POLICY FOR THE SAFE ADMINISTRATION OF INTRATHECAL CHEMOTHERAPY

Version: 1 Bwrdd Iechyd Prifysgol POLICY FOR THE SAFE ADMINISTRATION OF INTRATHECAL CHEMOTHERAPY MM05 Date to be reviewed: January 2015 No of pages: 21 Author(s): Tracy Parry-Jones Author(s) title: Cancer Network Pharmacist Responsible dept / Anne Bithell Chief of Staff, Pharmacy CPG director: Approved by: Cancer CPG Chemotherapy Group, BCUHB Medicines Policy and PGD Sub-Group Date approved: 12.9.11, 31.10.11 Endorsement by: Geoff Lang, Acting Chief Executive Date endorsed: 03.04.12 Date activated (live): May 2012 This document forms part of the implementation process for the overarching policy on the Safe administration of Intrathecal chemotherapy. Date EQIA completed: 15.12.11 Documents to be read This document MUST be read in conjunction with the alongside this policy: following guidance: Welsh assembly Government 2008 Safe handling and administration of intrathecal chemotherapy. CMO (2008) 4 / CPhA (2008) 1 / CDO (2008) 2 / CSA (2008) 1 published 6 th Aug 2008 A guide to the safe handling and administration of Vinca Alkaloids. CMO (2008) 5 Purpose of Issue/Description of current changes: To update the policy to reflect the re-organisation of BCUHB First operational: May 2012 Previously reviewed: Changes made yes/no: PROPRIETARY INFORMATION This document contains proprietary information belonging to the. Do not produce all or any part of this document without written permission from the BCUHB. MM05 Version: 1 Page 1 of 21 electronic version to ensure the version to hand is the most recent

Contents 1. Introduction and Background...3 2. Purpose and Scope...4 3. Definitions...4 4. Prescribing...4 5. Pharmacy Preparation...5 6. Delivery / Storage...5 7. Consent...6 8. Administration...6 9. Out of Hours Procedure...8 10. Training...8 11. Competency Registers...9 12. References and Bibliography...9 Appendices 1 Register...12 2a Pharmacy guidelines on checking &delivering...14 2b Pharmacy Competency...15 3a Nursing guidelines on administration...17 3b Nursing Competency...18 4 Medical guidelines on administration...20 5 Intrathecal Checklist...21 MM05 Version: 1 Page 2 of 21

Acknowledgements This document has been adapted from the original policy developed by Consultant Pharmacist at North Wales Cancer Treatment Centre. Additional References/Further Information Welsh assembly Government 2008 Safe handling and administration of intrathecal chemotherapy. CMO (2008) 4 / CPhA (2008) 1 / CDO (2008) 2 / CSA (2008) 1 published 6 th Aug 2008 A guide to the safe handling and administration of Vinca Alkaloids. CMO (2008) 5 1. Introduction and Background This policy includes a step-by-step guide for the administration of intrathecal chemotherapy which incorporates the recommendations contained in the Woods Report (Woods 2001), and subsequently the updated National Guidance from HSC 2003/010 and CMO 04/CNO 02/CDO 02/CSA 02/ CPhA 02 published on 4 th August 2005 and CMO 4/CPhA 1/CDO 2/CN 3/ CSA 1 published on 6 th August 2008. Since 1985 at least 13 patients have died or been paralysed as a result of accidental administration of Vincristine which was intended for intravenous administration. Vinca alkaloids may only be administered intravenously and are almost always fatal when administered intrathecally. In 2001 the Woods Report made recommendations to minimise the risk with the administration of intrathecal chemotherapy. Subsequently other national guidance has been published including; HSC 2003/010, CMO 04/CNO 02/CDO 02/CSA 02/ CPhA, and most recently CMO 4/CPhA 1/CDO 2/CN 3/ CSA 1 published in August 2008. By 31 st December 2008, all NHS Trusts in Wales had to be fully compliant with the National Assembly for Wales Guidance on the safe administration of intrathecal chemotherapy CMO (2008) 4 and the Updated National Guidance on the Safe Administration of Intrathaecal Chemotherapy, (HSC 2008/001). In order to comply with the national guidance, North Wales Cancer Network developed a policy for the safe administration of intrathecal chemotherapy. The Cancer Network Policy has now been updated to reflect the NHS reorganisation and establishment of. This policy therefore, intends to clearly document the requirements for safe practice of intrathecal chemotherapy administration within the Cancer, Haematology and Palliative Care Clinical Programme Group (CPG) of the (BCUHB) and to demonstrate compliance to the recommendations made in Welsh Guidance CMO(2008) 04. MM05 Version: 1 Page 3 of 21

