Prescription of High Dose Antipsychotic Medication

Transcription

1 Subject (M1) Title Medicine Prescription of High Dose Antipsychotic Medication Manual Mental Health Procedure No M1-P-2-MH Department Pharmacy Distribution All Author Rae McKnight Review 4 Reviewer Jonathan Bate Implementation Date August 2001 Status Approved Last Review Date June 2013 Approved by: Chief Pharmacist Next review Date June FUNCTION To ensure that all patients who are prescribed high dose antipsychotic medication are identified and monitored according to a standard process. This will allow regular review of treatment and facilitate audit of this patient group. 2. LOCATION NHS Fife 3. RESPONSIBILITY 3.1 The responsibility to commence or exceed BNF maximum doses of a single or combination of more than one antipsychotic drug rests with the consultant psychiatrist. 3.2 All practitioners who prescribe or administer high dose medication are responsible for ensuring that the process of monitoring is in operation. 3.3 Note: Supplementary prescribers should not make the decision to proceed to the use of high dose. 4. OPERATIONAL SYSTEM 4.1. There is limited evidence that the use of high dose antipsychotic medication either with a single agent or in combination is effective. The consultant psychiatrist should first consider the use of adjuvant therapy e.g. with mood stabilisers/benzodiazepines, the use of an atypical neuroleptic or clozapine [Refer to NHS Fife, Drug Treatment of Schizophrenia (18-65 years and over) Guideline, available on the Fife Formulary website]. A detailed medication history prepared by clinical pharmacy can be useful to review past treatments and to discuss future treatment options. If high doses are to be used this should be after evidence based strategies have failed, and as a carefully monitored therapeutic trial The decision to use high dose should be discussed with the multidisciplinary team, the patient and/or carer and valid consent be obtained. This decision must be recorded, with an explanation documented, when the patient has not been informed. 4.3 The decision to prescribe high dose should be documented in the case notes, including the risks and benefits of the strategy, the aims and when and how the outcome will be assessed. The use of rating scales to monitor outcomes/progress/side effects should be considered e.g. Glasgow Atypical Sideeffect Scale (GASS), GASS for Clozapine, Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS), Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression scale (CGI) Page 1 of 11

2 4.4 Dose escalation should be in relatively small increments and allow adequate time for response, and this includes prescribing once the high dose threshold has been passed When the patient has been on medication for a period of two months or longer during his/her detention under the Mental Health (Care and Treatment)(Scotland) Act 2003, the use of high dose antipsychotics must be documented within the Treatment Plan on the Form T2 or Form T3, whichever is applicable Identification of patients on HIGH DOSE Antipsychotic Medication The prescribing of HIGH DOSE ANTIPSYCHOTIC MEDICATION may occur in two ways: A single antipsychotic which is prescribed in a daily dose that exceeds the BNF recommended maximum dose (High-Dose single drug) The prescribing of more than one antipsychotic drug concurrently i.e. High-Dose through the prescribing of multiple drugs. Refer to M1-P3-MH, Regular prescription of more than one antipsychotic drug at the same time A convenient way to define what constitutes a high dose of antipsychotics for patients receiving more than one drug at doses within the normal BNF range is to add the percentages of the current dose of each individual drug, expressed as a percentage of the BNF recommended maximum dose for each antipsychotic. When this sum exceeds 100%, the patient is considered to be receiving "HIGH DOSE". e.g. A patient on oral Chlorpromazine 400mg daily and IM Zuclopenthixol 400mg weekly Sum of percentages = 40% + 67% = 107% (> 100%, high-dose) See Appendix 6.1 and 6.2 for assistance with calculating percentages Careful watch should be kept on the dosage in terms of total percentage arising from drug combinations, and the use of as required (PRN) medication. The use of PRN medication should be kept under regular review and staff administering PRN medication should be aware of its potential to raise the total daily dose of antipsychotic above the high dose threshold. To avoid undue monitoring of patients not actually receiving high dose antipsychotics, the monitoring should not be initiated until the patient is administered medication which takes them above 100% as defined above on a regular basis e.g. frequent prn administration The use of high dose antipsychotic medication for rapid tranquilisation is an exceptional practice, and should only be considered when other pharmacological and non-pharmacological strategies have not been successful. If high dose antipsychotic treatment has been used, it is particularly important that the routine monitoring of a sedated patient is carried out and recorded, with particular attention to regular checks of pulse, respiration, temperature and hydration. ECGs should be carried out frequently during dose escalation, if and when possible. Where assessment of cardiovascular disease and status is difficult and ECGs impossible it is prudent to avoid high doses of antipsychotics, particularly parenterally. Please refer to NHS Fife Policy for Rapid Tranquilisation in Adult Patients Page 2 of 11

