High Dose Antipsychotic Medication Policy Policy Title State previous title where relevant State if Policy New or Revised Policy Strand Org, HR, Clinical, H&S, Infection Control, Finance For clinical policies only - state index category Links to national regulatory standards: Care Quality Commission(CQC) NHS Litigation Authority (NHSLA) National Institute for Health & Clinical Excellence (NICE). Policy Lead/Author Job titles only Consultation State year and the individuals, groups, committees, service users, working partners etc. you have consulted with High Dose Antipsychotic Medication Policy Revised Clinical Policies Sub Category: Medicines Management National Patient Safety Agency (NPSA) Royal College of Psychiatrists - Consensus statement on high antipsychotic medication Council Report CR138 May 2006 Chief Pharmacist Senior Clinical Pharmacist 2012 - Medicines Management Committee, Clinical Policies Group 2014 - Medicines Management Committee Ratification State ratified by whom - Policy Ratification Group, Executive Committee Equality Impact Assessment Implementation Plan Policy Ratification Group Yes Yes Month/year policy first developed January 2013 Months/years policy reviewed. Keep review dates in chronological order January 2013, December 2014 Next review due December 2017 Review details Revisions made, changes etc include page numbers and paragraphs For Corporate Executive Support use Date Policy First Uploaded to Intranet January 2013 2012 - Policy adapted to reflect current practice for all areas of the Black Country Partnership NHS Foundation Trust. 2014 Title changed and policy updated due to changes in haloperidol imum s page 9. Date Policy Revised & Reloaded to Intranet December 2014 Version 2.0 December 2014
High Dose Antipsychotic Medication Policy Ref. Contents Page 1.0 Introduction 3 2.0 Purpose 3 3.0 Objectives 3 4.0 Definitions 3 5.0 Duties 3 6.0 Committee/Group Responsible for Approval of this Policy 5 7.0 Process 5 8.0 Monitoring Compliance 10 9.0 Standards/Key Performance Indicators 11 10.0 Equality Impact Assessment 11 11.0 Training 11 12.0 Data Protection Act and Freedom of Information Act 11 13.0 References 12 13.1 Legislation 12 14.0 Links to other Polices and Procedures 12 Appendices Appendix 1: High Dose Antipsychotic Monitoring Form 13 Review and Amendment Log Version Reason Status Date Description of Change V1.0 V2.0 Alignment of policies following TCS Updated due to changes in haloperidol imum s Ratified Ratified January 2013 December 2014 New Policy for BCPFT Table inserted at page 9 and title of policy changed (previously named Guidelines for the use of High Dose Antipsychotic Medication Policy ) Version 2.0 December 2014 2
1.0 Introduction These guidelines address the issues raised in the consensus statements on high antipsychotic medication from the Royal College of Psychiatrists from October 1993 and updated to include atypical antipsychotics in the May 2006 version. See section 4 for definition of high antipsychotic therapy. The National Patient Safety Agency report on patient safety incidents in mental health states that high prescribing needs to be reviewed within Trusts because of the increased potential for adverse effects which includes the unclear contribution towards ventricular tachycardia and sudden death. These guidelines highlight this issue to clinical staff and offers recommendations for using high antipsychotic therapy, including what monitoring should be in place. The guidance also protects the right to treatment of patients who do require higher s for effective treatment. For this to occur, each patient must be assessed carefully by a fully trained psychiatrist. Unless otherwise stated, s in the BNF are licensed s, any higher is therefore off-license. 2.0 Purpose The purpose of this document is to provide clear guidance to Black Country Partnership NHS Foundation Trust (BCPFT) staff on matters relating to the use of high antipsychotic medication. 3.0 Objectives There is a reviewed and ratified policy for the use of high antipsychotic medication. 4.0 Definitions Definition of High Dose Antipsychotic Therapy A total daily of a single antipsychotic which exceeds the upper limit stated in the BNF or summary of product characteristics (SPC) or a total daily of two or more antipsychotics which exceeds the summary of product characteristics or BNF imum using the percentage method The percentage method requires the conversion of the of each medication into a percentage of its BNF imum and adding the percentages together. A cumulative of more than 100% is a high. See Section 6.5 Antipsychotics Dose Percentage Conversion Table. Example: Zuclopenthixol depot 300mg weekly (50%) and Olanzapine 15mg daily (75%) = 50% + 75% = 125% (>100%, therefore high ) PRN As required medication should also be included in any calculations. 5.0 Duties Adherence to this Policy is the responsibility of all staff involved in the prescribing, administering and monitoring of patients prescribed high antipsychotics within BCPFT. Version 2.0 December 2014 3
