Formulary and Prescribing Guidelines

Transcription

1 SECTION 7: MANAGEMENT OF DEMENTIA Frmulary and Prescribing Guidelines

2 7.1 Apprved drugs fr use in cgnitive impairment f Alzheimer s disease Drug 3 Frmulatin 3 Dse 3 Licensed 4 Dnepezil Tablets 5 mg, 10 mg Ordispersible Tab 5mg, 10mg Initially 5 mg nce daily at bedtime, increased if necessary after 28 days max. 10 mg daily Mild t mderate dementia in Alzheimer s disease. Capsules 1.5mg, 3mg, 4.5mg, 6mg Oral slutin 2 mg/ml. Initially 1.5 mg twice daily, increased in steps f 1.5 mg twice daily at intervals f at least 14 days accrding t respnse & tlerance; usual range 3 6 mg twice daily; max. 6 mg twice daily Rivastigmine Patches, 4.6 mg/24 hurs; 9.5 mg/24 hurs Initially apply 4.6 mg/24 hurs patch daily, remving after 24 hurs; if well tlerated, increase t 9.5 mg/24 hurs patch daily after n less than 28 days; if patch nt applied fr mre than several days, treatment shuld be restarted with 4.6 mg/24 hurs patch. T be used in patients experiencing excessive gastrintestinal side-effects and dizziness with ral preparatin. Mild t mderate dementia in Alzheimer s disease Galantine Tablets 8mg, 12mg Oral slutin 4mg/mL. M/R Capsules 8mg, 16mg, 24mg XL) Initially 4 mg twice daily fr 28 days increased t 8 mg twice daily fr 28 days; maintenance 8 12 mg twice daily Initially 8 mg nce daily fr 28 days increased t 16 mg nce daily fr 28 days; maintenance mg daily Mild t mderate dementia in Alzheimer s disease. Tablets 5mg, 10mg, 20mg Memantine Oral slutin 5mg/actuatin (10mg/ml) Initially 5mg nce daily, increased in steps f 5mg at weekly intervals; max 20mg daily Mderate (see belw) t severe dementia in Alzheimer s disease Sluble Tablet 10mg, 20mg Apprved by Medicine Management Grup April

3 7.2 NICE Technlgy Appraisal NICE TA217, March 2011 (updated 2016). Dnepezil, galantine, rivastigmine and memantine fr the treatment f Alzheimer s disease Interventins fr cgnitive symptms and maintenance f functin Adults with Parkinsn's disease wh are in hspital r a care hme shuld take levdpa within 30 minutes f their individually prescribed administratin time. Individuals with mild t mderate dementia shuld be ffered the pprtunity t participate in structured grup cgnitive stimulatin prgrmes irrespective f the drug treatment ffered fr cgnitive symptms. In brief, NICE TA217 recmmends: The three acetylchlinesterase (AChE) inhibitrs dnepezil, galantine and rivastigmine as ptins fr managing mild t mderate Alzheimer s disease (AD). This is defined as a MMSE scre averaging between10-26 pints, and/r when ther assessments and investigatins prvide evidence they will be an effective treatment ptin. Memantine as an ptin fr the management f severe AD r fr mderate severity in thse wh are intlerant r have a cntraindicatin t AChE inhibitrs. This is defined as an MMSE scre f belw 20 fr thse wh cannt be treated with the AChE inhibitrs, r belw 10 pints (severe AD), and/r when ther assessments and investigatins prvide evidence this will be an effective treatment ptin. The assessment shuld be repeated n tw ccasins 2-4 weeks apart Nn-specialists can prescribe dnepezil, galantine, rivastigmine and memantine, as lng as they have taken advice frm a clinician wh has the necessary knwledge and skills. This includes: Secndary care medical specialists such as psychiatrists, geriatricians and neurlgists. Other healthcare prfessinals such as GPs, nurse cnsultants and advanced nurse practitiners with specialist expertise in diagnsing and treating Alzheimer s disease. Thse initiating these drugs must ensure the patient receives fllw up (6-mnthly) as required by the NICE TA 217 Prescribers shuld ensure that the effects f chlinesterase inhibitrs are nt negated by cncurrent use f medicines with significant antichlinergic effects. The fllwing nline tl can be used t determine whether any given medicine has clinically imprtant antichlinergic side effects. The tl allws users t quantify easily Apprved by Medicine Management Grup April

