Policy for the Management of Systemic AntiCancer Treatment for Adult Patients

Version 4

Date of Publication: Version 1 - June 2005 Version 2 – September 2007 Version 3 – September 2009

Authors: Sam Neale – Lead Chemotherapy Advanced Nurse Practitioner, UHCW NHS Trust

Version 4 – March 2012

Carole Connor – Nurse Consultant, South Warwick Foundation Trust

Name of responsible committee/individual:

Arden Cancer Network Chemotherapy Cross-Cutting Group

Target audience:

Date of Ratification: April 2012

Date for Review: March 2014

Staff involved in the prescribing, preparation, storage and administration and disposal of Cytotoxic chemotherapy Ratified by: Arden Cancer Network Executive Group

Policy for The Management of Systemic Anti Cancer Treatment for Adult Patients

Version History Version 4

Date February 2012

3

September 2009

2

April 2007

1

May 2005

Version 4

Brief Summary of Change Updated to reflect the National Chemotherapy Measures (DH 2011) Change in title of policy and terminology Incorporates action from the NPSA Rapid Response Reports – Risks of Incorrect dosing of oral anticancer medicines (NPSA/2008/RRR001); Using Vinca Alkaloid Minibags (Adult/Adolescent Units) (NPSA/2008/RRR004) Administration guidelines removed (separate procedures developed) Incorporates July 2005 Waste Regulations

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Contents Section

Page

1.0

Introduction

5

2.0

Purpose

5

3.0

General Principles

7

4.0

Prescribing

11

5.0

Preparation

13

6.0

Transportation

15

7.0

Storage

15

8.0

Administration

15

9.0

Extravasation

21

10.0

Waste

21

11.0

Risk Assessment and Management

21

12.0

Safe Handling

22

13.0

Minimising Exposure

22

14.0

Spillage

23

15.0

Accidental Contact

23

16.0

Disposal of Waste

24

17.0

Consultation and Communication Process

25

18.0

Equality Impact Assessment

25

19.0

Review and Revision Arrangements including Version Control

25

20.0

Dissemination and Implementation

25

21.0

References

25

22.0

Document Circulation

27

Appendices Appendix A Version 4

Lead Individuals for Organisation and Delivery of Chemotherapy Services February 2012

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Section

Page

Appendix B

Designated Areas for Administration of Intravenous Chemotherapy for Malignant Conditions

30

Appendix C

Opening Hours of each Designated Clinical Chemotherapy Treatment Area

31

Appendix D

Algorithm for Checking Chemotherapy Prescriptions – A guide to responsibility

32

Appendix E

Suggested Contents of the Basic Spillage Kit

33

Appendix F

Action to be Taken in the Event of a Spillage

35

Appendix G

Equality Impact Assessment Tool

37

Appendix H

Plan for Dissemination of Procedural

38

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1.0 Introduction This policy was developed by the Arden Cancer Network Chemotherapy Group incorporating; Alexandra Hospital (part of Worcestershire Acute Hospitals NHS Trust), George Eliot Hospital NHS Trust, South Warwickshire NHS Foundation Trust and University Hospitals Coventry and Warwickshire NHS Trust (UHCW) with support from individual Trust’s chemotherapy multi-professional teams Systemic anti cancer drugs are hazardous substances, which are administered for two purposes: Treating cancers Managing non-malignant conditions. Systemic anti cancer drugs have the potential to cause serious toxicity; therefore there must be appropriate assessment of clinical and non-clinical risks. Local toxicity due to accidental contamination includes dermatitis, inflammation of mucous membranes, allergic reactions, blistering and in extreme cases tissue necrosis. Long-term hazards are less well defined to but some drugs can be teratogenic, mutogenic or carcinogenic and thus pose a potential hazard to staff involved in their preparation and administration. The risks are minimised however, if treatment is delivered: By trained expert staff working within agreed policies, procedures and guidelines In an unhurried atmosphere With adequate checks on patient safety at every stage (DH 2011). This policy is intended to maximise safety for both adult patients and practitioners involved in the process of systemic anti cancer treatment administration. It must be applied to all administration routes; oral, parenteral, (subcutaneous, intramuscular and intravenous), topical, intracavity (pleural and peritoneal) and intravesical. Local procedures and guidelines must be developed for all routes of administration to support this document. 2.0 Purpose For the purpose of this policy systemic anti cancer treatment refers to cytotoxic drugs, monoclonal antibodies, and immunotherapy and enzyme therapy. This document applies to the administration of systemic anticancer treatment Cytotoxic drugs to paediatrics although it is recognised that UHCW is a shared Care Unit of Birmingham Children’s Hospital (BCH) and in some instances staff in paediatrics will follow BCH policies. Worcestershire Acute Hospitals NHS Trust is a Level 1 provider for Birmingham Children’s Hospital with inpatient and clinic services based at Worcester. Services are delivered conforming to the shared care service measures as outlined in the IOG for Children and Young People and the service follow the BCH policies. The county wide paediatric home care support service for children and young people (Orchard service) also administer IV bolus cytarabine in the community as agreed by the Children’s Cancer Network Co-ordinating group. Version 4

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Note: Please refer to separate policy for guidance on intrathecal drug administration.

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3.0 General Principles 3.1 Responsibility for the Patient The ultimate clinical responsibility for the patient lies with their named consultant. Responsibility for maintenance of safe operational procedures and standards of practice lie with medical, nursing and pharmacy staff within their clinical areas. 3.2 Lead Individuals Each Trust within the network will designate a Head of Service, Lead Chemotherapy Clinician, Lead Chemotherapy Pharmacist and Lead Chemotherapy Nurse who are responsible for the organisation and delivery of chemotherapy services (DH 20011). Appendix one details the names of the designated individuals for each Trust. 3.3 Network Chemotherapy Cross Cutting Group The Arden Cancer Network Chemotherapy Cross Cutting Group will meet as a minimum on a quarterly basis. There will be named representatives from each Trust. The group will report to the Arden Cancer Network Executive Group. Key responsibilities include: In consultation with the Network Site Specific Groups agree a list of acceptable systemic anticancer treatment algorithms and regimens for the network. Agree written guidelines/protocols for the network including: o Cytotoxic chemotherapy administration techniques. o The care of those aids to venous access used across the network (e.g. Hickman lines, PICC lines). o The recognition and treatment of cytotoxic extravasation. o The treatment of allergic reactions including anaphylactic shock o The use of drug delivery devices, o The use of devices to prevent alopecia, o The use of haemopoetic growth factors and patient support using blood and blood products. o The Management of Chemotherapy induced Emesis (Department of Health (DH) 2011). Implementation of National Guidance/Alerts. 3.4 Local Chemotherapy Multi-professional team There must be a named forum/local chemotherapy group call as above (appendix one) within each Trust. Membership should include the Head of Service, Consultant Haematologist (if relevant), Consultant Oncologist (if relevant), Lead Chemotherapy Nurse (who as regular personal involvement in chemotherapy administration as part of their timetable) and Lead Chemotherapy Pharmacist., relevant hospital manager. A member of this group must be a representative on the Trust Drugs & Therapeutic Committee.

