POLICY FOR INTRATHECAL CYTOTOXIC CHEMOTHERAPY

Transcription

1 Affiliated Teaching Hospital TPPP No: MedsMgt 9 POLICY FOR INTRATHECAL CYTOTOXIC CHEMOTHERAPY Version: 7 Date ratified: October 2016 Ratified by: (Name of Committee): Name of originator/author, job title and department: Medicines Management Committee Dr Matthew Lyttelton, Consultant Haematologist Director lead (Trust-wide policies) Associate Medical Director (Local Policies) Dr Mark Kwan, Consultant Haematologist Andrew Chilton Medical Director Date issued for publication: October 2016 Name of responsible committee: Quality Governance Board Review date: July 2019 Expiry date: October 2019 (Date 3 months following review date) Race impact assessed by: Emma Mills, Macmillan Lead Nurse (Name, job title and department) Date impact assessed: October 2015 Fundamental Standards: Regulation 12 Safe Care and Treatment

2 CONTRIBUTION LIST Individuals involved in developing the document Name Dr Matthew Lyttelton Scott Hillery Andrea Squires Dhiren Bharkhada Emma Mills Dr Mark Kwan Designation Consultant Haematologist Technical Team Manager Production Haematology CNS Pharmacist Advanced Cancer Services Lead Chemotherapy Nurse Consultant Haematologist & Clinical Lead for Intrathecal Chemotherapy Treatment Circulated to the following individuals for consultation Name Duane Mclean Karen Danns Dr Robert Reeve Dr Isaac Wilson-Morkeh Medicines Management Committee Membership Designation Chief Pharmacist Lilford Ward Manager Consultant Radiologist Clinical Director Haematology Approving Committee Page 2 of 49

3 TPPP MedsMgt9 No. Policy for Intrathecal Cytotoxic Chemotherapy Approval and Authorisation Completion of the following signature blocks signifies the review and approval of this process. Name Job Title Signature Date Dr Mark Kwan Clinical Lead for Intrathecal Treatment Duane Mclean Chief Pharmacist Mr Robin Lee Chair Medicine Management Clinical Committee Leanne Hackshall Chair Quality Governance Steering Group Page 3 of 49

4 Change History Version Date Author Reason /10/2005 Dr Matthew Lyttelton /11/2006 Dr Matthew Lyttelton /09/2007 Dr Matthew Lyttelton /12/2008 Dr Matthew Lyttelton /2/2010 Dr Matthew Lyttelton /7/12 Dr Matthew Lyttelton Various changes throughout document. Changes to p 14 and Appendix K. Changes to p 6 and p 10. Changes following HSC 2008/001 & NPSA/2008/RRR004. Revisions concerning delivery of intrathecal drugs, and booking of procedure; separate Appendix on intravenous Vinca Alkaloids; removal of verification from register; other minor changes Change in scheduling of intrathecal administration in dedicated intrathecal room to allow TYA use 2 days / week. Introduction of preasssessment checklist 5.0 Introduction of Non Luer Intrathecal system Designation of specified radiologists for CT guided lumbar puncture Policy regarding use of exception Additional checks regarding scheduling; 6.0 September October 2016 Dr Mark Kwan / Emma Mills Dr Mark Kwan Clinical Lead for Intrathecal Treatment changed from Dr Matthew Lyttelton to Dr Mark Kwan throughout the policy. Radiology supported intrathecal treatment hours of on Thursday included. Lead Trainer changed to Dr Mark Kwan. Emma Mills added as additional nurse trainer. Amendments to personnel and Intensivist involvement. Page 4 of 49

5 Equality Issues Issue Consultation Level Date Race Emma Mills October 2015 Disability Emma Mills October 2015 Gender Emma Mills October 2015 Human Rights Emma Mills October 2015 A translation service is available for this policy. The Interpretation/Translation Policy, Guidance for Staff (I55) is located on the library intranet under Trust wide policies. Page 5 of 49

6 Contents 1.0 Introduction Scope Aim Responsibilities Intrathecal Chemotherapy Prescription Intrathecal Chemotherapy Verification Intrathecal Chemotherapy Dispensing Intrathecal Chemotherapy Issuing Intrathecal Chemotherapy Administration Exceptional Intrathecal Treatment Outside the Designated 17 Area or Outside Normal Working Hours 11.0 Intrathecal Chemotherapy Training Programme Monitoring Compliance and Effectiveness Process for Implementation and Dissemination Document Reviews and Updates Equality Impact Assessment 26 Appendix A Patient Information - Intrathecal Chemotherapy 27 Appendix B Intrathecal Chemotherapy Assessment 29 Framework for Nurses Appendix C Assessment framework for Pharmacy Staff for the 32 verification or Issuing of Intrathecal Chemotherapy Appendix D Assessment Questionnaire for the safe 33 dispensing (preparation) of Intrathecal Chemotherapy Doses Appendix E Intrathecal Chemotherapy: Information Sheet for 34 staff on Lilford Ward, Centenary Wing & Pharmacy Appendix F Haematology Specialist Registrar Intrathecal 35 Chemotherapy Training Log Appendix G Intrathecal Chemotherapy Certificate of 36 Competence Appendix H Intrathecal Chemotherapy Prescription and 37 Administration Record Appendix I Safe Administration of Intrathecal Chemotherapy 39 Appendix J Intrathecal Slide for Hospital Induction Programme 42 Appendix K Intrathecal Chemotherapy Education Session for 43 Haematology & Pharmacy Staff not on the Intrathecal Register Appendix L Intrathecal Chemotherapy KGH Register of 44 Designated Personnel Appendix M Supplementary Information on Intravenously 46 Administered Vinca Alkaloids Appendix N Standardised preasssessment checklist 47 Appendix O Lilford Intrathecal Booking Proforma 48 Page 6 of 49

