**Form 1: - Consultant Copy** Telephone Number: Fax Number: Author: Dr Bernard Udeze Pharmacist: Claire Ault Date of issue July 2011

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1 Effective Shared Care Agreement for the treatment of Dementia in Alzheimer s Disease Donepezil tablets / orodispersible tablets (Aricept / Aricept Evess ) These forms (1 and 2) are to be completed by both the Consultant initiating the therapy and the GP who is continuing care. A copy of the completed form should be retained by the GP and a copy should be returned to the Consultant, for filing in the patient s notes. Patient Name: Date of Birth: **Form 1: - Consultant Copy** NHS Number: Patients (Or attach Addressograph label) And / or on behalf of the patient Carer s Name: Careers Consultant Name: Directorate: Fax Number: GP Name: Fax Number: 1 of 7

2 Effective Shared Care Agreement for the treatment of Dementia in Alzheimer s Disease Donepezil tablets / orodispersible tablets (Aricept / Aricept Evess ) These forms (1 and 2) are to be completed by both the Consultant initiating the therapy and the GP who is continuing care. A copy of the completed form should be retained by the GP and a copy should be returned to the Consultant, for filing in the patient s notes. Patient Name: Date of Birth: **Form 2: - GP Copy** NHS Number: Patients (Or attach Addressograph label) And / or on behalf of the patient Carer s Name: Careers Consultant Name: Directorate: Fax Number: GP Name: Fax Number: 2 of 7

3 Effective Shared Care Agreement for the treatment of: - Dementia in Alzheimer s Disease Donepezil tablets / orodispersible tablets (Aricept / Aricept Evess ) This shared care agreement outlines the ways in which the responsibilities for managing the prescribing of cholinesterase inhibitors for dementia in Alzheimer s disease will be shared between the specialist and general practitioner (GP). If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition will remain with the specialist. If a specialist asks the GP to prescribe this drug, the GP should reply to this request as soon as practical. Sharing of care assumes communication between the specialist, GP and patient / carer. The intention to share care should be explained to the patient / carer by the doctor initiating treatment. It is important that patients / carers are consulted about treatment and are in agreement with it. Patients with Alzheimer s dementia are usually under regular specialist follow-up, which provides an opportunity to discuss drug therapy. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. This shared care protocol is drawn from NICE Technology Appraisals TA217 Issued: March 2011 Summary Donepezil, Galantamine and Rivastigmine are now recommended as options for managing mild as well as moderate Alzheimer s disease. Memantine is now recommended as an option for managing moderate Alzheimer s disease for people who cannot take AChE inhibitors, and as an option for managing severe Alzheimer s disease. Author Dr Bernard Udeze Pharmacist: Claire Ault Date of issue: July of 7

4 RESPONSIBILITIES and ROLES Specialist responsibilities Initiation 1 Confirm diagnosis of Alzheimer s dementia. 2 Perform initial assessments. 3 Initiate treatment in accordance with NICE guidance, bearing in mind that the MMSE score should not be relied upon solely in circumstances where it would be inappropriate to do so (for example learning or other disabilities, linguistic or other communication difficulties, where it is not possible to apply the MMSE in a language in which the patient is sufficiently fluent) 4 Seek carer s views on the patient s condition at baseline. 5 Discuss benefits and side effects of treatment with patient and/or carer. 6 Inform patient and carer of the terms under which treatment will be discontinued. 7 Assess likelihood of compliance. 8 Prescribe medication until care is transferred to GP. 9 Ask the GP whether he or she is willing to participate in shared care and explain the intention to share care with the patient and carer. First follow-up assessment within two months and six-monthly assessments 10 Conduct appropriate assessment tests on cognition, BPSD, tolerability and make decision whether to continue treatment or change to an alternative in accordance with NICE guidance. 11 If treatment with cholinesterase inhibitor is not appropriate, manage change of treatment in accordance with NICE guidance and communicate the decision to the patient, carer and GP. Determine and discuss ongoing care needs. 12 If appropriate to continue treatment, titrate the dose if necessary and establish patient on a stable / effective dose. 13 Seek carer s views on the patient s condition at follow-up. 14 Check for side effects and report adverse events to the CSM. Support to GP 15 Provide copy of effective shared care agreement and supporting information. 16 Promptly communicate assessment reports, advising GP of any dosage adjustments required, when to refer back, and when and how to stop treatment. 17 Ensure clear backup arrangements exist for GP for advice and support General Practitioner responsibilities 1 Reply to the request for shared care as soon as practical. 2 Maintenance prescribing, as directed by the specialist. 3 Monitor patients response to treatment; make dosage adjustments if agreed with specialist 4 Monitor compliance 5 Check for possible drug interactions when newly prescribing medication and avoid prescribing interacting drugs. 6 Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment 7 Refer back to specialist if condition deteriorates 8 Report any suspected adverse events to specialist team and any severe adverse events to CSM 9 Stop treatment on advice of specialist Patient's / Carer s role 1 Take / administer medication according to doctors instructions. 2 Attend assessments and other appointments. 3 Report to the specialist or GP if he or she does not have a clear understanding of the treatment. 4 Share any concerns in relation to treatment or patient s condition. 5 Report any adverse effects to the specialist or GP. 4 of 7

