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Chemotherapy Policy - Ipswich Hospital

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<strong>Chemotherapy</strong><br />

<strong>Policy</strong><br />

Version 3.0<br />

Purpose:<br />

For use by:<br />

This document is compliant with<br />

/supports compliance with:<br />

To safeguard patients and staff by defining best practice for all<br />

disciplines involved in chemotherapy<br />

All staff involved in the prescription, dispensing, administration &<br />

disposal of anti-cancer cytotoxic drugs<br />

Care Quality Commission, Essential Standards of Quality and Safety<br />

(2009), Outcome 9<br />

NHS Litigation Authority Standards<br />

This document supersedes: <strong>Chemotherapy</strong> <strong>Policy</strong> Version 2, Registered Document 524<br />

Approved by:<br />

Medicines Management Committee<br />

Approval date: 28 October 2011<br />

Ratified by<br />

Patient Safety Committee<br />

Date Ratified 21 November 2011<br />

Implementation date: 1 December 2011<br />

Review date 1 November 2014<br />

In case of queries contact:<br />

Responsible Officer<br />

Business Unit and Department<br />

Archive Date ie date document no<br />

longer in force<br />

Date document to be destroyed: ie 10<br />

years after archive date<br />

Head Matron BU7 Ext 6954 / Bleep 606<br />

Clinical Support Services & Cancer, Oncology & Haematology/<br />

Pharmacy<br />

To be inserted by Information Governance Department when this<br />

document is superseded. This will be the same date as the<br />

implementation date of the new document.<br />

To be inserted by Information Governance Department when this<br />

document is superseded.<br />

Registered Document 1005 Page 1 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


Version and document control:<br />

Version<br />

number<br />

Date of<br />

issue<br />

Change Description<br />

2.1<br />

Section Change/update<br />

1.1<br />

Oct 11 1.3<br />

3.1<br />

3.2<br />

3.2<br />

3.2<br />

3.3<br />

3.12<br />

3.2<br />

3.2<br />

3.3<br />

3.12<br />

3.12<br />

3.12<br />

3.12<br />

3.12<br />

3.14<br />

4.1<br />

4.1<br />

Dates updated, intravenous added<br />

PTC – Primary Treatment Centre added to definitions<br />

Consent in child health added<br />

Treatment plan copy in medical notes removed<br />

Paediatric prescribing added<br />

Text corrected<br />

Oncology/Haematology notes instead of Medical notes<br />

Prescriber responsible for : completing treatment plan with<br />

details<br />

The development of new or amendments to existing protocols<br />

and associated documents will be approved by QUAD,<br />

detailed in work instruction<br />

Deviation from protocol section rewritten<br />

Changes made to reflect paediatrics, specify Boxford<br />

Assessment Unit as are to administer chemo. Sentence to<br />

specify where teenage & young adults receive chemo<br />

Double checking of chemo – checker must have completed<br />

modules 1-4 of Anglia Cancer Network education package<br />

Addition of „e.g. holistic assessment‟ to final bullet point<br />

Added „IV‟ to bullet point 1<br />

Refer to Trust Identification (wristband) <strong>Policy</strong><br />

Nurse responsibilities: Add history of toxicities and<br />

complications is documented<br />

Paragraph added for paediatrics re out of hours initiation and<br />

administration of chemo<br />

To update training and education requirements for paediatric<br />

nurses<br />

Training section updated in line with new Anglia Network<br />

<strong>Chemotherapy</strong> Core Education Package<br />

Author<br />

G Heard<br />

This is a Controlled Document<br />

Printed copies of this document may not be up to date.<br />

intranet for the latest version, destroy all previous versions.<br />

Please check the Trust<br />

Trust documents may be disclosed as required by the Freedom of Information Act 2000.<br />

Details about sharing this document with third parties are contained in Section 6 of this<br />

document.<br />

As part of the hospital‟s networking arrangements and sharing best practice, the hospital<br />

supports the practice of sharing documents with other organisations. However, where the<br />

hospital holds copyright to a document, the document or part thereof so shared must not be<br />

used by any third party for its own commercial gain unless this hospital has given its express<br />

permission and is entitled to charge a fee.<br />

Release of any strategy, policy, procedure, guideline or other such material must be agreed<br />

with the Lead Director or Deputy/Associate Director (for hospital -wide issues) or Business<br />

Unit/ Departmental Management Team (for Business Unit or Departmental specific issues).<br />

Any requests to share this document must be directed in the first instance to the Head<br />

Matron, Oncology/Haematology.<br />

Registered Document 1005 Page 2 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


CHEMOTHERAPY POLICY<br />

Summary<br />

The policy is intended to safeguard patients and staff, by defining best practice for<br />

all disciplines involved in the process of chemotherapy treatment.<br />

The prescribing of chemotherapy including the responsibilities of the prescriber,<br />

authorization of protocols and the details required on the prescription are stated within<br />

the policy.<br />

All parenteral cytotoxic medicines will be dispensed by pharmacy and issued under the<br />

supervision of an appropriately accredited pharmacist.<br />

Vinca alkaloids will be dispensed in accordance with NPSA Rapid Response Report<br />

004.<br />

All healthcare personnel who may be involved in the handling of cytotoxic drugs must be<br />

aware of the requirements for health and safety. The policy details the requirement for<br />

personal protection and action to be taken in the event of spillage.<br />

Only nurses or doctors, who have received appropriate training and have been assessed<br />

as competent, may administer systemic anti cancer therapy chemotherapy drugs. This<br />

should only be given within the Woolverstone Day Unit, <strong>Chemotherapy</strong> outreach clinics,<br />

Somersham Ward and the Paediatric department.<br />

The details with regard to bolus and infusional administration must be followed in all<br />

clinical areas to minimise any potential risk to the patient.<br />

Extravasation is a major risk when administering chemotherapy. The details contained<br />

in the policy must be followed and appropriate records completed.<br />

The prescribing and dispensing of oral anti-cancer chemotherapy must be carried out<br />

and monitored to the same standards as those for injectable therapy.<br />

(NPSA/2008/RRR001). All oral anti-cancer medicines must be prescribed in the context<br />

of a written protocol and treatment plan using an approved proforma and a copy filed in<br />

the medical notes.<br />

Prescriptions for oral chemotherapy drugs for oncology or haematology patients must<br />

state clearly for each course of treatment the dose, frequency of administration, intended<br />

start date, duration of treatment and where relevant the intended stop date.<br />

An appropriately trained and accredited pharmacist must screen all prescriptions before<br />

dispensing. All pharmacy staff who are, or could be, involved with dispensing oral<br />

anticancer drugs must have access to full copies of the relevant protocols.<br />

If a patient, member of staff or visitor is involved in a spillage of cytotoxic drugs or<br />

potentially contaminated patient waste the detailed procedures contained within the<br />

policy must be followed.<br />

This policy describes the competency and training requirements for Oncology &<br />

Haematology Nursing staff. Other directorates should use the policy to determine the<br />

level of competence required within their specialty.<br />

Registered Document 1005 Page 3 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


Contents<br />

1.1 <strong>Policy</strong> Statement and Rationale ................................................................................... 6<br />

1.2 Key Principles .............................................................................................................. 6<br />

1.3 Definitions .................................................................................................................... 7<br />

SECTION 2 – DUTIES AND RESPONSIBILITIES ................................................................. 7<br />

2.1 Senior Managers ......................................................................................................... 7<br />

2.2 Department Managers ................................................................................................. 7<br />

2.3 Employees ................................................................................................................... 8<br />

SECTION 3 – CHEMOTHERAPY POLICY ............................................................................ 8<br />

3.1 Consent for treatment (Oncology/haematology department) ........................................ 8<br />

3.2 Prescribing .................................................................................................................. 9<br />

3.3 Deviation from treatment algorithms and regimen protocols ...................................... 11<br />

3.4 Purchasing, Receipt and Storage in Pharmacy .......................................................... 12<br />

3.5 Screening and dispensing of prescriptions by pharmacy ........................................... 12<br />

3.6 Preparation and Dispensing ....................................................................................... 13<br />

3.7 Supply of Cytotoxic drugs .......................................................................................... 14<br />

3.8 Transportation ........................................................................................................... 16<br />

3.9 Storage in clinical areas ............................................................................................. 16<br />

3.10 Health and Safety ...................................................................................................... 16<br />

3.11 Venous Access .......................................................................................................... 18<br />

3.12 Administration ............................................................................................................ 19<br />

3.12.1 Administration of Intravenous <strong>Chemotherapy</strong> ..................................................22<br />

3.12.2 Intravenous infusional chemotherapy ..............................................................23<br />

3.12.3 Subcutaneous chemotherapy ..........................................................................24<br />

3.12.4 Intramuscular chemotherapy ...........................................................................25<br />

3.12.5 Intravesical administration ...............................................................................25<br />

3.12.6 Intrapleural administration Procedure ..............................................................27<br />

3.12.7 Intraperitoneal administration ..........................................................................28<br />

3.13 Extravasation ............................................................................................................. 29<br />

3.13.1 Diagnosis ........................................................................................................29<br />

3.13.2 Classification of cytotoxic drug ........................................................................30<br />

3.13.3 Intervention and Treatment .............................................................................33<br />

3.13.4 Hyaluronidase and saline flush out technique .................................................34<br />

3.13.5 Vesicant anthracycline extravasation and dexrazoxane ..................................34<br />

3.13.6 Plastic surgeon review ....................................................................................35<br />

3.13.7 Follow up care .................................................................................................35<br />

3.13.8 Documentation ................................................................................................35<br />

3.14 Out-of-hours initiation and administration of chemotherapy ....................................... 36<br />

3.15 Ambulatory and home chemotherapy treatment ........................................................ 36<br />

3.16 Oral chemotherapy preparations ................................................................................ 37<br />

3.16.1 Principles ........................................................................................................37<br />

3.16.2 Prescribing and administration of oral cytotoxic medication in non-oncology<br />

areas 40<br />

Registered Document 1005 Page 4 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


3.17 Disposal of cytotoxic waste ........................................................................................ 41<br />

3.17.1 Part used doses ..............................................................................................41<br />

3.17.2 Used disposal equipment ................................................................................41<br />

3.17.3 Patient Waste ..................................................................................................42<br />

3.18 Personal accidents and spillages ............................................................................... 42<br />

3.18.1 Skin contamination ..........................................................................................42<br />

3.18.2 Eye contamination ...........................................................................................43<br />

3.18.3 Needlestick injury ............................................................................................43<br />

3.18.4 Spillage ...........................................................................................................43<br />

SECTION 4 – TRAINING AND EDUCATION .......................................................................44<br />

4.1 Medical and Nursing Staff .......................................................................................... 44<br />

4.1.1 Oncology and Haematology Department .........................................................44<br />

4.1.2 Child Health ....................................................................................................45<br />

4.2 Pharmacy Staff .......................................................................................................... 45<br />

4.2.1 Handling ..........................................................................................................45<br />

4.2.2 Preparation .....................................................................................................46<br />

4.2.3 Clinical Screening of <strong>Chemotherapy</strong> Prescriptions ..........................................46<br />

4.2.4 Clinical screening and dispensing of Oral <strong>Chemotherapy</strong> Prescriptions ..........46<br />

4.3 Domestic Staff ........................................................................................................... 46<br />

4.4 Portering Staff ............................................................................................................ 46<br />

SECTION 5 – DEVELOPMENT AND IMPLEMENTATION INCLUDING DISSEMINATION ..46<br />

SECTION 6 – MONITORING COMPLIANCE AND EFFECTIVENESS .................................46<br />

SECTION 7 – CONTROL OF DOCUMENT INCLUDING ARCHIVING ARRANGEMENTS ..47<br />

SECTION 8 – SUPPORTING COMPLIANCE AND REFERENCES .....................................47<br />

Registered Document 1005 Page 5 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


SECTION 1 - INTRODUCTION<br />

1.1 <strong>Policy</strong> Statement and Rationale<br />

The <strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust is committed to ensuring the safe prescribing, handling,<br />

dispensing and administration of chemotherapy.<br />

Treatment with chemotherapy is often a complex process and concerns about safety and<br />

quality of chemotherapy services have been highlighted by the National <strong>Chemotherapy</strong><br />

Advisory Group report (Aug 2009) and a report of the National Confidential Enquiry into<br />

Patient Outcome and Death “For better or Worse” (Nov 2008). The Manual for Cancer<br />

Services (June 2011) sets out measures for clinical chemotherapy services and this policy is<br />

key to ensuring compliance with these measures.<br />

The handling and administration of cytotoxic drugs is potentially hazardous to both the health<br />

care professionals involved in their preparation and administration, and to the patients<br />

receiving them. While the risks to patients are, in the main, well documented and can be<br />

balanced against the clinical benefits, the risks to health care staff are largely theoretical. It<br />

is therefore prudent, with the present state of knowledge, to take every reasonable<br />

precaution to protect staff from unnecessary exposure. In addition the clinical use of these<br />

agents is not without patient safety risk and needs due diligence by all involved with their<br />

use.<br />

The policy aims to minimise these risks by promoting the safe prescribing and administration<br />

of chemotherapy and the safe handling of cytotoxic drugs. It should be read in conjunction<br />

with other relevant policies.<br />

The policy applies to the prescribing, preparation, dispensing and administration of all anticancer<br />

therapies used in the treatment of malignant disease in adult patients (with the<br />

exception of hormone treatments). Principally the guidance relates to systemic anti cancer<br />

therapy, however, the guidance regarding the storage, preparation, transportation, handling<br />

and administration of cytotoxic drugs applies across the Trust and regardless of the<br />

indication for use.<br />

It must be recognised that some intravenous and oral anti-cancer medicines are also used<br />

for non- cancer indications e.g. Methotrexate for rheumatoid arthritis, and pose similar risks<br />

to the patient.<br />

This document does not cover the practice of intrathecal chemotherapy. Please refer to The<br />

<strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust Intrathecal chemotherapy policy and national guidance.<br />

1.2 Key Principles<br />

This policy is intended to safeguard patients and staff, by defining best practice for<br />

all disciplines involved in the process of chemotherapy treatment.<br />

Systemic anti cancer therapy within the <strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust is provided by a<br />

multidisciplinary team in which doctors, specialist nurses and pharmacy staff work to<br />

approved protocols to provide integrated care both within the hospital and the<br />

community.<br />

If there is a clinical reason to deviate from this policy the rationale must be documented in<br />

the medical notes and signed by the relevant Consultant. The entry should be countersigned<br />

by the <strong>Chemotherapy</strong> lead, Principal Pharmacist for Oncology / Haematology and the lead<br />

Registered Document 1005 Page 6 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


chemotherapy nurse (or their deputies). Deviation from this policy should be reviewed every<br />

three months by the Head Matron and Principal Pharmacist and reported to the<br />