7 1.0 INTRODUCTION This policy is comprehensive, to be read in full and followed by all staff involved in intrathecal cytotoxic chemotherapy. Many steps involve more than one type of professional and it is essential that each member of the intrathecal cytotoxic chemotherapy team understand the policy as a whole. This policy is based on: The Updated National Guidance on the Safe Administration of Intrathecal Chemotherapy HSC2008/001. NPSA 2008/0004 concerning Vinca Alkaloid minibags NHS/PSA/D/2014/002 Non-Luer spinal (intrathecal) devices for chemotherapy Staff will only be allowed to be involved in any stage of the delivery of intrathecal chemotherapy if they: 1. Have been trained and deemed competent by the appropriate trainer. 2. Are listed on the appropriate part of the KGH Intrathecal Register. 3. Have read this current version of the guidelines as required in the above training process. 4. Are re-assessed and re-certified annually. OR 5. Are under the direct supervision of the relevant trainer. It is the responsibility of those individuals on the register to ensure that any colleague involved in a particular intrathecal procedure is on the register for the task in question. During training it is the responsibility of the practising individual involved with any stage of the delivery of intrathecal chemotherapy to check before participating in the process that their name is displayed at that time on the Intrathecal Register in the relevant section. If in exceptional circumstances a procedure has to be performed outside the prescribed areas (e.g. on ICU or in CCU) the policy and register are available for review on Lilford ward at all times. Intrathecal chemotherapy may only be given routinely in two prescribed areas e.g. Lilford Intrathecal Room and Radiology Interventional Suite. It may only be given anywhere else under exceptional circumstances, when the procedure for exceptional circumstances outlined on page 18 must be followed. Intrathecal chemotherapy will only be administered using non-luer lock lumbar puncture needles (currently Pajunk). This system requires dedicated non Luer syringes for the chemotherapy, and non Luer manometers if the filling pressure is to be measured. It is essential that the non Luer needles are only used for intrathecal chemotherapy. If they are used in other clinical situations, it will not be possible to connect the needle to standard syringes and manometers. Non Luer Page 7 of 49

8 needles will therefore be kept only in Pharmacy and issued with each intrathecal administration. Dedicated non Luer manometers and three way taps will be kept only in the intrathecal room on Lilford. The maintenance and distribution of the policy falls within the Document Management System managed by Pharmacy. Staff may only be entered on the register for a particular task by the relevant trainer: Prescription and administration by the trainer for medical staff. Checking by the trainer for nursing staff. Dispensing and issuing by the pharmacy trainer for dispensing and issuing Any clinical incident or near miss must be reported immediately to the designated Lead for Intrathecal Treatment, relevant Intrathecal Trainer, Consultant, Clinical Director and Chief Pharmacist, and recorded as a clinical incident involving cytotoxic chemotherapy via DATIX. Any exception to the guidelines (e.g. any treatment outside normal hours or not in the designated area) contained in this document must also be reported to the designated Lead for Intrathecal Treatment whose responsibility it is to maintain a log of such episodes for audit and future review of the guidelines. Approval for an exception must always be documented in the clinical notes, and each person on the IT register involved in that Intrathecal treatment must satisfy themself that the exception has been authorised by the Intrathecal Clinical Lead Being prepared to challenge All staff involved with the care and treatment of patients with chemotherapy must be encouraged to challenge colleagues, no matter how senior their position, if in their judgement, either the policy is not being adhered to or the actions of an individual may cause risk to a patient. Challenging of a colleague should not be seen as adversarial, but as an additional check to improve patient safety and reduce risk. If an individual is not satisfied with the outcome of challenging a colleague, then they should immediately inform the Intrathecal Clinical lead, and their line manager. 2.0 SCOPE This policy must be followed for all stages in the prescription, preparation, dispensing and administration of intrathecal chemotherapy. It also applies to the use of chemotherapy given by the intraventricular route as in the use of an Ommaya reservoir. This policy only applies to the treatment of adult haematology patients. The Trust runs a single unified intrathecal chemotherapy service, and does not administer intrathecal chemotherapy to adult oncology or any paediatric patients. Page 8 of 49

9 3.0 AIM This policy is written to ensure the safe delivery of intrathecal chemotherapy to adult haematology patients, in accordance with: The Updated National Guidance on the Safe Administration of Intrathecal Chemotherapy HSC2008/001. National Patient Safety Agency Rapid Response Report 4: Using Vinca Alkaloid Minibags (Adult/Adolescent Units) 2008 NHS/PSA/D/2014/002 Non-Luer spinal (intrathecal) devices for chemotherapy The policy is also written to ensure compliance with the Manual for Cancer Services Chemotherapy Measures Version 1.0 measures 14-3S-301 to 14-3S RESPONSIBILITIES The Trust Clinical Lead for Intrathecal Chemotherapy is Dr Mark Kwan and is accountable to the Trust Chief Executive for compliance with HSC 2008/001. The Trust Clinical Lead for Intrathecal Chemotherapy delegates the following training responsibilities: Andrea Squires / Emma Mills Nursing (checking) Scott Hillery Pharmacy staff (dispensing [preparation] & issuing) Dhiren Bharkhada Pharmacy staff (verifying) 5.0 INTRATHECAL CHEMOTHERAPY PRESCRIPTION 1. Intrathecal chemotherapy can only be prescribed by clinical staff authorised on the Intrathecal Chemotherapy Register to prescribe. Only consultant haematologists and haematology specialist registrars will be authorised to prescribe intrathecal chemotherapy. Prescriptions from other clinicians will not be prepared and referred back to intrathecal treatment lead. 2. Intrathecal treatment must always be prescribed on dedicated green intrathecal prescription sheet Intrathecal Prescription and Administration Record (Appendix H). 3. The dedicated green intrathecal prescription sheet can only be used for the prescription of intrathecal chemotherapy. 4. The clinician should indicate in the relevant box the planned schedule, e.g. total number of intrathecal treatments and on which day of the associated chemotherapy regimen (if appropriate). 5. The Clinician should check that any intravenous chemotherapy is not planned after the intrathecal chemotherapy for that calendar day. Page 9 of 49

10 Timings of intrathecal chemotherapy or intravenous chemotherapy may need rescheduling to ensure this does not occur. 6. Intrathecal chemotherapy prescriptions should be received by the Pharmacy Cytotoxic Reconstitution Suite at least 24 hours prior to planned treatment to help ensure appropriate scheduling of intrathecal dose and planning for preparation by approved Pharmacy staff. If, due to clinical necessity, it is necessary to prescribe intrathecal chemotherapy within 24 hours of administration, this must be approved by the Intrathecal Clinical Lead and recorded in the exception log. 7. The clinician must book the patient and intrathecal chemotherapy into the diary and e-diary on Lilford ward at the time of writing the prescription. The clinician must also fill out an intrathecal booking proforma to be sent to Lilford which must name the administering clinician (see Appendix O). The clinician should specify at the time of booking the name of the clinician who will be performing the administration of the intrathecal drug. Patients whose procedure is planned in Radiology Interventional Suite should also be booked into the chemotherapy e-diary on Lilford ward for coordination purposes. 6.0 INTRATHECAL CHEMOTHERAPY PRESCRIPTION VERIFICATION 1. Intrathecal chemotherapy can only be verified by a pharmacist authorised on the Intrathecal Chemotherapy Register to verify. Only pharmacists will be authorised to verify intrathecal chemotherapy. Prescriptions verified by other pharmacists will not be prepared and referred back to intrathecal treatment lead and appropriate trainer for verifying intrathecal chemotherapy. 2. Standard parenteral chemotherapy prescription verification procedure will be followed 3. The verifying pharmacist will also check that, within the same calendar day, any intravenous chemotherapy will not be scheduled for administration after the intrathecal chemotherapy. 4. The verifying pharmacist will also ensure that IV chemotherapy for future days e.g. weekends and bank holidays will not be left on the ward until after the intrathecal chemotherapy scheduled for that day has been administered. 5. If an intrathecal prescription is received which would require the intrathecal chemotherapy to be given before intravenous chemotherapy that same day, or where it would be necessary for doses of IV chemotherapy for that patient to be stored on the ward at the time of the intrathecal administration, the verifying pharmacist must always refuse the prescription which should be returned to the prescribing clinician. The Intrathecal Chemotherapy Clinical Lead should be notified. Page 10 of 49

