TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER
VINCA ALKALOIDS – ONCOLOGY AND HAEMATOLOGY AND PAEDIATRIC
DEPARTMENTS
Version
6
Name of responsible (ratifying) committee
Formulary and Medicines Group
Date ratified
17th January 2014
Document Manager (job title)
Senior Directorate Pharmacist for Oncology /
Haematology
Date issued
09th April 2014
Review date
January 2016
Electronic location
Corporate Clinical Policies
Related Procedural Documents
Cytotoxic drug management for adults in oncology and
haematology
Trust policy for Intrathecal chemotherapy in adults –
Oncology and Haematology Departments
Key Words (to aid with searching)
Vinca alkaloids; Safe labelling; dilution; Vincristine,
Vinblastine, Vindesine, Vinorelbine; mini-bags; Cancer;
Patient safety; Safety measures; Drug administration;
Adults; Nurses; Medical staff; Pharmacists;
Regulations
Version Tracking
Version
6
Date Ratified
Brief Summary of Changes
Author
Change to updated format. No changes to contents of
document
Catrin Watkinson
TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER VINCA
ALKALOIDS – ONCOLOGY AND HAEMATOLOGY AND PAEDIATRIC DEPARTMENTS:
Issue Number 6 Issue Date 09/04/2014
(Review date: January 2016 (unless requirements change)
Page 1 of 8
CONTENTS
1.
2.
3.
4.
5.
6.
7.
8.
9.
QUICK REFERENCE GUIDE.........................................................................................................
INTRODUCTION............................................................................................................................
PURPOSE .....................................................................................................................................
SCOPE ..........................................................................................................................................
DEFINITIONS ................................................................................................................................
DUTIES AND RESPONSIBILITIES ................................................................................................
PROCESS .....................................................................................................................................
TRAINING REQUIREMENTS ........................................................................................................
REFERENCES AND ASSOCIATED DOCUMENTATION ..............................................................
MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF, PROCEDURAL
DOCUMENTS ................................................................................................................................
TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER VINCA
ALKALOIDS – ONCOLOGY AND HAEMATOLOGY AND PAEDIATRIC DEPARTMENTS:
Issue Number 6 Issue Date 09/04/2014
(Review date: January 2016 (unless requirements change)
Page 2 of 8
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. The quick reference can take the form of a list or a flow chart, if the latter would more easily
explain the key issues within the body of the document
1. There have been reports of fatal and serious incidents from hospitals outside the UK in which
doses of vinca alkaloids intended for intravenous administration have been have been given by
the intrathecal (spinal) route in error. These include cases where doses had been diluted to 10
and 20ml in syringes.
2. The World Health Organisation (WHO) therefore issued guidance recommending doses of
vinca alkaloids should be prepared and administered in intravenous 50ml mini-bags to further
minimise the risk of wrong route errors. This led to the issuing of the Rapid Response Report
NPSA/2008/RRR004 – using vinca alkaloids in minibags.
3. When vinca alkaloids are prescribed, dispensed or administered in adult and adolescent units
doses in syringes should no longer be used
4. The prescribed dose should be supplied from the Pharmacy Manufacturing Unit ready to
administer in a 50ml minibag of sodium chloride 0.9%
5. The following warning “For intravenous Use Only - Fatal if administered by other routes”
should be on the label of every vinca alkaloid product.
6. In addition the minibag itself should also be placed inside a yellow vinca alkaloid warning bag.
7. When vincristine is used in a Paediatric unit and the patient is over 10 years the pharmacy will
dilute the prescribed dose to a maximum concentration of 0.1mg/ml and dispense it in (as a
minimum) a 20ml syringe. For intravenous vinblastine, vindesine or vinorelbine the prescribed
dose will be diluted to a minimum of 20mls. If these patients were on an adolescent unit then
syringes must not be used and minibags must be used instead. Portsmouth Hospitals NHS Trust
does not have an adolescent unit.
8. In a Paediatric unit where the patient is under 10 years of age intravenous vincristine,
vinblastine, vindesine or vinorebine will be diluted to a minimum volume of 10ml.
TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER VINCA
ALKALOIDS – ONCOLOGY AND HAEMATOLOGY AND PAEDIATRIC DEPARTMENTS:
Issue Number 6 Issue Date 09/04/2014
(Review date: January 2016 (unless requirements change)
Page 3 of 8
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 and the National Patient Safety Agency Rapid Response Report on using Vinca Alkaloid
minibags NPSA/2008/RRR004. This updated guidance replaces HSC 2003/010. 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 (Summary
Para 2 HSC 2003/010). It is a requirement of this guidance that there is a policy for the safe
labeling and dilution of vincristine and other vinca alkaloids and this should be separate from
the Intrathecal Chemotherapy Policy. Previous guidance to the NHS in England and Wales was
to dilute doses of vinca alkaloids to 10ml or greater in a syringe in order to reduce the risk of
wrong route errors. However, this guidance has been updated following the learning incidents
in other countries. This guidance applies to all healthcare organizations irrespective of whether
they also administer intrathecal chemotherapy. It does not apply to children and teenagers
being treated in a paediatric unit where minibags are not recommended to administer vinca
alkaloids. (Para 3 RRR04).
2. PURPOSE
This policy is designed to ensure the safe labeling and dilution of vinca alkaloids in Portsmouth
NHS Trust patients.
3. SCOPE
This is a Trust Policy, which applies to all Portsmouth Hospitals’ clinical, nursing and pharmacy
staff, particularly those working in Haematology, Oncology, Paediatrics and Pharmacy
Directorates. It applies primarily to the treatment of adults but includes provisions for the
treatment of children. This policy complements the Portsmouth Hospitals Policy for Intrathecal
Chemotherapy in Adults – Oncology and Haematology Departments.
It applies to the labeling and dilution of vinca alkaloids (vincristine, vinblastine, vindesine and
vinorelbine) - the intravenous chemotherapy drugs that, if injected intrathecally can cause
paralysis and death. If other intravenous alkaloids become available, they will be deemed to be
covered by the policy.
TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER VINCA
ALKALOIDS – ONCOLOGY AND HAEMATOLOGY AND PAEDIATRIC DEPARTMENTS:
Issue Number 6 Issue Date 09/04/2014
(Review date: January 2016 (unless requirements change)
Page 4 of 8
4. DEFINITIONS
4.1
Portsmouth Hospitals
Portsmouth Hospitals NHS Trust
4.2
The Trust
Portsmouth Hospitals NHS Trust
4.3
ST3
Specialist Registrar
4.4
Junior ST
Junior Doctor (ST1, ST2, FT1, FT2)
4.5
CSF
Cerebrospinal fluid
4.6
Guidance in HSC2008/001
National guidance provided in Health
Service Circular HSC 2008/001 Updated
National
Guidance
on
the
Safe
Administration of Intrathecal Chemotherapy
(August 2008).
4.7
Vinca Alkaloids
The following drugs are included in the
definition vincristine, vinblastine, vindesine
and vinorelbine
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 Pharmacist is accountable to the Chief Executive ensuring compliance with this policy
and that the relevant pharmacy staff are aware of its contents. The releasing officer is
responsible for ensuring that vinca alkaloids are labeled and diluted in accordance with this
policy in the dispensing process.
6. PROCESS
6.1
Overall Responsibility
6.1.1
Portsmouth Hospitals NHS Trust provides an intrathecal chemotherapy service
therefore the Chief Executive has overall responsibility for compliance with
Guidance in HSC 2008/0001.
6.1.2.
The Chief Pharmacist is accountable to the Chief Executive ensuring
compliance with this policy and that the relevant pharmacy staff are aware of
its contents. The releasing officer is responsible for ensuring that vinca
alkaloids are labelled and diluted in accordance with this policy in the
dispensing process.