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3.4.1 The team should have agreed terms of reference as stipulated within the Cancer Measures which specify that it has delegated responsibility from the head of service to be the team responsible for coordinating the multi-professional opinion across the service and being the final common path for advising the head of service on the following: implementation of the chemotherapy measures; monitoring of off protocol treatments as per the Network Policy; clinical governance, audit, quality assurance and quality control and documentation and investigation of incidents; risk management; change management, including introduction of new protocols, techniques and technologies; maintenance of training and competency and matching staff functions to competency. The terms of reference should specify that on quality management the team should report to a clinical governance committee in the host trust, outside the clinical chemotherapy service. 3.4.2 The team must agree: The list of acceptable regimens for its service which has been agreed through the Local Delivery Planning (LDP) process and is compatible with the Arden Cancer Network treatment algorithms and the regimen list (updated annually). The process for submitting individual case requests in exceptional circumstances. A written policy for preventing regular use of regimens not on the agreed list. 3.4.3 In addition, the team should be responsible for the implementation of: The production of written guidelines for the prevention and treatment of complications arising from cytotoxic chemotherapy. The production of shared care guidelines for general practitioners. The development of guidelines for patients undergoing systemic anticancer treatment. The development of supportive guidelines including: o Supportive drug therapy whilst on systemic anticancer treatment. o Management of neutropenic sepsis. o The use of anti-emetics.

3.5 Treatment Plan All patients must have a documented treatment plan. contain the following information: Diagnosis and staging Co-morbidities Performance status Treatment regime, number of cycles and intent Version 4

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Any deviation from the Arden Cancer Network Treatment Algorithm/Regimen index of the individual treatment protocol and the reason why Regime specific investigations required pre-treatment Frequency and method of assessment 3.5 Patient Information Before commencing a course of systemic anticancer treatment, the patient/carers will receive both verbal and written information in a language that they understand informing them about: Their planned treatment, which will include a specific leaflet (if available), informing them of the exact type(s) of drug(s) they are to receive and possible side effects. information should include contact details for specialist advice, which can be shared with non-specialist practitioners (24 hours a day, 7 days a week) (DH 2004). Written information which details the intended anticancer regimen, treatment plan and arrangements for monitoring (taken from the original protocol), which can be shared with non-specialist practitioners (NPSA 2008). In addition haematology/oncology patients must also receive written information on: Advice on dealing with neutropenic sepsis, extravasation, nausea and vomiting, stomatitis, mucositis and diarrhoea (DH 2011). (The management of these toxicities will be in collaboration with the Acute Oncology Service.) For intravesical chemotherapy – Advice on how to manage voided urine and specific side effects. A record of the information given to the patient should be recorded in the patient's notes. The Arden Cancer Network standard is to use patient information from Macmillan Cancer Support. 3.6 Patient Consent Before commencing a course of systemic anticancer treatment, patients must give their written informed consent. This must be planned (other than in an emergency) so that patients have sufficient time to read and discuss general and specific patient information leaflets about anticancer treatment and the relevant regimen (RCN 2010). If treatment with an alternative anticancer treatment regimen is subsequently proposed, patients should be provided with the relevant information leaflet(s) and written informed consent should again be obtained from the patient (RCN 2010). The consent form should contain the following information: 1. Risks and benefits of treatment 2. Long and short term side effects of treatment 3. Treatment Intention 4. Regimen to be used 5. Enable patients to acknowledge that they have received written information on toxicities which include: • generic written information and, if applicable, • regimen-specific information. Version 4

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Patients MUST sign the consent form prior to starting a course of systemic anti cancer treatment and a copy offered and given to the patient. Consent must only be taken by a member of the clinical team directly involved in the patient’s management and who has been designated and trained to do so.

3.7 Staff Training 3.7.1 General There must be a named lead chemotherapy nurse for the clinical chemotherapy service with responsibility for training in systemic anti cancer treatment administration. They should have an agreed list of responsibilities and an agreed minimum time allowed for those responsibilities in their weekly timetable (DH 20011). All staff working within the designated clinical chemotherapy treatment areas must receive induction training when they commence in post. They must be advised of their role and responsibilities in relation to systemic anti cancer treatment. 3.7.2 Medical Staff All medical staff consultant level and below must receive training prior to being involved in the prescribing, handling or administration of systemic anti cancer treatment as per the Arden Cancer Network Training and Assessment Guidelines.

3.7.3 Nursing Staff All staff who are required to administer systemic anticancer treatment must have completed training as agreed by the Arden Cancer Network and be assessed as competent in the safe administration of systemic anti cancer treatment as per the Arden Cancer Network Training and Assessment Guidelines.

3.7.4 Pharmacy Staff All staff involved in the handling, preparation and dispensing of chemotherapy must have received training as by the Arden Cancer Network and be assessed as competent in the safe administration of systemic anti cancer treatment as per the Arden Cancer Network Training and Assessment Guidelines. It is the responsibility of the Head of Service to ensure that all staff involved in the management of patients receiving systemic anti cancer treatment, within the designated areas must complete an annual update to ensure that they remain competent to practice within the remit of the ‘Policy for the Management of Systemic Anti Cancer Treatment for Adult Patients’. How this is measured will be up to each individual Trust.

3.8 Availability of Protocols Version 4

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3.8.1 Within the Hospital These need to be available in all areas administering systemic anti cancer treatment, this may be in hard copy or as an electronic version. A full copy of all systemic anticancer treatments must be available in the pharmacy department and a summary must be available in designated areas for administration of systemic anti cancer treatment. Details of all trial systemic anticancer regimens must be available, in a standard format in relevant clinical areas. Risk assessments and any subsequent action plans both clinical and non-clinical must be completed within individual Trusts as stated in 2.7.1 and discussed/minutes taken at the Local Chemotherapy MultiProfessional Team. 3.8.2 To Other Hospitals In situations where patient care is to be shared with another hospital, this must be agreed in advance and full details of the systemic anticancer treatment must be supplied in writing. Transfer of patient care should ideally occur in between cycles and not on days of drug administration. 3.8.3 To Primary Care At the beginning of each course of systemic anti cancer treatment, a copy of the treatment plan will be sent to the GP. The plan should include details of: • treatment regimen; • treatment start date; • planned duration; • treatment intent-palliative, curative, adjuvant, neo-adjuvant, other. The plan should be posted/faxed within 24 hours and will be in addition to the routine clinical letter. A copy of the plan will be filed within the patient’s notes. There must be written guidelines for primary care practitioners, covering advice to give and action to take when patients undergoing systemic anticancer treatment consult them with symptoms which may be related to complications. The guidelines should at least deal with advice and symptoms applicable to: For systemic anticancer treatment - neutropenic sepsis, cytotoxic extravasation, nausea and vomiting, stomatitis, other mucositis and diarrhoea. For intravesical chemotherapy – skin reactions and anaphylaxsis. As well as drug specific symptoms. 4.0 Chemotherapy Prescribing 4.1 Holistic Assessment Prior to a course of systemic anticancer treatment an individual holistic assessment of the patient’s and carers (if applicable) needs must take place. It must be undertaken by a Registered Nurse (who has been trained according to the network training specification) and occur separately from and after any consultations at which the treatment plan is agreed with the patient. For each patient, this must occur, prior to starting a new course of systemic anticancer treatment (whether it is their first Version 4

