Cytotoxic Drugs for Adult Patients in Oncology and Haematology

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Cytotoxic Drugs for Adult Patients in Oncology and
Haematology
(Prescribing, Handling and Administration)
Version
7
Name of responsible (ratifying) Committee
Chemotherapy Governance Committee (CGG)
Date ratified
21 November 2014
Document Manager (job title)
Senior Nurse Oncology/Haematology
Date issued
09 February 2015
Review date
08 February 2017
Electronic location
Clinical Policies
Related Procedural Documents
Key Words (to aid with searching)
Cytotoxic, Chemotherapy, Oncology,
Haematology, Oral, Intravenous,
Subcutaneous, Teratogenic, Safe Handling,
COSHH, Vesicant
Version Tracking
Version
Date Ratified
Brief Summary of Changes
Author
7
21/11/14
Change of format.
Change of Dr responsibilities to specify as Prescriber
responsibilities.
Clarification of non-medical prescribers and changes of
areas allowed to give chemotherapy to include Renal,
Out-patients, Theatres. To distinguish between nurses
who can administer just monoclonal drugs or all types of
chemotherapy.
Re-written section on workload issues
Removed Holistic Assessment as Appendix
Catrin Watkinson
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
Version: 7
Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
Page 1 of 37
CONTENTS
QUICK REFERENCE GUIDE....................................................................................................... 3
1. INTRODUCTION.......................................................................................................................... 4
2. PURPOSE ................................................................................................................................... 4
3. SCOPE ........................................................................................................................................ 4
4. DEFINITIONS .............................................................................................................................. 4
5. DUTIES AND RESPONSIBILITIES .............................................................................................. 5
6. PROCESS ................................................................................................................................... 8
7 TRAINING REQUIREMENTS ....................................................................................................... 22
8. REFERENCES AND ASSOCIATED DOCUMENTATION ............................................................. 23
9. EQUALITY IMPACT STATEMENT ............................................................................................... 23
10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS ......................................... 24
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
Version: 7
Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
Page 2 of 37
QUICK REFERENCE GUIDE
This policy must be followed in full when developing or reviewing and amending Trust procedural
documents.
For quick reference the guide below is a summary of actions required. This does not negate the need
for the document author and others involved in the process to be aware of and follow the detail of this
policy.
1. Chemotherapy should only be administered if prescribed on the correct prescription with all
the appropriate information and supporting evidence i.e. blood results, performance status,
consent etc. available on the chart.
2. Only staff who have received appropriate training and are deemed competent should
administer chemotherapy.
3. Patients must be told to inform a member of staff if, at any time the infusion is painful or they
feel unwell in any way.
4. Before administering chemotherapy staff need to ensure they have correctly identified the
patient and consent has been obtained.
5. All patients must be reviewed clinically prior to the administration of cytotoxic chemotherapy.
For day 1 of a cycle patients must be reviewed by the prescriber or their appointed deputy.
For subsequent days of treatments e.g. Day 8 and / or 15 this review may be carried out by a
nurse. In all cases this review for ‘fitness to proceed’ must be documented in the patient’s
healthcare record.
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
Version: 7
Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
Page 3 of 37
1. INTRODUCTION
Portsmouth Hospitals NHS Trust (PHT) is committed to safeguarding patients, staff and others
who may come into contact, either directly or indirectly with cytotoxic drugs. Cytotoxic drugs
work directly or indirectly by causing cell death and may be mutagenic, teratogenic and
carcinogenic. Their inherent toxicity has led to concerns over the potential hazards to health
workers and other personnel who may be exposed to them. It is essential that safe practices
and high standards of care are maintained at all times.
The National Chemotherapy Advisory Group (NCAG) was established to advise the National
Cancer Director and the Department of Health on the development and delivery of high quality
chemotherapy services. NCAG was asked to produce a report to address the significant
concerns raised over the past year in the National Confidential Enquiry into Patient Outcomes
and Death (NCEPOD) and from cancer peer review regarding the safety and quality of
chemotherapy services in this country. Their report addressing these concerns was published
for consultation and emphasizes the need for teamwork and for teams to work together within
hospitals and across networks. The careful provision of care by teams who communicate well
is central to this. The National Chemotherapy Advisory Group believes that the implementation
of the recommendations made in this report will ensure that these ‘3 Cs’ are ever present in
cancer chemotherapy so that the patient remains the true focus of all our efforts.
2. PURPOSE
The purpose of this policy is to:
 Provide a clear framework and guidance for the safe prescribing, handling and administration
of cytotoxic drugs to adult patients within the departments of Oncology and Haematology.
 To ensure a consistent approach to the prescribing, handling and administration of cytotoxic
drugs to adult patients within Oncology and Haematology.
 To ensure that all members of staff involved in any stage of the process of preparation,
handling, administration or disposal of cytotoxic drugs or the handling of equipment used in
their preparation, administration or disposal should be adequately prepared and trained
appropriate to their level of need.
3. SCOPE
All staff employed by the Trust who have contact with cytotoxic drugs and/or provide care to patients
receiving treatment with cytotoxic drugs within the departments of Oncology and Haematology at
Queen Alexandra Hospital will adhere to this policy. This will include doctors, nurses (including both
those professionally qualified and unqualified students and Health Care Support Workers), pharmacy
professionals, technical staff, facilities management and clerical staff working in the relevant areas.
Staff providing a chemotherapy outreach service to St Richard’s Hospital Chichester will abide by St
Richard’s local policies and guidelines.
All aspects of this policy and associated documents apply to both solid tumour Oncology and
Haematology adult patients unless otherwise specifically stated.
4. DEFINITIONS
The term “cytotoxic drug” is generally used for agents which are toxic to cells and hence can be used
in the treatment of cancers and in some non-malignant conditions such as rheumatoid arthritis.
For the purpose of this documents, the term chemotherapy refers to all drugs with direct anti-tumour
activity, including conventional cytotoxic chemotherapy, monoclonal antibodies as well as targeted
therapies e.g. imatinib.
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
Version: 7
Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
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COSHH (Control of Substances Hazardous to Health) regulations under the Health and Safety at
Work Act (1974) places a duty of care on all employers to ensure that measures are in place to
reduce the potential risks to staff and other personnel.
Extravasation. This is the inappropriate or accidental administration of chemotherapy into the
subcutaneous or sub-dermal tissues rather than into the intravenous compartment.
5.
DUTIES AND RESPONSIBILITIES
Head of Chemotherapy Services
 The Head of Chemotherapy Services will ensure PHT has an appropriate policy for the
safe handling and administration of chemotherapy and is responsible for ensuring
implementation and adherence to this policy.
 Role and Responsibilities: see Appendix 1
Lead Nurse for Chemotherapy
 Overall responsibility for training, health and safety.
 Role and Responsibilities: see Appendix 2
Lead Oncology / Haematology Pharmacist
 Overall responsibility for clinical issues relating to cytotoxic chemotherapy
 Responsibilities: see Appendix 3
Prescribers (including non-medical prescribers)
In keeping with the National Chemotherapy Advisory (NCAG) recommendations (2009) the decision
to treat a patient with chemotherapy should be made following an open discussion between the
patient and their consultant. Treatment options should be in line with standard practice and must be
discussed at an appropriate Multidisciplinary Team Meeting (MDT). This decision must take into
account what is believed to be in the best interest of the patient.
Prescribers who are able to prescribe Chemotherapy
Only appropriately qualified and competent clinicians, who have successfully undertaken agreed
training, are able to initiate and prescribe courses of chemotherapy for treatment of cancer patients.
These include:
 Consultant Medical Oncologists
 Consultant Clinical Oncologists
 Consultant Haematologists
 Staff Grade Registrars at level ST3 and above
 Non-medical prescribers who are registered at PHT and within their agreed scope of competency.
Non-medical prescribers cannot prescribe the first cycle of chemotherapy. (See further information
below).
The prescriber should inform the patient’s general practitioner of the intention to start the course of
chemotherapy and provide sufficient information for action to be taken in the event of the patient
experiencing side effects.
Prescribing of second or subsequent cycles may be delegated to Specialist Registrars in training
(ST3 or above) or non-medical independent prescribers who have completed the necessary training,
are registered with their professional body and are authorised by PHT to prescribe within their
competence. Delegation of this responsibility is only permitted if the relevant Consultant has given
clear written details of the patient’s treatment plan, documented this in the patient’s healthcare record
and if the regimen being prescribed is included in the PHT agreed list of regimens. If modifications of
doses are required, the Consultant or the Specialist Registrar in training (ST3 or above) must
document this in the healthcare record. For non-medical prescribers, if such modifications are
outlined in the patient’s protocol then the same applies.
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
Version: 7
Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
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Medical doctors who are provisionally registered with the GMC (FY1) MUST NOT prescribe
chemotherapy for the treatment of malignant disease.
Non-medical prescribers authorised to prescribe medicines at PHT will be included on a Trust
register of non-medical prescribers.
Non-medical prescribers must comply with the PHT Medicines Management Policy and related codes
of practice.
Non-medical prescribers may only prescribe medicines for NHS patients under the care of PHT
within the specialty in which they have demonstrated competence.
Non-medical prescribers will be expected to recognise those situations where it is inappropriate for
them to prescribe.
The non-medical prescriber is accountable for:
