MM05 POLICY FOR THE SAFE ADMINISTRATION OF …

Betsi Cadwaladr University Health Board Bwrdd Iechyd Prifysgol

MM05 Version: 1 of 21 Paper copies of this document should be kept to a minimum and checks made with the electronic version to

ensure the version to hand is the most recent

MM05 POLICY FOR THE SAFE ADMINISTRATION OF INTRATHECAL CHEMOTHERAPY

Date to be reviewed: January 2015 No of pages: 21

Author(s): Tracy Parry-Jones Author(s) title: Cancer Network Pharmacist

Responsible dept / director:

Anne Bithell Chief of Staff, Pharmacy CPG

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 alongside this policy:

This document MUST be read in conjunction with the 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

6th 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 Betsi Cadwaladr University Health Board. Do not produce all or any part of this document without written

permission from the BCUHB.

Version: 1

Bwrdd Iechyd Prifysgol Betsi Cadwaladr

University Health Board

MM05 Version: 1 of 21 Paper copies of this document should be kept to a minimum and checks made with the

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





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 6th 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 4th August 2005 and CMO 4/CPhA 1/CDO 2/CN 3/ CSA 1 published on 6th 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 31st 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 re-organisation and establishment of Betsi Cadwaladr University Health Board. 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 Betsi Cadwaladr University Health Board(BCUHB) and to demonstrate compliance to the recommendations made in Welsh Guidance CMO(2008) 04.





2. Purpose and Scope

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 Betsi Cadwaladr University Health Board. This document does not apply to paediatric patients or intrathecal administration of non-cancer 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





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





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 Betsi Cadwaladr University Health Board 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





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;

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:

The patient should be encouraged to participate in the checking process.

Patients’ details Each drug Full name regimen with name/dosage of each drug Hospital number intended administration date/time Date of birth route of administration Home address date/time of preparation Diagnosis date/time of expiry cycle number and day

drug packaging is intact

Patients’ details Each drug Full name regimen with name/dosage of each drug Hospital number intended administration date/time Date of birth route of administration Home address cycle number and day





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





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)





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 Title

Dr Catherine Bale Chemotherapy Lead, Cancer CPG Tracy Parry-Jones Cancer Network Pharmacist Sr Pat Pilkington Lead Oncology Nurse (Central) Sr Jane Heron Sister Heulwen Day Unit Sr Beryl Roberts Lead Oncology Nurse (East) Sr Laura Edge Lead Oncology Nurse (West)





Sr Jackie Jones Sister Alaw Ward Manon Williams Alaw Ward Manager Sr Anne-Marie Humphreys Sister Shooting Star Unit Prof N Stuart Consultant Oncologists Yvonne Lush ACoS Nursing , Cancer CPG Carmel Barnett Radiotherapy Damian Heron ACoS, Cancer CPG Bruce Burnett Consultant Pharmacist Oncology

(Central) Alistair Ellis-Jones Oncology Pharmacist (East) Mared Hughes Oncology Pharmacist (West) Sue Armstrong-France Audit Facilitator Geraint Roberts 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

(Central) 1.9.11

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





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 --/--/-----





Authorised to produce and dispense intrathecal cytotoxic drugs:

Person Role


At -------------------------------------only the following personnel are authorised to receive and/or check intrathecal chemotherapy with a designated Haematologist prior to administration:






Appendix 2a PHARMACY POLICY ON CHECKING & DELIVERY OF INTRATHECAL CHEMOTHERAPY

ACTION RATIONALE ♦ Pharmacists involved in checking and delivery of

intrathaecal chemotherapy have to be on a register, will have undergone specific training and have read 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 reduce risk and improve patient safety. Ensure competency of staff involved in this procedure.

♦ 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 of 21 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent

Appendix 2b COMPETENCE IN THE CHECKING & DELIVERY OF INTRATHECAL CHEMOTHERAPY Participant will demonstrate, through practical and theoretical knowledge, competence in the checking and delivery of Intrathecal Chemotherapy

No. Performance criteria Assessment Method

Attained Deferred Date Signature of Assessor

Signature of participant

Annual review Date

1.