Medical Director To ensure that all doctors prescribing high antipsychotics adhere to this Policy. Chief Pharmacist To ensure that all members of the pharmacy team checking prescriptions for patients prescribed high antipsychotics adhere to this Policy. Director of Nursing To ensure that all nursing staff administering high antipsychotics to patients adhere to this Policy. Doctor/Consultant Be responsible for initiating high antipsychotic medication, after discussion with the consultant psychiatrist if applicable. Check risk factors. Carry out baseline ECG before prescribing high antipsychotics, when mental state allows. Interpret results and act upon them if not within normal limits. An ECG should be repeated after a few days, every 1 3 months in the early stages of high treatment as clinically indicated and then repeated periodically (minimum 3 monthly). Carry out baseline U&Es, LFTs and FBC, when mental state allows. Interpret results and act upon them if not within normal limits. Repeat these tests after 1 month and then 3 monthly. Document in clinical notes if patient refuses any tests or mental state does not allow. Document reason for high in patient s notes, review regularly and ensure guidelines for the use of high antipsychotics are followed. Inform patient and document consent in notes. Check high antipsychotic therapy is on consent to treatment or second opinion form, if applicable. Check that a high antipsychotic monitoring form is being completed. Regularly review PRN antipsychotics. Do not prescribe for more than 7 days without review. If appropriate consider PRN lorazepam. Ensure on patient s discharge that GP and other relevant community mental health personnel are informed of high antipsychotic status and required checks needed. In CMHTs the consultant should identify the patient, initiate the high antipsychotic monitoring form and inform pharmacy. Pharmacist/ Pharmacy Technician Identify that a patient is on high antipsychotics or has the potential to require high s e.g. imum regular and PRN prescribed. Write High antipsychotics and the total % on the front of the treatment sheet and in the other directions/notes box on the inside if room (date and sign these entries). Initiate a high antipsychotic monitoring form if not already done by the doctor/consultant (Section A). Put one copy in the patient s notes to be completed by the doctor (Section B) and keep one copy in pharmacy (Sandwell, Dudley and Walsall). In Wolverhampton send one copy to the Treatment Centre and keep one copy in pharmacy. Version 2.0 December 2014 4
If time allows, document in patient s notes high antipsychotic therapy prescribed and form initiated (not possible in Home Treatment teams/ Assertive Outreach). Nursing Staff Temperature check baseline, weekly initially and then as clinically indicated. Blood pressure check baseline, weekly initially and then as clinically indicated. Document high status in the nursing care plan and daily progress notes. Develop care plan to check that high antipsychotic monitoring form is being completed and bring to attention of medical staff if checks have not been done. Counsel patient if necessary. Ensure that high status is discussed at review. 6.0 Committee/Group Responsible for Approval of this Policy The Medicines Management Committee is responsible for reviewing and/ or approving this Policy. 7.0 Process 7.1 Consensus statement on high antipsychotic medication Council Report CR138 May 2006 Recommendations from Royal College of Psychiatrists 1. Current evidence does not justify the routine use of high- antipsychotic medication in general adult mental health services, either with a single agent or combined antipsychotics. 2. If high s 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. 3. The decision to prescribe high (of either an individual agent or through combination) should be taken explicitly and should involve an individual riskbenefit assessment by a fully trained psychiatrist. This should be undertaken in consultation with the wider clinical team and the patient and a patient advocate, if available, and if the patient wishes their presence. 4. Non-medical prescribers should not make the decision to proceed to the use of high. 5. The decision to prescribe high 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. 6. Dose escalation should be in relatively small increments and allow adequate time for response and this includes prescribing once the high- threshold has been passed. 7. Careful watch should be kept on the dosage in terms of total percentage arising from drug combinations and the use of PRN (as required) medication. Local systems should be developed to alert the responsible psychiatrist/clinical team to patients currently being administered or at risk of receiving high s. 8. The use of PRN medication should be kept under regular review, with training of the clinical team and psychiatric trainees in the use of PRN and alternative ways of dealing with acute patient agitation. Staff administering PRN should be aware of its potential to raise the total daily of antipsychotic above the high- threshold. Version 2.0 December 2014 5
