Clozapine intramuscular (IM) Guideline, inpatients only

Transcription

1 SH CP 203 Clozapine intramuscular (IM) Guideline, inpatients only Summary: Guideline for use and monitoring of intramuscular clozapine treatment. Keywords: Target Audience: Clozapine, intramuscular, IM, Clozaril, Brocacef, treatment resistant schizophrenia Practitioners involved in using IM clozapine, where the oral route is refused. Next Review Date: May 2021 Approved & Ratified by: Medicines Management Committee Chair s approval Dr Shez Khan - Consultant Psychiatrist, New Forest (West) Adult CMHT Date of meeting: 16 th May 2018 Date issued: Author: Director: South London and Maudsley NHS Foundation Trust. Adapted for Southern Health by Rebecca Henry, Principal Pharmacist Specialist Services Dr Jane Collier Consultant Psychiatrist 1

2 Version Control Change record Date Author Version Page Reason for Change 6/3/17 Alex Weston Change from CPMS to generic clozapine patient monitoring service (CPMS/DMS) as clozapine monitoring service, due to practical experience. Additional advice obtained from Maudsley included. 12/4/`7 Rebecca Henry 16/5/17 Gillian Ritchie 16/5/17 Gillian Ritchie 16/5/17 Gillian Ritchie 16/5/17 Gillian Ritchie 30/5/17 Gillian Ritchie 7/3/18 Rebecca Henry 9/5/18 Rebecca Henry 2 Appendix 1 Appendix Appendix 4 Appendix 5 8 Add to SOAD section Please include paperwork with application T3 to specify clozapine intramuscular Include care plan templates, key points, monitoring sheet and alter appendix numbers Title reworded Deleted Appendix 4 ( key points ) because repeated content elsewhere in Guideline. Deleted Appendix 5 ( care plan ) because repeated content elsewhere in Guideline and care plans should be individualised. Changed criteria for approval to the revised requirement for approval from MDT, CSD, SOAD and either the NPU or a Consultant Psychiatrist external to the Trust. 2 4, 8, 10 Application forms for IM clozapine will be considered and approved / refused by the MMC Chair and not by the Chief Pharmacist. 2 8 Added section for Consultant s signature, printed name and date. Also added sentence as reminder that it should be faxed to the Chief Pharmacist s office together with Appendix , 8 All Added IM as a keyword. Removed all references to CPMS as they will not register patients who are prescribed IM clozapine. Replaced such references with DMS Denzapine Monitoring Service. Reviewed for grammar and good use of English. 2 5, 8 Added requirement for SOAD to specifically reference IM clozapine on the T3 form. 3 Throughout Added CPMS they now do register patients 3 Flow chart added Appendix 1 order changes to reflect practice Appendix 2 line added for chief pharmacist to sign Reviewers/contributors Name Position Version Reviewed & Date Rebecca Henry Principal Pharmacist MH Specialised Services/E&T 12 th April 2017 Gillian Ritchie Clinical Pharmacist 16 th May 2017 Gillian Ritchie Clinical Pharmacist 30 th May

3 Contents Section Title Page 1. What is IM clozapine 4 2. Which patients can be prescribed IM clozapine? 4 3. What is the purpose of using IM Clozapine? 4 4. Registration of patients for IM Clozapine 5 5. For how long can the treatment continue? 5 6. What are the equivalent oral and IM doses? 5 7. Starting IM clozapine 5 8. Monitoring of patients prescribed IM clozapine 5 9. Cost of IM clozapine 6 10 Glossary 6 Clozapine 25mg/ml short acting intramuscular (IM) injection 7 Flow chart Appendix 1 IM clozapine criteria to be fulfilled to be signed by Consultant 8 Appendix 2 Solent / SHFT Request and Declaration Form for Supply of an 9 Unlicensed Medicinal Product: to be completed by the Consultant Appendix 3 Clozapine Injection Titration Chart 11 Appendix 4 IM Clozapine Physical Health Monitoring Sheet 12 Appendix 5 Clozapine Physical Health Monitoring Sheet 13 Appendix 6 IM clozapine monitoring form 16 3

