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<strong>SHARED</strong> <strong>CARE</strong> <strong>PROTOCOL</strong> <strong>for</strong> DONEPEZIL, GALANTAMINE,<br />

RIVASTIGMINE AND MEMANTINE in Dementia.<br />

SCOPE<br />

Greater Manchester West Mental Health <strong>NHS</strong> Foundation Trust<br />

<strong>NHS</strong> Sal<strong>for</strong>d<br />

<strong>NHS</strong> Bolton<br />

<strong>NHS</strong> Traf<strong>for</strong>d<br />

Issue Date<br />

May 2011<br />

Author(s) Originator(s)<br />

Gillian Moss, GMWMHT, <strong>NHS</strong> Trust<br />

Sue Watts, MMG, GMWMHT, <strong>NHS</strong> Trust<br />

Joan Miller, MMG, GMWMHT, <strong>NHS</strong> Trust<br />

Claire Vaughan <strong>NHS</strong> Sal<strong>for</strong>d<br />

To be read in conjunction with the following documents<br />

NICE Technology Appraisal no 217,March 2011<br />

NICE Guideline Dementia, March 2011<br />

British National Formulary (current edition)<br />

Summary of Product characteristics <strong>for</strong> individual drugs<br />

Authorised by<br />

MMG, GMW Mental Health <strong>NHS</strong> Foundation Trust<br />

Bolton, Traf<strong>for</strong>d and Sal<strong>for</strong>d PCTs MMGs<br />

Review Date<br />

May 2013<br />

1. Introduction<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

1<br />

Reference Number<br />

MMG, GMW, NICE TA 217<br />

Classification<br />

<strong>SHARED</strong> <strong>CARE</strong> <strong>PROTOCOL</strong><br />

Replaces Local Shared care<br />

Protocols <strong>for</strong> prescribing of<br />

anti dementia drugs<br />

Donepezil, Galantamine and<br />

Rivastigmine November 2010.<br />

The National Dementia Strategy has identified the need <strong>for</strong> effective collaboration among agencies and<br />

seamless services between primary care and specialist services. Local Memory Clinics are now well<br />

established and this Shared Care Protocol (SCP) will facilitate the prescribing of these amber drugs in<br />

primary care.<br />

Please note that specialist services are unlikely to remain involved indefinitely with people with<br />

dementia and their carers and will focus mainly on patients mental health issues. At present, Primary<br />

Care is the main source of continuity of care and support <strong>for</strong> people affected by dementias from time of<br />

diagnosis until end of life. However, dementia services will review all patients being managed under this<br />

SCP every six months and will be available to be consulted regarding this shared care throughout the<br />

time patients remain managed under it.<br />

2. Scope<br />

This shared care protocol covers people referred with mild to moderate dementia who are clinically<br />

stable and those with moderate to severe dementia who require treatment with memantine as per NICE<br />

Guidance. Management of individuals with dementia with challenging behaviours, psychosis or<br />

significant mood disorder is beyond the scope of this document.


3. Drugs included<br />

Donepezil<br />

Galantamine<br />

Rivastigmine<br />

Memantine<br />

NICE concluded that therapy should be initiated with a drug with the lowest acquisition cost. However,<br />

an alternative acetyl cholinesterase inhibitor could be prescribed where it is considered appropriate<br />

having regard to adverse event profile, expectations around compliance, medical co morbidity,<br />

possibility of drug interactions, and dosing profiles. Memantine should only be used in patients with<br />

moderate Alzheimer’s disease who are intolerant of or have a contraindication to AChE inhibitors or<br />

those patients with severe Alzheimer’s disease.<br />

The drug patents <strong>for</strong> Rivastigmine, Galantamine and Donepezil all expire in early 2012 and generic<br />

