Effective Shared Care Agreement (ESCA) for drugs used in dementia- Donepezil, Galantamine, Rivastigmine and Memantine for the treatment of dementia AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of drugs in dementia and how this can be shared between the specialist /memory service and general practitioner (GP). Clinical responsibility for diagnosis and monitoring remains with the specialist service. Sharing of care assumes communication between the specialist/memory service, GP and patient. The Consultants working within the specialist memory service and who will be working within this ESCA will be Dr s Spencer and Goh. The intention to share care is explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients on dementia drugs are under regular follow-up, which provides opportunities to discuss drug therapy. The prescriber who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Memory Service / Specialist Responsibilities 1 Diagnose Alzheimer s Disease and initiate the dementia drug in line with the local pathway, stabilise patient on a maintenance dose and carry out on going assessment and need for continued treatment, in accordance with NICE Guidelines, treatment should be continued if having a worthwhile effect on treatment. 2 Discuss the benefits and side effects of treatment with the patient 3 Discuss with the patient/ carer the circumstances when the decision may be made to stop treatment. 4 Communicate promptly with the GP when treatment is initiated or the dose is amended, if the GP doesn t wish to share care for a patient then the specialist will continue to prescribe for that patient. 5 Have a mechanism in place to give advice to the GP in the event of a problem with the medication. 6 Agree a medication review date with the GP and give advice on stopping treatment. 7 Report adverse events to the CSM and GP using the Yellow Card reporting system accessed at the back of the BNF 8 Ensure that arrangements exist for GPs to obtain advice and support from the memory service within working hours. 9 Each patient is to be reviewed at least every 6 months in accordance with NICE Guidelines. General Practitioner Responsibilities 1 Conduct relevant physical examinations (Abbreviated Mental Test) and blood tests prior to referral to the specialist, this will include relevant Mental health and vascular history taking (i.e. previous stroke and TIA) 2 Refer to the specialist for diagnosis, initiation of treatment and management until the patient is stabilised (the first 6 months of treatment will be provided by the Specialist service) 3 Prescribe the drug specified in the table below at the dose specified by the specialist, once the patient has been stabilised on that same medication. 4 Adjust the dose as advised by the specialist. 5 Ask the patient/carer about any problems with the medication. 6 Report to and seek advice from the Memory Assessment Service on any aspect of patient care that is of concern and may affect treatment. 7 Refer patient to the memory service/specialist in the event of a problem with the medication or refer the patient via the standard procedure if his or her condition deteriorates. 8 Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises. 9 Report adverse events to the specialist and CSM using the Yellow Card reporting system accessed at the back of the BNF.
Patient's / Carer s Role 1 Report to the specialist or GP if he or she does not have a clear understanding of the treatment. 2 Share any concerns in relation to the treatment 3 Inform specialist or GP if any other medication is being taken, including over-the-counter products. 4 Report any problems to the specialist or GP whilst taking the specified drug 5 If the GP or specialist decides to stop treatment then this needs to be carried out 6 Understand the rationale behind the decision to stop treatment on specialist advice. BACK-UP ADVICE AND SUPPORT (Please contact the specialist who initiated the treatment) Contact details Telephone No. Specialist: Memory Service Consultant Psychiatrist Old Age Psychiatry- Drs Spencer and Goh Other: PCT Pharmaceutical Adviser PCT Mental Health Pharmacist Hospital Pharmacist GP details Patient details Name of drug initiated (decision of which drugs to be used should be in line with local pathway) Dose and form of drug initiated SUPPORTING INFORMATION (see SPC for complete details available at http://emc.medicines.org.uk/) Therapeutic Use of drugs in dementia NICE TAG 217 (March 2011) donepezil, galantamine and rivastigmine are recommended as options for managing mild as well as moderate (MMSE 21 10) Alzheimer s disease, and memantine is recommended as an option for managing moderate Alzheimer s disease for people who cannot take AChE inhibitors, and as an option for managing severe (MMSE < 10) Alzheimer s disease. Mini Mental State Examination (MMSE) score: mild Alzheimer s disease: MMSE 21 26 moderate Alzheimer s disease: MMSE 10 20 moderately severe Alzheimer s disease: MMSE 10 14 severe Alzheimer s disease: MMSE less than 10. If prescribing an AChE inhibitor (donepezil, galantamine or rivastigmine), treatment should normally be started with the drug with the lowest acquisition cost (taking into account required daily dose and the price per dose once shared care has started).