11 7.0 INTRATHECAL CHEMOTHERAPY DISPENSING (PREPARATION) Dispensing is the activity of preparing the dose, filling the syringe and placing the syringe in packaging for transportation. It will also include transport if the drug is not issued direct to the collector. Only staff appropriately trained and whose names appear on the current Intrathecal Register as competent to dispense may dispense. 1. The green prescription and administration record with a prescription signature will be treated as a signed order. In the specific case of intrathecal chemotherapy (no other routes) the dose will be prepared in advance of signed authority to proceed. 2. All cytotoxic intrathecal drugs are to be prepared in the Pharmacy Chemotherapy Unit and NEVER on a ward or other area. 3. After preparation a dose for intrathecal use must be final checked as soon as possible. 4. Final checking of a cytotoxic dose for intrathecal use must only be performed by an authorised person on the Intrathecal Chemotherapy Register of designated personnel. 5. Follow the procedure for final checking of all prepared products. 6. Take special care to ensure that the correct drug, concentration, quantity, labelling and patient details are double checked against the original prescription, worksheet and empty vials of drug used. The route of administration on the label will always be in bold and CAPITALS and will always read FOR INTRATHECAL USE ONLY 7. An intrathecal preparation must never be supplied in a volume greater than 5ml. 8. All intrathecal doses must be dispensed in the dedicated non-luer intrathecal compatible syringes. 9. Sign the check boxes on the worksheet and seal the outer bag. 10. Place the sealed bag and the original prescription in the designated bag labelled with for intrathecal use only. Intrathecal chemotherapy drugs must always be packed separately from other treatments. 11. Place sealed bag in designated fridge in the support room and lock the refrigerator. Retain the key. This fridge must only ever be used for the storage of intrathecal drugs. Page 11 of 49

12 8.0 ISSUING / RELEASE Only staff whose name appears on the Intrathecal Register as competent to issue may issue Intrathecal drugs. The dose is supplied upon the request of the clinician performing the procedure. Supply of intrathecal doses must be made by the person performing the final check at the correct time, to the correct place and person. The correct time is after all other IV chemotherapy has been given to that patient on that day ( day is defined as calendar day). The correct place is in the Pharmacy, Centenary Wing. The correct person is only the clinician administering the intrathecal chemotherapy. Supply must only be made to an authorised person. The intrathecal dose will be issued in a dedicated transport bag. A separate transport box will be issued which will also contain the necessary non-luer lock equipment e.g.: 20G 90mm x2 needles 20G 150mm x2 needles 22G 90mm x2 needles 22G 120mm x2 needles CHECK on the Clinichemo Computer System (always held in Pharmacy, Centenary Wing) to establish whether any IV chemotherapy has been supplied that calendar day for that patient. Prior to supplying the dose the person issuing the dose must see written evidence that any intravenous chemotherapy supplied that day for that patient has been administered. This may be obtained from the chemotherapy treatment chart (for IVs) in the Administration section(s). 1. When the clinician performing the procedure presents at Pharmacy, Centenary Wing in person to collect the intrathecal dose, he/she must present the IV chemotherapy treatment chart showing that any IV doses supplied that calendar day for that patient have been administered. If this written evidence is not available, the dose must not be supplied. 2. The designated bag is opened and the item and prescription is removed. 3. The Authority to proceed on the prescription is signed by the collecting clinician. Page 12 of 49

13 4. The Issued by box in the Pharmacy column is signed by the authorised person issuing the drug. 5. The Collected by box in the Pharmacy column is signed by the authorised clinician. 6. The designated transport bag containing the dose and non-luer spinal needles pack is collected by the clinician. The intrathecal chemotherapy must always be transported separately from other treatments. 7. After the procedure is completed the designated unused Non Luer spinal needles pack should be returned immediately to Pharmacy, Centenary Wing. The non Luer spinal needles must not be retained and must not be used for any other purpose except administration of chemotherapy. Any cytotoxic waste should be destroyed according to the Cytotoxic Policy (MM25). 9.0 INTRATHECAL CHEMOTHERAPY ADMINISTRATION Intrathecal treatment will ALWAYS be given by a consultant haematologist, associate specialist or SpR who are listed on the current Intrathecal Register as competent to Administer. The ONLY drugs given via the intrathecal route are: - methotrexate. - cytarabine. - hydrocortisone. These drugs will be issued in labelled 5 ml non-luer lock intrathecal compatible syringes, or smaller. Non Luer spinal needles (Pajunk) must always be used for intrathecal chemotherapy administration. A restricted supply will be kept in pharmacy and will only be issued for intrathecal chemotherapy administration. The Non Luer spinal needles must never be used for other purposes. Patient pre-assessment and consent FBC and clotting screen must be checked same day. Platelet support is required if platelet count < 50 x 10 9 /l. LP is contraindicated if coagulation profile is abnormal (PT, APTT or TT prolonged). Causes of abnormal coagulation should be investigated and corrected before LP is carried out. The patient must be formally assessed by a registered clinician prior to the procedure 1. To ensure that the patient is fit for the procedure. 2. To review test results. 3. To check that the correct chemotherapy has been ordered. Page 13 of 49

