Download FRAMEWORK - SHARED CARE

Shared Care Prescribing Guideline
Treatment of Alzheimer’s disease (including mixed Alzheimer’s dementia) with
acetylcholinesterase inhibitors (AChEIs) for mild to moderate severity, or memantine for
moderate severity (where AChEIs cannot be used) or in severe disease.
Additionally, the use of rivastigmine for Parkinson’s disease Dementia and Lewy Body
dementia.
Section A: To be completed by the specialist initiating treatment
GP Practice Details:
Patient Details:
Name: ………………………………………
Name: ………………………………………………
Address: ……………………………………
Address: ……………………………………………
Tel no: ………………………………………
DOB: ……/………/…………
Fax no: ………………………………………
Hospital number: …………………………………
NHS.net e-mail: ……………………………
NHS number (10 digits): …………………………
Specialist name: ……………………………
Clinic name: ………………………………….
Contact details:
Address: .........................................................................................................................
Tel no: ……………………………………… Fax no: ………………………………………
NHS.net e-mail: ……………………………
Diagnosis & Severity:
Drug name & dose to be prescribed by GP:
……………………………………………………
…………………………………………………………….
Last Specialist appointment:…………../…………../………Next Specialist appointment: ……/……/……..
Dear Dr. ……………………..,
Your patient was seen on the date above and I have started the medicine above for their diagnosis. I am requesting
your agreement to sharing the care of this patient from the next supply in 2-4 weeks’ time accordance with the
(attached) Shared Care Prescribing Guideline. Please take particular note of Section 2 where the areas of
responsibilities for the specialist, GP and patient for this shared care arrangement are detailed.
Patient information has been given outlining potential aims and side effects of this treatment. The patient has given
consent to treatment possibly under a shared care prescribing agreement (with your agreement) and has agreed to
comply with instructions and follow up requirements.
Please monitor the following:
1.
Encourage adherence.
2.
Monitor any side effects of medication.
3.
General health.
4.
Report any adverse reactions to the MHRA via the ‘yellow card system’.
5.
Check for interactions with other medicines.
6.
Refer back to the specialist between regular reviews if concerned about patient’s condition.
The following investigations have been performed and are acceptable for shared care.
Test / Assessment Tool
Result / Score
Date
e.g SMMSE/CAMCOG
Test / Assessment
Tool
Result / Score
Date
e.g. CT/MR
ECG (if indicated)
Other relevant information: ………………………………………………………………………………………..
………………………………………………………………………………………………………………………..
Section B: To be completed by the GP and returned to the specialist as per Section A above
Please sign and return your agreement to shared care within 14 days of receiving this request. Tick which applies:
□ I accept sharing care as per shared care prescribing guideline and above instructions
□ I would like further information. Please contact me on:……………………….
□ I am not willing to undertake shared care for this patient for the following reason:
……………………………………………………………………………………………………………….
GP name: ………………………………………….……….
GP signature: ………………………………………………Date: …/…/…..
Date approved: 09/2015
Review date: 09/2018
Version 201701
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Working in partnership
SHARED CARE PRESCRIBING GUIDELINE
Treatment of Alzheimer’s disease (including mixed Alzheimer’s dementia) with
acetylcholinesterase inhibitors (AChEIs) for mild to moderate severity, or memantine
for moderate severity (where AChEIs cannot be used) or in severe disease.
Additionally, the use of rivastigmine for Parkinson’s disease Dementia and Lewy Body
dementia.
NOTES to the GP
The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to
take clinical and legal responsibility for prescribing this drug.
The questions below will help you confirm this:
 Is the patient’s condition predictable or stable?
 Do you have the relevant knowledge, skills, diagnostic tools and access to equipment to allow you to monitor
treatment as indicated in this shared care prescribing guideline?
 Have you been provided with relevant clinical details including monitoring data?
 Have you followed treatment recommendations as per NICE?
If you can answer YES to all these questions (after reading this shared care guideline), then it is appropriate for
you to accept prescribing responsibility.
If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write
to the specialist within 14 days, outlining your reasons for NOT prescribing. If you do not have the confidence to
prescribe, we suggest you discuss this with your local Trust/specialist service, which will be willing to provide
training and support. If you still lack the confidence to accept clinical responsibility, you still have the right to
decline. Your CCG pharmacist will assist you in making decisions about shared care.
