Antidementia Medicines Shared Care Agreement
Section A: To be completed by the hospital consultant initiating the treatment
GP Practice Details:
Name: ………………………………………
Address: ……………………………………
Tel no: ………………………………………
Fax no: ………………………………………
NHS.net e-mail: …………………………… / Patient Details:
Name: ………………………………………………
Address: ……………………………………………
DOB: ……/………/…………
Hospital number: …………………………………
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: …/…/…..

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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 ofrivastigmine 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
Approved by (date approved):
SWL & St. George’s Mental Health NHS Trust’s DTC (3/6/15) / South West London Mental Health Interface Prescribing Forum(25/09/2013)

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
Dr Anthony Hughes, GPon behalf of Medicines Management Committee
Seema Buckley, Chief Pharmacist / SWL & St. George’s Mental Health NHS Trust
Dr. Debbie Stinson (Old Age Psychiatrist)
Dianne Adams (Chief Pharmacist)
Richmond CCG
Dr Darren Tymens, Associate Medical Director
Emma Richmond, Head of Medicines Management / St George’s Healthcare NHS Trust
Dr. Jeremy Isaacs (Neurologist, Dementia)
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

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Date prepared: 16/08/2013

Date approved:25/09/2013

Review date: Feb 2016

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
  1. When clinically appropriate undertake a CT or MRI scan to exclude vascular aetiology or other pathology.
  2. 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.
  3. Assess patient’s capacity and seek consent including, where appropriate, consultation with carers
  4. Identify a carer who will undertake to monitor concordance.
  5. Seek agreement that treatment will be stopped if no benefit or if deterioration.
  6. Prescribe for at least the first 4 weeks and seek GP agreement to shared prescribing.
  7. Exclude serious adverse effects during dose escalation.
  8. Check for interactions with other medicines.
  9. Report any serious adverse effects to the MHRA via ‘yellow card system’.
  10. 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).
  11. Seek carers views of patient’s condition at baseline and at each follow-up.
  12. 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)
  1. Activity /audit report regularly to commissioners.

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:
  1. 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.
  2. Ensure on-going engagement with secondary care services.
  3. Encourage concordance.
  4. Monitor any side effects of medication.
  5. Monitor general health and liaise with secondary care where appropriate.
  6. Report any adverse reactions to the MHRA via the ‘yellow card system’.
  7. Check for interactions with other medicines subsequently prescribed.
  8. Refer back to secondary care between regular reviews if concerned about patient’s condition (see below).
  9. Support and education of patients and carers.

NB: results of all tests and investigations should be copied by / to both consultant and GP
Patientand 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:
(the referral letter will indicate named consultant) / Out of hours contacts & procedures:
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 (
Patient information leaflets in 10 different languages available from SWLStG intranet, contact Mental health
team or MI above for copies.

4.CLINICAL INFORMATION

Indication(s) / 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.
Place in therapy / Acetylcholinesterase inhibitorsare 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.
Therapeutic summary / Donepezil, galantamine & rivastigmine: acetylcholinesterase inhibition
Memantine: moderate affinity and uncompetitive n-methyl- D-aspartate receptor antagonism
Dose and route of administration / Medicine / Frequency / Titration week & dose (mg)
1 / 2 / 3 / 4 / 5 / 7 / 9
Donepezil / Daily (oral) / 5 / 10
Galantamine
(modified release) / Daily (oral) / 8 / 16 / 24
Galantamine / Twice daily (oral) / 4 / 8 / 12
Rivastigmine* / Twice daily (oral) / 1.5 / 3 / 4.5 / 6
Rivastigmine patch* / Daily (clean dry skin) / 4.6 / 9.5
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 re-titrated 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:
  • 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)

Summary of adverse effects / Adverse effect / Frequency / Management
Acetylcholinesterase 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 / Gastro-intestinal symptoms (incl. anorexia, nausea, vomiting, diarrhoea) / Very common / Refer to specialist who may try an alternative acetylcholinesterase inhibitor or switch to memantine if severe
May enhance predisposition to peptic ulceration / Uncommon / rare / Care with active or predisposition to gastric or duodenal ulcers. Consult specialist.
May cause bradycardia / Uncommon / rare / Stop treatment and consult specialist. Caution in “sick sinus syndrome”, sinoatrial or atrioventricular block or concomitant treatment with digoxin or beta-blockers
May cause bronchoconstriction / No data available / Avoid in COPD or asthma, consult specialist to review treatment.
May exacerbate bladder outflow problems / No data available / Caution if history of prostatic conditions, urinary retention. (Galantamine contra-indicated in obstruction or post bladder surgery)
May lower seizure threshold / Uncommon / rare / Review treatment with specialist if seizures develop as may be caused by underlying disease.
Hepatic impairment (galantamine, rivastigmine) / No data available / Contra-indicated in severe impairment. Stop treatment and consult specialist.
Renal impairment (galantamine, rivastigmine) / No data available / Contra-indicated in severe impairment. Stop treatment and consult specialist.
Syncope (donepezil, galantamine & rivastigmine) / Uncommon / rare / Consult specialist.
Fatigue, dizziness and muscle cramps / Common / The ability of the patient to continue driving or operating complex machinery should be evaluated. Consult specialist if problematic for the patient.
Memantine
(See Summary of Product Characteristics (SmPC) for full list or BNF)
Common: >1/100, <1/10
Uncommon: >1/1000, <1/100 / Somnolence
Dizziness / Common / The ability of the patient to continue driving or operating complex machinery should be evaluated. Consult specialist if problematic for the patient.
Hypertension / Common / Avoid in those with uncontrolled hypertension or cardiac disease. Review treatment with a specialist if this develops.
Dyspnoea / Common / Avoid in those with uncontrolled COPD or asthma, consult specialist to review treatment.
Constipation
Headache / Common / Refer back to psychiatrist if severe or is not self limiting.
Fungal infections
Gait abnormal / Uncommon / Refer back to psychiatrist if severe.
Venous thrombosis/thromboembolism / Uncommon / Refer for treatment of VTE, and review memantine with a specialist.
Confusion
Hallucinations
Psychosis
Fatigue / Uncommon
(not known for psychosis) / Refer back to specialist for review.
Pancreatitis
Vomiting / Unknown
(uncommon for vomiting) / Stop if severe, refer back to specialist.
Monitoring Requirements: / Six to twelve-monthly review in secondary care (cognitive and behavioural clinical assessment) unless accepted for discharge back to primary care
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, DextromethorphanAmantadine avoid concomitant use, increased risk of CNS toxicity (psychosis).
DantroleneBaclofen’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.
Practical issues: / Ensure medicines are prescribed genericallyand 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

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, co-morbidity, 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).
Key references: /
  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.
  4. Summaries of Product Characteristics for Aricept, Exelon, Reminyl (as of January 25th 2008) 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.

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Date prepared: 16/08/2013

Date approved: 25/09/2013

Review date: Feb 2016