Administration of Intrathecal Cytotoxic Chemotherapy in NHS Grampian

Transcription

1 Administration of Intrathecal Cytotoxic Chemotherapy in NHS Grampian Lead Author/Coordinator: Jeff Horn / Sarah Howlett Macmillan Haematology CNS/ Pharmacist Reviewer: Gavin Preston Consultant Haematologist Approver: Jane Tighe Consultant Haematologist Signature: Signature: Signature: Identifier: Review Date: December 2017 Approval Date: December 2015 UNCONTROLLED WHEN PRINTED Version [number]

2 This document is also available in large print and other formats and languages, upon request. Please call NHS Grampian Corporate Communications on (01224) or (01224) This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative. Unique Identifier: Replaces: Subject (as per document Clinical Policy/Protocol registration categories): Key word(s): Document application: NHS Grampian Purpose/description: This policy provides a working framework that will allow NHS Grampian to meet the standards set out in the Chief Executives Letter (CEL) in the adult and paediatric service. It also provides the framework for the education and training of all professional groups involved in the prescribing, preparation, issuing, and administration of intrathecal chemotherapy in NHS Grampian. Responsibility: Responsibility for the effective management of the organisation s policy, protocol, procedure and process documentation ultimately lies with the Chief Executive. Delegation for formulating, disseminating and controlling these documents falls to either a named individual or a working group. Policy statement: It is the responsibility of supervisory staff at all levels to ensure that their staff are working to the most up to date and relevant policies and procedures Responsibilities for implementation: Organisational: Operational Management Team and Chief Executive Sector General Managers, Medical Leads and Nursing Leads Departmental: Clinical Leads Area: Line Manager Review date: December 2017 Responsibilities for review of this document: Lead Author/Co-ordinator: Jeff Horn Revision History: (if there is no previous document please insert N/A into the boxes in the top row of the table below) Revision Date Previous Revision Date Summary of Changes (Descriptive summary of the changes made) Changes Marked* (Identify page numbers and section heading ) N/A N/A N/A N/A * Changes marked should detail the section(s) of the document that have been amended i.e. page number and section heading. [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian]

3 Contents Contents Page number 1. Purpose and Scope Introduction Aims and Objectives Consultation Group 3 2. Statement of Policy General Points & the Register Roles in the Process Training Prescribing Preparation Administration Conclusions Professional Responsibility Responsibilities Organisational Arrangements Chief Executive Medical Director Director of Nursing Director of Pharmacy 13 References 14 Distribution List 14 [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 2

4 1. Purpose and Scope 1.1 Introduction In the UK since 1985, 13 patients have died due to errors associated with the administration of intrathecal cytotoxic chemotherapy. Vincristine administered by the intrathecal route has been the most common error. Adherence to this policy will minimise the risk to patients receiving intrathecal cytotoxic chemotherapy within NHS Grampian. This document complies with the updated Scottish Executive Health Department Documents: Safe Administration of Intrathecal Cytotoxic Chemotherapy CEL 21 (2009) and Guidance for the safe delivery of systemic anti-cancer therapy CEL 30 (2012) 1.2 Aims and Objectives CEL 21 (2009) requires NHS Grampian to produce a protocol for the prescribing, dispensing, and administration of intrathecal chemotherapy within a number of strict parameters. This policy provides a working framework that will allow NHS Grampian to meet the standards set out in the CEL in the adult and paediatric service. It also provides the framework for the education and training of all professional groups involved in the prescribing, preparation, issuing, and administration of intrathecal chemotherapy in NHS Grampian 1.3 Consultation Group Medical, Nursing and Pharmacy colleagues within Adult and Paediatric cancer services had opportunity to review the document. 2. Statement of Policy 2.1 General Points & the Register All relevant staff namely; doctors, nurses, pharmacy & theatre staff, who work in areas where there is a service providing intrathecal cytotoxic chemotherapy, must be aware of this policy and the national guidance CEL 21 (2009) and understand its impact on their practice even if not directly involved themselves All staff directly involved in provision of intrathecal cytotoxic chemotherapy must undergo intrathecal training with a certified trainer. The appointment of all trainers (medical, nursing and pharmacy) must be appointed by the haematology or paediatric head of service and approved by the Medical Director (medical trainer), Director of Nursing (nurse trainer) or Director of Pharmacy (pharmacy trainer). Approval should be recorded on the certificate of the individual and scanned/copied to the shared drive. [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 3

