Download Trust Policy for Intrathecal Chemotherapy in Adults – Oncology and

INTRATHECAL CHEMOTHERAPY IN ADULTS POLICY
- ONCOLOGY AND HAEMATOLOGY DEPARTMENTS
Version
15
Name of responsible (ratifying) committee
Formulary and Medicines Group
Date ratified
17 March 2017
Document Manager (job title)
Lead Pharmacist for Oncology/ Haematology
Date issued
25 April 2017
Review date
24 April 2019
Electronic location
Clinical Policies
Related Procedural Documents
Cytotoxic drug management for adults in oncology and
haematology
Trust policy for the safe labeling and dilution of
vincristine and other vinca alkaloids -oncology,
haematology and paediatric departments.
Key Words (to aid with searching)
Intrathecal; chemotherapy; intrathecal and intra-thecal
chemotherapy; intrathecal register; drug therapy;
intrathecal injections; cancer; patient safety; safety
measures; drug administration; adults; nurses; medical
staff; pharmacists; regulations
Version Tracking
Version
Date Ratified
15
17/03/17
14
21/11/2014
Brief Summary of Changes
Author
 Addition of vinflunine as a vinca alkaloid
Rob Williams
 Numbers of procedures updated with latest
information.
 Documented compliance with NHS/PSA/D/2014/002
Stage Three: Directive. Non – Luer spinal (intrathecal)
devices for chemotherapy. 20 February 2014
 Disposal of syringe if procedure fails / aborted.
 Change name of Pharmacist from Catrin Watkinson to
Rob Williams.
 Numbers of procedures were updated with latest
information.
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Catrin Watkinson
Page 1 of 20
CONTENTS
QUICK REFERENCE GUIDE....................................................................................................... 3
1. INTRODUCTION.......................................................................................................................... 4
2. PURPOSE ................................................................................................................................... 4
3. SCOPE ........................................................................................................................................ 4
4. DEFINITIONS .............................................................................................................................. 5
5. DUTIES AND RESPONSIBILITIES .............................................................................................. 5
6. PROCESS ................................................................................................................................... 6
7. TRAINING REQUIREMENTS .................................................................................................... 14
8. REFERENCES AND ASSOCIATED DOCUMENTATION .......................................................... 15
9. EQUALITY IMPACT STATEMENT ............................................................................................ 15
APPENDIX A: ................................................................................................................................... 17
EQUALITY IMPACT SCREENING TOOL ......................................................................................... 19
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 2 of 20
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. Intrathecal chemotherapy remains an important patient safety issue. A major patient safety
issue is the danger to patients if intravenous vinca alkaloids (vincristine, vinblastine, vindesine,
vinflunine and vinorelbine) are injected intrathecally (via spinal or intraventricular injections)
during the chemotherapy treatment of a cancer patient. Vinca alkaloids are intended for
intravenous use only. If injected intrathecally they cause paralysis almost always followed by
death.
2. NPSA/2008/RRR004 and supporting information on Using Vinca Alkaloid Minibags
(Adult/Adolescent Units) should be read in conjunction with this guidance.
3. A register has been established and maintained which lists designated personnel who have
been trained and authorised to prescribe, dispense, issue, check or administer intrathecal
chemotherapy. Staff moving from one hospital to another should not be automatically included
on the new hospital’s register.
4. The ‘designated lead’ has delegated responsibility for induction, training and continuing
professional development related to intrathecal chemotherapy to a lead trainer.
5. Tasks on the register are competency based i.e. they can be carried out by any members of
staff (except for training grades) who have been appropriately trained, deemed competent by the
designated lead or lead trainer(s) and whose names appears on the register of designated
personnel for that task. This is relevant to prescribing, dispensing, issuing, checking and
administration.
6. A purpose designed intrathecal chemotherapy chart is used.
7. Intrathecal chemotherapy drugs are kept in a dedicated lockable container/refrigerator in the
pharmacy between dispensing and issuing and are stored in a dedicated lockable
container/refrigerator between issuing and administration when they cannot be administered
immediately.
8. Intrathecal chemotherapy can only be administered in the designated areas on the combined
haematology and oncology day unit and on F5 ward.
9. Under normal circumstances intrathecal chemotherapy is administered within normal working
hours. (Monday to Friday 08.00 to 18.00)
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 3 of 20
1. INTRODUCTION
This document is produced in response to the updated National Guidance on the safe
administration of intrathecal chemotherapy, Dept of Health HSC 2008/001 issued 11 August
2008. This guidance was designed to achieve the Government target to reduce the number of
patients dying or being paralyzed by mal-administered spinal injections to zero by the end of
2001. This updated guidance replaces HSC 2003/010. It sets out the minimum that should be
expected of an NHS Trust providing an intrathecal chemotherapy service.