2. Purpose and Scope Bwrdd Iechyd Prifysgol The purpose of this policy is to ensure safe practice for intrathecal chemotherapy administration and minimise the risk of harm. This policy is to be regarded as an overarching policy for all intrathecal chemotherapy related activity for adults within clinical areas within the NHS hospitals of. This document does not apply to paediatric patients or intrathecal administration of noncancer drugs. Each chemotherapy unit/ward will have a site-specific procedure for the administration of Intrathecal chemotherapy. The site-specific procedures are to be used in conjunction with and support the implementation of this policy. 3. Definitions Intrathecal chemotherapy - the therapeutic administration of cytotoxic drugs via a lumber puncture into the cerebro-spinal fluid. Cytotoxic chemotherapy activity any activity pertaining to the handling, preparation, internal transportation, administration and/or disposal of cytotoxic chemotherapeutic agents. 4. Prescribing 4.1. Intrathecal chemotherapy should be approved and prescribed only by Consultant Haematologists, Staff Grade or Associate Specialist Haematologists who are authorised by the Lead Clinician for this specific area of clinical practice (Appendix 1). Grades FY1 FY2 ST1 ST2 and ST3 must not prescribe intrathecal chemotherapy. 4.2. Intrathecal chemotherapy must always be prescribed on the standardised intrathecal chemotherapy administration sheet and never on a patient s drug chart or other chemotherapy prescription sheet. In addition, a separate administration record will be provided for intrathecal chemotherapy given as part of a regimen. Intrathecal chemotherapy must be prescribed on a separate prescription from all other chemotherapy. Clear warnings will appear on the prescription sheet for all cytotoxic drugs to be administered intrathecally: For intrathecal administration only. To be administered by a named doctor only as detailed in the policy on administration of intrathecal chemotherapy. To be administered separately from all other chemotherapy MM05 Version: 1 Page 4 of 21

If it is not possible to prescribe using electronic prescribing software then all chemotherapy must be prescribed on a pre-printed prescription chart available from pharmacy. This chart is regimen specific and details all the necessary warnings. 5. Pharmacy Preparation 5.1. Checking: All intrathecal chemotherapy prescriptions are clinically checked by a validated cancer services pharmacist to ensure that they are appropriate for the patient. 5.2. Preparation: All intrathecal chemotherapy is prepared by qualified, validated technicians (see Appendix 1) following the site specific standard operating procedures. For intrathecal chemotherapy requests outside normal working see section 9. 5.3. Labelling: All chemotherapy is clearly labelled with the drug name, dose, volume, patient s name, hospital number, batch number, the date of preparation and the expiry date. All cytotoxic drugs for intrathecal use are clearly labelled with the warning: For Intrathecal Use Only. This guidance has been written in conjunction with the recommendations of the Committee on Safety of Medicines in their consultation letter - Medicines Control Agency (2001) Report to the Committee on Safety of Medicines from the Working Group on Labeling and Packaging of Medicines MLX 275 : Annex D. 6. Delivery / Storage Only designated pharmacy staff is allowed to issue intrathecal chemotherapy see Appendix 1. 6.1. Intrathecal chemotherapy will be heat sealed into a polythene bag and then sent to the ward in a container specifically used for the transport of Intrathecal Chemotherapy. 6.2. Cytotoxic drugs for intrathecal use have a short expiry time (six hours). A specific time for administration is agreed with the doctor and the drug is prepared for the specified time. Drugs for intrathecal chemotherapy are either collected by the doctor who will be administering the intrathecal chemotherapy or taken to the ward by a designated member of the pharmacy staff and handed to the doctor MM05 Version: 1 Page 5 of 21