5 2.1.3 Once training has been successfully completed, the staff member will be entered onto the NHS Grampian Intrathecal Register. The register will contain all names of staff members certified to be involved at any stage in the provision of intrathecal cytotoxic chemotherapy. The register includes the following sections: Medical Staff (see section for levels of medical registration) Nursing Staff Pharmacy Staff The NHS Grampian Intrathecal Register is a live document and is available in the Intrathecal Policy and Registers folder on the shared drive to which all key personnel have access The Clinical Pharmacist Team Leader for Cancer will ensure the NHS Grampian Intrathecal Register is available on the shared drive on behalf of the Medical Director and make arrangements to ensure it is accessible to : Chief Executive Medical Director Director of Nursing Director of Pharmacy Unit Clinical Director (Cancer) Clinical Lead of Paediatrics The Medical Director will, with the assistance of the Clinical Pharmacist Team Leader for Cancer, undertake to review the register and training processes on a 2 yearly basis and will confirm in writing the conclusions of the review In the Intrathecal Policy and Registers folder on the shared drive for Medical, Nursing and Pharmacy, a designated person responsible for maintaining each register ensuring that the register is regularly reviewed and updated. The designated person responsible is named on the register All staff involved with the care and treatment of patients receiving SACT must be encouraged to challenge colleagues if, in their judgement, the policy is not being adhered to or when the actions of an individual may cause potential risk to a patient. Challenging a colleague should not be seen as adversarial, but as an additional check to improve patient safety and reduce risk 2.2 Roles in the Process Medical Staff Depending on which level of training has been undertaken and which section of the register the doctor is listed: Initiating, prescribing and/or administering the intrathecal treatment and other required medicines, receiving the drug from pharmacy, reviewing the patient, Ensuring that platelet count is adequate for procedure [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 4

6 providing support and education to patients or carers prior to, during and after administration of intrathecal chemotherapy as required, confirming that the second checker is current on the live Intrathecal Register checking chemotherapy details in accordance with the intrathecal chemotherapy prescription check list prior to administration, performing a lumbar puncture and administration of the intrathecal cytotoxic chemotherapy, Ensuring the completed prescription form is filed and details of the procedure are documented in the medical notes. In RACH the administration of the intrathecal cytotoxic chemotherapy will be documented in the joint record by the medical and/or theatre staff Nursing checking that the doctor is current on the live Intrathecal Register checking intrathecal cytotoxic chemotherapy prior to administration with a registered doctor in accordance with the intrathecal cytotoxic chemotherapy prescription check list, providing support and education to patients or carers prior to, during and after administration of intrathecal cytotoxic chemotherapy as required, ensuring observing/monitoring of patients post-administration, reporting to medical staff any related problem or toxicity documentation of administration of intrathecal cytotoxic chemotherapy in the nursing notes In RACH the administration of the intrathecal cytotoxic chemotherapy will be documented in the joint record by the medical and/or theatre staff Pharmacy discussing timing of intrathecal administration according to the treatment protocol, clinically verifying the details of the prescription against patient and regimen parameters as required, dispensing the intrathecal cytotoxic chemotherapy according to procedures, releasing and issuing of the medication to a doctor registered to administer intrathecal cytotoxic chemotherapy according to policy or placing it in the designated intrathecal fridge. 2.3 Training All medical, nursing and pharmacy staff must receive training appropriate to their level of involvement in prescribing, verification, handling, preparation and administration of intrathecal cytotoxic chemotherapy. All groups of staff must be made aware of the potentially lethal consequences associated with the inadvertent administration of intravenous cytotoxic chemotherapy via the intrathecal route. [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 5