4 the antichlinergic burden assciated with individual medicines, either as mntherapy r in cmbinatin. A patient-specific summary can be printed r saved electrnically in a patient's clinical recrds. Carers views n the patient s cnditin at baseline, and during fllw up shuld be sught. Patients shuld be reviewed regularly by an apprpriate specialist te using cgnitive, glbal, functinal and behaviural assessments. (Please refer t lcal cntinuing care guidelines). If prescribing an AChE inhibitr, treatment shuld nrmally be started with the drug f lwest acquisitin cst (taking int accunt the required daily dse, additinal carer csts fr twice daily dses and the price per dse nce shared care has started). An alternative AChE may be prescribed if it is cnsidered apprpriate when taking int accunt adverse drug reactins (ADRs), expectatins abut adherence, medical cmrbidity, pssible drug interactins and dsing prfiles. The patient and carer will be prvided with written and verbal infrmatin abut the medicatin, including advice abut when the medicatin will be discntinued. There is n recmmendatin t use Memantine t augment the effects f AChE inhibitrs When assessing the severity f AD and the need fr treatment, healthcare prfessinals shuld nt rely slely n cgnitin scres in circumstances in which it wuld be inapprpriate t d s. These include: If the cgnitin scre is nt, r is nt by itself, a clinically apprpriate tl fr assessing the severity f that patient s dementia because f the patient s learning difficulties (cnsider CAMCOG, CAMDEX, DMR r DSDS) r ther disabilities (e.g. sensry impairment), linguistic r ther cmmunicatin difficulties r level f educatin. If it is nt pssible t apply the tl in a language in which the patient is sufficiently fluent fr it t be apprpriate fr assessing the severity f dementia. If there are ther similar reasns why using a cgnitin scre, r the scre alne, wuld be inapprpriate fr assessing the severity f dementia. In such cases healthcare prfessinals shuld determine the need fr initiatin r cntinuatin f treatment by using anther Apprved by Medicine Management Grup April

5 apprpriate methd f assessment, and shuld have flexibility t prescribe based n their clinical judgement. Details f any alternative assessments shuld be included in crrespndence with primary care clleagues wh may need this fr mnitring purpses If treatment is interrupted fr 3 days r mre, reintrduce with initial dse and increase gradually. Cntact specialist services if further advice is needed. At 3 mnths, treatment must be re-assessed and nly cntinued if there is dcumented evidence f imprvement, r lack f deteriratin in MMSE scre r equivalent. Treatment shuld be cntinued when having a wrthwhile effect n cgnitive, glbal, functinal r behaviural symptms as assessed by the specialist te. Treatment will be reviewed by the specialist service: If there is n evidence f imprvement with the medicatin If the MMSE falls belw 10 (r ther pareters) r AChE inhibitrs, r memantine is n lnger cnsidered t be useful. Please nte ther specialist assessments may indicate it is apprpriate t cntinue treatment as the patient s behaviural and psychlgical issues may still require treatment. At the pint where the patient scres less than 10 pints n the MMSE (r equivalent if using alternative scales- i.e. the patient is mving frm a diagnsis f mderate Alzheimer s Disease t severe Alzheimer s Disease) cnsideratin shuld be given t the clinical apprpriateness fr cntinuatin f the AChE inhibitr. There shuld be a discussin with the MDT, and if necessary a clinical review with the patient by an apprpriate member f the clinical te. Dnepezil, Rivastigmine and Galantine are nt licensed t treat severe Alzheimer s Disease s at this pint the prescriptin f these drugs becmes ff-licence. If there is a significant decline in cgnitive state r deteriratin in behaviur Apprved by Medicine Management Grup April

