NHS ONEL and NELFT Shared Care Guidelines. Management of medications for Alzheimer s disease. Patient Name : Date of Birth: NHS No:

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1 NHS ONEL and NELFT Shared Care Guidelines Management of medications for Alzheimer s disease DOCUMENT TO BE SCANNED INTO ELECTRONIC RECORDS AND FILED IN NOTES Patient Name : Date of Birth: NHS No: Name of Referring Consultant: Contact number: INTRODUCTION Indication and Licensing These guidelines have been produced to clarify the roles of primary and secondary care in the management of medications for Alzheimer s disease. They are based on the NICE Technology Appraisal 217 (March 2011) regarding Donepezil, Rivastigmine and Galantamine (acetylcholinesterase inhibitors or AChEIs) and Memantine. The previous shared care guidelines related only to the AChEIs. This updated guideline does not include specific guidance on the discharge of stable patients back to primary care or advice on criteria for re-referral to specialist services. However it is likely that such protocols will need to be developed in conjunction with ONEL PCT and Clinical Commissioning Groups via the ONEL Mental Health NELFT Clinical Forum. It is envisaged this will be necessary for a number of reasons. The local population is aging, the incidence of dementia is rising, awareness of dementia is rising and hence referral rates to memory services are increasing. This is occurring in the context of fiscal austerity, the impact of which is now being felt within the NHS locally. There is no reason to belief these factors are going to change in the near future. Together we need to provide high quality, efficient memory services in line with the national dementia strategy that provide early assessment, diagnosis, treatment and advice within the resources available. Given changes in local demographics and referral patterns this can not be achieved if all patients across ONEL with a diagnosis of dementia are retained in specialist memory services as a significant proportion of these patients will not require specialist input for significant periods of time. Informal agreements regarding follow up in primary care of patients taking medication for Alzheimer s Disease currently exist in some ONEL boroughs. Where this is working well for the benefit of patients this should continue. NICE guidance The three AChEIs are recommended as options for managing mild to moderate Alzheimer s disease under all the conditions specified in 3 and 4 below. 2. Memantine is an option for people with: Moderate Alzheimer s disease who are intolerant of or have a contraindication to AChEIs or Severe Alzheimer s disease. 3. Treatment should be under the following conditions: Only specialists in the care of patients with dementia should initiate treatment. 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. Again, carers views should be sought. Patients who continue on treatment should be reviewed regularly, but no time interval is specified. These reviews may be by an appropriate specialist team or reviews may also be through a shared care arrangement as this puts less pressure on local resources. The 2011 guidance places less emphasis on MMSE scores in assessing severity, pointing out that educational attainment, sensory problems and language barriers need to be taken into account. Combination of an AChEI and memantine is not recommended, and switching between the two is a clinical decision.

2 PATIENT PATHWAY- brief explanation of why planned arrangements for prescribing and monitoring between primary and secondary care are appropriate see above Clinical Speciality / Indication Old Age Psychiatry or Learning Disability Psychitary Prescribing Initiated by Prescribing Continued by (detail when suitable for transfer to occur) Old Age Psychiatry or GP (typical transfer of Learning Disability prescribing within 3 Psychiatry months or when patient stable) Monitored by (detail when suitable for transfer to occur IF APPROPRIATE) Old Age Psychiatry or Learning Disability Psychiatry (in conjunction with primary care once prescribing is transferred). Transfer of monitoring arrangements for some patients to primary care may be clinically appropriate if agreed with primary care. Reviews should be at least annually or sooner if clinically indicated Duration of treatment Determined on a case by case basis as clinically appropriate / as per NICE guidelines ORAL DOSE AND ADMINISTRATION Current medications for Alzheimer s disease can have modest but significant effects on cognition, psychiatric and behavioural symptoms and function in individuals. There is also evidence to support their use in mixed (Alzheimer and vascular) dementia and Lewy Body dementia. Donepezil (Aricept) Tablets/orodispersible tablets Dose: 5mg/d for 4 weeks, maintenance 10mg/d Common side effects include: diarrhea, muscle cramps, fatigue, nausea, vomiting, headache and insomnia Caution in: supraventricular conduction abnormalities, particularly bradyarythymias; gastric ulcers or people on NSAIDs; seizures; asthma or COPD; cholinergic agonists; beta blockers Donepezil will be out of patent in 2012 and therefore costs will most likely decrease. Galantamine (Reminyl) Tablets/oral solution/modified release capsules Dose: 8mg/d for 4 weeks, 16mg/d for 4 weeks, then if tolerated 24mg/d Tablets and oral solution need to be given in divided doses Side effects and cautions: see under donepezil Rivastigmine (Exelon) Capsules/oral solution Dose: 1.5mg bd for 4 weeks, then 3mg bd for 4 weeks, then 4.5mg for weeks and then if tolerated 6mg bd Patches. Dose: 4.6mg/24hrs for 4 weeks then 9.5mg/24hrs Side effects and cautions: see under donepezil Memantine (Ebixa) Differs from the AChEIs in being an NMDA antagonist Tablets/ oral drops