<strong>Chemotherapy</strong> Working Group and Cancer Network if required.<br />

1.3 Definitions<br />

Acronym Full Form<br />

AUC Area under (the) curve<br />

CNS Central Nervous System<br />

MHRA Medicines and Healthcare Products Regulatory Agency<br />

PIL Patient Information Leaflet<br />

QUAD Quality Assurance of Drugs<br />

TTA Drugs To Take Away<br />

COSHH Control of Substances Hazardous to Health<br />

IHNHST<br />

PTC<br />

<strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust<br />

Primary Treatment Centre<br />

PPE Personal Protective Equipment<br />

MDT Multidisciplinary Team<br />

BMI Body Mass Index<br />

NMC Nursing and Midwifery Council<br />

GFR Glomerular Filteration Rate<br />

GP General Practitioner<br />

DoH Department of Health<br />

SVC Superior Vena Cava<br />

UKCCSG UK Children‟s Cancer Study Group<br />

IV<br />

Intravenous<br />

CVAD Central Venous Access Device<br />

VIP Visual infusion phlebitis<br />

FY2 Foundation Year 2<br />

BCG Bacillus Calmette-Guerin<br />

MMC Medicines Management Committee<br />

POD Patient Own Drugs<br />

SECTION 2 – DUTIES AND RESPONSIBILITIES<br />

The duties & responsibilities of different staff groups in relation to the safe prescribing,<br />

administration and handling of chemotherapy is outlined below.<br />

2.1 Senior Managers<br />

Designate responsibility for the implementation and maintenance of local policies and<br />

policy for the safe administration of chemotherapy and the handling of cytotoxic drugs.<br />

Ensure that all managers and supervisory staff are familiar with, and adhere to the<br />

<strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust (IHNHST) chemotherapy policy.<br />

2.2 Department Managers<br />

Ensure that all relevant staff are fully familiar with the IHNHST <strong>Chemotherapy</strong> policy and<br />

the IHNHST Intrathecal chemotherapy policy, and that they are properly trained in, and<br />

comply with, all policies and procedures.<br />

If cytotoxic drugs are to be prescribed / administered in areas outside of the<br />

Woolverstone Wing department managers should ensure a risk assessment is<br />

undertaken and staff are competent to undertake the task.<br />

Registered Document 1005 Page 7 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


Ensure that staff that are pregnant, breastfeeding or trying to conceive, are not<br />

expected to be directly involved in the administration of cytotoxic drugs.<br />

Ensure that appropriate and properly maintained facilities and equipment are available to<br />

all staff handling cytotoxic drugs.<br />

Ensure that the service is reviewed against the current COSHH regulations with an<br />

authorised Trust COSHH advisor.<br />

2.3 Employees<br />

Ensure that all safety requirements according to the IHNHST <strong>Chemotherapy</strong> <strong>Policy</strong> are<br />

followed.<br />

Report all untoward incidents via the Trust risk management reporting system.<br />

Actively participate in training programmes provided.<br />

Inform managers if they are pregnant, breastfeeding or trying to conceive.<br />

SECTION 3 – CHEMOTHERAPY POLICY<br />

3.1 Consent for treatment (Oncology/haematology department)<br />

All staff should familiarise themselves with the <strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust<br />

Consent <strong>Policy</strong>, the Good Practice in Consent implementation guide (DOH 2001)<br />

and 12 Key Points on consent: the law in England (DOH 2001).<br />

Information given by all health care professionals, both verbal and written, should<br />

be documented in the Patient‟s notes and recorded on the consent form.<br />

All patients receiving chemotherapy should be fully informed of their treatment and must<br />

have given consent.<br />

Consent form 3 (where consciousness is not impaired) is used for consenting to<br />

chemotherapy within the Oncology and Haematology Directorate.<br />

A copy of the completed form should be kept with the chemotherapy chart until the<br />

course of chemotherapy, that the consent form relates to, is completed.<br />

The specific chemotherapy regimen should be documented on the consent form.<br />

If a change in chemotherapy regimen is necessary, patients should be re-consented,<br />

after having received regimen specific details. This should again be documented as<br />

before.<br />

Consent may be taken by Medical Staff or appropriately trained nursing staff.<br />

Nursing staff able to take consent for chemotherapy must meet all of the<br />

following criteria:<br />

o Have attended an approved consent study day.<br />

o Be chemotherapy competent (see section 4).<br />

o Be aware of their own knowledge and limitations and work within their<br />

own competence<br />

o Be working at Band 6 level or above.<br />

The clinician taking consent should complete the entire form with the patient and not<br />

complete in advance leaving the patient to sign at a later date.<br />

Registered Document 1005 Page 8 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


It is the administering nurse‟s responsibility to ensure that the consent form has<br />

been signed by the patient and to reconfirm consent immediately prior to<br />

treatment.<br />

If the consent form cannot be located prior to commencing the next cycle of<br />

treatment the administering nurse should refer to the patient‟s notes for<br />

information regarding the consent process. If there is no documented evidence of<br />

consent being taken the patient should be re consented.<br />

In Child Health a copy of the consent for treatment from the PTC (usually Addenbrooke‟s<br />

<strong>Hospital</strong>) should be kept in the patient‟s notes and checked prior to chemotherapy<br />

administration, with documented discussion.<br />

3.2 Prescribing<br />

The decision to treat a patient with chemotherapy for a cancer indication should be made<br />

by a consultant, and the patient should be discussed at an appropriate Multidisciplinary<br />

Team Meeting (MDT).<br />

For chemotherapy treatments within the Oncology / Haematology Directorate a<br />

chemotherapy treatment plan (CH/FORM/7) should be completed and a copy placed in<br />

the Oncology & Haematology notes . Prescriptions without an accompanying treatment<br />

plan will be referred back to the prescriber.<br />

Only appropriately qualified and competent Consultant Oncologists, Haematologists,<br />

Staff grade / Specialist Registrars in training for greater than three months or clinical<br />

assistants may initiate and prescribe systemic anticancer therapy.<br />

Only Paediatric Oncologists at a PTC can initiate systemic anticancer therapy and<br />

prescribe first cycles of <strong>Chemotherapy</strong>.<br />

First cycles must be countersigned by a Consultant.<br />

Prescribing of second or subsequent courses may be delegated to FY2 Doctors, but only<br />

if there are clear written instructions available, in the form of a recognised protocol or<br />

entry into the patients‟ medical notes. If modifications of doses are required, the<br />

Consultant or Specialist Registrar must document this in the medical notes.<br />

For Paediatric oncology patients; chemotherapy should only be prescribed by a<br />

Paediatric Oncology Consultant or their deputy (as listed on the Paediatric competency<br />

register). Except for first cycles emergency chemotherapy may be prescribed by another<br />

Paediatric Consultant or Specialist Registrar and the prescription faxed to the PTC to be<br />

checked. This is only to be done in agreement with the PTC and chemotherapy should<br />

not be administered until confirmation has been received.<br />

The prescriber is responsible for:<br />

Ensuring the patient is fully informed of their treatment and has given consent.<br />

Ensuring that all relevant investigational parameters, as outlined in the individual<br />

protocols have been checked and that the patient is fit to receive treatment and<br />

ensuring any medication affecting chemotherapy has been considered.<br />

Selecting the appropriate protocol.<br />

Ensuring that the body surface area calculations, where relevant, are correct, and<br />

have been made using a recent weight. If patients are 30% over their ideal body<br />

Registered Document 1005 Page 9 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


weight, or the body mass index (BMI) is greater than 30, the need for dose reduction<br />

or dose capping should be considered.<br />

Ensuring accurate dosing. A maximum of a 5% variance (according to protocol<br />

dosages) in dosage calculation is permitted.<br />

A Treatment plan should be completed to include performance status, relevant<br />

previous medical history, previous chemotherapy history and frequency of medical<br />

review.<br />

Prescribing all chemotherapy and supportive therapies including antiemetics and<br />

hydration.<br />

Ensuring that maximum cumulative doses of anthracyclines and bleomycin have not<br />

been exceeded.<br />

Specifying the route of administration, and for parenteral doses, the duration of<br />

infusion on the prescription, if necessary.<br />

Ensuring there is an appropriate interval between treatments, as defined by the<br />

protocol.<br />

If a patient is to be treated with a chemo-radiation protocol, it is essential that the<br />

prescriber makes this clear on the prescription and treatment plan, and notifies the<br />

relevant nursing and/or pharmacy staff.<br />

Wherever possible, chemotherapy should be initiated during normal working hours when<br />

access to specialist staff is more likely to be available. Only in exceptional circumstances<br />

should chemotherapy be initiated outside of normal working hours. See section 3.14 for<br />

further details.<br />

Prescriptions for chemotherapy must be clearly written with no amend mends. Verbal<br />

messages for chemotherapy are not permitted. Outpatient prescriptions should include<br />

the name of the patient, hospital number and address.<br />

Prescriptions that are not clear will be returned to the prescriber / Consultant.<br />

All new chemotherapy protocols in routine use should be authorised by the<br />

Oncology / Haematology Quality Assurance of Drugs (QUAD) group. In exceptional<br />

circumstances the chemotherapy lead or Chair of the Oncology / Haematology QUAD<br />

group may authorise regimens and report at the next QUAD meeting. Existing protocols<br />

which have been reviewed may be authorised by the Chair of the Oncology /<br />

Haematology QUAD group or the chemotherapy lead. All authorisation of protocols<br />

should correspond with the Network Regimen list located on the intranet.<br />

Regimen protocols and pre printed prescription sheets are available on the intranet to<br />

be printed off and filed as a combined document in the patient‟s chemotherapy<br />

folder, with the current or most recent course topmost.<br />

Prescriptions for chemotherapy must be complete, clear and simple to follow. Each<br />

prescription should contain the following:<br />

Date prescribed.<br />

Patient name, date of birth, and hospital number (address for out-patient<br />

prescriptions).<br />

Patients weight, height, body surface area where relevant.<br />

For carboplatin prescriptions, uncorrected GFR (Glomerular Filtration rate)should be<br />

stated for adult patients.<br />

Consultant name.<br />

Regimen name or clinical trial name.<br />

Cycle or course number.<br />

Registered Document 1005 Page 10 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


Name of drug - use approved generic drug names; no abbreviations.<br />

The individual dose in mg (milligrams) or units, and target AUC for carboplatin.<br />

The frequency per day and the number of days of treatment.<br />

Route of administration (abbreviations are not acceptable, for example<br />

intraperitoneal or intrapleural must be written in full).<br />

For infusions, details of diluent and volume.<br />

Duration of infusion and any other administration instructions.<br />

Starting dates (and times when appropriate).<br />

Antiemetics, hydration and any additional drugs as defined by the protocol.<br />

Reason for any dose modifications.<br />

Start and stop dates where applicable.<br />

At the end of a planned regimen the current prescription needs to be clearly marked as<br />

completed by drawing a line through the current chemotherapy record card. The number<br />

of cycles completed and the end date should be entered onto the chemotherapy<br />

treatment plan (CH/FORM/7).<br />

After the final cycle is given in a course, the prescriber should ensure that there is a<br />

treatment record for each patient that states whether the course was completed or not. If<br />

the course was not completed, the reasons for cessation should be documented. For<br />

completed courses of non-adjuvant treatment, a reference to the response should be<br />

included. This information will be documented in the medical notes.<br />

If a new or amended regimen is to be prescribed a new chemotherapy treatment plan<br />

(CH/FORM/7) should be completed and a new chemotherapy record card commenced.<br />

3.3 Deviation from treatment algorithms and regimen protocols<br />

Treatment algorithms and the associated chemotherapy regimen are approved by the<br />

Anglia Cancer Network. Wherever possible treatment should be prescribed according to<br />

these documents however there may be exceptional circumstances where a consultant<br />

wishes to treat a patient with a regimen not described within the relevant treatment<br />

algorithm.<br />

The definition of “deviation” from both algorithms and protocols is defined in the “Anglia<br />

Cancer Network policy for the Management of Algorithm Deviations” (Version 1 Sept<br />

2011)<br />

The Development of new or amendments to existing protocols and associated<br />

documents will be approved by QUAD, detailed in work instruction.<br />

Application for regular use of a new protocol should be made initially by application to the<br />

Oncology & Haematology QUAD and then to the Network SACT Group.<br />

Deviations from the approved algorithms and regimen protocols will be recorded and<br />

reported to the network as stated in the “Anglia Cancer Network policy for the<br />

Management of Algorithm Deviations”. This report will also be presented to the QUAD<br />

meeting on a regular basis.<br />

In the rare event that the proposed protocol is deemed inappropriate, pharmacy<br />

will be informed by the Chair of QUAD not to supply that regimen and the relevant<br />

consultant informed. Caveats may be placed on use due to resource implications.<br />

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If a deviation from an approved algorithm/protocol is to be used the Consultant must<br />

document the intended regimen in the patient‟s notes and prescribe the regimen. A form<br />

detailing the nature and reason for the deviation must be completed and placed within the<br />

patients chemotherapy folder. This must be completed in full prior to the commencement<br />

of treatment.<br />

Deviations from the approved algorithm and regimen may not be funded and therefore a<br />

source of funding must be approved (e.g cancer drugs fund, individual patient funding)<br />

before a patient is booked to commence therapy.<br />

The “off protocol” prescription must be signed by a Consultant Haematologist / Oncologist<br />

for each course of treatment.<br />

Unauthorised regimens for Paediatric Oncology patients should only be used at specific<br />

request and under the guidance of the PTC<br />

3.4 Purchasing, Receipt and Storage in Pharmacy<br />

The purchasing, receipt and storage of chemotherapy drugs in pharmacy is carried out in<br />

accordance with standard operating procedures by the Pharmacy Department. The<br />

pharmacy will ensure the effective control of the quality of these products.<br />

When purchasing cytotoxic drugs, risk assessments should be carried out in line with the<br />

Trust Purchasing for Safety Guideline as appropriate, to ensure that appropriate products<br />

are used. For example, wherever possible blister packed capsules or tablets are<br />

preferable to loose preparations, and products in vials would be preferable to ampoule<br />

formulations.<br />

Access to cytotoxic agent storage areas in pharmacy must be limited to authorised staff.<br />

All such storage areas will be clearly labelled with cytotoxic warnings.<br />

Main stocks of cytotoxic drugs will be held in the Pharmacy Department, under<br />

appropriate conditions.<br />

Clinical trial supplies of chemotherapy drugs should be kept separate from main stocks in<br />

pharmacy.<br />

<strong>Chemotherapy</strong> drugs are not available as ward stock. They should always be dispensed<br />

for individual patients.<br />

Cytotoxic drugs must be stored separately from other drugs.<br />

Storage must be designed in a manner that will prevent containers of cytotoxic agents<br />

from falling.<br />

Cytotoxic spillage kits should be available in all areas where cytotoxic drugs are stored.<br />

