POLICY DOCUMENT. Pharmacy MMG/MPG. Approved By and Date Medicines Management roup March March 2016

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1 POLICY DOCUMENT Document Title High dose and combination antipsychotic guidance Reference Number n/a Policy Type Prescribing and Treatment Guideline Electronic File/Location Clinical Resources/Pharmacy/Prescribing & Treatment guidelines Intranet Location /PrescribingandTreatmentguidelines.aspx Status Approved Version No/Date Version 2 March 2016 Author(s) Responsible for Writing and Monitoring Pharmacy MMG/MPG Approved By and Date Medicines Management roup March 2016 Implementation Date March 2016 Review Date March 2019 Copyright North Essex Partnership University NHS Foundation Trust (2016). All rights reserved. Not to be reproduced in whole or in part without the permission of the copyright owner. All matters or concerns regarding fraud or corruption should be reported to: Chris Rising, Senior Manager (Chris.Rising@bakertilly.co.uk ), Hannah Wenlock, LCFS Lead (Hannah.Wenlock@bakertilly.co.uk ) Mark Trevallion, LCFS Lead (Mark.Trevallion@bakertilly.co.uk ) OR the National Fraud and Corruption Line Page 1 of 12

2 Contents Section Topic Page Number 1 Introduction 3 2 Aim 3 3 Scope 3 4 Reference to other standards, policies or procedures 3 5 Reasons for high dose antipsychotic prescribing 3 6 Risks associated with high dose antipsychotic prescribing 4 7 Guidance on using high dose antipsychotics 4 8 Responsibilities 6 9 Three month review of HDAT 7 10 References 11 Summary of changes Appendices 1 High dose antipsychotic monitoring form 2 Page 2 of 12

3 HIGH DOSE AND COMBINATION ANTIPSYCHOTIC GUIDANCE 1 INTRODUCTION 1.1 A Royal College of Psychiatry Consensus Working Group report (2014) defines high dose antipsychotic therapy (HDAT) as follows: a total daily dose of a single antipsychotic which exceeds the upper limit stated in the SPC or BNF with respect to the age of the patient and the indication being treated, and a total daily dose of two or more antipsychotics which exceeds the SPC or BNF maximum using the percentage method. 1.2 The percentage method involves use of a ready reckoner available from Pharmacy. This converts the prescribed antipsychotic dose into a percentage of the licensed maximum dose. For combination antipsychotics, these percentages can then be added together to calculate the total percentage dose. Where this exceeds 100%, it is HDAT. 1.3 A Prescribing Observatory for Mental Health (POMH-UK) national audit in 2012 found 28% of adult inpatients were prescribed HDAT and 86% of these patients HDAT was due to combination antipsychotics (approximately two-thirds of which included a prn prescription). 2 AIM 2.1 The aim of this guidance is to provide a reference source for medical, nursing and pharmacy staff involved in the care of patients prescribed HDAT. It will also set out clear roles and responsibilities for managing HDAT. 3 SCOPE 3.1 This guidance applies to the above professions caring for inpatients being prescribed HDAT. 4 REFERENCE TO OTHER STANDARDS, POLICIES OR PROCEDURES Tab 5 Prescribing Tab 6 Assessment of side effects of psychotropic medicines Tab 19 PRN medication 5 REASONS FOR HIGH DOSE ANTIPSYCHOTIC PRESCRIBING 5.1 Higher doses of antipsychotics may be justified for pharmacokinetic (insufficient drug reaching the effect site) or pharmacodynamic (individual differences at effect site) reasons. For more information on this, see RCPsych Consensus Report Higher doses are sometimes prescribed due to poor response to standard dose treatment and unsuitability or poor tolerability of clozapine. Page 3 of 12

4 5.3 Prescriptions for antipsychotics can become high dose when combination antipsychotics are used. 5.4 Multiple antipsychotics can be prescribed for various reasons: Attempt to enhance therapeutic effect eg clozapine augmentation Manage challenging symptoms/behaviour including use of prn antipsychotics Manage adverse effects During a period of switching from one antipsychotic to another 5.5 Overall, there is little evidence to support the use of combination antipsychotics 6 RISKS ASSOCIATED WITH HIGH DOSE ANTIPSYCHOTIC PRESCRIBING 6.1 The main risk associated with HDAT is increased side effects such as: Extra-pyramidal side effects Sedation Postural hypotension Anticholinergic effects QTc prolongation Sudden cardiac death Seizures Hyperprolactinaemia 6.2 Use of HDAT can also increase the risk of drug interactions and particular caution must be used with erythromycin and ketoconazole (delayed cardiac repolarisation), antidepressants (potential for increased plasma level and arrhythmias), diuretics (electrolyte imbalance), antiarrhythmics (increased risk of cardiac event) and antihypertensives (increased risk of postural hypotension and falls). 6.3 The more complicated the treatment regime, the less likely the patient is to adhere to treatment. This includes the increased side effect burden. 6.4 Prescribing doses above the BNF maximum reduces the cost-effectiveness of treatment. 7 GUIDANCE ON USING COMBINATION AND HIGH DOSE ANTIPSYCHOTICS 7.1 The decision to prescribe combination antipsychotics should only be made by a Consultant, preferably after discussion with the MDT. A clear indication and rationale should be documented in the patient s clinical notes along with target symptoms to assess efficacy and response. 7.2 Where two or more antipsychotics are used, the prescription for each prescribed antipsychotic should be annotated with the % BNF dose in relation to the maximum Page 4 of 12

