Chemotherapy Policy - Ipswich Hospital
Chemotherapy Policy - Ipswich Hospital
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document is superseded.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document is superseded.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 />
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<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 />
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<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 />
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<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 />
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<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 />
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<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 />
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<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 />
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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 />
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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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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 />
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