Damaged cartons of cytotoxic agents are to be discarded into a rigid sharps box. These<br />

should be labelled as cytotoxic waste and dealt with as in Section 3.17 If there is any<br />

contamination of the area or personal exposure to cytotoxic material, refer to Section<br />

3.18.<br />

3.5 Screening and dispensing of prescriptions by pharmacy<br />

An appropriately trained and accredited pharmacist must clinically screen and validate all<br />

prescriptions for all oral and parenteral chemotherapy.<br />

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Prior to the preparation of a drug the pharmacist must verify the treatment plan and<br />

prescription according to the protocol or treatment regimen, clarify and resolve any<br />

discrepancies and check that:<br />

The appropriate protocol has been selected, with correct sequencing.<br />

All relevant investigational parameters such as complete blood counts, renal<br />

and hepatic function, as outlined in individual chemotherapy protocols, are<br />

reviewed and drug doses modified where necessary<br />

The body surface area calculations are correct. If patients are 30% over their<br />

ideal body weight, or the body mass index (BMI) is greater than 30, the<br />

pharmacist will contact the prescriber and discuss possible implications and<br />

the need for dose reduction or dose capping.<br />

An accurate dose has been prescribed. A maximum of a 5% variance<br />

(according to protocol dosages) in dosage calculation is permitted.<br />

Dose modifications to previous treatments are maintained if appropriate.<br />

All chemotherapy drugs and supportive therapies including antiemetics have<br />

been prescribed.<br />

Ensure that maximum cumulative doses of anthracyclines / bleomycin have<br />

not been exceeded.<br />

The route of administration and the duration of infusion have been specified<br />

on the prescription.<br />

The volume and diluent of infusion is appropriate with respect to the patient,<br />

protocol and pharmaceutical stability.<br />

There is an appropriate interval between treatments.<br />

If the prescription is for a new chemotherapy protocol or is „off protocol‟, the<br />

oncology/haematology pharmacist must discuss the case with the responsible consultant.<br />

A copy of an original paper from the responsible consultant detailing the protocol should<br />

be obtained. For further details, refer to section 3.3.<br />

Discrepancies exceeding plus or minus 5% of the dose, calculated according to the<br />

patient's treatment plan, must be clarified with the doctor.<br />

The pharmacist will resolve any discrepancies identified with the prescribing doctor prior<br />

to dispensing the medication(s). The actual prescription will be amended and any<br />

changes will be communicated to other team members as appropriate. The pharmacist<br />

will complete documentation of the discrepancy and the resolution.<br />

The pharmacist performing the clinical screening will document that the prescription is<br />

approved for preparation on the appropriate form.<br />

3.6 Preparation and Dispensing<br />

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Dispensing and preparation of cytotoxic agents must take place in Pharmacy in<br />

accordance with Standard Operating Procedures.<br />

Preparation of parenteral cytotoxic agents must take place in isolators situated in a<br />

specifically controlled and monitored environment. The equipment must be certified at<br />

least annually.<br />

All pharmacy staff preparing cytotoxic agents will follow the <strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust‟s<br />

pharmacy procedures.<br />

To facilitate drug preparation, changes to a previously written prescription may be made<br />

by an oncology or haematology pharmacist upon verbal confirmation from a doctor. Any<br />

changes on the prescriptions should be appropriately annotated by the pharmacist or<br />

prescriber.<br />

Appropriately trained and accredited pharmacy staff are responsible for the accurate<br />

preparation, documentation, labelling, determining and allocating the correct expiry date<br />

and time and storage conditions for a chemotherapy dose.<br />

The pharmacist performing the final product check will ensure correct documentation,<br />

computer entry, ensure appropriate order preparation, dispense and release the<br />

medication for the patient.<br />

The cytotoxic drug preparation service is open Monday to Friday 09.00 to 17.00 (except<br />

bank holidays).<br />

Whenever possible, all cancer chemotherapy should be initiated, and as much as is<br />

feasible, administered within normal working hours. However, there are some<br />

exceptional circumstances as outlined in section 3.14 where chemotherapy may need to<br />

be initiated and administered out of hours. If this is required the on call pharmacist<br />

should be contacted as soon as possible.<br />

In situations such as expired doses or split infusion bags, for patients who are receiving<br />

ongoing chemotherapy treatment regimens, contact the on call pharmacist for advice.<br />

3.7 Supply of Cytotoxic drugs<br />

Cytotoxic drugs are supplied as follows:<br />

Bolus IV, IM or SC doses<br />

Intravenous infusions<br />

Bladder instillation<br />

Intrapleural<br />

Intraperitoneal<br />

Tablets & capsules<br />

Oral liquids<br />

Topical<br />

in labelled Luer-locked syringes<br />

in sterile labelled bags of infusion fluid or<br />

appropriate device/ambulatory pump<br />

in labelled 50ml Luer-locked syringes, or a<br />

commercially available closed system device<br />

in labelled Luer-locked syringes<br />

In labelled Luer-locked syringes or infusion<br />

bags<br />

in clearly labelled bottles or cartons<br />

in clearly labelled bottles<br />

in clearly labelled tubes, ointment jars,<br />

dropper bottles or original packs<br />

The following details should also be stated on the parenteral preparation label:<br />

Generic drug name<br />

Amount of drug in container (in milligrams, grams or units)<br />

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Infusion solution (including volume)<br />

Route of administration<br />

Patient name<br />

<strong>Hospital</strong> Number<br />

Ward<br />

Batch number<br />

Expiry date and time<br />

Storage conditions<br />

Warning: Cytotoxic Drug<br />

Name and address of pharmacy department<br />

Labels for Cytotoxic Tablets, Capsules and Oral Liquids. The following details should also<br />

be stated on the preparation label:<br />

Generic drug name<br />

Strength of tablets or capsules, or concentration of oral liquid<br />

The number of tablets / capsules in the container, or volume of liquid<br />

Patient name<br />

Full directions and an indication of length of treatment<br />

Storage conditions<br />

Warning: Cytotoxic Drug / Handle with Care<br />

Name and address of pharmacy department<br />

Labels for Topical Preparations. The following details should also be stated on the<br />

preparation label:<br />

Generic drug name<br />

The strength of the cream/ointment or concentration of topical liquids<br />

The quantity of the preparation (either weight for creams or ointments, or volume<br />

for topical solutions).<br />

Patient name<br />

Full directions and an indication of length of treatment<br />

Expiry date where appropriate<br />

Storage conditions<br />

Warning: Cytotoxic Drug<br />

For external use only<br />

Name and address of pharmacy department<br />

All vinca alkaloids will be labelled in large, bold font “FOR INTRAVENOUS USE ONLY –<br />

FATAL IF GIVEN BY ANY OTHER ROUTE”<br />

ALL Vinca alkaloids for adults will be supplied in 50ml minibags in accordance with NPSA<br />

safety alert (NPSA 2008 / RRR 004 Using Vinca Alkaloid Minibags).<br />

For patients under the age of 10 years, vinca alkaloids may be diluted to a maximum<br />

concentration of 0.1ml/ml and dispensed in at least a 10ml luer-lok syringe. The<br />

requirement for a smaller volume than 20ml MUST be specified by the prescriber.<br />

For children over the age of 10 years Vincristine will be diluted to 20mls and supplied in a<br />

50ml syringe.<br />

All Vinca Alkaloids will be packed into a yellow outer bag printed with the above<br />

warnings.<br />

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3.8 Transportation<br />

Prepared cytotoxic agents must be transported in designated transport bags or boxes.<br />

These should be sturdy, secure and leak-proof and should be clearly labelled:<br />

CYTOTOXIC DRUGS - HANDLE WITH CARE. Additional precautionary labels should be<br />

added to the containers and the transport boxes as appropriate<br />

All Trust staff involved in the transportation of cytotoxic drugs must be trained to follow<br />

the Cytotoxic Spillage procedure.<br />

Pneumatic tubes must not be used for transporting cytotoxic agents (with the exception of<br />

oral tablets / capsules).<br />

If damaged or leaking cytotoxic products are received by clinical areas, the receiver<br />

should put on gloves and an apron, and place the damaged product into a leak proof<br />

container. This should be immediately labelled and returned to pharmacy, or disposed of<br />

appropriately on the ward/clinic as described in section 3.17<br />

Cytotoxic drugs that are to be transported outside of the hospital should be placed in<br />

sturdy, leakproof transport boxes. They should be clearly labelled as „Cytotoxic – handle<br />

with care‟. The label should also contain the name and address of the originating hospital<br />

and a direct contact in pharmacy in case of an emergency.<br />

<strong>Chemotherapy</strong> drugs must be delivered to a qualified nurse on the ward who takes<br />

responsibility for the appropriate storage, as defined on the label attached to the cytotoxic<br />

agent.<br />

Any cytotoxic drugs received by clinical areas, but not administered, must be safely<br />

returned to the Pharmacy Department as soon as possible.<br />

3.9 Storage in clinical areas<br />

Access to cytotoxic drug storage in clinical areas must be limited to authorised staff.<br />

Storage must be designed in a manner that will prevent containers of cytotoxic drugs<br />

from falling. Such storage areas should be clearly labelled with cytotoxic warning labels.<br />

A member of nursing staff must receive the cytotoxic drug dose in the transit box at its<br />

destination. Boxes will not be left unattended or with untrained staff on arrival.<br />

Nurses are responsible for the correct storage of cytotoxic drugs delivered to wards and<br />

clinics prior to use. The storage should be in appropriate and designated areas.<br />

Parenteral doses of chemotherapy should be stored in a designated locked<br />

chemotherapy refrigerator or cupboard separately from other drugs.<br />

Oral doses can be stored in a locked drug trolley, Patient Own Drugs (POD) locker,<br />

cupboard or refrigerator with other medication, as long as they are clearly labelled as<br />

cytotoxic.<br />

Any refrigerators used for the storage of chemotherapy doses should be monitored at<br />

least daily to ensure that the temperature is maintained between 2 to 8 degrees<br />

centigrade.<br />

3.10 Health and Safety<br />

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For healthcare personnel the potential of exposure to cytotoxic agents exists during tasks<br />

such as drug reconstitution and preparation, administration and disposal of waste equipment<br />

or patient waste. Hence, all staff involved in the prescribing, preparation, delivery,<br />

administration of cytotoxic drugs as well as staff caring for patients receiving cytotoxic drugs<br />

must be aware of all health and safety procedures. This applies to clinicians, nursing staff,<br />

pharmacy staff, domestic staff in the relevant pharmacy and clinical areas, and portering staff<br />

carrying cytotoxic drugs or cytotoxic waste.<br />

The more common routes of exposure are contact with skin or mucous membranes (e.g.<br />

spillage and splashing), inhalation (over-pressurising vials), and ingestion (e.g. through<br />

eating, drinking or smoking in contaminated areas or from poor hygiene). Less likely routes<br />

of exposure include needle-stick injuries, which can occur during the preparation or<br />

administration of these drugs.<br />

Some cytotoxic drugs can cause acute or short term health effects including irritation to the<br />

skin, eyes and mucous membranes.<br />

All relevant new employees should receive an induction related to the current<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> as soon as possible after commencement of employment.<br />

Records must be kept of all designated posts that require nursing, pharmacy or medical<br />

staff to reconstitute or administer cytotoxic drugs. The Health and Safety Executive<br />

recommends that the records should contain at least the following: surname, forename,<br />

gender, date of birth, permanent address and postcode, National Insurance Number,<br />

date when present employment started and a historical record of jobs in this employment<br />

involving exposure to cytotoxic drugs.<br />

Employees should notify their managers as soon as possible if they are pregnant, breast<br />

feeding or trying to conceive. This is particularly important as the greatest risk is during<br />

the first three months of pregnancy, when rapid cell division and differentiation occurs.<br />

At the point where an employee discloses pregnancy, a risk assessment specific to the<br />

individual should be carried out and any appropriate action taken.<br />

Pregnant or breastfeeding staff will be excluded from working with cytotoxic drugs. Staff<br />

will not be expected to be involved in directly preparing or administering cytotoxic agents<br />

or handling waste from patients treated with cytotoxic agents. If appropriate, the line<br />

manager and Human Resources Department, together with the member of staff, will<br />

agree any new temporary arrangements.<br />

New, expectant and breastfeeding mothers should be specifically advised against any<br />

direct involvement in the management of a cytotoxic drug spillage.<br />

A full COSHH (Control of Substances Hazardous to Health, 1998) assessment must be<br />

undertaken in all areas handling cytotoxic drugs.<br />

Pharmacy staff preparing cytotoxic drugs within pharmacy preparation units will wear<br />

personal protective clothes as defined by local standard operating procedures.<br />

The following protective equipment should be worn when administering cytotoxic drugs in<br />

clinical areas:<br />

Gloves NB Consideration needs to be given as to whether the procedure requires<br />

sterile or non-sterile protective gloves.<br />

Plastic apron.<br />

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Eye protection: The use of eye protection should be considered whenever<br />

splashes or sprays of cytotoxic drugs might be generated, for example during<br />

intracavitary administration.<br />

Protective equipment for handling waste from patients receiving cytotoxic agents:<br />

Gloves<br />

Plastic apron.<br />

Protective equipment to be used in the event of a cytotoxic spillage:<br />

Gloves<br />

Protective disposable gown.<br />

Protective plastic armlets.<br />

A recommended brand of goggles.<br />

Plastic overshoes.<br />

Masks (preferably respirators).<br />

Cuts and scratches on the skin should be covered with a waterproof dressing to prevent<br />

infiltration of the skin if gloves are damaged. Staff with dermatological conditions (e.g.<br />

eczema) should be referred to occupational health for assessment.<br />

No glove material is completely impermeable to cytotoxic drugs. Permeation of cytotoxic<br />

drugs depends upon glove material, thickness and integrity, the properties of the<br />

drug/solvents and the contact time with the drug. Since no material is completely<br />

impermeable to cytotoxic drugs and permeability increases with time, users should<br />

minimise contact and change their gloves regularly.<br />

Gloves must be changed immediately if damaged or if any contamination occurs.<br />

Gloves should be changed regularly and must always be changed between patients.<br />

Non-powdered gloves must be used since powder may absorb cytotoxic contamination.<br />

If the inner surface of a glove becomes contaminated, exposure will occur. Therefore<br />

once disposable gloves are removed, they should not be re-applied, but disposed of as<br />

detailed in section 3.17.<br />

Hands must be washed thoroughly with liquid soap or alcohol gel applied before gloves<br />

are put on and after gloves are removed.<br />

Spillage kits and bottles of sterile saline for dealing with eye contamination must be<br />

readily available in all areas where handling of cytotoxic drugs occurs.<br />

Respiratory protection should be used when dealing with a cytotoxic spillage.<br />