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course or they have previously undergone a course or courses of systemic anticancer treatment. This should incorporate a review of the patient and carers physical, social, psychological, emotional and spiritual needs (DH 2011). 4.2 Prescription Writing 4.2.1 Systemic anticancer treatment regimens must routinely be prescribed on the basis of a written recognised treatment algorithm, protocol and treatment plan (NPSA 2008, DH 20011). The protocol must be readily available and must have taken into account the toxic effects of medicines used. In the rare instance that drugs are not on the network approved list, the prescriber must carry out the following: If the drug/regimen can be managed within the existing budget/resource; the prescriber should liase with the Lead Pharmacist and the Lead Clinician for systemic anticancer treatment. If a consensus to prescribe is reached, the drug may be prescribed. This should be discussed and minutes taken at the next available local chemotherapy group. If the drug/regimen is planned to be prescribed on a more frequent basis, approval must be sought via the Network Chemotherapy Group via the LDP process and if agreed, the drug/regimen added to the Network Approved List. 4.2.2 Systemic anticancer treatment prescriptions must be where available prescribed electronically using the MOSAIQ electronic prescribing system. In the rare event that this is not available they must be Written or typed in indelible black ink. Legible. Unambiguous. Dated. Signed in full (not initials), With prescriber’s printed name (and GMC/PIN number if Trust policy states this is a requirement of prescribers) Prescribed on the designated chemotherapy prescription form (where available). Prescribed on the correct pre-printed prescription forms where available. Written by authorised Consultants or other senior medical staff authorised to do so, Nurse/Pharmacist Non Medical Prescribers who have completed the agreed training programme. 4.3 Initiation of Systemic anticancer Treatment The first cycle of a course of systemic anticancer treatment must only be prescribed and approved by a Consultant Haematologist/Oncologist. An Associate Specialist or post FRCR trainee /Senior Haematology SpR (years 4 or 5) following documented discussion with the named Consultant or deputising Consultant may also prescribe and approve the first cycle of treatment. It is their responsibility to ensure that all systemic anticancer drugs and any ‘regime specific’ treatments required for individual patients, be correctly prescribed according to the Arden Cancer Network Systemic Anticancer Treatment Algorithms and Formulary. 4.4 Checks prior to the Prescription of the First Cycle. The prescribing doctor Must ensure that the following information has been checked Version 4

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prior to prescribing the first cycle of systemic anticancer treatment: History of specific diseases or conditions affecting fitness for anticancer treatment. This includes that the minimum physical and investigational requirements have been met; Performance status; Prior history of systemic anticancer treatment; Current patient medication affecting systemic anticancer treatment; That informed consent has been obtained; Regimen is in accordance with departmental protocols; That a holistic assessment has been carried out or is scheduled. ` 4.5 Subsequent Cycles/Dose Changes or Discontinuation of Treatment Medical Staff/ Nurse/Pharmacist Non Medical Prescribers that have completed a training programme may prescribe subsequent cycles. Changes of dose or cessation of therapy may only be undertaken after discussion with the named consultant and a record of discussion documented in the patient’s notes. 4.6 For patients who are admitted to hospital mid way through a cycle of oral systemic anticancer treatment Treatment must not continue to be prescribed or administered until they have been reviewed by the Haematology/Oncology Consultant or relevant team member. 4.7 Route of Administration The prescription must clearly and unambiguously state the intended route of administration for all drugs. 4.8 Verification by a Pharmacist All systemic anticancer treatment prescriptions must be clinically verified by a Pharmacist who then signs the prescription. Systemic anticancer treatment will only be released on receipt of an authorised electronic or written, signed prescription. 4.9 Dispensing Staff dispensing systemic anticancer treatment must have access to information in the written protocol and treatment plan from the hospital where treatment is initiated and advice from a pharmacist with experience in cancer in that hospital. Staff dispensing systemic anticancer treatment must be able to confirm that the prescribed dose is appropriate for the patient, and that the patient is aware of the required monitoring arrangements (NPSA 2008) 5.0 Chemotherapy Preparation 5.1 Preparation All parenteral systemic anticancer treatment must be prepared, in a ready-to-administer form, by pharmacy aseptic services. All doses of vinca alkaloids prescribed for adult Version 4

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and teenage patients being treated in adult and adolescent chemotherapy units must be supplied from the hospital pharmacy ready to administer in a 50ml minibag. Doses in syringes must no longer be used (NPSA/2008/RRR004). 5.2 Pharmacy Facilities Within the pharmacy, facilities for the preparation of systemic anticancer treatment must: Provide adequate operator and product protection. Have procedures and facilities conforming to Regional Quality Control or Medicines and Healthcare Products Regulatory Agency Specification. Have equipment serviced on a regular basis. Have appropriate environmental monitoring. Have operators who perform regular documented competency assessments in the aseptic handling of systemic anticancer treatment.

5.3 Out of Hours Service Parenteral/intravesical/intracavity anticancer treatment will not be prepared out of hours in all hospitals/Trusts with the exception of University Hospitals Coventry and Warwickshire (UHCW). In emergency situations at UHCW at the request of an individual Oncology / Haematology Consultant, the Oncology Pharmacist may prepare cytotoxic chemotherapy providing it can be administered safely and by appropriately trained staff within the designated clinical area. 5.4 Labelling Information The Pharmacy Department must ensure that all labels on systemic anticancer treatment include the following: Identify the drug as a systemic anticancer preparation. Be clear and unambiguous. Detail patient name, hospital number, drug name and dose. Stipulate storage requirements. Include expiry time and date. Pharmacy batch number. 5.5 Vinca alkaloids Vinca alkaloids should only be supplied to adult and adolescent services in the form of minibags. The prescribed dose of vinca alkaloids should be supplied ready to administer in a 50ml minibag of sodium chloride 0.9% (for some brands of vinorelbine glucose 5% solution for injection may be used instead of sodium chloride 0.9%). All vinca alkaloid doses should be labelled 'For Intravenous Use Only - Fatal If Administered by Other Routes'. There should be judicious use of colour and design on the label, outer packaging and delivery bags to further differentiate minibags containing vinca alkaloids from other minibag infusions. (NPSA/2008/RRR004). The vinca minibag should be infused intravenously over 5 - 10 minutes. Version 4

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Children should not be treated in adult or adolescent clinical areas. In the unlikely situation that this requirement should arise, a local risk assessment should be undertaken to determine the safest method of intravenous vinca alkaloid treatment.

6.0 Transportation of Systemic Anticancer Treatment. When transporting systemic anti cancer treatment from pharmacy, all parenteral/intravesical/intracavity preparations must be transported securely in identified containers designated for the safe transportation of systemic anticancer treatment and labelled “Cytotoxic”. Please refer to section 13 for information for the procedure to follow in the event of a spillage during transport.

