Shared Care Guideline: For the Management of Patients Receiving Memantine

Transcription

1 SH CP 148 Shared Care Guideline: For the Management of Patients Receiving Memantine Summary: Keywords (minimum of 5): (To assist policy search engine) Target Audience: This shared care guideline has been produced to support the seamless transfer of prescribing and patient monitoring from secondary to primary care, and provides an information resource to support clinicians providing care to the patient. Memantine, Dementia, Alzheimer s disease, behavioural and psychological symptoms. Heads of Professions, Medical Staff, Nursing Staff working in clinical areas, Pharmacists, MHPs. Next Review Date: January Approved & Ratified by: Medicines Management Committee Portsmouth APC: 2013 Date of meeting: May 2013 Dec 2013 Date issued: Author: Sponsor: Dr V R Badrakalimuthu, OPMH Consultant Dr Helen McCormack, Chief Medical Officer 1

2 Version Control Change Record Amend. No. Issued Page Subject 1 V1 Feb & 9 Indications and dosage clarified (2.0) 2 V2 Jan Full revision in response to updated NICE guidelines. Page 9: Indication clarified (moderate-severe) Contact number for OPMH added Secondary care to send copy of shared care (6.0) Reviewers/contributors Name Position Version Reviewed & Date 2

3 Name of patient treated under this guideline: NHS number: Contact number for OPMH team: This shared care guideline has been produced to support the seamless transfer of prescribing and patient monitoring from secondary to primary care, and provides an information resource to support clinicians providing care to the patient. It does not replace discussion about sharing care on an individual patient basis. This guideline was prepared using information available at the time of preparation, but users should always refer to the manufacturer s current edition of the Summary of Product Characteristics (SPC or data sheet ) for more details. 1. Status of Memantine Memantine is an amber drug using our local traffic light system. This means that treatment will usually be initiated in secondary care and may be transferred to primary care if the initial response is good. The key principle is that the GP is provided with information and given the opportunity to accept (or decline) prescribing responsibility before the transfer occurs. 2. Indications and Dose Memantine is licensed for the treatment of moderate to severe Alzheimer s disease. Memantine acts on NMDA receptors by inhibiting glumatergic pathways thus preventing neuronal death by limiting intracellular influx of calcium. Memantine apart from its beneficial effect on cognitive outcomes, global outcomes and activities of daily living, also decreases agitated and aggressive behaviour, irritability, labile affect and appetite. NICE guidelines (TA 217) recommend Memantine for moderate Alzheimer s disease in patients who are unable to take acetylcholinesterase inhibitors and for severe Alzheimer s disease. NICE guidelines CG42 highlight the difficulty of treating patient groups with agitation/aggression because of the increased risk of cerebrovascular adverse events and death associated with antipsychotic use. NICE guidelines CG42 state that antipsychotics should therefore only be used in subjects with severe signs of agitation/aggression following an individual risk-benefit analysis. This includes balancing the risk of increasing cerebrovascular adverse events against the severe distress or immediate risk of harm to the person with dementia or others. Due to the potential for accumulated time dependent adverse events and mortality following the use of antipsychotics NICE guidelines CG42 advocates that the use of antipsychotics should be time limited. Within this context Memantine can be initiated as second line treatment by a consultant for patients with moderately severe to severe Alzheimer s disease with severe signs of agitation following an individual risk-benefit analysis in which it is felt 3