3.11 Venous Access<br />

A venous access assessment must be conducted and documented prior to the<br />

commencement of any intravenous chemotherapy regimen.<br />

Intravenous <strong>Chemotherapy</strong> should NOT be given if there is any doubt regarding the<br />

safety of the venous access device.<br />

Small gauge polyurethane cannulae, which preserve vein integrity and cause least pain<br />

to the patient, are recommended. A closed system with Luer-lock attachments should be<br />

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used. Peripheral cannulas should be changed every 72 hours irrespective of the<br />

presence of infection unless a clinical decision is made and recorded to leave the<br />

cannula insitu for longer for example in patients who have poor venous access.<br />

Central venous access is the route of choice if the drugs or fluids are to be administered<br />

over a long duration, are irritant to the peripheral veins, or have the potential to cause<br />

tissue necrosis.<br />

Where the recipient of therapy has insufficient or unsuitable peripheral veins, insertion of<br />

a central venous catheter may be indicated.<br />

Some therapies will justify the placement of non-tunnelled, percutaneous central venous<br />

catheters. However, several months of intensive therapy may indicate the need for longterm<br />

tunnelled catheters or implantable devices.<br />

The care of central venous catheters should follow Trust <strong>Policy</strong>.<br />

When choosing a suitable site, both the required cannula size and the size and condition<br />

of available veins must be taken into consideration. The following need to be considered:<br />

The purpose of the cannulation. For example a large vein required for high flow rate.<br />

Vesicant /Irritant solutions or drugs require good flow to assist haemodilution.<br />

The condition of the accessible vein, the lumen and blood flow.<br />

Small visible but impalpable superficial veins are rarely suitable for cannulation.<br />

In the elderly patient particularly, prominent, superficial veins may be sclerosed,<br />

tortuous, fibrosed or fragile and therefore unsuitable for cannulation.<br />

The superficial veins of the arm are commonly chosen for the cannulation as they are<br />

numerous, easily detectable with wide lumens and thick walls and the skin is less<br />

sensitive. Most common are: median cubital, basilic and cephalic veins.<br />

Veins in the lower limbs should be avoided in adults.<br />

Avoid use of dominant arm in order to maintain patient mobility and independence<br />

whenever possible.<br />

Avoid areas of joint flexion.<br />

Avoid use of cubital fossa, especially for vesicants.<br />

Avoid sites distal to recent cannulation or venopuncture to minimise the risk of fluid<br />

extravasation.<br />

Avoid areas proximal to skin lesions or wounds.<br />

Avoid veins close to arteries or deep lying vessels as accidental puncture can cause<br />

painful spasm or prolonged bleeding.<br />

Avoid areas affected by invading tumour, haematoma, inflamed or sclerosed areas.<br />

Avoid limbs where there is lymphatic impairment following surgery, chemical<br />

occlusion or radiotherapy even if there is no obvious lymphoedema.<br />

The venous access assessment should be reviewed if any problems are encountered<br />

during cannulation.<br />

If the patient is very nervous or needle phobic, local anaesthetic cream may be applied to<br />

the proposed site at least 30 minutes prior to the procedure. In severe circumstances<br />

sedation and / or relaxation techniques may be considered. The cream should be<br />

prescribed on the patient‟s drug chart.<br />

3.12 Administration<br />

The following section does not apply to patients admitted to non-oncology wards on oral anti<br />

cancer medication (please see section 3.16).<br />

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Only nurses who have received appropriate training and have been assessed as<br />

competent, may administer intravenous chemotherapy drugs (Oncology and<br />

Haematology Directorate only).<br />

Nurses participating in a programme of training to become competent in the<br />

administration of chemotherapy may administer chemotherapy under the direct<br />

supervision of a chemotherapy competent practitioner(Oncology and Haematology<br />

Directorate and Child Health only).<br />

Systemic anti cancer therapy should only be given within Woolverstone Day Unit,<br />

<strong>Chemotherapy</strong> outreach clinics, Somersham Ward and Boxford Assessment Unit (in<br />

exceptional circumstances on Bergholt ward).<br />

<strong>Chemotherapy</strong> given to Teenage & Young Adults (18-24) should only be given on<br />

Somersham ward or in a designated cubicle within Woolverstone Day Unit.<br />

In exceptional circumstances, chemotherapy may be administered to cancer patients on<br />

the critical care unit by chemotherapy competent nurses.<br />

Registered nurses are responsible for safe administration of chemotherapy prescribed to<br />

the correct patient as outlined in the Trust‟s Medication <strong>Policy</strong> and the Nursing and<br />

Midwifery Council (NMC) <strong>Policy</strong>.<br />

Nursing staff who solely check chemotherapy will be required to complete modules 1-4 of<br />

the Anglia Cancer Network <strong>Chemotherapy</strong> Core Education Package.<br />

All prescriptions and accompanying treatment plans for chemotherapy must be checked<br />

by a chemotherapy competent nurse as outlined in section 4 (Oncology and<br />

Haematology Directorate only).<br />

The administering nurse is responsible for ensuring that:<br />

All relevant investigational parameters have been checked as outlined in<br />

individual chemotherapy protocols.<br />

The patient is fully informed of their treatment and has given consent<br />

The correct weight and height have been recorded where relevant.<br />

The body surface area calculations are correct.<br />

An accurate dose has been prescribed. A maximum of a 5% variance (according<br />

to protocol dosages) in dosage calculation is permitted. Discrepancies must be<br />

clarified with the doctor.<br />

Dose modifications to previous treatments are maintained if appropriate.<br />

All chemotherapy and supportive therapies including antiemetics have been<br />

prescribed.<br />

The route of administration and the duration of infusion have been specified on<br />

the prescription.<br />

There is an appropriate interval between treatments.<br />

Any history of toxicities and complications from previous cycles is documented in<br />

the patient‟s medical notes.<br />

Patients should be assessed for the need of any additional psychological, emotional,<br />

social or spiritual support, e.g. holistic assessment. An assessment of the carer‟s<br />

needs should also be offered. This assessment will be carried out by either the<br />

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site specific nurse specialist or one of the chemotherapy nurses and will be<br />

documented.<br />

A nurse must not accept verbal orders for chemotherapy or for adjustments to doses of<br />

chemotherapy drugs.<br />

Double-checking of chemotherapy doses is required. A registered nurse, doctor or<br />

pharmacist (who has not been involved in the dispensing process) familiar with<br />

chemotherapy administration should perform the second check.<br />

All areas in which chemotherapy is administered must have the following equipment:<br />

Emergency call bell.<br />

Resuscitation equipment (or access to it as defined by local practice).<br />

Drugs for the management of emergencies – cardiac arrest and anaphylaxis.<br />

Extravasation kit.<br />

Cytotoxic spillage kit.<br />

Eye wash / access to running water.<br />

Prior to administering chemotherapy the health care professional to administer the drugs<br />

will:<br />

Check the patient/carer has been fully informed and has given consent to receive<br />

the proposed chemotherapy treatment.<br />

Check regimen and cycle number<br />

Check the number of administrations as per the schedule within the cycle<br />

Check the prescription is dated correctly, signed, written clearly and<br />

unambiguously and is in accordance with the chemotherapy protocol.<br />

Check body surface area and dose calculations, as necessary.<br />

Check pre-chemotherapy investigations, as outlined in the individual protocol,<br />

have been completed and results reviewed by an Oncology / Haematology doctor,<br />

designated chemotherapy competent nurse and an appropriate specialised<br />

pharmacist.<br />

Be aware of the side effects of all the drugs to be administered.<br />

Check cumulative doses have not been exceeded for anthracyclines / bleomycin.<br />

Check appropriate antiemetics have been prescribed and given.<br />

When the protocol contains premedications or hydration, ensure that these are<br />

prescribed and given in line with the protocol.<br />

Explain the procedure to the patient/carer and ensure written information has<br />

been provided.<br />

With a second person (as defined above), check the following details (if there is a<br />

discrepancy contact the Pharmacy Cytotoxic Preparation Unit or, out of hours, the on-call<br />

pharmacist):<br />

The patient‟s name and hospital number correspond with the prescription chart<br />

and pharmacy label.<br />

<strong>Chemotherapy</strong> must be administered on the date stated on the prescription.<br />

The name of the drug, the dose, route and for parenteral doses, the diluent, the<br />

prescription and pharmacy label must be identical.<br />

For parenteral doses the volume of fluid prescribed must correspond to the<br />

volume stated on the label OR the volume of fluid in a syringe must correspond to<br />

the volume stated on the label.<br />

Check the name on the patient's wristband corresponds to the prescription chart<br />

as per Trust Patient Identification (Wristband) <strong>Policy</strong><br />

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Check the route of administration is the same on the cytotoxic product label and<br />

the prescription.<br />

Check the expiry of all drug doses<br />

Check all parenteral doses for particulate contamination e.g. precipitation before<br />

administration.<br />

3.12.1 Administration of Intravenous <strong>Chemotherapy</strong><br />

Equipment required:<br />

Relevant patient documentation, consent form and prescription sheet.<br />

Sterile dressing pack or sterile field and gauze.<br />

<strong>Chemotherapy</strong> drugs in sealed plastic bags.<br />

Deep, impermeable tray, disinfected with 70% Isopropyl alcohol..<br />

Appropriate pump and giving set if required for infusional chemotherapy.<br />

A bag of a compatible infusion solution.<br />

Single use disposable wipe impregnated with 2% Chlorhexidine 70% Isopropyl<br />

alcohol for disinfection of hubs and ports<br />

Appropriate protective clothing.<br />

Cytotoxic sharps bin.<br />

Use of aseptic technique should be maintained throughout intravenous administration.<br />

The administering practitioner must ensure appropriate venous access with regards to:<br />

Site<br />

Position<br />

Patency<br />

Integrity<br />

Visibility<br />

Check the patency of the cannula or central line, by aspirating for blood and<br />

flushing with a compatible infusion fluid.<br />

If there are any doubts regarding cannula patency, recannulate the patient.<br />

If the placement or patency of central access is in doubt, imaging should be requested<br />

prior to commencing treatment.<br />

Inspect sealed bags before opening to ensure no spillage has occurred within the bag.<br />

Open the chemotherapy doses directly onto the disinfected tray.<br />

Patient details should be confirmed with their wristband, immediately prior to<br />

administration by the person giving the treatment.<br />

Thoroughly wash and dry hands or use alcohol hand gel prior to glove application. (Refer<br />

to Infection Control <strong>Policy</strong>).<br />

Ensure appropriate protective clothing is worn prior to handling syringes or infusion<br />

bags containing cytotoxic drugs.<br />

Disinfect injection ports with single use disposable disinfectant wipe impregnated with<br />

2% chlorhexidine 70% Isopropyl alcohol and allow to dry.<br />

Do not use the „Flip cap port‟ of the cannula, where present, for bolus administration.<br />

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Administration should be performed over a towel with waterproof backing to protect skin<br />

and surfaces from potential cytotoxic drug leakage.<br />

A fast running infusion of a compatible infusion solution should be used for the<br />

administration of all intravenous bolus drugs.<br />

Maintain a closed system by using Luer-lock syringes. Use intravenous administration<br />

sets and syringes with Luer-lock fittings.<br />

To ensure visibility at all times, bandages must not be applied to cannula sites when<br />

intravenous chemotherapy is in progress.<br />

Administer the drugs in the correct order, vesicants should be administered first. Vinca<br />

Alkaloid miniags, if part of the regimen, should be administered first except if an<br />

anthracycline is to be administered in which case this should be administered before the<br />

vinca alkaloid minibag.<br />

The patient and the vascular access device should be monitored frequently before,<br />

during, and after administration for:<br />

Leakage at the site.<br />

Venous irritation.<br />

Phlebitis.<br />

Flare reaction.<br />

Allergic reaction.<br />

Anaphylaxis.<br />

Extravasation.<br />

Known side effects.<br />

Stop administration if:<br />

There is any doubt about the checks that have been carried out.<br />

The patient requests the treatment to stop.<br />

The patient demonstrates side effects or complications, particularly signs of<br />

anaphylaxis or extravasation.<br />

The equipment fails to function effectively.<br />

Check for blood return every 2-5 mls during bolus administration and before and after<br />

each drug during bolus administration.<br />

Do not expel air from syringes. If air is in a syringe, hold it in such a way that the air is up<br />

near the plunger when the entire drug is expelled and the air is reached.<br />

3.12.2 Intravenous infusional chemotherapy<br />

Infuse the first 20mls of the flushing solution and ask the patient to report any discomfort.<br />

Using a non-touch technique, carefully insert the giving set into the infusion at waist<br />

height to minimise the risk of personal contamination in the event of a spillage. This<br />

should be carried out over a clean tray. It is recommended that the bag is in a horizontal<br />

position and the port through which the set is placed is not kinked. This reduces the risk<br />

of the giving set piercing through the port and causing a leakage.<br />

Ensure that the infusion pump is set to the correct rate according to prescription and<br />

protocol. Ensure that the infusion solution is covered to protect it from light if the drug is<br />

prone to photodegradation.<br />

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Advise patient to report adverse local and systemic symptoms.<br />

Commence infusion and ensure that the patient has easy access to a call bell and items<br />

for the management of potential emesis.<br />

Maintain regular observation of IV catheter sites for signs of swelling or inflammation, the<br />

patient for adverse signs and symptoms and the rate of infusion. VIP scores should be<br />

performed every 4 hours.<br />

Vinca alkaloid minibags should be administered first, unless an anthracycline is to be<br />

administered, via a gravity infusion over 5 to 10 minutes.<br />

The administering nurse should remain with the patient throughout the administration of<br />

vinca alkaloid minibags.<br />

If a special giving set or filter is required use only those recommended. Failure to use the<br />

correct infusion set and/or filter may risk personnel contamination, dose reduction and<br />

adverse clinical event for patient.<br />

On completion of dose administration clear away and dispose of all equipment, waste<br />

and sharps as outlined in section 3.17.<br />

Record the administration on the prescription sheet, in the medical and nursing notes.<br />

3.12.3 Subcutaneous chemotherapy<br />

Equipment required:<br />

Appropriate protective clothing.<br />

Clean impermeable tray.<br />

26 gauge needles for administration.<br />

Cytotoxic waste bin.<br />

Ensure patient privacy. Ensure the patient is comfortable and has any specific<br />

information required.<br />

Inspect sealed bag before opening to ensure there is no spillage within the bag. Open<br />

the bag directly onto the injection tray.<br />

Explain the procedure to the patient.<br />

Thoroughly wash hands or use alcohol gel prior to glove application. (Refer to Infection<br />

