CLOZAPINE ONE STOP CLINIC POLICY (SANDWELL) Revised

Transcription

1 1.18 CLOZAPINE ONE STOP CLINIC POLICY (SANDWELL) Policy Title 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 Ratification State ratified by whom - Policy Ratification Group, Executive Committee or Director Equality Impact Assessment Implementation Plan Clozapine One-Stop Clinic (Sandwell) Revised Clinical-medicine management policies & procedures - CQC Essential Standards of Quality and Safety Outcome 9 Mgt. of Medicines - NHSLA Risk Mgt. Standards NEQAS & CPA Senior Medicine Management Technician Hallam Clinic Staff, CMHT leaders, Pathology laboratory SWBHT, DGOH Pharmacy Service, BCPFT Pharmacy Team Yes Yes Month/year policy first developed December 2010 Months/years policy reviewed Keep review dates in chronological order May 2013 Next review due May 2016 Review details Revisions made, changes etc include page numbers and paragraphs For Corporate Executive Support use Date Policy First Uploaded to Intranet December 2010 Date Policy Revised & Reloaded to Intranet September 2013 Version 2. May 2013

2 CLOZAPINE ONE STOP CLINIC POLICY Ref. Contents Page 1.0 Introduction Purpose Objectives Definitions Duties Committee Responsible Service provision & Procedure Monitoring Compliance Equality Impact Assessment Data protection & Freedom act References Legislation Link to other polices 13 Review and Amendment Log Version Reason Status Date Description of Change 2.0 Brand of Clozapine changed to Novartis. Review overdue Ratified May 2013 References to old Brand removed Version 2.0 May

3 1.0 Introduction Clozapine is an atypical antipsychotic that requires validated full blood counts (FBC) to be available prior to issuing pre-dispensed Clozapine to the patient by a CPN from the Clozapine Clinic. The introduction of the Point of Care (PocHi) blood testing systems provides a result within 5 minutes and allows the patients to collect their medication on the same day. Advance dispensing of Clozapine, before a valid blood result is available, is a common practice to enable workflow planning in pharmacy departments. However it is noted that all three manufacturers state in their manuals that there should be a valid blood result before dispensing. This confuses the issue as the activity that actually happens when a valid blood result is received is the issuing of the tablets on receipt of a green result (the manipulation of product - dispensing - already having taken place). There is less consistency about who should hand over the medication: CPMS suggests any health professional, ZTAS seems more specific about it being a pharmacist who is able to dispense. However, there are several mental health trusts around the country where clinics are nurse-led, and they issue ( hand out ) the medication to patients on receipt of the green result from the POCT analyzer system. BCP and DGOH need to recognize the differences between the companies wording of their manuals (more specifically in our case, the CMPS manual) and what happens in practice. Nurse-led issuing of clozapine carries no greater risk than giving a patient a bag of TTOs on a ward, except that there is a preliminary stage of verifying a valid blood result. 2.0 Purpose The aim is to provide a safe and efficient one-stop-clozapine service for the patients, which also ensures safety of both patients and staff. This is to be achieved by close cooperation between the Psychiatric nurses, BCP clinical team, Guest pharmacy (DGOH), Infection Control and the Haematology laboratory. 3.0 Objectives We support the values expressed in the NICE Guidelines for treating and managing people with schizophrenia. The purpose of the clinic is to offer a holistic approach to meet the treatment needs of individual patients who attend in accordance with the principles of the recovery model of mental health. We believe: That development of the clozapine service should be in joint consultation with service users. That patients should take an active role in their care wherever possible and be encouraged to maintain a sense of responsibility for managing their own illness. Version 2.0 May

4 That holistic care should be delivered in accordance with trust policies and professional codes. That the service should as far as possible be (within the monitoring guidelines set up by CMPS) flexible to accommodate a person s individual need, e.g. provision for holidays. We Value: Our role as an education and information resource to our patients, their careers and other members of the multi-disciplinary team. Collaborative and multi-disciplinary teamwork. The therapeutic relationship between patients and staff that helps clients to feel at ease when having their blood test. Our role in providing advice and assistance to patients in signposting to other relevant agencies to meet their needs. 4.0 Definitions ABBREVIATIONS USED IN THIS POLICY CCN CCO CPMS CPN CPT DGOH FBC NICE PoCHI POCT SCN SOP SWBHT TTO ZTAS BCPFT Clozapine Clinic Nurse Community Care Officer Clozaril Patient Monitoring Service Community Psychiatric Nurse Clinical Pharmacy Team Dudley Group of Hospitals Full Blood Count National Institute of Health & Clinical Excellence Synonym for POCT Point of Care Testing (aka PoCHi ) Senior Clozapine Nurse Standard Operating Procedure Sandwell & West Birmingham Hospitals NHS Trust To Take Out Zaponex Treatment Access Service Black Country Partnership NHS Foundation Trust Version 2.0 May