4 that either the initiation or continued use of antipsychotic treatment confers too high a risk compared with its possible benefit. For Alzheimer s Disease patients with moderate agitation Memantine can be used as second line treatment following unsuccessful management with Citalopram but consideration should also be given to trying an alternative antidepressant first (Trazodone or Mirtazapine). Dose: Memantine The starting dose is 5mg in the morning for 1 week. Initially 5 mg once daily, increased in steps of 5 mg at weekly intervals to max. 20 mg daily. The tablets can be taken with or after food. 3. Referral Criteria Consultants will consider Memantine for patients referred to them with the indications described in section Patient Selection All of the following conditions apply 4.1 Patients with moderate and severe Alzheimer s disease (ICD-10). 4.2 Patients with moderate or severe signs of agitation. 4.3 Patients at high risk of cerebrovascular adverse effects following the initiation or continuation of an antipsychotic (severe agitation) or antidepressant (moderate agitation) following the managing behaviour problems in patients with dementia guidelines. High risk factors include diabetes; hypertension; hyperlipidaemia; atrial fibrillation and a history of previous stroke. 4.4 Diagnosis is made by a specialist team according to standard diagnostic criteria. 4.5 There has been an assessment of compliance. 4.6 Treatment should be continued, only when it is considered to be having a worthwhile effect on cognitive, global, functional or behavioural symptoms. 4.7 NICE guidelines TA 217 recommends that review by a specialist may be substituted by a shared care arrangement because this may put less pressure on local resources while still ensuring optimal treatment for patients. 5. Safety Issues 5.1 Contra-indications (see BNF or SPC) Pregnancy and breast feeding 4

5 5.2 Cautions (see BNF or SPC) Renal impairment. Avoid if severe. Epilepsy. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension patients should be closely supervised. 5.3 Common Side Effects (See BNF or SPC) Common side effects include confusion, headache, hallucinations, tiredness and less commonly vomiting, anxiety, hypertension, cystitis and increased libido. 5.4 Drug Interactions (see BNF or SPC) Ketamine; dextromethorphan. Possible interactions with primidone; antimuscarinics; antipsychotics; barbiturates; dopaminegics, selegiline; amantadine; baclofen and dantrolene. 5.5 Pre-treatment Assessment (a) GP Medical history Cognitive examination Availability of care giver to monitor compliance Full blood count. Folate, urea and electrolyte, blood glucose, TSH, liver function, B12 creatinine tests. (b) Secondary care Cognitive function Behaviour and psychiatric symptoms Carer burden Availability of carer to supervise medication and ensure compliance Brain imaging if indicated If clinically appropriate treatment is initiated. 5.6 Routine Safety Monitoring Parameter Compliance checks Adverse effects Check for interactions with newly prescribed drugs By Whom Primary and Secondary care Primary and Secondary care Primary and Secondary care 6. Role of Secondary Care Team (a) To assess the suitability of the patient for the drugs (b) To carry out initial investigations (c) To give the patient the appropriate drug information leaflets (d) To complete copy of shared care guidelines and send it to the GP (e) To explain the possible side effects of the medication to the patient (f) To emphasise the need for the carer to supervise medication and ensure compliance 5

6 (g) To initiate treatment and monitor patient until maintenance dose has been reached (h) To write to the GP enclosing a copy of these guidelines requesting that a shared care agreement be initiated and provide clear information on the indication for use of memantine treatment objectives and recommended review dates and treatment objectives (i) To arrange follow up two months after reaching maintenance dose keep GP informed of any changes and recommendation from the follow-up at 2 months. (j) To decide when to stop therapy and inform GP with in the 2 months of follow-up. Secondary care may stop medication completely or instigate a trial discontinuation/drug holiday of no more than six weeks with review after two to four weeks. If marked deterioration is evident during this period, reinstating Memantine is advocated. If there is no deterioration after a drug holiday, then secondary care will recommend the GP to discontinue prescribing. This will be explained to the patient and carer by secondary care. 7. Role of GP (a) To refer patients with moderately severe to severe dementia to CMHT and undertake assessment and investigations as outlined in 5.5(a). (b) To ensure all relevant staff within the practice are aware of the shared care guidelines. (c) To provide prescriptions of the drug once a maintenance dose has been achieved. (d) To monitor for compliance. (e) To monitor for side-effects. (f) To monitor for progress of dementia, behavioural and psychological problems and change in activities of daily living. (g) To be aware of drug-interactions whilst changing medications. (h) To refer back to secondary care if there is deterioration in mental state after ruling out delirium, emergence of behavioural and psychological symptoms, change in care needs, when considering cessation of treatment due to poor compliance, lack of adverse consequences or if the patient asks to stop. 8. Responsibilities of the Carer (a) To assist in completion of carer burden assessment (b) Ensure compliance (c) Report any side effects 9. Cessation of treatment Cessation of treatment may be recommended if: Evidence of poor compliance with no available strategies to improve compliance Major adverse effects Patient asks to stop Continued agitation despite full maintenance dose for one month Drug holiday demonstrates that treatment is no longer needed Focus of treatment is end-of-life care and palliation. 6