<strong>for</strong>ms with a cheaper acquisition cost are likely to become available. The solution, sustained release<br />

tablets and patch <strong>for</strong>mulations will, however, remain branded products and the price of these will not<br />

reduce. For this reason these <strong>for</strong>mulations should be reserved <strong>for</strong> when there are severe swallowing<br />

difficulties or compliance issues.<br />

4. Licensed indications<br />

DRUG INDICATION DOSAGE RANGE FORMULATION<br />

Donepezil Mild to moderate<br />

5-10mg per day Tablets<br />

Alzheimer’s disease<br />

Orodispersible tablets.<br />

Galantamine Mild to moderate<br />

8-24mg per day as single Sustained release tablets<br />

Alzheimer’s disease daily dose<br />

8-24mg per day in 2 divided<br />

doses<br />

4mg per ml Oral solution<br />

8-24mg per day in 2 divided<br />

doses<br />

Tablets<br />

Rivastigmine Mild to moderate<br />

3 - 12mg daily in 2 divided Hard Capsules<br />

Alzheimer’s disease, doses<br />

dementia in Parkinson’s 3 - 12mg daily in 2 divided 2mg per ml oral solution<br />

disease<br />

doses<br />

4.6mg in 24hours<br />

Transdermal patches<br />

9.5mg in 24 hours<br />

4.6mg or 9.5mg/24hr<br />

Memantine Treatment of patients The recommended starting Tablets<br />

with moderate to severe dose is 5 mg per day, which 5mg<br />

Alzheimer's disease.<br />

is stepwise increased over<br />

the first 4 weeks of treatment<br />

10mg<br />

15mg<br />

reaching the recommended<br />

maintenance dose as follows:<br />

20mg<br />

Oral solution pump<br />

Week 1: 5mg once daily<br />

Week 2: 10mg once daily<br />

Week 3: 15mg once daily<br />

Week 4: 20mg once daily<br />

Recommended maintenance<br />

dose is 20mg once daily<br />

5mg/0.5mls ( one pump)<br />

Lewy Body Disease<br />

This is a diagnosis of exclusion and there are no definitive investigations. Patients with Lewy Body<br />

Disease may present with complex and challenging symptoms, which are very difficult to manage.<br />

Patients with LBD are notoriously sensitive to medication, especially anti-psychotics and this causes<br />

unique management problems. There is no ICD 10 classification <strong>for</strong> LBD, however, Dementia in<br />

Parkinson’s disease is classified and is part of the same spectrum of disorder. It is recognised within<br />

the NICE Guideline <strong>for</strong> Dementia that this condition may respond very well to the prescription of acetyl<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

2


cholinesterase inhibitors and as such their use is included within this protocol. Rivastigmine is licensed<br />

<strong>for</strong> Dementia in Parkinson’s disease. The GMMMG RAG group has recently reclassified the use of<br />

acetyl cholinesterase inhibitors in the treatment of Lewy Body Disease as amber, and so it is covered by<br />

this SCP.<br />

5. Therapeutic use<br />

These drugs will be prescribed in line with NICE guidance TA 217; March 2011.<br />

6. Contraindications and Cautions<br />

For full list of cautions/ contra indications and more in<strong>for</strong>mation see BNF/SPC.<br />

Cholinesterase Inhibitors<br />

Contraindications<br />

Patients with known sensitivity to the active ingredient or excipients<br />

Pregnancy and lactation<br />

Severe liver disease (see individual SPCs <strong>for</strong> advice)<br />

Severe renal disease (see individual SPCs <strong>for</strong> advice)<br />

Although not an absolute contraindication, the service would advise avoiding cholinesterase<br />

inhibitors in individuals with second or third degree heart block, sick sinus syndrome or<br />

bradycardia persistently less than 50 until assessed and treated.<br />

Avoid or stop in patients with gastro-intestinal obstruction or recovering from gastrointestinal<br />

surgery.<br />

Cautions<br />

First degree AV Block and any bradycardia<br />

Other acute or uncontrolled cardiac conditions<br />

Predisposal to seizures (Note that the illness itself can cause predisposal to seizures - in<br />

investigating such patients the possibility of heart block or long sinusal pauses should be<br />

considered.)<br />

History of syncope<br />

Active peptic ulceration or predisposition to same as cholinesterase inhibitors can cause an<br />

increase in gastric acid secretions<br />

Patients predisposed to urinary obstruction (theoretical risk of bladder outflow obstruction)<br />