It would not normally be expected that a GP would decline to share prescribing on the basis of cost.
The patient’s best interests are always paramount
Date prepared:
Review date:
Sept 2018
South West London Mental Health Interface
Approved by (date approved):
Prescribing Forum (Oct 2015), GPwSI update
SWL & St. George’s Mental Health NHS Trust’s DTC
approved by MHIPF Dec 2016
(16/08/2013), (3/6/15) and October 2015
This shared care prescribing guideline has been signed off by the following individuals on behalf of
their respective organisations:
Participating Clinical Commissioning Groups (CCG)
Participating Hospital Trusts
NHS Merton CCG
SWL & St. George’s Mental Health NHS Trust
Dr Farooq Ahmad, Clinical Director Dementia and
Dr. Debbie Stinson (Old Age Psychiatrist)
Diabetes Merton CCG DUK Clinical Champion
Dianne Adams (Chief Pharmacist)
Sedina Agama, Chief Pharmacist Merton CCG
NHS Sutton CCG
St George’s University Hospitals NHS Foundation
Dr Chris Keers, Mental Health Lead
Trust: Dr. Jeremy Isaacs (Neurologist, Dementia)
Sarah Taylor, Chief Pharmacist
Chris Evans (Chief Pharmacist)
NHS Kingston CCG
Dr Jonathan Edwards, GP on behalf of Medicines
Management Committee
Dr Anthony Hughes, GP, Kingston CCG
NHS Richmond CCG
Dr Stavroula Lees, Lead GP for Mental Health
Emma Richmond, Head of Medicines Management
NHS Wandsworth CCG
Dr Gillian Ostrowsky, Associate Medical Director
Nick Beavon, Chief Pharmacist
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Date approved: 09/2015
Review date: 09/2018
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SHARED CARE PRESCRIBING GUIDELINE
1.
CIRCUMSTANCES WHEN SHARED CARE IS APPROPRIATE
 Prescribing responsibility will only be shared when the specialist and the GP are in agreement that the patient’s
condition is stable or predictable and in accordance with NICE Technological Appraisal 217.
 Treatment of mild or moderate severity dementia with non-cognitive symptoms with an AChEI, or treatment with
memantine in severe disease with/ without non-cognitive symptoms.
 Additionally, shared care may be appropriate in the use of rivastigmine for Parkinson’s disease Dementia, and
Lewy Body Dementia.
 Patients will only be referred to the GP once the GP has agreed in each individual case and the specialist service
will continue to provide prescriptions until successful transfer of responsibilities as outlined below.
 The specialist service will provide the patient with a minimum initial supply of 4-12 weeks therapy; duration will
depend on severity, indication and tolerability of medicine.
Severity and Type of Dementia
Severe Alzheimers (SMMSE score <10)
Parkinson’s Disease and Lewy Body Dementia
Alzheimer’s dementia of any severity with non-cognitive symptoms
For Shared Care
Yes
Yes
Yes
Behavioural & Psychological Symptoms in Dementia (BPSD)
Symptoms of BPSD (e.g. hallucinations, delusions, anxiety, agitation, aggression, other behavioural issues:
wandering, hoarding, sexual disinhibition, apathy, shouting) can present GPs with a difficult clinical scenario. They
often occur together and recurrently,1,2&3 prevalence estimates range between 60% and 80%, with an incidence of
90% in patients with dementia.4
EXCLUDED
Combination treatment with memantine and an acetylcholinesterase inhibitor is not recommended, and should only be
initiated on approval from SWLStG Drug and Therapeutics committee as it is outside this agreement and NICE
guidance.
Date approved: 09/2015
Review date: 09/2018
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SHARED CARE PRESCRIBING GUIDELINE
2.