9. The possible contraindications to high, for the drug(s) in the patient concerned should be considered before prescribing a high. 10. Consider possible drug interactions when prescribing high- antipsychotic medication. 11. Before prescribing high- antipsychotics carry out an ECG to establish a baseline, and exclude cardiac contraindications, including long QT syndromes. An ECG should be repeated after a few days and then every 1-3 months in the early stages of high- treatment. The ECG should be repeated as clinically indicated. 12. Services should be structured, managed and resourced to preclude or minimise the perceived need for high. 13. Each service should establish the audit of antipsychotic s as a matter of routine practice. 14. A fully trained psychiatrist should carefully and regularly assess patients whose illnesses have proved unresponsive to conventional s of antipsychotics (for example, treatment-resistant schizophrenia). The possible contribution to poor response of non-adherence to prescribed medication should be considered. 15. Before resorting to a high of antipsychotic medication, evidence-based strategies for treatment resistance should be exhausted, including use of clozapine. 16. The use of high should be treated as a limited therapeutic trial in treatmentresistant schizophrenia and the reduced back to conventional levels after a 3-month period unless the clinical benefits outweigh the risks. 7.2 Risks & problems associated with high antipsychotic therapy Risk factors Illicit drug use Tobacco and alcohol use Impaired glucose tolerance Hepatic or renal impairment Patients taking any drug which may lower the seizure threshold Patients with a history of adverse effects to high s of antipsychotics Cardiac disorder history (family history, MI, arrhythmias, abnormal ECG) Obesity Old age Diabetes Hyperlipidaemia Ischaemic heart disease (including hypertension) Potential Drug Interactions Caution when prescribing with medicines known to prolong the QT interval or increase blood antipsychotic levels. Refer to current edition of BNF. Side Effects Increased risk of side effects such as: Tachycardia Sedation Hyperprolactinaemia Postural hypotension Seizures Version 2.0 December 2014 6
Extrapyramidal side effects (EPSE) including akathisia Increased mortality It is thought high antipsychotic prescribing may contribute towards ventricular tachycardia and sudden death although there is no consensus on whether a true causal association exists. Non-concordance Making drug regimes more complicated, or the development of side effects can lead to a reduction in concordance. Lack of supporting evidence The evidence for combining two or more antipsychotics or using high s has not been established, but there is evidence for an increased risk of side effects. Increased cost Difficulty in determining cause and effect 7.3 High antipsychotic prescribing Fully trained psychiatrists can prescribe high antipsychotic medication. If this is not the consultant psychiatrist, it should only be done after discussion with the consultant. The decision should be documented in the patient s clinical notes. Discuss the reasons for the treatment, and consideration of alternatives, with the multidisciplinary team, and if possible the patient and their family or advocate. Informal patients should give their consent to high antipsychotic treatment and this should be documented in their notes. Where in use, consent to treatment forms should include a statement about high antipsychotic treatment. Inpatient treatment sheets must indicate when a patient is receiving high antipsychotics. The front of the chart must be annotated with High antipsychotics, the BNF percentage and signed and dated. A high antipsychotic monitoring form must be completed. One copy must be put in the patient s notes and one kept in the pharmacy department (Sandwell). In Wolverhampton one copy must be sent to the Treatment Centre and one kept in the pharmacy department. Increase the of antipsychotic(s) slowly. Consider -related adverse reactions and cumulative adverse reactions. PRN (as required) antipsychotics should not be given for more than 7 days without review. If appropriate, consider PRN lorazepam. Patient s progress should be reviewed at least 3 monthly and the reduced to within the licensed range if no significant progress is observed and alternatives considered. This must be recorded in the patient s notes. Version 2.0 December 2014 7