5 5.0 DUTIES The Clinic will be run by the Clozapine Clinic Nurses, with support from the Clinical Pharmacy Team. The Designated Clinician is responsible for monitoring of individual patient cases and concerns about prescription doses and a patient s mental health should be referred to them or their junior doctor. The Senior Clozapine Nurse has responsibility for the management of the clinic and will be line managed by the Adult Recovery Service Manager. They will have line management responsibility for the nursing staff and Community Care Officers (CCOs) working in the clinic. The Senior Clozapine Nurse: as a key user. will train others in its use as appropriate. This will include ensuring that: all staff are appropriately trained & maintenance requirements are carried out on schedule user for each clinic. according to the traffic light system, and medication is available for the patient to take with them upon leaving the clinic. Will be responsible for all aspects of Health and Safety in the clinic Will ensure all equipment & consumables required for the clinic is available for each clinic session There are two nurses who have been trained by Sysmex, at least one will be in charge during clinic sessions Community Care Officer (CCO) CCO s assist with the physical health monitoring. They will not be issuing any medication or using the analyzer The Medicines Management Technicians will have responsibility for the organization of the dispensing and distribution of medication with our dispensing partner and the clinic nurses. POCT Group After initial set up, the multidisciplinary POCT group will meet when issues relating to the development and running of the clinic need reviewing. A register of staff involved with the clinic and their training and competencies will be maintained by the group. Staff attending will be: Deputy Director Service Delivery Clinic Nursing Staff Medical Staff Deputy Chief Pharmacist Version 2.0 May

6 Senior Technician Guest Hospital Medicines Management Technicians Pathology representative Infection Control Nurse Specialist Minutes will be taken and distributed and reported to the Medicine Management Committee. An update report will be provided every six months. 6.0 Committee/Group Responsible for Approval of this Policy POCT Committee Group who in turn report to Medicine Management Committee 7.SERVICE PROVISION AND PROCEDURES 7.1 Referral Procedure Referrals are accepted from inpatient and outpatient sources and can be made by Medical and Nursing staff. The Clozapine Clinic referral form must be completed and sent to the clinic with the current risk assessment at the earliest opportunity, preferably as soon as the decision to commence clozapine has been taken. Staff will ensure all details have been correctly completed and file it in the patient s clinic file. 7.2 Registration with CPMS Initial blood tests must have been completed to enable a patient to be registered with CMPS. All patients undertaking clozapine therapy must be registered. This is the responsibility of the patient s consultant. A registration form must be completed as per CPMS procedures. This form can be obtained from the CPMS website or the Pharmacy Team. Patients already on clozapine therapy transferring into Sandwell will be switched to Clozaril if not already having this brand. This will be the responsibility of the consultant who accepts the patient. 7.3 Blood Monitoring Services Haematology supplies are the responsibility of the senior clinic nurse. An initial baseline blood sample is taken from the patient to establish baseline blood result tests prior to commencing clozapine. This will be by the initiating team. Version 2.0 May

7 The first dispensing and administration of medication must take place within ten days of baseline blood test. This will usually be the responsibility of the initiating team. Blood tests are then carried out as per CMPS protocols: - Every seven days for the next eighteen weeks - After eighteen weeks blood tests are reduced to fortnightly for the next thirty four weeks - After one year tests are reduced to every twenty-eight days. These are subject to alteration by CPMS depending on the patients blood results. All venepuncture procedures will comply with Trust Standards and adhere to Infection Control Procedures. Staff undertaking the procedure will have attended an appropriate phlebotomy course and have certification. In the event of difficulty in obtaining a sample from a patient they may be asked to attend the Sandwell General Hospital Phlebotomy Department. 7.4 Point of Care testing A blood anaylser machine is used in the clinic to enable a patient s blood to be tested on site and the result transmitted directly to CPMS The Senior Charge Nurse has responsibility for ensuring a rota is in situ designating the key user for each clinic. The senior clinic nurse will ensure blood results are checked according to the traffic light system, and medication is available for the patient to take with them upon leaving the clinic. Nurses who are handing out (issuing) the previously-dispensed clozapine will have had training and be signed off as competent to carry out this task. All initial blood tests will be sent to SWBHT haematology laboratory for testing. Any bloods that need to be done out of clinic hours are sent to Sandwell General Hospital. Either Sandwell pathology request forms or the CPMS Haematology forms may be used but the word clozapine must appear on the form and the patient s CPMS PIN must also be included. All clinical procedures will be undertaken in accordance with Professional Codes, Trust Standards for Venepuncture and Infection Control, which includes Universal Precautions. CPMS and the appropriate Clinic SOPs will be observed at all times. Version 2.0 May