Asthma or Chronic Obstructive Pulmonary Disease - observe <strong>for</strong> any worsening of airways<br />

disease<br />

Body weight below 50kg (GI side effects more likely)<br />

Epilepsy<br />

Parkinsonian Syndrome (May cause a worsening of extra pyramidal symptoms).<br />

Administration concomitantly with other inhibitors of acetyl cholinesterase - agonists or<br />

antagonists of the cholinergic system should be avoided. (See drug interactions).<br />

Memantine<br />

Contraindications<br />

Hypersensitivity to the active substance or to any of the excipients.<br />

Cautions<br />

Caution in epilepsy, <strong>for</strong>mer history of convulsions or patients with predisposing factors <strong>for</strong><br />

epilepsy<br />

Concomitant use of NMDA antagonists such as amantadine, ketamine and dextromethorphan<br />

should be avoided. Adverse drug reactions esp. CNS-related may be more frequent or more<br />

pronounced.<br />

Some factors that may raise urine pH may necessitate careful monitoring of the patient. These<br />

include drastic changes in diet e.g. from carnivore to vegetarian or massive ingestion of<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

3


alkalising gastric buffers. Urine pH may also be increased by states of renal tubular acidosis<br />

(RTA) or severe infections of the urinary tract with Proteus bacteria.<br />

Patients who have had a recent MI, uncompensated CCF(NYHA III-IV), or uncontrolled<br />

hypertension should be closely monitored due to limited evidence.<br />

Oral solution contains sorbitol. Patients with rare hereditary problems of fructose intolerance<br />

should not take this medicine.<br />

7. Prescribing in pregnancy and lactation<br />

N/A<br />

8. Dose regimen and titration<br />

Drug Initial Dose Increased / Maximum Doses<br />

Donepezil 5mg once daily at increased if necessary to 10mg after one month<br />

bedtime 1<br />

Galantamine 4mg twice daily<br />

<strong>for</strong> 4weeks<br />

Galantamine XL 8mg once daily<br />

<strong>for</strong> 4 weeks<br />

Rivastigmine 1.5mg twice daily<br />

<strong>for</strong> at least<br />

2weeks<br />

Rivastigmine<br />

patches<br />

Initially<br />

4.6mg/24hour<br />

applied daily <strong>for</strong><br />

at least 4weeks<br />

Memantine 5mg od <strong>for</strong> 7 days<br />

Memantine<br />

solution<br />

5mg/0.5mls : one<br />

downward pump<br />

<strong>for</strong> 7 days<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

Increased to 8mg twice daily <strong>for</strong> 4weeks then<br />

consider increasing to 12mg twice daily<br />

Increased to 16mg once daily <strong>for</strong> 4 weeks then<br />

consider increasing to 24mg daily<br />

3mg twice daily <strong>for</strong> at least two weeks, 4.5mg twice<br />

daily <strong>for</strong> at least two weeks,6mg twice daily <strong>for</strong> at<br />

least two weeks. Usual maintenance dose 3-6mg<br />

twice daily.<br />

Then 9.5mg/24hour daily<br />

(site of replacement patches needs to be rotated.<br />

Avoid using same area <strong>for</strong> 14days<br />

Then<br />

10mg once daily <strong>for</strong> 7 days<br />

15mg once daily <strong>for</strong> 7 days<br />

20mg once daily thereafter<br />

Then<br />

10mg/1mls; two downward pumps <strong>for</strong> 7 days<br />

15mg/1.5mls three downward pumps <strong>for</strong> 7 days<br />

20mg/2mls; four downward pumps thereafter<br />

For detail explanation of using the pump see PIL or<br />

SPC.<br />

1 Although the SPC suggests taking the once daily dose at bedtime, generally it is preferable to take the tablet after food, which reduces<br />

the risk of side effects in addition it may be practical to prescribe the tablet to be taken in the morning or when home carers visit.<br />

An individual who is frequently sensitive to a range of medications may need a smaller starting<br />

dose and a slower titration.<br />

Individuals who have difficulty with swallowing tablets may prefer a liquid or orodispersible<br />

preparation.<br />

A patient who suffers unpleasant gastrointestinal side effects may tolerate a transdermal patch.<br />

