG13

L1 CATATONIA

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

ACUTELY DISTURBED BEHAVIOUR PG27

LORAZEPAM IM

RAPID TRANQUILLISATION

CP10 CP11

13-010

L1 CATATONIA (administration of oral medication not possible)

LORMETAZEPAM INSOMNIA Not recommended - Cost Insufficient clinical data to support superiority over available hypnotics and significantly more expensive than zopiclone

PG02

LOXAPINE powder for inhalation

Indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.

LURASIDONE SCHIZOPHRENIA Devon Clinical Policy Committee reviewed in May 18 and rejected. Process for Non-approved medicines MM26 applies. For transfer to primary care prescribing follow the CCG individual patient funding request process application form here: https://www.newdevonccg.nhs.uk/permanent-link/?rid=119423

PG10

MAGNESIUM GLYCOPHOSPHATE

L3 NUTRITION / EATING DISORDERS Correction of mineral deficiency (oral) PG24

MELATONIN (CAMHS AND LEARNING DISABILITY SERVICES)

INSOMNIA Use restricted to specialist CAMHS and Learning Disability clinicians to aid sleep cycle synchronisation in children with sensory impairment, autistic spectrum disorder, in other neurodisability / neuropsychiatric / neurodevelopmental disorders including ADHD when behavioural measures have been insufficient and also to induce sleep in children undergoing sleep EEG Melatonin m/r 2mg tablets are licensed for use in adults over 55, use in children is an ‘off label' use. The MHRA state that, where available a licensed preparation should be used where possible (ie. 2mg m/r tablets, Circadin®)

PG02

MELATONIN (ADULT) INSOMNIA (Licensed indication for individuals >55 years of age but still subject to PG02

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non-approved process as non-formulary)

Insufficient clinical data to support superiority over available hypnotics to justify increase in prescribing costs associated with this medication

Process for Non-approved medicines MM26 applies.

MEMANTINE ALZHEIMERS DEMENTIA PG15 √

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

MEPROBAMATE

ANXIETY No longer recommended: less effective than benzodiazepines and hazardous in overdose

METHADONE (Schedule 2 Controlled Drug)

OPIOID MAINTENANCE, DETOXIFICATION AND RECOVERY (NICE TA 114) PG20

METHYLPHENIDATE (Schedule 2 Controlled Drug)

METHYLPHENIDATE (Schedule 2 Controlled Drug) continued…..

ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) CAMHS

Modified release formulations must be prescribed by brand

PG16 √

CAMHS

L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) SPECIALIST ADULT ADHD SERVICE ONLY NB Off-license indication for initiation of treatment in adults (Concerta XL®licensed for continuation of treatment initiated in young people <18 Yrs)

Modified release formulations must be prescribed by brand

PG16 PG17

The CCG are recommending that GPs pre scribe this product as a branded generic (Xenidate® XL) Concerta XL will also remain on the formulary, but Xenidate® XL should now be the preferred brand of choice where treatment is initiated.

MIANSERIN DEPRESSION No longer routinely prescribed in practice

PG03

MIDAZOLAM IM (Schedule 3 Controlled Drug)

L1 RAPID TRANQUILLISATION Only use when lorazepam IM unavailable CP11

MIRTAZAPINE DEPRESSION

PG03

L1 PTSD (POST-TRAUMATIC STRESS DISORDER)

PG11

L1 PANIC DISORDER PG11

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L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

MOCLOBEMIDE DEPRESSION PG03

MODAFINIL

Refer to South and Western or Northern and Eastern Joint formulary Specialist initiation only

L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Children and Adolescents Use in accordance with NICE guidance (CG72)

PG16

MULTIVITAMIN NUTRITION / EATING DISORDERS Correction of vitamin or trace element deficiency (oral)

Forceval or Forceval soluble® Dalivit®

PG24

NALMEFENE ALCOHOL DEPENDENCE Treatment initiated in primary care

NALOXONE NALOXONE CHALLENGE TEST PG20

OPIOID OVERDOSE CP25

NALTREXONE

ABSTINENCE FOLLOWING ALCOHOL DETOXIFICATION PG19

ABSTINENCE FOLLOWING OPIOID DETOXIFICATION (NICE TA 115) PG20

NICOTINE REPLACEMENT THERAPY

Refer to locally agreed joint formulary guidelines for recommended formulations (South and Western or Northern and Eastern Joint formulary)

PG22

NITRAZEPAM INSOMNIA Long half-life. Increased risk of side effects / drowsiness the following day. Risk of accumulation (especially in elderly) leading to confusion and ataxia.

