CONTINUING CARE GUIDELINES AND INFORMATION FOR NEP STAFF AND GENERAL PRACTITIONERS IN NORTH ESSEX

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1 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST POLICY DOCUMENT MEDICINES GUIDANCE CONTINUING CARE Document Title Acetylcholinesterase (AChI) inhibitors and memantine prescribing and treatment continuing care guidelines Reference Number Policy Type Electronic File/Location Intranet Location Status Medicines management/clinical P:Data/Word/Policies/Medicines management/prescribing and treatment continiung care guidelines i-connect/ Policies/ Medicines Management/ Prescribing and treatment guidelines/acetylcholinesterase inhibitors and memantine prescribing and treatment continuing care guidelines Approved by MMG and by West Essex CCG prescribing committee Version No./Date Version 4 May 2013 Author(s) Responsible for Writing and Monitoring Approved By Associate Director for Pharmacy Operational Service manager Older adults West Chief Pharmacist West Essex CCG Medicines Management Group West Essex CCG Approval Date Implementation Date May 2013 Review Date May 2016 Copyright North Essex Partnership University NHS Foundation Trust (2013). All rights reserved. Not to be reproduced in whole or in part without the permission of the copyright owner. All matters or concerns regarding fraud or corruption should be reported to: Priti Amin, Local Counter Fraud Specialist (LCFS) Mobile: pamin@deloitte.co.uk. OR the National Fraud and Corruption Line Continuing care Guidelines and information for staff and General Practitioners Page 1 of 11

2 ACETYLCHOLINESTERASE (AChI) INHIBITORS AND MEMANTINE PRESCRIBING AND TREATMENT GUIDELINES Section Title Page no. 1 Introduction 1 2 Indications for use 1 3 Referral 2 4 Specialist assessment 2 5 Initiation and ongoing treatment by specialist service following appropriate 3 diagnosis 6 Continuation of care by GP service 4 7 Withdrawal of medication 4 8 Choice and cost of medication 4 9 Dosage and side effects 5 10 Adverse effects 5 11 Care in prescribing 6 12 Interactions 6 13 Contact details for consultants or other staff in North Essex 6 14 Advice and useful information 7 15 Authors 7 App1 Algorithm for the use of cholinesterase inhibitors or memantine for the treatment of alzheimer s disease App 2 App 3 tym 2.tif Test your memory tool for referral Care review plan 1. Introduction The treatment and care of people with alzheimer s disease and other dementias involves a wide-ranging set of strategies and/or therapies by healthcare professionals, carers and other people and organisations. Medicines may or may not be one small part of an effective care package which will help people with this progressive illness. This guidance follows the publication of NICE technology appraisal guidance 217 Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer s disease (review) March 2011, and the NICE clinical guideline 42 Dementia Nov It recommends the use of this specific group of medicines for the treatment of alzheimer s disease if and when appropriate. Non-pharmacological treatments of this illness are essential, but they are not within the scope of this guidance. 2. Indications for use of these medications 2.1. The three AChE inhibitors are recommended as options for managing mild to moderate Alzheimer s disease. The AChE inhibitor with the lowest acquisition cost (Drug tariff prices) should be first choice. Alternatives may be considered if there is an adverse event profile, adherence issues, medical comorbidity, possibility of drug interactions and dosing profiles Memantine is recommended as an option for managing Alzheimer s disease for people with either moderate Alzheimer s disease if they are intolerant or have a contra-indication to AChE inhibitors or severe Alzheimer s disease. Continuing care Guidelines and information for staff and General Practitioners Page 2 of 11

3 2.3. Treatment with the AChE inhibitors or Memantine should be under the following conditions: Initiation of treatment must be by specialists in the care of dementia (psychiatrists, including specialists in learning disability). It is recommended that neurologists, and physicians specialising in the care of older people should not initiate these medicines if they or the GP are unable to carry out the 6-monthly monitoring required by the NICE TG 217. Carers views on the patient s condition at baseline should be sought Treatment should be continued ONLY when it is considered to be having a worthwhile effect on cognitive, global, functional or behavioural symptoms. Patients who continue on treatment should be reviewed regularly using cognitive, global, functional and behavioural assessment. Treatment should be reviewed by an appropriate specialist team, unless there are locally agreed protocols for shared (continuing) care. Carers views on the patients condition at follow-up should be sought Please refer to the NICE Clinical Guideline 42 P17 for treatment of other forms of dementia (for example, vascular dementia or lewi body dementia) There is no recommendation to use Memantine to augment the effects of AChE inhibitors. 3. Referral for consideration of these medications 3.1. By GP or other secondary care consultant, for diagnosis by a Psychiatrist for Older adults, neurologist, physician for the care of the elderly, psychiatrist for adults of working age who treats patients with young onset dementia, or psychiatrists for learning disabilities. NOTE: neurologists, physicians specialising in the care of the elderly and psychiatrists for adults of working age may not have the facility to do the monitoring required by the NICE TG Referral should be for patients of any age with dementias which require a specialist opinion. He/she should have shown a persistent and progressively declining memory problem for more than 6 months. NOTE: Delirium should be excluded 3.3. People who have a MMSE score of less than 10, who are not taking one of these medications, and who are settled need not be referred unless there is a change in behaviour Referral should include the form AD8 (appendix 2) 3.3. Provide FBC, serum B12 and folate, serum calcium, liver function, thyroid function, Us and Es, random blood glucose, and also urinalysis results if indicated The results of an MRI scan should be included (crossed-charged to NEP), or CT scan if MRI is not appropriate Risk factors and a printout of the patient history should be included Provide a recent report of physical examination, and ECG if appropriate Provide written information on background, life, psychiatric and physical history, and current medication. Continuing care Guidelines and information for staff and General Practitioners Page 3 of 11