 The assessment of patients with diagnosed or undiagnosed conditions and for decisions
about the clinical management required, including prescribing.
 Carrying out reviews of the patient’s progress at regular intervals, including the recording
of performance status, investigational results and serious toxicities following a previous
cycle of chemotherapy, depending on the nature and stability of the patient’s condition.
 Identifying possible drug related adverse incidents and reporting them via the PHT Datix
scheme and where appropriate to the MHRA via the Yellow card scheme.
 Accepting professional accountability and clinical responsibility for their prescribing.
All prescribers are responsible for:
 Checking the allergy status of the patient and checking for any potential interaction
between patient’s current medicines and their chemotherapy or supportive care
medicines.
 Confirming the appropriate regimen from the agreed list of regimens for the tumour site
concerned.
 Where appropriate completing any necessary processes to secure Cancer Drugs Fund
approval.
 Ensuring that the body surface area (BSA) calculations are appropriate and have been
made using a recent weight.
 Amending doses in line with agreed dose banding agreements.
 Prescribing and monitoring of all cytotoxic drugs and supportive therapies including
antiemetics and hydration. This includes the on-going monitoring of toxicities and
amendment of supportive medicines where required.
 Ensuring that maximum cumulative doses of anthracyclines and bleomycin have not been
exceeded.
 Specifying the route of administration and for parenteral doses, the duration of infusion on
the prescription.
 Ensuring the patient has appropriate venous access prior to prescribing infusions of
vesicants.
 Ensuring there is an appropriate interval between each treatment day and cycle within the
course, as defined by the protocol.
 Ensuring the patient is given written information regarding the chemotherapy treatment
they will be given.
 Ensuring the patient is fully informed of their treatment and has given consent.
 Ensuring the patient’s treatment plan is summarised and sent to their GP, prior to starting
a course of treatment. The plan should include details of:
Treatment regimen
Planned duration
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
Version: 7
Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
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Treatment intent: palliative, curative, adjuvant, neo-adjuvant, other
Planned start date, if known
Ensuring that all relevant safety parameters such as blood counts, renal and hepatic
function have been checked and that the patient is fit to receive treatment. If doses are
modified due to variance of these parameters, the reason for dose modification should be
recorded on the prescription and in the patient’s healthcare record.
If a patient is to be treated with a chemo-radiation protocol it is essential that this is clear
on the prescription.
If the patient is to be treated ‘off-protocol’ then the necessary form must be completed and
approved. (Available from pharmacy pages on intranet.)
Wherever possible, chemotherapy should be initiated during normal working hours when
access to specialist staff is more likely to be available. Only in exceptional circumstances
may chemotherapy be initiated outside of normal working hours.
Prescriptions for all cytotoxic drugs should be produced electronically on Aria (or preprinted proforma for those not available on Aria), not verbally, and changes to any
prescriptions must be documented electronically or in writing and signed and
communicated to all those necessary – specifically pharmacy.
Ensuring pre-prescription of the majority of elective IV chemotherapies preferably 48
hours prior to treatment so that doses can be prepared in advance of patients attending
for treatment.
Alerting the pharmacy in the event of re-issuing an already fully-authorised treatment
where there have been changes made to drugs or doses (i.e. not just a change in date).
After the final cycle within a given course, the prescriber should ensure that there is a
treatment record for each patient stating whether the course was completed or not. If the
course was not completed, the reasons for early cessation should be documented. For
completed courses of non-adjuvant treatment, a reference to the response should be
documented.
An ‘End of treatment’ summary should be offered to the patient and sent to the patient’s
GP and any other relevant health care professionals.
Registered Nursing Staff
 To ensure that they undertake training and achieve and maintain competency in
chemotherapy administration.
 Correct storage of drugs before use.
 Clarify that the prescription chart is completed correctly and that blood results are doublechecked and are satisfactory before proceeding.
 Confirm that the patient has consented to chemotherapy treatment. The nurses must
double-check the consent form and discuss the side effects of chemotherapy with the
patient and give the patient a copy.
 Ensure that the patient is fit to receive chemotherapy by checking the patient’s
performance status and that their clinical status has not changed since the last medical
review.
 To undertake a holistic assessment.
 To administer the correct prescribed drug and dose to the right patient.
 To carefully monitor the patient during the administration of drugs being vigilant to observe
any signs of extravasation, severe allergic reactions, fluid overload, etc.
 To make appropriate referrals and provide patient information regarding the treatment and
any side effects during and following treatment.
 To provide a HEAT card containing key information about contact details in case of
emergency and written information about the side effects of chemotherapy.
 To document the administration of chemotherapy including any adverse events.
 To rehearse with patients what they should do in the event of developing a complication.
This should include consideration of which hospital they would attend and how they would
get there both during and out of working hours.
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
Version: 7
Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
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Liaising with the community nursing team and/or key worker as appropriate to ensure
ongoing support.
Unregistered Nursing Staff (students and Health Care Support Workers)
 To provide support to trained staff in the performance of their duties.
 To be aware of and observe appropriate precautions when handling contaminated
equipment and waste including body fluids.
Pharmacist Responsibilities
An appropriately trained pharmacist who is accredited and on the Trust register, must clinically
screen all prescriptions for cytotoxic drugs intended for the treatment of malignant disease and
document that the prescription has been clinically screened.
Prior to a cytotoxic dose being prepared the pharmacist must verify the prescription according to the
protocol or treatment regimen, clarify and resolve any discrepancy and check that:
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The appropriate regimen / protocol / proforma has been selected, with correct
sequencing.
If an ‘off protocol’ regimen is prescribed that the necessary paperwork and approval is in
place.
To confirm when required that approval for funding is in place e.g. Cancer Drugs Fund.
The route of administration and duration of infusion have been specified on the
prescription.
To check most recent blood results (no more than 72 hours old for 3 weekly
chemotherapy and no more than 24 hours for weekly and day 8 chemotherapy) and
liaise with clinicians if results are outside of the normal range.
To check that dose modifications are applied and appropriate and that when required
are maintained for subsequent cycles (as necessary).
To ensure that administration details are correct for the chosen protocol, that the
duration of treatment is appropriate and associated treatments e.g. anti-emetics,
hydration are prescribed.
To ensure there is an appropriate interval between treatment and cycles.
To ensure that maximum cumulative doses for anthracyclines and bleomycin have not
been exceeded.
To ensure the safe and accurate compounding of chemotherapy, including drug/ drug,
or drug /vehicle compatibility, labeling, determination of expiry and storage conditions
and appropriate presentation of the drug.
To ensure that relevant documentation is completed.
To check all chemotherapy regimens. If the prescription does not comply with agreed
protocol / network approved list or the pharmacist has any queries then these are
discussed with the appropriate consultant.
6. PROCESS
Table 1: Areas where chemotherapy is administered
Location
Queen
Alexandra
Hospital
Types of chemotherapy administered
Haematology/
Oncology Day
Unit
Oral
Intravenous
Subcutaneous/
Intramuscular
Intrathecal
Yes
Yes
Yes
Yes
Procedure
Room 4
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
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Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
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(B1312)
Queen
Alexandra
Hospital
Haematology/
Oncology Outpatient Clinic
Rooms
Yes
No
Yes – specifically
monoclonal
antibodies
No
Queen
Alexandra
Hospital
Haematology/
Oncology wards
F5/F6/F7
Yes
Yes
Yes
Yes
Room
(F1321)
Renal
In-patient wards
Yes
No
Yes
No
No
Yes – Specifically
electrochemotherapy
No
No
Theatre
A separate policy exists to ensure safe prescribing, dispensing, delivery and administration of
intravesical chemotherapy within the Department of Urology.
This policy does not apply to areas where cytotoxic agents are used for non-malignant conditions
where such practice is governed by local/department policies and guidelines
Chemotherapy administration should only be carried out in the areas defined in table 1. These are
areas where there are nursing staff competent in the administration, care and management of side
effects of the chemotherapy treatments in use. All these clinical areas will be provided with the
appropriate protective clothing and equipment. Areas will have available to them details of the
regimens and protocols in current use. Although Renal and Theatres are listed as an appropriate
area it must be chemotherapy trained nurses who administer the medicines. This must be arranged
directly with the Sister of HODU or the Bleep holder for F level (bleep 0070).
In exceptional circumstances cytotoxic drugs may be required to be administered outside a
designated area for example ITU and the medical floor. If this situation does arise:
 This must be agreed by the prescribing oncologist / haematologist, the oncology
pharmacist, a senior chemotherapy nurse and the medical and nursing staff of the area
concerned.
 The prescriber and lead / senior chemotherapy nurse must ensure that the chemotherapy
is given by fully trained chemotherapy nurses, and that the staff caring for the patient will
receive appropriate explanation and training regarding post-chemotherapy aftercare.
 Relevant policies and treatment protocols must be available.
 All relevant equipment (cytotoxic spillage kit, bins etc) must be provided.
Emergency Administration Out-of-Hours
Pharmacy will accept requests for chemotherapy treatment between the hours of 0800 – 1700 hours
(Monday to Friday). On the Haematology/Oncology day unit whenever possible chemotherapy should
be administered / commenced during the normal working day i.e. 0800 – 2000 hours (Monday to
Friday) to ensure access to support services, key personnel and clinical expertise is available.
On F-Level (Haematology/Oncology wards) initiation of inpatient cytotoxic chemotherapy must
whenever possible be undertaken during the normal day time hours (Monday to Friday 0800 to
1800). There is always at least one member of staff on duty on F-level who is chemotherapy trained.
The exceptions are:
Continuous infusions