who will be administering the chemotherapy. This removes the need to store drugs for intrathecal use at ward level. 6.3. In both instances, the member of the pharmacy staff and the doctor should sign the prescription / tamper evident container to indicate delivery and receipt of the drugs. 6.4. No other medication is sent to the ward in the same bag as the intrathecal dose. 6.5. For patients receiving both intravenous and intrathecal chemotherapy on the same day, the intravenous drugs will be issued first. The intrathecal chemotherapy will only be issued on production of the signed chemotherapy prescription for the intravenous drugs as proof that all intravenous chemotherapy has been administered. This will be documented on the intrathecal chemotherapy prescription. Once completed the tamper evident bag and prescription should be returned to pharmacy for copies to be taken. The original prescription will then be returned to the patients notes. 6.6. Any intrathecal chemotherapy which is issued and is not subsequently administered must be returned to the pharmacy department immediately, along with the prescription and intrathecal chemotherapy bag and given to a pharmacist on the register in Appendix 1. 7. Consent Written explicit consent from the patient must be obtained by the Consultant Haematologist, Staff Grade or Associate Specialist in accordance with BCUHB policies. Patients will be provided with information about the procedure. Consent will be obtained and recorded at the start of the course of treatment. 8. Administration Intrathecal chemotherapy in should only be administered in the designated areas. The designated areas are: Glan Clwyd - Enfys Ward or Heulwen Day Unit. Bangor - Alaw Ward Wrexham - Shooting Star Unit/ Mason Ward. 8.1. Intrathecal chemotherapy will only be administered within the normal working day by Consultant Haematologists authorised to prescribe and administer intrathecal chemotherapy. 8.2. Intrathecal chemotherapy will only be dispensed and delivered to the ward when the dispensing pharmacist has seen written evidence that all intravenous chemotherapy dispensed for the patient that day has been administered or intravenous infusion. This will be in the form of MM05 Version: 1 Page 6 of 21

the ward staff returning the patient s intravenous chemotherapy chart to pharmacy with the record of administration including the time of administration and staff signatures. The pharmacist will then keep a record of the evidence to meet audit trail requirements. 8.3. When chemotherapy for intrathecal administration is received on to the ward or day unit it should be checked against the prescription for the patient to verify details. Checks should include; Patients details Full name Hospital number Date of birth Home address Diagnosis Each drug regimen with name/dosage of each drug intended administration date/time route of administration date/time of preparation date/time of expiry cycle number and day drug packaging is intact 8.4. The intrathecal chemotherapy injection must be checked prior to administration by the Consultant Haematologist, Staff Grade or Associate Specialist and one other person trained in the administration of chemotherapy and therefore authorised to do so (Appendix 1). The person administering the intrathecal chemotherapy must ensure that the person assisting them is on the intrathecal register. 8.5. Prior to administration the intrathecal chemotherapy should be checked in the presence of the patient at their bedside. The patient must have a name identification band attached and this must be checked. Checks should include: Patients details Full name Hospital number Date of birth Home address Each drug regimen with name/dosage of each drug intended administration date/time route of administration cycle number and day The patient should be encouraged to participate in the checking process. MM05 Version: 1 Page 7 of 21

8.6. At the time of administration no other intravenous or chemotherapy activity must take place in that designated area for the intrathecal administration. The designated area should be a separate room with walls and doors. A sign will be placed on the door indicating that an intrathecal procedure is taking place and that staff should not be disturbed. 8.7. The lumbar puncture procedure used should be performed in accordance with an approved technique such as is detailed in Appendix 5 (an amended version taken from The Royal Marsden Hospital Manual of Clinical Nursing Procedures [Mallett 2000]), the patient may also be sitting upright. A good flow of CSF must be obtained before proceeding. The patient should remain lying for up to 4 hours (30 minutes minimum). Only staff included on the administration register may perform the procedure. 8.8. In the event of an incident or near miss in relation to intrathecal chemotherapy administration the incident must be formally reported in accordance with BCUHB incident reporting policies and procedures 9. Out of Hours Procedure Under normal circumstances intrathecal chemotherapy should not be administered out with normal working hours. If there is a clinical need for intrathecal chemotherapy then the on call pharmacist must be contacted by a Consultant Haematologist. The on call pharmacist must contact the BCUHB Intrathecal Chemotherapy Lead before this procedure takes place. The BCUHB Intrathecal Chemotherapy Lead will discuss the case with the Consultant Haematologist and assess whether the procedure can safely continue. The procedure for the preparation, dispensing, checking and administration of out of hours intrathecal chemotherapy will be the same as detailed above. If designated personnel cannot be contacted the procedure will not take place until the next working day. 10. Training Only personnel who have successfully completed a recognised course of training for the specific procedure of intrathecal chemotherapy APPROPRIATE TO THEIR PROFESSION will be authorised to appear on the registers for intrathecal chemotherapy. The training should include the principles and practice of the preparation, handling, administration and disposal of chemotherapy and this will be certificated. It is the responsibility of the appropriate designated lead clinician to ensure competency of staff whose names are on the register. Staff whom are not directly involved in the provision of intrathecal chemotherapy are not required to have an induction about intrathecal chemotherapy or confirm in MM05 Version: 1 Page 8 of 21