7.0 Storage of Systemic Anti Cancer Treatment All systemic anticancer treatment must be stored in a locked designated cupboard/fridge in the designated anticancer treatment areas. This must be stored separated from other medications (DH 20011). Some intravenous products require protection from light and must be stored in the light protective wrapper supplied by pharmacy. This must also be kept over the infusion bag during administration. Labels must be checked carefully to see if the drug needs to be stored in the fridge or at room temperature. Staff food or drink must not be consumed or stored in areas of systemic anticancer treatment preparation or administration. 8.0 Administration of Systemic Anticancer Treatment Intravenous systemic anticancer treatment must only be administered in designated areas (appendix 2). A list of designated areas must be kept and maintained by the lead chemotherapy nurse. Initiation and administration of day or inpatient cytotoxic chemotherapy must whenever possible be undertaken within the departments normal working hours (See Appendix C), since the danger of error multiplies outside this period. The exceptions are: Continuous infusions. Regimens where systemic anticancer treatment is administered for more than 5 consecutive days. Timed systemic anticancer treatment. Systemic anticancer treatment administered more than once a day. Intravesical chemotherapy that needs to be administered within six hours post surgery. Emergency systemic anticancer treatment. Each designated area must have a process in place to deal with an unexpected event Version 4

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that may delay the completion of treatment beyond normal working hours to ensure that treatment can continue in a safe manner. 8.1 Checks Prior to Administration The patient’s fitness for treatment as well as all blood tests and relevant results/investigations as identified by the specific regimen must be reviewed by the doctor/nurse before administration occurs (RCN 2010). A sample algorithm for checking systemic anticancer treatment is included in appendix c. 8.2 Verification Procedure This must be undertaken by two registered nurses or a registered nurse and a doctor who have been trained and assessed as competent to check or administer systemic anticancer treatment. This must occur before administration of treatment. 8.2.1 Verification of the Patient Positive patient identification is essential at all stages of the checking procedure. Prior to administration of systemic anticancer treatment, the patient must be asked to identify him/herself to provide his/her date of birth which must be checked against their cytotoxic chemotherapy prescription chart and their identity bracelet. 8.2.2 Verification of a Patient’s Systemic Anticancer Treatment To verify a patient's systemic anticancer treatment, for each drug: The name of the drug and dose must match exactly with that prescribed on the drug chart or prescription. The name of the drug must correspond exactly with the regimen recorded within the patient’s notes. The dose corresponds with the body surface area measurements. The drug is to be administered by the route intended. The drug is to be administered in the correct sequence as prescribed. The drug will not expire before administration is completed. Note: Pharmacy must be consulted in individual cases where there is a possibility that the drug may expire before administration is complete. The details on the prescription chart match with the patient’s identification bracelet. Any dose or schedule modification must be documented clearly, with reasons for changes, in the patient’s notes Note: If there are any discrepancies do not proceed and seek advice from a senior colleague or pharmacist. 8.3 The Use of Drug Delivery Devices Drug delivery devices used in the administration of systemic anti cancer treatment are infusion pumps and elastomeric devices. The manager of each clinical area is responsible for ensuring that: All chemotherapy nurses are trained and assessed as competent to operate any devices used to deliver systemic anti cancer treatment in an accurate and safe Version 4

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manner and that staff who have not undertaken specific training are aware that they must not use that item of equipment. The manager is also responsible for ensuring that records of staff training are maintained. The correct drug delivery is used for the correct purpose/regimen of treatment/task. Reporting any deterioration or change in the drug delivery device performance or condition, which leads them to suspect that the accuracy or precision of the device may be in question, Ensuring that the device is used in a suitable way, under proper operating conditions to make sure that accuracy is maintained. Ensuring that it is reported as a clinical adverse event in the event that the device is found to be out of calibration or not working as per manufacturer instructions if in use. All drug delivery devices are suitably controlled, maintained and calibrated, and that records of maintenance are kept.

8.4 Administration of Systemic Anticancer Treatment 8.4.1 INTRAVENOUS SYSTEMIC ANTICANCER TREATMENT

Administration of treatment MUST be stopped if: There is any doubt about the checks that have taken place The patient requests the treatment to stop The patient demonstrates side effects or complications, particularly signs of anaphylaxis or extravasation, The equipment fails to function properly, Using a peripheral cannula: Select an appropriate vein (avoiding use of the anti-cubital fossa) and place a waterproof and absorbent towel under the chosen limb. Cannulate the patient according to Trust guidance. Check the patency of the cannula in the following ways: o Acceptance of free flowing compatible infusion fluid o Gently applying negative pressure by pinching the infusion set and ensuring that a back flow of blood is observed o Lowering the bag of infusion fluid and ensuring that a back flow of blood is observed Ensuring that the site is not painful for the patient and that there is no evidence of redness or swelling at the infusion site. Version 4

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8.4.2 Using a central venous access device (PICC Line, Hickman Line): Access central venous access device ensuring that the ACN Guidelines for ‘The Insertion & Management of Peripherally Inserted Central Catheters (PICC) By Registered Nurses’ and the ACN Guidelines for ‘The Care & Management of SkinTunnelled Catheters (Hickman Lines) by Registered Nurses’, Trust Guidelines for Administration of Intravenous Drugs are followed. 8.4.3 Bolus intravenous anticancer treatment: Either by using the injection port of an infusion set or the B line of an Infusion Pump: Administer each syringe of drugs in the correct sequence as prescribed, Ensure that the treatment is administered at the correct rate ensuring the intravenous route is patent throughout the administration period by either using the methods as described above as a minimum every 5mls or by monitoring the pressure setting on the infusion pump and ensure that the cannula site is checked on a regular basis. Ensure the patient is aware to tell the administering nurse if they feel any pain or discomfort at the cannula site or distant to the cannula site throughout the administration period. After the administration of each drug ensure that the line is flushed with at least 20mls of a compatible infusion fluid. 8.4.4 Infusional intravenous anticancer treatment: Always change infusion bags at waist height using a plastic tray and a trolley to avoid contamination if the intravenous bag is accidentally punctured. Ensure the intravenous route is patent using the methods as described above throughout the infusion period. Ensure the drug is running to correct prescribed flow rate. If using an infusion pump, the rate, volume and pressure must be set and checked as per Trust Policy. Ensure the patient is aware to tell you if he feels pain or discomfort at the cannula site or distant to the cannula site throughout the administration period. If at any time redness, swelling or pain occurs around the infusion site whilst drugs are being administered, the administration/infusion should be stopped and the ACN Guidelines for the Management of Extravasation be initiated. After the administration of each drug ensure that the line is flushed with at least 20mls of a compatible infusion fluid. Version 4