The section (including the waiver) on dilutions of intravenous vinca alkaloids originally in
HSC2003/010 has been removed. The guidance now cross-refers to a new national Patient
Safety Agency (NPSA) rapid response report NPSA/2008/RRR004 entitled Using Vinca
Alkaloid
Minibags
(Adult/Adolescent
Units)
which
can
be
found
at
http://www.npsa.nhs.uk/patientsafety/alerts-and-directives/rapidrr and which should be read in
conjunction with this document.
2. PURPOSE
This policy is designed to ensure the safe prescribing, handling and administration of
Intrathecal Chemotherapy for Portsmouth Hospitals NHS Trust patients.
3. SCOPE
PHT has a unified intrathecal chemotherapy service which caters for adult patients with solid
tumours and haematological malignancies. PHT does not provide intrathecal chemotherapy for
children. This is a single divisional policy, which applies to all Portsmouth Hospitals’ clinical,
nursing and pharmacy staff, particularly those working in Haematology, Oncology and
Pharmacy . It applies to the induction, training, assessment and continuing professional
development of staff on the intrathecal register, and also of those staff not on the register who
are prohibited from involvement in any aspect of intrathecal activity. It applies to prescribing,
managing intrathecal chemotherapy drugs, patient consent, reviews, location, checks and
administration to patients and when the service will be available. It also describes where in the
Trust to find copies of key documents such as national guidance, relevant local policies,
procedures and the Intrathecal Chemotherapy Register.
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 4 of 20
4. DEFINITIONS
Portsmouth Hospitals
Portsmouth Hospitals NHS Trust
The Trust
Portsmouth Hospitals NHS Trust
ST3
Specialist Registrar
LP
Lumbar Puncture
Junior ST
Junior Doctor (ST1, ST2, FT1, FT2)
CSF
Cerebrospinal fluid
Designated personnel
Personnel whose names appear on the
Intrathecal Chemotherapy Register who
have been trained and certified competent
in one or more of the following tasks:
prescribing, dispensing, checking and
administration of intrathecal chemotherapy
Intrathecal
Register
. All references to “the register” in this
policy
refer
to
the
Intrathecal
Chemotherapy Register and not to any
other register such as the medical register.
This register will be located on the
pharmacy web pages of the PHT intranet
website and specified locations within the
Trust (see Para 6.3 below).
Chemotherapy
Guidance in HSC 2008/001
Designated Lead
Designated Lead Trainer
National guidance provided in Health
Service Circular HSC 2008/001 Updated
National
Guidance
on
the
Safe
Administration of Intrathecal Chemotherapy
(August 2008).
The single lead clinician appointed by the
Chief Executive to oversee compliance with
Guidance in HSC 2008/001,
The Lead Pharmacist for Oncology and
Haematology Services to be responsible
for training and day-to-day maintenance of
the Intrathecal Chemotherapy Register.
5. DUTIES AND RESPONSIBILITIES
Portsmouth Hospitals NHS Trust provides an intrathecal chemotherapy service therefore the
Chief Executive has overall responsibility for compliance with Guidance in HSC 2008/0001.
The Chief Executive has appointed Dr A O’ Callaghan as the single lead clinician to oversee
compliance with Guidance in HSC 2008/001. She will be accountable to the Chief Executive.
This lead person is referred to as the Designated Lead.
The Designated Lead has appointed a Designated Lead Trainer, the Senior Directorate
Pharmacist for Oncology and Haematology Services, Rob Williams to oversee training within
the Trust.
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 5 of 20
Staff may only perform the specific task(s) for which they have been trained and certified
competent unless performing a task under direct supervision, in the constant presence of an
assessor, for the specific purpose of being assessed for inclusion on the intrathecal register.
6. PROCESS
Overall Responsibility
Portsmouth Hospitals NHS Trust provides an intrathecal chemotherapy service therefore
the Chief Executive has overall responsibility for compliance with Guidance in HSC
2008/0001.
The Chief Executive has appointed Dr A O’ Callaghan as the single lead clinician to
oversee compliance with Guidance in HSC 2008/001. She will be accountable to the Chief
Executive. This lead person is referred to as the Designated Lead.
The Designated Lead has appointed a Designated Lead Trainer, the Lead Pharmacist for
Oncology and Haematology Services, Rob Williams to oversee training within the Trust.
Volume of Service
In Portsmouth Hospitals Trust there were 43 intrathecal chemotherapy administrations
between April 2014 - March 2015 and 41 administrations between April 2015 – March 2016.
It therefore is neither a low volume provider nor a high volume provider.
Document Availability and Control
A system is in place to ensure that only the latest edition of the national guidance, this
policy and the intrathecal chemotherapy register is available to Trust staff. Master copies of
each of the above are held on the pharmacy intranet website. In addition papers copies are
kept at the following locations:
Copy Number
Location
1
2
3
4
5
6
Oncology Pharmacy QAH
Pharmacy Manufacturing Unit – Railway Triangle
F5 QAH Procedure Rm F1321
HODU – Haematology / Oncology Day unit
Designated Lead
Designated Trainer
Pharmacy Work Instruction PHPSWI.22.003 describes how up-to-date hard copies are
maintained in the above locations. The maintenance of up-to-date documentation is the
subject of annual audit as part of the pharmacy medicines management audit process.
This policy complements the Portsmouth Hospitals Policy for administration of
chemotherapy and is subject to separate document control work instructions.
Intrathecal Chemotherapy Register
Portsmouth Hospitals NHS Trust has a single intrathecal chemotherapy register of people
who have been trained and certified competent in one or more of the following tasks:

Prescribing intrathecal chemotherapy;

Clinical screening (verification) of intrathecal chemotherapy;

Dispensing intrathecal chemotherapy (i.e. preparing the dose, filling the syringe,
production pharmacist release and placing it in packaging for transport);

Checking and Issuing intrathecal chemotherapy from the pharmacy;
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 6 of 20



Checking intrathecal chemotherapy drugs prior to administration;
Administering intrathecal chemotherapy.
Assessors for intrathecal chemotherapy training.
Staff may only perform the specific task(s) for which they have been trained and certified
competent unless performing a task under direct supervision, in the constant presence of
an assessor, for the specific purpose of being assessed for inclusion on the intrathecal
register.
Following the successful completion of induction, formal training, and performance of the
intrathecal task under supervision by an assessor, only the Designated Lead or the Lead
Trainer can authorise the inclusion of that person onto the relevant section of the intrathecal
register.
Registration only lasts a year, an individual will therefore be deleted from the register unless
the individual can satisfactorily demonstrate continued competence.
The Designated Lead has overall responsibility for holding the register and ensuring that it
is maintained and kept up-to-date. Day-to-day responsibility for holding the register and
ensuring that it is maintained and kept up-to-date is delegated to the Designated Lead
Trainer (Para 22 ).
Pharmacy Work Instruction PHPSWI.22.003 describes the system to ensure that only the
latest edition of the intrathecal chemotherapy register is available to Trust staff. Master
copies of each of the above are held on the pharmacy intranet website. In addition paper
copies are kept at the locations listed in Document and Availability Control above.
The Designated Lead is responsible for monitoring how often staff on the register carry out
procedures related to intrathecal chemotherapy and assessing whether they remain on the
register. She will be assisted in this process by the Senior Directorate Pharmacist, who will
monitor prescriptions and report individual activity annually.
The Designated Lead will hold a regular review of staff participation, continued competence,
confirmation of rereading national and local guidance. The Designated Lead has the
authority to delete individuals from the register if they fail to demonstrate satisfactory
competence in intrathecal tasks. Individuals performing a low number of procedures may
require refresher training under supervision before re-certification and re-inclusion on the
register.
Staff transferring from other trusts
Automatic inclusion in Portsmouth Hospitals’ intrathecal chemotherapy register will not
occur. Staff who were on the intrathecal register at their previous hospital at the time of
transfer will need to provide written confirmation of their certification, undergo the
Portsmouth Hospitals Trust induction, perform one supervised procedure, and demonstrate
their competence.
No form of “provisional” entry to the register is allowed for any staff.
Induction, training and continuing professional development
The designated lead for intrathecal chemotherapy for the Trust has overall
responsibility for induction, training, assessment, annual recertification and
Continuing professional development related to intrathecal chemotherapy.
The responsibility for training for all professionals is delegated to the lead trainer. For
medical staff training is delivered by clinical lead overseen by training lead. For nursing staff
the clinical educator assists in this training role. The lead trainer will ensure that the
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 7 of 20
following are in place:

Induction for all staff in departments involved in intrathecal chemotherapy. All staff
including consultants who are new to the ward or department involved with intrathecal
chemotherapy are provided with a formal induction covering all potential clinical
hazards associated with intrathecal chemotherapy and the danger posed to patients if
intravenous vinca alkaloids are accidentally administered intrathecally.