A patient or carer who has difficulty with complicated dose titrations may prefer the relatively<br />

straight<strong>for</strong>ward titration regime of Donepezil.<br />

A patient who is receiving supervision in the community may need the drug prescribed at a<br />

specific time or via a monitored dosage system, which may dictate the choice of drug.<br />

9. Drug Interactions<br />

Individuals being treated with drugs affecting cognitive function will require review as below be<strong>for</strong>e<br />

initiation of these drugs.<br />

Alcohol misuse:<br />

4


Patients currently drinking unsafe amounts of alcohol will not be treated with cholinesterase<br />

inhibitors or memantine, but may be considered <strong>for</strong> treatment if they have Alzheimer’s disease<br />

or Lewy Body Disease and their alcohol intake is reduced to be within safe limits.<br />

Benzodiazepines:<br />

Consideration must be given to whether the benzodiazepines may be affecting cognitive<br />

function especially in large doses, if so they must be reduced gradually and stopped.<br />

Non Steroidal Anti Inflammatory Drugs (NSAID): Increased risk of acid production with<br />

Cholinesterase inhibitors review need <strong>for</strong> NSAID. Patients may need increased monitoring <strong>for</strong><br />

gastric complications if using NSAID.<br />

Drugs that may cause bradycardia e.g. digoxin, beta blockers: There is an increased risk<br />

of potentiation of bradycardia with cholinesterase inhibitors. This is particularly important in<br />

‘sick sinus syndrome’ or AV block. Increased monitoring is required.<br />

Tricyclic antidepressants have anticholinergic effects:<br />

Tricyclic antidepressants as an antidepressant:<br />

Consider changing to an SSRI/ SNRI or Mirtazapine if still requiring treatment. Individual drugs<br />

vary in their capacity to interact so check be<strong>for</strong>e prescribing an antidepressant. For example<br />

there is an interaction between paroxetine and galantamine, which may increase the levels of<br />

the cholinesterase inhibitor.<br />

Tricyclic Antidepressants as an adjunct to pain control:<br />

If prescribed <strong>for</strong> pain in small dosage, and still required after review, continue with caution.<br />

Other Anticholinergic drugs: review the need <strong>for</strong> these drugs as they may oppose the effect<br />

of cholinesterase inhibitors.<br />

Drugs with Cholinomimetic properties:<br />

o Peripherally Acting Cholinesterase inhibitors: Such as neostigmine or<br />

pyridostigmine.<br />

o Cholinergic drugs e.g. pilocarpine.<br />

Drug Interactions with memantine<br />

Warfarin: Memantine has been seen to increase INR in some patients and so close monitoring<br />

of INR may be required until patient is stabilised.<br />

L-dopa.dopaminergic agonists and anticholinergics may be enhanced. Effects of<br />

barbiturates and antipsychotics may be reduced. Concomitant administration with<br />

antispasmodics, dantrolene or baclofen can modify their effects and dosage adjustment may<br />

be necessary.<br />

Amantadine should be avoided due to risk of pharmacotoxic psychosis. Ketamine and<br />

dextromethorphan may have same effects and one case with phenytoin.<br />

Increased plasma levels possible with cimetidine, ranitidine, procainamide, quinidine, quinine<br />

and nicotine.<br />

Possible reduced serum level of hydrochlorothiazide<br />

10. Adverse effects<br />

See SPC <strong>for</strong> full list of side effects<br />

The main side effects seen in clinical practice <strong>for</strong> cholinesterase inhibitors are diarrhoea, muscle<br />

cramps, fatigue, nausea, vomiting, anorexia and insomnia. These are usually seen at initiation and at<br />

dose increases.<br />

The main side effects <strong>for</strong> memantine are dizziness, headache, constipation, somnolence and<br />

hypertension though adverse events were usually mild to moderate.<br />

11. Baseline investigations<br />

Be<strong>for</strong>e referral to the memory service or specialist the GP should have carried out<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

5


Full Blood count<br />

Biochemical profile (include U and E’s and LFT’s)<br />

Thyroid function<br />

Serum B12 and folate<br />

Syphilis serology if applicable<br />

Lipid profile<br />

Cognitive screening (e.g. AMTS etc)<br />

12. Ongoing monitoring by the GP<br />

The GP will monitor <strong>for</strong> ongoing side effects and discuss with memory clinic or specialist if any arise <strong>for</strong><br />

advice on dose reduction, discontinuation etc. If patients cardiac health changes appropriateness of<br />

prescription will need to be discussed with the memory clinic team/specialist.<br />