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8.4.5 Continuous infusional anticancer treatment: Patient must have Central Venous Access Device insitu. Ensure that the correct Infusion Device is used as per pre-printed prescription. Ensure the drug is running to correct prescribed flow rate. If using an infusion pump, the rate, volume and pressure must be set and checked by the 2 nurses who have checked the drugs. All staff using infusion devices to be trained and assessed as competent to do so. Ensure that patient has been given instructions on the use of the infusion device and the action to be taken should any alarm or fault occur, including telephone contact information (ACN 24 Hour Telephone Advice Service for Patients) Reinforce side effects and discuss any possible problems that the patient may be experiencing. After the administration of each drug ensure that the line is flushed with at least 20mls of a compatible infusion fluid. At the end of treatment, remove the intravenous device, and cover with sterile gauze and apply digital pressure until bleeding stops, or flush central venous access device as per Network Guidelines. Apply an appropriate sterile dressing. 8.4.6 Vesicant Drugs

Vesicant drugs should be administered first if giving drugs in combination and it is ideal to administer vesicant drugs into a newly sited cannula, if this is not possible the member of staff must be confident that the cannula is patent before proceeding with any infusion of treatment. For Adults only - VINCA ALKALOID DRUGS MUST BE administered in a 50ml mini infusion bag of Sodium Chloride 0.9% via a free flowing infusion over 5 -10 minutes as prescribed. The nurse MUST stay with the patient and observe the cannula site throughout the infusion (NPSA/2008/RRR04). 8.4.7 Administration of Intramuscular Anticancer Treatment: (VESICANT DRUGS MUST NEVER BE ADMINISTERED VIA THIS ROUTE) Only volumes of less than 3mls are recommended to be administered via the intramuscular route.

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Platelets must be checked prior to administration and should usually be >50x109/L for an intramuscular injection. Attach a 23 gauge needle to the syringe containing the anti cancer treatment. Clean muscle area using a chloraprep wand. Administer drug using a z-track technique. Rotate sites of administration to prevent local irritation. 8.4.8 Administration of Sub-Cutaneous Anticancer Treatment: (VESICANT DRUGS MUST NEVER BE ADMINISTERED VIA THIS ROUTE) Only volumes of less than 3mls are recommended to be administered via the sub-cutaneous route. Platelets must be checked prior to administration. Attach a 23 gauge needle to the syringe containing the anti cancer treatment. Clean subcutaneous tissue using a chloraprep wand. Administer drug into the subcutaneous tissue as per manufacturer’s instructions. Rotate sites of administration to prevent local irritation. 8.4.9 Administration of Oral Systemic Anticancer Treatment: Nurses dispensing tablets must use a no-touch technique. Gloves must be worn if touching is unavoidable. Hands must be washed thoroughly before and after administration. Patient must swallow tablets or capsules whole do not crush tablets or break open capsules. If crushing/breaking open tablets/capsules are essential, advice must be sought from pharmacy. Do not use any tablets or capsules if there is any loose powder or liquid present in the container – inform pharmacy and request a replacement. If a tablet is dropped it should be placed in a bag and returned in original box to hospital at their next visit. Ensure that both members of staff (one who has checked the drugs and one who has administered the relevant drug) have signed the systemic anticancer treatment prescription to record that the drug(s) have been administered; and completed the relevant documentation. Version 4

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9.0 Extravasation of Systemic Anti Cancer Treatment Many systemic anticancer agents have an irritant, vesicant or allergenic action and cause local damage to skin and mucous membranes. For many anticancer drugs, extravasation (injection into extra-vascular tissue) can have serious consequences with permanent tissue damage, regardless of the efforts made to rescue the situation. Every effort must be made to prevent this occurring during the administration of systemic anticancer treatments. Please refer to the separate Arden Cancer Network Guidelines for the Management of Extravasation. 10.0 Minimising Wastage In order to minimise wastage, unused prepared treatment that is no longer required must be returned to the Pharmacy Aseptic Unit the same day: To ensure safe and proper storage conditions. To maximise the potential for re-issue by the Aseptic Unit. The original outer wrap must not be opened. The aseptic laboratory must be informed of the reason(s) for return. It must be returned to pharmacy in the identified containers designated for the safe transport of systemic anti cancer treatment and labelled “Cytotoxic” following the same procedure for transporting systemic anti cancer treatment from pharmacy. 11.0 Risk Assessment and Management 11.1 Risk Assessment Risk assessments must be carried out in conjunction with local Trust policies and procedures and updated annually. A designated person in each Trust who has been trained in risk assessment techniques must, in areas where systemic anti cancer treatments are used, assess the risks and take suitable precautions necessary (HSE MISC615). 11.2 Risk Management An incident/adverse event form must be completed in the event of any near miss, error or extravasation injury. Where appropriate, this must include an agreed action plan which is implemented and evaluated. Information relating to these must be collated by a designated individual within each Trust (appendix A) and discussed/minuted at the local chemotherapy group. On a quarterly basis errors relating to systemic anticancer treatments, from each individual Trust will be discussed and minuted at the Network Nurses & Pharmacists Group and a anonymised summary will be presented to the Network Chemotherapy Cross Cutting Group, this will include details of the error in question and the agreed actions and follow-up. Version 4

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12.0 Safe handling of Systemic Anti Cancer Treatment 12.1 Health Surveillance The results of the risk assessment for staff potentially exposed to systemic anti cancer treatment should be used to determine whether health surveillance is necessary. Where this has shown that exposure is most unlikely to result in any disease or adverse health effect, health surveillance is not required. In practice, the criteria for health surveillance are unlikely to be met for employees handling systemic anti cancer treatment. However, it is recommended that employers keep a health record on all staff potentially exposed to these compounds. The health record should contain at least the following: surname, forenames, gender, date of birth, permanent address and post code, National Insurance Number, date when present employment started and a historical record of jobs in this employment involving exposure to systemic anticancer treatment (HSE MISC615). 12.2 Pregnant Staff and Nursing Mothers Employers must identify hazards within each clinical area where systemic anti cancer treatment administration occurs as there is a potential health and safety risk to new and expectant mothers (HSG122). The Line Manager/Lead Chemotherapy Nurse is responsible for undertaking the risk assessment. Systemic anti cancer treatments have mutagenic, teratogenic and carcinogenic properties, however the associated risk to administrators is unclear (Conrad 2002, National Institute for Occupational Safety and Health 2004). As pregnancies are often unplanned or unknown for several weeks the emphasis must therefore be to ensure safe practice at all times for all staff (Marc guidelines 2005). Although there is no conclusive proof that foetal damage occurs when pregnant staff handle cytotoxic drugs, pregnant women or women breast feeding should be advised of potential risks associated with handling systemic anti cancer treatment and given the opportunity to refrain from preparing or administering these agents (RCN 2003). This should be discussed and documented with the line manager. Note: Staff are encouraged to discuss any issues relating to pregnancy or breastfeeding with their line manager and Occupational Health.