writing that they understand NOT to get involved Staff on the register will be responsible for ensuring they only involve staff whom are on the register. 11. Competency Registers Only personnel whose names appear on specific registers for each Trust are authorised to prescribe, dispense, check and administer intrathecal chemotherapy (Woods 2001). Adequate numbers of personnel on these registers will ensure appropriate cover arrangements in the event of sickness or absence. These live registers (Appendix 1) and will be updated regularly (every 12 months).this will be co-ordinated and issued by the Lead Chemotherapy Pharmacist and Lead Consultant Haematologist on each hospital site. Personnel will be issued with a certificate annually. All staff that have been deemed competent will be placed on the appropriate hospital specific register. The register will be updated when changes occur. This also applies to staff operating on multiple sites within BCUHB they should undergo training and be on the register of each site they visit if they are to administer intrathecal chemotherapy. Registers will be on the intranet and paper copies will be held in pharmacy and in clinical area where the procedure will take place. When changes occur it is the responsibility of the Lead Oncology Pharmacist for each site to ensure that any paper copies are replaced. There should be a data audit trail of this. 12. References and Bibliography Department of Health (2001) External Inquiry into the adverse incident that occurred at Queen's Medical Centre, Nottingham, 4th January 2001, London: Department of Health, Department of Health (2001) Manual of Cancer Services Standards, London: NHS Executive Department of Health (2001) Reference guide to consent for examination or treatment, London: Department of Health Expert Committee on Learning from Experience in the NHS. (2000) An organisation with a memory: report of an expert group on learning from adverse events in the NHS / chaired by the Chief Medical Officer L Donaldson, London: Stationery Office Mallett, J & Dougherty, L. (2000) The Royal Marsden Hospital Manual of Clinical Nursing Procedures, Oxford: Blackwell Science (Intrathecal administration pages 188-189 and 355-359) MM05 Version: 1 Page 9 of 21

Medicines Control Agency (2001) Report to the Committee on Safety of Medicines from the Working Group on Labelling and Packaging of Medicines MLX 275 : Annex D Recommendations for the labelling of Vinca alkaloids, London: Medicines Control Agency National Assembly for Wales (2001) Guidance on the safe administration of intrathecal chemotherapy WHC (2001) 102, Cardiff: National Assembly for Wales North Wales Cancer Services (2000) Cytotoxic Chemotherapy Policy, Bodelwyddan: Conwy & Denbighshire NHS Trust Royal College of Radiologists' Clinical Oncology Information Network (2001) Guidelines for cytotoxic chemotherapy in adults : A document for local expert groups in the United Kingdom preparing chemotherapy policy documents Clinical Oncology (Royal College of Radiologists) 13(1):s209-48, 2001. Woods, K. (2001) The prevention of Intrathaecal medication errors a report to the Chief Medical Officer, London: Department of Health Department of Health (2003) Updated National Guidance on the Safe Administration of Intrathaecal Chemotherapy, London: Department of Health Welsh Assembly Government (2005). Safe handling and administration of intrathecal chemotherapy. CMO (2005) 04 / CNO (2005) 02 / CDO (2005) 02 / CSA (2005) 02 / CPhA (2005) 02 Department of Health (2008) HSC 2008/001 Updated national guidance on the safe administration of intrathecal chemotherapy. National Patient Safety Agency, Rapid Response Report, Using vinca alkaloid minibags (Adult/Adolescent units) NPSA/2008/RRR004 Design for patient safety A guide to labelling and packaging of injectable medicines. National Patient Safety Agency, Patient Safety Division, Edition 1 2008 Welsh assembly Government 2008 Safe handling and administration of intrathecal chemotherapy. CMO (2008) 4 / CPhA (2008) 1 / CDO (2008) 2 / CSA (2008) 1 published 6th Aug 2008 Members of the Chemotherapy Group: Name Dr Catherine Bale Tracy Parry-Jones Sr Pat Pilkington Sr Jane Heron Sr Beryl Roberts Sr Laura Edge Title Chemotherapy Lead, Cancer CPG Cancer Network Pharmacist Lead Oncology Nurse (Central) Sister Heulwen Day Unit Lead Oncology Nurse (East) Lead Oncology Nurse (West) MM05 Version: 1 Page 10 of 21