14 4. To ensure that a member of staff is identified for checking who is on the Intrathecal Register. This review must be recorded in the notes, using the pre-assessment checklist (see appendix N), which will be inserted in the clinical notes. The patient will be consented at this time. Informed consent must be obtained for each lumbar puncture with intrathecal treatment. At this time the patient must be explicitly told the nature of the procedure, and the specific drug to be administered. The clinician must ensure that the Trust copy of the consent form is filed in the notes, and that a copy is offered to the patient. The patient should be given the information leaflet Patient Information Intrathecal Chemotherapy (Appendix A) and the specific drug information leaflets. Consent for a block or course of intrathecal treatments is not sufficient. Location Intrathecal treatment is only given in two locations: 1. The Intrathecal Room on Lilford Ward. This room will NEVER be used for intravenous chemotherapy administration on the days allocated for IT administration (Tuesday, Thursday, Friday), but may be used for other treatments or procedures (e.g. transfusion etc.). This room will be used for intrathecal treatment only, during that session (e.g. half day). The room is also dedicated for Teenage and Young Adult Cancer Treatments including systemic chemotherapy on Mondays and Wednesdays. It will never be used for intrathecal chemotherapy on those days of the week 2. Radiology Interventional Suite when x-ray guidance is required for the procedure of lumbar puncture. Patient review and consenting must take place on Lilford Ward prior to transfer. The lumbar puncture needle may be inserted by the consultant radiologist (Dr Reeve) who will then handover to the attendant haematologist on the intrathecal register for administration. The procedure (including lumbar puncture) should not start without the registered administering clinician and checker with the intrathecal drug being present. Consent in this situation must be taken by the haematologist. The collection, checking and administration of the intrathecal chemotherapy in this situation will only involve staff on the Intrathecal Register. The radiologist must never be asked either to administer or check the intrathecal chemotherapy Page 14 of 49

15 drugs. It is the responsibility of the consultant haematologist administering the dose to check that the needle is correctly in position. Only the Interventional Suite in the Radiology department will be used. The Interventional Suite will display the Intrathecal Register and contain a copy of the Trust intrathecal policy. The consultant radiologists identified for the performance of this part of the procedure is Dr Robert Reeve Because it is necessary for the radiologist inserting the needle to be aware of the need to use only non Luer lock needles, assistance only from the radiologist identified will be allowed. In the absence of available radiologist, please contact consultant anaethetists ( Dr Hollos or Dr Jakkampudi) to arrange for consultant anaesthetist to come to insert the lumbar puncture needle only, who will then handover to the attendant haematologist on the intrathecal register for administration. The procedure should be carried out at the designated intrathecal room only. ( or in exceptional cases outside the designated area or outside normal working hours- see section 10) The procedure (including lumbar puncture) should not start without the registered administering clinician and checker with the intrathecal drug being present. Consent in this situation must be taken by the haematologist. Please give as much advance notice ( at least 1 week ) to the anaethetist to arrange to come to do the lumbar puncture. Timing Intrathecal treatment will always be given after all IV chemotherapy for that patient for that calendar day has been administered. If the patient is receiving continuous intravenous infusional chemotherapy that day, then the patient will be considered to have received all intravenous drugs when the last bag has been set up. Intrathecal treatment will only be given within normal working hours (Monday Friday 09:00 17:00). If the late arrival of either the patient or necessary staff delays the procedure to outside these hours, the procedure must be rescheduled to another time within normal working hours. The designated intrathecal bed should only be used for intrathecal treatment on Tuesday, Thursday and Friday, always after 14:00. If, under exceptional circumstances, treatment is needed at other times within the routine working day then the intrathecal lead must be notified and approval sought. Intrathecal administration requiring radiological support should be scheduled for 12.00hrs on Thursdays to ensure required radiological support. Transport and storage Pharmacy staff, in Centenary Wing, and listed on the current Intrathecal Register as competent to Issue will issue the intrathecal drug packed separately in a designated intrathecal chemotherapy bag and the designated transport box Page 15 of 49

16 including the non-luer spinal needles and deliver directly to the clinician performing the LP when they attend Centenary Wing Pharmacy, and (where applicable) will not issue intrathecal drugs unless they have received the IV chemotherapy chart with signed evidence that IV chemotherapy for that calendar day has been given. The issuing person will NEVER leave the drugs in the temporary storage locker in the Intrathecal room. This locker is only for temporary storage AFTER the clinician has taken receipt. The clinician will sign the green intrathecal prescription for authority to proceed AND collected by and from the Pharmacy must proceed directly to lumbar puncture and administration. The drug must be received directly from the issuer from Pharmacy. If the clinician is not available to take receipt of the intrathecal drugs, or the patient is not ready, the drugs will always be returned to pharmacy by the issuing pharmacy staff. If after taking receipt of the drugs, the doctor is unexpectedly called to an emergency or the patient unable to undergo the procedure, the clinician should place the intrathecal drugs in the storage locker in the intrathecal room, lock and retain the key. The drugs may be so stored for up to one hour. If the procedure still cannot proceed after one hour then the clinician must return the drug(s) to pharmacy. Checking The doctor must be certified as competent to administer and the nurse must be certified as competent to check intrathecal chemotherapy. Both names must be displayed on the currently displayed register. The clinician must check that informed consent has been obtained (for each individual lumbar puncture with intrathecal treatment), check patient identity with the patient, and inform the patient as to the drug being administered prior to the procedure. The clinician must check (where applicable) in the notes that IV chemotherapy prescribed for that day has already been administered. The clinician must check that the checking nurse is on the current register. The clinician and nurse must each cross check against the prescription chart (at the same time): o drug name o drug dose o drug volume o expiry date o route of administration o prescribed date of administration o patient s name o patient s date of birth o patient's Hospital Number Page 16 of 49

17 The clinician must check that the transport box contains the necessary non Luer spinal needles, and that the intrathecal dose has been prepared in a non-luer intrathecal compatible syringe. The checking of intrathecal chemotherapy must be carried out in the presence of the patient/responsible adult. The patient should be given the opportunity to check the drug themselves if they wish. If the patient wishes to check the actual drug preparation, then the fact that they have done so should be recorded in the patient notes with the patient s signature. If the intrathecal chemotherapy is being given under general anaesthesia, arrangements should be made for an additional check to be made in theatre by another member of staff such as the Senior Theatre Nurse in place of the patient. The nurse also: - must ensure that cytotoxic drugs to be administered by the intrathecal route are prescribed by an authorised consultant haematologist, on a designated intrathecal chemotherapy chart. - must ensure intrathecal chemotherapy is only collected from Pharmacy by authorised staff on the register designated to do so. - Must ensure that the name of the administering clinician is displayed on the current Intrathecal Register. - must ensure that the intrathecal chemotherapy is only administered within normal working hours in the designated areas (Lilford Intrathecal room or Radiology Interventional Suite). - Must ensure patient has received all their intravenous chemotherapy for that day and this is correctly documented on their intravenous chemotherapy chart. - Must ensure that written consent has been taken from the patient. - Another doctor (even if registered to administer) may never check the drug with the administering doctor. Both doctor and nurse must sign on the prescription chart that they have checked according to this policy. The doctor must then also sign separately for the administration of the drug after the lumbar puncture and treatment has been completed EXCEPTIONAL INTRATHECAL TREATMENT OUTSIDE THE DESIGNATED AREA OR OUTSIDE NORMAL WORKING HOURS In the rare situation where the patient is too sick to be moved e.g. either on ICU or CCU, then the reasons must be clearly indicated in the notes by the consultant concerned, and the intrathecal treatment administered after any intravenous chemotherapy. The designated lead for intrathecal chemotherapy must be informed at the time. If the designated lead is the consultant responsible for the patient at the time, then the Medical Director or Associate Medical Director for Safety & Governance should be informed. The collection, checking and administration of the intrathecal chemotherapy as in all other normal situations will only involve staff on the Intrathecal Register. Page 17 of 49

