Clinical. High Dose Antipsychotic Prescribing Procedures. Document Control Summary. Contents

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1 Clinical High Dose Antipsychotic Prescribing Procedures Document Control Summary Status: Version: Author/Owner/Title: Approved by: Ratified: Related Trust Strategy and/or Strategic Aims Implementation Date: Review Date: Key Words: Associated Policy or Standard Operating Procedures Contents New (extracted from former Medicines Used outside of, or without, a product licence) 1 Date: December 2015 Mo Azar, Deputy Director of Pharmacy Policy and Procedures Committee Trust Board Medicines Optimisation Strategy January 2016 January 2019 Date: Date: HDAP, monitoring, responsibilities, high dose antipsychotics, combined antipsychotics, prescribing, off-label, unlicensed Medicines Code Trust Formulary Off-label and Unlicensed Medicines Policy Rapid Tranquillisation Policy Assessing and Managing the Physical Health Needs of Service Users Policy High Dose Antipsychotic Monitoring Form POMH-UK Ready Reckoner (max dose comparator) 1. Introduction Purpose Scope Identifying High Dose Antipsychotic Prescribing Procedure once High Dose Antipsychotic Prescribing is agreed Process for Monitoring Compliance and Effectiveness References... 7 Appendix 1: High Dose Antipsychotic Therapy (HDAT) Monitoring Form... 8

2 Change Control Amendment History Version Dates Amendments 1 December 2015 Extracted and updated from the original medicines used outside of or without a product licence policy. Monitoring form re-formatted Page 2 of 9

3 1. Introduction This procedure sets out the responsibilities and steps to be undertaken when prescribing antipsychotics above the licenced or recommended maximum daily dose. The definition for what constitutes high dose prescribing is set out later in this document. The procedure falls within the scope of the Off-label and Unlicensed Medicines Policy and it should also be read in conjunction with the Medicines Code, Trust Formulary and the Assessing and Managing the Physical Health Needs of Service Users Policy. 2. Purpose The prescribing of antipsychotics above the licensed recommended maximum doses is associated with a significantly greater risk to the service user in respect of morbidity and mortality, whilst only conferring limited clinical benefits. Instances of unexpected sudden death have been reported across health services and are typically associated with the prescribing of high doses of antipsychotics with poor physical health monitoring in place. When considering the need for prescribing above the licensed dose, firstly consider alternative approaches including adjuvant therapy or switching to an alternative antipsychotic. The prescribing of high doses should be restricted to exceptional practice rather than the routine. The aim of this procedure is, however, not to prohibit the use of antipsychotics above their licensed maxima but to draw attention to the risks; the need for regular, timely review and the monitoring recommended with continued use only in cases where it is deemed necessary and benefiting for the service user 3. Scope This procedure sets out the responsibilities of each staffing group involved in the prescribing, supply and administration of high dose antipsychotics. The overall responsibility lies with the service user s consultant clinician. Only consultant or associate specialist psychiatrists should make the decision to use high dose antipsychotics regularly and the decision and justification should be documented in the patient s notes. Junior doctors and non-medical prescribers may prescribe high dose antipsychotics (for inpatients) in the short-term on an as required basis and when operating under the rapid tranquillisation policy. The consultant psychiatrist, being responsible for the full care plan, should be notified of such prescribing. 4. Identifying High Dose Antipsychotic Prescribing NB: although the BNF maximum is commonly referred to, the licensed maximum dose is that which is stated in the Summary of Product Characteristics for an individual medicine. It is this value that determines whether prescribing is within or outside the product licence. Typically doses in the current BNF reflect those in the current product licence but there may be differences occasionally. Note also that when prescribing in elderly patients, recommended maximum doses are typically reduced. When identifying high dose antipsychotic prescribing attention should be given to ensure the dose is appropriate for the age of the patient. Page 3 of 9

4 A) Single antipsychotic drug prescribed at a daily dose above the BNF upper recommended limit. B) More than one antipsychotic prescribed concurrently including PRN and prescribing via different routes. In defining what constitutes a high dose of antipsychotics for patients receiving more than one antipsychotic at individual doses within the normal BNF range, it is necessary to convert the doses to their percentage of the BNF maximum. These percentages are then added together and where this total exceeds 100%, the patient is considered to be receiving a high dose. For long-acting/depot antipsychotics the prescribed dose should first be converted to the equivalent weekly dose the patient is receiving before converting to the percentage of the BNF maximum. This enables different frequencies of administration to be compared more easily. In the case of as required (PRN) antipsychotics, it is the total daily dose prescribed that is used in the calculation and not the doses administered. Unless specifically stated on the prescription that the total daily dose includes any regular prescription already written up, the PRN and regular doses will be added together. Where separate routes are prescribed, such as oral and IM, the total daily doses will be added together, unless specifically stated that the second route may only be administered if the first route is refused or impractical to give. Where there are differences in bioavailability between routes, care should be taken to ensure that comparative doses are prescribed. For example imagine a patient is prescribed: Zuclopenthixol decanoate IM 300mg every two weeks PLUS Olanzapine PO 15mg once a day PLUS Olanzapine IM 10mg PRN max once a day Depots are calculated at their equivalent mg/week. Therefore 300mg every two weeks is equivalent to 150mg once a week. The BNF maximum for zuclopenthixol decanoate is 600mg once a week 150mg / 600mg x 100 = 25% The BNF maximum for olanzapine is 20mg/day in total (whether IM or PO). 15mg / 20mg x 100 = 75% The prescribed PRN dose is calculated even if not being administered. 10mg / 20mg x 100 = 50% The three percentages are then summated: = 150% Page 4 of 9