13.0 Minimising Exposure Each Trust must undertake a COSHH assessment. This assessment will detail how to minimise exposure. This includes: Adopting safe handling techniques Wearing protective equipment when dealing with systemic anti cancer treatment particularly in the handling of syringes, infusion bags, infusion devices and infusion tubing containing systemic anti cancer treatments (Wilkes, Ingwersen, Barton-Burke 2002). 13.1 Handling Vomit and Excreta Version 4

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In addition to the risk of carrying bacteria or viruses, blood, vomit and excreta of patients receiving systemic anti cancer treatment may contain measurable levels of cytotoxic drugs and their metabolites. Staff must wear well fitting latex or nitrile gloves and waterproof aprons when dealing with vomit, urine or stools. Hands must be washed thoroughly afterwards. Disposable bedpans, urinals and vomit bowls must be used or these items be double sluiced.

14.0 Management of Accidental Anti Cancer Treatment Contamination and/or Spillage - See Appendix E A clinical incident/adverse event form must be completed for all incidents involving accidental contamination and/or spillage. The report should include the: Nature of spillage. Where and when it occurred. Drug(s) involved its form and approximate quantity. Any contamination of patients/staff/visitors. Staff involved in cleaning operation. Basic spillage kits must be available in all areas where systemic anticancer treatment is administered. These kits are available from pharmacy. Spillages must be dealt with as soon as possible by the staff member responsible. Everyone else must be kept away from the area of contamination. Spillage must be dealt with by an individual trained in the management of anticancer treatment waste and must never be delegated to untrained or domestic staff. Appendix E includes the contents of a suggested basic spillage kit and appendix five the action required in the event of a spillage. .

15.0 Accidental Contact with Systemic Anti Cancer Treatment In all situations/circumstances pharmacy must be contacted for advice on specific antidotes. Medical advice must also be sought and the area examined by a doctor. The incident should be reported to the Occupational Health Department and an incident/accident form completed. During out of hours, the on-call site co-ordinator must be informed and the employee must report to Accident and Emergency. Occupational health must be informed as soon as possible. Any staff experiencing accidental exposure to cytotoxic drug through spillage, spraying, or needle stick must: Seek immediate medical attention in person or through their line manager from Occupational Health. All incidents of accidental exposure to Systemic Anti Cancer substances must be telephoned to the Heath & Safety Office (out of hours a voicemail message should be left) The incident must be reported to Occupational Health. A clinical incident form must be completed. 15.1 Needle Stick Injury Version 4

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Squeeze the area to make it bleed and hold under running water, consult medical staff/occupational health for further treatment. Follow local Trust policy on needle stick injuries. 15.2 Body Fluids/Excreta Body fluids including blood of patients who are/have recently received systemic anti cancer treatments may contain potentially hazardous amounts of drug, or their active metabolites. These are mostly eliminated by renal or faecal excretion. Excreta from patients receiving systemic anti cancer treatment should be assumed hazardous for at least 48 hours after completion of treatment (Wilkes, Ingwersen, Barton-Burke 2002). 15.2.1 Recommended Precautions Patients must be informed of the risk of exposure. Protective clothing (latex gloves/plastic apron) must be worn by staff dealing with blood, vomit, urine and faeces from patients who have received systemic anti cancer drugs within the last 48 hours (Wilkes, Ingwersen, Barton-Burke 2002). All protective clothing must be treated as hazardous and disposed of accordingly. Double sluicing of bedpans, vomit bowls and other items contaminated with waste materials must be carried out. 16.0 Disposal of Anticancer Treatment Waste from Wards and Clinics The Hazardous Waste Regulations 2005 prohibit the mixing of different types of waste with non-hazardous and other clinical waste, therefore all anticancer treatment waste must be disposed of in a designated cytotoxic waste container (HMSO 2005) Potentially hazardous equipment includes: Sharps (vials, ampoules, needles). Syringes. Infusion sets and bags. Protective clothing. 16.1 Unused Injections or Infusions These must be returned to pharmacy immediately for disposal or re-issue. The original packaging should not be opened. 16.2 Completed Infusions Upon completion of the infusion, the roller clamp must be closed and the administration set should remain attached to the empty infusion bag and be disposed within the designated cytotoxic container. 16.3 Incomplete Infusions All part-used infusions should be placed in a designated cytotoxic sharps bin. The bin should be sealed, labelled and disposed of in the same manner as all systemic anticancer waste. Version 4

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16.4 Protective Equipment, Syringes or Other Items in Contact with Anticancer Treatment All anticancer treatment waste should be separated from other clinical waste (HMSO 2005). Disposable items must be treated as clinical waste and disposed of according to individual Trust policies. All sharp items must be placed in ‘Designated Cytotoxic Sharps’ boxes and disposed of according to individual Trust ‘sharp’ policies. 16.5 Non-disposable Items All non-disposable items – eye protection, trolleys etc. must be washed using hot soapy water and dried thoroughly whilst wearing protective gloves and apron.

17.0 Consultation and Communication Process The consultation process involves dissemination of draft documents for comment to: the Arden Cancer Network Drugs and Therapeutics Committee, consultant haematologists, oncologists and haematology/oncology specialist nurses, ward managers and pharmacists at George Eliot Hospital, South Warwickshire NHS Foundation Trust, University Hospitals Coventry and Warwickshire and Worcestershire Acute Hospitals NHS Trust. 18.0 Equality Impact Assessment See Appendix F. 19.0 Review and Revision Arrangements including Version Control The Chair of the Arden Cancer Network Chemotherapy Group will nominate an individual to undertake a review of the guidance 3 months prior to the revision date. 20.0 Dissemination and Implementation Once documents are ratified, notification will be sent by email to the lead chemotherapy clinician, nurse and pharmacist for each Trust. It will be their responsibility to disseminate and implement the protocol locally. The final version of documents will be placed on the Arden Cancer Network intranet and each individual Trust’s intranet via a designated lead for each Trust. Hard copies will not be circulated. It will be the responsibility of departmental managers to remove outdated copies and to ensure staff are aware of the new version. It is the responsibility of departmental managers to implement any identified training or support. (Appendix G).

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21.0 References Barton-Burke M, Wilkes GM, Ingwerson K (2001) Cancer Chemotherapy (3 rd Edition), Sudbury, Jones and Bartlett Bromley Hospitals NHS Trust (2002) The Safe Prescribing and Handling of Cytotoxic Drugs, London, Bromley Hospitals NHS Trust Conrad W (2002) Draft Guidance: Occupational Health Management of New and Expectant Mothers Employed in the National Health Service. Available from www.anhops.com, accessed 03.07.2006 Control of Substances Hazardous to Health (2002) Control of Substances Hazardous to Health, London, Stationary Office Control of Substances Hazardous to Health (multiple manufacturers) Department of Health (2008) Updated National Guidance on the Safe Administration of Intrathecal Chemotherapy London, Department of Health HSC 2003/001 Department of Health (2004) Manual for Cancer Services, London, DH Health and Safety Executive (2003) Safe Handling of Cytotoxic Drugs – HSE Information Sheet MISC615 09/03, London, HSE Books Health and Safety Executive (2002) New and Expectant Mothers at Work. 2nd Edition, London, HSE Books