18 In the very rare situation that it is clinically essential that intrathecal chemotherapy should be given outside normal working hours (Monday to Friday 09:00 17:00), then the reasons must be clearly indicated in the notes by the consultant concerned, and the intrathecal treatment administered after any intravenous chemotherapy. Members of Pharmacy and a nurse, both of whom are on the Intrathecal Register, must be called in to the hospital. If the relevant registered staff is not contactable or available out of hours, then the intrathecal chemotherapy must not be given. The designated lead for intrathecal chemotherapy must be informed at the time. If the designated lead is the consultant responsible for the patient at the time or is not contactable, then the Medical Director or Associate Medical Director for Safety & Governance should be informed. In any of the above situations where intrathecal chemotherapy is not administered in the Lilford Intrathecal Room or the Radiology department during normal working hours (Monday to Friday 09:00 17:00), it must only be performed by consultant staff and never by trainees. In any of the above situations the designated lead will record the incident in a log of deviations from policy. Page 18 of 49

19 11.0 INTRATHECAL CHEMOTHERAPY TRAINING PROGRAMME All staff at all grades and of all professions will require training and assessment before being entered onto the KGH Intrathecal Register for any part of the process. Certification from other Trusts will not be acceptable. The designated Trust lead for intrathecal chemotherapy has overall responsibility for induction, training and CPD related to intrathecal chemotherapy. The following are the designated trainers for their discipline: Dr Mark Kwan Andrea Squires Emma Mills Scott Hillery Dhiren Bharkhada Medical staff & lead trainer (prescribing administering) Nursing (checking) Nursing (checking) Pharmacy staff (dispensing [preparation] & issuing) Pharmacy staff (verifying) The nursing and pharmacy trainers will be annually appraised as trainers by the Intrathecal lead trainer. The Intrathecal lead trainer will be annually appraised by the Associate Medical Director for Safety and Governance. Medical staff may only be certified as competent in prescribing and administration. Nursing staff may only be certified as competent in Checking. Pharmacy staff may only be certified as competent in Dispensing and Issuing. Upon completion of training and assessment, all staff will be issued with an Intrathecal Chemotherapy Certificate of Competence for Prescribing, Dispensing, Issuing, Checking and Administration as appropriate (Appendix G). All staff will keep the original certificate. Copies will be kept with the master copy of the Intrathecal Chemotherapy Register of Designated Personnel. Staff with a certificate may not participate in the process of intrathecal cytotoxic chemotherapy until a revised Intrathecal Chemotherapy Register of Designated Personnel has been issued and displayed in the relevant places. The trainer must give the copy of the certificate to the Lead Trainer, who will update the register. The designated Intrathecal trainer for nurses will then coordinate the reissue of the Register. Annual re-assessment of staff on register Every October all staff on register will be assessed and their competency reviewed. This will be performed by the relevant trainer. The pharmacy trainers for Dispensing [preparation] & Issuing, and Verification, and nurse trainer for Checking will be appraised by the Intrathecal lead. Re-assessment will include: 1. Review of frequency with which the relevant task has been performed using the log completed at the time of issue of each dose. 2. Review of local and national policy and any changes introduced since last assessment. 3. Completion of relevant assessment framework. Page 19 of 49

20 4. Review of training role where applicable 5. Signing of certificate of competence (Annex G). If the trainer decides that there are any issues about current competency, or the frequency with which the competency is being performed, then the individual will be removed from the register and re-trained if appropriate. The Trust lead for intrathecal chemotherapy must be informed if anybody is removed from the register. Training for medical staff Only Consultants, Associate Specialists, Staff Grades and Specialist Registrars in Haematology may undergo training and certification. The above may be accredited for Administration and/or Prescription of intrathecal cytotoxic chemotherapy. Training and assessment of medical staff will require: Demonstration of competency in performing the procedure of lumbar puncture including awareness of the complications of lumbar puncture. Demonstration of familiarity with the background to the National Guidance HSC 2008/001 and local policy. Demonstration of familiarity with NPSA 2008/RRR04 Demonstration of familiarity with NHS/PSA/D/2014/002 Understanding of the rationale for the use of intrathecal drugs, and of the specific drugs that may be used. Detailed knowledge of the local KGH Policy for Intrathecal Cytotoxic Chemotherapy for all stages of the process. Training & Assessment Programme for haematology medical staff without full specialist accreditation and prior experience of intrathecal cytotoxic chemotherapy (Intrathecal Cytotoxic Chemotherapy Training Log, Appendix F) will consist of: 1. Receipt of copies of KGH Policy for Intrathecal Cytotoxic Chemotherapy. The National Guidance on the Safe Administration of Intrathecal Chemotherapy HSC 2008/001. Lumbar Puncture (J M S Pearce). NPSA 2008/004 NHS/PSA/D/2014/002 Page 20 of 49

21 2. One to one induction teaching session with the Intrathecal lead to discuss the topics and documents listed above. Prescription Teaching will include discussion of the importance of good prescribing practice, checking of protocols at the time of prescription, and timing of the presentation of the prescription. Administration Teaching will include: the method of taking consent. pre-assessment of patient. place and time of administration. receipt of drug. side effects of Intrathecal chemotherapy. NPSA 2008/RRR04 NHS/PSA/D/2014/ Performance of at least three intrathecal prescriptions and lumbar punctures with administration of intrathecal chemotherapy under the supervision of Dr Mark Kwan. 4. Completion of Intrathecal Chemotherapy Assessment Framework for Doctors (Appendix I) as final assessment before certification. Training & Assessment Programme for haematology medical staff with full specialist accreditation and prior experience of intrathecal cytotoxic chemotherapy will consist of: 1. Receipt of copies of KGH Policy for Intrathecal Cytotoxic Chemotherapy The National Guidance on the Safe Administration of Intrathecal Chemotherapy HSC 2008/001 Lumbar Puncture (J M S Pearce) 2. One to one induction teaching session with Dr Mark Kwan to discuss the topics and documents listed above. Prescription Teaching will include discussion of the importance of good prescribing practice, checking of protocols at the time of prescription, and timing of the presentation of the prescription. Page 21 of 49