6 If side effects utweigh advantages If cncrdance is t pr t cntinue. The patient will be seen during dse reductin and at 4-6 weeks after discntinuatin. Therapy may be restarted after reassessment if clinically indicated Withdrawal f Medicatin Reasns fr withdrawal include: Marked deteriratin in behaviur and mental state, a decline in MMSE t less than 10, peptic ulcer, physical illness, majr side effects, pr cncrdance, the wishes f the patient r carer(s). Please nte decline in MMSE scre des nt always necessitate withdrawal f the medicatin as the patient s behaviural and psychlgical demands may require treatment. This shuld be assessed by the specialist te. The medicatin shuld be withdrawn fllwing advice f the specialist service. They are respnsible fr ensuring that supprt and advice are given t the patient and carer(s). Withdrawal shuld be gradual if pssible, t lessen the impact n the patient and carer(s). Unless part f a suitably cnstructed clinical study, AChE inhibitrs r memantine shuld nt be used fr cgnitive decline in vascular dementia r in MCI. 7.3 Interventins fr nn-cgnitive symptms and behaviur that challenges 1,2 Dementia is an illness characterised by impairments in shrt and lng-term memry and seen mre cmmnly in lder adults. In additin t changes in cgnitive functin there is a range f behaviural disturbances, sme psychlgical, which develp during the later stages f dementia. Psychlgical behaviurs include agitatin, anxiety, depressin, withdrawal and aggressin. Nn-psychlgical behaviurs include wandering, inapprpriate mtr activity, shuting and incntinence. Cllectively, these nn-cgnitive behaviurs are referred t as Behaviural and Psychlgical Symptms f Dementia, r BPSD. These symptms are frequently respnsible fr the admissin t secndary care (fr assessment/respite). BPSD has in the past, been treated predminantly with antipsychtics (mre recently, atypical antipsychtics). Their use in the dementia ppulatin is nt withut risk f cerebrvascular adverse events (CVAs). A review f the literature n this subject can be summarised thus: Apprved by Medicine Management Grup April

7 Nn pharmaclgical interventins shuld be tried initially (first line) and if a persn with dementia develps distressing nn-cgnitive symptms r behaviur that challenges, ffer an early assessment t identify factrs that may influence behaviur (e.g. depressin, pain, infectin, envirnmental factrs, side effects f medicatins, etc.) and develp an individual care plan. NICE/SCIE recmmends the fllwing nn-pharmaclgical measures: armatherapy, multisensry stimulatin, therapeutic use f music/dancing, animal-assisted therapy, and massage. Additinally, these can be delivered by a range f health and scial care staff and vlunteers. Health and scial care staff shuld ensure that sme ptins are available. Seek lcal services fr further infrmatin. Only cnsider medicatin fr nn-cgnitive symptms r behaviur that challenges in the first instance if there is severe suffering, distress r an immediate risk f harm t the persn with dementia r thers. Cmplete Appendix 1 if antipsychtics are cnsidered abslutely necessary. There are a number f risks with limited benefits in using medicatin fr BPSD. On-ging review is mandatry if treatment is deemed abslutely necessary Antipsychtics It is essential that NICE guidance is fllwed; dcumenting the nnpharmaclgical measures taken t reduce distress suffered by dementia patients and, where they have been unsuccessful, the dcumentatin f the risks versus benefits f using antipsychtics in these individuals 1 (see appendix 1). Antipsychtics are nt first line and nn-pharmaclgical ptins shuld be attempted in the first instance. In additin ther ptential causes f the symptms (eg, pain, delirium, agitated depressin r anxiety) must be ruled ut r treated but the symptms persist befre an antipsychtic drug can be cnsidered. Antipsychtics may be cnsidered fr severe (and nt mild t mderate) nn-cgnitive symptms f dementia (all frms: that is, AD, VaD, mixed, and DLB) if: The risks and ptential benefits have been fully discussed with the patient and/r carer and dcumented; including an assessment f cerebrvascular risk factrs (risk f strke/transient ischaemic attack) and pssible adverse effects n cgnitin. Capacity t give cnsent shuld be cnsidered- including best interest decisins taken in discussin with fily and/r carers. Changes in cgnitin are regularly assessed and recrded, and alternative medicatin cnsidered (if necessary). Target symptms have been identified, quantified and dcumented and changes are regularly assessed and recrded. Apprved by Medicine Management Grup April

