NHS Grampian Guidance For Staff Working In The Mental Health Service For The Use Of High-Dose Antipsychotic Medication

Transcription

1 NHS Grampian Westholme Woodend Hospital Queens Road ABERDEEN AB15 6LS Date 20 th November 2014 Our Ref HDAT_MGPG/Nov14 Enquiries to Caroline Hind Extension Direct Line Dear Colleague NHS Grampian Guidance For Staff Working In The Mental Health Service For The Use Of High-Dose Antipsychotic Medication This guidance is currently under review but completion has been delayed pending clarification from the MHRA relating to recent changes made to maximum daily doses by one of the manufacturers of haloperidol. The NHS Grampian Medicines Guidelines and Policies Group have agreed that, in the interim, the November 2011 version which was due for review in November 2013 may be used until June If you have any queries regarding this please do not hesitate to contact the Pharmacy and Medicines Directorate. Yours sincerely Caroline Hind Deputy Director of Pharmacy and Medicines Directorate Chair Medicines Guidelines and Policies Group

2 Mental Health NHS Grampian Mental Health Pharmaceutical Service Guidance For Staff Working In The Mental Health Service For The Use Of High-Dose Antipsychotic Medication Co-ordinators: Pharmacy Manager, Royal Cornhill Hospital Consultation Group: Mental Health Operational Medicines Management Group Approver: Medicine Guidelines and Policies Group Signature: Signature: Signature: Identifier: NHSG/HDApsyc/ MGPG485 Review Date: November 2013 Date Approved: November 2011 Uncontrolled when printed Version 3

3 Title: Identifier: Replaces: NHS Grampian Mental Health Pharmaceutical Service Guidance For Staff Working In The Mental Health Service For The Use Of High-Dose Antipsychotic Medication NHSG/HDApsyc/MGPG485 Guidelines For The Use Of High Dose Antipsychotic Medication, MGPG254 Across NHS Boards Organisation Wide Directorate Clinical Service Sub Department Area Yes This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative. Lead Author/ Co-ordinator: Subject Key word(s): Document application: Purpose: Pharmacy Manager, Royal Cornhill Hospital Prescribing and prescription Guidance, mental health, high dose, high-dose, antipsychotic medication, antipsychotics, neuroleptics, major tranquillisers NHS Grampian Mental Health Service To provide staff working in the mental health service prescribing guidance for the use of high-dose antipsychotic medication. Responsibilities for implementation: complete as appropriate Organisational: Corporate: Departmental: Area: Hospital/Interface services: Operational Management Unit: Policy statement: Review: Management teams and chief executives Senior managers Heads of services/clinical Leads Heads of services/clinical Leads Assistant General Managers and Group Clinical Directors Unit Operational Managers It is the responsibility of supervisory staff at all levels to ensure that their staff are working to the most up to date and relevant policies, protocols and procedures. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. This policy will be reviewed at least every two years or sooner if current treatment recommendations change. UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG485 - i -

4 This document is also available in large print and other formats and languages, upon request. Please call NHS Grampian Corporate Communications on (01224) or (01224) Responsible for review of this document: Responsible for ensuring registration of this document on the NHS Grampian Information/ Document Silo: Physical location of the original of this document: Job/group title of those who have control over this document: Responsible for disseminating document as per distribution list: Mental Health Operational Medicines Management Group Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate Mental Health Operational Medicines Management Group Mental Health Operational Medicines Management Group Revision history Date of Approval change date of PGD that is being superseded September 2007 August 2011 Summary of Changes (Descriptive summary of the changes made) References updated. Kardex noted as kardex/prescription and Administration Record Remove If high doses are to be used in an individual case, this should only be after evidence based strategies have failed and as a carefully monitored therapeutic trial and insert The regular use of high dose antipsychotics should be not be routine clinical practice Insert The ultimate responsibility lies with the consultant psychiatrist Insert information on consent Insert Ongoing assessment. As required medication section updated Changes Marked* (Identify page numbers and section heading ) throughout Page No.1 Page 1 No 3 Page 1 No 4 Page 1 No 5 Page 1 No 7 UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG485 - ii -