Control <strong>Policy</strong>).<br />

Choose a suitable site for the injection.<br />

Carefully remove the connector top from the Luer-lock syringe and attach a 26-gauge<br />

needle with a needle length of 8mm. Ensure needles for administration are secure<br />

taking great care to minimise risk of spillage on the skin.<br />

Using a pinch technique, administer the injection using a 90 0 angle. Aspiration is not<br />

required prior to the injection.<br />

Remove the syringe and needle, covering the site with gauze and ensuring there is no<br />

leakage from the site.<br />

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If further injections are required, rotate the site of administration.<br />

Dispose of all cytotoxic contaminated waste immediately as described in section 3.17.<br />

3.12.4 Intramuscular chemotherapy<br />

Equipment required<br />

Appropriate protective clothing.<br />

Clean impermeable tray.<br />

24 or 22 gauge needles for administration.<br />

Skin cleanser- 2% Chlorhexidine 70% Isopropyl alcohol (Chloraprep)..<br />

Cytotoxic waste bin.<br />

Ensure patient privacy. Ensure patient is comfortable and has any specific information<br />

required.<br />

Inspect sealed bag before opening to ensure there is no spillage within the bag. Open<br />

the bag directly onto the injection tray.<br />

Explain the procedure to the patient.<br />

Thoroughly wash hands or use alcohol hand gel prior to glove application. (Refer to local<br />

Infection Control <strong>Policy</strong>).<br />

Choose a suitable site for the injection, and prepare the skin as per local policy.<br />

Carefully remove the connector top from the Luer-lock syringe, attach a green or orange<br />

needle. Ensure needles for administration are secure taking great care to minimise risk<br />

of spillage on the skin.<br />

Administer the intramuscular injection using the Z track technique. The Z-track technique<br />

involves displacing the skin and the subcutaneous layer in relation to the underlying<br />

muscle so that the needle track is sealed off before the needle is withdrawn, therefore<br />

minimising reflux.<br />

Remove the syringe and needle, covering the site with low lint gauze and ensuring there<br />

is no leakage from the site.<br />

If further injections are required, rotate the site of administration.<br />

Dispose of all cytotoxic contaminated waste immediately as described in section 3.17.<br />

3.12.5 Intravesical administration<br />

Mitomycin and occasionally epirubicin can be given by the intravesicular route.<br />

Careful consideration and discussion with the Urology nurse practitioner and Doctor<br />

responsible must occur if the patient has heavy haematuria or a urinary tract infection, or is<br />

immunosuppressed, due to the potential increase in side effects.<br />

Equipment required<br />

1 pair of disposable latex / PVC gloves.<br />

1 pair of sterile gloves.<br />

Urinary drainage bag or catheter valve for in patient treatment.<br />

Disposable incontinence pads.<br />

Cytotoxic waste bin.<br />

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Dressing trolley.<br />

Chemical safety glasses.<br />

Dressing pack.<br />

Clamps.<br />

Luer lock adaptor<br />

Procedure with a catheter in situ<br />

Thoroughly wash hands. (Refer to local Infection Control <strong>Policy</strong>).<br />

Clean dressing trolley with locally approved cleaning solution.<br />

If required, catheter insertion and management of existing catheters should follow local<br />

policy and principles of best practise.<br />

Ensure that consent has been obtained.<br />

Ensure patient privacy. Ensure the patient is comfortable and has any specific<br />

information required.<br />

Advise the patient to report any adverse local and systemic symptoms.<br />

Provide the patient with a gown and assist patient to assume a recumbent or semirecumbent<br />

position and expose the catheter.<br />

Lay an incontinence pad under the catheter and over the thighs.<br />

Thoroughly wash hands prior to glove application. (Refer to local Infection Control<br />

<strong>Policy</strong>).<br />

Open and assemble the sterile products and don one pair of sterile gloves.<br />

If an irrigation bag is in use, disconnect the fluid and spigot the catheter inlet.<br />

Clamp the catheter.<br />

If necessary, disconnect the drainage bag from the catheter. Document the volume of<br />

urine to ensure an accurate fluid balance is recorded. Put the catheter valve in a closed<br />

position to provide a means of blocking the catheter and to facilitate drainage after the<br />

recommended time.<br />

Connect the syringe securely to the catheter via the luer lock adapter release the clamp<br />

and instill the drug slowly into the bladder. Rapid instillation can be painful, especially if<br />

the bladder wall is scarred from previous surgery.<br />

Carefully check that there are no signs of leakage of drug around the catheter site.<br />

Clamp the catheter. Disconnect the syringe from the valve using a cotton swab to<br />

absorb any drops left on the end of the valve.<br />

If a drainage bag is being used, connect this to the valve but do not open the valve, to<br />

allow retention of the drug within the bladder for at least one hour.<br />

Clear away all contaminated disposables. (See section 3.17).<br />

Ensure the comfort of the patient, assisting him/her to reposition themselves and ensure<br />

they have easy access to a call bell.<br />

Advise the patient of the need to retain the drug for one hour if possible. If the patient<br />

has an urge to void or if the catheter is bypassing, it will be necessary to open the valve<br />

before the allotted time.<br />

After one hour: Wash hands thoroughly before putting on disposable gloves.<br />

Attach a urine drainage bag. Unclamp the catheter and allow drainage of the bladder<br />

contents into the drainage bag for 15 minutes.<br />

Remove the drainage bag and connect a new one if the catheter is to remain in situ, as<br />

per local policy.<br />

If the catheter is to be removed attach a syringe to the balloon inlet of catheter. Once<br />

correct balloon inflation volume has been removed with syringe, gently remove the<br />

catheter completely, ensuring disposable sheet under meatus of urethra.<br />

The contents of the drainage bag (drug and urine) should be emptied into a sluice<br />

followed by two flushes. The bag should then be disposed of as cytotoxic waste.<br />

Dispose of all cytotoxic contaminated waste immediately as described in section 3.17.<br />

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Procedure without a catheter in situ<br />

Thoroughly wash hands. (Refer to local Infection Control <strong>Policy</strong>).<br />

Clean dressing trolley with locally approved cleaning solution.<br />

Ensure that consent has been obtained.<br />

Ensure patient privacy. Ensure the patient is comfortable and has any specific<br />

information required.<br />

Advise the patient to report any adverse local and systemic symptoms.<br />

If necessary, provide the patient with a gown and assist patient to assume a recumbent<br />

or semi-recumbent position.<br />

Catheterise the patient (as per guidelines) using disposable self lubricated single use<br />

catheter size 10Ch. .<br />

Thoroughly wash hands prior to glove application. (Refer to local Infection Control<br />

<strong>Policy</strong>).<br />

Open and assemble the sterile products and don one pair of sterile gloves.<br />

Connect the bladder syringe securely to the catheter, open the valve and instill the drug<br />

slowly into the bladder. Rapid instillation can be painful, especially if the bladder wall is<br />

scarred from previous surgery.<br />

Remove the catheter (and attached syringe).<br />

Clear away and dispose of all cytotoxic contaminated waste immediately as described in<br />

section 3.17.<br />

Advise the patient of the need to retain the drug for one hour.<br />

After one hour: Advise the patient to go to the bathroom to void urine into toilet. Men<br />

must void sitting down to minimise splashing. The toilet should be flushed , with the lid<br />

down (again to minimise splashing).<br />

If patient unable to void insert self lubricated single use catheter (as before) and drain<br />

the bladder.<br />

Advise patients to wash genitalia thoroughly with plenty of soap and water and wash<br />

their hands afterwards, to minimise potential skin problems following contact with<br />

cytotoxic drugs.<br />

Advise patient to maintain hygiene as normal after the initial emptying of their bladder.<br />

If any cytotoxic drug comes in contact with the patients skin, refer to section 3.18.<br />

3.12.6 Intrapleural administration<br />

Following drainage of a pleural effusion, the doctor may wish to instil a cytotoxic drug, usually<br />

bleomycin, into the pleural cavity, via the mechanism used for drainage, i.e. the pleural drain.<br />

Equipment required<br />

Dressing trolley and dressing pack.<br />

10 ml Sodium Chloride 0.9%.<br />

10 ml syringe and needles, as required.<br />

Sterile gloves and plastic apron.<br />

Chemical safety glasses.<br />

Incontinence sheet (x 2).<br />

Hypoallergenic tape.<br />

Procedure<br />

Thoroughly wash hands before preparing required equipment.<br />

Ensure patient privacy. Ensure the patient is comfortable and has any specific<br />

information required.<br />

Advise the patient to report adverse local and systemic symptoms.<br />

Position the patient sitting up, as for drainage of pleural effusion.<br />

Take equipment trolley to the bedside.<br />

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Place an incontinence sheet under the patient and another over clothing on the side of<br />

the aspiration/instillation.<br />

Thoroughly wash and dry hands prior to glove application. (Refer to local Infection<br />

Control <strong>Policy</strong>).<br />

Ensure protective eyewear is worn.<br />

Open and assemble sterile products and one pair of sterile gloves.<br />

Nursing staff should assist with the administration procedure as required.<br />

Pre-medication should be administered prior to the pleurodesis procedure, as<br />

prescribed.<br />

The cytotoxic drug should be instilled into the pleural cavity by an appropriately trained<br />

and accredited doctor.<br />

The intercostals tube should be clamped for one hour following intrapleural<br />

administration of the cytotoxic drug. This prevents the drug from immediately draining<br />

back out of the pleural space.<br />

Patient rotation is not necessary after intrapleural administration, except for when talc is<br />

used (reference 14).<br />

Following administration by the doctor, ensure the patient has easy access to a call bell<br />

and items for the management of potential emesis.<br />

Dispose of all cytotoxic contaminated waste immediately into cytotoxic waste bin.<br />

Wash hands thoroughly after the procedure.<br />

Drain fluid if required and dispose of as “Cytotoxic Waste” (see section 3.17).<br />

3.12.7 Intraperitoneal administration<br />

Following drainage of the peritoneum, the doctor may wish to instil a cytotoxic drug(s) into<br />

the peritoneal cavity, via the mechanism used for drainage.<br />

Equipment required<br />

Dressing trolley and dressing pack.<br />

10 ml Sodium Chloride 0.9%.<br />

10 ml syringe and needles, as required.<br />

Sterile gloves and plastic apron.<br />

Chemical safety glasses.<br />

Incontinence sheet (x 2).<br />

Hypoallergenic tape.<br />

Procedure<br />

Wash hands before preparing the required equipment<br />

Ensure patient privacy. Ensure the patient is comfortable and has any specific<br />

information required.<br />

Advise the patient to report any adverse local and systemic symptoms.<br />

Position the patient supine with one or two pillows and with the peritoneal access site<br />

exposed.<br />

Take equipment trolley to the bedside.<br />

Place an incontinence sheet under the patient and another over clothing on the side of<br />

the aspiration/instillation.<br />

Thoroughly wash and dry hands prior to glove application. (Refer to local Infection<br />

Control <strong>Policy</strong>).<br />

Ensure protective eyewear is worn.<br />

Open and assemble sterile products and one pair of sterile gloves.<br />

The cytotoxic drug should be instilled into the peritoneal cavity by an appropriately<br />

trained and accredited doctor.<br />

Nursing staff should assist with the administration procedure as required.<br />

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Following administration by the doctor, ensure patient has easy access to call bell and<br />

items for the management of potential emesis.<br />

Dispose of all cytotoxic contaminated waste immediately into cytotoxic waste bin.<br />

Wash hands thoroughly after the procedure.<br />

To ensure the drug comes into contact with the entire peritoneal cavity, turn the patient<br />

as follows<br />

Lay on left side.<br />

Lay on the back.<br />

Lay on the right side.<br />

Lay on the front.<br />

The duration in each position should be 15 minutes, unless otherwise prescribed. Wash<br />

hands thoroughly after the procedure.<br />

Drain fluid if required and dispose of as “Cytotoxic Waste” (see section 3.17).<br />

3.13 Extravasation<br />

Extravasation refers to the accidental infiltration of a drug that has been administered via the<br />

intravascular route into surrounding subcutaneous tissues. It can be associated with<br />

extensive tissue damage.<br />

Speed of diagnosis and prompt initiation of treatment is imperative in the effective<br />

management of extravasation of cytotoxic agents.<br />

Treatment will be dependant on the classification of the cytotoxic drug.<br />

All assessment and treatment interventions must be prescribed by a Consultant,<br />

Specialist Registrar, Staff grade or Clinical Assistant.<br />

The patient‟s consultant must review any extravasation of cytotoxic drugs.<br />

Extravasation of a vesicant drug should be treated as a medical emergency and<br />

treatment should ideally be initiated within 1 hour of the incident.<br />

A referral to a plastic surgeon should be considered for extravasations of vesicant<br />

drugs and patients referred promptly if felt necessary.<br />

If clinical judgement dictates alternative treatment to that described in this protocol full<br />

details of the rationale and the intervention should be documented in the patient‟s<br />

notes.<br />

3.13.1 Diagnosis<br />

Extravasation should be suspected if one or more of the following symptoms occur:<br />

Increased resistance when administering IV drugs<br />

Lack of blood returned from the cannula/CVAD<br />

Change in infusion quality, i.e. reduce flow rate<br />

Any change in colour such as redness/blanching at the injection site<br />

Swelling or oedema around the cannula<br />

Pain or discomfort around the cannula site (stinging or burning)<br />

Inflammation, erythema or blistering around the infusion site<br />

Note: The above points are not diagnostic but in combination they MAY indicate<br />

extravasation.<br />

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The degree of damage caused by extravasation relates to the type and amount<br />

of drug extravasated and the speed with which it is recognised and treated.<br />

Delays in recognition and treatment can increase the risk of tissue necrosis.<br />

3.13.2 Classification of cytotoxic drug<br />

Drugs are classified in this protocol according to whether they are irritant, exfoliant, nonvesicant<br />

or vesicant. Treatment of vesicant extravasation is further classified as<br />

anthracycline or non-anthracycline.<br />

Vesicant: capable of causing pain, inflammation and blistering of the skin, underlying<br />

flesh and necrosis, leading to tissue death and necrosis.<br />

Exfoliant: capable of causing inflammation and shedding of the skin but less likely to<br />

cause tissue death.<br />

Irritants: capable of causing inflammation and irritation, rarely proceeding to breakdown<br />

of tissue.<br />

Drug Classification Treatment<br />

Aclarubicin<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Actinomycin D<br />