Sr Jackie Jones Manon Williams Sr Anne-Marie Humphreys Prof N Stuart Yvonne Lush Carmel Barnett Damian Heron Bruce Burnett Alistair Ellis-Jones Mared Hughes Sue Armstrong-France Geraint Roberts Bwrdd Iechyd Prifysgol Sister Alaw Ward Alaw Ward Manager Sister Shooting Star Unit Consultant Oncologists ACoS Nursing, Cancer CPG Radiotherapy ACoS, Cancer CPG Consultant Pharmacist Oncology (Central) Oncology Pharmacist (East) Oncology Pharmacist (West) Audit Facilitator General Manager, Cancer CPG Consultation has taken place with: Name Title Date Consulted Dr Shan Griffiths Staff Grade Haematologist 2.9.11 Anne Bithell CoS Pharmacy CPG Dr C Hoyle Consultant Haematologist 30.8.11 Dr J Seale Consultant Haematologist 30.8.11 Dr M Hamilton Consultant Haematologist 30.8.11 Dr D Edwards Consultant Haematologist 30.8.11 Dr E Heartin Consultant Haematologist 30.8.11 Dr J Goodrick Consultant Haematologist 30.8.11 Dr D Watson Consultant Haematologist 30.8.11 Dr L Desoysa Consultant Haematologist 30.8.11 Ffion Johnstone ACoS Pharmacy CPG Helen Flint Clinical Lead Haematology 1.9.11 (Central) Julian Smith Intrathecal Chemotherapy Auditor for Wales 1.9.11 Persons responsible for document implementation and review: Intrathecal Chemotherapy Lead Cancer Network Lead Pharmacist Cancer CPG Chemotherapy Lead Document location: BCUHB intranet Administration areas Pharmacy departments MM05 Version: 1 Page 11 of 21

Appendix 1 Register of staff authorised to prescribe, dispense, check and administer intrathecal chemotherapy. Only personnel whose names appear on specific registers for each site are authorised to prescribe, dispense, check and administer intrathecal chemotherapy. At only the following doctors are authorised to prescribe and administer intrathecal medicines: Designated Lead for the Health Board: Correct as of --/--/----- -------------------------------------------------------------------------------------------------------- Personnel authorised to prepare and release intrathecal chemotherapy from the pharmacy department at ---------------------------------------------------- Authorised to check and issue intrathecal cytotoxic drugs: Person Role Correct as of --/--/----- MM05 Version: 1 Page 12 of 21

Authorised to produce and dispense intrathecal cytotoxic drugs: Person Role Correct as of --/--/----- At -------------------------------------only the following personnel are authorised to receive and/or check intrathecal chemotherapy with a designated Haematologist prior to administration: MM05 Version: 1 Page 13 of 21

Correct as of --/--/----- Appendix 2a PHARMACY POLICY ON CHECKING & DELIVERY OF INTRATHECAL CHEMOTHERAPY ACTION RATIONALE Pharmacists involved in checking and delivery of To reduce risk and improve patient intrathaecal chemotherapy have to be on a register, safety. Ensure competency of staff will have undergone specific training and have read involved in this procedure. the Policy on the Safe Administration of Intrathecal Chemotherapy and the Chemotherapy Policy. All prescriptions for intrathecal chemotherapy must be clinically checked prior to preparation and must conform to the requirements of the intrathaecal policy. Ensure that intrathecal chemotherapy is prepared in accordance with departmental SOPs Ensure that intrathecal chemotherapy is labelled according to the intrathaecal policy in line with MLX 275 Ensure that the intrathecal chemotherapy is packaged in accordance with the intrathaecal policy. Ensure the intrathecal chemotherapy is delivered separately from other chemotherapy drugs, is only handed to the doctor administering the chemotherapy and that the prescription and tamper evident bag are signed. If IV chemotherapy is also required, ensure signed prescription is returned to pharmacy before IV chemotherapy is released. If, during any part of the procedure the pharmacist has any concerns they should seek appropriate advice. To ensure that chemotherapy is safe and appropriate for the intended patient. To minimise the risk of bacterial and particulate contamination of the chemotherapy. Clear and precise labelling reduces the risk of errors occurring. Prevents mix up with intravenous chemotherapy and ensures an audit trial for collection. To ensure intrathecal chemotherapy is not delivered at same time as intravenous chemotherapy, and prevents intravenous chemotherapy being incorrectly delivered via intrathecal route. To ensure intrathecal chemotherapy is not delivered at same time as intravenous chemotherapy, and prevents intravenous chemotherapy being incorrectly delivered via intrathecal route. Maintain patient safety. MM05 Version: 1 Page 14 of 21