PG02

NORTRIPTYLINE DEPRESSION No longer routinely prescribed in practice

PG03

OLANZAPINE L1 DEPRESSION For augmentation of antidepressant (not to be prescribed alone) in accordance with NICE CG 90

PG03

SCHIZOPHRENIA PG10

BIPOLAR DISORDER Manic episode or preventing recurrence in bipolar disorder

PG13

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

L1 PTSD (POST-TRAUMATIC STRESS DISORDER) For augmentation of antidepressant (not to be prescribed alone) in accordance with

PG11

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NICE CG 26

Personality disorders – not recommended due to weak evidence base PG26

OLANZAPINE IM RAPID TRANQUILLISATION CP11

OLANZAPINE EMBONATE ▼

SCHIZOPHRENIA Commissioned with condition that prescribing is in accordance with PG10 and PG23 Process for Non-approved medicines MM26 applies Requires 3 hour post administration monitoring with resus facilities

ZYPADHERA®

PG10 PG23

13-010

ORPHENADRINE MANAGEMENT OF EXTRA PYRAMIDAL SIDE EFFECTS secondary to antipsychotic medication. Orphenadrine tablets due to discontinued December 2015. No plans for orphenadrine oral solution ( 50mg/ml) to be withdrawn at present

OXAZEPAM

INSOMNIA

PG02

L1 BENZODIAZEPINE WITHDRAWAL (in hepatic impairment) PG20

OXCARBAZEPINE L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - insufficient evidence

PG14

OXYGEN

CP01 CP06 CP20

PALIPERIDONE SCHIZOPHRENIA PG10

PALIPERIDONE IM

SCHIZOPHRENIA Commissioned with condition that prescribing is in accordance with PG10 and PG23 Process for Non-approved medicines MM26 applies

XEPLION®

3 monthly Paliperdone: TREVICTA®

Only for individuals stabilised on XEPLION for 4 or more months.

PG10 PG23

13-010

PAROXETINE SOCIAL ANXIETY DISORDER, GAD, PANIC DISORDER, PTSD PG11

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Associated with increased suicidal behaviour and discontinuation effects

OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25

PERICYAZINE SCHIZOPHRENIA AND OTHER PSYCHOSES No longer routinely prescribed in practice

PG10

PERPHENAZINE

SCHIZOPHRENIA AND OTHER PSYCHOSES No longer routinely prescribed in practice PG10

PHENELZINE DEPRESSION PG03 GAD (GENERALIZED ANXIETY DISORDER) PG13

L1 PANIC DISORDER Limited evidence, may be appropriate to consider it in severe or treatment resistant cases.

PG13

PHOSPHATE NUTRITION / EATING DISORDERS Correction of electrolyte deficiency (oral)

PG24

PIMOZIDE SCHIZOPHRENIA Not routinely recommended due to cardiac toxicity

PG10

PIRENZEPINE L3 HYPERSALIVATION secondary to treatment with clozapine

CP19

Increased cost if prescribed on FP10 (56 x 50mg tab - £140 on FP10, £13 if supplied by Acute Trust Supply Pharmacy)

POTASSIUM SUPPLEMENTS (ORAL)

NUTRITION / EATING DISORDERS Correction of electrolyte deficiency (oral) PG24

PREGABALIN GAD (GENERALISED ANXIETY DISORDER)

PG11

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - insufficient evidence

PG14

PROCHLORPERAZINE BUCCAL

NAUSEA AND VOMITING associated with substance withdrawal PG20

PROCYCLIDINE MANAGEMENT OF EXTRA PYRAMIDAL SIDE EFFECTS secondary to antipsychotic medication.

PROMAZINE

AGITATION AND RESTLESSNESS Now considered less suitable for prescribing

PG10

L2 INSOMNIA PG02

PROMETHAZINE INSOMNIA

PG02

Personality disorders recommended by NICE PG26

PROMETHAZINE IM L1 RAPID TRANQUILLISATION CP10

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CP11

QUETIAPINE

L2

INSOMNIA Insufficient evidence and risk of potential side effects out-weighs expected benefits. Proposed that effect mediated through antihistaminic effects, therefore consider sedative antihistamine.

PG02

SCHIZOPHRENIA PG10

BIPOLAR DISORDER Treatment and prevention of mania / hypomania and depression PG13

DEPRESSION (Adjunct treatment with antidepressant)

PG03

OBSESSIVE COMPLUSIVE DISORDER (OCD) May have some efficacy in doses up to 400mg/day but there are a number of trials showing it to be ineffective.

PG25

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) Not recommended - insufficient evidence and concerns over safety PG14

Personality disorders – not recommended due to inadequate evidence PG26

Rationalising use of Quetiapine Modified release (MR): Immediate release (IR) formulations should always be prescribed in preference to MR products. However, in order to achieve optimal treatment for an individual, there may be occasions where MR products are indicated. There are now several different products available for quetiapine MR ® and the CCG advises GPs to prescribe using this ‘branded generic’ name (Zaluron® XL) to maximise cost savings.

