Download 1. circumstances when shared care is appropriate

Antidementia Medicines Shared Care Agreement
Section A: To be completed by the hospital consultant initiating the 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): …………………………
Consultant name: ……………………………
Clinic name: ………………………………….
Contact details:
Address: .........................................................................................................................
Tel no: ……………………………………… Fax no: ………………………………………
NHS.net e-mail: ……………………………
Diagnosis & Severity:
Drug name & dose to be prescribed by GP:
……………………………………………………
Next hospital appointment: ……/……/……..
…………………………………………………………….
Dear Dr. ……………………..,
Your patient was seen on …../..…/….. and I have started …………………………………………….(insert
drug name and dose) for the above diagnosis. I am requesting your agreement to sharing the care of this
patient from …../.…./…….. in accordance with the (attached) Shared Care Prescribing Guideline (approval
date: …./…./……..). Please take particular note of Section 2 where the areas of responsibilities for the
consultant, GP and patient for this shared care arrangement are detailed.
Patient information has been given outlining potential aims and side effects of this treatment and
……………………………………* supplied (* insert any support materials issued such as patient held monitoring book etc
where applicable). The patient has given me consent to treatment possibly under a shared care prescribing
agreement (with your agreement) and has agreed to comply with instructions and follow up requirements.
.
The following investigations have been performed on ……/……/……… and are acceptable for shared care.
Please monitor………...........every ………..
Test / Assessment Tool
Result / Score
Test / Assessment Tool
Result / Score
Other relevant information: ………………………………………………………………………………………..
………………………………………………………………………………………………………………………..
Section B: To be completed by the GP and returned to the hospital consultant as
detailed in 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: …/…/…..
1
working in partnership
SHARED CARE PRESCRIBING GUIDELINE
Treatment of Alzheimer’s disease with acetylcholinesterase inhibitors (AChEIs) for
mild to moderate severity, or with memantine for moderate severity
(where AChEIs cannot be used) or in severe disease.
Additionally, the use of rivastigmine for Parkinson’s disease 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 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?
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 consultant 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 updated (by Jonathan Cavan): 16/08/2013
Review date:
Feb 2016
South West London Mental Health Interface
Approved by (date approved):
Prescribing Forum (25/09/2013)
SWL & St. George’s Mental Health NHS Trust’s DTC
(3/6/15)
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
Kingston CCG
SWL & St. George’s Mental Health NHS Trust
Dr Anthony Hughes, GP on behalf of Medicines
Dr. Debbie Stinson (Old Age Psychiatrist)
Management Committee
Dianne Adams (Chief Pharmacist)
Seema Buckley, Chief Pharmacist
Richmond CCG
St George’s Healthcare NHS Trust
Dr Darren Tymens, Associate Medical Director
Dr. Jeremy Isaacs (Neurologist, Dementia)
Emma Richmond, Head of Medicines Management
Chris Evans (Chief Pharmacist)
Merton CCG
Dr Andrew Otley, Mental Health Lead
Sedina Agama, Interim Chief Pharmacist
NHS Wandsworth
Dr Gillian Ostrowsky, Associate Medical Director
Nick Beavon, Chief Pharmacist
Sutton CCG
Dr Chris Keers, Mental Health Lead
Sarah Taylor, Interim Chief Pharmacist
Date prepared: 16/08/2013
Date approved: 25/09/2013
Review date: Feb 2016
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SHARED CARE PRESCRIBING GUIDELINE
Acetylcholinesterase Inhibitors and Memantine
1.
CIRCUMSTANCES WHEN SHARED CARE IS APPROPRIATE
 Prescribing responsibility will only be transferred when the consultant and the GP are in agreement
that the patient’s condition is stable or predictable and in accordance with NICE Technological
Appraisal 217.
 Patients will only be referred to the GP once the GP has agreed in each individual case and the
hospital will continue to provide prescriptions until successful transfer of responsibilities as outlined
below.
 The hospital will provide the patient with a minimum initial supply of 4 weeks therapy.
2.
AREAS OF RESPONSIBILITY
Consultant (Old Age or Learning Disabilities Psychiatrist, Care of the Elderly Physician or Neurologist)
1. Confirm diagnosis of Alzheimer’s disease (or Parkinson’s disease 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) 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
3. When clinically appropriate undertake a CT or MRI scan to exclude vascular aetiology or other pathology.
4. 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.
5. Assess patient’s capacity and seek consent including, where appropriate, consultation with carers
6. Identify a carer who will undertake to monitor concordance.
7. Seek agreement that treatment will be stopped if no benefit or if deterioration.
8. Prescribe for at least the first 4 weeks and seek GP agreement to shared prescribing.
9. Exclude serious adverse effects during dose escalation.
10. Check for interactions with other medicines.
11. Report any serious adverse effects to the MHRA via ‘yellow card system’.
12. Arrange secondary care assessment after one month, then at 2-4 months, and every 6-12 months
thereafter (whilst patient is still receiving the drug or discharged to primary care).