Appendix 2b COMPETENCE IN THE CHECKING & DELIVERY OF INTRATHECAL CHEMOTHERAPY Name : Grade : Hospital/Dept: Expected date of completion: Participant will demonstrate, through practical and theoretical knowledge, competence in the checking and delivery of Intrathecal Chemotherapy Assessment Signature of Signature of Annual No. Performance criteria Attained Deferred Date Method Assessor participant review Date 1. 2. 3. 4. 5. No. Background Reading Cytotoxic Chemotherapy Policy Intrathecal Policy Nottingham Report Training Pack Experience Witnessed intrathecal chemotherapy being administered Complete questions on Cytotoxic Chemotherapy Checking Checks prescription according to Cytotoxic SOP 6.1 Checks that all intrathecal chemotherapy correctly labelled Performance criteria Evidence / Questioning Observation Questioning Observation Observation Assessment Method Attained Deferred Date Signature of Assessor Signature of participant Annual review Date MM05 Version: 1 Page 15 of 21

6. 7. 8. 9. 10. 11. 12. Knowledge of Cytotoxic Drugs involved. Actions, possible side-effects / interactions Knowledge of appropriate dosages Clinical features of maladministration Action to be taken in event of mal-administration Delivery Checks that intrathecal chemotherapy has been appropriately packaged Ensures that intrathecal chemotherapy is collected by an appropriate person. Ensures that the signed prescription is returned prior to issuing of any intravenous chemotherapy. Questioning Questioning Questioning Questioning Observation Observation Observation Further Comments & Recommendation: Signature of Trainer: Print name: Date signed: Signature of Trainee: Print name: Date signed: MM05 Version: 1 Page 16 of 21

Appendix 3a NURSING POLICY ON ADMINISTRATION OF INTRATHECAL CHEMOTHERAPY ACTION RATIONALE Nurses assisting with intrathecal procedure have to be on a register, will have undergone specific training and read the Policy on the Safe Administration of Intrathaecal Chemotherapy and the Chemotherapy Policy. Ensure the intrathecal chemotherapy is delivered separately from other chemotherapy drugs and handed to the doctor administering the chemotherapy. Ensure the patient is informed and consent signed. Pharmacy/doctor to have signed tamper evident bag/prescription on receiving drug. Ensure that the doctor performing the procedure is a named person on the intrathaecal policy Patient is in a comfortable position, lying on a bed in a designated area Ensure drug is checked at bedside in front of patient, with doctor administering drug and nurse assisting. Check: drug, dose, expiry date and time, method of delivery, patient name, patient ID number and both sign prescription sheet and checklist. Reassure patient while undergoing procedure. If, during any part of the procedure the nurse has any concerns/questions the nurse should request the procedure to be stopped and seek appropriate Advise e.g. Medical staff/pharmacy To reduce risk and improve patient safety. Ensure competency of staff involved in this procedure. To ensure intrathecal chemotherapy is not delivered at same time as intravenous chemotherapy, and prevents intravenous chemotherapy being incorrectly delivered via the intrathaecal route. Patient fully aware of procedure. To indicate delivery and receipt of drugs. Chemotherapy administered by appropriately named staff. Patient is treated in an area away from the storage of intravenous chemotherapy and other drugs. Privacy for patient to be examined beforehand. Formal checking procedure to ensure right drug and dose is given to right patient. Enable 100% patient safety and minimise risk of inadvertent intrathaecal administration of Vinca alkaloids. Ensure patient is calm throughout procedure. Maintain Patient safety throughout. MM05 Version: 1 Page 17 of 21