Regimens where cytotoxic chemotherapy is administered for consecutive days
Timed cytotoxic chemotherapy
Cytotoxic chemotherapy given more than once a day
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
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Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
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Emergency cytotoxic chemotherapy
Planned chemotherapy activities on Saturday:
To cope with the demand and also to ease the pressure during long holiday periods over Easter and
Christmas, elective chemotherapy and supportive treatments may need to be delivered on a few
Saturdays in a year. The following criteria must be met before planning these activities on Saturdays:
1. There is sufficient medical support available to safely manage the patient.
2. There are appropriately trained nursing staff to safely administer chemotherapy.
3. The pharmacy department has sufficient capacity to safely prepare and dispense the
chemotherapy.
4. All chemotherapy patients should be ideally pre-assessed and all chemotherapy preprescribed before Saturday.
Whenever possible, the decision to treat adult patients with chemotherapy should be made and
treatment initiated within normal working hours. Wherever possible, patients should be given other
supportive therapies to permit the administration of parenteral chemotherapy to take place during
normal working hours. e.g. for a patient with newly diagnosed acute leukaemia – hydroxycarbamide
to reduce the white cell count, alongside hydration and allopurinol (300mg PO od) to protect against
tumour lysis syndrome; for newly diagnosed aggressive lymphoma - high dose steroids (e.g. 1g
methylprednisolone IV), alongside hydration and allopurinol (300mg PO od) to protect against tumour
lysis syndrome.
In exceptional circumstances, it may be clinically indicated that emergency cytotoxic chemotherapy
should be initiated outside normal working hours. In such a circumstance a decision to treat must be
made by the consultant Oncologist/Haematologist in conjunction with a senior member of the nursing
team and on call pharmacy staff.
The following situations have been agreed where the supply of out-of-hours chemotherapy would be
deemed essential. This paperwork is available on the Intranet on the pharmacy pages
http://pharmweb/Publications/Oncology/charts.aspx?id=Out%20of%20Hours%20Chemotherapy
Adult Haematology:
1. Acute Myeloid Leukaemia (AML): Unanticipated admission of a newly diagnosed patient with a
high white cell count or clinically unwell.
2. Acute Promyelocytic Leukaemia (APML)
3. Acute Lymphocytic Leukaemia (ALL)
4. Non-Hodgkin’s Lymphoma (NHL): if tumour threatening function of a vital organ e.g. tracheal,
ureteric obstruction.
5. Anthracycline extravasation
Adult Oncology:
1. Small Cell Lung cancer (SCLC): with superior vena cava obstruction or
2. spinal cord compression
3. Anthracycline extravastion
Medical Responsibilities
The patient must be reviewed by a consultant oncologist or haematologist. They should endorse the
decision to start chemotherapy in writing in the patient’s case notes.
A consultant or specialist registrar must contact the on-call pharmacist to discuss the need for
chemotherapy out-of-hours. The on-call pharmacist may wish to refer the call to a more senior
colleague or an oncology/haematology pharmacist.
The consultant or SpR must complete all sections of the ‘Request for Essential Out-of Hours
Chemotherapy’ form and return it to the on-call pharmacist.
Cytotoxic Drugs for Adult Patients in Oncology and Haematology
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Issue Date: 06 February 2015
Review Date: 05 February 2017 (unless requirements change)
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The consultant must:
Ensure that there is sufficient medical support available to safely manage the patient over the
weekend.
Ensure that there are appropriately trained nursing staff on all shifts over the weekend during which
the patient will receive chemotherapy
The consultant or specialist registrar (SpR) must prescribe the full course of chemotherapy using one
of the approved pre-printed prescriptions relevant to their area.
Pharmacy Responsibilities:
A pharmacist will discuss the need for chemotherapy with the requesting consultant.
Once the pharmacist has agreed that chemotherapy will be provided they will make arrangements for
it to be prepared.
The pharmacist will check that the consultant or specialist registrar has completed the ‘Request for
Essential Out-of Hours Chemotherapy’ form.
The pharmacist will check the prescription and that the doses have been calculated correctly. Any
issues will be resolved with the prescriber before preparation of the chemotherapy.
Once the chemotherapy has been prepared it will be sent to the appropriate ward. If chemotherapy
has been ordered in anticipation of a patient deteriorating further the chemotherapy will be retained in
pharmacy until the patient is ready to receive treatment.
Request for Essential Out-of Hours Chemotherapy
To be completed by the prescribing consultant or specialist registrar.
The consultant or specialist registrar will be taking full responsibility for the clinical assessment of the
patient.
Patient Name:
Hospital Number:
Date of Birth:
Or attach addressograph label
Ward:
Consultant:
Chemotherapy Details
Regimen requested
Disease state / reason for request
Full cycle of chemotherapy required
Y/N
Day 1 only required
Y/N
Chemotherapy prescribed by (consultant or SpR only)
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Signature of consultant
Print name
Designation
Date
Signature of Pharmacist
Print name
Designation
Date
6.1 HEALTH & SAFETY
Cytotoxic drugs are classed as substances that pose a serious risk to health and are therefore
subject to COSHH regulations.
Risk Assessment and Risk Management
 A register of all staff involved in the handling of cytotoxic drugs must be kept by the manager of
each area involved.
Pregnancy and Breastfeeding
There should be no significant exposure to cytotoxic drugs if good handling practices are strictly
adhered to. As some pregnancies are unplanned, or staff may be unwilling to discuss plans for
conception, the emphasis must be on the reduction of exposure to all staff at all times. There have
been some studies suggesting adverse effects on the foetus as a result of the mother working with
cytotoxic drugs. Many of these studies, however, were carried out, or based on exposure during the
1980s at a time when the use of personal protective equipment and safety isolators was not well
established. Some later studies have failed to find a significant association with foetal adverse
effects.
As the pre-conception period is not include in any health and safety advice, managers must ensure
that a COSHH (Control of Substances Hazardous to Health) assessment is carried out in all areas
where cytotoxic drugs are handled in order to assess the level of risk and the adequacy of control
measures in place. Directions on how risk assessments can be completed can be found at
http://www.hse.gov.uk/risk/index.htm. The risk assessment should assume that there may be a new
or expectant mother working in the environment in the following 12 months. Precautions must be in
place at all times to minimize exposure by using protective garments, appropriate equipment, as well
as safe and validated work practices. This applies to both male and female staff exposed to both
investigational agents and licensed drugs.
This policy aims to reduce the risk of exposure to these drugs as far as possible. However, as there
is no known limit where exposure is thought to be safe, employees must be informed of the potential
reproductive risks.
Employees should notify their managers as soon as possible if they are pregnant, trying to conceive
or breast feeding. This is particularly important as the greatest risk is during the first three months of
pregnancy, when rapid cell division and differentiation occurs. This is also to comply with HSE
guidance stating that all pregnant staff, or those trying to conceive, should be removed from duties
involving the preparation of cytotoxic drugs.
At the point where an employee discloses pregnancy, a risk assessment specific to the individual
should be carried out and any appropriate action taken.
All staff should be fully informed of the reproductive risks by:
 Receiving verbal and written information on induction
 Signing to say they have read and understood the relevant risk assessments
 Providing opportunities for discussion of any concerns
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Review Date: 05 February 2017 (unless requirements change)
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Pregnant or breastfeeding staff will be expected to make an informed choice about working with
cytotoxic drugs. Staff who choose not to work with cytotoxic drugs will not be expected to be involved
in directly preparing or administering chemotherapeutic agents or handling waste from patients
treated with chemotherapy. If appropriate, the line manager and Human Resources Department will
agree any new temporary arrangements together with the member of staff and ensure that she is
adequately supported during her pregnancy.
New, expectant and breastfeeding mothers should be specifically advised against any direct
involvement in the management of a cytotoxic drug spillage.
Monoclonal Antibodies (MAbs)
Monoclonal antibodies affect a range of biological functions and staff handling them should be aware
of the nature of each product and specific associated problems. As these agents may contain
material of animal origin, they are potentially biohazardous and so direct handling should be
minimized and protective clothing worn to the same level as for traditional cytotoxic medicines. There
is also a theoretical risk of operator sensitization as MAbs are proteinaceous in nature and staff
should be made aware of this.
The preparation of MAbs should be individually risk assessed, taking into account the allergic
potential based on the origin of the MAb and toxicities arising from the therapeutic use. Together with
the NPSA risk assessment tool for intravenous medicines, an overall risk could then be used to
decide whether manipulation should be within an aseptic unit (high risk) or permitted in a clinical
area.
Administration of MAbs
Although full cytotoxic nurse administration training is not required for the administration of MAbs
they have specific toxicity and administration risks associated with them. All nursing staff who are
required to administer these drugs but who have not completed full cytotoxic training may be
assessed by the Clinical Educator for Oncology. A register of these nurses will be held and
maintained by the clinical educator in addition to the full chemotherapy trained register. Suitability to
remain on this Moncolonal Register will be assessed annually.
6.2 STORAGE AND TRANSPORTATION OF CHEMOTHERAPY
Storage
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Pharmacy staff are responsible for correct storage of drugs prior to delivery to wards.
Bags or boxes should not be left unattended or with untrained staff on arrival.
Access to cytotoxic agent storage areas must be limited to authorised staff.
Cytotoxic drugs should be stored in a safe, accessible area at the lowest level of practical
shelf storage.
Careful layering should be used to avoid undue stress and pressure on the packaging.
Nurses are responsible for correct storage of drugs delivered to wards and clinics and
appropriate monitoring of storage facilities.
Cytotoxic agents must be stored separately from other drugs
Parenteral doses of chemotherapy should be stored in a designated locked fridge or locked
cupboard.
Oral doses must be stored in a designated locked trolley, fridge or cupboard.
Any refrigerators used for the storage of chemotherapy doses should be monitored daily to
ensure that the temperature is maintained between 2 to 8 degrees centigrade.
Transportation