AREAS OF RESPONSIBILITY
Specialist (Old Age or Learning Disabilities Psychiatrist, Care of the Elderly Physician, GP with Special
Interest Dementia, or Neurologist)
1. Confirm diagnosis of Alzheimer’s disease of: mild to moderate severity with non-cognitive symptoms, severe
Alzheimer’s Disease with or without non-cognitive symptoms, Parkinson’s Disease Dementia, or Lewy Body
Dementia with duration > 6 months and communicate the severity to the GP (for example based on SMMSE
score). In certain circumstances the SMMSE will be inappropriate for assessing severity as scores are biased by
learning disability, high or low education, where English is not the first language, with deafness and by cultural
factors. Other tools (e.g. CAMCOG, CAMDEX, DMR, DSDS, DSQIID) may be appropriate and assessment of
severity will be a matter for specialist clinical judgement.
2. Specialist assessment including:
 Tests of cognitive domain (e.g. SMMSE or MoCA)
 Clinical evaluation of non-cognitive domains (e.g. hallucinations, delusions, agitation, behaviours that
challenge)
 Assessment of activities of daily living (ADLs)
 Assessment of global function
 Likely compliance with treatment, before drug is prescribed
 The main therapeutic targets should be confirmed e.g. cognition, psychosis, behaviours that challenge and/or
ADL
 Level of carer distress
3. When clinically appropriate undertake a CT or MRI scan to exclude vascular aetiology or other pathology.
4. Test for syphilis serology or HIV in patients at risk due to their histories, or if clinically indicated.
5. ECG to be performed if a cardiac contra-indication to acetylcholinesterase inhibitor treatment (e.g. sick sinus
syndrome or other supraventricular conduction abnormalities) is suspected.
6. Assess patient’s capacity and seek consent including, where appropriate, consultation with carers
7. Identify a carer who will undertake to monitor concordance and agree with the treatment plan.
8. Seek agreement that treatment will be stopped if no benefit or if deterioration.
9. Check for medication interactions
10. Exclude serious adverse effects during dose escalation.
11. Report any serious adverse effects to the MHRA via the ‘yellow card system’.
12. Arrange secondary care assessment within 12 weeks of diagnosis, and until the patient is stabilised on medication
(at least 4-12 weeks of treatment will be supplied, duration will depend on severity, indication and tolerability of the
medicine).
13. Seek carers’ views of patient’s condition at baseline and at each follow-up.
14. Stop treatment if:




Poor concordance
Major adverse effects
Patient asks to stop
Medication not effective (global, functional & behavioural condition is below a level where the drug is
considered to have a worthwhile effect e.g. which may be an SMMSE <10)
15. Activity /audit report to be sent regularly to commissioners.
GP responsibilities
1. Before referral confirm history (including time period) of cognitive decline from patient or independent informant;
exclude delirium with recent onset of cognitive impairment. Communicate the carers views to the specialist where
they are assessed.
2. As per NICE guidance before referral undertake initial dementia blood screening (blood glucose, FBC, U&E,
calcium, B12, folate, TFTs & LFTs).
Date approved: 09/2015
Review date: 09/2018
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SHARED CARE PRESCRIBING GUIDELINE
SHARED CARE
Diagnosis of Alzheimer’s disease of mild to moderate severity with non-cognitive symptoms, severe
Alzheimer’s Disease with or without non-cognitive symptoms, Parkinson’s Disease Dementia, or Lewy Body
Dementia:
Assessments related to functional, cognitive and behaviour of the patient will be undertaken by the specialist and
communicated to the GP as per the specialist responsibilities in section 2.
GP recommended action
Continue prescribing after
specialist has commenced
treatment for at least 4-12 weeks
(duration will depend on severity,
indication and tolerability of the
medicine), by when serious
adverse effects have been
excluded and patient has been
stabilised.
Encourage adherence
Comment
Supply the formulation as
recommended by the specialist
and add to the practice system as
per local prescribing
recommendation in relation to
quantities and duration of review.
Management
Support and education of patients
and carers.
Refer back to a specialist if there
is poor adherence or the patient
asks to stop.
For more information on
prescribing for non-cognitive
symptoms associated with
dementia, refer to: Medicines for
behavioural and psychological
symptoms in dementia (BPSD).
See the SWLStG website:
http://www.swlstg-tr.nhs.uk/forhealth-professionals/
Report any adverse reactions to
the MHRA via the ‘yellow card
system’.
Monitor any side effects of
medication or interaction(s)
Monitor general health
Communicate Physical
observations to specialist teams
at least annually as per NICE
guidance.
If there is clinical deterioration,
refer back to the specialist team.