13. Secondary care contact in<strong>for</strong>mation<br />

See local appendices.<br />

14. Criteria <strong>for</strong> shared care<br />

Patient has been assessed in line with NICE guidance by memory services/specialist services.<br />

15. Responsibilities <strong>for</strong> secondary care<br />

NICE guidelines state that these medications should be initiated by specialist services after a <strong>for</strong>mal<br />

diagnosis has been made. Monitoring of the effects of these medications is undertaken by specialist<br />

services within a shared care protocol.<br />

See Appendices <strong>for</strong> local procedures in Bolton, Sal<strong>for</strong>d and Traf<strong>for</strong>d.<br />

The following is a list of interventions that should be provided but this is subject to local variation and<br />

available resources.<br />

Undertake a comprehensive assessment of people newly presenting with possible mild to<br />

moderate dementia – including domiciliary assessment when appropriate<br />

Arrange, undertake or refer <strong>for</strong> specialist investigations as appropriate, <strong>for</strong> example:<br />

o Neuroimaging – MRI, SPECT, CT<br />

o Psychometric assessment<br />

Sensitive delivery of diagnosis<br />

Formulate an appropriate care plan involving other agencies as necessary<br />

Provide in<strong>for</strong>mation and support including adjustment to diagnosis, advice around secondary<br />

prevention and management of condition to patients and carers.<br />

Provide advice about psychosocial management of cognitive impairments<br />

Occupational Therapy interventions, as required<br />

Initiate, or provide in<strong>for</strong>mation <strong>for</strong> GP to initiate or continue medication where appropriate.<br />

Monitor effects of medication and associated side effects<br />

Signpost patients to other services where appropriate<br />

In<strong>for</strong>m GP of patient’s progress.<br />

In<strong>for</strong>m GP of any change in medication or if medication is to be stopped.<br />

Liaison with<br />

o Primary Care<br />

o Social services<br />

o Liaison with local voluntary agencies<br />

o CMHT<br />

o Cerebral Function Unit or local specialist neurology service.<br />

o Other agencies as relevant e.g. Court of Protection, DVLA, Police<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

6


If and when dementia becomes severe or treatment has been ineffective, review and<br />

discontinue medication as appropriate, provide support and further signposting to services as<br />

needed.<br />

16. Responsibilities <strong>for</strong> GP<br />

Provide regular prescriptions <strong>for</strong> cholinesterase inhibitors or memantine as per locally agreed<br />

protocols.<br />

See Appendices <strong>for</strong> local procedures in Bolton, Sal<strong>for</strong>d and Traf<strong>for</strong>d.<br />

Be aware of side effects and common drug interactions as documented in this SCP.<br />

Provide regular health checks including where relevant the review of clients with vascular<br />

dementia or mixed dementia and provision of advice about lifestyle.<br />

In<strong>for</strong>m specialist services of any relevant physical health problems at the earliest opportunity.<br />

If patient suffers any adverse reaction, GP should liaise with secondary care/specialist services.<br />

If patient develops bradycardia with symptoms on cholinesterase inhibitors, such as lightheadedness<br />

or syncope, stop the drug and notify Memory Clinic. If patient develops<br />

bradycardia without symptoms and if the rate is persistently less than 50, stop the drug and<br />

notify Clinic, if rate is 50-60, continue drug and notify Memory Clinic.<br />

If patient develops second or third degree AV block, stop drug, consider referral to cardiology<br />

and notify memory clinic.<br />

The specific needs of older and cognitively impaired people should be taken into account. Please<br />

consider:<br />

Simple drug regimes, preferably no more than once or twice daily dosages<br />

Use of compliance aids<br />

Involving carers in discussions about medication and heath promoting advice<br />

Providing essential in<strong>for</strong>mation in writing<br />

Effects of polypharmacy – medication regimes need regular review and simplification<br />

Prompt treatment of intercurrent physical conditions that may worsen symptoms of dementia<br />