7 2.3.2 Ensuring staff are appropriately trained will be the responsibility of the Unit Clinical Director (cancer) or Clinical Lead of Paediatrics this also includes re-accreditation training at two years. They will appoint registered staff as trainers and delegate the task of maintaining the training of new staff and the two year rolling re-accreditation requirements to the named trainers Trainers and trainee should formally document the training. The training will cover theory and practice. Training will be deemed complete when the trainer and trainee sign the Safe Handling & Administration of Cytotoxic Intrathecal Drugs training certificates Staff moving to this hospital may provide their certificate of training or a training logbook or other training record as proof of their competence. Professional Heads must however ensure that all these staff are provided with a formal period of induction and review this NHS Grampian policy relevant to the prescribing, dispensing, checking and administering of chemotherapy including intrathecal therapy. Staff should confirm in writing that they have received and read the correct policies and received the appropriate training on local policy issues before being placed on the register for NHS Grampian. The retraining period will be set to coincide with the retraining period set at their previous employment Certificates will be issued to staff on completion of the training, Medical Training Medical training will be undertaken by an appropriate Consultant trainer within the haematology or paediatric service. The trainers will be approved by the Unit Clinical Director (Cancer) or Clinical Lead of paediatrics, their names being recorded on the NHS Grampian register Medical staff can enter the register on any one or all of the following capacities:: Initiation of Intrathecal cytotoxic chemotherapy (Consultant only) Prescribing of Intrathecal cytotoxic chemotherapy Administration of Intrathecal cytotoxic chemotherapy To enter the section of the register Administration of Intrathecal cytotoxic chemotherapy the medical trainer will assess the competence of the trainee in performing a lumbar puncture by examining their training records and previous experience. If the trainee is deemed not to have sufficient experience they will undertake further training on lumbar punctures prior to undertaking the training for intrathecal cytotoxic chemotherapy administration Elements of the medical training may be delegated to other staff group trainers e.g. another doctor, nurse or pharmacy trainer, although the training consultant has the responsibility to assess the overall competence of the medical trainee and confirm entrance onto the intrathecal register on the appropriate sections/s. [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 6

8 Only a Consultant may initiate a course of cytotoxic intrathecal chemotherapy Only a Consultant, Specialist Trainee (ST3 and above) and nonconsultant career grade doctor may be trained to prescribe and administer cytotoxic intrathecal chemotherapy All training will cover theory. Additionally, if entering onto the Administration of intrathecal cytotoxic chemotherapy section of the register, practical training must be included. Medical Staff must observe the administration of intrathecal cytotoxic chemotherapy and then be supervised on a minimum of one occasion Trained staff will be re-accredited on a 2 yearly basis by registered trainers. Nursing/Pharmacy Training Nurse and Pharmacy training will always be undertaken by staff registered as trainers on the register. The Director of Nursing and Director of Pharmacy will approve the list of nursing and pharmacy trainers respectively The training will cover theory and practice of safe handling & administration of cytotoxic intrathecal drugs Trained staff will be re-trained on a two yearly basis by the registered trainers The Pharmacy and Nursing trainers will update the hospital database (held on the shared drive) of trained staff by sending a copy of the staff member s completion certificate to the Clinical Pharmacist Team Leader for Cancer or Paediatrics (scanning and saving a copy in the shared drive folder) The Director of Nursing and the Director of Pharmacy will be kept informed of changes to the central database on a three monthly basis. They will undertake to assist the Medical Director NHS Grampian in the two yearly review of the service. 2.4 Prescribing Medical staff must be trained and registered to initiate, prescribe and/or administer intrathecal cytotoxic chemotherapy Intrathecal cytotoxic chemotherapy must be initiated by an intrathecal registered Consultant and this decision, along with a treatment plan recorded in the medical records Intrathecal cytotoxic chemotherapy must only be prescribed and authorised by an intrathecal registered Consultant, Specialist Trainee (ST3 and above) and non-consultant career grade doctor. [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 7