Indication

Recommendation Comment Notes

1. There is no proven clinical benefit to MR over IR therapeutically.

2. IR is likely to be more sedating than MR so weighting towards a larger night-time dose may improve tolerability.

3. The half-life of quetiapine is too short to use once daily for schizophrenia and manic episodes and loss of therapeutic benefit cannot be guaranteed.

4. An active metabolite of quetiapine is the antidepressant agent and this has a longer half-life so once daily administration is appropriate for these indications (MDD)

5. The doses listed in the table are for a guide only and can be altered to suit individual

Schizophrenia (new treatment)

Commence MR 300mg day 1, 600mg Day 2 Change to IR 200mg OM, 400mg ON

MR is only to be continued following a failed trial of IR

Schizophrenia (on-going treatment)

Maintain total daily dosage they responded to if changing to IR

If MR previously then split dose as per table below

Manic episodes associated with bipolar disorder

Commence MR 300mg day 1, 600mg Day 2 Change to IR 200mg OM, 400mg ON

MR is only to be continued following a failed trial of IR

Major depressive episodes in bipolar disorder

Commence IR once daily at night 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). The recommended daily dose is 300 mg.

Preventing recurrence in bipolar disorder in patients

Maintain total daily dosage they responded to if changing to IR

If MR previously then split dose as

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whose manic, mixed or depressive episode has responded to quetiapine treatment.

per table below preference.

Recommended doses of IR when switching from a pre-existing MR Regime

XL Dose IR dose

300mg 100mg OM, 200mg ON or 300mg ON (for depressive illness)

400mg 100mg OM, 300mg ON

500mg 200mg OM, 300mg ON

600mg 200mg OM, 400mg ON

700mg 300mg OM, 400mg ON

800mg 300mg OM, 500mg ON

Add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy 1

Commence IR once daily at night 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). The recommended maximum daily dose is 300 mg.

1 Only indication where MR is licensed and IR is not

REBOXETINE DEPRESSION PG03

RISPERIDONE L1 DEPRESSION (Adjunct with antidepressant treatment)

PG03

OBSESSIVE COMPLUSIVE DISORDER (OCD) Has the most evidence and is effective as SSRI augmentation.

PG25

SCHIZOPHRENIA AND PSYCHOSES PG10

MANIA PG13

AGGRESSIVE BEHAVIOUR IN DEMENTIA (BPSD) PG14

CONDUCT DISORDER IN CHILDREN AND YOUNG PEOPLE (Persistent aggression) NICE CG158

Personality disorders – not recommended due to lack of evidence PG26

RISPERIDONE LONG ACTING INJECTION (LAI)

SCHIZOPHRENIA AND OTHER PSYCHOSES Recommended that risperidone long-acting is not initiated for new patients (because of the practical advantages of paliperidone over risperidone LAI formulation and similar cost). NB There is a cohort of patients where continuation of existing treatment with risperidone LAI will be appropriate. Process for Non-approved medicines MM26 applies.

Risperdal Consta®

PG10

PG23 13-010

RIVASTIGMINE

MILD TO MODERATE ALZHEIMERS DISEASE

PG15

Where clinically appropriate and safe to do so, switch to equivalent treatment option with lower acquisition cost e.g donepezil (NICE TA 217)

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L2 BPSD (Behavioural And Psychological Symptoms Of Dementia)

PG14

SERTRALINE DEPRESSION PG03

L1 GAD (GENERALISED ANXIETY DISORDER) PG11

OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25

PANIC DISORDER PG11

PTSD (POST-TRAUMATIC STRESS DISORDER) PG11

SOCIAL ANXIETY DISORDER PG11

SULPIRIDE SCHIZOPHRENIA PG10

TESTOSTERONE L2 GENDER DYSPHORIA Female to Male pre-surgical patients Testosterone undecanoate (Nebido) OR Testosterone gel (Tostran)

PG12

TEMAZEPAM INSOMNIA (Controlled drug)

PG02

Relatively more expensive compared with other recommended hypnotic medication

THIAMINE ALCOHOL DETOXIFICATION Correction of vitamin deficiency (oral) Management or prevention of Wernicke’s encephalopathy (IM Pabrinex ®)

PG19

NUTRITION / EATING DISORDERS Prevention of re-feeding problems (oral) Management or prevention of Wernicke’s encephalopathy (IM Pabrinex ®)

PG24

TOPIRAMATE L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

TRANYLCYPROMINE DEPRESSION

PG03

Significantly more expensive compared with other recommended medication

TRAZADONE DEPRESSION PG03

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

TRIFLUOPERAZINE SCHIZOPHRENIA PG10

TRIHEXYPHENIDYL MANAGEMENT OF EXTRA PYRAMIDAL SIDE EFFECTS secondary to antipsychotic medication.

