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 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. 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 , 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 'Off-label' prescribing of a licensed drug where use is recognised in prescribing guidelines (L1) 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 'Off-label' prescribing of a licensed drug where supporting evidence is weak. (L2) 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 Prescribing of an Unlicensed drug (Medication without UK Marketing authorisation or (L3) 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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Prescribing Support Documents MEDICATION Indication and Prescribing Recommendations Prescribing Clinical Shared Safety (Approved name) guideline Protocol Care Briefing AGOMELATINE ▼ DEPRESSION Acquisition cost of agomelatine is considerably higher than currently available PG03 therapies. Link to full statement: Suicide & https://nww.devonpctinfo.nhs.uk/EPC/post/2010/01/Agomelatine-(Valdoxan)-in-the- depression treatment-for-depression.aspx SCHIZOPHRENIA AMISULPRIDE PG10 CP10

BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 PG14 Not recommended - evidence base weak 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 PTSD (POST-TRAUMATIC STRESS DISORDER) L1 PG11 Prescribe in accordance with NICE CG26 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 is PG02 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. ANTICOAGULATION Refer to local Joint formularies for recommended prescribing options CP02 Link to NPSA alert: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=61777&p=3 VENOUS THROMBOEMBOLISM (VTE) CP14

Prevention and treatment CP17 ARIPIPRAZOLE SCHIZOPHRENIA PG10 CP10

ACUTE HYPOMANIA PG13 Considered 3rd line where other treatment ineffective or not tolerated (NB ONLY CP10 commissioned in South Devon) Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 4 of 22

PG25 OBSESSIVE COMPLUSIVE DISORDER (OCD) May have some efficacy augmenting SSRIs BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 PG14 Not recommended - evidence base weak Personality disorders – not recommended, evidence base weak PG26 ARIPIPRAZOLE IM RAPID TRANQUILLISATION CP11

ARIPIPRAZOLE LONG SCHIZOPHRENIA (WHEN STABLE ON ORAL ARIPIPRAZOLE) ACTING INJECTION ▼ Commissioned with condition that prescribing is in accordance with PG10 and PG23 PG10 Process for Non-approved medicines MM26 applies. 13-010 PG23

ABILIFY MAINTENA®

ASENAPINE BIPOLAR DISORDER Not currently approved due to high acquisition cost and lack of evidence of superiority over existing agents PG13 CP10 Process for Non-approved medicines MM26 applies.

ATOMOXETINE ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Children and Young People PG16 √ CAMHS ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) PG17 Specialist Adult ADHD Service INSOMNIA BARBITURATES PG02 Safer treatment alternatives now available ANXIETY SPECTRUM DISORDERS PG11 Safer treatment alternatives now available BENPERIDOL L2 SCHIZOPHRENIA ANTISOCIAL SEXUAL BEHAVIOUR PG10 EATING DISORDERS / ANOREXIA NERVOSA BISPHOSPHONATES PG24 Refer to local Joint formularies for recommended prescribing options L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) BUPROPION (Children and Adolescents) Use in accordance with NICE guidance (CG 72) OPIOID MISUSE - DETOX AND RECOVERY (NICE TA 114) BUPRENORPHINE PG20 (Schedule 2 Controlled Drug) OPIOID MISUSE BUPRENORPHINE Buprenorphine prolonged-release injection may be an option where there is a risk of Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 5 of 22