5 dose. If the combined percentage is greater than 100%, the patient is receiving HDAT. This may also be achieved by using one antipsychotic at greater than the licensed dose ie >100% BNF maximum dose. 7.3 For prn prescriptions, the percentage dose should be calculated based on the maximum prescribed dose in 24 hours. If the use of this prn prescription takes the total prescribed antipsychotic dose (including regular prescriptions) above 100%, HDAT documentation and monitoring will be required. The exception to this is rapid tranquilisation as this should not be being given regularly. Clear indications on prn prescriptions are therefore essential (see Medicines policy Tab 19 for more information on prn prescribing). 7.4 Where a single antipsychotic is prescribed above the licensed BNF maximum dose for a drug holding UK marketing authorisation, this becomes an off-label use. Prescribers should refer to and follow relevant professional guidance eg GMC, Royal College of Psychiatrists. 7.5 The above mentioned report from the Royal College of Psychiatrists (2014) states that any prescription of high dose antipsychotic should: Be seen as an explicit, time-limited individual trial with a distinct treatment target Have a clear plan for regular clinical review including safety monitoring Only be continued if the trial shows evidence of benefit that is not outweighed by tolerability or safety problems after at most, three months. 7.6 Before using HDAT, ensure that: Sufficient time has been allowed for response At least two different antipsychotics have been tried sequentially (one atypical) at adequate doses Clozapine has failed or not been tolerated due to agranulocytosis or patient refuses clozapine Adherence to existing therapy has been assessed and addressed through use of alternative formulations eg orodispersible, depot injections Adjunctive medications are not indicated or have failed Psychological approaches are not indicated or have failed Baseline ECG, FBC, U&E, LFT, lipid profile, renal function, physical examination, blood pressure, pulse, temperature, BMI, blood glucose should all be performed 7.7 Consent should be sought and documented for formal (detained) and informal patients. T2 and T3 forms should make reference to HDAT, including combinations and percentage doses. 7.8 The HDAT monitoring form (appendix 1) should be completed to document the above and be filed in the patient s notes. The patient s drug chart should be annotated on the front to state that they are receiving HDAT and monitoring is required. Page 5 of 12

6 7.9 Once the patient has started to receive HDAT, ongoing monitoring should be performed and recorded on the monitoring form in appendix 1. This should include: A repeat ECG after 1 week then monthly Repeat of baseline tests monthly for 3 months Pulse, blood pressure and temperature daily for one week, weekly to 4 weeks Need for continued HDAT weekly for 1 month then every 3 months 7.10 Side effects should be monitored following guidance in the Medicines policy Tab 6 assessment of adverse effects of psychotropic medicines. This should occur after 1 week then monthly for 3 months 7.11 Where abnormal results are found, the responsible clinician should assess the abnormal finding and document whether HDAT is to continue, stop or any other action taken. This should be on REMEDY as a minimum For patients admitted on HDAT, this must be discussed at the first MDT review. The three month review form in Appendix 2 should be completed on admission and then every three months as required. 8 RESPONSIBILITIES 8.1 Doctors responsibilities Record reason for HDAT in clinical notes Inform patient and document consent Complete baseline and further monitoring Complete HDAT monitoring form and side effect monitoring in conjunction with nursing staff Ensure T2/T3 is complete and current referencing HDAT if applicable If HDAT to continue post-discharge ensure GP and community teams are aware of HDAT status and required monitoring. Please note that patients prescribed HDAT are unlikely to be transferred to GP care but should this be the case a comprehensive care plan should be in place. 8.2 Nurses responsibilities Perform baseline and ongoing monitoring as required in conjunction with medical staff Ensure all nursing staff are aware of HDAT status Add HDAT stickers where HDAT is identified Ensure HDAT monitoring is being completed and raise with doctors if action is required Document HDAT in care plan and risk assessment Page 6 of 12