HSG 122,

Her Majesties Stationary Office (2005) Statutory Instrument 2005 No. 894 The Hazardous Waste (England and Wales) Regulations 2005 London, HMSO Marc Guidelines (2005) Pregnancy in staff handling cytotoxics, version 2, available from www.marcguidelines.com, accessed 03.07.2006 MARCH panel (Graham Sewell) (June 2007a) MARCH guideline: Spillages: management and containment. MARCH panel (Graham Sewell) (June 2007b) MARCH guideline: Personal protective equipment (PPE): selection and use. National Patient Safety Agency (2008) Rapid Response Report – Risks of incorrect dosing of oral anticancer medicines National Patient Safety Agency (NPSA/2008/RRR001)

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National Patient Safety Agency (2008) Rapid Response Report – Using Vinca Alkaloid Minibags (Adult/Adolescent Units (NPSA/2008/RRR004) Royal College of Nursing (2003) Standards for Infusion Therapy, London, RCN Royal College of Nursing (1998) The Administration of Cytotoxic Chemotherapy, London, RCN Wilkes GM, Ingwersen K, Barton-Burke M, (2002) Oncology Nursing Drug Handbook, Sudbury, Jones and Bartlett

22.0 Document Circulation Name Dr Jag Gandla Elaine Watkins Melanie Taylor* Stephanie Cooke Fay Lanham Sue Sharpe

Ann Sullivan

Glenis Adams Dr Anton Borg Carole Connor* Nicola Evans Dr Lydia Fresco

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Title Lead Chemotherapy Clinician Lead Chemotherapy Nurse Lead Chemotherapy Pharmacist Lead Chemotherapy Pharmacist Chemotherapy Unit Manager Macmillan Chemotherapy/Radiot herapy Project Nurse Cancer services Manager/Lead Cancer Nurse Lead Chemotherapy Nurse Lead Chemotherapy Clinician Head of Chemotherapy Lead Chemotherapy Pharmacist Lead Chemotherapy Clinician

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Trust George Eliot Hospitals NHS Trust

Worcestershire Acute Hospitals NHS Trust

Dates Circulated 21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12

South Warwickshire NHS Foundation Trust University Hospitals

21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12

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Dr Beth Harrison**

Dr Clive Irwin

Sue Robinson Sam Neale* Stephanie Connell***

Chair of the Haematology Network Site Specific Group Chair of Arden Cancer Network Chemotherapy Group Lead Pharmacist Cancer Services Lead Chemotherapy Nurse Cancer Services Redesign Manager

Coventry and Warwickshire NHS Trust

21/02/12 13/3/12

21/02/12 13/3/12

Arden Cancer Network

21/02/12 13/3/12 21/02/12 13/3/12 21/02/12 13/3/12

*Responsible for circulating to relevant staff within their Trust including clinical nurse specialists, oncologists and ward managers. **Responsible for circulating to Haematology Network Site Specific Group Members ***Responsible for circulating to Network Chemotherapy Cross Cutting Group

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Appendix A Lead Individuals for Organisation and Delivery of Chemotherapy Services Alexandra Hospital

Head of service, lead nurse and lead pharmacist responsible for the organisation and delivery of chemotherapy services

Named lead chemotherapy nurse responsible for training, and maintaining the register of nursing staff who have attended training and are competent to administer chemotherapy Named lead pharmacist responsible for training and maintaining a register of pharmacy staff who have attended specific training

South Warwickshire NHS Foundation Trust Head of service Head of service

University Hospitals Coventry and Warwickshire

Dr Jag Gandla

Dr Anton Borg

Dr Jane Worlding

Lead nurse

Lead nurse

Lead nurse

Lead nurse

Fay Lanham ? Glenis Adams Lead Pharmacist

Elaine Watkins

Carole Connor

Sam Neale

Lead Pharmacist

Lead Pharmacist

Lead Pharmacist

Stephanie Cook

Melanie Taylor

Nicola Evans

Sue Robinson

Glenis Adams

Elaine Watkins

Carole Connor

Sam Neale

Stephanie Cook

Melanie Taylor

Nicola Evans

Sue Robinson

Fay Lanham

Elaine Watkins

Carole Connor

Sam Neale

Worcestershire Chemotherapy Group

Chemotherapy Group

Chemotherapy Forum

UHCW NHS Trust Chemotherapy Action Group

Head of service To be confirmed

George Eliot Hospital NHS Trust

Head of service

Responsibility for risk management

Name of Chemotherapy Group within each Trust

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Appendix B Designated Clinical Areas for the Administration of Intravenous Chemotherapy for Malignant Conditions

Alexandra Hospital George Eliot Hospital NHS Trust

South Warwickshire NHS Foundation Trust

University Hospitals Coventry and Warwickshire

Garden Suite

Outpatients D

Intensive Care Unit

Ward 34

Outpatients Department (oral)

Intensive Care Unit

The Aylesford Unit

Haematology Day unit

Outpatients Department (oral)

Outpatients Department (oral)

Outpatients Department (oral) Ward 35 Arden Cancer Centre Chemotherapy Suite Clinical Trials Centre Paediatric Unit Ward 16 Surgical Day Unit Intensive Care Units

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Appendix C Working Hours of each Designated Clinical Chemotherapy Treatment Area

Trust

Designated Clinical Chemotherapy Area Alexandra Hospital Garden Suite

Hours of Opening

Days of the Week Monday - Friday Monday – Friday

Outpatients (Oral)

Monday – Friday

George Eliot NHS Outpatients D Trust Intensive Care Unit

7 days per week

Outpatients (Oral)

Monday – Friday

UHCW NHS Trust Ward 34

24 hours per day

7 days per week

Ward 35

24 hours per day

7 days per week

Arden Cancer

8am – 5pm

Monday – Friday

Centre

(occasional Bank

Chemotherapy Suite Haematology Day

Holidays) 9am – 5pm

Unit

Monday – Friday (occasional Bank Holidays)

Clinical Trials Centre 8am – 5pm

Monday – Friday

Paediatric Unit –

24 hours per day

7 days per week

Surgical Day Unit

8am – 5pm

Monday – Friday

Intensive Care Unit

24 hours per day

Outpatients (Oral)

9am – 5pm

Ward 16

Monday – Friday

South The Aylesford Unit Warwickshire Foundation Trust Intensive Care Unit Outpatients (Oral)

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Appendix D Algorithm for Checking Chemotherapy Prescriptions - A Guide to Responsibility Primary Responsibility D

Choice of Protocol

Ultimate Responsibility D

N

Height and Weight Patient

N

N,P,D, SP

Calculate Body Surface Area

P

N,P,D, SP

Check Doses with Respect to Protocol/Proforma

P

N,P,D, SP

Baseline FBC, U&E and LFT’s, plus any other additional critical tests as per individual regimen.

D

N,P,D, SP

EDTA/Creatinine Clearance & Additional Specified Tests

D

N,P,D, SP

History of toxicities, complications from previous cycles/Drug Induced Dosage Reduction

D

The minimum monitoring requirements by physical examination and by investigation are being met N,P,D,SP

Is Chemotherapy Prescribed?

D

N,D

Has the Patient Suitable Venous Access?