RIVASTIGMINE Licensed Indications Rivastigmine is indicated for the symptomatic treatment of mild to moderately severe Alzheimer s dementia or mild to moderate dementia in Parkinson s disease. Prior to prescribing basic health screening and investigations should be carried out to exclude physical/reversible causes of symptoms. This should include FBC, LFT, ESR, U and E s, glucose, lipids, calcium, B12/folate, TSH, MSU and ECG. It would usually be conducted by the GP prior to specialist referral and any problems treated as appropriate. Dosage and Administration Rivastigmine is available as capsules, liquid and patches. Capsules/Liquid: 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. It should be taken with or after food. Patches: Treatment is started with 4.6 mg/24 h. After a minimum of four weeks, if well tolerated, this dose should be increased to 9.5 mg/24 h, which is the recommended effective dose. Transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing. It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine. The patch should not be applied to skin that is red, irritated or cut. Reapplication to the exact same skin location within 14 days should be avoided to minimise the potential risk of skin irritation. N.B. if treatment is interrupted for more than several days then it will need to be reintroduced and titrated upwards as above Adverse effects include nausea, vomiting, dizziness, anorexia, diarrhoea, abdominal pain, dyspepsia, headache, drowsiness to use are pregnancy, breast feeding, hyper sensitivity to rivastigmine, and severe hepatic impairment. Cautions for Use Gastric or duodenal ulcers (or susceptibility to ulcers), sick sinus syndrome, conduction abnormalities, history of asthma or chronic obstructive pulmonary disease, history of seizures, bladder outflow obstruction, hepatic impairment, renal impairment (if egfr is < 49ml/min then consult the BNF re: dosing). Other acetylcholinesterase inhibitors (galantmaine and donepezil) should not be co-administered with rivastigmine. The effects of rivastigmine may be antagonised by medications having anticholinergic activity e.g. procyclidine, benzhexol, orphenadrine. Rivastigmine enhances succinylcholine-type muscle relaxation during anaesthesia. Rivastigmine antagonises the effects on non-depolarising muscle relaxants.
DONEPEZIL Licensed indications Donepezil is indicated for the symptomatic treatment of mild to moderately severe Alzheimer s dementia. Prior to prescribing basic health screening and investigations should be carried out to exclude physical/reversible causes of symptoms. This should include FBC, LFT, ESR, U and E s, glucose, lipids, calcium, B12/folate, TSH, MSU and ECG. It would usually be conducted by the GP prior to specialist referral and any problems treated as appropriate. Dosage and Administration Donepezil is available as a tablet and as an oro-dispersible tablet. Treatment is initiated at 5mg once daily at bedtime, increased if necessary after one month to a maximum of 10mg daily. Nausea, vomiting, diarrhoea, headache, dizziness and agitation to use are pregnancy, breast feeding or hyper sensitivity to donepezil. Cautions for use Sick sinus syndrome or other supraventricular conduction abnormalities, Susceptibility to peptic ulcers, Asthma and chronic obstructive pulmonary disease, Hepatic impairment Other acetylcholinesterase inhibitors (rivastigmine and galantamine) should not be co-administered with donepezil. The effects of donepezil may be antagonised by medications having anticholinergic activity e.g. procyclidine, benzhexol, orphenadrine. Donepezil possibly enhances succinylcholine-type muscle relaxation during anaesthesia. Donepezil may antagonise the effects on non depolarising muscle relaxants GALANTAMINE Licensed Indications Galantamine is indicated for the symptomatic treatment of mild to moderately severe dementia of Alzheimer type. Prior to prescribing basic health screening and investigations should be carried out to exclude physical/reversible causes of symptoms. This should include FBC, LFT, ESR, U and E s, glucose, lipids, calcium, B12/folate, TSH, MSU and ECG. It would usually be conducted by the GP prior to specialist referral and any problems treated as appropriate. Dosage and Administration Galantamine is available as standard release tablets, modified release capsules and liquid.