7 Memantine for Dementia Abridged GP Summary as part of Shared Care Agreement This guideline was prepared using information available at the time of preparation, but users should always refer to the manufacturer s current edition of the Summary of Product Characteristics (SPC or data sheet ) for more details. For further information please refer to the full Shared Care Guideline. Licensed indications Memantine (Ebixa) is licensed for use in the treatment of Alzheimer s disease, specifically for moderate to severe disease. Following NICE review of guidance TA217 Memantine is recommended for the treatment of moderate to severe Alzheimer s disease. Memantine acts on NMDA receptors by inhibiting glumatergic pathways thus preventing neuronal death by limiting intracellular influx of calcium. Memantine apart from its beneficial effect on cognitive outcomes, global outcomes and activities of daily living, also decreases agitated and aggressive behaviour, irritability, labile affect and appetite. Patient Selection by OPMH consultant Patients with moderate to severe Alzheimer s disease (ICD-10) may be prescribed Memantine. A commonly used assessment of severity is the mini-mental state examination (MMSE) score (mild Alzheimer s Disease MMSE 21-26; moderate MMSE 10-20; severe <10 points). However, when using assessment scales to determine severity of Alzheimer s disease, healthcare professionals should take into account any physical, sensory or communication difficulties or learning disabilities that could affect the results and make any adjustments they consider appropriate. This includes the use of alternative assessments that do not rely solely on cognitive scores. Patients with moderate or severe signs of agitation. Patients at high risk of cerebrovascular adverse effects following the initiation or continuation of an antipsychotic (severe agitation) or antidepressant (moderate agitation) following the managing behaviour problems in patients with dementia guidelines. Role of GP (i) (j) (k) (l) (m) (n) (o) (p) To refer patients with moderately severe to severe Alzheimer s dementia to CMHT. To ensure all relevant staff within the practice are aware of the shared care guidelines. To provide prescriptions of the drug once a maintenance dose has been achieved. To monitor for compliance. To monitor for side-effects. To monitor for progress of dementia, behavioural and psychological problems and change in activities of daily living. To be aware of drug-interactions whilst changing medications. To refer back to secondary care if there is deterioration in mental state after ruling out delirium, emergence of behavioural and psychological symptoms, change in care needs, when considering cessation of treatment due to poor compliance, lack of adverse consequences or if the patient asks to stop. 7

8 GP Quick Reference Guide: Memantine Usual Dose: Initially 5 mg once daily, increased in steps of 5 mg at weekly intervals to max. 20 mg daily. Contraindications: Pregnancy and breast-feeding. Cautions: Renal impairment Recent MI, cardiac failure and hypertension Epilepsy Monitoring: To monitor for progress of dementia, behavioural and psychological problems and change in activities of daily living. To be aware of drug-interactions whilst changing medications. Renal function can be monitored on a yearly basis. Interactions: Ketamine; dextromethorphan. Possible interactions with primidone; antimuscarinics; antipsychotics; barbiturates; dopaminegics, selegiline; amantadine; baclofen and dantrolene. Main side effects (refer to BNF or SPC for full list): Confusion, headache, hallucinations, tiredness and less commonly vomiting, anxiety, hypertension, cystitis and increased libido. 8