22 Administration Teaching will include: the method of taking consent. pre-assessment of patient. place and time of administration. receipt of drug. side effects of Intrathecal chemotherapy. NPSA 2008/RRR04 NHS/PSA/D/2014/ Performance of at least one intrathecal prescription and lumbar puncture with administration of intrathecal chemotherapy in the presence of Dr Mark Kwan. 4. Completion of Intrathecal Chemotherapy Assessment Framework for Doctors (Appendix I) as final assessment before certification. Training for nursing staff Only Nurses who are trained and accredited in the administration of chemotherapy may undergo training and certification for Intrathecal Cytotoxic Chemotherapy. Training and assessment will require: Awareness of the Guidelines laid down by the NMC regarding the Scope of Professional Practice, The Code of Professional Conduct and The Administration of Medicines. Demonstration of familiarity with the background to the National Guidance HSC 2008/001 and local policy. Understanding of the rationale for the use of intrathecal drugs, of the specific drugs that may be used, and of the hazards and complications. Detailed knowledge of the local KGH Policy for Intrathecal Cytotoxic Chemotherapy for all stages of the process. Training & Assessment Programme for nursing staff will consist of: 1. Receipt of copies of KGH Policy for Intrathecal Cytotoxic Chemotherapy The National Guidance on the Safe Administration of Intrathecal Chemotherapy HSC 2008/001 NPSA 2008/RRR04 NHS/PSA/D/2014/ One to one teaching session with Andrea Squires / Emma Mills to discuss the topics and documents listed above. Page 22 of 49

23 3. Checking of at least two intrathecal chemotherapy doses under the supervision of Andrea Squires/ Emma Mills. 4. Completion of Intrathecal Chemotherapy Assessment Framework for Nurses (Appendix B) as final assessment before certification. Training for Pharmacy staff Only registered pharmacists, pharmacy technicians and designated ATOs who have completed the Aseptic Unit Training Programme may undergo training and certification in dispensing and/or issuing of intrathecal chemotherapy. Dispensing and issuing should be kept separate. Only registered pharmacists may undergo training and certification in verification. Training and assessment will require: Demonstration of familiarity with the background to the National Guidance HSC 2008/001 and local policy. Understanding of the rationale for the use of intrathecal drugs, and of the specific drugs that may be used. Detailed knowledge of the local KGH Policy for Intrathecal Cytotoxic Chemotherapy for all stages of the process. Demonstration of competency in verification, dispensing and/or issuing of intrathecal chemotherapy. Training & Assessment Programme for Pharmacy staff will consist of: 1. Receipt of copies of: KGH Policy for Intrathecal Cytotoxic Chemotherapy. The National Guidance on the Safe Administration of Intrathecal Chemotherapy HSC 2008/001. NPSA Vinca Alkaloids NPSA non Luer 2. One to one teaching session with Scott Hillery (dispensing & issuing) or with Dhiren Bharkhada (verification) to discuss the topics and documents listed above. 3. Performance of at least three issuing or dispensing procedures under the supervision of Scott Hillery, or verification procedures under the supervision of Dhiren Bharkadha. 4. Completion of Assessment Framework for Pharmacy Staff for the Issuing of Intrathecal Chemotherapy (Appendix C) and/or Assessment Questionnaire for the Safe Preparation of Intrathecal Chemotherapy Doses (Appendix D) as final assessment before certification. Page 23 of 49

24 Training of non-registered clinical staff in the division All new staff on Centenary Wing, Lilford Ward and in Pharmacy who are not on the Intrathecal Register must have a specific education session concerning national and local intrathecal policy within 2 weeks of starting their post. This session will consist of: 1. Discussion about the reasons for the policy 2. Instruction concerning the key points of the policy relating to staff not on the KGH Intrathecal Register 3. Receipt of the relevant information leaflet (Appendix E) 4. Signing of statement (Appendix K) at the end of the session These education sessions will be given by: Ward Matron / Lead Nurse, Lilford Ward for Lilford Ward staff (except medical) Unit Matron / Lead Nurse, Centenary Wing and Chemotherapy Services Supportive Treatment Unit (CSSTU) for Centenary and CSSTU staff Production Services Manager, Pharmacy for all Pharmacy staff Intrathecal Trainer, medical staff for all medical staff Signed statements will be retained by the person giving the instruction who will file them as a record. Very short-term locum or bank staff should be provided with the relevant information sheet (Appendix E) and asked to sign the statement (Appendix K) on arrival on the ward. All new staff of all disciplines will receive, in their KGH Induction Programme, information and instruction about intrathecal cytotoxic chemotherapy and the fact that they must not be involved in any stage of the process, even if asked by a senior member of hospital staff (Appendix J). The following reports are available in the Centenary Wing, Kettering General Hospital: The Prevention of Intrathecal Medication Errors. HSC 2008/001 Updated National Guidance on the Safe Administration of intrathecal Chemotherapy. NPSA 2008/RRR04 NHS/PSA/D/2014/002 Safe Handling of Cytotoxic Drugs District Pharmacy Service Policy P/P/1. Frequently Asked Questions and Further Information Relating to HSC 2001/022. Manual of Cancer Services Standards December Page 24 of 49

25 12.0 MONITORING COMPLIANCE AND EFFECTIVENESS All clinical staff on the Intrathecal Register will be required to undergo annual reappraisal by their designated trainer as described in the section on Training. The appraisal process will include assessment of the number of procedures in which the individual has participated each year. All deviations from the policy will be recorded in an exception log by the Clinical Lead for Intrathecal Chemotherapy. All significant deviations from this policy will be reported immediately by the Clinical Lead for Intrathecal Chemotherapy to Associate Medical Director Clinical Services, and the appropriate process for clinical incident reporting followed. The Intrathecal Chemotherapy Service will be audited annually with regard to adherence to this policy, and will include audit of the number of procedures performed in the Trust each year. This audit will be presented to the Local Chemotherapy Group, Haematology Clinical Directorate, and then to CMT Governance. The Intrathecal Chemotherapy Service will be subject to the standardised process of internal self-assessment and external Peer Review defined by the Cancer Standards PROCESS FOR IMPLEMENTATION AND DISSEMINATION The policy is an integral part of the training programme for all members of staff on the Register. The master copy of these standards and guidelines is kept in the Pharmacy office. Other copies will be available from: Centenary Wing Treatment area Lilford ward Lilford Intrathecal Room Pharmacy Centenary Wing Pharmacy Medicines Information Radiology Interventional Suite The Trust intrathecal policy is also available on the KGH intranet. The master copy of the Intrathecal Register will be kept and maintained by the designated Trust Lead for Intrathecal chemotherapy. A full copy of the Register will be displayed in an easily visible place on: Lilford Intrathecal Room Lilford main ward area Pharmacy Centenary Wing Radiology Interventional Suite Page 25 of 49