Staff working in areas where chemotherapy is prescribed and administered or in the
pharmacy service, but who are not involved in providing an intrathecal chemotherapy
service, must be made aware that there is strict national guidance and this local policy,
which prohibits their involvement in any aspect of the service.

All staff are required to read the local training documentation. All staff are required to
sign a written confirmation that they have read this documentation before being allowed
to practice their respective roles.

As part of the induction training it is made clear to all staff involved with the treatment
and care of patients receiving intrathecal chemotherapy that they should challenge
colleagues if, in their judgement, either protocols are not being adhered to or the
actions of an individual may cause potential risk to a patient. Challenging should not be
seen as adversarial but as an additional check to improve patient safety and reduce
risk.

It is the responsibility of staff who are on the Intrathecal Register to ensure that all other
colleagues that are participating in the process are also on the Intrathecal Register.
Training of Staff for intrathecal chemotherapy

There is a common formal induction course for nursing, pharmaceutical and medical
staff including consultants new to the hospital. This covers all potential clinical hazards
associated with intrathecal chemotherapy and the danger posed to patients if
intravenous vinca alkaloids are accidentally administered intrathecally. It includes
information appropriate to their proposed role in the intrathecal chemotherapy service
i.e. prescribing, dispensing, issuing, checking and administration of intrathecal
chemotherapy.

All staff participating in the intrathecal service must read the national guidance on
intrathecal chemotherapy and this local policy.
Assessment

Assessment will be performed by personnel designated as assessors on the register.

Staff will be required to demonstrate satisfactory completion of the training course,
written confirmation that they have read both the national guidance and local protocol
and satisfactorily perform the relevant task under the supervision of an assessor.

Staff will receive a certificate to confirm that they have completed their training and are
competent and become eligible to be included on the register for their designated
task(s)

The Designated Lead will agree with the Lead Trainer those staff who are competent to
assess the competence of others to perform the tasks listed in the Intrathecal
Chemotherapy Register above and authorise entry of the names of those who have
been trained and certified competent in one or more of the tasks listed.
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 8 of 20
Annual Confirmation of Competence

All staff on the register must provide annual written confirmation that they have
reread the national guidance and local policy. They must be able to demonstrate they are
competent in the roles they undertake and that this competence is reviewed annually.

The practical administration of intrathecal chemotherapy is regarded as part of
continuing professional education and training for all professional staff who remain on the
register.