5 Therefore the patient is on high dose antipsychotics (as total over 100%) even though each individual prescription is within its BNF maximum. The use of a dose comparator such as the Ready Reckoner produced by the Prescribing Observatory for Mental Health may help clinicians. The current version may be obtained from the Pharmacy and Medicines Optimisation Department or via this intranet link. It should be noted that for the purposes of this procedure and for simplification of audit, BNF maxima are being compared. However, this should not be confused with having equivalent or comparative antipsychotic effects. Consider olanzapine PO 10mg/day and risperidone PO 8mg/day Both doses are 50% of their respective BNF maximum; however, it is clear that the doses are in no way equivalent in antipsychotic effect. Comparing effective doses is outside the scope of this procedure and reference should be made to available, published literature sources. If intending to switch between antipsychotics a cautious cross-taper depending on the individual s response is usually advocated. It is also outside the scope of this procedure to assign clinical merit to any combination of antipsychotics. The evidence base for benefit is poor, the risk of adverse effects is high and the pharmacological rationale is often counter-productive. Combinations of first generation and second generation antipsychotics may well lose the perceived benefit of second generation antipsychotics in avoiding extra-pyramidal side effects. Combinations of oral and long-acting dose forms may undermine the original rationale for opting for a long-acting injection if that had been to avoid the need to take tablets every day and support adherence. The only antipsychotic combination with reasonable good evidence is the augmentation of clozapine with another, complementary treatment such as amisulpride. This applies to combinations that would be calculated as less than 100% and, as such, not strictly subject to this procedure. Good practice suggests that these combinations still be regularly reviewed to identify therapeutic value. Sometimes these combinations arise when a planned cross-titration stalls part of the way through and were not initially intended. Reviews should be undertaken at least every three months and especially once an acute episode as resolved. The benefits and the risks of continuing the combination should be evaluated and compared against those of altering therapy. The patient s (or carers ) views should be taken into account. 5. Procedure once High Dose Antipsychotic Prescribing is agreed i. Indicate on the front of the Medicines Treatment and Record Sheet ( Medicines Card ) that the patient is receiving high dose antipsychotics and set up an alert on the patient s RiO record for the duration the high dose prescription is in place. ii. Complete a High Dose Antipsychotic Prescribing Monitoring Form (Appendix 1) for the patient and attach to the current medicines card. Once the Form is completed or the Page 5 of 9

6 doses reduced to 100% or less of the BNF maximum it should be scanned into the investigations section on RiO. iii. Consider: (a) Risk Factors: Cardiac history (particularly myocardial infarction, arrhythmias, abnormal ECG) Hepatic / renal impairment Diabetes / Metabolic Syndrome Alcoholism / smoking tobacco Old Age Obesity Illicit drug use (b) Potential Drug Interactions, specifically aiming to avoid concomitant treatment with: Diuretics Anti-arrhythmics Anti-hypertensives Tricyclic antidepressants Drugs which might prolong QT interval Drugs which inhibit metabolism that may raise the plasma levels of antipsychotics further (e.g. clarithromycin, paroxetine as well as eating grapefruit) Also note any drugs which induce metabolism that may be necessitating a higher dose of an antipsychotic to achieve a therapeutic response (e.g. carbamazepine and also smoking tobacco products the quitting of which may lead to drug accumulation) iv. Obtain a baseline ECG (for some antipsychotics this is stated as a pre-treatment requirement in the product licence and NICE recommend an ECG is conducted for all inpatients). If a prolonged QT interval is recorded (e.g. QT c > 440ms -1 ), review treatment; consider cardiology assessment. If it is decided to continue treatment, record reasons for doing so in the patient s RiO notes. Repeat an ECG, periodically i.e. after one month and then for every three months the high dose prescribing continues. If an ECG is not performed the reason should be documented in the patient s notes. v. Serum urea and electrolytes, full blood count and liver function should be checked before prescribing, after one month and then every three months to ensure liver or renal failure or bone marrow suppression are not developing. Pulse, lying and standing blood pressure, temperature, and clinical signs of dehydration should be checked for one week after dose changes, at one month and then every three months. This monitoring may also be required under the Trust s Assessing and Managing the Physical Health Needs of Service Users policy, and under the specialist responsibilities within Essential Shared Care Agreements with GPs. NB: High dose antipsychotic prescribing should not usually be transferred to primary care and should remain with the specialist team. vi. Where possible increase the dose slowly, ideally over intervals of at least one week; noting that antipsychotics take a period of time to take effect. Review progress at least once every three months, reducing doses to within the licensed range if no significant improvement in mental health is observed and consider alternatives, e.g. adjuvant therapy or atypical antipsychotics or clozapine. Continued use of high dose therapy where there is no clinical response should be justified in the patient s notes and consultants should consider seeking a second opinion from a colleague. The review should be documented in the patient s notes. Page 6 of 9