All cytotoxic drugs are clearly labeled as such and must be transported from pharmacy
directly to the designated areas in an appropriately labeled and sturdy transportation bag.
If the product(s) requires refrigeration, the cold chain should be maintained.
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All Trust staff involved in the transportation of chemotherapy drugs must be trained to follow
the ‘Cytotoxic Spillage’ guideline.
6.3 MINIMISING EXPOSURE
Clothing
The following guidance applies to all staff handling cytotoxic drugs during administration of treatment,
handling of patient waste and cleaning of spillages.
 Gloves: Nitrile synthetic rubber gloves must be worn at all times. No glove is completely
impervious to cytotoxic drugs. Gloves must always be changed between patients, and
immediately if damaged or if significant contamination occurs. Standard infection control
procedures should be followed.
 Gowns: A plastic apron is to be worn at all times during administration.
 Eye protection: Goggles must be available and may be worn when reconstituting chemotherapy
or if a spillage occurs.
 Masks: Should be available and must be worn whenever there is a possibility of inhaling droplets.
Equipment
Available at each area will be:

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
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Extravasation kit, hot and cold packs.
Eye wash kits.
Spillage kit.
Cytotoxic waste bins, bags and sharps boxes.
Protective clothing.
Cardiac arrest trolley.
Equipment and drugs for management of anaphylactic shock.
Blood pressure / thermometer / pulse oximeter.
Paxman scalp cooler (oncology only).
Syringes – must always be luer lock.
Administration sets. Vygon luer lock chemotherapy giving sets are to be used unless
infusional chemotherapy is being administered.
Infusional pumps.
Spillage
Detailed spillage guidelines are available via PHT Drug Therapy Guidelines home page
“Guidance on managing a cytotoxic spillage”




Managers must ensure that all staff are made aware of the spillage procedures that must
be adopted and the protective clothing that must be worn.
A cytotoxic drug spillage kit is available in all designated areas
All spillages of cytotoxic drugs involving staff or patients must be reported using the
standard Adverse Incident Form and processed as per the Adverse Event Reporting and
near Misses Management Policy.
Patients will be educated regarding potential spillage management when being
discharged with infusion devices.
Handling Waste and Waste Disposal
When dealing with patient waste and other contaminated waste, the following approaches must be
used:
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All staff who handle cytotoxic drugs, waste or work in areas where they are used, must have been
appropriately trained/educated, supervised and updated regarding:



The risks of handling and disposing of waste.
Appropriate practices for handling and disposing of waste.
Local policies and protocols, legal requirements, and the principles behind them.
It is the responsibility of clinical staff to ensure that in any environment where cytotoxic chemotherapy
is administered; the drug is kept safely and securely stored, and disposed of correctly – thus causing
no danger to any staff working in the area. Only staff who have received information and training
regarding waste disposal of cytotoxic drugs should dispose of cytotoxic drugs. On no occasion
should staff who haven’t received training be expected to deal with this special waste.
Equipment Waste



Contaminated materials such as bottles, vials and other materials used in the preparation and
administration of cytotoxic agents must be placed in a cytotoxic sharps bin. These are sealed,
taped with cytotoxic tape when full and labeled with the name of the clinical area. Also placed in
the cytotoxic sharps bins are contaminated needles, syringes, giving sets and tubing which
should be disposed of intact.
Personal protective equipment i.e. gloves, aprons, etc. should be disposed of in a cytotoxic waste
bag (orange and white) labeled cytotoxic.
The method for disposal of hazardous waste is by incineration. Waste should be segregated and
should not be allowed to accumulate. The integrity of the packaging should be safeguarded
during storage and transport and should not expose personnel to any risk.
Patient Waste


Personnel disposing of patient waste should wear gloves and aprons.
Urine, sweat, faeces and vomit may contain high concentrates of cytotoxic or active metabolites
for up to seven days after treatment has stopped. As a general rule, most patient waste can be
hazardous for up to 48 hrs.
Cleaning


Contaminated equipment, such as ambulatory pumps, must be cleaned and disposed of
appropriately, according to the PHT Decontamination of Healthcare Equipment Policy, by
trained staff who are aware of the hazards of ineffective cleaning.
Contaminated settings must be cleaned appropriately, according to local policies, by trained
staff who are aware of the hazards of ineffective cleaning.
Laundry


Patients’ soiled bed linen or nightwear should be treated as infected linen and placed in an
inner dissolvable and an outer solid red bag.
Patient/staff clothing contaminated with cytotoxic agents or waste from a patient receiving
chemotherapy must be removed immediately. Personnel should wear appropriate clothing for
dealing with a spillage. Rinse the clothing under running tap water. Squeeze dry and place in
a plastic bag. Personal clothing should be taken home for laundering on the hottest wash.
Handle all pre-washed laundry with gloves. If contaminated clothing is non-essential,
disposal is advised
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6.4 INFORMATION REGARDING CHEMOTHERAPY
Written information will be offered to all patients covering both general and specific information
about chemotherapy, side effects, preventive measures and support.
Current Macmillan Cancer Support information will be offered relating to specific drugs and regimens.
Details of the 24-hour emergency contact number are provided on wallet-sized cards to all patients
for patients receiving Intravenous (IV) and oral chemotherapy.
Materials are available in languages other than English through the Macmillan Information and
Support centre.
Holistic Assessment
In addition to a physical assessment each patient must have their holistic needs (Social,
Psychological, Emotional and Spiritual) assessed prior to, during and at the end of chemotherapy
treatment and appropriate action implemented. This may include referral to and liaison with other
agencies and services providing supportive care. The needs of carers should also be taken into
account.
6.5 CONSENT FOR CHEMOTHERAPY
All patients who are to receive chemotherapy must sign a Consent Form prior to commencing a
course of treatment. Signing the consent form acknowledges that the patient has received generic
written information and regimen-specific information where appropriate.
In order that patients fully understand the nature of the proposed treatment, information relating to
the treatment intent, risks and benefits should be given verbally and supported by the use of patient
information leaflets.
The information must be given initially by the medical practitioner responsible for the patient’s care,
either a consultant, staff grade or specialist registrar, and will be re-enforced by an appropriately
trained chemotherapy nurse.
The medical practitioner or chemotherapy-trained nurse must document the information given to the
patient in the patient’s healthcare record.
6.6 PRESCRIBING CHEMOTHERAPY
Safe systems of work ensure that the prescription is clear, unambiguous, accurate and appropriate
for that patient
Each drug should be administered by the route most appropriate for the drug formulation, the
treatment regimen and the needs of the patient.
See section 5 for prescriber’s responsibilities.
The following information must be documented on the prescription sheet or when e-prescribing.
 Patient’s demographic details.
 Patient’s performance status
 Patient’s height, weight and calculated surface area.
 Consultant’s name (responsible for this treatment plan).
 Diagnosis
 Treatment intent (palliative, curative, adjuvant, neo-adjuvant etc.).
 Investigations
 Intended number of cycles.
 Cytotoxic drug regimen/cycle number.
 Drugs, dosage and route of administration.
 Date, time and duration of administration.
 Infusion fluid where applicable.
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Doctor’s signature/date of prescription.
The clinical review box on all chemotherapy charts must be signed by the clinician before the
chemotherapy can be given
Confirmation that consent has been obtained
6.7 VERIFICATION PROCEDURES
Nurses must ensure that a formal checking procedure is undertaken to ensure that the correct drugs
and correct doses are given to the correct patient on each occasion in accordance with PHT
Management of Medicines policy. All chemotherapy checks should include two registered nurses of
which at least one should be on the chemotherapy register
 Identity band
 MRSA screening
 Check: Patient’s full name and date of birth, both verbally with the patient and against patient
identify band for all patients.
 Known allergy history.
 Patient’s identification on prescription chart is the same as on all labeled drugs.
 Drugs:
o Dose of drug
o Administration route and duration
o Expiry date
o Check for precipitation or discoloration
o Dilution i.e. volumes
 Cycle number.
 Results of clinical tests i.e. Full Blood Count (FBC)/Urea and Electrolytes (U&E).
 Confirm with patient date of most recent test
 Supporting medication is prescribed, i.e. anti emetics, medication to take home (TTO).
 Hydration if required.
 Regimen and individual drug identification within that regimen.
 The review clinician box is signed by the clinician.
 Nurse signs clinical review for day 8 and 15 as per regimen charts
 Any doubt or question will result in administration being withheld until discussed/checked with
the clinician and/or oncology pharmacist
 Patients understanding and consent
6.8 ADMINISTRATION
Routes of administration
Cytotoxic drugs can be administered via a variety of routes. Regardless of the route used there are
certain pre-administration principles which the nurse should apply.
The nurse should remember that the administration of medicine is a collaborative process that
involves the patient, nurse, doctor and pharmacist. (Doughty and Lister 2004)
The nurse must identify and remedy any knowledge or practice deficit (NMC 2002)
Oral administration procedures
Appropriate gloves should be worn when handling containers and chemotherapy.
The “no touch” principle applies to handling oral preparations of cytotoxic drugs. Whenever possible,
tablets should be used in preference to solutions and should be blister or foil packed so that a “no
touch” opening technique may be used. In pharmacy departments, only designated counting
triangles must be used.
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If liquids need to be used advice from the pharmacy department should be sought about safe
handling.
Labels on oral preparations should warn all users of the hazards of touching tablets or liquids directly.
Crushing tablets, opening capsules or chewing is not recommended.
Do not crush tablets. If the patient cannot swallow the tablet, seek advice from pharmacy regarding
the possible use of elixir or soluble forms.
Disposable medicine cups/spoons used for administration of oral chemotherapy must be disposed of
in a designated cytotoxic waste container.
Please also refer to any individual specific drug protocols.
Intravenous administration procedures
This is the most commonly used route of administration via a peripheral or central vein.
It enables:

Rapid and reliable delivery of cytotoxic drug – into the bloodstream to the tumour site.