3 4.6.5 It is good practice to mark High Dose Antipsychotic or affix a High Dose Antipsychotic sticker (if available) in the allergy section of the patient s kardex when the High Dose Antipsychotic Monitoring Form is commenced. This will ease identification of patients on High Dose especially when medication is being administered. For outpatients on high dose antipsychotic therapy good practice would be to include a statement on high dose in each clinic letter to aid identification and prompt monitoring Monitoring of Patients on High Dose Antipsychotics The consultant psychiatrist is responsible for initiating the High Dose Antipsychotic Monitoring Form (See appendix 6.3 and 6.4) The High Dose Antipsychotic Monitoring Form should be filed in the Investigation section within the patient's medical notes once completed For Inpatients: During ongoing high dose antipsychotic therapy the High Dose Antipsychotic Monitoring Form may be filed behind the medicine kardex. Wards that have several patients on high dose antipsychotics could elect to keep all the current High Dose Antipsychotic Monitoring Forms together in a high dose monitoring folder For Outpatients: During ongoing high dose antipsychotic therapy the High Dose Antipsychotic Monitoring Form should be filed in an accessible and obvious location so that when the patient is seen it is clear that the high dose review must be completed A specific high dose antipsychotic nursing care plan is available and must be initiated for all patients administered high dose antipsychotics. See Appendix The Royal College of Psychiatrists Consensus Statement on High-Dose Antipsychotic Medication highlighted the increasing risk of sudden death or dose related side-effects in some patients who are prescribed doses in excess of the BNF recommended maximum dose. Certain risk factors were identified along with potential drug interactions that may exacerbate risk Consider and record any potential risk factors for cardiac events that may affect the decision to proceed. These include cardiac history, hepatic or renal impairment, age over 65 years, obesity, alcoholism, smoker, illicit substance misuse Consider potential drug interactions with the aim to avoid concomitant use with: ACE Inhibitors, Angiotensin-II antagonists, Anaesthetics, Analgesics (Opioid), Anti-arrhythmics, Antibacterials, Antifungals, Antidepressants, Antivirals, Antihypertensives, Antimalarials, Beta- Blockers, Calcium Channel blockers, Cimetidine, Diuretics. See BNF Appendix 1: Interactions. Request the advice of a clinical pharmacist where possible. Page 3 of 11

4 4.7.7 Obtain a base-line ECG to exclude cardiac contraindications and record the QT c interval In adults the QT C interval should be less than 440ms -1 for men and 470ms -1 for women. Elderly patients may have higher ranges and results should be discussed with the clinical team. Refer the patient for a cardiology assessment, if required. If the QT C interval exceeds the above ranges record the reasons if deciding to continue with high-dose therapy. If there is a significant change in length of QTc (>60ms) consideration should be given to review of treatment and referral to cardiology. If a patient has a history of cardiovascular disease, ECG s should be performed every few days following initiation of high dose therapy or during periods of dose escalation, until it is judged that steady state concentrations have been reached. An ECG must be performed within 1 week and then every 1-3 months in the early stages of high-dose treatment. The ECG should be repeated at least 6-12 monthly throughout treatment with high-dose antipsychotics and also at times of acute illness, when potentially interacting drugs are introduced or if the patient experiences symptoms that could be due to arrhythmia, for example syncope or fits. Record the QT C interval on each occasion Obtain baseline Urea and Electrolytes (U&E s), particularly potassium, and record whether or not the results are within the normal reference range. Continue to monitor these and record on the monitoring sheet at least 6-12 monthly throughout treatment with high-dose antipsychotics and also at times of acute illness, when potentially interacting drugs are introduced or if the patient experiences symptoms that could be due to arrhythmia, for example syncope or fits Obtain baseline liver function tests (LFTs) and record whether or not the results are within the normal reference range. Continue to monitor these and record on the monitoring sheet at least 6-12 monthly throughout treatment with high-dose antipsychotics Initiate a FEWS chart and obtain baseline blood pressure, pulse and temperature. Monitor and record once daily for the first seven days and once weekly for the first month. Thereafter, monitor as dictated by clinical concerns. In outpatients where daily observations prove impractical, a clinical decision must be documented on the minimum acceptable frequency of monitoring to be achieved A full and systematic review of the patient s progress must be documented in the medical notes after the following intervals: one week, monthly for the first three months, then three monthly for the first year of high dose treatment. Thereafter individually defined according to clinical progress if on long term high dose treatment If no significant improvement in the mental state or the level of functioning is noted, reduce the dose of antipsychotics to below the high dose threshold and consider alternative medications e.g. Clozapine. Consultants may wish to seek a second opinion from a colleague A decision to continue high-dose antipsychotic treatment despite a lack of significant response must be documented in the patient's medical notes, along with the reasons for doing so. Page 4 of 11