9 2.4.4 All prescriptions for intrathecal cytotoxic chemotherapy must be prescribed on a standardised pre-printed prescription form for intrathecal doses only. Referral to the additional prescription may be made on the cytotoxic chemotherapy prescription used for any other chemotherapy treatment, but this cannot be used for the intrathecal treatment Abbreviations must not be used i.e. IT intrathecal must always be written out in full All intrathecal cytotoxic chemotherapy must be professionally verified by an intrathecal registered specialist oncology, haematology or paediatric pharmacist. 2.5 Preparation Cytotoxic chemotherapy must not be kept as ward or theatre stock The preparation of all intrathecal doses of cytotoxic chemotherapy must only be carried out in a cytotoxic isolator which provides an air quality which complies with the EC Guide to GMP (2007) No abbreviations for the route of administration will be included on labels Labels will be written in the largest font size possible in emboldened type Additional warning labels on the outside packaging must be used e.g. 'Vinca' alkaloids Infusions FOR INTRAVENOUS USE ONLY FATAL IF GIVEN BY ANY OTHER ROUTE. Drug intended for Intrathecal use FOR INTRATHECAL USE ONLY Vinca Alkaloids must no longer be supplied to adult patients in syringe doses, they must always be supplied in 50mL mini-bag infusions. In RACH vincristine will be administered via a 30ml syringe (with doses of 1mg being diluted to 10ml and >1mg diluted to 20ml with sodium chloride 0.9%) as a slow bolus. For vinorelbine and vinblastine refer to specific RACH pharmacy worksheets The release for issue of doses of intrathecal cytotoxic chemotherapy from pharmacy must be carried out by a Pharmacist or Pharmacy Aseptic Checking Technician who is intrathecal registered to perform release for issue If an intravenous dose is to be given on the same day as an intrathecal dose due to clinical need, there must be separation in time between administration. All non-intrathecal parenteral chemotherapy must be issued first and proof of administration produced before intrathecal chemotherapy is issued [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 8

10 Confirmation of this is by means of the completed prescription sheet being brought to the pharmacy by the collector or being faxed to the pharmacy. The only exceptions that can be made to the sequencing of intrathecal chemotherapy being administered before intravenous is in the treatment of children using RACH specific protocols Once prepared, intrathecal doses must be stored in a separate location from intravenous doses of chemotherapy Pharmacy staff will only issue the prepared intrathecal doses to practitioners who are named on the intrathecal register. A copy of the prescription must be present in pharmacy and signed by the preparing technician and the collector If two intrathecal medicines are to be administered simultaneously to the same patient as part of a treatment schedule, both medicines may be made and released at the same time to the collector The practitioner collecting the chemotherapy will only be supplied with the intrathecal doses. No other chemotherapy will be handed over at the same time If the member of the pharmacy staff does not recognise the practitioner to be one that is registered, they may check the registration status of the practitioner with the copy of the record held in either the Pharmacy Department or the ward If the prepared intrathecal dose is no longer required and beyond the expiry time it must be removed from the designated fridge and disposed of in a cytotoxic bin. The prescription and worksheet must be scored, annotating cancelled and destroyed on the front and retained in the filing for that day. 2.6 Administration Vinca alkaloids MUST NEVER be administered intrathecally. To improve patient safety all vinca alkaloids are prepared in minibags for adults but be aware that vinca alkaloids are supplied in syringes for paediatrics (CEL 21, 2009) Intrathecal cytotoxic chemotherapy must only be administered by a Consultant, Specialist Trainee (ST3 and above) and non-consultant career grade doctor who have been trained and specifically named on the Administration of intrathecal cytotoxic chemotherapy section of the intrathecal register Scheduling of intrathecal cytotoxic chemotherapy must take into account the availability of trained staff For inpatients, unless clinically indicated, intrathecal and bolus intravenous cytotoxic chemotherapy injections will not be administered to the [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 9