Rapid dilution of a drug to reduce local irritation and the risk of tissue damage.
Cytotoxic drugs must not be removed from their packaging before all checks on patient identification
and prescription are complete. On completion of these checks, place patient identity labels which are
found on the outside packaging onto the syringes or bags which are to be administered. This will
ensure safe administration of the correct drug to the correct patient.
Appropriate Personnel Protection should be worn when handling containers and chemotherapy i.e.
gloves and aprons.
Drugs used to treat anaphylaxis should be available and practitioners familiar with anaphylaxis
treatment guidelines, including the drugs used to treat anaphylaxis.
Venous Access
The Vascular Access Device
Vascular access devices for cytotoxic drug administration must be selected and used by a
practitioner who has completed their competency and has been assessed in practice to use them
appropriately.
Factors for consideration may be summarised as follows
Therapy related factors
Device Related Factors
Type of therapy
Length of therapy
Device associated with the
least complications.
Potential complications.
Maintenance/care.
Latest technology.
Cost of placement and
aftercare.
Technical expertise of staff to
properly use device.
Preference of the nurses
caring for the device.
General experience of centre.
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Patient Related Factors
Suitability/availability of
patient veins.
Self-care ability.
Dexterity of patient.
Patient preference.
Co-morbid conditions.
Patients’ lifestyle
(occupational and
recreational activities).
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Cytotoxic drugs should not be administered if there is any doubt regarding the safety of the venous
access device. Due consideration should be given to the site, position, patency, integrity, visibility
and need for site care of the chosen device.
Peripheral Venous Access
Newly placed small gauge Teflon or silicone cannulae are recommended for the administration of
cytotoxic therapy. Small gauge cannulae (22 or 24) permit an increased blood flow round the cannula
and therefore haemodilution of the drug, which reduces the risk of chemical phlebitis.
Insertion site
 Large veins of the forearm.
Areas to avoid
 Antecubital fossa.
 Lower limbs.
 Inflamed or sclerosed veins.
 Sites distal to recent cannulation.
 Any limb with compromised circulation should also be avoided.
 Any limb with suspected or potential lymphoedema i.e. post axillary clearance in breast
cancer patients
Central Venous Catheters
Central venous access i.e. skin tunneled or non-skin tunneled catheters or Peripherally Inserted
Central Catheters (PICCs) may be used when:
 The patient has poor peripheral venous access.
 Needle phobia.
 The patient is to undergo intensive chemotherapy.
 Continuous infusional chemotherapy.
 Patient choice.
 Drugs to be administered are irritants to the vein and may lead to increased risk of
extravasation and chemical phlebitis.
Full guidelines on Peripheral Cannulation, Central Venous Access are available on the Intranet.
Cytotoxic drugs must not be given if there is any doubt about the patency and integrity of the venous
access.
The patency of the cannula or central line should be checked by aspirating and flushing with 10mls of
appropriate / compatible IV infusion fluid.
Vesicant drugs and Non-vesicant drugs
Vesicant drugs have the potential to cause severe tissue damage and necrosis if inadvertently
administered into the subcutaneous tissue.
The administering nurse must be aware of the agents that are capable of causing tissue necrosis
which are documented in the Cytotoxic Extravasation treatment guidelines and drug protocols.
Vesicant drugs should be given first out of a group of agents as
 vascular integrity decreases over time.
 the vein is most stable and least irritated at the start of treatment.
 initial assessment of vein patency is the most accurate.
 the patient’s awareness of changes is more accurate.
Peripheral Vein Administration – Bolus drugs
Prior to the administration of chemotherapy it is vital to check the patients blood results.
 Assess the patient’s peripheral venous access
 A small cannula should be inserted into a recommended site.
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Patency should be checked at the start of administration by achieving a blood return and then
flushing with 10mls of 0.9% sodium chloride to ensure there is no resistance, swelling or pain.
All cytotoxic agents should be injected / administered slowly via a needle-less system, whilst
the infusion is flowing rapidly and freely.
Vesicant agents must never be administered as an infusion directly into a peripheral vein via
a cannula.
During any IV infusion the cannula should be checked regularly for signs of inflammation and
/ or infection.
If the IV infusion is not flowing freely at a fast rate, the chemotherapy must be stopped
immediately and the vein patency rechecked.
If more than one non-vesicant drug is to be administered by bolus injection or infusion a flush
of a compatible IV fluid must be given in between drugs to prevent any interaction.
At the end of the chemotherapy administration the giving set must be flushed through with
50mls of 0.9% sodium chloride to clear the line and the cannula.
All used equipment must be placed in appropriate labeled designated cytotoxic containers.
Complete appropriate documentation i.e. sign prescription chart and document in nursing
notes.
Central vein administration
Using aseptic technique
 Patency should be checked at the start of administration by achieving a blood return and then
flushing with 10mls 0.9% sodium chloride to ensure there is no resistance, swelling or pain
 Chemotherapy agents may be infused / injected directly via a central line using a needle-free
system
 Care should be taken when injecting cytotoxic chemotherapy via a central line as the patient
may experience unpleasant sensations such as dizziness, palpitations if some drugs are
administered too quickly.
 At the end of the infusion / injection the line must be adequately flushed through with 50mls
0.9% sodium chloride.
 All used equipment must be placed in a designated cytotoxic waste container.
 Complete appropriate documentation i.e. sign prescription chart and document in nursing
notes.
Recommended practice for administration of continuous infusional cytotoxic chemotherapy
via a Baxter pump
Ambulatory chemotherapy has enabled cancer patients to receive intravenous chemotherapy at
home. It has the reported advantages of improving treatment outcomes and enhancing psychological
benefit to the patient. Ambulatory chemotherapy must be administered via a central venous catheter.
 Patency should be checked at the start of administration by achieving a blood return and then
flushing 10mls 0.9% sodium chloride to ensure there is no resistance, swelling or pain
 Using aseptic technique ensure central line is patent.
 Remove Luer cap at the end of Baxter pump set and wait for fluid to show.
 Once visible attach end of pump to central line.
 Place infusor in provided holder.
 Dress line according to Central Venous Catheters: Care and management policy
 Complete appropriate documentation i.e. sign prescription chart and document in nursing
notes.
 Arrange for disconnection and flushing of the line and removal of the pump.
 Provide 24-hour on-call telephone numbers.
Additional support for community nurses should be offered i.e. training in pump and line
management.
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Subcutaneous Chemotherapy and Intramuscular Chemotherapy
 Ensure patient is comfortable and has any specific information required.
 Inspect sealed bag before opening to ensure there is no spillage within the bag. Open the bag
directly onto the injection tray.
 Choose a suitable site for the injection and prepare the skin as per policy.
 Carefully remove the connector top from the syringe and attach a 25 gauge needle (orange).
Ensure needles for administration are secure taking great care to minimize risk of spillage
onto the skin.
 Using a pinch technique for subcutaneous chemotherapy administer the injection using a 90degree angle. Aspiration is not required prior to the injection.
 For intramuscular chemotherapy administer injection using Z track technique. The Z track
technique involves displacing the skin and the subcutaneous layer in relation to the underlying
muscle so that the needle is sealed off before the needle is withdrawn therefore minimizing
reflux.
 Remove the syringe and needle, covering the site with low lint gauze ensuring there is no
leakage from the site.
 All used equipment must be placed in appropriate labeled designated cytotoxic containers.
 If further injections are required, rotate the site of administration.
Extravasation
Extravasation of a vesicant or irritant drug may have serious implications for the patient. Intravenous
chemotherapy administration procedures and techniques are designed to prevent and minimise the
occurrence of extravasation incidents. Early detection and prompt appropriate action is required to
prevent damage which may in extreme cases result in necrosis and functional loss of the tissue or
limb involved.
For specific guidance on the management of suspected extravasation see PHT Drug Therapy
Guideline “cytotoxic extravasation treatment” available via the intranet. Guidelines and extravasation
kits for the treatment of cytotoxic extravasation are available in all designated areas.
6.9 WORKLOAD - POTENTIALLY UNSAFE CHEMOTHERAPY WORKLOADS
The term “chemotherapy workload” refers to the administration of systemic, intravenous,
intramuscular, oral, subcutaneous or intrathecal chemotherapy in an in-patient, out-patient or day
case setting.
The decision that chemotherapy workload has reached an unsafe level can be made by: The Sister in charge of HODU
 The Sister in charge of F5/F6/F7
 The Head of Chemotherapy Service
 The Lead Haematology-Oncology Pharmacist
The variables that influence whether or not it is safe to administer chemotherapy may include:
 Staffing levels – nursing
 Staffing levels – medical
 Staffing levels – pharmacy
 Staffing levels – other
 Availability of beds (in-patient / day case)
 Availability of chairs (day case)
 Availability of central pharmacy cytotoxic reconstitution service
 Acuity of patient/s
 Inclement weather conditions
 Major Incident (Internal / External)
It should be noted that this may not be an exhaustive list.
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In the event that one or more of these variables are such that the staff detailed above consider
chemotherapy workload has reached an unsafe level, they may take the following action.
 Assess whether local action can be taken to resolve the situation and make it safe (e.g.
postponing patient admissions, redistributing staff) and take action accordingly.
 If further action is required the staff member should escalate the situation for further
discussion and for the development of an appropriate and safe action plan, which may include
existing resources from elsewhere or in extreme circumstances sending the patient to another
NHS Trust.
o Bleep Holder F5/F6/F7
o Sister in charge of HODU
o Sister in charge of F5/F6/F7
o Matron for cancer services
o Head of nursing Surgery and Cancer
o Head of chemotherapy service
o Lead Haematology / Oncology Pharmacist
o Manager of Railway Triangle (licensed cytotoxic unit)
o General Manager Surgery and Cancer
o Business Manager CHOC
It is the responsibility of the relevant nurse in charge of the affected area to complete a Datix web
incident form relating to the period of unsafe chemotherapy workload which should be investigated
according to the Trust’s governance policy.
Any patient cancellations or deferrals should be recorded in the patient’s medical record.
7 TRAINING REQUIREMENTS
Cytotoxic chemotherapy should be given only by nursing staff who are experienced and competent in
the administration and care of patients receiving cytotoxic drugs and the management of possible
side effects, or staff under the supervision of such an individual. Staff administering chemotherapy
have a yearly competency assessment completed by the Clinical Educator in chemotherapy and
attend training at either network level or a recognized chemotherapy course at university.
All aspects of this policy will be included in audits relevant to each area of practice; these will be
discussed at the Chemotherapy Governance Group.
The clinical educator keeps a register of staff competency and staff deemed competent to be
included on the trust chemotherapy register which is signed off annually by the lead nurse and
clinical director.
Training of all medical, nursing, pharmacy, facilities management and any other staff who handle
cytotoxic drugs or cytotoxic waste are essential.
Such staff should understand the potential hazards associated with cytotoxic drugs and be familiar
with relevant procedures, i.e. management of spillage, disposal and treatment of extravasation.
Medical staff
Medical staff who are involved in the prescribing of cytotoxic drugs should be familiar with: 
The Safe Prescribing Handling and Administration of Cytotoxic drugs for Adults.