8 C-mrbid cnditins such as depressin, UTI, pain, etc., have been cnsidered and treated. Current medicatin is reviewed and ratinalised as apprpriate, as these culd influence mental state and cgnitive abilities. The drug is chsen after an individual risk-benefit analysis. The treatment with antipsychtic is at the lwest effective dse and is time limited and regularly reviewed and the utcme f this review dcumented including therapeutic respnse and pssible adverse effects nt mre than 2 weeks initially then at 4 weekly intervals). All patients are mnitred fr severe untward adverse reactins (especially extra-pyridal side effects). In patients with DLB mnitring fr untward reactins, particularly neurleptic sensitivity reactins (develent f/r wrsening f extrapyridal side effects r severe acute, physical deteriratin). Care plans shuld include infrmatin abut trigger factrs, nn-drug strategies and plans fr medicatin reductin r review, and these shuld be revised regularly. Discharge planning shuld include plans fr the reductin and/r discntinuatin f antipsychtics (and benzdiazepines). The discharge letter shuld give clear advice abut the discntinuatin plan. The care c-rdinatr r cmmunity te wrker assigned t the patient shuld fllw this up at 3 mnths, and cntact the GP r the cnsultant if necessary. Reducing dses: The lwest effective dse shuld be prescribed. Reductins can be made in a stepwise manner depending n the drug and dse prescribed. Discntinuing treatment: If the antipsychtic has been prescribed fr less than a mnth small dses can be stpped withut tapering ff. If the drug has been prescribed fr between 1-3 mnths it can be tapered ff ver a perid f 4 weeks. Smaller dses can be stpped in a shrter time. Patients wh have been prescribed antipsychtics fr lnger than 3 mnths shuld have them withdrawn mre slwly (fr exple 4 weekly). The dse can be halved fr each step dwn t the lwest dse recmmended befre stpping. If withdrawal effects are bserved the dse shuld stay the se fr anther mnth befre review fr further reductin. Sudden withdrawal can cause increased behaviural prblems, nausea, sweating, acute anxiety, nightmares and pr sleep Apprved by Medicine Management Grup April

9 The patient shuld be mnitred regularly fr signs and symptms f relapse r withdrawal effects. Ensure the plan is cmmunicated t the service wh will fllw up the patient- i.e. the GP r the cmmunity mental health te. Antipsychtics shuld nt be prescribed: T rutinely sedate the patient fr ease f management. Because they have been prescribed mre than 3 mnths ag withut review. Because they were prescribed in secndary care and the symptms r circumstances in which they were prescribed n lnger apply. Antipsychtics shuld nly be prescribed with cautin by a specialist fr peple with Lewy Bdy Dementia. Central t the use f antipsychtics in dementia (as per NICE CG42) is regular review (Appendix 1) and physical mnitring (appendix 1 f sectin 2) with cnsideratin given t dse reductin and/r terminatin f the antipsychtic. Chice f Drug (see als appendix 2) Risperidne is the nly UK drug licensed fr the BPSD in the UK. It is indicated fr the shrt term treatment f (up t 6 weeks) f persistent aggressin in patients with mderate t severe Alzheimer s disease unrespnsive t nn-pharmaclgical appraches and when there is risk f harm t self r thers 6. In all cases, regardless f what agent is used, clinicians shuld clearly dcument the reasning behind using antipsychtics whilst cnsidering the statements highlighted in appendix Banerjee Reprt 5 The reprt, The use f antipsychtic medicatin fr peple with dementia: a time fr actin (Banerjee reprt) was published in 2009 after cmmissin frm the DH. The reprt identified that antipsychtics were being verprescribed, when alternative, nn-pharmaclgical appraches t dealing with anxiety and behaviural prblems were available. The reprt cntains 11 recmmendatins that will, if implemented, reduce the use f these drugs t the level where benefit will utweigh risk and assure us that patients are being managed safely and effectively. As the reprt pints ut, behaviural prblems in peple with dementia can be distressing and dangerus, s in sme cases antipsychtic medicatin may be the best ptin Acetylchlinesterase inhibitrs (AChEs) There is little clinical evidence f efficacy f AChE inhibitrs in agitatin f BPSD and ever increasing evidence f pr tlerability due t bradycardia and syncpe. AChE inhibitrs are nt recmmended fr nn-cgnitive Apprved by Medicine Management Grup April