4 Clozapine intramuscular (IM) Guideline, inpatients only 1. What is IM clozapine? Intramuscular clozapine is an unlicensed product made in the Netherlands by Brocacef and imported to the UK via Durbin PLC. It is a clear yellow solution for injection. The strength of the injection is 25mg/ml and each ampoule contains 5mls (125mg). It is administered by deep intramuscular (IM) injection into the gluteal muscle. The injection is painful and the maximum volume that can be injected into each site is 4ml (100mg). For doses greater than 100mg daily, the dose may be divided and administered into two sites. 2. Which patients can be prescribed IM clozapine? IM clozapine is indicated only for inpatients with a treatment-refractory psychotic disorder who are refusing oral treatment. It can be prescribed for patients who have never previously received clozapine or for patients who have previously been treated with clozapine and are known to have responded to it but who have subsequently relapsed owing to noncompliance. The need for clozapine injection must be agreed by the multidisciplinary team (MDT), approved by the Clinical Services Director (CSD) and a SOAD, in addition to being recommended by the National Psychosis Unit (NPU). It must be specifically referenced by the SOAD on the T3 form as a named drug and route with specified dosing information. If it is not possible to obtain a referral to the NPU (owing to lengthy waiting lists, for example), then the patient must instead be reviewed by a Consultant Psychiatrist external to the Trust whose findings subsequently include a recommendation for IM clozapine. In such an instance, the previously detailed requirement for MDT agreement, approval by the CSD and a SOAD would continue to apply. Therefore to summarise, recommendations are needed from the following: MDT CSD SOAD (it must be specifically referenced by the SOAD on the T3 form as a named drug and route with specified dosing information) NPU / Consultant Psychiatrist external to the Trust These recommendations from four independent parties must be fully documented on the MDT Assessment Form (Appendix 1) which must be signed by the Consultant. This completed form should be faxed to the Chief Pharmacist s office together with the completed form in Appendix 2 ( Solent / SHFT Request and Declaration Form for Supply of an Unlicensed Medicinal Product ). These two forms will form the basis upon which the Medicines Management Committee (MMC) Chair will formulate their decision to either grant their approval for use of IM clozapine in a particular patient, or to refuse such approval. IM clozapine may only be prescribed and administered following the written approval of the MMC Chair. 3. What is the purpose of using IM Clozapine? IM clozapine is a short-term intervention only. It potentially enables the initiation of clozapine in patients who refuse oral medication, with a view to converting to oral clozapine as soon as possible. 4

5 4. Registration of patients for IM Clozapine After IM clozapine has been approved by the MMC Chair, the patient must be registered with the Denzapine Monitoring Service (DMS) or Clozaril monitoring service (CPMS), as the aim is to use IM clozapine only for the shortest possible time before switching to oral clozapine. However, it should be noted that DMS does not hold any responsibility for the use of IM clozapine; this rests with the consultant. 5. For how long can the treatment continue? IM clozapine should be used for the shortest duration possible. Before administering each injection, the patient should be offered clozapine orally. The need for ongoing IM clozapine must be reviewed regularly by the MDT. In general, the injection should be used for no longer than two weeks. However, in exceptional cases, the injection may be used for longer than two weeks if approved by the MDT, SOAD, NPU / Consultant Psychiatrist external to the Trust and the MMC Chair. If the patient accepts oral doses initially and then after a few weeks starts to refuse it, the patient should be allowed to refuse it and if 48 hours or more elapse, the clozapine should be re-titrated, using IM clozapine if necessary. 6. What are the equivalent oral and IM doses? The oral bioavailability of clozapine is about half that of the intramuscular injection. For example, 50mg daily of the IM injection is roughly equivalent to 100mg daily of the tablets. 7. Starting IM clozapine The patient must be registered with the DMS/CPMS the week before commencing treatment. Treatment should start on a Monday whenever possible. Clozapine should be prescribed on the main drug chart and this should be cross-referenced to the separate Clozapine Injection Titration Chart (Appendix 3). Each dose on the clozapine titration chart must be signed and dated by the prescriber. The Clozapine Injection Titration Chart must be attached to the main drug chart. The patient should always be offered oral clozapine first and if the patient refuses, then IM clozapine should be administered. Nursing staff must clearly indicate the route of administration used on the Clozapine Injection Titration Chart. 8. Monitoring of patients prescribed IM clozapine Baseline assessment before starting clozapine must include ECG, FBC, lipids, plasma glucose, U&Es, LFT, CRP and troponin. It is anticipated that daily monitoring of blood pressure, pulse, respiratory rate and temperature will be difficult to achieve for many patients. However, every effort must be made to obtain these and patient refusal of observations must be documented. Importantly, patients should be observed for any signs of being unwell, such as pallor, cough, shortness of breath, sweating etc. After each dose of IM clozapine, the patient must be observed every 15 minutes for the first two hours to monitor for excessive sedation. The usual weekly blood tests should be performed whilst on treatment; the sample could be taken at the same time as the administration of clozapine injection if needed. The usual precautions for amber and red warnings relating to treatment with clozapine apply (refer to SH CP 114, the Trust s Clozapine Guideline for further details). N.B. If IM lorazepam is required leave at least ONE HOUR between administration of IM clozapine and IM lorazepam. 5