5 Supplies of High Dose Antipsychotic Monitoring Forms and High Dose Antipsychotic stickers (if available) may be obtained by contacting: Pharmacy Services, Pentland House, Lynebank Hospital, Dunfermline, Telephone: RISK 5.1 The purpose of this Procedure is to minimise risk to patients and staff As the evidence for using antipsychotic medication in high dose is limited there could be risks to patients safety if the monitoring requirements detailed in this document are not carried out Documentation of all decisions regarding prescribing high dose antipsychotic medication should be carried out according to the procedure so that in case of injury to patient it is clear that all the necessary safeguards were carried out and the decision was not solely down to one person Audit of the Prescription of High Dose Antipsychotic should be performed on an annual basis to monitor compliance with this procedure. 6. RELEVANT DOCUMENTATION / FORMS 6.1 Appendix 1 Oral Antipsychotic Dosage Ready Reckoner 6.2 Appendix 2 Long-acting and Short-acting Injectable Antipsychotic Dosage Ready Reckoner 6.3 Appendix 3 - High Dose Antipsychotic Monitoring Form 6.4 Appendix 4 Long term High Dose Antipsychotic Monitoring Form 6.5 Appendix 5 - High Dose Antipsychotic Monitoring. Nursing Care Plan 7. REFERENCES 7.1 NHS Fife, Guidance on Drug Treatment of Schizophrenia in Patients 18 years and over, Appendix 4A, Fife Formulary. Available from NHS Fife. Procedure for the Regular prescription of more than one antipsychotic. M1-P3-MH 7.3 NHS Fife. Policy for Rapid Tranquilisation in Adult Patients. M1-G2-MH 7.4 The Royal College of Psychiatrists. Consensus Statement on High-Dose Antipsychotic Medication. May Royal College of Psychiatrists, London 7.5 British Medical Association: Royal Pharmaceutical Society of Great Britain, British National Formulary No.65 (March 2013).London: BMJ Publishing Group RPS Publishing. 7.6 Taylor D, Paton C, Kapur S. Maudsley Prescribing Guidelines in Psychiatry 11 th Edition. Wiley-Blackwell, Oxford, UK, ACKNOWLEDGEMENTS 8.1 NHS Greater Glasgow and Clyde. High Dose Antipsychotic Therapy Guideline. July 2012 Page 5 of 11

6 Appendix 1 - Oral Antipsychotic Dosage Ready Reckoner Dose in mg/day Percentage of BNF Maximum Adult Daily Dose % % Amisulpride Oral Aripiprazole Oral Asenapine S/L Chlorpromazine Oral Clozapine Oral Flupentixol Oral Haloperidol Oral Levomepromazine Oral Olanzapine Oral Paliperidone Oral Perphenazine Oral Promazine Oral Quetiapine* Oral Risperidone Oral Sulpiride Oral Trifluoperazine** Oral Zuclopenthixol Oral * 750mg/day maximum dose for schizophrenia, 800mg/day maximum dose for mania or if XL preparation used. Percentage given for schizophrenia ** No maximum dose stated in BNF or SPC. 50mg used by convention.

7 Appendix 2 - Long-acting and short acting injectable antipsychotic dosage ready reckoner Long - Dose in mg/week Short Dose in mg/day Percentage of BNF Maximum Adult Daily Dose % % Flupentixol decanoate Fluphenazine decanoate Haloperidol decanoate Paliperidone Palmitate * Pipotiazine palmitate Risperidone Consta ** Zuclopenthixol decanoate Long Long Long Long Long Long Long Aripiprazole Short Chlorpromazine Short Haloperidol Short Olanzapine Short Zuclopenthixol acetate (Acuphase) ** Short * Maintenance dose. Paliperidone is administered on a monthly basis ** Risperidone Consta is administered on fortnightly basis *** A maximum of 150mg in any 48 hour period and a maximum cumulative dose of 400mg in any two week period