The Designated Lead and Lead Trainer will hold a regular intrathecal meeting to
review the competence of all staff on the register
Training is in the form of an “in house” training package titled “Intrathecal Chemotherapy –
Training package for designated staff to allow entry onto the intrathecal register” and
includes reference to the national training toolkit issued by the Department of Health.
Prescribing
Only Consultant Medical Staff, Associate Specialists or ST3 grade or above, whose names
appear on the current intrathecal chemotherapy register as prescribers shall prescribe
intrathecal chemotherapy. No other persons may prescribe intrathecal chemotherapy
under any circumstances.
Newly appointed medical staff, including consultants, will be informed at induction that they
cannot prescribe intrathecal chemotherapy until they have received the appropriate
induction/training and, their name added to the Intrathecal chemotherapy register as
competent to prescribe intrathecal chemotherapy.
Junior medical grades below ST3 are not, in any circumstances, permitted to prescribe
intrathecal chemotherapy.
Drugs prescribed intrathecally:
Adult Oncology:
Methotrexate
Cytarabine
Depocyte (Liposomal Cytarabine)
Adult Haematology:
Methotrexate
Cytarabine
Depocyte (Liposomal Cytarabine)
Hydrocortisone
The use of an intrathecal drug not on the above list must be discussed with the Designated
Lead and the Senior Directorate Pharmacist Oncology/Haematology. Its use must be
recorded in compliance with the agreed local and network policy
Prescription Chart (See Appendix 1)
A purpose designed intrathecal chemotherapy prescribing and administration record chart
will be used for recording the prescribing, issue, collection/delivery, nurse checking and
administration of intrathecal chemotherapy. It will not be part of any other chemotherapy
chart. The drug and route of administration will be clearly written on the chart and it will
have space for the full signatures of all those undertaking prescribing, issue,
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 9 of 20
collection/delivery, nurse checking and administration of intrathecal chemotherapy to
ensure a clear audit trail
There is continuous audit of intrathecal chemotherapy administration and audit sheet must
be completed with details of each procedure
Intrathecal chemotherapy is documented in patients clinical notes
Following administration the prescription chart will be filed in the Intrathecal Folder for the
unit where the procedure has been performed, prior to filing in the patient’s notes.
Managing intrathecal chemotherapy drugs
Dispensing
Only pharmacy staff, who appear on the intrathecal chemotherapy register will dispense
intrathecal chemotherapy drugs. For the purposes of this policy, dispensing is the activity
of preparing the dose, filling the syringe and placing the syringe in packaging for transport.
Dispensing will take place only in the Pharmacy Manufacturing Unit based at Railway
Triangle, Farlington.
Batches of intrathecal chemotherapy may be prepared but they will always be issued as
individual patient doses and signed for as such before they are released from the
pharmacy.
To ensure compliance with NHS/PSA/D/2014/002 Stage Three directive. Non – Luer spinal
(intrathecal) devices for chemotherapy 20 February 2014 intrathecal injections are
manufactured using Surety syringes, needles and hubs. These have been independently
evaluated for physical, microbiological and clinical efficacy by an independent laboratory on
behalf of NHS England.
At the point of administration a Surety spinal needle is used.
Storage in the pharmacy
Intrathecal chemotherapy drugs (except Depocyte®) will only be stored in dedicated,
lockable refrigerators at QAH pharmacy, reserved solely for the purpose of storing
intrathecal chemotherapy drugs. The refrigerators will be clearly labeled and they will never
be used to store any other products including intravenous chemotherapy. Intrathecal
chemotherapy drugs (except Depocyte) will not be stored in any other location.
Depocyte® is stored at room temperature in a dedicated lockable box, reserved solely for
the storage of depot cytarabine, in QAH pharmacy, positioned adjacent to the intrathecal
refrigerator.
Issuing of Intrathecal chemotherapy drugs
Only pharmacy staff on the intrathecal register for issuing can issue intrathecal
chemotherapy drugs.
Intrathecal chemotherapy drugs will only be issued from either QAH pharmacy, immediately
prior to administration, to the registered doctor who will be administering the drug (the
collector) or taken to the ward by a designated member of pharmacy staff whose name
appears on the intrathecal chemotherapy register. If the drugs are taken to the ward they
must be handed to the doctor who will be administering the intrathecal chemotherapy.
Once received by the administering doctor, individual patient dose(s) of intrathecal
chemotherapy drug(s) will be placed on the lower shelf of the lumbar puncture trolley, in the
intrathecal area, ready for administration. If treatment is delayed for any purpose the
intrathecal chemotherapy will be returned to the pharmacy for secure storage.
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 10 of 20
Administration to patients
Patient consent
Full written, informed patient consent is required for the course of intrathecal chemotherapy