5 Insert where possible into first sentence, and potential drug interactions updated ECG measuring altered, BP, LFTs and U&Es measuring updated Insert or GASS (Glasgow Antipsychotic Side- effect Scale) Aripiprazole IM added Maximum licensed dose of Quetiapine and changed to reflect indications. Quetiapine XL added Maximum suggested dose for trifluoperazine reduced to 30mg. Deleted 3monthly checks more frequently if clinically indicated Under LFTs inserted words if clinically indicated Page 2 No 10 Page 2 No 11 Page 3 No 11 Page 4 App 1 (table) Appendix 3 page (first table) UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG485 - iii -

6 NHS Grampian Mental Health Pharmaceutical Service Guidance For Staff Working In The Mental Health Service For The Use Of High-Dose Antipsychotic Medication Mental Health For the purpose of this guidance high-dose is defined as a total daily dose of a single antipsychotic which exceeds the upper daily limit stated in the British National Formulary (BNF) or a total daily dose of two or more antipsychotics which exceed the BNF maximum using the percentage method (refer to Appendix 1). 1. Current evidence does not justify the routine use of high-dose antipsychotic medication in general adult mental health services, either with a single agent or combined antipsychotics. 2. The regular use of high-dose antipsychotics should not be routine clinical practice. 3. The decision to prescribe high-dose (of either an individual agent or through combination) should be taken explicitly and should involve an individual riskbenefit assessment by a consultant psychiatrist. This should be undertaken in consultation with the wider clinical team, the patient and a patient advocate, if available, and the patient wishes their presence. The ultimate responsibility lies with the consultant psychiatrist. 4. The patient s consent should be obtained and recorded in the clinical notes. If the patient refuses consent then the use of Mental Health (Care and Treatment) (Scotland) Act 2003 will need to be considered If the patient is incapable of giving informed consent, use of the Adults with Incapacity (Scotland) Act 2000 may be required. Also consider any advanced statement the patient may have made. 5. Ongoing assessment including documentation of target symptoms, response and side effects, ideally using validated rating scales, should be standard practice so that there is ongoing consideration of the risk-benefit ratio for the patient. Close physical monitoring including ECG is essential. 6. Dose escalation should be in relatively small increments allowing adequate time for response, and this includes prescribing once the high-dose threshold has been passed. 7. The use of as required medication should be kept under regular review and staff administering as required should be aware of its potential to raise the total daily dose of antipsychotic above the high-dose threshold. 8. High-dose antipsychotic medication may be prescribed in an emergency for acute symptoms (refer to NHS Grampian Guidance for Rapid Tranquillisation of Psychiatric Emergencies in Psychiatric Hospitals, General Hospitals and Accident and Emergency Departments). This should be discussed with the consultant or specialist registrar before it is prescribed. UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG

7 9. Consider potential risk factors before prescribing high-dose antipsychotic therapy, e.g. Cardiac history (particularly MI, arrhythmias, abnormal ECG) Hepatic/renal impairment Alcoholism/smoking/substance misuse Old age Obesity/anorexia nervosa Extreme physical exertion/stress or shock Metabolic disturbance (hypokalaemia, hypomagnesaemia, hypocalcaemia) Female gender. 10. Consider any potential drug interactions, specifically aiming to avoid where possible concomitant treatment with: Drugs which alter electrolyte balance, e.g. diuretics. Drugs which prolong QT interval, e.g. methadone, tricyclic antidepressants, anti-arrhythmics, certain antibiotics and antimalarials, etc. Drugs which can increase blood antipsychotic levels, e.g. inhibitors of Cytochrome P450 (fluoxetine). NB: Refer to current BNF and Maudsley Prescribing Guidelines for further information. 11. High-Dose Monitoring/Review A High-Dose Antipsychotic Therapy Monitoring Sheet (Appendix 3) should be initiated at start of treatment. Any risk factors, interacting medications, baseline and ongoing monitoring results must be recorded in the appropriate sections of the form. For professional responsibilities relating to high-dose antipsychotic monitoring see Appendix 2 Obtain a baseline ECG before commencing treatment. If a prolonged QT interval is recorded (QT c > 440ms for a male, QT c > 470ms for a female) review treatment. Consider cardiology assessment. If it is decided to continue treatment, record reasons for doing so in patient s case notes. An ECG should be repeated after a few days and then every 1-3 months in the early stages of high-dose treatment. Thereafter an ECG should be repeated as clinical indicated, or at least 6-12 monthly. If an ECG is not performed the reason should be documented in the notes. Obtain baseline blood pressure, LFTs and U&Es. Repeat as clinically indicated or at least annually. In patients with cardiovascular disease or at high risk of electrolyte abnormalities electrolyte assessment is recommended at least 3 monthly. In patients with risk factors for hepatic disease e.g. a history of alcohol or drug misuse or established hepatic disease repeat LFTs at least 3 monthly. The High-Dose Antipsychotic Therapy Monitoring Sheet should be kept with the drug kardex/prescription and Administration Record for in-patients and in the relevant section of the patient s psychiatric case notes for outpatients. UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG

8 Review progress at least once every 3 months, reducing dose to within the licensed range if no significant progress is observed and consider alternatives. Continued use of high-dose therapy should only be considered if benefits outweigh the risks. Consultants should consider seeking a second opinion from a colleague. The review should be documented in the patient s case notes. Improvement in psychotic symptoms could be measured using rating scales such as BPRS (Brief Psychiatric Rating Scale), side effects could be monitored using LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale) or GASS (Glasgow Antipsychotic Side-effect Scale). It is suggested that these are performed at weeks 0, 6 and 12, then for each 3 monthly review. 12. Prior to patients being discharged from hospital to the community it should be discussed and agreed who will be responsible for the ongoing monitoring and review. This should be clearly documented in the care plan and discharge letter. References 1. The Royal College of Psychiatrists: Consensus on the use of High-Dose Antipsychotic Medication (Council Report 138) May Taylor D et al: The Maudsley Prescribing Guidelines 10th Edition British National Formulary 61 March 2011 UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG

9 Appendix 1: Identification of patients on high-dose antipsychotic medication High-dose antipsychotic prescribing may be achieved in TWO ways: 1. Single antipsychotic drug prescribed at a daily dose above the BNF upper recommended limit (high dose single drug). Mental Health 2. More than one antipsychotic prescribed concurrently that, when expressed as a percentage of their maximum recommended dosages and added together, result in a cumulative dose of > 100% NB: In defining what constitutes a high-dose of antipsychotics for patients receiving more than one antipsychotic at doses within the normal BNF ranges, it is probably most satisfactory to add the percentages of the patient s current dose of antipsychotic expressed as a percentage of the recommended upper dose for each antipsychotic. Where this exceeds 100%, the patient is considered to be receiving a high-dose. For example: a patient on zuclopenthixol depot 300mg weekly and olanzapine 15mg daily. Sum of percentages: 50% + 75% = 125% (>100%, therefore high-dose). ANTIPSYCHOTIC MAXIMUM LICENCED (Adult) DAILY DOSE (100%) Oral administration in mg/day unless stated otherwise (ref BNF 61 unless otherwise stated) Amisulpride 1200 Aripiprazole intramuscularly Chlorpromazine Intramuscularly Clozapine 900 Flupentixol 18 Haloperidol Intramuscularly Olanzapine Intramuscularly Pimozide* 20 Quetiapine Standard Release Quetiapine Sustained Release (XL) 750 schizophrenia, 800 in bipolar disorder 800 schizophrenia and bipolar disorder Risperidone 16 Sulpiride 2400 Trifluoperazine Not stated by manufacturer (Suggest 30) [2] Zuclopenthixol Zuclopenthixol Acetate mg total given intramuscularly in divided doses within a 14 day period 400mg/week 100mg/fortnight 300mg/month 200mg/month 50mg/fortnight Flupentixol depot Fluphenazine depot Haloperidol depot Pipotiazine depot Risperdal Consta Zuclopenthixol depot 600mg/week *Subject to special monitoring requirements irrespective of dose prescribed. Refer to BNF Use of discretionary ( as required ) antipsychotic medication should also be taken into account UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG

10 Appendix 2: High-Dose Antipsychotic Monitoring: Responsibilities. Pharmacist Responsibilities for In-Patients: Identify in-patients on high-dose antipsychotics and inform relevant consultant of high-dose status (standard letter). Mental Health Complete patient details on High-Dose Antipsychotic Monitoring Form. Complete high-dose details and % on High-Dose Antipsychotic Monitoring Form. Identify any co-prescribed medication, which could increase the risk of adverse effects and notify medical staff. Complete interacting medicines section on High- Dose Antipsychotic Monitoring Form. Attach high-dose label to drug kardex/prescription and Administration Record. Audit use of high-dose antipsychotic medication. Medical Responsibilities: Use of high-dose antipsychotic therapy is ultimately the responsibility of the consultant. Ensure the Guidelines for the use of High-Dose Antipsychotic Medication are followed for both in-patients and out-patients. Identify out-patients on high-dose antipsychotics. Document reason for high-dose antipsychotic medication in case notes. Inform patient and document consent in notes. Fill in Risk Factors on High-Dose Antipsychotic Monitoring Form. Order ECGs. Check U&Es. Check LFTs. Ensure high-dose antipsychotic status is mentioned on T2/T3 Form, if applicable. Ensure on patient s discharge that GP and other relevant community mental health personnel are informed of high-dose antipsychotic status and of monitoring required. Agree monitoring plan with relevant community mental health personnel and/or GP. Check that monitoring sheet is being completed. Ensure high-dose status is regularly reviewed. Nursing Staff Responsibilities Ensure all patients on high-dose are identified on the nursing documentation and that there is a specific care plan for this. Ensure all patients on high-dose antipsychotic therapy have their blood pressure measured and recorded on High-Dose Antipsychotic Monitoring Form prior to commencing treatment. Ensure ongoing monitoring as per protocol. Make comparison with previous recordings and report any abnormalities to medical staff. Record future ECG and blood test review dates for in-patients in the nursing care plan. UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG

11 NHS Grampian Mental Health Pharmaceutical Service High-Dose Antipsychotic Therapy Monitoring Sheet Mental Health To be completed for all high-dose therapy patients preferably before commencing treatment. NB: Both sides to be completed. Appendix 3 Patient name: Consultant: CHI Number: Ward: Risk Factors please circle Cardiac History Yes / No Hepatic impairment Renal Impairment Obesity? Old Age Heavy smoker Substance Misuse Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Interacting Medication Yes / No (If yes complete section below) Specify details: Doctor s Signature: Date: High-Dose Antipsychotic Medication Specify drug(s) and dose Start date Stop date Total combined % BNF Dose. Complete each time prescription amended Signature & Date Interacting medications? Y / N: Specify: Start date Stop date Clinical significance Signature & Date UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG

12 Appendix 3 High-Dose Antipsychotic Therapy Monitoring Sheet (continued) High-Dose Antipsychotic Monitoring. For abnormal results record actions/comments Date ECG check (QTc interval ) Baseline At steady state U&Es ( if OK) LFTs if clinically indicated ( if OK) Blood Pressure (mm Hg) Reason for HDAT documented in case notes? Y / N Consent obtained and documented? Y/N HDAT mentioned on form T2/T3? (Circle as appropriate ) Doctor s signature N/A Yes/No N/A Yes/No N/A Yes/No N/A Yes/No N/A Yes/No Date Abnormal Result Action/Comments Doctor s Signature During hospital admission to be filed in the patient s drug kardex/prescription and Administration Record. On discharge to be filed in the appropriate section of the patient s notes. UNCONTROLLED WHEN PRINTED Review Date: November 2013 Identifier: NHSG/HDApsyc/MGPG