(Dactinomycin)<br />

Vesicant<br />

Hyaluronidase and saline flush<br />

out<br />

Alemtuzumab<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Amsacrine Vesicant Hyaluronidase and saline flush<br />

out<br />

Arsenic<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Aspariginase<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Azacytidine<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Bevacizumab<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Bleomycin<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Bortezomib<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Busulfan Vesicant Hyaluronidase and saline flush<br />

out<br />

Carboplatin<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Carmustine Vesicant Hyaluronidase and saline flush<br />

out<br />

Cisplatin<br />

Cladribine<br />

Irritant/Exfoliant/Non<br />

Vesicant<br />

Irritant/Exfoliant/Non<br />

Vesicant<br />

Cold compress<br />

Cold compress<br />

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Clofarabine<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Cyclophosphamide<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Cytarabine<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Cetuximab<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Dacarbazine Vesicant Hyaluronidase and saline flush<br />

out<br />

Dactinomycin<br />

(Actinomycin D)<br />

Vesicant<br />

Hyaluronidase and saline flush<br />

out<br />

Daunorubicin Vesicant anthracycline Hyaluronidase and saline flush<br />

out<br />

+ dexrazoxane<br />

Docetaxel<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Doxorubicin Vesicant anthracycline Hyaluronidase and saline flush<br />

out<br />

+ dexrazoxane<br />

Epirubicin Vesicant anthracycline Hyaluronidase and saline flush<br />

out<br />

+ dexrazoxane<br />

Etoposide<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Floxuridine<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Fludarabine<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Fluorouracil<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Gemcitabine<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Gemtuzumab<br />

Irritant/Exfoliant/Non Cold compress<br />

Ozogamicin<br />

(Mylotarg)<br />

Vesicant<br />

Idarubicin Vesicant anthracycline Hyaluronidase and saline flush<br />

out<br />

+ dexrazoxane<br />

Ifosfamide<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Interleukin – 2<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Irinotecan<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Liposomal<br />

Irritant/Exfoliant/Non Cold compress<br />

Daunorubicin<br />

Liposomal<br />

Doxorubicin<br />

(Adriamycin)<br />

Melphalan<br />

Methotrexate<br />

Vesicant<br />

Irritant/Exfoliant/Non<br />

Vesicant<br />

Irritant/Exfoliant/Non<br />

Vesicant<br />

Irritant/Exfoliant/Non<br />

Vesicant<br />

Cold compress<br />

Cold compress<br />

Cold compress<br />

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Mitomycin C Vesicant Hyaluronidase and saline flush<br />

out<br />

Mitoxantrone<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Mylotarg<br />

Irritant/Exfoliant/Non Cold compress<br />

(Gemtuzumab<br />

Ozogamicin)<br />

Vesicant<br />

Oxaliplatin<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Paclitaxel<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Panitumumab<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Pegasparaginase<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Pemetrexed<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Raltitrexed<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Rituximab<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Streptozocin Vesicant Hyaluronidase and saline flush<br />

out<br />

Teniposide<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Thiotepa<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Topotecan<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Trastuzumab<br />

Irritant/Exfoliant/Non Cold compress<br />

Vesicant<br />

Treosulfan Vesicant Hyaluronidase and saline flush<br />

out<br />

Vinblastine Vesicant Hyaluronidase and saline flush<br />

out<br />

Vincristine Vesicant Hyaluronidase and saline flush<br />

out<br />

Vindesine Vesicant Hyaluronidase and saline flush<br />

out<br />

Vinorelbine Vesicant Hyaluronidase and saline flush<br />

out<br />

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3.13.3 Intervention and Treatment<br />

Use the above table to assess classification of drug and treat according to classification of<br />

drug and type of venous access.<br />

Extravasation Suspected<br />

Peripheral line<br />

Stop infusion/injection immediately<br />

DO NOT REMOVE CANNULA<br />

Disconnect Infusion<br />

Aspirate as much of the drug as possible<br />

from the cannula with a 10ml syringe<br />

Collect the extravasation kit & inform Dr<br />

immediately of irritant/vesicant suspected<br />

extravasation<br />

Central Venous Access Device<br />

Stop infusion/injection immediately & disconnect<br />

Aspirate drug from line<br />

Collect extravasation kit and inform Dr<br />

immediately of suspected irritant/vesicant<br />

extravasation<br />

Central line to remain in-situ<br />

Mark around area with a pen<br />

Remove cannula and mark around the area<br />

with a pen<br />

Elevate Limb<br />

Dr to prescribe treatment according to classification of drug and inform responsible<br />

consultant (out of hours consultant on-call)<br />

Irritant/ Exfoliant/ Non-Vesicants<br />

Apply cold compress to affected area for 20<br />

minutes, 4 times daily for 24 – 48 hours<br />

Vesicants (including vesicant<br />

anthracyclines)<br />

Dr to undertake “Hyaluronidase and saline flush out”<br />

procedure under local anesthetic if required. (see<br />

section3.13.4)<br />

If drug is a vesicant anthracycline, Consultant<br />

Oncologist / Haematologist to prescribe Dexrazoxane<br />

on prescription chart if indicated (see section 3.13.5).<br />

Peripheral line<br />

CVAD<br />

Consultant to consider referral to Plastic<br />

Surgeon for advice on further<br />

management and consideration of<br />

liposuction.<br />

Consultant to refer patient to Plastic<br />

Surgeon urgently for advice on further<br />

management<br />

Complete documentation<br />

• Datix form<br />

• National Extravasation Reporting Scheme Green Card / Extravasation form<br />

• Medical & nursing Documentation<br />

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3.13.4 Hyaluronidase and saline flush out technique<br />

This should only be undertaken by an SpR or Consultant.<br />

Hyaluronidase is most effective if administered within 2 hours of the injury occurring, but<br />

still has benefits up to 12 hours.<br />

Under aseptic conditions clean the site of injury and the immediate surrounding area.<br />

Reconstitute one or two 1500 unit vials of Hyaluronidase in 5-10mls of Lidocaine 1%.<br />

Infiltrate the subcutaneous layer of the area immediately under the site of extravasation.<br />

Using a scalpel make at least 4 small “incisions” into the subcutaneous layerevenly<br />

spaced around the area to be treated.<br />

Insert the tip of a size 18/20g cannula, or 18g “drawing up needle” (which is blunt),<br />

through one of the 4 incisions.<br />

Using a syringe attached to a three-way tap flush up to 1000ml, in 10-20ml aliquots, of<br />

0.9% sodium chloride in turn through each of the 4 incisions.<br />

If the area surrounding the extravasations becomes oedematous gently massage the<br />

area towards the nearest incision site to allow excess fluid to be removed.<br />

Once the procedure has been completed, dress the area with a layer of jelonet and<br />

gauze and elevate the limb for 24 hours.<br />

Consider prescription of prophylactic antibiotics.<br />

The stab incisions should be allowed to close spontaneously and never be sutured.<br />

3.13.5 Vesicant anthracycline extravasation and dexrazoxane<br />

Vesicant anthracyclines are associated with considerable morbidity when involved in<br />

extravasation incidents.<br />

In the event of vesicant anthracycline extravasation, the plastic surgeons should be<br />

consulted and they should be specifically informed that the extravasation involves a<br />

vesicant anthracycline. Hyaluronidase and saline flush out technique should be<br />

performed as per section 3.13.4. If the flush out involves no significant delay it should be<br />

carried out prior to the dexrazoxane, otherwise commence the dexrazoxane without<br />

delay.<br />

Ideally, the plastic surgeon will make a baseline assessment.<br />

However, the administration of dexrazoxane should not be delayed while waiting for their<br />

advice.<br />

Dexrazoxane must be prescribed by a Consultant Oncologist or Haematologist or by the<br />

Plastic Surgeons.<br />

Dexrazoxane is recommended for the following indications:<br />

Anthracycline volume >5ml where extravasation is certain<br />

Anthracycline volume >10ml if extravasation is unclear<br />

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Extravasation from central or PICC line.<br />

Dexrazoxane is administered into the unaffected arm daily for 3 days so appointments<br />

should be made for days 2 and 3 for administration of dexrazoxane and for assessment<br />

by plastic surgery.<br />

Following the 3 day administration of dexrazoxane, the plastic surgery team will advise<br />

on further management.<br />

3.13.6 Plastic surgeon review<br />

If the extravasation occurs via a peripheral line plastic surgeon referral should be considered.<br />

The patient should be referred for an urgent review by the plastic<br />

surgeon if:<br />

Drug is a vesicant or vesicant anthracycline<br />

Drug extravasated via a CVAD<br />

The skin is compromised<br />

Extreme swelling<br />

Significant extravasation<br />

Skin necrosis<br />

3.13.7 Follow up care<br />

The patient should be made aware that the site will remain sore for several days.<br />

Extravasation sites should be observed for pain, erythema, induration and necrosis and the<br />

findings recorded in the medical/nursing documentation.<br />

If the extravasation was caused by a vesicant drug appropriate arrangements should be<br />

made for follow up by the oncologist/haematologist or plastic surgeon.<br />

If the extravasation was caused by a non-vesicant drug the patient should be asked to report<br />

immediately any increase discomfort or significant change, i.e., peeling or blistering of the<br />

skin, to the Department.<br />

3.13.8 Documentation<br />

The signs, symptoms, date and time of the injury should be recorded on a National<br />

Extravasation Reporting Scheme Green Card / Extravasation form. This should then be<br />

photocopied and filed in the patient‟s medical notes as a permanent record of the<br />

assessment of the injury.<br />

The follow up report for the National Extravasation Reporting Scheme should be completed<br />

within 1 month following the incident.<br />

The following information should be documented in the medical records<br />

Time of review by medical staff<br />

Referrals made (who & time)<br />

Arrangements for subsequent follow up appointments required<br />

Outcome of follow up assessments<br />

A datix form should be completed.<br />

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3.14 Out-of-hours initiation and administration of chemotherapy<br />

Whenever possible, all cancer chemotherapy should be initiated, and as much as is<br />

feasible, administered within normal working hours. The risk of accidents is increased<br />

when complex cytotoxic regimens are given outside normal working hours, particularly<br />

errors of incorrect drug and patient identification, and using the incorrect route of<br />

administration of cytotoxic drugs.<br />

Patients may only be commenced on a new chemotherapy regimen beyond normal<br />

Monday to Friday (09.00 to 17.30) working hours in the following circumstances:<br />

Acute Leukaemia - unanticipated admission of a newly diagnosed patient or a<br />

newly diagnosed relapsed patient.<br />

Haematological malignancy patient with CNS involvement.<br />

Superior vena cava (SVC) obstruction - in a patient with small cell lung cancer,<br />

germ cell tumour or a haematological malignancy.<br />

Spinal cord compression – in a patient with germ cell tumours, Ewing‟s sarcoma,<br />

neuroblastoma or a haematological malignancy.<br />

In exceptional circumstances, acute medical crisis brought on by rapidly growing<br />

tumour.<br />

A Consultant Oncologist or Haematologist must determine that it would be absolutely<br />

inappropriate to delay chemotherapy. The decision must be recorded in the medical<br />

notes by the responsible Consultant.<br />

Out of hours oral chemotherapy must only be prescribed by a Consultant or Senior<br />

Registrar who should consult the current UKALL protocol (located in the Paediatric<br />

Oncology nurses office). Patient‟s most recent blood results and drug percentages<br />

documented in the patient‟s notes as well as drug dosage on the front sheet of the<br />

patient‟s blue treatment folder ((located in the Paediatric Oncology nurses office).<br />

Pharmacy and relevant nursing staff should be contacted as soon as possible after the<br />

decision to treat a patient with chemotherapy out of hours has been made.<br />

3.15 Ambulatory and home chemotherapy treatment<br />

<strong>Chemotherapy</strong> is usually given in an appropriate hospital based facility. However, current<br />

practice of chemotherapy and cancer management means that many patients now receive<br />

chemotherapy in settings outside of conventional hospital facilities.<br />

The hospital-based team, regardless of the place of chemotherapy drug delivery retains<br />

the overall responsibility for the patient. It is essential however that the patients GP is<br />

informed of the method and place of chemotherapy delivery and the support package<br />

available, including 24 hour contact numbers.<br />

Many patients may be treated with regimens in which most of the chemotherapy doses<br />

are administered within the hospital setting, but may involve some part of their treatment<br />

also being managed or delivered at home or in the community setting.<br />

Such patients should be regularly reviewed by the hospital based medical or nursing<br />

team to ensure that they are still fit for treatment. The frequency of review will be<br />

dependant on local practice and the chemotherapy regimen.<br />

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Patients must be provided with all appropriate supplementary equipment. This may<br />

include gloves, aprons, cytotoxic sharps bins, cytotoxic spillage kits and dressing packs.<br />

It is essential that patients and carers have received full information and advice<br />

concerning their chemotherapy treatment. They should also have been given adequate<br />

training and support regarding safe handling, storage and disposal of the drug doses and<br />

management of spillages and suspected extravasation. All patients are given emergency<br />

24 hour telephone numbers.<br />

The hospital based nursing or medical staff will undertake an assessment of patient<br />

suitability for continuous infusional chemotherapy before a patient is allocated to receive<br />

treatment.<br />

Walkmed pumps are available for patients receiving infusional chemotherapy.<br />

Only appropriately trained nurses/pharmacists will be allowed to program the device.<br />

Re-programming should take place after each completed patient episode.<br />

Patients based at the <strong>Ipswich</strong> <strong>Hospital</strong> requiring a mechanical device to infuse<br />

chemotherapy over a period of days would be connected to the infusion at <strong>Ipswich</strong><br />

<strong>Hospital</strong> Oncology and Haematology department or an outreach clinic; by an<br />

appropriately trained nurse ; and then arrangements would be made for the patient to<br />

return to the department for disconnection of the infusion. At no point would the<br />

community staff or patient be expected to take on this role.<br />

The administration of subcutaneous cytotoxic boluses in this setting may be by the<br />

patient, the carer or an appropriately trained community nurse. The hospital based<br />

nursing or medical staff will undertake an assessment of patient suitability for treatment in<br />

the home or community setting.<br />

The patients understanding of the above will be assessed using a teaching checklist.<br />

Additional supplementary written information will also be provided.<br />

An home delivery services set up should be in accordance with the Trust Home Delivery of<br />

Medicines <strong>Policy</strong>.<br />

3.16 Oral chemotherapy preparations<br />

3.16.1 Principles<br />

Oral anti-cancer medicines are increasingly being used in hospitals and in the<br />

community. Risks are increased if non-specialist practitioners prescribe, dispense or<br />

administer these oral medicines and bypass the normal safeguards used for injectable<br />

anti-cancer medicines (NPSA/2008/RRR001).<br />

The prescribing and dispensing of oral chemotherapy should be carried out and<br />

monitored to the same standards as those for injectable anti- cancer therapy.<br />

All oral anti-cancer medicines must be prescribed in the context of a written protocol and<br />

treatment plan using an approved proforma and a copy filed in the Medical notes.<br />