4 3.8. Advise patient and carer that referral is for assessment only initially. The assessment may need to be repeated several times, and treatment with these medications may not be offered Arrange that a relative/friend/carer attends with the patient to receive and provide information. NOTE: THIS IS FREQUENTLY CRUCIAL TO ACCURATE DIAGNOSIS 4. Specialist assessment In accordance with NICE guidelines, to include: 4.1. Relevant history (with NOK/carer) 4.2. MRI or CT scan if it has not been done already. NEP will arrange as soon as the referral is received Mini-Mental State Examination MMSE (30-point, or equivalent) Mild Alzheimer s disease: MMSE Moderate Alzheimer s disease: MMSE Moderately severe Alzheimer s disease: MMSE Severe Alzheimer s disease: MMSE less than 10 NOTE: The accuracy of this test may vary for several reasons: for example, English as a foreign language, educational attainment, sensory impairment. It may not be the most significant parameter in assessment for all individuals. In these circumstances the clinician should have the flexibility to prescribe outside the score of or Assessment of mood/other psychopathology 4.5. Investigations, including further blood tests, CT or MRI scan, EEG, if indicated The ability to survive in an independent setting and a significant improvement in quality of life should also be considered Specific assessments will be used for people with learning disabilities 5. Initiation and ongoing treatment by specialist service following appropriate diagnosis 5.1. Treatment with AChE inhibitors will only be initiated if the MMSE score averages between 10 and 26 points and/or the other assessments and investigations provide evidence that cholinesterase inhibitors will be an effective treatment Treatment with memantine will only be initiated if the MMSE score is below 20 for those who cannot be treated with AChE inhibitors, or below 10, and/or the other assessments and investigations provide evidence that memantine will be an effective treatment The assessment should be repeated on two occasions 2-4 weeks apart The patient and carer will be provided with written and verbal information about the medication, including advice about when the medication will be discontinued The carer will be advised to attend all specialist clinic appointments where possible The carer s views on the patient s condition should be sought at each appointment The GP will be informed of treatment initiation. Continuing care Guidelines and information for staff and General Practitioners Page 4 of 11

5 5.8. In West Essex the GP will carry out the 6-monthly checks after the patient has been stabilised. In Mid and North East Essex the GP will be offered the option of carrying out the 6-monthly checks after the patient has been stabilised, or using the memory clinic for 6-monthly checks. (appendix 3) 5.9. The patient will be referred to a specialist clinic for appointments at baseline (when treatment commences) one month, and 3 months. All prescriptions will be through specialist care At 3 months, treatment must be reassessed and only continued if there is evidence of improvement, or lack of deterioration in MMSE score, OR EQUIVALENT recorded in the notes The specialist service must continue to prescribe until the dose/patient is stabilised, then agree continuing care with the GP. Thereafter the specialist may advise the GP to make minor changes in treatment, according to an agreed care plan The GP will be provided with contact details of specialist staff The specialist staff will provide a rapid response to GP concerns In Mid and North East Essex the specialist staff will provide monitoring at 6-monthly intervals, including MMSE, global, functional and behavioural assessment if the GP has elected not to do it themselves Treatment will be reassessed if the patient s circumstances change (for example, a move to an enhanced care facility or residential home) Patients who are already living in a care setting will be reviewed regularly If the specialist service changes the dose they will advise the GP of the change Treatment will be discontinued by the specialist service if there is no evidence of improvement with the medication if the MMSE falls below 10 (or other parameters) for cholinesterase inhibitors, or memantine is no longer considered to be useful. if there is a significant decline in cognitive state or deterioration in behaviour if side effects outweigh advantages if concordance is too poor to continue. The patient will be seen during dose reduction and at 4-6 weeks after discontinuation. Therapy may be restarted after reassessment if clinically indicated If a patient moves area the specialist service should notify the new Trust, but the responsibility for referral will lie with the GP for discontinuation and/or ingoing care. 6. Continuation of care by GP service 6.1. The GP will be informed that treatment has commenced and that medication will be provided initially by the specialist service When the patient is stable (minimum 3 months) the specialist service will ask the GP to prescribe, and provide a care plan to include prescribing. In Mid and N.E.Essex it should also state whether the patient will be seen 6-monthly by the GP, or by the memory clinic If the GP is to continue to monitor 6-monthly he/she should notify the CCG of the date of commencement. Continuing care Guidelines and information for staff and General Practitioners Page 5 of 11

