Alzheimer's
diseasePrinciples
This shared care protocol has been prepared in accordance with the requirements of the Northumberland Mental Health Advisory Group and has been agreed for the locality by Northumberland Primary Care Groups.
The Principles that underpin this guidance are;
- Management of the patients’ disease.
- Therapy as a combined responsibility of the GP, the Specialist (old age psychiatrist, neurologist, care of the elderly physician) and the patient or patient’s carers.
- The clinical responsibility lies with the professional who will undertake the prescribing once the treatment is stabilised (i.e. the G.P.)
- The Specialist will be responsible for monitoring the response to treatment.
- It is the responsibility of all three parties to ensure that appropriate information is available to each party as required.
- Shared Care guidance containing relevant patient details and information on the management of treatment will be provided by the Specialist to the GP, prior to shared care arrangements being implemented.
- The GP is not under any obligation to accept the shared care arrangement if this is considered to be inappropriate but in this instance will be required to complete and return Appendix 1 to the Consultant stating a reason.
- The specialist is responsible for treatment discontinuation.
Introduction
Alzheimers disease is caused by a functional lack of Acetylcholine in the C.N.S.
Three drugs including donepezil (Aricept), rivastigmine (Exelon), and galantamine (Reminyl) are recommended by N.I.C.E for the treatment of Alzheimers. These cholinesterase inhibitors reduce the breakdown of acetylcholine in the brain and thereby reduce the apparent loss of cholinergic neurotransmitter. In addition, galantamine enhances the action of acetylcholine on nicotinic receptors in the brain.
Whilst taking a cholinesterase inhibitor, as the acetylcholine produced is preserved for longer, the symptoms of the disease are alleviated to a variable degree, however not all patients taking a cholinesterase inhibitor benefit. For those who do not show an improvement, or at least a rest of decline, the mechanism of action of these drugs suggest that they would be extremely unlikely to show any subsequent benefit and treatment should be discontinued. Cholinesterase inhibitors have been shown to be clinically effective in some patients with mild to moderate dementia (MMSE score 10-26). There is no evidence that they slow the progression of Alzheimers. They show a modest dose-related effect on cognition, which equates to about 6 months of preserved cognitive function. Choice should be based on clinical and cost effectiveness.
Further research is required as to whether all three drugs are of similar efficacy.
- Adverse effects include nausea, vomiting, diarrhoea, and abdominal pain. Effects are worse at higher doses and during rapid titration.
- All drugs with anticholinergic effects should be avoided as they may reduce efficacy of the of the cholinesterase inhibitor.
- Further research is needed to determine the place of these drugs in severe dementia, non-cognitive symptoms and behavioural disturbance in dementia and whether they are of benefit in other forms of dementia. These agents are currently unlicensed for use in these conditions.
Diagnosis performed by a specialist (old age psychiatrist, care of the elderly physician and neurologist) will include cognitive, global and behavioural functional tests / assessment.
Improvement is usually defined as no deterioration in MMSE score together with evidence of global improvement on the basis of behavioural and/ or functional assessment.
For those patients who do not show improvement, or a slowing down of the disease in the first few months, it is unlikely that they will show benefit later on therefore the medication should be stopped.
Patients and carers will be informed of the likely magnitude of effect, possibility of adverse effects and the likelihood of treatment failure.
Continuing management of people with AD can take place under the supervision of GP’s in the community on the basis of this shared-care protocol.
Compliance with the protocol will be subject to annual audit.
Cholinesterase Inhibitors |
|||
|
DRUG
|
Prescribing Status |
Advantages |
Disadvantages |
|
Donepezil (Aricept) |
Amber |
Once a day
|
|
|
Rivastigmine (Exelon) |
Amber |
|
Twice daily administration |
|
Galantamine (Reminyl) |
Amber |
Cost effective at higher doses May have dual mechanism of action |
Twice daily administration |
* Prescribing Status defined by D and T Committee * Amber – Shared Care Prescribing *Red – Hospital Prescribing
Combined protocol and shared care drug information sheets
Shared Care Guidelines for the Treatment of Alzheimers Disease
The objectives of these guidelines are to define each of the health care professionals key responsibilities in the management of selected patients identified for shared care. The document will be sent to G.P.’s to be filed in the patients’ medical records.
Patients may be considered suitable for shared care providing:
- The patients’ cognitive state has been stabilised
- The patients’ dosage has been stabilised
- The patients’ treatment is approved for shared care.
- Suitable arrangements have been made for shared community base care.
- The GP has agreed to accept the prescribing and management responsibility.
- *Stabilised is defined when a patient has completed their response to medication, there are no recognised problems with compliance, and have no significant deterioration in function.
The following patients are not suitable for shared care:
- Patients receiving drugs prescribed outside of the product license.
- Patients where the G.P. has deemed “shared care” to be inappropriate.
- (Having returned completed form Appendix 1 to the Consultant)
Responsibilities of the Specialist.
- To assess the patient, establish the diagnosis, and determine an individual patient management strategy.
- To initiate therapy, monitor the patient and review their therapy at regular appropriate intervals.
- To ensure the patient and carers are fully informed about the treatment including associated problems and how to avoid them and when treatment will be stopped.
- To provide the patients therapy until their dose and condition are stabilised.
- To issue a request for a G.P. to take over prescribing for an appropriate
patient to include:
- Patient Details.
- Details of treatment accompanied by an information sheet.
- When they will require their supply of medication from the G.P.
- Details of the patients’ management including the date of their next outpatient visit and frequency of follow-up, which will be no less than 6 monthly.
- Prior to transfer, to ensure that the patient has received at least one month’s supply of treatment.
- To be available for advice if the patients condition changes.
- To ensure that procedures are in place for rapid re-referral.
- To review the overall management of patients as necessary and give written notification to the GP of any changes in therapy.
- To Monitor and liase with the GP for any adverse drug reactions (ADR) which occur during treatment including reporting of serious ADR’s to the CSM.
- To discontinue treatment.
Responsibilities of the General Practitioner.
- To initially refer the patient for Specialist advice complete with a pre referral assessment including results from the following:
- ECG and report.
- FBC, U&E’s, LFT’s, ESR, TFT’s, Glucose, VDRL, PSA, B12 and Folate
- Summarised information on past psychatric and medical history.
- To contact the Specialist immediately if they are unhappy to accept the transfer by returning the completed form appendix 1.
- To prescribe medication at monthly intervals if requested.
- If requested to monitor compliance.
- To manage the patients’ general health at least 6 monthly.
- To monitor physical parameters as required and forward copies to the Specialist.
- To monitor and liase with the Specialist for any adverse drug reaction (ADR) including the reporting of any serious ADR’s to the CSM.
- To re-refer the patient if any of the following occur:
- Sudden deterioration in cognitive function.
- Patient intolerance or adverse side effects to medication.
- Non-compliance, lack of efficacy or a need for alteration of the dose of therapy.
- Unusual prescribing circumstances e.g. initiation of potentially interacting medication.
Responsibilities of the Hospital Pharmacist
- To provide compliance aids when deemed necessary, following formal trust assessment, until transfer to shared care.
- To facilitate in the continuity of medication supply in the community.
- To provide information and support on therapy for Specialist, G.P. and Patient.
Newcastle Northumberland and North Tyneside NHS Mental Health Trust (Northumberland Locality), Northumberland Health Authority, and North, Central, Blyth Valley and West Primary Care Groups.
July 2001
This document has been produced in consultation with
- Drugs and Therapeutics Committee
- St George’s Hospital
- Northumberland Mental Health Advisory Group