Prescriptions for oral chemotherapy drugs must state clearly for each course of treatment<br />

the dose, frequency of administration, intended start date, duration of treatment and<br />

where relevant the intended stop date.<br />

For drugs for which a variety of schedules are common (e.g. capecitabine), it is essential<br />

that the intended schedule is unambiguously specified on every prescription.<br />

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All intended deviations from protocol such as dose modifications should be clearly<br />

identified as such.<br />

Responsibility for the administration of oral drugs ultimately lies with the patient or their<br />

carer, but it is the responsibility of all members of the multi-disciplinary team to ensure as<br />

far as practically possible that they are adequately prepared for this.<br />

Effective communication between primary and secondary care, and with patients, is<br />

pivotal to safe and effective treatment. The prescribing and dispensing should remain the<br />

sole responsibility of the hospital-based oncologist or haematologist and pharmacist<br />

respectively.<br />

Before every treatment cycle, all patients should be seen by an oncologist,<br />

haematologist, specialist pharmacist or nurse.<br />

As most oral chemotherapy will be taken by patients in their home, it is essential that<br />

patients are adequately counselled about their drug therapy, the storage conditions and<br />

handling precautions.<br />

Patients should be advised that medicine spoons, oral syringes or cups should be<br />

reserved for cytotoxic treatment only, and not used for the administration of other drug<br />

doses. They should be washed thoroughly between doses, and safely disposed of after<br />

the treatment course.<br />

The oncologist, haematologist, specialist pharmacist or nurse must ensure that the<br />

patient or carer understand:<br />

How and when to take their medicines, including treatment „gaps‟<br />

What to do in the event of missing one or two doses<br />

What to do in the event of vomiting after a dose<br />

Likely adverse effects and what to do about them<br />

The need for, and how to obtain, further supplies<br />

The role their GP is expected to play in their treatment<br />

Principles of safe handling, storage and disposal (see appendix I)<br />

The use of medicine spoons, oral syringes or cups<br />

As much of this information as possible should first be given at the pre-treatment visit and<br />

reinforced on subsequent visits.<br />

Patients should be provided with details of appropriate and readily accessible 24-hour<br />

points of contact, if further advice is needed.<br />

All Prescriptions must be screened by an appropriately trained and accredited pharmacist<br />

before dispensing.<br />

All pharmacy staff who are, or could be, involved with dispensing oral anticancer drugs<br />

must have access to full copies of the relevant protocols. The information available to the<br />

dispensary staff must address the management of toxicity, the criteria for midcourse dose<br />

adjustments or stopping treatment, and identify in what circumstances and with which<br />

drugs continuous rather than intermittent treatment may be used.<br />

All dispensary staff must have ready access to specialist oncology/haematology<br />

pharmacy advice.<br />

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Dispensary staff should work to detailed standard operating procedures.<br />

Wherever possible pharmacy will purchase only blister or foil packed tablets or capsules<br />

of oral cytotoxic drugs. This will help ensure that accidental contamination is minimised.<br />

All oral chemotherapy drugs dispensed for all prescriptions, including inpatients, should<br />

be labelled as a TTA. The drug name, strength of the preparation, patient‟s name,<br />

quantity provided, full directions and an indication of length of treatment should be on the<br />

label as per local procedure. If the duration of treatment is not clear on the prescription,<br />

the prescriber should be contacted to clarify this. If the treatment is intended for a short<br />

defined course the labels should state this. For example, „Take THREE capsules ONCE<br />

a day for FIVE days, then STOP‟.<br />

All containers of oral cytotoxic preparations, for inpatients and outpatients, should be<br />

labelled with a „Cytotoxic‟ warning label.<br />

When dispensing within pharmacy, tablets or capsules should not be handled directly. All<br />

staff should use a „no touch‟ technique or wear gloves, to minimise the risks of exposure.<br />

Designated counting triangles, which are only used for cytotoxic drugs should be used.<br />

These should be cleaned after use with IMS (Industrial Methylated Spirit 70%), or an<br />

alternative locally approved agent, and a wipe. Wipes should be disposed of in a<br />

Cytotoxic Sharps bin after use.<br />

Oral cytotoxic tablets or capsules should not be dispensed in multi-compartment<br />

compliance aids or monitored dose systems without advice from a specialist Oncology<br />

pharmacist.<br />

When dispensing tablets or capsules, the complete course of treatment should be<br />

supplied.<br />

When dispensing short distinct courses of cytotoxic drugs in liquid formulations, the exact<br />

quantity required (plus an overage of approximately 10mls) should be supplied. Work<br />

over a leak-proof tray to contain any solution in the event of a spillage. For patients who<br />

are on maintenance treatment, it is more appropriate to dispense the drug in its original<br />

container.<br />

All patients must be given patient information leaflets.<br />

Oral cytotoxic preparations can be potentially hazardous if handled carelessly.<br />

Every step should be taken to ensure that accidental exposure, which may arise from<br />

handling uncoated tablets, loose capsules or oral liquids, is minimised.<br />

Oral formulations of cytotoxic drugs should not be handled directly. All staff should use a<br />

„no touch‟ technique or wear gloves, to minimise the risks of exposure.<br />

After handling any oral cytotoxic preparation, hands should be washed thoroughly.<br />

Tablets should never be crushed or halved and capsules should never be opened.<br />

Advice should be sought from pharmacy if alternative formulations are not available and<br />

this is thought to be essential. If an oral liquid formulation is not commercially available,<br />

the Pharmacy Department may be able to prepare an alternative liquid form. In such<br />

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cases, doses will be extemporaneously prepared in an appropriate controlled<br />

environment to give a suitable form ready for administration to the patient.<br />

Patients should swallow tablets or capsules whole and not chew. Patients and carers<br />

should be advised to wash their hands thoroughly after taking or administering any<br />

cytotoxic medication.<br />

Do not use any tablets or capsules if loose powder or liquid is present in the container.<br />

Inform the Pharmacy Department and request replacements.<br />

Oral doses should be dispensed into a medicine pot/cup, prior to administration to a<br />

patient. If the tablet or capsule comes in a blister or foil packed presentation, the dose<br />

units should NOT be pushed out of the original packing. Instead, cut the required<br />

number of dose units from the dispensed strip and put in a medicine pot. The dose can<br />

then be pushed through the blister/foil wrapping by the patient or nurse at the bedside.<br />

This reduces the number of manipulations with the capsules or tablets, and prevents<br />

exposure from opened blisters kept in original containers.<br />

If a tablet or capsule is dropped, pick it up wearing gloves and put the dose in a plastic<br />

bag and dispose of it into a Cytotoxic Sharps box. Damp dust the area with a wet paper<br />

towel to ensure all fragments/particles are collected, and dispose of the towel as<br />

contaminated waste.<br />

If an oral liquid formulation is spilt, wearing gloves, soak up the spill and then clean the<br />

area immediately using soapy water and wipes or paper towels. Dispose of these into a<br />

Cytotoxic Sharps box. For large volumes (e.g. volumes greater than 50mls) consider the<br />

use of the cytotoxic spillage kit.<br />

After administration of oral cytotoxic drugs in hospital, spoons, medicine pots and oral<br />

syringes should be disposed of in a cytotoxic sharps bin.<br />

3.16.2 Prescribing and administration of oral cytotoxic medication in non-oncology<br />

areas<br />

Patients admitted to non-oncology wards on oral anti-cancer medication are at risk from<br />

uncontrolled prescribing. The Doctor must assess the patient‟s current medical condition<br />

to ensure suitability for continued treatment with the medicine and a detailed medication<br />

history must be taken to ensure all information on the dosage of the oral anti-cancer<br />

medicine is known. This also applies to oral anti-cancer medication for non-cancer<br />

indications (such as methotrexate for rheumatoid arthritis). A copy of the original<br />

prescription for the oral anti-cancer medication must be checked and the original<br />

prescriber informed of the admission. Where possible use the patient‟s own supply as the<br />

whole course will have been dispensed.<br />

Oral chemotherapy doses must be CLEARLY prescribed on the drug chart stating the<br />

dose, route and frequency of administration. This is especially important for weekly<br />

doses of chemotherapy medication, namely methotrexate, where crosses should be<br />

marked on the chart grid to avoid daily dosing.<br />

The duration of chemotherapy medication should also be marked on the drug chart for<br />

short(er) courses to avoid unnecessary dangerous continuation.<br />

The prescription must be clinically validated by a pharmacist at ward level before the drug<br />

can be dispensed and/or administered. To show this validation has occurred the chart<br />

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will be endorsed by the pharmacist with „confirmed‟, „pharmacist‟ and their initials and<br />

date. A nurse/midwife must not administer an oral cytotoxic medication without this<br />

validation. This validation will also involve the checking of a patients own supply of<br />

medication when available to ensure it is safe and appropriate to administer. The oral<br />

cytotoxic drug will be marked with a purple sticker by pharmacy to indicate extra cautions<br />

are required.<br />

A nurse/midwife must also check with the patient that their chemotherapy medication is<br />

due before administration.<br />

A list of cytotoxic medication can be found as a laminated version in the drug trolley and<br />

on the Medicines Management intranet site.<br />

3.17 Disposal of cytotoxic waste<br />

3.17.1 Part used doses<br />

Place the syringe/bag in a yellow bag and place into a cytotoxic sharps box. These<br />

should be labelled as cytotoxic waste and sent for incineration.<br />

It should be clearly documented how much of the dose was administered and the<br />

reasons for discontinuation of treatment. Medical staff and pharmacy should also be<br />

notified.<br />

Unused Oral Doses. Any unused oral doses (e.g. tablets that have been dropped or oral<br />

liquids that have been refused etc) should be disposed of in a cytotoxic sharps box. To<br />

minimise the risk of damage and potential contamination, they should be discarded as<br />

follows:<br />

o Loose tablets/capsules: Put into a sealable plastic bag or a medicine bottle /<br />

sample pot securing the lid, before placing in a cytotoxic sharps box.<br />

o<br />

Oral liquids: Pour into a sample pot securing the lid, before placing in a cytotoxic<br />

sharps box.<br />

3.17.2 Used disposal equipment<br />

While wearing gloves and plastic apron place any needles, syringes, giving sets, empty<br />

ampoules/vials, infusion bags or packaging into a rigid cytotoxic sharps disposal box.<br />

Giving sets should not be removed from infusion bags prior to disposal.<br />

The sharps disposal box should be clearly labelled as cytotoxic waste so it can be<br />

incinerated at 1000ºC to ensure degradation of the cytotoxic agent.<br />

Sharps disposal boxes containing cytotoxic waste must be regularly collected.<br />

Re-usable plastic or metal trays should be rinsed with cold water (to remove traces of<br />

cytotoxic agents) and then washed with detergent and hot water (to prevent crosscontamination).<br />

Wear gloves.<br />

Reusable equipment (eyewear and respirators) may be cleaned thoroughly with mild<br />

detergent and water for reuse.<br />

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Protective clothing, plastic aprons and gloves worn during the administration of<br />

chemotherapy should be placed in a clinical waste disposal bag or sharps box, marked<br />

as cytotoxic waste and sent for incineration.<br />

3.17.3 Patient Waste<br />

Patient waste e.g. urine, faeces, vomit may contain high concentrations of cytotoxic drugs<br />

or active metabolites both during administration and up to seven days after treatment has<br />

ceased. Particular care should be taken with patients receiving high dose chemotherapy<br />

or intravesical treatment.<br />

It has been shown that these unchanged cytotoxic drugs or active metabolites can be<br />

irritant to the skin, eyes and mucous membranes. Although evidence of long-term toxicity<br />

is inconclusive and conflicting, all staff handling waste should take reasonable<br />

precautions to limit exposure and ensure absorption does not occur.<br />

The use of universal precautions applies here as with all body fluids<br />

Wear gloves and protective aprons.<br />

Double flushing of sluices after emptying potentially cytotoxic contaminated<br />

matter from bedpans, catheter bags, dialysis bags etc is recommended.<br />

Staff are advised to follow the precautions described in the Control of Infection<br />

<strong>Policy</strong>.<br />

Soiled bedding and linen should be placed in a red soluble –seamed bag, closed and<br />

then placed into a red material bag and a cytotoxic hazard label attached. .<br />

3.18 Personal accidents and spillages<br />

3.18.1 Skin contamination<br />

If a patient, member of staff or visitor is involved in a spillage of cytotoxic drugs or<br />

potentially contaminated patient waste the following procedures must be followed.<br />

All such events/accidents should be reported to a senior member of staff and fully<br />

documented on a datix incident report form.<br />

Remove any contaminated clothing immediately.<br />

The contaminant must be removed as rapidly as possible by flushing the affected area<br />

with a large volume of cold water. If running water is not immediately available, bottles or<br />

bags of sterile water or normal saline should be kept as an alternative.<br />

After initial copious flushing with water, the contaminated skin should be thoroughly<br />

washed with liquid soap or antiseptic scrub and water. After rinsing, the process should<br />

be repeated.<br />

Shower facilities should be available for use if large areas of skin are contaminated.<br />

Do not use hand creams and emollients as these may aid absorption of the drug.<br />

Medical attention may be sought from the Accident & Emergency Department.<br />

A datix form must be completed, and the Head of Department & Occupational Health<br />

informed.<br />

Any contaminated clothing must be removed immediately. Put on gloves and an apron.<br />

Rinse the clothing under running tap water. Squeeze dry and place in a plastic bag.<br />

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Uniforms or hospital linen contaminated with cytotoxic material should be placed in a red<br />

soluble- seamed bag, closed and then into a red material bag and a cytotoxic hazard<br />

label attached. .<br />

Personal clothing should be taken home for laundering. Such items should be laundered<br />

twice where possible. The first wash should be separate from other clothing. They may<br />

be laundered with other items for the second wash.<br />

Dispose of gloves and apron into a double yellow clinical waste bag.<br />

If there is a likelihood that the drug has soaked through the outer clothing, underwear<br />

must be removed and treated as above, and the area of skin treated as above.<br />

3.18.2 Eye contamination<br />

If contact occurs with the eyes the contaminant must be removed as rapidly as possible<br />

by flushing the eyes and surrounding areas with a large volume of sterile normal saline /<br />

water. Alternatively cold tap water can be used if necessary.<br />

Medical attention must be sought immediately from the Accident & Emergency<br />

Department.<br />

A datix incident report form must be completed and the Head of Department &<br />

Occupational Health informed.<br />

3.18.3 Needlestick injury<br />

In the event of a needlestick injury<br />

Allow the wound to bleed freely.<br />

Wash the puncture site/wound thoroughly with copious amounts of cold water.<br />