The justification for the continued use of high therapy where there is no clinical response should be recorded in the patient s medical notes. 7.4 Monitoring advice for high antipsychotic prescribing Carry out baseline ECG before prescribing high antipsychotics to establish a baseline, and exclude cardiac contraindications, including long QT syndromes. An ECG should be repeated after a few days, every 1 3 months in the early stages of high- treatment as clinically indicated, and then repeated periodically (minimum 3 monthly), while the is still high. If QTc is prolonged (>450ms for men and >470ms for women) or other adverse abnormality develops, treatment should be reviewed and cardiology assessment considered. Serum urea and electrolytes and liver function should be checked before prescribing, after 1 month and then 3 monthly. Monitor blood pressure, pulse, temperature and hydration status weekly initially. Consider extending monitoring interval (minimum 3 monthly) when treatment is stable. In the community, monitor baseline tests and, at a minimum, monitor patient at each outpatient appointment and/or CPN visit according to clinical need. Document in clinical notes if the patient refuses any of the above tests or if mental state does not allow. Version 2.0 December 2014 8
7.5 Antipsychotics Dose Percentage Conversion Table Oral s 20% 25% 33% 40% 50% 66% 75% 80% 100% Typicals Chlorpromazine 200mg 250mg 330mg 400mg 500mg 660mg 750mg 800mg 1000mg Flupentixol 6mg 9mg 12mg 18mg Haloperidol 5mg 10mg 15mg 20mg Promazine 200mg 400mg 600mg 800mg Sulpiride 600mg 1200mg 1800mg 2400mg Trifluoperazine 10mg 20mg 25mg 40mg 50mg Zuclopenthixol 30mg 60mg 75mg 120mg 150mg Atypicals Amisulpride 300mg 400mg 600mg 900mg 1200mg Aripiprazole 10mg 15mg 20mg 30mg Clozapine 225mg 300mg 450mg 600mg 675mg 900mg Olanzapine 2.5mg (12.5%) 5mg 7.5mg (37.5 %) 10mg 12.5mg (62.5%) 15mg 17.5mg (87.5%) 20mg Quetiapine 150mg 250mg 300mg 375mg 500mg 600mg 750mg in schizophrenia Quetiapine 200mg 300mg (37.5%) 400mg 600mg 800mg in mania Risperidone 2mg (12.5%) 4mg 6mg (37.5%) 8mg 12mg 16mg Intramuscular injection 20% 25% 33% 40% 50% 66% 75% 80% 100% DAILY DOSE Aripiprazole 9.75mg 15mg 22.5mg 30mg Haloperidol 3mg 6mg 9mg 12mg Olanzapine 5mg 10mg 15mg 20mg Clopixol Acuphase Max of 4 injections & 400mg in 2 week period Depots 20% 25% 33% 40% 50% 66% 75% 80% 100% WEEKLY DOSE Flupentixol Decanoate 80mg 100mg 120mg (30%) 150mg (37.5%) 200mg 250mg (62.5%) 300mg 350mg (87.5%) 400mg Fluphenazine Decanoate 12.5mg 25mg 37.5mg 50mg Haloperidol Decanoate 12.5mg (17%) 18.75mg 25mg 37.5mg 50mg 75mg Paliperidone 50mg 75mg 100mg 150mg monthly monthly monthly monthly Pipotiazine Palmitate 12.5mg 25mg 37.5mg 50mg Zuclopenthixol Decanoate 150mg 200mg 300mg 400mg 450mg 500mg (83%) 600mg Risperdal Consta 25mg 37.5mg 50mg 2 weekly 2 weekly 2 weekly Version 2.0 December 2014 9
7.6 Resuscitation All clinicians should have experience in resuscitation and know how to use the resuscitation equipment in the hospital. Each ward should have an appropriate procedure for dealing with cardiac arrest. All sudden unexpected deaths which might be associated with antipsychotic prescribing should be reported using the yellow card scheme and a Trust incident form (DATIX) completed online. 8.0 Monitoring Compliance The key elements of the policy that need to be monitored: 1. Correct documentation in patients notes 2. Documentation on front of treatment sheets high and percentage 3. Completion of high antipsychotic monitoring form 4. Evidence of physical health monitoring Who will perform the monitoring? Each Divisional Care Governance Group is responsible for monitoring that there is a systematic and consistent approach to providing efficient and effective medicine management for the services they are responsible for. Care Governance Committee meets monthly with Clinical Directors from each division to monitor the work of Divisional Care Governance Groups to implement the care governance agenda across the services areas they are responsible for. In addition, Medicines Management Committee monitors that there is a systematic and consistent approach to providing efficient and effective medicine management across the three divisions of mental health, learning disabilities and children and young people s services. How often will monitoring of the key elements of the policy be undertaken? This will correspond to the level of risk posed by each key element of the policy. The Pharmacy Department will undertake their own audits to monitor compliance with the Standard Operating Procedure (SOP) through clinical supervision. What method will be used to monitor compliance? As described above. Where will the results of the monitoring be reported? Any evidence of poor adherence to the policy will be reported to the MMC. What will happen if any shortfalls are identified? Required actions will be identified by each Divisional Care Governance Group to rectify any shortfalls and they will appoint appropriate person(s) to implement them. Similarly, the Medicines Management Committee will appoint appropriate person(s) to implement particular actions e.g. Chief Pharmacist, Risk Manager, where they have identified that they have a Trust-wide rather than a divisional significance. How will the resulting action plan be progressed and monitored? Appropriate person or persons identified by each Divisional Care Governance Group will be expected to action the required changes to practice within a specific time Version 2.0 December 2014 10