6 6.3. The GP will be advised by the specialist service of subsequent changes in treatment if memory services are to be used The GP should notify the specialist care service of any severe/unusual side effects or any concerns requiring a reassessment or cessation of treatment, including the patient moving from home into a care facility The GP or the carer(s) should notify the specialist service if they wish to discontinue the medication at any time The GP may make dose changes or discontinue the medication if necessary. In this case the GP must notify the specialist service Patients who have moved to a new GP from a different area should be referred to specialist services as necessary when they register Care homes and GPs should ensure that new residents with symptoms of dementia are referred to specialist services. 7. Withdrawal of medication 7.1. Reasons for withdrawal include: Marked deterioration in behaviour and mental state, a decline in MMSE to less than 10, peptic ulcer, physical illness, major side effects, poor concordance, the wishes of the patient or carer(s) The medication may be withdrawn by either the GP responsible for the 6- monthly monitoring, or the specialist service. They are responsible for ensuring that support and advice are given to the patient and carer(s) Withdrawal should be gradual if possible, to lessen the impact on the patient and carer(s) If the GP stops therapy the specialist service should be informed. 8. Choice and cost of medication 8.1. The least expensive medication should be first line treatment: however the additional carer cost for a twice daily dosage should be taken into consideration. Other considerations include adverse events profile, expectation of concordance, medical co-morbidity, drug interactions, dosing profiles, need for soluble or liquid form, carer support Galantamine XL and Donepezil are both given daily. Rivastigmine patch is used once a day. Rivastigmine oral is given twice a day. Generic oral preparations are available for Donepezil, Galantamine and Rivastigmine oral, but not patches Med n Galantamine cap. XL 8mg Galantamine cap. XL 16mg Galantamine cap. XL 24mg Galantamine 4mg/ml oral solution Pack size Cost Annual cost Med n Pack size Cost Annual cost Rivastigmine cap.1.5mg BD Rivastigmine cap. 3mg Rivastigmine cap. 4.5mg 100ml to Rivastigmine cap. 6 mg Rivastigmine 120ml oral sol. 2mg/ml Rivastigmine patches 4.6mg Rivastigmine Continuing care Guidelines and information for staff and General Practitioners Page 6 of 11

7 Donepezil tab. 5mg Donepezil tab. 10mg Donepezil orodisp. 5mg Donepezil orodisp.10mg patches 9.5mg Patches 13.3mg Memantine tab.10mg Memantine tab. 20mg Initiation pack 7x5mg N/A 7x10mg 7x15mg 7x 20mg Memantine 100g HCl oral to drops mg/0.5ml N.B. Galantamine tablets (BD) are non-formulary in North Essex to avoid prescribing errors. 9. Dosage and side effects See the BNF or Summaries of Product Characteristics (SPCs) for each preparation for full details GALANTAMINE (Reminyl XL) Initially 8mg once daily for 4 weeks, increasing by 8mg monthly to usual dose of 16-24mg daily RIVASTIGMINE (Exelon) Initially 1.5mg twice daily, increasing by 1.5mg not more than fortnightly according to response and tolerance, to 3-6mg twice daily 9.3. DONEPEZIL (Aricept) Initially 5mg at night, increased after 4 weeks to 10mg if necessary MEMANTINE (Ebixa) Initially 5mg once a day, increasing by 5mg at weekly intervals to max. 20mg daily. If treatment is interrupted for more than several days, reintroduce with initial dose and increase gradually. 10. Adverse effects: See individual SPCs for details Acetyl Cholinesterase Inhibitors Gastro-intestinal: nausea, vomiting, diarrhoea, weight loss, abdominal pain, dyspepsia, gastric or duodenal ulcers, GI haemorrhage. CNS: Headache, anorexia, dizziness, convulsions, insomnia, drowsiness, fatigue, malaise, depression, psychiatric disturbance, hallucinations, agitation, confusion, aggression, EPSE, cerebrovascular disease, exacerbation of parkinson s disease. Cardiovascular: Bradycardia, syncope, rarely sino- atrial block, AV block, arrythmias, myocardial infarction, angina pectoris. Other: Hepatitis, Muscle cramps, minor increase in plasma-creatinine kinase conc. Asthenia, sweating, rhinitis,urinary incontinence, UTI, bladder flow obstruction, tremor, rashes, pruritis, rhinitis, fever, paraesthesia, tinnitus, dehydration, hypokalaemia, sweating Memantine Constipation, hypertension, dyspnoea, headache, dizziness, drowsiness Less commonly Vomiting, thrombosis, heart failure, confusion, fatigue, hallucinations, abnormal gait Continuing care Guidelines and information for staff and General Practitioners Page 7 of 11