26 The distribution and replacement of the register will be managed by the designated trainer for nursing staff (checking). Only five copies of the register will be printed for distribution as above. Upon replacement, the old versions will be removed, marked as cancelled and filed, as evidence that all previous versions have been removed from circulation. Each member of the staff will be required to document in their training log that they have read a new version of the policy when it is released. The delegated trainer will be responsible for ensuring this. The method for ensuring that members of staff not involved in intrathecal chemotherapy are aware that they must not have any role is documented in the section on training Document Reviews and Updates This document will be reviewed on an annual basis, and will be updated at least every 3 years Equality Impact Assessment As part of its development, this policy and its impact on equality has been reviewed. The purpose of the assessment is to minimise and if possible remove any disproportionate impact on the grounds of race, gender, disability, age, sexual orientation or religious belief. No detriment was identified. Page 26 of 49

27 APPENDIX A Patient Information Intrathecal Chemotherapy Your doctor has prescribed intrathecal chemotherapy (which is cytotoxic or cell toxic treatment) for your condition. This means that you will have cell toxic drugs given by injection into the fluid around the spinal cord by a lumbar puncture procedure. What will happen? Prior to receiving any treatment you will be given written information about the drugs you are about to receive and asked to read this. Please ask any questions that may arise after reading this information. The whole procedure will be explained. You, or your guardian, will be asked to sign a consent form prior to the procedure. Because this is a special procedure you will be moved to a designated area whilst it takes place. Only specially trained staff will be involved. You will be offered the opportunity to check the drug yourself before it is given. Personal details will be asked prior to the procedure, for example name and date of birth. Lumbar Puncture Procedure for the Administration of Intrathecal Chemotherapy There are 2 usual positions for this procedure. Lying down You will be asked to lie on your side, with your knees drawn up to your tummy and held in place by your hands. The nurse may support you in this position by gently holding you behind your knees and neck. Page 27 of 49

28 Sitting You will be asked to sit with your back facing the doctor, your arms folded, supported over some pillows or the back of a chair, with your head resting on your arms. The procedure in either position continues as follows: It is important that you remain very still, but do tell the doctor how you are feeling throughout the procedure. The skin will be cleaned with antiseptic cleansing agents. The area to be punctured will have local anaesthetic put into the skin. The spinal needle will be inserted into your spine. A small quantity of spinal fluid will be drained off and sent for analysis. The intrathecal chemotherapy will be given via a small syringe. The needle will be taken out and a small dressing put over the area. You will be asked to lie flat on your back on the bed for a short while. Some patients experience headaches following this procedure. may be taken. Paracetamol Some patients require additional medication to minimise side effects from some of the drugs given this will be fully explained if the medication is needed. Page 28 of 49

29 APPENDIX B Intrathecal Chemotherapy Assessment Framework for Nurses Questions 1. Have you received and read: Updated National Guidance on the Safe Administration of Intrathecal Chemotherapy (HSC 2008/001) KGH Policy on Administration of Intrathecal Chemotherapy NPSA 2008/0004 NPSA 20014/002 Video / DVD? Responses (tick or circle responses and write additional comments if necessary) 2. For what reasons have the National Guidance been issued? 3. Who can prescribe intrathecal chemotherapy? 4. On what must intrathecal chemotherapy be prescribed? 5. What is the difference between dispensing and issuing of drugs? Who can dispense and issue intrathecal chemotherapy? 6. Where must intrathecal chemotherapy be stored? 7. Who can transport the intrathecal chemotherapy? Page 29 of 49

30 Questions Responses (tick or circle responses and write additional comments if necessary) 8. If a patient is having intravenous and intrathecal chemotherapy, which must be administered first? 9. How do we ensure, for a given patient, that intravenous is given before intrathecal chemotherapy? 10. Where is the dedicated area for administration of intrathecal chemotherapy? 1. Which needles and syringes must be used for the administration of intrathecal chemotherapy, and why? 12. Who is allowed to check intrathecal chemotherapy? 13. Describe your role as a certified checker (checking procedure). 14. What is the idea behind involving the patient/carer in the checking? 15. How is the patient/carer check recorded? 16. Describe the out of hours policy. Page 30 of 49

31 Questions Responses (tick or circle responses and write additional comments if necessary) 17. What is the concept of negative labelling and how does this affect recommended labelling of intrathecal chemotherapy? 18. How is the concept of differentiating products by their volume used locally to reduce the risk of intrathecal chemotherapy, and what are the recommendations of the NPSA Rapid Response Report 2008/0004 concerning Vinca Alkaloid minibags? Page 31 of 49

32 APPENDIX C ASSESSMENT FRAMEWORK FOR PHARMACY STAFF FOR THE DISPENSING, ISSUING & VERIFICATION OF INTRATHECAL CHEMOTHERAPY Questions 1. Have you read and understood: The Updated National Guidance on the Safe Administration of Intrathecal Chemotherapy HSC2008/001. the NPSA Rapid Response Report 2008/0004 concerning Vinca Alkaloid minibags? NPSA 2014/002 The Kettering General Hospital NHS Trust Policy for Intrathecal Cytotoxic Chemotherapy? 2. Describe the background why national guidance has been issued on the safe administration of intrathecal chemotherapy. 3. Which drugs would you expect to see prescribed by the intrathecal route? 4. Why are they prescribed in this way and what dose would you expect to see? 5. What is the purpose of the register of designated personnel? 6. What precautions have been put in place to ensure that drugs not intended for intrathecal administration are not administered by this route? 7. Where are the designated areas for administration of intrathecal chemotherapy? 8. If a patient is having intravenous and intrathecal chemotherapy on the same day what is the sequence for administration? 9. What checks and precautions do you make prior to supply? 10. How should the product for intrathecal administration be supplied? 11. What precautions should be taken with Vinca Alkaloids to ensure they are only administered by the intravenous route? Page 32 of 49

33 APPENDIX D ASSESSMENT QUESTIONNAIRE FOR THE SAFE DISPENSING (PREPARATION) OF INTRATHECAL CHEMOTHERAPY DOSES ACTION (what) RATIONALE (why) Prescription received at least 24 hours before treatment Intrathecal prescription chart used to prescribe intrathecal doses, by designated medical staff Intrathecal written in full on prescription Initial check performed by designated Pharmacy personnel Dose prepared only when treatment has been prescribed All cleaning logs and isolator logs are up to date 5ml syringe used to measure/supply dose Use of Surety syringes only Intrathecal printed in full on label Double checking of drug and strength (concentration) at EACH stage of preparation Use of authorised starting materials (vials, consumables) Strict aseptic technique adhered to throughout Maximum 12 hour shelf life given Intrathecal treatment given in designated area not used for other chemotherapy Delivery of intrathecal doses by designated personnel to designated place Dose stored and locked in designated refrigerator Final check performed immediately dose is prepared by designated Pharmacy personnel Final check performed by designated personnel Intrathecal doses not stored in any location except Pharmacy or storage locker in Lilford intrathecal room VINCA ALKALOIDS - SPECIAL REQUIREMENTS Special labelling for vinca alkaloid preparations (for IV use only - fatal if given by any other route) on each package, and use of 50ml minibags If other chemotherapy supplied on that day to that patient, intrathecal dose withheld until all IV chemotherapy given Page 33 of 49