8 7.5 Blood Results The Designated Analyser Key User is responsible for the transmitting of blood results to CPMS and for actioning the relevant status of the blood test i.e. Red /Amber /Green as per Clinic SOP. They will communicate an alert status of RED or Amber to the relevant health care professional responsible for the patient and ensure requests for further blood tests are organized. Action taken on alert status will be taken as per Clinic SOP. Blood results from the analyzer are filed in the patient s clinic records. The paper results from CPMS go to the Consultant: some file the results in the medical notes not the clinic notes. 7.6 Frequency of Blood Testing for Patients The Nursing Staff will maintain a diary that enables them to co-ordinate patients attending the clinic for testing at the relevant time period. The Clinical Pharmacy Team will liaise with clinic staff about changes in monitoring frequency and can access blood results on the CPMS system in the event of a query being raised. The CPT will also maintain a diary and schedule of patients attending the clinic. If the frequency changes, clinic staff will discuss thjs change with the patient when they attend the clinic and the alteration runs from the next appointment. 7.7 Health Promotion and Education Staff in the clinic will promote general health issues in matters relating to clozapine therapy with patients. They will discuss issues relating to: Side effects Weight gain Smoking Exercise using appropriate assessment tools they will give guidance to patients on management of their symptoms provide information and literature on healthy eating, and inform the care coordinator of the problem. Can sign-post to appropriate services discuss smoking cessation sign-post to appropriate services if a patient indicates they wish to stop. Leaflets are available in the clinic Patients must be informed that ceasing smoking may increase the levels of clozapine in their body and the dose may need to be adjusted. This needs to be brought to the attention of the medical staff if the patient asks, staff can remind them of the benefits of exercise. Clinic staff can signpost patients to appropriate facilities Version 2.0 May

9 Clinic Staff will ensure any identified need or problem is communicated to the relevant Health Care Professional/ Care Coordinator of the patient. At every patient attendance at the clinic staff will observe the patient for any decline in their mental and physical health and communicate this directly to the relevant Care Co-coordinator and RMO. 7.8 Dispensing and Issue of Clozapine Clozapine will be dispensed and accuracy checked by the Guest Pharmacy for all inpatients and outpatients as per appropriate pharmacy SOP. Note that the supply for outpatients will be dispensed in advance of the blood test and sent to the clinic as per the SOP. The supply will be quarantined in the clinic (as per PSOP 18) and not given to any patient until an appropriate blood result has been obtained. Only staff who have had the training for issuing quarantined clozapine supplies after the appropriate blood result has been obtained can give the patient their clozapine. The training for this procedure will consist of reading and understanding the SOP (by completing a tick list), and demonstrating to pharmacy staff that the process and the responsibilities associated with it have been understood. A certificate will be issued to successful individuals. 7.9 HEALTH RECORDS Staff will be required to comply with Professional and Trust Standards with regard to record keeping (see Trust policy BCPFT-CLIN-POL Care Record Keeping Standards & Practice). An individual file, which is provided by CPMS with relevant bar codes for blood bottles, will be kept for each patient. The file will be kept in accordance the appropriate Trust policy (BCPFT-CLIN-POL Record Management Policy for Patient Related Records). This will include: - The Referral Form or Patients details form for existing patients - Risk assessment - Care plan - Nursing progress notes Patient prescription cards will be kept alphabetically in the filing cabinet in the pharmacy. Version 2.0 May