prolonged-release diversion of opioid substitution medicines or concerns about the safety of medicines injection (Buvidal) 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 PG11 should only be used when other treatments have proved ineffective. BIPOLAR DISORDER PG13 L1 WITHDRAWAL PG19 L1 WITHDRAWAL PG20 BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 PG14 Not recommended - evidence base weak 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 PG10 the CCG individual patient funding request process application form here: https://www.newdevonccg.nhs.uk/permanent-link/?rid=119423 CALCIUM AND VITAMIN NUTRITION / EATING DISORDERS D Correction of vitamin and mineral deficiency (oral) PG24 Prevention of osteoporosis SCHIZOPHRENIA PG10 BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 PG14 Not recommended - safety concerns CHLORPROMAZINE RAPID TRANQUILLISATION CP11 INTRAMUSCULAR Not recommended - safety concerns CHLORAL HYDRATE INSOMNIA Not recommended - safety concerns PG02 Insufficient clinical data to support superiority over available hypnotics to justify use. Toxic in overdose CHLORDIAZEPOXIDE ALCOHOL DETOXIFICATION PG19 DEPRESSION PG03 Suicide & CITALOPRAM depression PANIC DISORDER PG11 SOCIAL ANXIETY DISORDER PG11 (if other SSRIs ineffective or not tolerated) OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25

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BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 PG14 Not recommended - insufficient evidence ALCOHOL DETOXIFICATION CLOMETHIAZOLE PG19 preferred and safer alternative INSOMNIA PG02

CLOMIPRAMINE DEPRESSION Suicide & PG03 depression L1 PANIC DISORDER PG11 OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25 CLONIDINE L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Children and Adolescents PG16 Use in accordance with NICE guidance CG72 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 L1 ACUTE MANIA / HYPOMANIA proposed treatment plan of when to review, reduce and/or discontinue treatment.

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

PG10 CP19 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

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 PG10 CP19 ‘Denzapine® (in accordance with CP19)

CLOZAPINE (Zaponex® 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg Zaponex® Orodispersible Orodispersible tablets) 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 L2 GENDER DYSPHORIA PG12 ACETATE For male to female non-orchiectiomised patients ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) DEXAMFETAMINE PG16 (Schedule 2 Controlled Drug) CAMHS L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) PG17 Specialist Adult ADHD Service Refer to local Joint formularies and Trust Clinical Protocol DIABETES CP04 Link to NPSA alert: DIAZEPAM INSOMNIA PG02 GAD (GENERALISED ANXIETY DISORDER) Short term (up to 4 weeks) for immediate management of anxiety symptoms if PG11 distressing or disabling (NICE CG113) PANIC DISORDER PG11 Benzodiazepines associated with a poorer outcome (NICE CG113) SOCIAL ANXIETY DISORDER Short term (up to 4 weeks) for immediate management of anxiety symptoms if PG11 distressing or disabling 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 ALL INDICATIONS PG03 NHS England has stated that Dosulepin should not be newly initiated and where

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appropriate its use should be reviewed. Not recommended - safety concerns SCHIZOPHRENIA PG10 (no longer routinely prescribed) DULOXETINE DEPRESSION (Not commissioned / non-formulary for depression) PG03 Suicide &

Process for Non-approved medicines MM26 applies. depression

GAD (GENERALISED ANXIETY DISORDER) (Not commissioned / non-formulary for GAD) evidence for duloxetine in GAD was unconvincing and did not support its inclusion PG11 in the GAD guideline Process for Non-approved medicines MM26 applies.

ESCITALOPRAM GENERALISED ANXIETY DISORDER PG11 OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25 DEPRESSION PG03 SOCIAL ANXIETY DISORDER (NICE CG159) Process for Non-approved medicines MM26 applies. PG11 Suicide & depression

ALL OTHER INDICATIONS Insufficient clinical data to support superiority over existing SSRI to justify significant increase in prescribing costs associated with this medication. (Improved cost-effectiveness compared with existing treatment not demonstrated). PG11 Process for Non-approved medicines MM26 applies.