People with dementia may need a more flexible appointments system<br />

It may be in the best interests of people with dementia to keep carers in<strong>for</strong>med and capacity<br />

assessments may need to be undertaken when considering issues of confidentiality<br />

Assessment of needs and health of in<strong>for</strong>mal carers should be offered.<br />

Advice <strong>for</strong> patients having General Anaesthetics:<br />

Donepezil, Galantamine and Rivastigmine<br />

Donepezil, Galantamine and Rivastigmine can enhance the effects of suxamethonium and the<br />

duration of the block may be prolonged. Donepezil and Rivastigmine can antagonise the effects of<br />

non-depolarising muscle relaxants such as atracurium, cisatracurium, mivacurium, pancuronium,<br />

rocuronium, vecuronium.<br />

Memantine<br />

No specific studies looking at use of memantine in patients undergoing surgery.In addition the<br />

company are not aware of any studies looking at memantine use with anaesthetics. Theoretically there<br />

may be a risk of pharmacotoxic psychosis if memantine is used concomitantly with ketamine. This is<br />

based on a report <strong>for</strong> amantadine as there are no reports with ketamine specifically (April2011).<br />

Neuroleptics and anticholinergics used in surgical procedures may interact with memantine. The<br />

effect of neuroleptics may be reduced and the effect of anticholinergics may be enhanced although<br />

these interactions may be overcome by change of dose. See section 9 and SPC <strong>for</strong> full list of drug<br />

interactions.<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

7


Drug Situation Advice<br />

Donepezil Planned operations Stop 2 – 3 weeks be<strong>for</strong>e operation <strong>for</strong> complete wash out.<br />

Rivastigmine<br />

Galantamine<br />

Emergency<br />

In<strong>for</strong>m the anaesthetist of potential of prolonged muscle<br />

operations<br />

relaxation.<br />

Post-operative Re-introduce during post-surgical rehabilitation.<br />

Planned Operations Miss the last dose prior to surgery, i.e., if the operation is in the<br />

morning miss the previous night-time dose.<br />

Emergency<br />

In<strong>for</strong>m the anaesthetist of potential of prolonged muscle<br />

operations<br />

relaxation.<br />

Post-operative Re-introduce during post-surgical rehabilitation.<br />

Planned Operations stop two days be<strong>for</strong>e surgery <strong>for</strong> washout<br />

Emergency<br />

In<strong>for</strong>m the anaesthetist of potential of prolonged muscle<br />

operations<br />

relaxation.<br />

Post-operative re-introduce during post-surgical rehabilitation<br />

Memantine Planned operations If a decision is made to discontinue memantine be<strong>for</strong>e surgery<br />

the total washout period would be 2 to 3weeks. When to<br />

restart memantine will depend on the dose and half life of the<br />

drug used in surgery.<br />

17. Responsibilities of the patient/carer<br />

The GP or memory clinic/specialist staff should be in<strong>for</strong>med of any adverse effects to treatment,<br />

compliance issues with treatment, deterioration in physical health and progression of dementia.<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

8


18. Supporting documentation<br />

APPENDIX 1 : Statement of Agreement between GP and Consultant.<br />

REFFERAL FORM FROM CONSULTANT PSYCHIATRIST TO GP<br />

<strong>SHARED</strong> <strong>CARE</strong> <strong>PROTOCOL</strong> <strong>for</strong> CHOLINESTERASE INHIBITORS<br />

From:<br />

(Name of Consultant Psychiatrist)<br />

Name of GP practice:<br />

Name of Patient:<br />

Date of Birth:<br />

<strong>NHS</strong> Number:<br />

Medication Prescribed:<br />

Reason <strong>for</strong> Choice (tick<br />

as appropriate):<br />

Indication (delete as<br />

appropriate):<br />

Name of Memory Clinic<br />

Contact:<br />

Telephone Number<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

9<br />

To:<br />

(Name of GP)<br />

Cost effectiveness<br />

Poor tolerance of other options<br />

Simplicity of regime<br />

Licensed indication<br />

Swallowing problems<br />

Side effect profile<br />

Compliance<br />

Other<br />

Alzheimer’s Disease / Dementia in Parkinson’s Disease<br />

For the Consultant Psychiatrist<br />

I would be grateful if we could adopt the shared care protocol <strong>for</strong> the above patient.<br />