3 Dose: 5mg/d for 1 week, the 10mg/d for 1 week, then 15mg/d for 1 week, then 20mg/d Side effects: dizziness, headache, constipation, somnolence, hypertension MONITORING STANDARDS FOR MEDICATION AT NELFT Note: be clear about what needs monitoring, normal parameters, how often and by whom. What results warrant referral back to the hospital team 1) Pre treatment ECG (usually carried out in primary care) advised for Acetylcholinesterase inhibitors to look for supraventricular conduction abnormalities and bradyarythmias. 2) Monitoring of cognitive function, global functional abilities and behavioural problems (taking in to account views of carers). Frequency not specified in NICE guideline. Good practice suggests this should be at least yearly for stable patients. This monitoring can be carried out in primary care or in secondary care for those who need ongoing specialist follow up. If follow up is in primary care patients can be referred back to specialist services at any time (e.g. if GP is concerned that patient has developed Behavioural and Psychological Symptoms of Dementia (BPSD) such as depression, anxiety, psychosis, agitation, aggression). 3) No requirement for regular blood tests in relation to the prescription of medication for Alzheimers Disease. Parameter Target level Frequency of monitoring Action KEY ADVERSE EFFECTS & ACTIONS Adverse effects For Donepezil, Galantamine and Rivastigmine Common side effects include: diarrhea, muscle cramps, fatigue, nausea, vomiting, headache and insomnia Caution in: supraventricular conduction abnormalities, particularly bradyarythymias; gastric ulcers or people on NSAIDs; seizures; asthma or COPD; cholinergic agonists; beta blockers Symptoms/signs (specify what would prompt action) Severe and / or persistent common side effects that outweigh benefits of treatment should prompt consideration regarding discontinuation. New or worsening cardiovascular symptoms (if they occur are usually secondary to bradycardia) e.g. dizziness, syncope. Exacerbation of COPD / Asthma / Epilepsy / Peptic Ulcer Disease associated with starting these drugs should prompt review. Actions (what action should the GP take if identified in primary care) Discontinue if side effects severe, otherwise discuss with old age psychiatry or Learning disability psychiatry re: appropriate action. For symptoms suggestive of cardiovascular side effects examine cardiovascular system and consider ECG For Memantine Side effects: dizziness, headache, constipation, somnolence, hypertension Severe and / or persistent common side effects that outweigh benefits of treatment should prompt consideration regarding discontinuation. Discontinue if side effects severe, otherwise discuss with old age psychiatry or Learning disability psychiatry re: appropriate action