8 Appendix 3. High Dose Antipsychotic Monitoring Form This form must be completed for all high dose therapy patients preferably prior to commencing treatment Name: CHI No. : D.O.B.: Consultant: (Medical Records Label may be attached) Date of initiation of High Dose: High Dose therapy checklist please circle as appropriate PMH Contraindications / Cautions Possible Drug Interactions History of cardiac disorders? Y N Identified interaction Y N (detail drugs below) Hepatic impairment? Y N 1. Drugs known to prolong QTc interval Renal Impairment? Y N Obesity? Y N Heavy smoker? Y N 2. Pharmacokinetic interaction Heavy alcohol intake? Y N Illicit Substance misuse? Y N Old Age? Y N Details: 3.Diuretics If there are any relative contraindications highlighted please state reasons why high dose therapy is to continue: Rationale for High Dose Antipsychotic Therapy Failure to respond to clozapine Failure to tolerate clozapine Partial response to clozapine: as augmentation During the switch of one antipsychotic to another As a temporary measure during exacerbation of illness Other: Consent obtained Patient consent Section 47 T2 T3 Prescription details Start Date Antipsychotic(s) Dosage / Frequency % BNF Max Combined % total Signature: Print Name: Date: Record of clinical monitoring (tick box when occurs). If results are abnormal, record in nursing medical notes and inform the patient s consultant. It is not anticipated that every patient will have rating scales completed for side effects / symptoms / progress e.g. LUNSERS, GASS, CGI, BPRS but it is considered good practice Test Pre-HDAT After dose changes Date ECG U&E s LFTs Rating scale for side effects / outcome Progress review recorded in notes Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing * TO BE FILED IN INVESTIGATIONS SECTION IN PATIENT S CASE NOTES WHEN COMPLETE

9 Appendix 4. Long Term High Dose Antipsychotic Monitoring Form This form must be completed for all high dose therapy patients Name: CHI No. : (Medical Records Label may be attached) D.O.B.: Consultant: Date of initiation of High Dose: Indicate below the frequency of monitoring required e.g. monthly, bi-annual, annual: Date Frequency of monitoring Prescription details Start Date Antipsychotic(s) Dosage / Frequency % BNF Max Combined % total Record of clinical monitoring (tick box when occurs). If results are abnormal, record in nursing medical notes and inform the patient s consultant. It is not anticipated that every patient will have rating scales completed for side effects / symptoms / progress e.g. LUNSERS, GASS, CGI, BPRS but it is considered good practice Test Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Date ECG U&E s LFTs Rating scale for side effects / outcome Progress review recorded in notes Test Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Date ECG U&E s LFTs Rating scale for side effects / outcome Progress review recorded in notes * TO BE FILED IN INVESTIGATIONS SECTION IN PATIENT S CASE NOTES WHEN COMPLETE

10 Appendix 5 Medicine - High Dose Antipsychotic Monitoring (M2) Ward /Dept Name: Care Plan Number C.H.I. Number Unit Number Date Commenced Consultant / G.P. Named Nurse Date Resolved Description of Need: Patients prescribed anti-psychotic medication, either singly or in combination, which exceeds the BNF maximum recommended dose require close monitoring as high dose medication has increased risk of serious adverse effects. Objective/Expected Outcome To minimise the risks associated with high dose antipsychotic treatment by ensuring monitoring is carried out in accordance with NHS Fife Prescription of High Dose Antipsychotic Medication procedure. M1-P-2-MH Actual Outcome Evaluation/Review No Date Due Evaluation/Review No Date Due

11 Appendix 5 Medicine - High Dose Antipsychotic Monitoring (M2) Patient/Client Name Unit/CHI No ACTION TO BE TAKEN: - Date/Time Signature 1. Build and maintain trusting therapeutic relationships with patient. 2. Utilise regular 1:1 sessions with patient to allow discussion of any medication related issues or concerns they may have. 3. Obtain baseline blood pressure (BP), pulse, temperature, ECG, LFTs and U& Es, prior to high dose being prescribed. 4. Repeat ECG within one week of commencing on high dose. 5. a) Initiate FEWS chart. Monitor and record BP, pulse and temperature once daily for the first seven days. b) Thereafter once weekly for the first month of high dose treatment. c) Following the first month, BP, pulse and temperature to be monitored and recorded as directed by clinical concerns: Date Frequency of monitoring d) The patient should be observed for signs of dehydration and encouraged to drink an adequate amount of fluid on a daily basis 6. Ensure dates for subsequent ECG s and blood tests (U&E s and LFT s) are forwarded in ward diary. 7. Ensure patient s High Dose Antipsychotic Monitoring Form (Appendix 6.3 or 6.4 of Prescription of High Dose Antipsychotic Medication procedure) is kept up to date, prompting medical staff where necessary. 8. Observe, monitor and report to medical staff any other adverse effects of medication e.g. complete side effect rating scales e.g. GASS 9. Encourage patient to look after their own health e.g. a) Diet b) Smoking cessation c) Exercise d) Moderation of alcohol intake 10. Document relevant information in nursing notes and report to medical staff Discuss plan of care with Patient/Client and if appropriate their Relative/Carer. Where appropriate ask the patient to sign that they agree /disagree with this care plan. If you do not ask for acceptance please record reason in Care Notes I have had the plan of care explained to me and I do/do not wish this to be initiated: Signature