I accept my responsibilities as outlined in the enclosed SCP.<br />

Signed Consultant<br />

Date:<br />

Psychiatrist/Senior<br />

Clinician<br />

For the GP<br />

I accept my responsibilities as outlined in the enclosed guideline. YES/NO<br />

Signed GP<br />

Date:


Local Sal<strong>for</strong>d Service Variations<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

10<br />

Appendix 2<br />

Diagnosis and Early Intervention <strong>for</strong> Mild to Moderate Dementias Including Treatment with Antidementia<br />

Drugs.<br />

1. Referrals to the Memory Clinic<br />

1.1 Referrals may be received from a variety of sources; mainly from Primary Care, but many are<br />

received from Social Services, CMHT’s, Neurology, Department of Health Care <strong>for</strong> the Elderly,<br />

General Psychiatry services and other secondary care sources. Prior to referral, the referring agent<br />

should explain the reason <strong>for</strong> the referral to the patient and carer as appropriate with a brief<br />

description of the service to which they are being referred.<br />

1.2 The Memory Clinic accepts referrals of individuals of all ages with possible mild to moderate<br />

dementia requiring assessment, diagnosis and consideration <strong>for</strong> treatment in keeping with the<br />

recommendations of the National Dementia Strategy:<br />

www.dh.gov.uk/en/SocialCare/Deliveringadultsocialcare/Olderpeople/NationalDementiaStrategy/DH_0<br />

83362. This may include individuals with mild cognitive impairment, some of whom will later progress<br />

to dementia (see NICE, NDS).<br />

1.3 The service does not see urgent referrals or people whose main presenting problems<br />

include significant challenging behaviours, major mood disorder or psychotic symptoms.<br />

Referrals of people with these problems should be addressed initially to the Older People’s<br />

CMHT single point of entry (Tel: 0161 607 7111), or A and E in an emergency.<br />

1.4 If major physical investigations are in progress consider delaying referral until stable/consult clinic<br />

<strong>for</strong> advice.<br />

1.5 Referrals should include the following in<strong>for</strong>mation (see standard referral <strong>for</strong>m attached)<br />

Demographic data<br />

Brief history of presenting problem<br />

Dementia screening test results (see below)<br />

In<strong>for</strong>mation about recent physical assessment<br />

Blood pressure<br />

Medical history and current medication<br />

Use of compliance aids<br />

ECG if possible/available<br />

Recent hospital correspondence/test results if relevant<br />

In<strong>for</strong>mation about smoking and alcohol intake (and other substance misuse if relevant)<br />

Contact details <strong>for</strong> patient and main carer<br />

Risks<br />

Whether it is reasonable to ask patient to attend a clinic<br />

1.6 Dementia screening tests<br />

Full Blood count<br />

Biochemical profile (include U and E’s and LFT’s)<br />

Thyroid function<br />

Serum B12 and folate<br />

Syphilis serology if applicable<br />

Lipid profile<br />

Cognitive screening (eg AMTS etc)<br />

2.0 Specialist Service Responsibilities<br />

Undertake a comprehensive assessment of people newly presenting with possible mild to<br />

moderate dementia – including domiciliary assessment when appropriate<br />

Arrange, undertake or refer <strong>for</strong> specialist investigations as appropriate, <strong>for</strong> example:


o Neuroimaging – MRI, SPECT, CT<br />

o Psychometric assessment<br />

Sensitive delivery of diagnosis<br />

Formulate an appropriate care plan involving other agencies as necessary<br />

Provide in<strong>for</strong>mation and support including adjustment to diagnosis, advice around<br />

secondary prevention and management of condition to patients and carers<br />

Advice about psychosocial management of cognitive impairments<br />

Occupational Therapy interventions<br />

Recommend medication based on cost effectiveness, individual patient tolerance, simplicity<br />

of dosage regime, licensed indication, ability to swallow, side effect profile etc.<br />

Provide in<strong>for</strong>mation <strong>for</strong> GP to initiate or continue medication where appropriate<br />