Background Reading � Cytotoxic Chemotherapy

Policy � Intrathecal Policy � Nottingham Report � Training Pack

Evidence / Questioning

2.

Experience Witnessed intrathecal chemotherapy being administered

Observation

3. Complete questions on Cytotoxic Chemotherapy

Questioning

4.

Checking Checks prescription according to Cytotoxic SOP 6.1

Observation

5. Checks that all intrathecal chemotherapy correctly labelled

Observation

No. Performance criteria Assessment Method



Annual review Date

Name : Grade :

Hospital/Dept: Expected date of completion:

MM05 Version: 1 of 21 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent

6.

Knowledge of Cytotoxic Drugs involved. Actions, possible side-effects / interactions

Questioning

7. Knowledge of appropriate dosages

Questioning

8. Clinical features of mal-administration

Questioning

9. Action to be taken in event of mal-administration

Questioning

10.

Delivery Checks that intrathecal chemotherapy has been appropriately packaged

Observation

11.

Ensures that intrathecal chemotherapy is collected by an appropriate person.

Observation

12.

Ensures that the signed prescription is returned prior to issuing of any intravenous chemotherapy.

Observation

Further Comments & Recommendation:

Signature of Trainer: Print name: Date signed:

Signature of Trainee:

Print name: Date signed:

MM05 Version: 1 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 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.


Appendix 3b COMPETENCE IN ADMINISTRATION OF INTRATHECAL (IT) CHEMOTHERAPY Participant will demonstrate, through practical and theoretical knowledge, competence in the procedure for safe administration of Intrathecal Chemotherapy

No Performance criteria Assessment Method



Annual Review Date

1.

Background Reading Participant has read and can refer to relevant policies relating to procedure � Policy on the Administration of

Intrathaecal Chemotherapy � North Wales Cancer Service –

Cytotoxic Chemotherapy Policy � National Guidance on the safe

Administration of intrathecal Chemotherapy

Questioning

2

Preparation Provide accurate verbal explanation of procedure for administration of intrathecal administration of chemotherapy

Questioning

3.

Identify and demonstrates pre administration safety checks

Questioning/Observation

4.

Assesses and presents evidence of written informed consent process

Observation/Evidence

5.

Clarifies Named Doctor administering chemotherapy complies with policy

Observation

Name : Grade :

Hospital/Dept: Expected date of completion:


No Performance criteria Assessment Method



Annual Review Date

6.

Knowledge of Cytotoxic Drugs Involved Actions / Possible side effects / interactions

Questioning

7. Knowledge of appropriate dosage Questioning

8. Clinical features of mis-administration

Questioning

9. Action to be taken in event of misadministration

Questioning

10.

Patient Assessment/Safety Assesses patients understanding of procedure

Observation

11.

Maintain patients comfort and safety throughout the procedure

Observation

12.

Administration Correct checking procedures and written documentation is consistent with policy

Observation

13.

Correct disposal of all equipment as per chemotherapy policy

Observation

Further Comments & Recommendations

Signature of Trainer:

Signature of Trainee:

Print name:

Print Name:

Date signed:

Date signed:


Appendix 4 MEDICAL POLICY ON ADMINISTRATION OF INTRATHECAL CHEMOTHERAPY

ACTION RATIONALE

♦ 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.


♦ 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.


Appendix 5

Checklist List for Intrathecal Chemotherapy

No. Item Checked by Doctor

Checked by Nurse

Checked in presence of Patient

1 Are Doctor and Nurse registered to check / administer intrathecal chemotherapy?

2 Has patient been assessed by a registered doctor prior to administration of intrathaecal chemotherapy?

3 Is the intrathecal chemotherapy being administered in a designated area?

4 Is the chemotherapy still in its tamper-evident bag?

5 Check patient’s name and G number with the patient and against the prescription and the chemotherapy.

6 Check the drug name, dose and route of administration against the prescription and the chemotherapy.

7 Check the expiry date of the chemotherapy.

8 Ensure unused intrathecal chemotherapy is returned to pharmacy immediately.

9 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

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