7 8.3 Pharmacy responsibilities Calculate and endorse antipsychotic prescriptions with % BNF dose using current ready reckoner available from Pharmacy Check for interactions and discuss as necessary with medical staff Check HDAT monitoring is being completed Attach HDAT sticker to drug chart 9 THREE MONTH REVIEW OF HDAT 9.1 After three months, there should be a full MDT review to assess the need for ongoing used of HDAT. 9.2 This review should include assessment of progress against target symptoms, side effects and test results for the previous three month period. 9.3 If it is decided HDAT should continue, this must be documented using Appendix 2 with reference made in the patient s clinical notes with monitoring completed as follows: ECG every 3 months until 1 year, then annually (unless dose change or clinical need to repeat) Repeat of baseline tests at months 3, 6 12 and then annually Side effects at least every three months to one year and then annually Pulse, blood pressure and temperature every 3 months 9.4 Every three months the patient remains on HDAT, a full review should occur to determine the need for continued HDAT. This should be documented on Appendix REFERENCES Royal College of Psychiatrists, Consensus statement on high dose antipsychotic medication. College report CR190 Maudsley Prescribing Guidelines in Psychiatry, 12 th Edition, SUMMARY OF CHANGES Date December 2015 Page Summary of Changes Number(s) All New format applied Definition moved to introduction and updated based on latest 3 RCPsych report 3 Section 5 reasons for HDAT - added Guidance expanded to provide more detail on baselines tests, 4-6 percentage dosing, off-label prescribing and ongoing monitoring 6 Section 8 responsibilities added Page 7 of 12

8 7 Section 9 three month review of HDAT - added Appendices: HDAT monitoring form re-designed Consent form removed as other Trusts aren t using one 8-10 Side effect monitoring from removed and signposted to side effect monitoring policy to standardise forms used Three month review form added Page 8 of 12

9 Appendix 1 High Dose Antipsychotic Monitoring form - Initiation This form must be completed for all patients prior to prescribing high dose antipsychotics Patient s Name: Consultant: Reason for HDAT (including target symptoms): NHS Number: Date of HDAT decision: Pre-treatment decision checklist Has the patient failed to respond to at least two antipsychotics at adequate doses taken for adequate duration? (circle) Does the patient have any of the following risk factors? (circle) History of cardiac disorders? Hepatic impairment? Renal impairment? Obesity / high BMI? Diabetes? Raised cholesterol? If yes to any of the above, outline a risk management / minimisation plan: Are there any significant drug interactions that require treatment modification? (circle) If yes, which drugs interact? Baseline tests (enter results where possible or tick if in range) Test: Result: Date: Test: Result: Date: ECG (QTc interval) Total cholesterol FBC BP U&E Pulse LFT Temperature egfr Creatinine Blood glucose BMI Consent Has consent been obtained and documented? (circle) If applicable, has MHA paperwork (ie T2 or T3) been updated to reflect HDAT? (circle) Name of person completing form: Signature: Date: Designation: Page 1 of 2 Page 9 of 12

10 High dose antipsychotic therapy monitoring first 3 months Summary of monitoring requirements ECG repeat after 1 week then monthly for 3 months Other baseline tests monthly for 3 months Pulse, blood pressure and temperature daily for 1 week, weekly to 4 weeks then every 3 months Side effects after 1 week then monthly for 3 months (as per Trust policy, Tab 6) Need for continued high dose antipsychotic therapy weekly for 1 month then every 3 months (document in clinical notes on REMEDY) ECG Week 1 (Date) QTc Interval Week 5 (date) QTc Interval Week 9 (Date) QTc Interval Week 13 (Date) QTc Interval Other baseline tests (enter result or tick if complete and not possible to enter result) FBC U&E LFT egfr Blood glucose Total cholesterol BMI Month 1 Date: Month 2 Date: Month 3 Date: Pulse, Blood Pressure and Temperature Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Week 2 Week 3 Week 4 Pulse Blood Pressure Temperature Page 10 of 12

11 Page 2 of 2 Appendix 2 High Dose Antipsychotic Monitoring Three monthly review Patient s Name: Consultant: NHS Number: Date of HDAT review: Assessment of response of target symptoms to HDAT: Ongoing Monitoring Have all monitoring requirements in 9.3 been completed for the past 3 months? (circle) Results Test: Result: Date: Action taken / required Page 11 of 12

12 Outcome of Review Following review, does the patient still require HDAT? (circle) Consent (complete only if HDAT to continue) Does the patient still consent to receiving HDAT? (circle) If applicable, is MHA paperwork (ie T2 or T3) current and up to date? (circle) Plan Outline below the plan for the next three months with regard to desired response to HDAT and proposed medication changes: Name of person completing form: Signature: Designation: Date: Page 12 of 12