No specific physical health
checks are recommended for
these medicines other than those
at baseline and initiation or dose
change.
Stop the medicine and refer back
where there are intolerable or
serious side-effects (see section
5).
Refer back if there are new major
co-morbid contraindications that
mean the medicine needs to be
stopped e.g. acute cardiac
deterioration.
Patient and carers’ responsibilities
Should report any adverse effects, deterioration and response to medicines to the mental health team and/or GP.
Date approved: 09/2015
Review date: 09/2018
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SHARED CARE PRESCRIBING GUIDELINE
3.
COMMUNICATION AND SUPPORT
Specialist contacts:
(the referral letter will indicate named specialist)

Kingston Older Peoples (OP) CMHT 020 3513 5205

Kingston Dementia Support Service: 020 8549 4747

Merton OP CMHT 020 3513 6325

Richmond OP CMHT 020 3513 3680

Sutton OP CMHT 020 8335 4116

Wandsworth OP CMHT 020 3513 6320
Out of hours contacts & procedures:
Advice via on call specialist doctor (organisation
switchboard) or on call Mental Health Pharmacist
via SWLStG switchboard (020 3513 5000).
Fax:
E-mail:
Kingston Dementia Support Service:
[email protected]
Specialist support/resources available to GP including patient information:
Information is available from your psychiatric Medicines Information (MI): 020 3513 6829 and the ‘Choice and
Medication’ website (http://www.choiceandmedication.org/swlstg-tr/)
Patient information leaflets in 10 different languages available from SWLStG intranet, contact Mental health
team or MI above for copies.
Date approved: 09/2015
Review date: 09/2018
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SHARED CARE PRESCRIBING GUIDELINE
4. CLINICAL INFORMATION
Indication(s)
Place in therapy
Therapeutic summary
Dose and route of
administration
Acetylcholinesterase inhibitors (donepezil, galantamine and rivastigmine) are licensed
for the treatment of mild to moderate Alzheimer’s disease. Additionally, rivastigmine
is licensed for the treatment of mild to moderate dementia in Parkinson’s disease.
Memantine is licensed for the treatment of moderate to severe Alzheimer's disease.
Acetylcholinesterase inhibitors are recommended as 1st line treatment for mild to
moderate Alzheimer’s disease (and rivastigmine for the treatment of mild to moderate
dementia in Parkinson’s disease or dementia with Lewy body).
Memantine may be used 2nd line for moderate severity Alzheimer’s dementia where
acetylcholinesterase inhibitors are ineffective or not tolerated. Combination treatment
with memantine and an acetylcholinesterase inhibitor is not recommended, and
should only be initiated on approval from SWLStG Drug and Therapeutics committee
as it is outside this agreement and NICE guidance.
Rivastigmine patches may be used where there are swallowing difficulties or where
there has been a best interests discussion approving the use of covert administration
(following organisational policy) or the patient is under the Mental Health Act.
The patches should be switched to oral as soon as clinically appropriate. Doses of
4.6mg and 9.5mg/24 hour patch correspond to 3mg BD PO and 6mg BD PO
respectively. Manufacturers advise to consider re-titration in cases where GI side
effects occur. Lower oral doses may be used in situations where this has been agreed
with the specialist.
Donepezil, galantamine & rivastigmine: acetylcholinesterase inhibition
Memantine: moderate affinity and uncompetitive n-methyl- D-aspartate receptor
antagonism
Titration week & dose (mg)
Medicine
Frequency
1
2
3
4
5
7
9
Donepezil 1st line
Daily (oral)
5
10
Galantamine 2nd line
Daily (oral)
8
16
24
(modified release)
Galantamine
4
8
12
Twice daily (oral)
Rivastigmine
1.5
3
4.5
6
Twice daily (oral)
Daily (clean dry skin)
4.6
9.5
Rivastigmine patch*
Memantine
Daily (oral)
5
10 15 20
Dose of rivastigmine patch may be increased to 13.3mg/24hrs after 6 months if required
Duration of treatment
The Psychiatrist will decide when treatment should be stopped. This is considered if:




Poor concordance
Major adverse effects
Patient asks to stop
Medication not effective (global, functional & behavioural condition is below a level
where the drug is considered to have a worthwhile effect e.g. which may be an
SMMSE <10)
 GPs should refer back to a specialist should a patient need to stop their
medicines.