6 Further information Please refer to Clozapine guideline SH CP Cost of IM clozapine Clozapine injection costs around 100 per injection (or part thereof, as any unused portion must be discarded) 10 Glossary IM intramuscular DMS Denzapine monitoring service CPMS Clozaril monitoring service Unlicensed medicine. Section 9 of the Medicines Act (1968) permits the use by doctors of unlicensed medicines on a named patient basis. A doctor prescribing an unlicensed medicine does so entirely on his/her own responsibility, carrying the total burden for the patient s welfare, and may be called upon to justify his/her actions in the event of an adverse reaction. Vicarious liability for the use of an unlicensed medicinal product or use outside the terms of a Product Licence rests with Southern Health NHS Foundation Trust providing the Trust Policy has been followed 6

7 Clozapine 25mg/ml short acting intramuscular (IM) injection Identify suitable patients; Treatment refractory and refusing oral treatment, (previous clozapine treatment is not required) Complete MDT assessment form, obtain approval, appendix 1 Complete Solent/SHFT unlicensed medicines form, appendix 2 Specifically reference clozapine IM on T3 Complete baseline observations, ECG, FBC, lipids, plasma glucose, U&Es, LFTs, CRP and troponin Register with clozapine monitoring service, DMS or CPMS Prescribe on main drug chart and cross reference to clozapine injection titration chart, appendix 3 Always offer oral clozapine first and clearly indicate the route of administration on the clozapine titration chart Monitor patient as per appendix 4 and 5, if not possible document refusal and any physical observations for any signs of being unwell e.g. pallor, cough, shortness of breath, sweating Complete IM clozapine monitoring form appendix 6, if IM is administered Review regularly N.B. If IM lorazepam is required leave at least ONE HOUR between administration of IM clozapine and IM lorazepam. 7

8 Appendix 1: IM Clozapine criteria to be fulfilled to be signed by Consultant Patient Name... Ward. Date of birth.. NHS number.. Consultant Indication for IM clozapine Does the patient have any physical comorbidities that lead to the contraindication of clozapine? Yes / No Has the patient previously been prescribed clozapine? Yes / No If yes, please state reason clozapine was stopped Criteria Document MDT discussion in patient record, MDT to include pharmacist NPU recommendation OR Recommendation of Consultant Psychiatrist external to the Trust Please include paperwork with application. SOAD recommendation The SOAD must specifically reference IM clozapine on the T3 form as a named drug and route with specified dosing information Please include T3 form with application Date completed Sign CSD approval Solent/SHFT unlicensed application form (Appendix 2) sent to Chief Pharmacist MMC Chair approval Patient registered with DMS/CPMS Clozapine im/po prescribed Clozapine IM requested from St Mary s Hospital Pharmacy Consultant signature confirming completion of above criteria. Printed name of Consultant.. Date... Please return completed form to Chief Pharmacist offfce Fax: shft.mmt@nhs.net 8

9 FOR GLUTEAL ADMINISTRATION ONLY Appendix 2 Solent / SHFT Request and Declaration Form for Supply of an Unlicensed Medicinal Product: to be completed by the consultant This form must be completed by a consultant wishing to use an unlicensed product. It should be used in conjunction with the Trust Policy on the use of Unlicensed Medicines which contains detailed information on definitions, processes, legal implications, patient and procurement issues involved in the prescribing and supply of unlicensed medicinal products. Name of Unlicensed Medicine Clozapine Clinical Indication Patient Name Preparation (form and strength) IM injection 25mg/ml (5ml ampoules) Dosage (strength, frequency and duration) Increasing Hospital number and DOB The product is requested in the full knowledge that it has no UK product licence Section 9 of the Medicines Act (1968) permits the use by doctors of unlicensed medicines on a named patient basis. A doctor prescribing an unlicensed medicine does so entirely on his/her own responsibility, carrying the total burden for the patient s welfare, and may be called upon to justify his/her actions in the event of an adverse reaction. Vicarious liability for the use of an unlicensed medicinal product or use outside the terms of a Product Licence rests with Southern Health NHS Foundation Trust providing the Trust Policy has been followed. Indication Diagnosis/indication for the drug: Rationale for request (claimed advantage over formulary drug(s)) Previous medication used (dosages, duration, effectiveness, tolerability, reasons for stopping) 9

10 Consultant s details Name: Base: Contact telephone number: Fax number: I have read the above information and accept responsibility for the use of this product. It is my clinical judgment that the use of this medicinal product will benefit the patient(s) under my care. Consultant signature: Print name: Date: Clinical Services Director signature: Print name: Date: Please return completed form to Chief Pharmacist office Fax: shft.mmt@nhs.net Chief Pharmacist signature: Print name: Date: To be completed by MMC Chair or deputy Authority to proceed with purchase and supply: MMC Chair or deputy signature: Print name: Date: 10