7 vii. It may help to review symptom response quantitatively over time using validated rating scales such as the BPRS (Brief Psychiatric Rating Scale). Side effect burden can be assessed using validated scales such as LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale), SESCAM (Side Effects Scale/Checklist for Antipsychotic Medication) or GASS (Glasgow Antipsychotic Side-effect Scale). These should be performed at weeks 0, 4, 12, then for each three month review. Clinicians should familiarise themselves with these assessment tools prior to use to gain most benefit from them. Some of these scales are available on the Trust s website. 6. Process for Monitoring Compliance and Effectiveness This procedure will be supported by the Trust s Clinical Pharmacists (for inpatients and community teams) although compliance remains the responsibility of the consultant psychiatrist in charge of the prescribing. The Trust takes part in the national audit programme run by the Prescribing Observatory for Mental Health UK (a subsidiary of the Royal College of Psychiatrists). High dose antipsychotic prescribing is a focus of one of their audits and the Trust s results can be compared against other mental health trusts in the country. The data can also be broken down internally amongst individual teams. These audits are scrutinised by the Medicines Optimisation Committee and also by the Trust Board through the Clinical Audit Department. 7. References Consensus Statement on High Dose Antipsychotic Medication. CR190, Royal College of Psychiatrists, November 2014 The British National Formulary (refer to current edition). Joint Formulary Committee of the British Medical Association and the Royal Pharmaceutical Society available online via Medicines Complete POMH-UK Antipsychotic Dosage Ready Reckoner (use latest version available via the pharmacy department). Royal College of Psychiatrists, Page 7 of 9

8 Appendix 1 1/2 High Dose Antipsychotic Therapy (HDAT) Monitoring Form To be completed for all high dose therapy patients preferably before commencing treatment Patient Name: DoB: NHS Number: Ward: Community Team: High Dose Antipsychotic Monitoring Initiation After 1 Month 3/12 Reviews Post Initiation Date Antipsychotics Specify drug(s), dose(s), & route(s) Total % (add together % doses of ALL antipsychotics prescribed including PRN) Cardiac observations Blood Pressure Sitting (mmhg) Standing Pulse (bpm) ECG check [ QTc interval] (msec) Metabolic observations & blood profile BMI or waist circumference (cm) U&Es ( if OK or record action) LFTs ( if OK or record action) Prolactin level ( if OK or record action) Glucose regulation (HbA1c or fasting glucose level) (please write result) HDL cholesterol level (please write result) Triglycerides level (please write result) Other bloods (please specify) Others Temperature ( o C) Weight (kg) Smoker Y / N (if Y, specify number) Reason for HDAT documented in notes? Date when LUNSERS last completed: Consent obtained and documented? Doctor s name and initials: Consultant s signature: Please record any abnormal investigation results and actions in the patient s progress notes When the form is complete, please scan into RiO Further copies can be obtained from the Pharmacy Department

9 Appendix 1 2/2 High Dose Antipsychotic Monitoring Date Antipsychotics Specify drug(s), dose(s), & route(s) 3/12 Reviews Post Initiation Total % (add together % doses of ALL antipsychotics prescribed including PRN) Cardiac observations Blood Pressure (mmhg) Pulse (bpm) Sitting Standing ECG check [ QTc interval] (msec) Metabolic observations & blood profile BMI or waist circumference (cm) U&Es ( if OK or record action) LFTs ( if OK or record action) Prolactin level ( if OK or record action) Glucose regulation (HbA1c or fasting glucose level) (please write result) HDL cholesterol level (please write result) Triglycerides level (please write result) Other bloods (please specify) Others Temperature ( o C) Weight (kg) Smoker Y / N (if Y, specify number) Prescriber Responsibilities Order ECG Check U&Es Check LFTs Document reason for HDAT in progress notes Inform patient and document consent in progress notes Ensure on patient s discharge that GP and other relevant community mental health personnel are informed of HDAT status and required checks Ensure a system by which the required tests and reviews will be conducted by agreement with the community mental health team and/or GP Use of HDAT is solely the responsibility of the consultant, so the sheet should be signed after each review and check that appropriate action is being taken on any recorded abnormalities Nursing Staff Responsibilities Measuring and recording full set of physical observations, e.g. temperature, pulse, lying and standing blood pressure, with appropriate referral to prescriber as required Document HDAT status in notes Check that monitoring sheet is being completed - bring to medical staff attention if checks have not been done Undertake rating scales for measures of improvement in psychotic symptoms (e.g. BPRS) and side effects (e.g. LUNSERS). These are available at n-for-professionals/useful-tools Scan the completed form into RiO Ensure that HDAT status is discussed at review Ensure that community team is aware of high dose if it is to be continued on discharge Please record any abnormal investigation results and actions in the patient s progress notes When the form is complete, please scan into RiO Further copies can be obtained from the Pharmacy Department

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