34 APPENDIX E INTRATHECAL CHEMOTHERAPY: INFORMATION SHEET FOR STAFF ON LILFORD WARD, CENTENARY WING AND PHARMACY As you may be aware intrathecal chemotherapy (anticancer drugs given into spinal fluid at the time of lumbar puncture) is sometimes required for the treatment of certain patients with cancer. Depending on the nature of your training you may be involved in certain aspects of the administration of intravenous chemotherapy, or your involvement may be minimal. Intrathecal chemotherapy (chemotherapy given into spinal fluid at the time of lumbar puncture) is routinely administered either in the Intrathecal room on Lilford ward or Radiology Interventional Suite. The Trust has strict policies which follow national guidelines concerning the administration of intrathecal chemotherapy. These policies have been put in place to prevent the repetition of a number of fatal errors occurring in the administration of intrathecal chemotherapy in recent years in the UK. Only specialists (pharmacists, nurses and doctors) specifically trained and registered in intrathecal chemotherapy administration are allowed to be involved in any stage in intrathecal chemotherapy administration. At times you may be required to accompany a patient into the Intrathecal Room or Radiology Interventional Suite when he is transferred there for treatment. Under no circumstances will you be asked to perform any part of the intrathecal chemotherapy procedure on the Lilford intrathecal room or anywhere else. If you are asked to collect intrathecal chemotherapy from Pharmacy you must refuse. If you are asked to accept delivery of intrathecal chemotherapy from Pharmacy staff you must refuse. If you are asked to check an intrathecal drug with a doctor you must refuse. Only those staff listed on the register displayed in the Lilford intrathecal room Treatment Area are permitted to perform any of these functions. A full version of The Policy for Intrathecal Cytotoxic Chemotherapy is kept on Lilford Ward, the Centenary Wing and in Pharmacy. Page 34 of 49

35 APPENDIX F HAEMATOLOGY SPECIALIST REGISTRAR INTRATHECAL CHEMOTHERAPY TRAINING LOG KGH Policy for Intrathecal Cytotoxic Chemotherapy The National Guidance on the Safe Administration of Intrathecal Chemotherapy HSC 2008/001 NPSA 2008/RRR04 Date Trainee & Trainer Signature Comments NHS/PSA/D/2014/002 Lumbar Puncture (J M S Pearce) Theoretical teaching session Supervised intrathecal treatment 1 Supervised intrathecal treatment 2 Supervised intrathecal treatment 3 Certification Page 35 of 49

36 APPENDIX G KETTERING GENERAL HOSPITAL NHS FOUNDATION TRUST Intrathecal Chemotherapy Certificate of Competence NAME POSITION Has been assessed as competent to perform the following with regard to intrathecal chemotherapy: Date Current policy & Guidance (record version) Role Trainer signature Trainee signature Page 36 of 49

37 APPENDIX H Page 37 of 49

38 Page 38 of 49

39 APPENDIX I KETTERING GENERAL NHS FOUNDATION TRUST Safe Administration of Intrathecal Chemotherapy Assessment Framework for Doctors Aim: To assess the competence of Doctors to fulfil the following role: Personal involvement in intrathecal chemotherapy (prescribing and administering) Note: It is essential that the individual being assessed should not just answer the questionnaire correctly but also demonstrate a commitment to the principles of ensuring patient safety, and an awareness of their full responsibilities. If the assessor has any doubts, he should not certify the individual concerned. Doctor: (name) (post) Assessor: name) post) Date: Questions Responses (tick or circle responses and write additional comments if necessary) 1. Have you received a copy, and read the Kettering General Hospital NHS Foundation Trust Policy for Intrathecal Cytotoxic Chemotherapy? Have you read: National Guidance HSC 2008/001? NPSA 2008/RRR04? NHS/PSA/D/2014/002? 2. Describe the background to why National Guidance has been issued. Page 39 of 49

40 Questions Responses (tick or circle responses and write additional comments if necessary) 3. One of the main themes of the guidance is induction and training to ensure that staff know what they re doing. What is our role in training staff involved with chemotherapy? 4. What do you understand by the section on being prepared to challenge? How will you respond if challenged? How would you challenge a consultant? 5. Who can prescribe Intrathecal chemotherapy? 6. On what must Intrathecal chemotherapy be prescribed? 7. How will you receive Intrathecal chemotherapy drugs prior to their administration? 8. If a patient is having IV and Intrathecal chemotherapy, which must be administered first? 9. How do we ensure, for a given patient, that IV is given before Intrathecal chemotherapy? 10. When transporting Intrathecal chemotherapy, how are risks minimised? 11. Before Intrathecal chemotherapy is given, a Patient Review is required. Why? 12. In which areas may Intrathecal chemotherapy be administered in this Trust? 13. When Intrathecal chemotherapy is to be given, what should you check the area for? Page 40 of 49

41 Questions Responses (tick or circle responses and write additional comments if necessary) 14. What is your own personal checking procedure before you administer a medicine? 15. Who needs to be involved in the check before Intrathecal chemotherapy is given? 16. What is the idea behind involving the patient/carer in the checking? 17. How is the patient/carer check recorded? 18. Would the system be any different if the Intrathecal chemotherapy was given out-ofhours? 19. What is the concept of negative labelling and how does this affect recommended labelling of Intrathecal chemotherapy. 20. How is the concept of differentiating products by their volume used locally to reduce the risk of Intrathecal chemotherapy? 21. What type of LP needle must be used, and why? What must you check for regarding this. Comments? Page 41 of 49

42 APPENDIX J INTRATHECAL SLIDE FOR HOSPITAL INDUCTION PROGRAMME Cancer boy dies after blunder Daily Mail, 3rd February 2001 Two junior doctors who mistakenly injected an anti-cancer drug into an 18-year-old's spine faced manslaughter charges after the teenager died on Friday. Leukaemia sufferer Wayne Jowett never regained consciousness after he slipped into a coma following the blunder at the Queen's Medical Centre in Nottingham. Only designated staff who are on the register may have anything (even handling) to do with intrathecal chemotherapy at KGH Page 42 of 49