rather than each dose within the course. However, when attending for each dose, patients
will be explicitly told the nature of the procedure, the route of administration and the drug to
be administered and ongoing consent confirmed verbally
In clinical circumstances where consent is not possible due to nature of condition being
treated effecting capacity appropriate procedure for obtaining consent will be followed.
Once patient has regained capacity they will provide informed consent for ongoing
treatment course
Patient reviews
A consultant or appropriately trained and nominated deputy from the Intrathecal
chemotherapy register who can administer intrathecal chemotherapy will review each
patient before intrathecal chemotherapy is administered. This is to ensure that the patient
is fit for treatment, the correct tests have been conducted, the correct chemotherapy has
been prescribed and that arrangements have clearly been made for the intrathecal
chemotherapy to be administered by the appropriate medical staff. The completion of this
review process will be signed for on each occasion by the administering Doctor, on the
Intrathecal Chemotherapy Chart
Location
Intrathecal chemotherapy will be administered in an area or room where no other
chemotherapy drugs are stored or administered. For Portsmouth Hospitals these areas are
as follows:
HODU – Procedure Rm 4 – B1512
F5 – Procedure Rm – F1321 - This is the designated area for any in-patients regardless on
whether they are on F5, F6 or F7.
The bed/area designated for the administration of intrathecal chemotherapy will be reserved
for that purpose for the duration of that session. When intrathecal chemotherapy is being
administered in that area it will not be used for any other purpose. Under no circumstances
will any other form of chemotherapy take place in this area during that session.
Chemotherapy drugs for intravenous infusion must never been stored in these areas, even
when the area is not in use.
In exceptional circumstances it may be necessary to administer intrathecal chemotherapy in
a non-designated place. This should only be considered after careful consultation with the
Trust Lead for Intrathecal Chemotherapy. The reason should be documented in the
patient’s notes, and noted in annual report and reviewed at annual Intrathecal review
meeting. These circumstances could include a patient too ill to move, infection control
hazard, or requirement for placement of the lumbar puncture needle in theatre with
anesthetic assistance.
In these exceptional circumstances, the intrathecal administration of chemotherapy must be
performed by a consultant on the intrathecal register, in the presence of a nurse registered
to check intrathecal chemotherapy.
Checks
Medical staff, when preparing a patient for treatment with intrathecal chemotherapy, will use
a formal checking procedure to ensure that the right drug and the right dose is given to the
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 11 of 20
right patient via the correct route. These checks will include a chemotherapy trained nurse /
pharmacist whose name appears on the Intrathecal chemotherapy register, the patient and,
if appropriate the relative or guardian
As a minimum the doctor administering the intrathecal chemotherapy will confirm the
identity of the patient, verbally and with wrist band identification explain the nature of the
procedure, the drug that is to be administered and the route of administration
The patient, and the name and dose of drug must be checked by a chemotherapy trained
nurse or pharmacist who is on the register for checking intrathecal chemotherapy.
A chemotherapy trained nurse is a nurse who has been assessed to be competent both to
administer intravenous chemotherapy and check both intravenous and intrathecal
chemotherapy. Named nurses other than those who are chemotherapy trained nurses may
check intrathecal chemotherapy provided they have been trained, certified competent to
check intrathecal chemotherapy and whose names appear of the Intrathecal chemotherapy
register.
At Portsmouth Hospitals NHS Trust two doctors checking is NOTan appropriate substitute
for a chemotherapy trained nurse / pharmacist in any circumstances.
Some patients may choose to check the name and dose of the drug(s) written up on the
chart with those on the label of the syringe. They will be enabled to do this if they so wish.
Patients will not be expected to take on a burden of responsibility greater than they would
be comfortable with.
The checks made must be recorded using the intrathecal chemotherapy prescribing and
administration record
Intrathecal chemotherapy is not administered under anaesthesia in Portsmouth Hospitals.
except in exceptional circumstances which must be discussed on a case by case basis with
the clinical lead for intrathecal chemotherapy and a clear plan ensuring safety must be in
place
Methotrexate, the most commonly used drug given intrathecally, is yellow. If may be
helpful to remember this but this does not reduce the burden on the clinician nurse or
pharmacist on the intrathecal chemotherapy register to check the label on the relevant
container
Administration of Drugs
The following doctors can be included in the register as authorised to administer intrathecal
chemotherapy provided that their names appear on the current Intrathecal chemotherapy
register as authorised to administer intrathecal chemotherapy:




Consultants;
Specialist Registrars ( ST3 grade and above)
Associate Specialist
Staff grades
It will be made clear to medical staff (including consultants) new to the hospital that they do
not administer intrathecal chemotherapy until they have received appropriate training, their
competency agreed and documented and their name included on the Intrathecal
chemotherapy register, as for all other staff seeking inclusion on the register.
A technically difficult lumbar puncture may need assistance from staff not on the Intrathecal
chemotherapy register, for example, an anaesthetist or radiologist to position the needle
under imaging control. This is acceptable, however, these staff will never be involved in
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 12 of 20
any other aspect of the process and they will never administer intrathecal chemotherapy
The intrathecal administration must be performed by a consultant on the intrathecal
register, in the presence of a nurse / pharmacist registered to check intrathecal
chemotherapy.
If the procedure fails or is aborted the intrathecal syringe will be disposed of by the
administering doctor as cytotoxic waste on the ward or on the day unit. This will be
documented on the intrathecal prescription.
In Portsmouth Hospitals NHS Trust Junior medical grades below ST3 will never administer
intrathecal chemotherapy. Neither may they perform a lumbar puncture for the purpose of
intrathecal chemotherapy.
Times for administration of intrathecal chemotherapy
Under normal circumstances intrathecal chemotherapy will only be administered during
normal working hours Monday to Friday 08.00 – 18.00, i.e. at times when a full range of
specialist expertise is available.
Out of hours
Only in exceptional circumstances (e.g. CNS relapse of leukaemia, requiring emergency
treatment) intrathecal chemotherapy may be administered out-of-hours, when there is a
clear clinical need that cannot wait until the next working day.
Only Methotrexate is to be used out of hours.
Only a consultant whose name appears on the Intrathecal chemotherapy register can
prescribe the intrathecal chemotherapy out-of-hours but thereafter all normal procedures
will apply.
The pharmacy will be contacted through the pharmacy on-call system and an oncology /
haematology pharmacist on the intrathecal chemotherapy register will issue and deliver the
intrathecal chemotherapy. The pharmacy will issue an intrathecal chemotherapy syringe of
intrathecal Methotrexate 12.5 mg held in the designated locked intrathecal refrigerator at
QAH specifically for this purpose. The prescribing consultant will inform the Designated
Lead, on the next working day. The designated lead will document the out-of-hours
administration, reason and outcome.
All such instances must be reported to the monthly Chemotherapy Users Group meeting
and discussed at the annual Intrathecal review Meeting.
Prescribing and administering intraventricular chemotherapy (via omaya reservoir )
All requirements of this policy apply equally to the control of intraventricular chemotherapy
and will be followed in full. If the patient has an Ommaya reservoir in place an intrathecal
needle is not required as the intrathecal syringe is compatible with the device as they are
both manufactured by Surety.
In the Event of an Error
If a medication has been given intrathecally in error, assess the clinical risk to
the patient and take appropriate action, as specified below.
The Designated Lead and the Senior Clinical Nurse must be informed immediately and they
are responsible for completing an adverse incident form.
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 13 of 20
If a vinca alkaloid has been administered intrathecally, management must be to transfer the
patient to the Neurosurgery Department at University Hospital Southampton NHS
Foundation Trust as soon as practicable.
The Nurse assisting must Call 999 for transfer to neurosurgery.
Contact must be made with the on-call Neurosurgical registrar and they should be advised
of type of error and imminent transfer.
If the LP needle is still in place, 20mls of CSF must be aspirated as soon as possible. A
further 20mls should be allowed to drain freely if possible. N.B. the needle must be
removed prior to transfer.
The patient should be transferred in the sitting position.
The patient should be informed of events.
A nurse must accompany the patient to University Hospital Southampton.
If lignocaine has been administered, management must be to transfer the patient to the
Intensive Care Unit and assess the need for ventilation
7. TRAINING REQUIREMENTS
Training of Staff for intrathecal chemotherapy
 There is a common formal induction course entitled “Intrathecal Chemotherapy – Training
package for designated staff to allow entry onto the intrathecal register” This covers all
groups of staff - nursing, pharmaceutical and medical staff including consultants new to the
Trust. This covers all potential clinical hazards associated with intrathecal chemotherapy
and the danger posed to patients if intravenous vinca alkaloids are accidentally
administered intrathecally. It includes information appropriate to their proposed role in the
intrathecal chemotherapy service i.e. prescribing, dispensing, issuing, checking and
administration of intrathecal chemotherapy.