ESTRADIOL L1 GENDER DYSPHORIA For male to female non-orchiectiomised patients PG12 Transdermal (i.e. estradiol valerate patch / estradiol gel) or oral formulation FLUOXETINE BULIMIA NERVOSA DEPRESSION PG03

L1 PANIC DISORDER Only consider if licensed treatment intolerable of ineffective. Keep initial doses very PG11 low (2.5-5mg) OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25 PTSD (POST-TRAUMATIC STRESS DISORDER) L1 PG11 Only consider if licensed treatment intolerable or ineffective Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 9 of 22

FLUPENTIXOL SCHIZOPHRENIA PG10 SCHIZOPHRENIA DECANOATE IM F55 Antipsychotic Long Acting Depot Prescription and Administration Record (Community Use) PG10 13-010

DEPRESSION FLUVOXAMINE PG03 No longer routinely prescribed (poorly tolerated and increased likelihood of drug

interactions) OBSESSIVE COMPLUSIVE DISORDER (OCD) No longer routinely prescribed (poorly tolerated and increased likelihood of drug PG25 interactions)

GABAPENTIN L2 PANIC DISORDER Not recommended - insufficient evidence PG11

BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 PG14 Not recommended - insufficient evidence 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. PG16 Agreed to be non-approved via CAMHS process HALOPERIDOL SCHIZOPHRNENIA PG10 CP10 RAPID TRANQUILLISATION CP10 HALOPERIDOL IM CP11 HALOPERIDOL SCHIZOPHRENIA DECANOATE IM F55 Antipsychotic Long Acting Depot Prescription and Administration Record PG10 CP10 13-010 (Community Use) Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 10 of 22

HALDOL DECANOATE ®

HYOSCINE L1 HYPERSALIVATION secondary to treatment with clozapine CP19 HYDROBROMIDE No commissioned by Local Clinical Commissioning Groups HOMEOPATHY

DEPRESSION PG03 (No longer routinely prescribed) L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Children and adolescents Not recommended - safety concerns DEPRESSION ISOCARBOXAZID PG03 (No longer routinely prescribed) LAMOTRIGINE BIPOLAR DISORER (PREVENTION OF DEPRESSIVE EPISODES) PG13 BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 PG14 Not recommended - insufficient evidence SCHIZOPHRENIA (No longer routinely prescribed) LISDEXAMFETAMINE ▼ ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) (Schedule 2 Controlled Drug) CAMHS PG16 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. ADULT Submitted to CPC Dec 15 for review for appropriateness in Adult ADHD PG17 Decision at Dec DTC to include as “non-approved drug” pending CPC decision LIOTHYRONINE DEPRESSION (AUGMENTATION) Prescribe in accordance with British Association of Psychopharmacology (BAP) PG03 (AUGMENTATION) L1 Strategy not supported by NICE CG90. NHS England has advised no new patients should be started on Liothyronine. MM26 Non Approved Process Applies LITHIUM BIPOLAR DISORDER Link to NPSA alert: (Treatment and prophylaxis of http://www.nrls.npsa.nhs.uk/alerts/?entryid45= YES PG13 bipolar depression and hypomania 65426&p=2 South CP05 / mania) Devon UNIPOLAR DEPRESSION only PG03 DEPRESSION PG03

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LOFEXIDINE OPIOID DETOXIFICATION PG20 LOPRAZOLAM INSOMNIA Not recommended - Cost PG02 Insufficient clinical data to support superiority over available hypnotics and more expensive than zopiclone LORAZEPAM ANXIETY L1 MANIA / HYPOMANIA PG13 L1 CATATONIA L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14 ACUTELY DISTURBED BEHAVIOUR PG27 RAPID TRANQUILLISATION CP10 LORAZEPAM IM 13-010 CP11 L1 CATATONIA (administration of oral medication not possible) LORMETAZEPAM INSOMNIA Not recommended - Cost PG02 Insufficient clinical data to support superiority over available hypnotics and significantly more expensive than zopiclone powder for Indicated for the rapid control of mild-to-moderate agitation in adult patients with inhalation schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. SCHIZOPHRENIA Devon Clinical Policy Committee reviewed in May 18 and rejected. Process for Non-approved medicines MM26 applies. For transfer to primary care prescribing PG10 follow the CCG individual patient funding request process application form here: https://www.newdevonccg.nhs.uk/permanent-link/?rid=119423 MAGNESIUM L3 NUTRITION / EATING DISORDERS PG24 GLYCOPHOSPHATE Correction of mineral deficiency (oral) MELATONIN INSOMNIA (CAMHS AND Use restricted to specialist CAMHS and Learning Disability clinicians to aid sleep cycle synchronisation in children with sensory impairment, autistic LEARNING DISABILITY spectrum disorder, in other neurodisability / neuropsychiatric / neurodevelopmental SERVICES) disorders including ADHD when behavioural measures have been insufficient and PG02 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®) MELATONIN (ADULT) INSOMNIA (Licensed indication for individuals >55 years of age but still subject to PG02 Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 12 of 22