PHT Intrathecal Policy and National Guidance

Network Guidelines.
With the exception of medical staff on the intrathecal register medical staff do not administer
chemotherapy.
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All medical staff below the level of consultant and permanent staff grade doctors in the haematologyoncology department who involved in the assessment and prescription of chemotherapy should be
formally assessed as competent. (See Appendix 4).
8. REFERENCES AND ASSOCIATED DOCUMENTATION
Internal
1.
2.
3.
4.
Safe handling and disposal of sharps – Safe Handling and Disposal of Sharps Policy
Standard Infection Control Precautions - Infection Control Standard Precautions Policy
Aseptic Technique– Aseptic Technique Policy
Hand Hygiene Policy – Hand Hygiene Policy
External
1. Cancer reform strategy.pdf
2. NCAG Report 2009.pdf
3. The code in full Nursing and Midwifery Council.mht
4. Central South Coast Cancer Network CSCCN, cancer services Hampshire, Wiltshire, Isle of
Wight, Portsmouth, Southampton, and Basingstoke.mht
9. EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably
practicable, the way we provide services to the public and the way we treat our staff reflects
their individual needs and does not discriminate against individuals or groups on any grounds.
This policy has been assessed accordingly
Our values are the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They
are beliefs that manifest in the behaviours our employees display in the workplace.
Our Values were developed after listening to our staff. They bring the Trust closer to its vision
to be the best hospital, providing the best care by the best people and ensure that our patients
are at the centre of all we do.
We are committed to promoting a culture founded on these values which form the ‘heart’ of our
Trust:
Respect and dignity
Quality of care
Working together
No waste
This policy should be read and implemented with the Trust Values in mind at all times.
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10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS
This document will be monitored to ensure it is effective and to assurance compliance.
Minimum requirement to
be monitored
Lead
Datix involving chemotherapy
handling or administration to
be reviewed
Dr S
Muthuramalingam
Catrin Watkinson
Tool
Audit
Frequency of Report
of Compliance
Annual
Reporting arrangements
Policy audit report to:

Chemotherapy governance group
Lead(s) for acting on
Recommendations
Chair of chemotherapy
governance group
Lead matron for Cancer
Policy audit report to:

Policy audit report to:

The effectiveness in practice of all procedural documents should be routinely monitored (audited) to ensure the document objectives are being achieved.
The process for how the monitoring will be performed should be included in the procedural document, using the template above.
The details of the monitoring to be considered include:






The aspects of the procedural document to be monitored: identify standards or key performance indicators (KPIs);
The lead for ensuring the audit is undertaken
The tool to be used for monitoring e.g. spot checks, observation audit, data collection;
Frequency of the monitoring e.g. quarterly, annually;
The reporting arrangements i.e. the committee or group who will be responsible for receiving the results and taking action as required. In most
circumstances this will be the committee which ratified the document. The template for the policy audit report can be found on the Trust Intranet
Trust Intranet -> Policies -> Policy Documentation
The lead(s) for acting on any recommendations necessary.
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APPENDIX 1: RESPONSIBILITIES: HEAD OF CHEMOTHERAPY SERVICE

Provision of suitable and appropriate equipment for administration of chemotherapy.

Co-ordination of specified chemotherapy regimens within the network.

Supervision of chemotherapy prescribing by clinicians and pharmacists.

Administration of chemotherapy by appropriately trained staff

Use of guidelines for the prevention and treatment of side effects and complications of
chemotherapy.

Minimising delays in starting treatments.

Clear and comprehensive documentation of chemotherapy delivery.

Chair of the Chemotherapy Governance Group

Represent Portsmouth in the Wessex SCN chemotherapy meetings
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APPENDIX 2: RESPONSIBILITIES OF THE LEAD CHEMOTHERAPY NURSE FOR THE
PORTSMOUTH HOSPITALS NHS TRUST’S CLINICAL CHEMOTHERAPY SERVICE (ADULT)
The Lead Chemotherapy Nurse will:

Work clinically directly with patients receiving chemotherapy as agreed in local job plan.

Work with multidisciplinary colleagues and the Chemotherapy Governance Group to identify
issues influencing the safe delivery of cancer chemotherapy.

Lead the nursing service to effect changes that will enhance the delivery of cancer
chemotherapy in the locality according to national and network guidelines and best practice.

Work with colleagues within the trust and within the Wessex SCN to ensure that an effective
training programme is in place for all staff involved in the administration of cancer
chemotherapy.

Maintain an up-to-date register of PHT nursing staff authorised as competent to administer
cancer chemotherapy unsupervised.

Work in conjunction with the Trust’s Intrathecal Lead and Intrathecal Training and Education
Lead to ensure training and competency assessment is in place for nurses and an Intrathecal
Chemotherapy register is maintained in accordance with national guidance and local policy.

Assist in the development of relevant local guidelines and policies.

Work closely with the Head of the Clinical Chemotherapy Service and as part of the
Chemotherapy Governance Group to ensure the development of a chemotherapy service that
is patient focused and responsive to changing needs.

Collaborate with colleagues to ensure patients have access to an appropriately staffed 24
hour, seven days a week telephone advice service on the side effects and complications of
chemotherapy treatment and how to obtain help and treatment for them, via the Acute
Oncology Service based on F7 ward.

Ensure the HEAT training (neutropenic sepsis tool) is rolled out amongst staff at PHT,
delivered by the Acute Oncology team.

Ensure that PHT is represented at the Wessex SCN Chemotherapy Group and the
Chemotherapy Nurses Sub Group
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APPENDIX 3: RESPONSIBILITIES: LEAD HAEMATOLOGY /ONCOLOGY PHARMACIST

The provision of clinical pharmacy services and pharmaceutical advice to Oncology and
Haematology departments.

To ensure both inpatients and outpatients receiving cytotoxic chemotherapy receive optimal
pharmaceutical care and monitoring.

To advise staff and the chemotherapy users group on the safe prescribing, dispensing,
handling and administration of chemotherapy and the development and implementation of
related policies and guidelines in line with current recommendations.

To monitor use of chemotherapy regimens on the Trust and Scan’s list of agreed regimens.

To be the designated Trust training lead for intrathecal chemotherapy ensuring that national
guidance is followed.

To evaluate the potential costs and benefits of new chemotherapy drugs to inform and assist
directorate and divisional clinical and management team decision-making

To lead on the setting-up, administration and management of oncology/haematology clinical
trials.

To monitor, evaluate and report on the cost of NICE-approved medicines on an individual
patient basis.

To ensure regimen-appropriate charts are available on the intranet for each regimen used
and in a timely fashion for new regimens and clinical trial regimens.