If the needle contained any cytotoxic drug contaminant, check the vesicant status of<br />

the drug by referring to the extravasation policy, or by seeking advice from a senior<br />

oncology or haematology pharmacist.<br />

Report the incident immediately to a senior member of staff.<br />

Follow the Trust‟s Needle stick injury procedure, and consider seeking advice from<br />

the Accident & Emergency Department or Occupational Health, especially if the<br />

needle had been in contact with a patient.<br />

3.18.4 Spillage<br />

A cytotoxic spillage kit must be available, at all times, in all clinical areas where cytotoxic<br />

drugs are administered, and in all pharmacy areas where cytotoxic drugs are handled or<br />

stored. All staff must know how to use it and where it is stored. If a kit is used it must be<br />

replaced immediately. At no times must access to a kit be impeded by blocking the<br />

surrounding area.<br />

Cytotoxic spillage kits are available from oncology pharmacy.<br />

In the event of a cytotoxic spillage<br />

Restrict access to the spillage area.<br />

Alert other members of staff in the vicinity and inform a senior member of staff.<br />

If you have been injured or contaminated, another member of staff must deal with the<br />

spillage while you receive attention for the injury or contamination following the<br />

procedure detailed in Section 3.18.1/2/3<br />

New and expectant mothers should not have direct involvement in the management<br />

of a cytotoxic spillage.<br />

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Turn off all fans and reduce any draughts.<br />

Open a Cytotoxic Spillage Kit and follow the instruction within.<br />

If protective clothing has been contaminated during the spillage, remove the<br />

contaminated items and put on fresh protective clothing from the spillage kit. Place<br />

all contaminated items in the 'sharps' bin.<br />

The procedure as outlined in the pack should be followed. Such procedures should<br />

also be accessible in all relevant ward, clinic and pharmacy areas.<br />

SECTION 4 – TRAINING AND EDUCATION<br />

Training of all medical, nursing, pharmacy, portering, domestic and any other staff who<br />

handle cytotoxic drugs or cytotoxic waste is essential. Such staff should understand the<br />

potential hazards associated with cytotoxic drugs and be familiar with relevant procedures.<br />

4.1 Medical and Nursing Staff<br />

4.1.1 Oncology and Haematology Department<br />

Nursing and medical staff who are likely to be involved in the prescribing, preparation and/or<br />

administration of cytotoxic drugs should undergo the following initial training programme:<br />

Be familiar with all relevant local guidance.<br />

Be familiar with the national guidance and local policy on intrathecal chemotherapy and<br />

receive training on the administration of intrathecal chemotherapy where appropriate.<br />

This will include warning about the dangers of inadvertent administration of vinca<br />

alkaloids.<br />

Be familiar with local treatment protocols and information on the specific hazards<br />

associated with the drugs used.<br />

Have completed an agreed training programme and have had their competence<br />

assessed.<br />

Be familiar with the procedures for intravenous, oral and other routes of chemotherapy<br />

administration<br />

Be familiar with peripheral and central venous access devices, including line<br />

complications.<br />

Be familiar with mechanical pumps and other devices used for chemotherapy service<br />

delivery.<br />

Able to recognise signs and complications of myelosuppression.<br />

Be familiar with common chemotherapy side effects including nausea, vomiting,<br />

stomatitis, diarrhoea, phlebitis and alopecia.<br />

Be familiar with chemotherapy related oncological emergencies including extravasation,<br />

anaphylaxis and neutropenic sepsis.<br />

Be familiar with the<br />

Treatment of anaphylaxis.<br />

Treatment of extravasations of vesicant and non-vesicant agents.<br />

Management of anaphylaxis<br />

Management of neutropenic sepsis<br />

Be familiar with the procedure for handling cytotoxic spillages.<br />

Be aware of the location of information sources, and extravasation and spillage kits.<br />

Nursing staff who have not previously been competent in administering<br />

chemotherapy will attend a formal study day relating to chemotherapy administration.<br />

Following training, nursing staff will work through the agreed Anglia Cancer Network<br />

<strong>Chemotherapy</strong> Core Education Package with the assistance of their mentor They may<br />

not administer unsupervised until they have been assessed as competent using the<br />

agreed competencies. Once these have been signed off by their assessor a copy will<br />

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e filled in the staff member‟s personal file and their name added to the<br />

chemotherapy competent register.<br />

Nursing staff who solely check chemotherapy will be required to complete modules 1-4 of the<br />

Anglia Cancer Network <strong>Chemotherapy</strong> Core Education Package.<br />

The chemotherapy competent register of named nursing staff who have been reviewed as<br />

competent to administer chemotherapy unsupervised is maintained and held within the<br />

Quality Manual.<br />

The roles of mentor and assessor are clearly defined within the Anglia Cancer Network<br />

<strong>Chemotherapy</strong> Core Education Package.<br />

The lead <strong>Chemotherapy</strong> Nurse will sign off assessors at band 7, thereafter the role of<br />

assessor will be undertaken by designated band 6 chemotherapy nurses, all assessors will<br />

be required to complete the competency for chemotherapy administering chemotherapy<br />

(NSW/REC/19) at assessor level.<br />

Nursing staff on the register will be asked to re confirm their competence annually<br />

and should attend a chemotherapy update session annually as well as completing the<br />

competency for administering chemotherapy (NSW/REC/19) and Nursing staff competencies<br />

(NSW/REC/10).<br />

The chemotherapy nurses based on Somersham ward are responsible for the<br />

chemotherapy education and training of ward based nursing staff and the outpatient<br />

matron is responsible for the education and training of outpatient based nursing staff .<br />

Areas administering cytotoxic agents outside of Oncology / Haematology will need to define<br />

the specific training requirements and competency levels of staff involved.<br />

4.1.2 Child Health<br />

Nurses and Medical staff must have attended the ACN training day and have<br />

completed the appropriate modules of the ACN Paediatric <strong>Chemotherapy</strong> education<br />

package for community and shared care.<br />

Medical staff involved in the prescribing of Paediatric regimens will receive further<br />

training from the PTC.<br />

The Paediatric Oncology training register of named nursing staff who have been<br />

reviewed as competent to administer chemotherapy unsupervised is maintained<br />

and held centrally on the communications drive and a hard copy maintained and kept<br />

in the Paediatric Oncology Office.<br />

4.2 Pharmacy Staff<br />

4.2.1 Handling<br />

Pharmacy staff who are involved in the handling of cytotoxic drugs e.g. receipt of goods,<br />

packaging, storage, transportation etc., must have their names entered on a central file at<br />

each Trust, having satisfactorily completed the following initial training programme:<br />

Read the sections in the cytotoxic guideline that are relevant to their work.<br />

Have received training and education on the health risks associated with handling<br />

cytotoxic drugs.<br />

Be familiar with local treatment protocols and information on the specific hazards<br />

associated with the drugs used.<br />

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Read local pharmacy procedures and receive a practical demonstration of the relevant<br />

activities (such as dealing with a cytotoxic spillage), provided by the designated officer or<br />

the pharmacist acting under his / her authority.<br />

4.2.2 Preparation<br />

Professional and technical staff who are expected to participate in the preparation of<br />

parenteral cytotoxic drugs must be approved following the completion of the competency<br />

program. The pharmacy manager will maintain a register of approved staff and will ensure<br />

their training is updated at appropriate intervals.<br />

4.2.3 Clinical Screening of <strong>Chemotherapy</strong> Prescriptions<br />

Pharmacists who are involved in the clinical screening of chemotherapy prescriptions and/or<br />

provide a clinical pharmacy service to wards where Haematology/Oncology patients are<br />

cared for should undertake an additional training program. Only once assessed as<br />

competent, can prescriptions be checked unsupervised.<br />

4.2.4 Clinical screening and dispensing of Oral <strong>Chemotherapy</strong> Prescriptions<br />

Pharmacists who are involved in the clinical screening and dispensing of oral chemotherapy<br />

prescriptions should undertake an additional training program. Only once assessed as<br />

competent, can prescriptions be screened or dispensed doses checked unsupervised.<br />

4.3 Domestic Staff<br />

All domestic staff involved in cleaning duties in clinical areas should have received training<br />

and education on the health risks associated with cytotoxic drugs and cytotoxic waste, and<br />

the consequences of ineffective cleaning.<br />

4.4 Portering Staff<br />

All portering staff involved in transporting cytotoxic drugs should have received training and<br />

education on the health risks associated with cytotoxic drugs and cytotoxic waste.<br />

SECTION 5 – DEVELOPMENT AND IMPLEMENTATION INCLUDING<br />

DISSEMINATION<br />

Following approval this policy will be disseminated within the Oncology and Haematology<br />

directorate and other directorates involved in the administration of cytotoxic chemotherapy<br />

for cancer. It will also be placed on the intranet.<br />

The clinical practices in this policy were implemented following initial approval. Any change in<br />

clinical practice will be reflected in the updating of this policy in consultation with the<br />

<strong>Chemotherapy</strong> Working Group.<br />

SECTION 6 – MONITORING COMPLIANCE AND EFFECTIVENESS<br />

Adherence to this policy will be monitored by the Oncology and Haematology directorate as<br />

part of established governance arrangements. This includes review of clinical incidents<br />

relating to chemotherapy in both CST (Clinical Service Team) and Governance and<br />

<strong>Chemotherapy</strong> Working Group meetings.<br />

Ongoing clinical audit will also be utilised to measure compliance.<br />

The effectiveness of the policy will be subject to ongoing review by the <strong>Chemotherapy</strong><br />

Working Group.<br />

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SECTION 7 – CONTROL OF DOCUMENT INCLUDING ARCHIVING<br />

ARRANGEMENTS<br />

7.1 Once ratified by the Patient Safety Committee the Responsible Officer will forward<br />

this document to the Information Governance Department for a document index<br />

registration number to be assigned and for the document to be recorded onto the<br />

central hospital master index and central library of current documentation.<br />

7.2 In order that this document adheres to the hospital‟s Records Management <strong>Policy</strong>,<br />

the Information Governance Department will:<br />

Ensure that the most up-to-date version of this document is stored on the<br />

documentation library.<br />

Archive previous versions of this document.<br />

Retain previous versions of this document for a period of time in accordance with<br />

the NHS Records Retention and Disposal Schedule.<br />

This policy will be made available on the trust‟s intranet.<br />

The Oncology Matron is responsible for ensuring that this procedure adheres to the Trust‟s<br />

Record Management <strong>Policy</strong>, including retention and archiving arrangements.<br />

SECTION 8 – SUPPORTING COMPLIANCE AND REFERENCES<br />

As part of the Trust‟s networking arrangements and sharing best practice, the Trust supports<br />

the practice of sharing documents with other organisations. However, no document or part<br />

thereof so shared must be used by any third party for its own commercial gain.<br />

Release of any strategy, policy, procedure, guideline or other such material must be agreed<br />

with the Lead Director or Deputy/Associate Director (for Trust-wide issues) or Directorate/<br />

Departmental Management Team (for Directorate or Departmental specific issues). Any<br />

requests to share this document must be directed in the first instance to Oncology Matron. If<br />

it is thought that the document may attract Intellectual Property rights, the advice of the<br />

Trust‟s Intellectual Property Lead should be sought.<br />

When the document is forwarded to another organisation, the Trust must give its express<br />

(i.e. written) permission for the document to be used by the requesting organisation which<br />

may only reproduce it internally within their own organisation for their own requirements. The<br />

requesting organisation may not forward it onto any other party. Ownership/copyright is<br />

acknowledged at the beginning of the document by including the phrase:<br />

"Reproduced with the kind permission of the (insert name) department, The <strong>Ipswich</strong> <strong>Hospital</strong><br />

NHS Trust."<br />

Where <strong>Policy</strong> or any other document are used in clinical or other situations that might give<br />

rise to litigation the following phrase must also be inserted in the document and reemphasised<br />

in the covering letter to the requesting organisation:<br />

"The copyright of this document lies with The <strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust and the author(s)<br />

as employee(s) are not liable for its contents. The <strong>Ipswich</strong> <strong>Hospital</strong> NHS Trust cannot be held<br />

responsible for any loss, damage or injury incurred by any individual or group using these<br />

<strong>Policy</strong>."<br />

Further advice is available from the Trust's Legal Services Manager.<br />

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<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011


References<br />

1. Department of Health (2004) Manual for Cancer Services<br />

2. Department of Health (2008) HSC 2008/001 Updated national guidance on the safe<br />

administration of intrathecal chemotherapy<br />

3. HSE Information Sheet (2003) MISC 615. Safe handling of cytotoxic drugs<br />

4. Practice for the Safe Handling of Cytotoxic Drugs in Pharmacy Departments. Aud J<br />

<strong>Hospital</strong> Pharm. 1999; 29 (2): 108-116<br />

5. Risk Assessment Requirements. HSE.<br />

6. COSHH Regulations 2002. HSE.<br />

7. March guidelines (www.marchguidelines.com)<br />

8. Good Practice in Consent (2001), HSC 200/023<br />

9. Mallet J and Dougherty L (ed) (2000). Manual of clinical nursing procedures fifth edition.<br />

The Royal Marsden <strong>Hospital</strong>. Blackwell Science.<br />

10. Standards for Infusion Therapy. Royal College of Nursing. October 2003.<br />

11. Antunes G et al. BTS Guidelines for the Management of Malignant Pleural Effusions.<br />

Thorax 2003 (Suppl II):ii29-ii38.<br />

12. Dougherty L (1999) Safe handling and administration of intravenous cytotoxic drugs. In<br />

Dougherty L, Lamb J (1 st ed.) Intravenous therapy in nursing practice. Edinburgh:<br />

Churchill Livingston. Chapter 16.<br />

13. Allwood M, Stanley A, Wright P (2002) The Cytotoxics Handbook 4 th ed. Radcliffe<br />

Medical Press. ISBN 1 857775 504<br />

14. Gault D T (1993) Extravasation injuries. British Journal of Plastic Surgery March: 46<br />

(2):1991-1996.<br />

15. Stamford B L & Hardwicke F. A Review of Clinical Experience with Paclitaxel<br />

Extravasations. Support Care Cancer (2003) 11; 270-277<br />

16. Mourisden H.T. et al Ann Oncol doi: 10.1093/annonc/mdl413<br />

17. For better, for worse A review of the care of patients who died within 30 days of<br />

receiving systemic anti-cancer therapy. National Confidential Enquiry into patient<br />

outcome and death, 2008.<br />

18. <strong>Chemotherapy</strong> Services in England: Ensuring quality and safety. A report from the<br />

National <strong>Chemotherapy</strong> Advisory Group, 2008.<br />

19. National Patient Safety Agency Rapid Response Report, 2008, RRR004, Using Vinca<br />

Alkaloid mini bags (Adult / Adolescent units) 11 th August 2008.<br />

20. National Patient Safety Agency, 2008, RRR001. Risks of incorrect dosing of oral anticancer<br />

medication.<br />

Registered Document 1005 Page 48 of 48<br />

<strong>Chemotherapy</strong> <strong>Policy</strong> v3.0 Implementation Date 1 December 2011

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