10 symptms r behaviur that challenges in vascular dementia except as part f an apprpriately cnstructed clinical study. AChE inhibitrs may be cnsidered fr patients with DLB wh have nncgnitive symptms causing significant distress r leading t behaviur that challenges. They may als be suitable fr individuals with all severities f AD wh have symptms and/r behaviur that challenges causing significant distress r ptential harm t the individual if: Nn-pharmaclgical measures are inapprpriate r ineffective. Antipsychtic drugs are inapprpriate r ineffective. References Despite apparently psitive findings in (ften manufacturer-spnsred) studies the use f cgnitin-enhancing agents fr BPSD remains cntrversial NICE CG42, Nvember Dementia: supprting peple with dementia and their carers in health and scial care. (Updated September 2016) 2. NICE TA 217, May Dnepezil, Galantine, Rivastigmine and Memantine fr the treatment f Alzheimer s disease BNF 72 nd, Sep Summary f Prduct Characteristics [accessed Sep 2017] 5. The use f antipsychtic medicatin fr peple with dementia: Time fr actin. A reprt fr the Minister f State fr Care Services by Prfessr Sube Banerjee, Nv Suth Lndn & Maudsley NHS Fundatin Trust Prescribing Guidelines 12 th editin, Wiley Blackwell 2015 Apprved by Medicine Management Grup April

11 Appendix 1 Antipsychtics in Behaviural & Psychlgical Symptms f Dementia Ne: DOB: NHS number: Diagnsis: INITIATION DATE MEDICATION & DOSE TARGET BEHAVIOUR(S) HAVE YOU CONSIDERED THE FOLLOWING STATEMENTS? Has UTI/cnstipatin/ther infectin/ ther medical prblem(s) been ruled ut? YES/NO Is the patient in pain? Has depressin r anxiety been diagnsed? Has Behaviural (nn-pharmaclgical) management been tried? Des the patient have risk factrs fr Strke/TIA? If yes, please specify: Have yu discussed the risks and benefits f antipsychtics with the patient/ fily/ care staff (as apprpriate) REVIEW: (please indicate the next review date) Review Date: Outcme n target behaviur: better/se/wrse Adverse effects: + / - Management (cntinue se dse /reduce/ discntinue r cnsider alternative measures) Apprved by Medicine Management Grup April

12 Appendix 2 Chice f antipsychtic fr BPSD Drug Dse range Cmment Risperidne 250 micrgr 1mg up t twice a day Is licensed fr use fr peple with dementia fr up t 6 weeks. It has fewer side effects than the lder antipsychtics. It des have significant antichlinergic effects at higher dses and shuld nt be used fr peple with Parkinsn s disease r Lewy Bdy Dementia. It affects bld sugars (cautin in diabetes). It can raise prlactin levels, which may cause steprsis. Olanzapine 2.5-5mg daily in ne r tw dses Unlicensed use. Less antichlinergic side effects, but may cause weight gain and bld sugar dyscrasias. Sedative. In lder adults select a lwer initial dse and gradual dse increase especially if female and/r a nnsmker. Quetiapine mg daily in ne r tw dses Unlicensed use, althugh cnsidered the preferred drug in practice. Less antichlinergic side effects. May be used cautiusly in Parkinsn s Disease r Lewy Bdy Dementia. Less effect n weight, bld sugars and prlactin levels. Aripiprazle mg daily in the mrning Unlicensed use. As fr Quetiapine but less likely t cause drwsiness. Negligible effect n the QT interval, use a lwer initial dse in lder adults. May cause agitatin in first 2 weeks. Halperidl 250 micrgr 1mg up t BD Unlicensed use. Check ECG befre using. Antichlinergic side effects (akathisia and stiffness). D nt use if patient has Parkinsn s disease r Lewy Bdy Dementia. Nte: nly use this drug with extreme cautin and in discussin with a specialist in dementia. Apprved by Medicine Management Grup April

13 Appendix 3 - Flw chart fr prescribing antipsychtics in BPSD Apprved by Medicine Management Grup April

14 Appendix 4 Managing behaviural prblems in peple with dementia - 24-hur sleep and activity chart A recrd f when and hw ften behaviur prblems ccur may be helpful t all wh supprt the patient in planning their care. Please cmplete this chart and bring it t yur next appintment r discuss it with..n (date). Ne f patient.. Persn cmpleting Key: Active invlvement in tasks/interests Restlessness, agitated Resting, settled E A R Day & Date Sleeping S 7 Please write any ther cmments verleaf Apprved by Medicine Management Grup April

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