11 same patient on the same day. If this is not possible due to clinical need, procedure must be followed Vinca Alkaloids supplied for the treatment for adult patients will always be administered in a mini-bag infusions of 50mL infused over 10 minutes. In RACH vincristine will be administered via a 30ml syringe (with doses of 1mg being diluted to 10ml and >1mg diluted to 20ml with sodium chloride 0.9%) as a slow bolus. For vinorelbine and vinblastine refer to specific RACH pharmacy worksheets The registered doctor administering intrathecal cytotoxic chemotherapy must personally collect or receive the dose from pharmacy or the designated intrathecal fridge and sign the prescription as a record of this Intrathecal chemotherapy must only be administered in the following designated areas of Aberdeen Royal Infirmary and RACH: Ward 307 Ward 310 Ward 112 Ward 114 Theatre Suite (see 2.6.7) RACH theatre Suite On occasions it may be necessary to administer intrathecal cytotoxic chemotherapy in the theatre suite of ARI. In this instance, intrathecal registered staff from the haematology service are responsible for all aspects of the intrathecal treatment. Theatre staff must be made aware of the NHS Grampian intrathecal policy but are not entered onto the register and must not be involved in the intrathecal process at any stage Intrathecal doses must be administered in a room where no other chemotherapy is being stored or administered at the same time Intrathecal doses must be supplied from pharmacy just prior to administration and not stored in the clinical area. In the event that administration of an intrathecal dose is unavoidably delayed, it must be locked in the designated intrathecal fridge in wards 307, 112 or RACH Theatre Suite. No other medicines should be stored in this fridge at any time and if not administered must be disposed of once beyond the expiry time (see for disposal) The prescription must be present with the intrathecal cytotoxic chemotherapy at the time of administration No other syringes containing bolus doses medicine (other than drugs necessary for required local or general anaesthetics) should be within the area where the intrathecal cytotoxic chemotherapy is being administered. It is however permissible to continue intravenous or subcutaneous infusions which are already connected, including intravenous methotrexate and cytarabine but not other cytotoxic agents [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 10

12 Two registered members of staff i.e. doctor/doctor, doctor/nurse, doctor/pharmacist must always independently and silently check the following details of all intrathecal cytotoxic chemotherapy before administration against the intrathecal prescription form checklist: Patient s Name, Date of Birth and CHI number The Drug The Dose The Route of Administration (i.e. intrathecal) The Expiry Date The two registered members of staff must initial the given by/checked by section of the prescription form, one individual as administrator and the other as a witness If chemotherapy is cancelled after being supplied to the Doctor, the dose must be immediately discarded in a cytotoxics sharps bin, pharmacy informed and the prescription annotated that the dose was cancelled and destroyed. The cancelled prescription may not be re-used. A new prescription form must be written if the intrathecal dose is rescheduled at a later date Intrathecal cytotoxic chemotherapy should only be administered within normal working hours ( Monday to Friday). 2.7 Conclusions Professional Responsibility The administration of intrathecal cytotoxic chemotherapy is an extremely high-risk procedure. This policy must be adhered to at all times. All staff involved in the care and treatment of patients receiving intrathecal cytotoxic chemotherapy must be encouraged to ensure that this policy is adhered to at all times. Deviations from policy are not acceptable. If any member of staff has any doubts regarding their responsibility they should immediately contact their line manager to seek clarification, and if necessary, further training Any member of staff who judges that the policy is not being adhered to or who considers that the action of an individual may cause potential risk to a patient, must challenge that individual in order to ensure patient safety. If required the staff member may report their concerns to their line manager and seek clarification before the procedure is undertaken The care of patients depends on the untiring vigilance of all relevant staff. Check before you inject. 3. Responsibilities Roles and Responsibilities 3.1 The policy must be rigidly adhered to at all times, as administration of the wrong drug or dose by the intrathecal route is likely to be fatal. [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 11