10 Health records of patients no longer attending the clinic will be sent to: - Either location of the main health records for incorporation into the notes if the patient is no longer receiving clozapine therapy - Or the health care professional who will be responsible for taking further bloods HEALTH AND SAFETY The Senior Clozapine nurse will be responsible for all aspects of Health and Safety in the clinic. They will ensure all staff are aware of Health and Safety Legislation in relation to the clinic activities and that each individual is aware of their individual responsibilities under the Act. Equipment - any defective equipment or potential hazard will be reported immediately to the appropriate department. Equipment testing schedules will be adhered to and a record kept as evidence they have been complied with. Accidents - all accidents or injuries to patients, staff or visitors must be documented in Datix. Fire Policy Trust policies and annual training must be followed Personal Alarms there is an alarm in the analyzer room for attracting assistance Nursing Staffing Arrangements The Senior Clozapine Nurse will co-ordinate the staff required to operate the clinic on a weekly basis. Annual leave should be co-coordinated in order to maximize staffing. There should only be one member of the team off at any one time. In the event of both prime clinic nurses being unavailable, the clinic will be run by CCOs who have been trained to cover for this eventuality. Patients will be required to have local testing at Sandwell. Another CPN in the team should be present to deal with any problems with medication. Training will be provided. Each clinic session should have a minimum of two staff in attendance, one of whom must be a registered nurse who has experience and knowledge of monitoring patients undergoing clozapine therapy. This person should have had training in the use of the analyzer and have had the training for issuing clozapine from the quarantined supply. The Senior Clozapine Nurse will be responsible for providing professional and organizational support, ensuring that staff are compliant with Nursing and Midwifery Council codes and Trust standards on clinical supervision. Version 2.0 May

11 They will ensure they and the clinic nursing staff have undertaken appraisals and have a professional development plan. They will have responsibility for professional development and training within the clinic for nursing staff. Student Nurses may observe in the clinic as part of their training and will be given an information pack on attendance. If a patient objects to their presence or the clinic staff believe it not to be in patients best interests the student may be asked to leave whilst particular interventions are carried out. There will be no more than one observer or student at each clinic session duties COSHH all equipment and reagent guidance provided by Sysmex and NQAS must be followed. 8.0 Monitoring compliance Following NEQAS & CPA standards the analyser and related equipment will undergo routine quality control checks and evidence held within the clinic. The POCT group will be informed of any problems within the clinic or service and report to the Medicines Management Committee. 9.0 Equality Impact Assessment The Black Country Partnership NHS Foundation Trust is committed to ensuring that the way 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 & Diversity Team on or EqualityImpact.assessment@bcpft.nhs.uk 10.0 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. 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 References Clozaril Patient Monitoring Service Duthie Report) published by the Royal Pharmaceutical Society of Great Britain. Version 2.0 May

12 Standards for Better Health NPSA Alerts NICE guidance Safer Management of Controlled Drugs: A guide to good practice in secondary care (England) DOH October 2007 gateway ref: 8913 Safer management of controlled drugs: a guide to good practice in secondary care (England): Department of Health Publications September 2000 GMC / Good Practice in Prescribing Medicines Nursing and Midwifery Council of Great Britain 1st November 2008 Standards for Medicines Management Nursing and Midwifery Council - Standards for medicines management ooklet.pdf Patient safety first campaign 2008 Medicines, Ethics and Practice Guide. RPSGB and Legislation Health Act 2006 Medicines Act 1968 and subsequent revisions The Controlled Drugs (Supervision of Management and Use) Regulations SI 2006/3148 The Misuse of Drugs Regulations /3998 The Misuse of Drugs (Safe Custody) Regulations 1973, amended 2007 Control of Substances Hazardous to Health Regulations 1988 (COSHH) 13.0 Trust Policies referenced in this document or otherwise related to the function of the Hallam St Hospital Clozapine Clinic SMHSCT-CLIN-POL Phlebotomy Policy SMHFT-CLIN-POL Management of Medical Devices SMHFT-COI-POL Infection Control Assurance Policy SMHSCT-COI-POL Standard Precautions for the Control Of Infection BCPFT-COI-POL Hand Hygiene Policy SMHSCT-COI-POL Decontamination of Blood and Body Fluid Spillages SMHSCT-COI-POL Decontamination of Equipment prior to Service or Repair SMHSCT-COI-POL Single Use Equipment SMHSCT-ORG-POL Waste Management Policy SMHSCT-COI-POL Environmental Cleaning Policy SMHSCT-HS-POL Health & Safety Policy Statement Version 2.0 May