6.2
Document Availability and Control
6.2.1
This Policy will be maintained on the Clinical Policy section of the Trust’s
TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER VINCA
ALKALOIDS – ONCOLOGY AND HAEMATOLOGY AND PAEDIATRIC DEPARTMENTS:
Issue Number 6 Issue Date 09/04/2014
(Review date: January 2016 (unless requirements change)
Page 5 of 8
intranet website. This will be the only controlled copy of the policy. Paper
copies of the policy may be made but they will only be controlled copies on the
day that they are printed.
6.3
6.3.1
6.3.2
6.3.3
6.4
6.4.1
6.4.2
6.4.3
Labelling on vinca alkaloids
Work instruction WI – PO11 “Labelling and Bagging” and WI – Q002 “Aseptic
release” state the appropriate bag and checks for vinca alkaloids.
For vinca alkaloids labels will have the patient name, name of the product,
route of administration and a warning as follows: “For intravenous use only –
fatal if administered by other routes.” Negative labelling (i.e. Not for
…………use.”) will not be used.
Pharmacy chemotherapy batch documents will specify the labelling required
for each vinca alkaloid. After completion of labelling and packaging the
finished product will then be placed inside the specific yellow bag marked for
vinca alkaloid use only. This will specifically differentiate the products from all
others produced by the Pharmacy Manufacturing Unit.
Dilution of vinca alkaloids
When vinca alkaloids are prescribed or administered in adult or adolescent
units, doses in syringes should not be used. The prescribed dose should be
supplied from the hospital pharmacy manufacturing unit in a 50ml minibag of
sodium chloride 0.9%.
For patients being treated on the paediatric unit over the age of 10 years, the
pharmacy will dilute the volume of intravenous vincristine to a maximum
concentration of 0.1mg/ml and dispense it in (as a minimum) a 20ml syringe.
For patients over 10 years the pharmacy will dilute the volume of intravenous
vinblastine, vindesine or vinorelbine to a minimum volume of 20ml. If these
patients were being treated on an adolescent unit then syringes must not be
used and minibags must be used instead as per adult guidelines – See 6.4.1.
Currently Portsmouth Hospitals NHS Trust does not have an adolescent unit.
For patients under the age of 10 years intravenous vincristine, vinblastine,
vindesine or vinorelbine will be diluted to a minimum volume of 10ml.
Pharmacy chemotherapy batch documents specify the dilutions required for
each vinca alkaloid.
7. TRAINING REQUIREMENTS
Staff being trained in the Prescribing, Dispensing, Administration and Checking of intravenous
chemotherapy will be made aware of this policy and the need for compliance with it.
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
TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER VINCA
ALKALOIDS – ONCOLOGY AND HAEMATOLOGY AND PAEDIATRIC DEPARTMENTS:
Issue Number 6 Issue Date 09/04/2014
(Review date: January 2016 (unless requirements change)
Page 6 of 8
PHPSWIO14D Work Instruction – Pharmacy Dispensing
PHPSWI016D Work Instruction – Dispensing Injectable Cytotoxic Medicines
Could add the NPSA 2009/PSA 004A
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.
TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER VINCA
ALKALOIDS – ONCOLOGY AND HAEMATOLOGY AND PAEDIATRIC DEPARTMENTS:
Issue Number 6 Issue Date 09/04/2014
(Review date: January 2016 (unless requirements change)
Page 7 of 8
1. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS
Minimum requirement to
be monitored
Lead
Compliance with Labelling
and Dilution of all vinca
alkaloids
Pharmacy
Manufacturing
Quality
Assurance
manager
Tool
Ecternal Audit MHRA
Frequency of Report
of Compliance
Bi-annually
Reporting arrangements
Policy audit report to:

Chief Pharmacist
Lead(s) for acting on
Recommendations
Pharmacy Manufacturing
Quality Assurance
Manager
This document will be monitored to ensure it is effective and to assurance compliance.
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.
TRUST POLICY FOR THE SAFE LABELLING AND DILUTION OF VINCRISTINE AND OTHER VINCA ALKALOIDS – ONCOLOGY AND HAEMATOLOGY
AND PAEDIATRIC DEPARTMENTS:
Issue Number 6 Issue Date 09/04/2014
(Review date: January 2016 (unless requirements
change)
Page 8 of 8