frame. Progress to completion will be monitored by each Divisional Care Governance Group. For Trust-wide issues, the Medicines Management Committee will do likewise. How will the results inform or improve current practice? The results can inform or improve current practice in a variety of ways and below are examples of the different forms this may take:- policy review review of training analysis needs improving the methods used to communicate to staff introduction of new procedures, SOPs introduction of, or increase in the frequency of audits review relevant data differently or more frequently. 9.0 Standards / Key Performance Indicators Key Performance Indicator Correct documentation in patients notes Documentation on front of treatment sheets high and percentage Completion of high antipsychotic monitoring form Evidence of physical health monitoring Method of Assessment Audit of patients notes Audit of treatment sheets Checking as part of clinical supervision within the pharmacy department Audit of form in patients notes (At Penn audit of forms at Treatment Centre) Audit of patient s notes/haematology results (At Penn audit of information documented at Treatment Centre) 10.0 Equality Impact Assessment The Black Country Partnership NHS Foundation Trust is committed to ensuring that the way that we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group. The Equality Impact Assessment for this policy has been completed and is readily available on the intranet. If you require this in a different format e.g. larger print, Braille, different languages or audio tape, please contact the Equality and Diversity Team on 0121 612 8067 or email EqualityImpact.assessment@bcpft.nhs.uk 11.0 Training Training on this policy should be given to all new members of staff who are expected to work under it. Staff should ensure they maintain a working knowledge of this policy and read as often as required to ensure competence under it. Staff should be re-trained on this policy when an incident occurs. Where specific training needs are identified, please contact the pharmacy team for advice/guidance. 12.0 Data Protection Act and Freedom of Information Act All staff have a responsibility to ensure that they do not disclose information concerning the Trust s activities or about service users in its care to unauthorised individuals. This responsibility applies whether you are currently employed or after your employment ends and in certain aspects of your personal life e.g. use of social networking sites etc. Version 2.0 December 2014 11
The Trust seeks to ensure a high level of transparency in all its business activities but reserves the right not to disclose information where relevant legislation applies. 13.0 References Royal College of Psychiatrists Consensus statement on the Use of High Dose Antipsychotic Medication, Council Report CR26 October 1993 Royal College of Psychiatrists (2006). Consensus statement on High Dose Antipsychotic Medication (Council Report CR138) London: Royal College of Psychiatrists Guidelines for the use of high antipsychotic medication, Bradford District NHS Care Trust Guidelines for use of high antipsychotic medication, East London and The City Mental Health NHS Trust High and combination antipsychotic prescribing, Medicines Information Bulletin, Oxfordshire and Buckinghamshire Mental Health Partnership NHS Trust Guidance on the use of high antipsychotic therapy, Leicestershire Partnership NHS Trust NICE clinical guideline 82, March 2009. Schizophrenia, Core interventions in the treatment and management of schizophrenia in adults in primary and secondary care BNF British National Formulary published by the British Medical Association & Royal Pharmaceutical Society of Great Britain 13.1 Legislation Medicines Act 1968 and subsequent revisions 14.0 Links to other Policies and Procedures This policy should be read in conjunction with the Trust s Medicines Policy. Version 2.0 December 2014 12
HIGH DOSE ANTIPSYCHOTIC MONITORING FORM Appendix 1 Initial checklist to be completed by Please circle Name.. Doctor Reason for High antipsychotic Y N NA Hospital No therapy documented on case notes? Consent obtained and documented? Y N NA Date of Birth.. High antipsychotic therapy Y N NA Ward.. mentioned on consent to treatment/second opinion form? Consultant SECTION A Date Regular Oral Total daily Total daily Total daily When Required (PRN) Total daily Total daily Total daily Depot Weekly Weekly Weekly Combined % total Completed by: SECTION B RISK FACTORS Please circle Risk factors Please circle Cardiac history Y N Illicit drug use Y N Family history of heart disease Y N Heavy smoker Y N Old age Y N Alcohol use Y N Impaired glucose tolerance Y N Obesity Y N Hepatic or renal impairment Y N Diabetes Y N Taking any drug(s) which may interact Y N Previous history of adverse effects to high s of antipsychotics Y N MONITORING Baseline 3-5 days 1 month 3 months 6 months Date due Date completed ECG (QTC interval) LFTs ( if ok) U&Es ( if ok) FBCs ( if ok) Temperature ( if ok) Blood pressure ( if ok) Pulse Medication reviewed Y/N Discrepancies acted upon Y/N Doctor s signature Version 2.0 December 2014 13