Donepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa ) ESCA: For the treatment of Alzheimer s disease. SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR Patient s name... Date of birth.. Address NHS number.....mh number... Date treatment commenced. One copy of agreement sent to general practitioner (One copy filed in patient s notes) Tick box One copy of information leaflet given to patient Name of initiating doctor/advanced nurse practitioner Consultant. Speciality.. Fax Number: 01902 Telephone Number: 01902. PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER I agree*/don t agree* to enter into a shared care arrangement for the treatment of the above patient with this medicine (*delete as appropriate) G.P. Name Signature.. Date. Once signed please detach this sheet and fax to the number shown above. BACK-UP ADVICE AND SUPPORT Contact details Telephone No. Fax: Consultant: Dr Jenkins 01902 444140 01902 444127 Consultant: Dr Viswanathan 01902 442509 01902 444127 1
Consultant : Dr Bhattacharyya 01902 445497 01902 444127 Consultant: Dr Prasanna 01902 575151 01902 444127 Memory clinic 01902 445794 01902 444730 Hospital Pharmacy Dept: Mrs Helen Woods PCT Pharmacist: Mr David Birch 01902 445817 01902 445606 01902 575184 01902 444522 2
Donepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa ) Shared Care Agreement for the treatment of Alzheimer s disease. (The three acetylcholinesterase (AChE) inhibitors donepezil, galantamine and rivastigmine are recommended as options for managing mild to moderate Alzheimer s disease. Memantine is an option for managing Alzheimer s disease for people with moderate Alzheimer s disease who are intolerant of or have a contraindication to AChE inhibitors or severe Alzheimer s disease.nice technology appraisal guidance 217 Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer s disease (review) March 2011). Patient s name... Date of birth.. Address NHS number.....mh number... Date treatment commenced.. AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE The aim of an Effective Shared Care Agreement (ESCA) is to provide information to general practitioners (GPs) and hospital staff about therapies that their patients may receive following specialist referral. An ESCA will only be written when it has been agreed that shared care is an appropriate option and will include a statement of Specialist Unit / GP responsibilities. Shared Care Guidelines will ensure that all GPs have sufficient information to enable them to undertake prescribing responsibility for specialist therapies and other therapies that may affect / interact with specialist therapies. Acceptance of the Effective Shared Care Agreements will be endorsed by the Prescribing Support Board and drugs will, where appropriate, be added to the list of high cost drugs used when setting prescribing budgets. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Specialist responsibilities 1 Confirm diagnosis of Alzheimer s disease using cognitive, global, functional and behavioural assessment. Carers views on the patient s condition at baseline should be sought. 2 The three AChE inhibitors donepezil, galantamine and rivastigmine are recommended as options for managing mild to moderate Alzheimer s disease. Memantine is an option for managing Alzheimer s disease for people with moderate Alzheimer s disease who are intolerant of or have a contraindication to AChE inhibitors or severe Alzheimer s disease. 3 The least expensive drug should normally be chosen as first line, unless there are patient specific reasons not to. 3
4 Obtain consent and ensure provision of information on disease, treatment, side-effects and discontinuation of medication to patient and/or carer. 5 Initiate treatment, optimise dose and prescribe until the dosage is stabilised. 6 Send a letter to the GP to obtain consent to share prescribing responsibility, informing the GP of formal assessments undertaken, results and confirmation that the patient has mild, moderate or severe Alzheimer s disease. 7 Once stabilised, review patient s clinical condition, carer s views, response to treatment, drug compliance and use cognitive, global, functional and behavioural assessment every 6 months. Communicate these results and any dosage adjustments promptly to the GP. 8 Review and consider discontinuing treatment if there is no clinically significant benefit. Treatment should be continued only when it is considered to be having a worthwhile effect on cognitive, global, functional or behavioural symptoms. 9 Ensure that backup advice is available at all times. 10 Advise and support patients and their carers. 11 Notify the GP of patient s failure to attend appointments. 