To contribute to production of prescribing guidelines, patient care pathways, patient group
directions and chemotherapy proofreads to ensure safe use of medicines and maximise
benefits to patients within available resources.
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Appendix 4
Training and Competency Assessment for the Prescribing, Dispensing and Administration of
Chemotherapy
There are three specific groups who require training and regular assessment with regards to the safe
administration of chemotherapy



Medical staff who prescribe SACT (Systemic Anti cancer Therapy) and ITC (Intrathecal
Chemotherapy)
Pharmacy staff undertaking reconstitution, checking and dispensing SACT and ITC
Nursing staff undertaking patient assessment immediately prior to a cycle of SACT and ITC and
also the safe administration of SACT
ITC Training and Competency assessment policy is covered in the Trust ITC policy. This policy is
only applicable to SACT prescribed, dispensed and administered in adult patients with malignancy.
Medical Team
Consultant Haemato-oncologists are considered competent to assess patients and initiate courses of
chemotherapy and these clinicians can be supported by trainees but only staff whose name appears
on the chemotherapy register are able to prescribe chemotherapy.
It is policy within this service that junior medical staff below the level of ST3 are not allowed to
prescribe or administer chemotherapy. However, they can observe the procedure in order to gain a
better understanding of what is involved.
All health care professionals below the level of consultant and permanent staff grade doctors in the
haematology-oncology department who involved in the assessment and prescription of SACT should
be formally assessed as competent.
Oncology SpR/ST3 and above: The Wessex Deanery Specialist Training committee has recently
approved a structured 5 level competency assessment tool to assess and document the competency
for the health care professionals involved in the prescription of SACT. Portsmouth CCS has agreed
to use the tool for the oncology SpR/ST3 and above. During their induction, the trainee should
undergo the competency assessment with their educational or clinical supervisors to document the
level of competency before entering their names into the chemotherapy register. Ideally progress
needs to be monitored throughout training through regular interval assessments as necessary
(depending upon the level of competency identified during the initial assessment and the length of
the training in Portsmouth).
Haematology SpR/ST3 and above:
Criteria (1)
All Haematology trainees must read and be aware of the PHT Cytotoxic administration policy. They
will be given a copy of this at induction.
Criteria 2 (a)
For 1st year trainees - Haematology Trainees are required to perform a MiniCEX around prescribing
competency in Year 1 Haematology StR Curriculum. Once it is done they must meet criteria 3.
Criteria 2 (b)
Post year 1 - Pre FRCPath part 1 pass they must provide evidence of this miniCEX in their
educational portfolio and perform two prescriptions with a clinical or educational supervisor.
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Criteria 2 (c)
Haematology StR (or SpR) with FRCP part 1 - to prescribe at least first prescription under
supervision, prescription to be countersigned.
Criteria (3)
If relevant part of Criteria (2) met - the Educational Supervisor will sign off the approval for
Chemotherapy prescriptions appendix of the induction sheet given to the Trainee when they started
by Dr R Corser as part of their induction. A copy of this will be sent to the Chair of the Chemotherapy
Governance Group
Criteria (4)
All trainees -Specimen signature must be supplied to Pharmacy with Countersignature by
Educational Supervisor.
Pharmacy
Senior haemato-oncology pharmacists assess the competency of all pharmacy staff and technicians
for checking, reconstitution and dispensing of SACT. Records of training and competence are kept in
the aseptic suite and the names are recorded on a register also documented within the Policy for
Administration of Chemotherapy.
The head of the service has overall responsibility for ensuring competency of all staff who check,
reconstitute or dispense chemotherapy although the haemato-oncology pharmacist undertakes dayto-day responsibility and maintains the training records.
Nursing Staff
All new members of nursing staff who join the HODU and inpatient wards follow an induction process
to understand the service and enable them to function efficiently and safely at their level of
knowledge and experience.
The Wessex Cancer Network has a training course which assists in the development of trained
nurses who are working with patients receiving chemotherapy. Once the ward manager is satisfied
that a registered nurse is ready to administer chemotherapy, and the nurse is prepared to undertake
the training, an application is made to the Network for the next available training dates. Whilst they
are undergoing their training they have full supervision when administering chemotherapy and a
dedicated mentor for support with any written work. Once they have completed their open learning
package they forward their work to the Lead Chemotherapy Nurse for marking.
There is an agreed list of assessors of competence within the Policy for Administration of
Chemotherapy and only nurses named on this register are able to assess competence in
administering chemotherapy at PHT. This list has been agreed with the chemotherapy head of
service and will include all bands of nurses who have successfully completed the recognised network
training. The band 7 clinical educator/ lead chemotherapy nurse holds the training records of all
nurses working in the day unit and on the wards. Annual competency assessment for IV
chemotherapy is managed by the chemotherapy lead nurse, working closely with pharmacy, the
clinical chemotherapy learning facilitator and the ward manager if any specific training needs are
highlighted. Competence also requires reassessment if there has been a prolonged period of
absence (e.g. maternity leave).
Competencies for nurses include:Cannulation
 Accessing central venous access devices
 Holistic assessment
 Good understanding of cytotoxic drugs and targeted therapies including
 Department of Health circulars (e.g. specific vinca alkaloid policy )
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






Good communication skills in delivery of information to patients
Good understanding of blood results so that chemotherapy can be delivered safely
Drug calculations
Management of side effects
When to defer treatments or withhold a dose/drug
Management of oncology/chemotherapy emergencies (e.g. extravasation)
Managing general medical emergencies
The head of service has overall responsibility for ensuring competency of all staff who administer
chemotherapy although the chemotherapy lead nurse undertakes day-to-day responsibility and
maintains the training records.
Criteria for acting as an Assessor of competence for SACT:
Portsmouth Clinical Chemotherapy Service (CCS) complies with the Wessex Network criteria for
acting as an assessor of competence for systemic chemotherapy.
Medical and Clinical Oncologists and Haematologists
An assessor of competence should meet the following criteria:


Be a consultant haematologist or oncologist
Undertake regular continuing professional development
Documentation approved by the Royal Colleges must be used to evidence the competence of
trainees (SpR/ST3 and above). (In development)
Consultants should use the competencies defined for each of the four levels of practice to assess
trainee competence, see below:




Review of patient to receive systemic anti-cancer therapy (SACT) and authorisation of the
next cycle to proceed
Ability to prescribe SACT, within local guidelines, or to continue a planned course of treatment
but not initiate the first course of treatment
Ability to initiate SACT for patients with a range of malignancies, whilst prescribing within local
guidelines
Ability to initiate all appropriate SACT for a tumour specific area of clinical practice. Ability to
participate in the evaluation of relevant therapies within clinical trials and therefore have a
detailed knowledge of the regulatory framework defined for clinical research
Pharmacy
Pharmacists and pharmacy technicians who assess competency must be registered with the General
Pharmaceutical Council (GPhC). Pharmacists and Technicians must complete the local Trust’s
training and assessment programme or equivalent. They must undertake continuing professional
development in accordance with the requirements of the GPhC and must have no areas of concern
with their practice e.g. acceptable error rates as defined by each local acute trust.
Any pharmacists or technicians involved with clinical trials must undertake Good Clinical Practice
(GCP) training and be aware of Investigation Medicinal Products (IMP) handling and recording.
Pharmacy activities can be grouped into three distinct but overlapping and complimentary areas.
Each activity is not distinct to the area in which it is grouped. For example clinical screening of
prescriptions may occur on in-patient wards, the dispensary or aseptic unit. It should be noted that
individuals may specialise or work in one or more of these areas. As such it may be impossible to
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spend 50% of their time working in the field of oncology and must have been deemed competent in
the areas for which they are acting as assessors.
Assessing competence for Clinical competencies include activities such as:


Screening of both in-patient and out-patient chemotherapy and supportive treatments in
accordance with local procedures or the British Oncology Pharmacy Association standards.
Advising other staff and patients in relation to chemotherapy and supportive treatments
Assessing competence for dispensary includes:



Labelling, dispensing and checking (final release) of prescriptions for oral chemotherapy and
supportive treatments for cancer patients
Labelling, dispensing and checking (final release) of prescriptions for non-oral chemotherapy
and supportive treatments for cancer patients where these are commercially available
products
Safe storage and handling of chemotherapy
Assessing competence for aseptic includes:












Good manufacturing practice
Development of worksheets and standard labels
Completion of the necessary documentation prior to dispensing an aseptic product e.g. batch
sheets, labels etc.
Clean room behaviour e.g. procedures for entering aseptic rooms, cleaning of rooms and
cabinets
Environmental monitoring requirements for aseptic areas
Aseptic preparation of chemotherapy
Labelling of aseptic products
Final release of aseptic products including labelling, dispensing and checking (final release) of
prescriptions for oral chemotherapy and supportive treatments for cancer patients
Final release of aseptic products including labelling, dispensing and checking (final release) of
prescriptions for non-oral chemotherapy and supportive treatments for cancer patients where
these are commercially available products
Safe storage and handling of chemotherapy
Safe transportation of chemotherapy
Spillage procedures for chemotherapy
Nursing staff
Nurses working within the Wessex Cancer Network, who have not previously undertaken a
recognised chemotherapy education programme e.g., ENB-N59, are expected to undertake or be
working towards a network recognised chemotherapy training programme including chemotherapy
practice competencies within 6- 12 months of commencing post.
Chemotherapy nurses who continue to work in the field of chemotherapy should have their clinical
knowledge and skills peer reviewed annually against the network recognised skills for health
competencies as part of the local appraisal process. Use an annual chemo update
Only staff who have demonstrated advanced practice in chemotherapy administration and
assessment will be eligible to undertake the assessment of other staff. (See Training)
They must:
 Have been identified through appraisal or annual peer review process as being competent to
assess. This review process will be monitored by the Trust Lead Chemotherapy Nurse.
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