TRIPTORELIN L2 GENDER DYSPHORIA For male to female non-orchiectiomised patients or for female to male pre-surgical patients where necessary to achieve menopause

PG12

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TRYPTOPHAN DEPRESSION (adjunctive to antidepressant) DISCONTINUED BY MANUFACTURER

PG03

VALPROATE

L2 PANIC DISORDER Limited evidence may be appropriate to consider it in severe or treatment resistant cases.

PG11

BIPOLAR DISORDER (manic episodes predominate) PG13

L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14

Personality disorders – not recommended due to lack of evidence PG26

VENLAFAXINE GENERALISED ANXIETY DISORDER Maybe necessary to increase dose to 225mg/day (off-license dose) in order to achieve recovery

PG03 PG11

L1 PANIC DISORDER Only consider if licensed treatment intolerable of ineffective More commonly associated with discontinuation reaction

PG11

L1 PTSD (POST-TRAUMATIC STRESS DISORDER) Only consider if licensed treatment intolerable or ineffective

PG11

Prescribe immediate release tablets (twice daily dosing) in preference to modified release preparations. Where a modified release formulation is indicated to optimise treatment for an individual, prescribe generically as venlafaxine modified release tablets OR use the branded generic name of Vensir® OR Venlablue® (for GAD) The CCG are recommending the use of Vensir® (branded generic), except when prescribed for General Anxiety Disorder where Venlablue® (branded generic) is recommended (Vensir brand is not licensed for GAD). This products are ‘ modified release capsules’ , but if prescribed by brand name (branded generic) this will result in a cost saving of £500,000 across the health care community.

VITAMIN B CO STRONG ALCOHOL DETOXIFICATION

NUTRITION / EATING DISORDERS Prevention of re-feeding problems

PG24

VORTIOXETINE

Vortioxetine is recommended as a possible treatment for adults having a first or recurrent major depressive episode, if the current episode has not responded to 2 antidepressants. Refer to NICE guidance: www.nice.org.uk/guidance/ta367

PG03

ZALEPLON

INSOMNIA- Prescribe in accordance with NICE TAG TA77 Insufficient clinical data to support superiority over available hypnotics and more expensive than alternatives

PG02

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ZINC SULPHATE (ORAL)

NUTRITION / EATING DISORDERS Correction of vitamin deficiency (oral) PG24

ZOLPIDEM INSOMNIA PG02

ZOPICLONE INSOMNIA PG02

ZUCLOPENTHIXOL SCHIZOPHRENIA AND OTHER PSYCHOSES PG10

ZUCLOPENTHIXOL ACETATE IM

MANIA AND PSYCHOSES (ACUTE OR EXACERBATION OF CHRONIC) Short term treatment only

PG21 13-010

ZUCLOPENTHIXOL DECANOATE IM

SCHIZOPHRENIA

PG10

13-010

Prescribing Guidelines (PG)

All Guidelines are available on the Trust Internet

Clinical Protocols (CP)

All Protocols are available on the Trust Internet

PG02 Insomnia CP01 Anaphylaxis

PG03 Unipolar depression CP02 Oral Anticoagulation

PG10 Schizophrenia and Related Psychoses CP04 Diabetes Medication

PG11 Anxiety and Related Disorders CP05 Lithium Therapy

PG12 Gender Dysphoria CP06 Medical Gases

PG13 Bipolar Disorder CP10 High Dose Antipsychotic Therapy

PG14 Behavioural and Psychological Symptoms of Dementia CP11 Rapid Tranquillisation

PG15 Dementia CP12 Point of Contact Haematological Analysis

PG16 ADHD in Children and Young People CP13 Safer Use of Injectables

PG17 ADHD in Adults CP14 Low Molecular Weight Heparins for VTE

PG18 Perinatal Mental Health Conditions CP17 Assessment and prevention of VTE

PG19 Alcohol Use disorders CP18 Nicotine Replacement Therapy

PG20 Substance Misuse CP19 Clozapine

PG21 Zuclopenthixol Acetate (Clopixol Acuphase) CP20 Management of Acute Chest Pain

PG22 Smoking Cessation Therapy Guidelines CP21 Hypoglycaemia in adults with Diabetes Mellitus

PG23 Choice of Long-Acting Injectable Antipsychotic CP22 Management of Seizures in People with Epilepsy

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PG24 Eating Disorders CP23 Emergency Management of Seizures

PG25 Obsessive Compulsive Disorder CP24 Hepatitis B Vaccination

PG26 Borderline Personality Disorder CP25 Opioid Intoxication

PG27 Unipolar Depression in Children and Young People CP26 Screening of Blood Bourne Viruses

CP28 Olanzapine Long Acting Injection

Click here to see all Safety Briefings issued by Medicines Optimisation

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