4 This only lists the key important ADRs-For comprehensive information on cautions, contra-indications and interactions, please refer to the current British National Formulary and Summary of Product Characteristics. Detail any important cautions see above For comprehensive information please refer to the current British National Formulary and Summary of Product Characteristics. SHARED CARE Shared care guideline: is a document which provides information allowing patients to be managed safely by primary care, secondary care and across the interface. It assumes a partnership and an agreement between a hospital specialist, GP and the patient and also sets out responsibilities for each party. The intention to shared care should be explained to the patient and accepted by them. Patients are under regular follow-up and this provides an opportunity to discuss drug therapy. Intrinsic in the shared care agreement is that the prescribing doctor should be appropriately supported by a system of communication and cooperation in the management of patients. The doctor who prescribes the medicine has the clinical responsibility for the drug and the consequence of its use. Consultant 1. Ensure that the patient/carer is an informed recipient in therapy. 2. Ensure that patients and carers understand their treatment regimen and any monitoring or follow up that is required (using advocacy if appropriate). Issue any local patient information leaflets where appropriate. 3. Ensure baseline investigations are normal before commencing treatment. Give the patient a patient held booklet for result monitoring if appropriate. 4. Initiate treatment and prescribe until the GP formally agrees to share care (as a minimum, supply the first month of treatment or until patient is stabilised). 5. Send a letter to the GP requesting shared care for this patient along with the shared care protocol. 6. Clinical and laboratory supervision of the patient by blood monitoring and routine clinic follow-up on a regular basis. 7. Send a letter/results notification to the GP after each clinic attendance ensuring progress, current dose, most recent blood results (if applicable) and frequency of monitoring are stated (unless otherwise covered by letter eg from Clinical Nurse Specialist ). 8. Where the GP is not performing the phlebotomy, the blood test form MUST be annotated to request that blood results are also copied to the GP. 9. Evaluation of any reported adverse effects by GP or patient. 10. Advise GP on review, duration or discontinuation of treatment where necessary. Where urgent action is required following tests the hospital team will telephone the patient and inform GP. 11. Inform GP of patients who do not attend clinic appointments. 12. If applicable counsel the patient on contraception and what to do if pregnancy occurs. Document in the notes. 13. Ensure that backup advice is available at all times. General Practitioner 1. Ensure that the patient and/or carer understands the nature, effect and potential side effects of the drug before prescribing it as part of the shared care programme and contact the specialist for clarification where appropriate. 2. Monitor patient s overall health and well-being. 3. Report any adverse events to the consultant, where appropriate. 4. Report any adverse events to the MHRA, where appropriate. 5. Help in monitoring the progression of disease 6. Maintain a patient held monitoring booklet where used 7. Prescribe the drug treatment as described. PCT 1. To provide feedback to trusts via Trust Medicines Committee. 2. To support GPs to make the decision whether or not to accept clinical responsibility for prescribing. 3. To support trusts in resolving issues that may arise as a result of shared care. Patient/ Carer 1. Report any adverse effects to their GP and/or specialist 2. Ensure they have a clear understanding of their treatment.

5 3. Report any changes in disease symptoms to GP and/or specialist 4. Alert GP and/or specialist of any changes of circumstance which could affect management of disease e.g. plans for pregnancy 5. Take/ administer the medication as prescribed 6. Undertake any monitoring as requested by the GP and/or specialist Costs Drug Product Cost in primary care Based on BNF edition.. Give the cost of a 1 month course of treatment for each drug listed RESOURCES AVAILABLE North East London NHS Foundation Trust North East London NHS Foundation Trust (NELFT) OLD AGE PSYCHIATRY Havering Prof Martin Orrell Dr Janet Carter Dr Afifa Qazi Dr Jo Rodda Dr Amber Selwood Ext 5721 Ext 5723 Ext 5722 Ext 5731 Ext 5731 Barking and Dagenham Dr Mike Devine Dr Mohan Bhat Redbridge Dr Hilary Kinsler Dr Kate Maxmin Dr Viv Gould Dr Beata Mougey Ext 5213 Ext ( from 2/4/12) Ext 7819 Ext 7819 Ext 8999 Waltham Forrest Dr Andrew Winnett Dr Shakil Khawaja Ext 8705 Ext 8709 Old Age Liaison (Queens Hospital) Dr Stephen O Connor (Associate Medical Director) Ext 6831 or Ext 4792 LEARNING DISABILITIES Dr Susil Attale (Havering) Dr Ehab Khattab (Barking and Dagenham) Dr Anit Bhattacharyya (Redbridge) Dr Emmanuel Akuffo (Waltham Forrest)

6 Out of hours Contact NELFT Mental Health Direct on ( from 2/4/12) Clinical Nurse Specialist (where appropriate) N/A Drug Monitoring Clinic Pharmacist (where appropriate) NHS ONEL Prescribing Team N/A To confirm new number References NICE Technology Appraisal 217 (March 2011) Refer to the NHS ONEL website to obtain the latest version of this guideline

7 Appendix 1 Tel: Fax: Waltham Forest Memory Service Red Oak Lodge 17 Thorne Close Leytonstone E11 4HU SHARED CARE MEDICATIONS FOR ALZHEIMERS DISEASE AGREEMENT LETTER Name of GP. Address Dear GP Re: Patient s Name... Date of Birth. Hospital Number... This patient is being seen in the Memory Service. Medications for dementia are being prescribed from the clinic initially. When the patient is stable on a maintenance dose, you will be asked to carry on this prescription if you agree to shared care. Details of the current treatment are in the enclosed letter and you will be updated about any future changes. The shared care guidelines and contact details for all NELFT Old Age and Learning Disability Psychiatry Consultants are available at management/shared%20care/alzheimers_sc_nelft.pdf Please sign below and return this letter to the Memory Clinic Lead, if you agree to the shared care arrangements for this patient. Many thanks For the Memory Clinic GP Signature... Name..... Date... Signature... Name... Date If you are not taking on shared care for this patient please state the reason why and return this letter to the Specialist.

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