Appendix 3b COMPETENCE IN ADMINISTRATION OF INTRATHECAL (IT) CHEMOTHERAPY Name : Grade : Hospital/Dept: Expected date of completion: Participant will demonstrate, through practical and theoretical knowledge, competence in the procedure for safe administration of Intrathecal Chemotherapy No Performance criteria Assessment Signature of Signature of Annual Attained Deferred Date Method Assessor participant Review Date 1. Background Reading Participant has read and can refer to relevant policies relating to procedure Policy on the Administration of Intrathaecal Chemotherapy Questioning North Wales Cancer Service Cytotoxic Chemotherapy Policy National Guidance on the safe Administration of intrathecal Chemotherapy 2 Preparation Provide accurate verbal explanation of procedure for Questioning administration of intrathecal administration of chemotherapy 3. Identify and demonstrates pre administration safety checks Questioning/O bservation Assesses and presents evidence 4. Observation/E of written informed consent vidence process Clarifies Named Doctor 5. administering chemotherapy complies with policy Observation MM05 Version: 1 Page 18 of 21

No Performance criteria Assessment Method Knowledge of Cytotoxic Drugs 6. Involved Actions / Possible side effects / Questioning interactions 7. Knowledge of appropriate dosage Questioning 8. Clinical features of misadministration Questioning 9. Action to be taken in event of misadministration Questioning 10. Patient Assessment/Safety Assesses patients understanding Observation of procedure 11. Maintain patients comfort and safety throughout the procedure Observation Administration 12. Correct checking procedures and written documentation is consistent Observation with policy Attained Deferred Date Signature Assessor of Signature of participant Annual Review Date 13. Correct disposal of all equipment as per chemotherapy policy Observation Further Comments & Recommendations Signature of Trainer: Print name: Date signed: Signature of Trainee: Print Name: Date signed: MM05 Version: 1 Page 19 of 21

Appendix 4 MEDICAL POLICY ON ADMINISTRATION OF INTRATHECAL CHEMOTHERAPY ACTION Doctors performing the intrathecal procedure have to be on a register, will have undergone specific training and read the Policy on the Safe Administration of Intrathecal Chemotherapy and the Chemotherapy Policy. Ensure the intrathaecal chemotherapy is duly assigned to the patient and has been checked with the assisting nurse Ensure the patient is informed and consent signed. Pharmacy/doctor to have signed tamper evident bag/prescription on receiving drug. Patient is in a comfortable position, lying on a bed in a designated area Ensure drug is checked at bedside in front of patient, with nurse assisting. Check: drug, dose, expiry date and time, method of delivery, patient name, patient ID number and both sign prescription sheet and checklist. Reassure patient while undergoing procedure. RATIONALE To reduce risk and improve patient safety. Ensure competency of staff involved in this procedure. To ensure correct delivery of the intrathaecal drug Patient fully aware of procedure. To indicate delivery and receipt of drugs. Patient is treated in an area away from the storage of intravenous chemotherapy and other drugs. Privacy for patient to be examined beforehand. Formal checking procedure to ensure right drug and dose is given to right patient. Enable 100% patient safety and minimise risk of inadvertent IT administration of Vinca alkaloids. Ensure patient is calm throughout procedure. MM05 Version: 1 Page 20 of 21

Appendix 5 Checklist List for Intrathecal Chemotherapy No. Item 1 2 3 Are Doctor and Nurse registered to check / administer intrathecal chemotherapy? Has patient been assessed by a registered doctor prior to administration of intrathaecal chemotherapy? Is the intrathecal chemotherapy being administered in a designated area? Checked by Doctor Checked by Nurse Checked in presence of Patient 4 Is the chemotherapy still in its tamper-evident bag? 5 6 Check patient s name and G number with the patient and against the prescription and the chemotherapy. Check the drug name, dose and route of administration against the prescription and the chemotherapy. 7 Check the expiry date of the chemotherapy. 8 9 Ensure unused intrathecal chemotherapy is returned to pharmacy immediately. Ensure signed prescription is returned to pharmacy if intravenous chemotherapy is still to be administered. 10 Ensure all waste is disposed of appropriately. Please file in Patient s Notes MM05 Version: 1 Page 21 of 21