Summary of adverse
effects
Adverse effect
Acetylcholinesterase Gastro-intestinal
symptoms (incl. anorexia,
inhibitors
(See Summary of Product
Characteristics (SmPC) for
full list or BNF)
Very common: >1/10
Common: >1/100, <1/10
Uncommon: >1/1000, <1/100
Rare: >1/10,000, <1/1000
nausea, vomiting,
diarrhoea)
May enhance
predisposition to peptic
ulceration
Date approved: 09/2015
Review date: 09/2018
Version 201701
Frequency
Very common
Uncommon / rare
Management
Refer to specialist who may
try an alternative
acetylcholinesterase inhibitor
or switch to memantine if
severe
Care with active or
predisposition to gastric or
duodenal ulcers. Consult
specialist.
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SHARED CARE PRESCRIBING GUIDELINE
May cause bradycardia
Uncommon / rare
May cause
bronchoconstriction
No data available
May exacerbate bladder
outflow problems
No data available
May lower seizure
threshold
Hepatic impairment
(galantamine,
rivastigmine)
Renal impairment
(galantamine,
rivastigmine)
Syncope (donepezil,
galantamine &
rivastigmine)
Fatigue, dizziness and
muscle cramps
Uncommon / rare
No data available
No data available
Uncommon / rare
Common
Memantine
(See Summary of Product
Characteristics (SmPC) for
full list or BNF)
Somnolence
Dizziness
Common
Common: >1/100, <1/10
Uncommon: >1/1000, <1/100
Hypertension
Common
Dyspnoea
Common
Constipation
Headache
Fungal infections
Gait abnormal
Venous
thrombosis/thromboembol
ism
Confusion
Hallucinations
Psychosis
Fatigue
Date approved: 09/2015
Review date: 09/2018
Version 201701
Stop treatment and consult
specialist. Caution in “sick
sinus syndrome”, sinoatrial
or atrioventricular block or
concomitant treatment with
digoxin or beta-blockers
Avoid in COPD or asthma,
consult specialist to review
treatment.
Caution if history of prostatic
conditions, urinary retention.
(Galantamine contraindicated in obstruction or
post bladder surgery)
Review treatment with
specialist if seizures develop
as may be caused by
underlying disease.
Contra-indicated in severe
impairment. Stop treatment
and consult specialist.
Contra-indicated in severe
impairment. Stop treatment
and consult specialist.
Consult specialist.
Common
Uncommon
Uncommon
Uncommon
(not known for psychosis)
The ability of the patient to
continue driving or operating
complex machinery should
be evaluated. Consult
specialist if problematic for
the patient.
The ability of the patient to
continue driving or operating
complex machinery should
be evaluated. Consult
specialist if problematic for
the patient.
Avoid in those with
uncontrolled hypertension or
cardiac disease. Review
treatment with a specialist if
this develops.
Avoid in those with
uncontrolled COPD or
asthma, consult specialist to
review treatment.
Refer back to psychiatrist if
severe or is not self-limiting.
Refer back to psychiatrist if
severe.
Refer for treatment of VTE,
and review memantine with
a specialist.
Refer back to specialist for
review.
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SHARED CARE PRESCRIBING GUIDELINE
Pancreatitis
Vomiting
Monitoring
Requirements:
Unknown
(uncommon for vomiting)
Stop if severe, refer back to
specialist.
There are no specific physical health checks recommended for ongoing monitoring of
these medicines. Assessments are of the functional, cognitive & behavioural features
of dementia are required (as recommended in the specialist and GP responsibilities
above).
Twelve-monthly review at the specialist service (functional, cognitive and behavioural
clinical assessment), review may be more frequent dependent upon clinical needs of
the patient.
Review of adherence and physical health is recommended.