12 Report adverse events to the Medicines and Healthcare products Regulatory Agency (MHRA) using the yellow card system. General Practitioner responsibilities 1 Reply to the specialist requesting shared care. 2 Provide repeat prescriptions following initiation and stabilisation by specialist, at dose advised, ensuring no interacting drugs are prescribed e.g. erythromycin with galantamine. It is recommended that no more than one month s prescription should be issued at a time. 3 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. 4 Act upon results communicated by specialist. 5 Encourage patient s ongoing engagement with secondary care services. 6 If patient s condition deteriorates the GP should advise specialist for earlier review. 7 Ensure all relevant staff within the practice are aware of the shared care guidelines. 8 Report any adverse events to the specialist and the MHRA using the yellow card system. Patient's/carer s role 1 Report to the GP or specialist if he or she does not have a clear understanding of the treatment. 2 Ensure regular attendance at appointments for review and monitoring. 3 Be aware of side effects and report any adverse effects to the specialist or GP. 4 Inform the GP or specialist if health problems arise. 5 Inform the GP or specialist of any other medication being taken including over the counter products. SUPPORTING INFORMATION See current edition of the British National Formulary (BNF) and Summary of Product Characteristics (SPCs) for Aricept, Reminyl XL, Exelon and Ebixa (http://www.emc.medicines.org.uk/) for full details of licensed indications, dosage and administration, contraindications, cautions, side-effects and drug interactions. Licensed indications Donepezil, galantamine and rivastigmine - mild to moderate dementia in Alzheimer s disease Memantine - moderate to severe dementia in Alzheimer s disease Dosage and administration 4
Donepezil (Aricept ): Initially 5mg once daily at bedtime, increased if necessary after one month to maximum 10mg daily. Galantamine XL (Reminyl XL ): Initially 8mg once daily (swallowed whole with food) for 4 weeks increased to 16mg once daily for 4 weeks; maintenance 16-24mg daily. Rivastigmine (Exelon ): Initially 1.5mg twice daily, increased in steps of 1.5mg twice daily at intervals of at least 2 weeks according to response and tolerance; usual range 3-6mg twice daily; maximum 6mg twice daily. Patches initially apply 4.6mg/24 hours patch to clean, dry, non-hairy, non-irritated skin on back, upper arm, or chest, removing after 24 hours and siting a replacement patch on a different area (avoid using the same area for 14 days); if well tolerated increase to 9.5mg/24 hours patch daily after no less than 4 weeks; if patch not applied for more than several days, treatment should be restarted with 4.6mg/24 hours patch. Memantine (Ebixa ): Initially 5mg once daily, increased in steps of 5mg at weekly intervals; max. 20mg daily. Contraindications Hypersensitivity to the active substance or to any of the excipients Breast-feeding Galantamine contra-indicated in renal impairment (avoid if creatinine clearance less than 9mL/minute) Cautions Patients with sick sinus syndrome or other cardiac conduction abnormalities Patients with susceptibility to peptic ulcers, asthma, chronic obstructive pulmonary disease, hepatic and renal impairment Pregnancy Memantine caution in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy. Side Effects (see patient information leaflet) Common side-effects include nausea, vomiting, anorexia, diarrhoea, dizziness, fatigue, headache, insomnia Drug Interactions Plasma concentration of galantamine increased by erythromycin, paroxetine and ketoconazole Galantamine, rivastigmine and possibly donepezil enhance the effect of suxamethonium but antagonise the effect of non-depolarising muscle relaxants Concomitant use of memantine and amantadine should be avoided. The same may be true for ketamine and dextromethorphan. The effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dosage adjustment may be necessary. Close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants. Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine may also possibly interact with memantine leading to a potential risk of increased plasma levels. (For further interactions see current addition of BNF and SPC). This format is based on an original template developed by Midlands Therapeutics Review and Advisory Committee (MTRAC) 5
This shared care agreement has been approved for use in Wolverhampton by: Signature Date Medical Director (Mental Health) Dr. S. Edwards 21.9.11 PCT Prescribing Board Chairman Dr. J. Parkes 13.9.11 6