Monitor effects of medication and associated side effects. This takes place in accordance<br />

with NICE guidance utilising a local protocol and takes place at least 6 monthly, in some<br />

cases by telephone.<br />

In<strong>for</strong>m G.P. of any change in medication including drug titration schedules or if medication<br />

is to be stopped.<br />

Signpost patients to other services where appropriate<br />

In<strong>for</strong>m G.P. of patient’s progress.<br />

Liaison with<br />

o Primary Care<br />

o Social Services<br />

o Age Concern/local voluntary agencies<br />

o CMHT<br />

o Cerebral Function Unit<br />

o Other agencies as relevant e.g. Court of Protection, DVLA, Police<br />

If and when dementia becomes severe, review and discontinue medication as appropriate,<br />

provide support and further signposting to services as needed.<br />

Educational Role – Within available resources, memory clinic staff will contribute to<br />

educational programmes <strong>for</strong> a variety of agencies and including service users and carers.<br />

Research, evaluation and audit – Memory Clinics will participate in well-designed research<br />

projects and continuously evaluate and audit services. Approaches will assess patient and<br />

carer experience will be incorporated on a regular basis.<br />

3. Written in<strong>for</strong>mation provided to patient<br />

3.1 In<strong>for</strong>mation leaflets about the Memory Assessment and Treatment Service are provided with<br />

appointment details and may be provided to primary care if requested.<br />

3.2 In<strong>for</strong>mation leaflets are available about all 3 cholinesterase inhibitors and are provided to<br />

patients and carers as appropriate.<br />

3.3 In<strong>for</strong>mation leaflet on memantine are provided to patients and carers as appropriate<br />

All patients and carers receive in<strong>for</strong>mation about their diagnoses, implications and proposed<br />

management. After initial face-to-face discussion, this may be provided in the <strong>for</strong>m of standardised<br />

leaflets or individualised written material or a combination of both. This includes as appropriate,<br />

In<strong>for</strong>mation about driving in dementia,<br />

Issues relevant to mental capacity including<br />

o Lasting Power Of Attorney<br />

o Advance Directives<br />

In<strong>for</strong>mation about local support services <strong>for</strong> service users and carers.<br />

Other sources of relevant in<strong>for</strong>mation such as web sites.<br />

4. General Practitioner and Primary Care Services<br />

Refer to service according to guidance in paragraph 1.5<br />

Initiate and continue regular prescriptions <strong>for</strong> cholinesterase inhibitors as per guidance from<br />

specialist services/secondary care.<br />

Be aware of side effects and common drug interactions<br />

Provide regular health checks including where relevant the review of clients with vascular<br />

dementia or mixed dementia and provision of advice about lifestyle.<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

11


In<strong>for</strong>m specialist services of any relevant physical health problems at the earliest opportunity.<br />

If patient suffers any adverse reaction, GP should liaise with secondary care/specialist<br />

services.<br />

If patient develops bradycardia with symptoms, such as light-headedness or syncope, stop the<br />

drug and notify Memory Clinic. If patient develops bradycardia without symptoms and if the rate<br />

is persistently less than 50, stop the drug and notify Clinic, if rate is 50-60, continue drug and<br />

notify Memory Clinic.<br />

If patient develops second or third degree AV block, stop drug, consider referral to cardiology<br />

and notify memory clinic.<br />

Back-up care available to GP from Hospital, including emergency contact procedures and help<br />

line numbers.<br />

Sal<strong>for</strong>d Memory Assessment and Treatment Service - 0161 703 1045<br />

The Memory Clinic is not an emergency service, so there is no out of hours arrangement at present.<br />

During the day there is an answer phone system when administrative staff are not available.<br />

During the working day there is an emergency Duty System <strong>for</strong> the Department of Psychiatry of Later<br />

Life based at Humphrey Booth Resource Centre, and accessed via 0161 607 7111).<br />

Emergencies out of hours should be referred to the Out of Hours GP service or A&E.<br />

SCP <strong>for</strong> Donepezil, Galantamine, Rivastigmine<br />

and Memantine <strong>for</strong> the treatment of AD<br />

Issued May 2011<br />

Review date May 2013<br />

12

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