5 SUPPORTING INFORMATION FOR DONEPEZIL (ARICEPT ) EFFECTIVE SHARED CARE AGREEMENT This information should be read in conjunction with the Summary of Product Characteristics for Donepezil (Aricept ) available from Licensed indications Symptomatic treatment of mild to moderately severe Alzheimer s dementia. Dosage and Administration Initially 5mg once daily at bedtime, increased if necessary after one month to maximum 10mg daily. The orodispersible tablets (Aricept Evess ) should be placed on the tongue, allowed to disperse, and swallowed. Contraindications Patients with a known hypersensitivity to donepezil hydrochloride, piperidine derivatives or to any excipients used in the formulation, including lactose. Precautions for Use Cholinesterase inhibitors may have vagotonic effects on heart rate (e.g., bradycardia). The potential for this action may be particularly important to patients with "sick sinus syndrome" or other supraventricular cardiac conduction conditions, such as sinoatrial or atrioventricular block. Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. Therapeutic Use Refer to NICE technology appraisal guidance 111 (issued March 2011) Donepezil, Galantamine, Rivastigmine and Memantine for the treatment of Alzheimer s disease, available from Monitoring Weight monitoring. MMSE score in accordance with the latest NICE guidance. Side Effects Very common (>1/10): diarrhoea, nausea, headache Common (>1/100, <1/10): common cold, anorexia, hallucinations**, agitation**, aggressive behaviour**, syncope*, dizziness, insomnia, vomiting, abdominal disturbance, rash, pruritis, muscle cramps, urinary incontinence, fatigue, pain 5 of 7

6 Uncommon (>1/1000, <1/100): seizure*, bradycardia, gastrointestinal haemorrhage, gastric and duodenal ulcers, minor increase in serum concentration of muscle creatine kinase Rare (>1/10,000, <1/1000): extrapyramidal symptoms, sino-atrial block, atrioventricular block, liver dysfunction including hepatitis*** * In investigating patients for syncope or seizure, the possibility of heart block or long sinusal pauses should be considered. ** Reports of hallucinations, agitation and aggressive behaviour have resolved on dose-reduction or discontinuation of treatment. *** In cases of unexplained liver dysfunction, withdrawal of donepezil should be considered. The ability of Alzheimer s patients on donepezil to continue driving or operating complex machinery should be routinely evaluated. Drug Interactions Donepezil may increase the neurotoxic effect of antipsychotics. Metabolism is via cytochrome P450 enzymes 3A4 and 2D6. Metabolism may be inhibited (levels increased) by ketoconazole, quinidine, itraconazole, erythromycin, cimetidine, paroxetine and fluoxetine. Metabolism may be increased (levels reduced) by rifampicin, carbamazepine, phenytoin and alcohol. Donepezil may increase the neuromuscular-blocking effect of succinylcholine and may increase the adverse effects of cholinergic agonists. It may also increase the bradycardic effect of beta-blockers, diltiazem, verapamil, digoxin and amiodarone. Donepezil may antagonise the effect of anti-cholinergic medications. Primary Care Costs (BNF March 2011) Aricept 5mg / 28 tablets 10mg / 28 tablets References Date of access 30/6/2011 British National Formulary No 61 (March 2011). BMJ and Pharmaceutical Press: London. NICE. TA217 Alzheimer's disease - donepezil, galantamine, rivastigmine and memantine: guidance (March 2011). Accessed via Aricept Summary of Product Characteristics. Eisai Ltd. Last updated 27/07/ /07/11 Accessed Aricept Evess Summary of Product Characteristics. Eisai Ltd. Last updated 27/07/2010. Accessed 14/07/11. 6 of 7

7 BACK-UP ADVICE AND SUPPORT Contact details Specialist: Telephone No. Bleep: Fax: address: GP: Hospital Medicines Information Dept: uhns.nhs.uk Other: 7 of 7