Standard Release Tablets/Liquid: Initially 4mg twice daily for 4 weeks increased to 8mg twice daily for four weeks. Maintenance dose 8-12mg twice daily. (NB: 4mg tablets are no longer manufactured) Modified release capsules: Initially 8mg once daily for 4 weeks increased to 16mg once daily for 4 weeks. Maintenance dose 16-24mg daily. All preparations should be taken with or after food. Adverse effects include nausea, vomiting, dizziness, anorexia, diarrhoea, abdominal pain, dyspepsia, headache, sleep disturbance. to use are pregnancy, breast feeding, hyper sensitivity to galantamine, severe renal impairment (egfr <9ml/min), and severe hepatic impairment. Cautions for Use Cardiac disease including sick sinus syndrome or other supraventricular conduction abnormalities, unstable angina, congestive heart failure, electrolyte disturbances, susceptibility to peptic ulcers, asthma and chronic obstructive pulmonary disease, hepatic impairment, urinary outflow obstruction, in recovery from bladder surgery, gastrointestinal obstruction. Other acetylcholinesterase inhibitors (rivastigmine and donepezil) should not be co-administered with galamtamine. Plasma concentration of galantamine is increased by erythromycin, paroxetine and ketoconazole The effects of galantamine may be antagonised by medications having anticholinergic activity e.g. procyclidine, benzhexol, orphenadrine. Galantamine enhances succinylcholine-type muscle relaxation during anaesthesia. MEMANTINE Licensed Indication Memantine is indicated in moderate to severe dementia in Alzheimer s disease. Dosage and administration Memantine is available as 5, 10, 15 and 20mg film coated tablets and a 5mg/ actuation (10ml/ml) oral solution. Initially 5 mg once daily, increased in steps of 5 mg at weekly intervals; max. 20 mg daily. Adverse effects include constipation; hypertension; dyspnoea; headache, dizziness, drowsiness; less commonly vomiting, thrombosis, heart failure, confusion, fatigue, hallucinations, and abnormal gait; very rarely seizures; pancreatitis, psychosis, depression, and suicidal ideation also reported include hypersensitivity to the active substance or to any of the excipients. Due to lack of data avoid in severe hepatic impairment and in renal impairment avoid if e-gfr is less than 5ml/min. It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs. Women taking memantine should not breast-feed. Cautions for use
Caution in patients with a history of convulsions. Memantine should not be used during pregnancy unless clearly necessary. Avoid concurrent use of amantadine, ketamine and dextromethorphan due to increased risk of CNS toxicity when memantine. References Summary of Product Characteristics for Rivastigmine. Available at www.emc.medicines.org.uk Summary of product characteristics for Donepezil. Available at www.emc.medicines.org.uk Summary of Product Characteristics for Galantamine. Available at www.emc.medicines.org.uk Summary of Product Characteristics for Memantine. Available at www.emc.medicines.org.uk The British National Formulary. Number 61. March 2011. RPSGB and BMA. MTRAC Verdict and Summary. Donepezil. January 2008. VS08/02 National Institute for Health and Clinical Excellence. Donezepzil, galantamine, rivastigmine and memantine for the treatment of Alzheimer s disease (review). Technology Appraisal 217. March 2011. Available at www.nice.org.uk