Clinically relevant drug
interactions:
(See (SmPC) for full list)
Acetylcholinesterase inhibitors:
Erythromycin, ketoconazole & itraconazole, fluoxetine, paroxetine, fluvoxamine
increase plasma concentration of galantamine and donepezil
Quinidine increases plasma concentration of donepezil
Enzyme inducers may reduce levels of donepezil
Donepezil, galantamine, rivastigmine may alter effect of succinylcholine-type muscle
relaxants
All three AChEIs are not to be given with cholinomimetics and are antagonised by
anticholinergic medications
Memantine:
Ketamine, Dextromethorphan & Amantadine avoid concomitant use, increased risk of
CNS toxicity (psychosis).
Dantrolene & Baclofen’s effects are modified.
Warfarin, Selegiline, antimuscarincs & dopaminergics effects are enhanced.
Primidone, antipsychotics & Barbiturates therapeutic effects may be reduced.
Cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine may cause
increase in memantine serum levels.
Date approved: 09/2015
Review date: 09/2018
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SHARED CARE PRESCRIBING GUIDELINE
Practical issues:
Ensure medicines are prescribed generically and orodispersible preparations,
solutions and patches should usually be reserved for those with swallowing difficulties
only.
Donepezil
Oral: once daily
Tablets (5mg & 10mg)
Orodispersible tablets (5mg & 10mg)
Galantamine Oral: twice daily:
Tablets (4mg, 8mg & 12mg)
Solution (4mg in 1ml)
once daily:
XL prolonged release capsules (8mg, 16mg, 24mg)
Rivastigmine Oral: twice daily
Capsules (1.5mg, 3mg, 4.5mg, 6mg)
Solution (2mg in 1ml)
Transdermal patches: skin patch replaced once a day
(4.6mg/24hours, 9.5mg/24hours, 13.3mg/24hrs)
Memantine Oral: once daily
5mg/pump oral solution (pump five times before first use, refer to
patient information leaflet for more information available at
www.medicines.org.uk)
Tablets (10mg and 20 mg)
NICE recommendation for acetylcholinesterase inhibitors: Use the drug with the
lowest acquisition cost (taking into account the daily dose, adverse effects, comorbidity, drug interactions and dosing profile). Donepezil is currently recommended
as the 1st line acetylcholinesterase inhibitor for mild to moderate Alzheimer’s disease.
If a patient does not tolerate one acetylcholinesterase inhibitor (e.g. due to diarrhoea),
it may be reasonable to try another (see SmPC for full details) or switch to
memantine.
*N.B. Rivastigmine is also licensed for the symptomatic treatment of Parkinson’s
disease Dementia (PDD), and its use as described in the NICE Clinical Guideline 42
for PDD is supported and included under this shared prescribing guideline. The
respective areas of responsibility of the specialist and the GP remain the same as for
its use in Alzheimer’s Disease (as outlined in Section 2).
Key references:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Date approved: 09/2015
Review date: 09/2018
Version 201701
Lyketsos CG, Steele C, Galik E, et al. Physical aggression in dementia patients and its relationship to
depression. American Journal of Psychiatry 1999;156(1):66–71.
Levy ML, Cummings JL, Fairbanks LA, et al. Longitudinal assessment of symptoms of depression,
agitation, and psychosis in 181 patients with Alzheimer’s disease. American Journal of Psychiatry
1996;153(11):1438–43.
Holtzer R, Tang MX, Devanand DP, et al. Psychopathological features in Alzheimer’s disease: course
and relationship with cognitive status. Journal of the American Geriatrics Society 2003;51(7): 953–60.
Parnetti L, Amici S, Lanari A, Gallai V. Pharmacological treatment of non-cognitive disturbances in
dementia disorders. Mechanisms of Ageing and Development, 2001;122(16): 2063–9.
Schneider et al, Clinical Antipsychotic Trials of Intervention Effectiveness- Alzheimer’s disease
(CATIE-AD) trial. NEJM 2006;355:1525-1538.
NICE Technology Appraisal 217, March 2011 (replaces NICE TA 111, November 2006) Alzheimer's
disease - donepezil, galantamine, rivastigmine and memantine
NICE Clinical Guideline 42, November 2006 (updated Oct 2012 and includes TA 217) Dementia:
supporting people with dementia and their carers in health and social care British National Formulary,
65th Edition accessed on line, 16/8/13. www.BNF.org
Summaries of Product Characteristics for Aricept , Exelon, Reminyl (as of January 25th 2008)
http://www.medicines.org.uk/, document histories checked for updates (24/8/15)
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