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 OPIOID MAINTENANCE, DETOXIFICATION AND RECOVERY METHADONE PG20 (Schedule 2 Controlled Drug) (NICE TA 114) METHYLPHENIDATE ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) (Schedule 2 Controlled Drug) CAMHS PG16 √ CAMHS Modified release formulations must be prescribed by brand

ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) L1 SPECIALIST ADULT ADHD SERVICE ONLY

NB Off-license indication for initiation of treatment in adults (Concerta XL®licensed PG16 for continuation of treatment initiated in young people <18 Yrs) PG17

Modified release formulations must be prescribed by brand METHYLPHENIDATE The CCG are recommending that GPs pre scribe this product as a branded generic (Schedule 2 Controlled Drug) (Xenidate® XL) continued….. Concerta XL will also remain on the formulary, but Xenidate® XL should now be the preferred brand of choice where treatment is initiated. DEPRESSION PG03 No longer routinely prescribed in practice L1 RAPID TRANQUILLISATION MIDAZOLAM IM CP11 (Schedule 3 Controlled Drug) Only use when lorazepam IM unavailable DEPRESSION PG03

PTSD (POST-TRAUMATIC STRESS DISORDER) L1 PG11

PANIC DISORDER L1 PG11

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BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 PG14 MOCLOBEMIDE DEPRESSION PG03

Refer to South and Western or Northern and Eastern Joint formulary MODAFINIL Specialist initiation only L1 ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER) Children and Adolescents PG16 Use in accordance with NICE guidance (CG72) MULTIVITAMIN NUTRITION / EATING DISORDERS Correction of vitamin or trace element deficiency (oral)

PG24 Forceval or Forceval soluble® Dalivit®

ALCOHOL DEPENDENCE NALMEFENE 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 Refer to locally agreed joint formulary guidelines for recommended formulations REPLACEMENT (South and Western or Northern and Eastern Joint formulary) PG22 THERAPY NITRAZEPAM INSOMNIA Long half-life. Increased risk of side effects / drowsiness the following day. Risk of PG02 accumulation (especially in elderly) leading to confusion and ataxia. DEPRESSION PG03 No longer routinely prescribed in practice

OLANZAPINE L1 DEPRESSION For augmentation of antidepressant (not to be prescribed alone) in accordance with PG03 NICE CG 90 SCHIZOPHRENIA PG10 BIPOLAR DISORDER PG13 Manic episode or preventing recurrence in bipolar disorder L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14 PTSD (POST-TRAUMATIC STRESS DISORDER) L1 PG11 For augmentation of antidepressant (not to be prescribed alone) in accordance with

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NICE CG 26

Personality disorders – not recommended due to weak evidence base PG26 IM RAPID TRANQUILLISATION CP11 OLANZAPINE SCHIZOPHRENIA EMBONATE ▼ Commissioned with condition that prescribing is in accordance with PG10 and PG23 PG10 Process for Non-approved medicines MM26 applies 13-010 Requires 3 hour post administration monitoring with resus facilities PG23

ZYPADHERA®

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

PG10 13-010 PG23 XEPLION®

3 monthly Paliperdone: TREVICTA® Only for individuals stabilised on XEPLION for 4 or more months.