11 Appendix 3: Clozapine Injection Titration Chart Surname: First name(s): Date of birth: Consultant: Ward: NHS number: Allergies/previous serious adverse drug reactions: Mental Health Act Section: Date T2/T3 T2/T3 attached: YES/NO (circle) ALWAYS OFFER ORAL CLOZAPINE FIRST Date Day Clozapine oral dose Clozapine IM dose (25mg/ml) If oral refused mg 6.25mg (0.25ml) Prescribers signature and date Pharm Screen Specify route given PO or IM, if IM state side given Given, sign and date 2 25mg 12.5mg (0.5ml) 3 25mg 12.5mg(0.5ml) 4 50mg 25mg(1ml) 5 50mg 25mg(1ml) 6 75mg 37.5mg(1.5ml) 7 75mg 37.5mg(1.5ml) 8 100mg 50mg(2ml) 9 100mg 50mg(2ml) mg 62.5mg(2.5ml) mg 62.5mg(2.5ml) mg 75mg(3ml) mg 75mg(3ml) mg 87.5mg(3.5ml) 11

12 Appendix 4 IM Clozapine Physical Health Monitoring Sheet (To be kept with Medication chart or in clinical room if JAC) Sheet no: Patient name: NHS no: CPMS no: Clozapine start date: Baseline observations: Time: Date: Weight: Height: BMI: Temp: Pulse: BP sitting/lying: BP standing: Respiration(RR): During initiation omit if temperature>38.5 c, postural drop> 30mmHg or pulse> +/- 15% baseline, inform the doctor Observations; please document if the patients refuses and document any signs of being unwell, such as pallor, cough, shortness of breath and sweating. After giving IM medication observe the patient every 15 minutes for the first two hours to check for excessive sedation. Day Date Time Temp Pulse RR, (normally breaths per minute) Lying BP Standing BP Other side effects, particularly flu like symptoms, hypersalivation, palpitation, chest pain, constipation Outcome (state if Dr informed) Signature 12

13 Appendix 5: Clozapine Physical Monitoring Sheet (to be kept with medication chart). The track and trigger tool may be used in place of the monitoring sheet but the frequency of monitoring should be the same. Patients name CPMS no: Hospital/NHS No. Clozapine start date Baseline observations time: date: Wt Height...BMI Temp: Pulse: BP (standing): BP standing / lying: Respiration: During initiation: Omit if temperature >38.5 C, postural drop >30mmHg or pulse > +/- 15% baseline, and inform the Doctor. Observations Day (use the morning dose where possible) 1 Before dose 2hrs post, if awake 6hrs post, if awake 2 Before dose 2hrsafter dose 6hrs after dose 3 Before dose 6hrs after dose Date Time Temp Pulse Respiratory rate (normal rate breaths per minute) Lying BP Standing BP Other side effects, particularly flu like symptoms, hypersalivation, palpitations, chest pain, constipation Outcome if Dr informed Sign 13

14 Day (use the morning dose where possible) 4 Before dose 6hrs after dose 5 Before dose 6hrs after dose 6 Before dose 6hrs after dose 7 Before dose 6hrs after dose 8 Date Time Temp Pulse Respiratory rate (normal rate breaths per minute) Lying BP Standing BP Other side effects, particularly flu like symptoms, hypersalivation, palpitations, chest pain, constipation Outcome if Dr informed Sign

15 Day (use the morning dose where possible) 15 Date Time Temp Pulse Respiratory rate (normal rate breaths per minute) Lying BP Standing BP Other side effects, particularly flu like symptoms, hypersalivation, palpitations, chest pain, constipation Outcome if Dr informed Sign

16 Appendix 6: IM clozapine monitoring form Patient name Date of birth. NHS number Consultant.. Date IM clozapine given Dose IM clozapine given Why IM being given? Was IM given under restraint? Y/N How easy was it to draw up the IM clozapine? How easy was it to administer the IM clozapine? Observe patient for presence of injection site reaction At time of After 60 After two After four injection minutes hours hours Y/N Y/N Y/N Y/N Observe patient every 15 minutes for two hours after an IM clozapine dose Any Any Any Any Any excessive unusual cough? shortness excessive sedation? pallor? Y/N of sweating? Y/N Y/N breath? Y/N Y/N If occurs, please specify timings of these side effects To be completed by the Pharmacist: Is the patient ultimately stabilised on oral clozapine? Y/N If No, please state the reasons for this If yes, does this lead to improved patient outcomes? Y/N As this is a high cost drug, what was the cost of administering IM clozapine to this patient? 16