All staff participating in the intrathecal service must read the national guidance on
intrathecal chemotherapy and this local policy.
Assessment
 Assessment will be performed by personnel designated as assessors on the register.

Staff will be required to demonstrate satisfactory completion of the training course, written
confirmation that they have read both the national guidance and local protocol and
satisfactorily perform the relevant task under the supervision of an assessor.

Staff will receive a certificate to confirm that they have completed their training and are
competent and become eligible to be included on the register for their designated task(s)

The Designated Lead will agree with the Lead Trainer those staff who are competent to
assess the competence of others to perform the tasks listed in 6.4.1 above and authorise
entry of the names of those who have been trained and certified competent in one or more
of the tasks listed in 6.4.1 above:
Annual Confirmation of Competence
 All staff on the register must provide annual written confirmation that they have reread the
national guidance and local policy. They must be able to demonstrate they are competent
in the roles they undertake and that this competence is reviewed annually.
 The practical administration of intrathecal chemotherapy is regarded as part of continuing
professional education and training for all professional staff that remain on the register.

The Designated Lead and Lead Trainer will hold a regular intrathecal meeting to review
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 14 of 20
the competence of all staff on the register
Training will be in the form of an “in house” training package and will include reference to the
national training toolkit issued by the Department of Health.
8. REFERENCES AND ASSOCIATED DOCUMENTATION
Updated National Guidance on the safe administration of Intrathecal Chemotherapy, Dept of
Health HSC 2008/001 11th October 2008.
NPSA/2008/RRR004 – National Patient Safety Agency (NPSA) rapid response report using
Vinca Alkaloid Minibags (Adult/Adolescent Units) which can be found at
http://www.npsa.nhs.uk/patientsafety/alerts-and-directives/rapidrr
PHPSWIO14D Work Instruction – Pharmacy Dispensing
PHPSWI016D Work Instruction – Dispensing Injectable Cytotoxic Medicines
Could add the NPSA 2009/PSA 004A
NPSA 2009/PSA 004A. Compliance with this guidance will occur when the devices become
available. A Trust working group is leading this.
http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=65257&type=full&servicet
ype=Attachment
NPSA /2011/PSA is an update to NPSA 2009/PSA 004A and has been issued to allow more
time to become compliant due to lack of availability of devices.
http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=94507&type=full&servicet
ype=Attachment
NHS/PSA/D/2014/002 Stage Three: Directive. Non – Luer spinal (intrathecal) devices for
chemotherapy. 20 February 2014
https://www.england.nhs.uk/wp-content/uploads/2014/02/non-Luer-spinal-supp.pdf
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
Efficiency
This policy should be read and implemented with the Trust Values in mind at all times.
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 15 of 20
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
Competency of
all Individuals on
Intrathecal
Register
Lead
Designated
Lead
Tool
Audit
Frequency of Report
of Compliance
Annual Review
Reporting
arrangements
Lead(s) for acting on
Recommendations
Policy audit report to:
Annual Inthrathecal
Review meeting
Chemotherapy
Governance Group for
noting
Competency /
Frequency of
Tasks of all
Individuals on
Intrathecal
Register
Senior
Directorate
Pharmacist
Audit
Annual
Review
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Policy audit report to:
Annual Intrathecal
Review meeting
Chemotherapy
Governance Group for
noting
Designated Lead
The Designated Lead has
the Authority to delete
individuals
from
the
register if they fail to
demonstrate satisfactory
competence
in
inthrathecal tasks.
Individuals performing a
low number of procedures
may require refresher
training under supervision
before re-certification and
re-inclusion
on
the
register.
Designated Lead
Page 16 of 20
APPENDIX A:
INTRATHECAL CHEMOTHERAPY PRESCRIPTION CHART
Complete or Attach Patient label
Blood
results
Ward:
Hospital Number:
Patient
Review
completed by:
Haem:
(full signature)
Consultant:
Surname:
Diagnosis:
First Name:
Indication:
WBC:
Prophylaxis / Treatment *
Neut:
(*delete as appropriate)
Date of Birth:
Prescription
Date:
Course:
date taken:
Drug:
Dose:(mg)
Route:
(written in full)
Plat:
Prescribed by:
Doctor:
(please print)
(full signature)
INTRATHECAL
Has intravenous chemotherapy been
prescribed for this patient for this date
YES
NO
Doctor: (full Signature)
I confirm that all intravenous chemotherapy
prescribed for this date has been
administered
Date:
Time:
Pharmacist OR Doctor: (full Signature)
Screening Pharmacist: (full Dispensed by:
signature)
(full signature)
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Batch
Number:
Expiry date
/ Time:
Page 17 of 20
Issuing
Pharmacist: Accepted by: Administrating
Doctor ONLY (full signature)
(full signature)
Nurse Checked by:
(full signature)
Patient Written
Consent taken:
Patient ID checks
completed:
Time of Administered by:
(please print)
Admin
(Please tick and initial to confirm) (Please tick and initial to confirm)
Nurse
Doctor
PHPS FORM Intrathecal Cyto Prescription May 2013
ALL SECTIONS OF THIS CHART MUST BE COMPLETED
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 18 of 20
Administered by:
(full signature)
EQUALITY IMPACT SCREENING TOOL
To be completed and attached to any procedural document when
submitted to the appropriate committee for consideration and approval
for service and policy changes/amendments.
Stage 1 - Screening
Title of Procedural Document: Intrathecal Chemotherapy In Adults Policy - - Oncology And
Haematology Departments
Date of Assessment
Name
of
completing
assessment
09/03/17
person Robert Williams
Responsible
Department
Job Title
Haematology / oncology
Haematology
pharmacist
/Oncology
Does the policy/function affect one group less or more favourably than another on the basis
of :
Yes/No
 Age
No
 Disability
Learning disability; physical disability; sensory
impairment and/or mental health problems e.g.
dementia
No
 Ethnic Origin (including gypsies and travellers)
No
 Gender reassignment
No
 Pregnancy or Maternity
No
 Race
No
 Sex
No
 Religion and Belief
No
 Sexual Orientation
No
Comments
If the answer to all of the above questions is NO,
the EIA is complete. If YES, a full impact
assessment is required: go on to stage 2, page 2
More Information can be found be following the link
below
www.legislation.gov.uk/ukpga/2010/15/contents
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 19 of 20
Stage 2 – Full Impact Assessment
What is the impact
Level of
Impact
Responsible
Officer
Mitigating Actions
(what needs to be done to minimise /
remove the impact)
Monitoring of Actions
The monitoring of actions to mitigate any impact will be undertaken at the appropriate level
Specialty Procedural Document:
Specialty Governance Committee
Clinical Service Centre Procedural Document:
Clinical Service Centre Governance Committee
Corporate Procedural Document:
Relevant Corporate Committee
All actions will be further monitored as part of reporting schedule to the Equality and Diversity
Committee
Intrathecal Chemotherapy in Adults Policy
Version: 15
Issue Date: 25 April 2017
Review Date: 24 April 2019 (unless requirements change)
Page 20 of 20