PAROXETINE SOCIAL ANXIETY DISORDER, GAD, PANIC DISORDER, PTSD PG11 Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 15 of 22

Associated with increased suicidal behaviour and discontinuation effects OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25 SCHIZOPHRENIA AND OTHER PSYCHOSES PERICYAZINE PG10 No longer routinely prescribed in practice SCHIZOPHRENIA AND OTHER PSYCHOSES PG10 No longer routinely prescribed in practice PHENELZINE DEPRESSION PG03

GAD (GENERALIZED ANXIETY DISORDER) PG13 L1 PANIC DISORDER Limited evidence, may be appropriate to consider it in severe or treatment resistant PG13 cases. NUTRITION / EATING DISORDERS PHOSPHATE PG24 Correction of electrolyte deficiency (oral) SCHIZOPHRENIA PIMOZIDE PG10 Not routinely recommended due to cardiac toxicity PIRENZEPINE L3 HYPERSALIVATION secondary to treatment with clozapine Increased cost if prescribed on FP10 (56 x 50mg tab - £140 on FP10, £13 if CP19 supplied by Acute Trust Supply Pharmacy)

POTASSIUM NUTRITION / EATING DISORDERS PG24 SUPPLEMENTS (ORAL) Correction of electrolyte deficiency (oral) GAD (GENERALISED ANXIETY DISORDER) PREGABALIN PG11

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

PROCHLORPERAZINE NAUSEA AND VOMITING associated with substance withdrawal PG20 BUCCAL MANAGEMENT OF EXTRA PYRAMIDAL SIDE EFFECTS secondary to antipsychotic medication.

AGITATION AND RESTLESSNESS PG10 Now considered less suitable for prescribing L2 INSOMNIA PG02 INSOMNIA PG02

Personality disorders recommended by NICE PG26 PROMETHAZINE IM L1 RAPID TRANQUILLISATION CP10 Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 16 of 22

CP11 INSOMNIA Insufficient evidence and risk of potential side effects out-weighs expected benefits. PG02 L2 Proposed that effect mediated through antihistaminic effects, therefore consider sedative . 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 PG25 showing it to be ineffective. 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

Schizophrenia (new Commence MR 300mg day 1, 600mg MR is only to be 1. There is no proven clinical benefit to MR over treatment) Day 2 continued following IR therapeutically. Change to IR 200mg OM, 400mg ON a failed trial of IR 2. IR is likely to be more sedating than MR so Schizophrenia (on-going Maintain total daily dosage they If MR previously weighting towards a larger night-time dose treatment) responded to if changing to IR then split dose as may improve tolerability. per table below 3. The half-life of quetiapine is too short to use once daily for schizophrenia and manic Manic episodes associated Commence MR 300mg day 1, 600mg MR is only to be episodes and loss of therapeutic benefit with bipolar disorder Day 2 Change to IR 200mg OM, continued following cannot be guaranteed. 400mg ON a failed trial of IR 4. An active metabolite of quetiapine is the Major depressive episodes Commence IR once daily at night antidepressant agent and this has a longer in bipolar disorder 50 mg (Day 1), 100 mg (Day 2), 200 half-life so once daily administration is mg (Day 3) and 300 mg (Day 4). The appropriate for these indications (MDD) recommended daily dose is 300 mg. 5. The doses listed in the table are for a guide Preventing recurrence in Maintain total daily dosage they If MR previously only and can be altered to suit individual bipolar disorder in patients responded to if changing to IR then split dose as Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 17 of 22

whose manic, mixed or per table below preference. depressive episode has Recommended doses of IR when switching responded to quetiapine from a pre-existing MR Regime treatment. XL Dose IR dose Add-on treatment of major Commence IR once daily at night 300mg 100mg OM, 200mg ON or depressive episodes in 50 mg (Day 1), 100 mg (Day 2), 200 300mg ON (for depressive illness) patients with Major mg (Day 3) and 300 mg (Day 4). The 400mg 100mg OM, 300mg ON Depressive Disorder (MDD) recommended maximum daily dose 500mg 200mg OM, 300mg ON who have had sub-optimal is 300 mg. 600mg 200mg OM, 400mg ON response to antidepressant monotherapy 1 700mg 300mg OM, 400mg ON 800mg 300mg OM, 500mg ON