Undertaken an accredited course in chemotherapy at HEI academic level 6 (degree level
module) or equivalent.
Have undertaken an accredited course in teaching and/or assessing in clinical practice or
have covered this in pre-registration training.
Regularly undertake administration of chemotherapy as part of their role.
The particular competencies for which they are deemed capable as an assessor include:
Assessment of patients prior to chemotherapy, administration of chemotherapy and all
aspects of the care pathway, pre-during and post administration.
PRESCRIPTION OF SYSTEMIC ANTI-CANCER THERAPY: COMPETENCY ASSESSMENT
All Health Care Professionals (HCPs) involved in the assessment and prescription of systemic anticancer therapy (SACT) should be formally assessed as competent.
The following document should serve as a record of assessment of competency.
Competencies should be signed off by the HCPs Supervisor (e.g. named Consultant, Clinical and / or
Educational Supervisor). For Medical Trainees, where possible, competencies should be assessed
using validated assessment tools (e.g. DOPS, Mini-CEX or CbDs).
Oncology Pharmacy should hold a summary record of assessment for all SACT prescribers.
HCPs may undertake duties relating to a level of competence above a level at which they have
demonstrated competence, but only under the appropriate supervision / countersignature of a
suitably competent person which will usually be the patient’s named Consultant Oncologist.
Only clinicians performing duties at level 5 do not require supervision.
RECORD OF ASSESSMENT FOR PRESCRIBERS OF SACT
Name (please print):
…………………………………………………………………………………………………..
Position:……………………………………………………………………………………………………………………..
Usual signature:
…………………………………………………………………………………………………………
Start
date:………………………………………………………………………………………………………………..
Level 1
A level 1 person is able to undertake a review of a patient receiving systemic therapy and can
authorise the next cycle of treatment to proceed. This professional could be medically qualified or an
appropriately qualified chemotherapy nurse, oncology pharmacist or a professional allied to
medicine. It is estimated that suitable training would take 3 months within the Specialist Training
grade. During this period, medically qualified trainees will require the countersignature of a more
senior qualified person on all prescriptions.
Knowledge Assessment
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LEVEL 1 COMPETENCY
DATE
ACHIEVED
SUPERVISOR
SIGNATURE
Ability to authorise treatment to proceed following assessment of the
patient and relevant laboratory investigations.
Ability to review a prescription for systemic therapy and accurately
identify errors or omissions.
To demonstrate knowledge and understanding of the methods for
calculating the correct dose of medication for administration
including those based on body surface area, pharmacokinetic and
pharmacodynamic principles.
Ability to define the scientific basis of causation of nausea and
vomiting and ability to identify the likely mechanism of emesis in
patient receiving systemic therapy.
Ability to determine the antiemetic requirements of patients receiving
systemic therapy.
Ability to define the principles for dose delay or dose reduction of
systemic therapies, based upon haematological toxicity.
ALL LEVEL 1 COMPETENCIES ACHIEVED
#1 prescriptions require countersignature
Prescriptions from #2 onwards without countersignature.
GMP
Level 2
A level 2 person is able to prescribe systemic therapy, within local guidelines, or to continue a
planned course of treatment but not initiate the first cycle of treatment. This professional is likely to be
medically qualified or a senior non-medical prescriber. It is estimated that suitable training would be
completed within the first 3-4 months within the Specialist Training grade.
Knowledge Assessment
LEVEL 2 COMPETENCY
DATE
SUPERVISOR
ACHIEVED
SIGNATURE
To define the range of systemic therapies utilised in the treatment of
patients with cancer and define the likely adverse effects of the
agents in more common usage within a clinical service.
Ability to prescribe and order systemic therapies following
assessment of the patient and relevant laboratory investigations,
using appropriate systems defined by the local authorities.
Ability to accurately prescribe systemic therapies using various
methods for calculating the correct dose of medication for
administration including those based on body surface area,
pharmacokinetic and pharmacodynamic principles.
To define the scientific basis and parameters for dose modifications
to systemic therapy in the light of clinical data relating to the liver,
renal, haematological and other organ systems.
Ability to institute appropriate modifications in the prescription of
systemic therapy in the light of clinical data that will relate to dose
modification parameters relating to organ function.
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Ability to perform a thorough assessment of toxicity and record the
clinical information using defined systems such as the Common
Toxicity Criteria.
Ability to prescribe antiemetic medications appropriate to the chosen
therapy and modified following review of the patients’ situation and
symptoms following previous treatments.
Ability to define and initiate appropriately the pharmacological and
non-pharmacological supportive measures that may be required by
patients receiving systemic therapy, including growth factors and
antibiotics.
Ability to define the indications for and adverse reactions associated
with the use of blood products and ability to initiate appropriate
prescription following assessment of patients’ requirements.
Prescription of blood products is at present not permitted by nonmedical prescribers.
Ability to obtain informed consent for procedures and initiation of
treatments.
Ability to request assistance and advice when a situation requires
the involvement of a more senior colleague.
Ability to determine the appropriateness of continuing treatment,
particularly in patients with poor performance status or significant
comorbid conditions.
Ability to assess objective tumour responses and toxicity and make a
balanced judgement about continuing.
ALL LEVEL 2 COMPETENCIES ACHIEVED
#1 prescriptions require countersignature.
Prescriptions from #2 onwards without countersignature
Level 3
A person at level 3 is able to initiate systemic therapy for patients with a range of malignancies, whilst
prescribing within local guidelines. This professional will be medically qualified. It is estimated that
suitable training would be completed within the first 6 months within the Specialist Training grade.
Methods
LEVEL 3 COMPETENCY
DATE
SUPERVISOR
ACHIEVED SIGNATURE
To define the scientific mechanism of action of the systemic therapies
used in the management cancer patients.
Ability to initiate systemic therapy for common cancers following
detailed assessment of a patient and considering the decisions made
during a multidisciplinary team meeting.
Ability to modify the dosage of systemic therapy based on
pharmacokinetic and pharmacodynamic information relating to a
patient.
Ability to appropriately request assistance or advice when a situation
requires the involvement of a more senior colleague.
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Demonstrate a knowledge and understanding of the structure of
network agreed regimens and what processes are required to agree
use of non-approved regimens, either on a one off basis, or more
frequently.
ALL LEVEL 3 COMPETENCIES ACHIEVED
All prescriptions without countersignature.
Treatment plan to be agreed with supervising consultant.
Level 4
A level 4 person is able to initiate all appropriate systemic therapies for a tumour specific area of
clinical practice. They will also be able to participate in the evaluation of relevant therapies within
clinical trials and therefore have a detailed knowledge of the regulatory framework defined for clinical
research. This professional will be medically qualified. It is estimated that suitable training would be
completed within the 6 months requirement for each mandatory clinical module within the Specialist
Training grade. Therefore a level 4 competence is a requirement to complete training in the clinical
modules required for CCT.
GMP
LEVEL 4 COMPETENCY
DATE
SUPERVISOR
ACHIEVED
SIGNATURE
Ability to critically evaluate and interpret published evidence
relating to the investigation of a new therapeutic agent.
Authorise treatment to proceed following assessment of the patient
and relevant laboratory investigations.
Trainees at this level are encouraged to become investigators on
clinical trials within the tumour specific area.
Ability to define the regulatory framework for the development of
new therapies used in the treatment of patients with cancer.
Ability to request assistance and advice when a situation requires
the involvement of a more senior colleague.
ALL LEVEL 4 COMPETENCIES ACHIEVED
All prescriptions without countersignature.
Treatment plan to be agreed with supervising consultant.
Level 5
A level 5 person is able to introduce a new therapy into a clinical department. This may be following a
critical review of published evidence or as a clinical trial to evaluate a new therapy. This person can
also devise a new treatment for a condition and propose appropriate methods for critical evaluation
and determination of the cost-effectiveness. This professional will be medically qualified and likely to
be a Consultant Oncologist. The demonstration of this level of competence will be by the award of
Certificate of Completion of Training (CCT) in Oncology. Suitable training will take 48 months in an
approved training programme within the Specialist Training grade. A level 5 clinician will have
demonstrated competence at level 4 in all clinical modules required for CCT in Oncology.
LEVEL 5 COMPETENCY
DATE
ACHIEVED
SUPERVISOR
SIGNATURE
Ability to define strategies to introduce a new therapy within a clinical
department.
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Ability to critically review the evidence of benefit for a new therapy
and to advise the local authorities regarding the cost-effectiveness
and likely benefits to patients treated within the clinical service
Ability to identify the training needs of all health care professionals
involved in the delivery of a systemic therapy service, required to
introduce a new therapy into a clinical service.
Ability to customise a treatment to an individual patient, based on all
investigative information, when local guidelines are not applicable to
the clinical situation, or when there is a lack of clinical evidence for a
particular situation (such as a rare tumour for which randomised
controlled trial data is not available).
Ability to lead a clinical trial as a local Principal Investigator.
Ability to be an educational supervisor and oversee those training in
chemotherapy competencies.
ALL LEVEL 5 COMPETENCIES ACHIEVED
Consultant level prescriber.
Knowledge Assessment
ONCOLOGY PHARMCY SUMMARY RECORD OF ASSESSMENT
FOR PRESCRIBERS OF SACT
Name (please print):
…………………………………………………………………………………………………..
Position:……………………………………………………………………………………………………………………..
Usual signature:
…………………………………………………………………………………………………………
Start
date:…………………………………………………………………………………………………………..
AGREED COMPETENCY LEVEL
DATE ACHIEVED SUPERVISOR
SIGNATURE
Level 0
All prescriptions require countersignature.
Level 1
#1 prescriptions require countersignature.
Prescriptions from #2 onwards without countersignature.
Level 2
#1 prescriptions require countersignature.
Prescriptions from #2 onwards without countersignature.
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Level 3
All prescriptions without countersignature.
Treatment plan to be agreed with supervising consultant.
Level 4
All prescriptions without countersignature.
Treatment plan to be agreed with supervising consultant.
Level 5
Consultant level prescriber.
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