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 regularly to commissioners.
Date prepared: 16/08/2013
Date approved: 25/09/2013
Review date: Feb 2016
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SHARED CARE PRESCRIBING GUIDELINE
GP
Before referral:
1. Confirm history of cognitive decline from patient or independent informant.
2. Undertake initial dementia blood screening (blood glucose, FBC, U&E, B12, folate, TFTs & LFTs).
3. Conduct an initial cognitive assessment.
After confirmation of diagnosis:
4. Continue prescribing after specialist has commenced treatment for at least 4 weeks, by when serious
adverse effects have been excluded and the patient is stabilised.
5. Ensure on-going engagement with secondary care services.
6. Encourage concordance.
7. Monitor any side effects of medication.
8. Monitor general health and liaise with secondary care where appropriate.
9. Report any adverse reactions to the MHRA via the ‘yellow card system’.
10. Check for interactions with other medicines subsequently prescribed.
11. Refer back to secondary care between regular reviews if concerned about patient’s condition (see below).
12. Support and education of patients and carers.
NB: results of all tests and investigations should be copied by / to both consultant and GP
Patient and carers’
1. Ensure any adverse effects, deterioration and response to medicines is reported to the mental health
team and/or GP.
3.
COMMUNICATION AND SUPPORT
Hospital contacts:
Out of hours contacts & procedures:
(the referral letter will indicate named consultant)
Hospital name
Consultant names
Tel:
Fax:
E-mail:
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 prepared: 16/08/2013
Date approved: 25/09/2013
Review date: Feb 2016
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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 (donepezil
being the preferred formulary choice) for mild to moderate Alzheimer’s disease (and
rivastigmine for the treatment of mild to moderate dementia in Parkinson’s disease).
Memantine may be used 2nd line for moderate severity Alzheimer’s dementia where
acetylcholinesterase inhibitors are ineffective or not tolerated. It may also be used in
the treatment of severe Alzheimer’s disease. Combination treatment with memantine
and an acetylcholinesterase inhibitor is not recommended.
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
Daily (oral)
5
10
Galantamine
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
*Manufacturer advises that treatment with rivasitgmine should be temporarily interrupted if
gastrointestinal adverse reactions are observed until these adverse reactions resolve
(gastrointestinal disturbances less likely with patches, refer to BNF for guidance on
switching between capsules and patches). Treatment can be resumed at the same dose if
treatment is not interrupted for more than three days. Otherwise treatment should be retitrated from 1.5mg twice daily or the 4.6 mg/24 h patch. 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:




Summary of adverse
effects
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)
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
Frequency
Very common
Uncommon / rare
May cause bradycardia
Uncommon / rare
Date prepared: 16/08/2013
Date approved: 25/09/2013
Review date: Feb 2016
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.
Stop treatment and consult
specialist. Caution in “sick
sinus syndrome”, sinoatrial
or atrioventricular block or
concomitant treatment with
digoxin or beta-blockers
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SHARED CARE PRESCRIBING GUIDELINE
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
Pancreatitis
Vomiting
Monitoring
Requirements:
Date prepared: 16/08/2013
Date approved: 25/09/2013
Review date: Feb 2016
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)
Unknown
(uncommon for vomiting)
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.
Stop if severe, refer back to
specialist.
Six to twelve-monthly review in secondary care (cognitive and behavioural clinical
assessment) unless accepted for discharge back to primary care
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SHARED CARE PRESCRIBING GUIDELINE
Clinically relevant drug
interactions:
(See (SmPC) for full list)
Practical issues:
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.
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 consultant and the GP remain the same as for
its use in Alzheimer’s Disease (as outlined in Section 2).
Date prepared: 16/08/2013
Date approved: 25/09/2013
Review date: Feb 2016
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SHARED CARE PRESCRIBING GUIDELINE
Key references:
Date prepared: 16/08/2013
Date approved: 25/09/2013
Review date: Feb 2016
1. NICE Technology Appraisal 217, March 2011 (replaces NICE TA 111, November
2006) Alzheimer's disease - donepezil, galantamine, rivastigmine and memantine
2. 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
3. British National Formulary, 65th Edition accessed on line, 16/8/13. www.BNF.org
4. Summaries of Product Characteristics for Aricept, Exelon, Reminyl (as of
January 25th 2008) http://www.medicines.org.uk/, document histories checked for
updates (16/8/13)
5. Summary of Product Characteristics. Ebixa 5mg/pump oral solution, 20mg and 10
mg Tablets and Treatment Initiation Pack. last updated on the eMC: 24/5/2012.
http://www.medicines.org.uk/
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