1 Only indication where MR is licensed and IR is not REBOXETINE DEPRESSION PG03 DEPRESSION RISPERIDONE L1 PG03 (Adjunct with antidepressant treatment) OBSESSIVE COMPLUSIVE DISORDER (OCD) PG25 Has the most evidence and is effective as SSRI augmentation. 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 SCHIZOPHRENIA AND OTHER PSYCHOSES ACTING INJECTION Recommended that risperidone long-acting is not initiated for new patients (because of the practical advantages of paliperidone over risperidone LAI (LAI) formulation and similar cost). NB There is a cohort of patients where continuation PG10 of existing treatment with risperidone LAI will be appropriate. 13-010 Process for Non-approved medicines MM26 applies. PG23

Risperdal Consta® RIVASTIGMINE MILD TO MODERATE ALZHEIMERS DISEASE

Where clinically appropriate and safe to do so, switch to equivalent PG15 treatment option with lower acquisition cost e.g donepezil (NICE TA 217)

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BPSD (Behavioural And Psychological Symptoms Of Dementia) L2 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 PG12 Testosterone undecanoate (Nebido) OR Testosterone gel (Tostran) INSOMNIA TEMAZEPAM PG02 (Controlled drug) Relatively more expensive compared with other recommended hypnotic medication

THIAMINE ALCOHOL DETOXIFICATION Correction of vitamin deficiency (oral) PG19 Management or prevention of Wernicke’s encephalopathy (IM Pabrinex ®) NUTRITION / EATING DISORDERS Prevention of re-feeding problems (oral) PG24 Management or prevention of Wernicke’s encephalopathy (IM Pabrinex ®) TOPIRAMATE L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14 TRANYLCYPROMINE DEPRESSION Significantly more expensive compared with other recommended medication PG03

TRAZADONE DEPRESSION PG03 L2 BPSD (Behavioural And Psychological Symptoms Of Dementia) PG14 SCHIZOPHRENIA PG10 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- PG12 surgical patients where necessary to achieve menopause Medicine Directory Devon Partnership Trust - Drugs and Therapeutics Committee Version 18.0 – Feb 19 Page 19 of 22

DEPRESSION (adjunctive to antidepressant) TRYPTOPHAN PG03 DISCONTINUED BY MANUFACTURER VALPROATE L2 PANIC DISORDER Limited evidence may be appropriate to consider it in severe or treatment PG11 resistant cases. 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 GENERALISED ANXIETY DISORDER VENLAFAXINE PG03 Maybe necessary to increase dose to 225mg/day (off-license dose) in order to PG11 achieve recovery L1 PANIC DISORDER Only consider if licensed treatment intolerable of ineffective More commonly PG11 associated with discontinuation reaction PTSD (POST-TRAUMATIC STRESS DISORDER) L1 PG11 Only consider if licensed treatment intolerable or ineffective 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 PG24 Prevention of re-feeding problems 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 PG03

2 antidepressants. Refer to NICE guidance: www.nice.org.uk/guidance/ta367

ZALEPLON INSOMNIA- Prescribe in accordance with NICE TAG TA77 Insufficient clinical data to support superiority over available hypnotics and more PG02 expensive than alternatives

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ZINC SULPHATE NUTRITION / EATING DISORDERS PG24 (ORAL) Correction of vitamin deficiency (oral) ZOLPIDEM INSOMNIA PG02 ZOPICLONE INSOMNIA PG02 SCHIZOPHRENIA AND OTHER PSYCHOSES PG10 ZUCLOPENTHIXOL MANIA AND PSYCHOSES (ACUTE OR EXACERBATION OF CHRONIC) ACETATE IM Short term treatment only PG21 13-010

ZUCLOPENTHIXOL SCHIZOPHRENIA PG10 13-010 DECANOATE IM

Prescribing Guidelines (PG) Clinical Protocols (CP) All Guidelines are available on the Trust Internet 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 Documents without internet links are in development

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