8 Very rarely Seizures, pancreatitis, psychosis, depression, suicidal ideation 11. Care in prescribing 11.1 AChE inhibitors : Hepatic or renal impairment, sick sinus syndrome, other supraventricular abnormalities, asthma, obstructive airways disease, patients at risk of developing gastric or duodenal ulcers, history of seizures, bladder outflow impairment, pregnancy Memantine : Hepatic or renal impairment, history of convulsions 12. Interactions: Galantamine levels increased by erythromycin, paroxetine, ketoconazole Anticholinesterase effects reduced by antimuscarinics. Suxamethonium effects may be increased by anticholinesterases. Increased risk of CNS toxicity if memantine is given with ketamine, dextromethorphan, amantidine. Memantine possibly enhances warfarin, antimuscarinics, dopaminergics and selegiline. Memantine possibly reduces effects of primidone, antipsychotics and barbiturates. Memantine possibly modifies effects of baclofen and dantrolene. 13. Contact details for consultants or other staff in North Essex West Essex: Memory Clinics: St Margaret s Hospital, Epping and Latton Bush Harlow Consultants: Dr Z Walker , Dr T Stevens Dr K Suresh Dr T Dannhauser Learning disabilities Dr E Da Costa North East Essex Memory Clinics King s Wood Colchester and Landemere, Clacton Landermere Centre, Clacton Consultants: Dr L Davis Dr M Holman Dr J Marley and Dr S Bhan-Kotwal Learning disabilities Dr Opute X235 or Mid Essex Memory Assessment Support Services, Crystal Unit Chelmsford Consultants Dr Elanchenny (Braintree & Witham) , Dr Castle and Dr McDowall (Maldon) , Dr Leontis (Chelmsford) Learning disabilities Dr Fernando Advice and useful information NICE technology appraisal guidance or /TA217quickrefguide or /TA217publicinfo NICE clinical guideline 42 November NICE Public Health Guideline 16 Continuing care Guidelines and information for staff and General Practitioners Page 8 of 11

9 NIHR s mini-website on dementia will launch Friday 30 August Summary of product characteristics for Aricept, Reminyl and Exelon or ABPI medicines compendium. BNF or NeLM (National electronic Library for Medicines) Alzheimer s society helpline info@alzheimers.org.uk Royal College of Psychiatry For patient information leaflets and comparison of treatments NEP Pharmacy Specialist nurse for dementia Mary Kennedy Medicines Information Harlow PAH MI Colchester General MI Broomfield Hospital Authors Judith Woolley (Associate Director for Pharmacy, NEP) Steph Rea (operational lead for older adults, West Essex) NEP Medicine Management Group NEP Consultant psychiatrists of old age Consultation with the PCOs and acute Trusts in North Essex Continuing care Guidelines and information for staff and General Practitioners Page 9 of 11

10 ALGORITHM FOR THE USE OF CHOLINESTERASE INHIBITORS OR MEMANTINE FOR TREATMENT OF ALZHEIMER S DISEASE GP considers referral for dementia after evidence of deterioration over at least 6 months Eliminate other causes of symptoms Rationalise medication regimen Delirium considered and treated Refer to secondary care using form AD8 (appendix 2) Consultant for older adults Neurologist NEPFT Psychiatrist for adults Memory clinic or psychiatrist for older adults Learning disabilities consultant Diagnosis of alzheimer s, medicines considered appropriate Diagnosis, and initiation of treatment if medication is appropriate Initiate treatment only if monitoring available. Supply first 3 months Monitor and supply for first 3 months Referral to GP for prescribing under continuing care guidance. Continuing care monitoring by GP 6-monthly Monitor/review efficacy 6-monthly Mid and N.E. only Refer to secondary care if patient or carer requires review Discontinue if ADR or other urgent reason. Inform secondary care Initiate slow discontinuation/reduction if no worthwhile effect, adverse effects, or symptoms that could be exacerbated by these drugs, the carer requests, change in home circumstances, other Review within 3 months. Restart or go slower only if necessary Continuing care Guidelines and information for staff and General Practitioners Page 10 of 11

11 Test Your Memory.pdf tym 2.tif Test your memory tool for referral Appendix 2 Dementia Care for GP 11_2012.ppt Care plan for GP monitoring Appendix 3 Continuing care Guidelines and information for staff and General Practitioners Page 11 of 11