13 3.2 For the purpose of this policy an intrathecal cytotoxic drug refers to methotrexate, cytarabine (including Depocyte ) or hydrocortisone given by intrathecal injection as part of a cytotoxic chemotherapy regimen. The regimens are approved and assigned onto the chemotherapy electronic prescribing and administration system (Chemocare). 3.3 Within this document registered means being trained, using the NHS Grampian training package with a certified trainer and recorded as such on the Intrathecal Register. 3.4 Non-cytotoxic intrathecal medicines are excluded from this policy. 3.5 A Consultant in Haematology or Oncology wishing to administer to any patient in Grampian any intrathecal cytotoxic chemotherapy other than the drugs set out above, must set out their requirements in writing with supportive evidence. This information should be passed on to their Unit Clinical Director (Cancer) and the Principal Clinical Pharmacist. The Medical Director will liaise with the Principal Clinical Pharmacist to collate all issues and will then provide written approval to the consultant before treatment can be prescribed and administered. The approval process must be undertaken in a way that meets clinically driven timeframes. 3.6 Consultants in specialities other than Haematology and Oncology may not under normal circumstances prescribe intrathecal cytotoxic chemotherapy. If they wish to do so they must set out their requirements in writing, with supportive evidence. This information must be copied to their Unit Clinical Director (Cancer) and Clinical Pharmacist Team Leader for Cancer. The Unit Clinical Director (Cancer) will seek advice from other medical staff with the relevant clinical expertise and will give written approval only if the treatment is deemed appropriate. Only trained staff who are registered within NHS Grampian would be allowed to prescribe and administer the intrathecal chemotherapy. 3.7 A lumbar puncture may occasionally need to be performed by staff not on the register for example, when in training or in the event of a difficult procedure where a neurologist or radiologist is required to position the needle. This is acceptable however, these staff must never be involved in any other aspect of the process and, specifically, must never administer the intrathecal chemotherapy. 4. Organisational arrangements 4.1 Chief Executive: Is responsible for the complete implementation and compliance with CEL 21 (2009) Must maintain a NHS Grampian database in conjunction with the Medical Director, Acute Division of all registered staff and their training status. The Chief Executive will have access to the database and will receive a [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 12

14 personal copy of the register produced by the database on a three monthly basis. 4.2 Medical Director: Has delegated responsibility from the Chief Executive for ensuring implementation and compliance with CEL 21 (2009) Will approve the appointment of Medical Trainers according to policy Will hold and approve the register of all trained staff from the different professional groups Will undertake a two yearly review of the policy, compliance and training issues. 4.3 Director of Nursing: Is responsible for all nursing issues related to the implementation and compliance with CEL 21 (2009) Will ensure the record of all nurse trainers and trained registered nursing staff is accurately maintained Will approve the appointment of all nurse trainers Will support the Medical Director in undertaking a two yearly review of the policy, compliance and training issues. 4.4 Director of Pharmacy: Is responsible for all pharmacy issues related to the implementation and compliance with CEL 21 (2009) Will ensure the record of all pharmacy trainers and trained registered pharmacy staff is accurately maintained Will approve the appointment of all pharmacy trainers Will support the Medical Director in undertaking a two yearly review of the policy, compliance and training issues. [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 13

15 References: Scottish Government (2009) CEL 21 Safe Administration of Intrathecal Cytotoxic Chemotherapy. Available from: [Accessed 29th July 2015] Scottish Government (2012) CEL 30 Guidance for the Safe Delivery of Systemic Anti-Cancer Therapy Available from: [Accessed 29th July 2015] Distribution list: Clinical leads Unit Operational Managers Unit Nurse Managers, Acute sector Senior pharmacy staff Professional and Practice Development Unit Uploaded on NHS Grampian Intranet Uploaded onto Q Pulse Sent via global [Unique Identifier] [Administration of Intrathecal Cytotoxic Chemotherapy NHS Grampian ] 14