N

N,P,D

Course Number & Lifetime Cumulative Dose (if applicable)

D

N,P,D

Check Sequence & Timing of Regimen (*see note)

P

N,P,D

Check Appropriate Day/Week of Regimen

N

N,P,D

Check Pharmaceutical Stability

P

N,P,D

Check Appropriate Dilution & Rate of Administration

N

N,P,D

N,D

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Check that supportive drugs have been given as per protocol: Hydration Antiemetics Adjuvant Treatments Interactions Mouth care, eye care regimens etc Check that peripheral blood stem cells/bone marrow rescue is available prior to administration of chemotherapy (If applicable)

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D

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** 1. Give in order: Hydration Antiemetics Bolus injection Infusions

2. Peripheral Administration Give vesicant drugs first

3. Oral drugs to have stop date indicated

Administration route and duration Key: N=Nurses, P=Pharmacists, D=Doctors, SP=Supplementary Prescribers/Nurse Independent Prescribers

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Appendix E Suggested Contents of the Basic Spillage Kit These items must form the contents of a basic spillage kit. However clinical areas must adapts these to meet the potential needs of staff/patients should a spillage occur ITEM

QUANTITY

Filtered face piece respirator (FFP2 or FFP3)

1

Blue Roll (absorbent paper)

1

Absorbent pad (50x40cm)

2

Nitrile gloves (non sterile) (large)

4

Chemoprotect gown (codan)

1

Overshoes

4

Safety glasses (BS EN 166)

1

Plastic tweezers

1

Plastic aprons

2

Armlets

4

Cytotoxic waste bag (yellow and purple)

2

Black bag ties

2

Sodium Bicarbonate 8.4% 250 ml (where

2

mitomycin used) Bottle sterile water 1 litre

1

Cytotoxic spillage sign

1

Spillage instructions

1

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Appendix F Action to be taken in the Event of a Cytotoxic Spillage in Clinical Areas GENERAL POINTS Do not delegate cleaning of a spill to domestic staff. After using a spill kit contact the pharmacy department or pharmacist on call as soon as possible for a replacement. COSHH data sheets for all cytotoxic products are held within pharmacy departments at each Trust. NOTE there is currently no evidence to support the use of specific decontamination agents to denature cytotoxic drugs.

LIQUID SPILL 1. 2. 3. 4. 5. 6.

Call for assistance and warn others Cordon off the area to avoid spreading DO NOT LEAVE THE SPILL UNGUARDED. Obtain the cytotoxic spillage kit. Put the cytotoxic spill sign in place to warn others. From the kit put on:Respirator mask Two pairs of nitrile gloves Goggles Overshoes Chemoprotect gown 7. Soak up the spill using blue roll for small spills OR absorbent pad for large spills by working from the outside of the spill to the inside the spill, placing the blue roll or pad gently over the spill to avoid splashing. 8. Pick up any broken or sharp material with tweezers. 9. Place the blue roll or pad and any sharp material in the cytotoxic waste container. 10. Using blue roll, clean the spill area with detergent and water at least three times. Use a new section of blue roll for each clean and place into the cytotoxic waste container. 11. Treat all waste and personal protective equipment used as cytotoxic. 12. Place all waste into cytotoxic waste container or cytotoxic waste bag. 13. Complete printed label section details on waste bag or waste container used. 14. Use black bag ties to seal waste bag. 15. Decontaminate hands thoroughly. 16. Dispose of waste following normal cytotoxic waste procedures. 17. Complete the incident form include all standard information required and also Drug spilt Approximate volume

SPILLAGE ON BED LINEN Put all contaminated bed linen into a cytotoxic waste bag. Complete printed label section details on waste bag. Use black bag ties to seal waste bag. Dispose of waste following normal cytotoxic waste procedures. Complete an incident form including: Drug spilt Approximate volume Version 4

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SPILLAGE ON CLOTHES Change immediately from contaminated clothes Put all contaminated clothes into a cytotoxic waste bag. Complete printed label section details on waste bag. Use black bag ties to seal waste bag. Dispose of waste following normal cytotoxic waste procedures. (If this is not possible, the clothes must we washed several times with copious amounts of hot soapy water.) Complete an incident form including: Drug spilt Approximate volume

SKIN CONTAMINATION MITOMYCIN- Rinse the skin thoroughly with copious amounts of Sodium Bicarbonate 8.4%solution followed by copious amounts of soap and water. ALL OTHER CYTOTOXIC PRODUCTS- Rinse thoroughly with copious amounts of water for 15minutes. Seek medical advice if irritation occurs. Complete an incident form including Drug involved For hospital staff, contact the occupational health department.

EYE CONTAMINATION MITOMYCIN- Rinse the eye thoroughly with copious amounts of Sodium Bicarbonate 8.4%solution holding the eye open. ALL OTHER CYTOTOXIC PRODUCTS- Rinse thoroughly with copious amounts of water for 15minutes, holding the eye open. Seek medical advice immediately. Complete and incident form including Drug involved For hospital staff, contact the occupational health department

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Appendix G - Equality Impact Assessment Tool Yes/No

Comments

1. Does the document/guidance affect one group less or more favourably than another on the basis of: Race

No

Ethnic origins (including gypsies and travellers)

No

Nationality

No

Gender

No

Culture

No

Religion or belief

No

Sexual orientation including lesbian, gay and bisexual people

No

Age

No

Disability - learning disabilities, physical disability, sensory No impairment and mental health problems 2. Is there any evidence that some groups are affected No differently? 3. If you have identified potential discrimination, are there No any exceptions valid, legal and/or justifiable? 4. Is the impact of the document/guidance likely to be No negative? 5. If so, can the impact be avoided? 6. What alternative is there to document/guidance without the impact?

N/A achieving

7. Can we reduce the impact by taking different action?

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Appendix H - Plan for Dissemination of Procedural Documents Policy for the Management of Systemic Anti Cancer Treatment for Adult Patients

Title of document:

Dissemination lead:

Date finalized: Previous document already being used?

Sam Neale – Lead Chemotherapy Advanced Nurse Practitioner, UHCW NHS Trust

Yes

If yes, in what format and where? Proposed action to retrieve out of date copies of the document: To be disseminated to:

How will it be disseminated, who will do it and when?

Stephanie Connell – Arden Cancer Network

To inform all areas that Electronic revised network wide electronic version available on Trusts intranet and Arden Cancer network site with 7 days of receipt

Elaine Watkins – Acting Lead Cancer Nurse – George Eliot Hospitals NHS Trust Carole Connor –Nurse Consultant - South Warwickshire NHS Foundation Trust

Format (i.e. paper or electronic)

Comments:

Sent by email

Sam Neale – Lead Chemotherapy Nurse – University Hospitals Coventry and Warwickshire NHS Trust

Dissemination Record - to be used once document is approved Date put on register / library of procedural documents:

Date due to be reviewed:

Disseminated to: Format Date (either directly or (i.e. paper Disseminated: via meetings, or etc.) electronic) Directly

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No. of Copies Sent:

Contact Details / Comments:

One

Sam Neale – Lead Chemotherapy Nurse – Arden Cancer Network

Electronic

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