Download National Nursing Standards for Antineoplastic Drug Administration

National Nursing Standards for
Antineoplastic Drug Administration
in New Zealand
National Nursing Standards Working Group
Contents
Introduction ........................................................................................................................................... 1
How The Standards were developed....................................................................................................... 2
How to use The Standards ........................................................................................................................... 2
Standard 1.0: Informed consent ..................................................................................................... 3
Rationale ............................................................................................................................................................. 3
Good practice points....................................................................................................................................... 3
Standard 2.0: Patient education...................................................................................................... 4
Good practice points....................................................................................................................................... 4
Standard 3.0: Patient assessment .................................................................................................. 5
Good practice points....................................................................................................................................... 5
Standard 4.0: Administration .......................................................................................................... 6
Good practice points....................................................................................................................................... 6
Standard 5.0: Staff education ........................................................................................................... 7
Standard 6.0: Staff safety ................................................................................................................... 8
Good practice points....................................................................................................................................... 8
Standard 7.0: Waste management ................................................................................................. 9
Good practice points....................................................................................................................................... 9
Appendices
Appendix I: National Nursing Standards Working Group membership ................................ 10
Appendix II: Bibliography ......................................................................................................................... 11
Appendix III: Assessment tool ................................................................................................................. 13
Appendix IV: Glossary................................................................................................................................. 15
Appendix V: Standards assessment tool ............................................................................................. 16
National Standards for Antineoplastic Drug Administration
Page ii
Introduction
The New Zealand Nurses Organisation (NZNO) Cancer Nurses College has recognised the
need to develop a national certification process for antineoplastic drug administration
since 2009. In 2014, in collaboration with the Nursing in Cancer Care Collaborative
Steering Group (now disestablished) it discussed a proposal for a nationwide
antineoplastic education programme for nurses with the Medical Oncology Working
Group (MOWG). It was acknowledged that there are difficulties in implementing a national
education programme and national certification process in the absence of nationally
agreed, evidenced-based practice standards for antineoplastic drug administration. In
June 2015, under Cancer Nurses College leadership, a national working group was formed
to develop national standards for antineoplastic drug administration (now known as The
Standards).
The Standards apply to all types of antineoplastic drugs, including: cytotoxic
chemotherapy; hormonal therapies; biologic therapies such as monoclonal antibodies;
targeted small molecules such as kinase inhibitors; immunotherapies such as checkpoint
inhibitors; antibody–drug conjugates; and radiolabelled agents. (Refer to Appendix IV for
an explanation of these terms.)
These classes of antineoplastics vary widely in the complexity of their treatment regimen,
the therapeutic window (e.g. the dose range that produces therapeutic response without
having a significant adverse effect), the potential risk for patients and the recommended
handling precautions. Some agents have mutagenic, teratogenic and carcinogenic
properties that have the potential to cause harm to those handling and administering
these drugs.
In New Zealand, nurses administer most antineoplastic drugs, with the exception of oral
agents. It is essential to ensure adequate precautions are in place to protect both people
administering and those receiving antineoplastic drugs.
New Zealand has six tertiary cancer centres but a significant proportion of antineoplastic
agents are administered in regional, rural and private centres across the country. The
Standards will ensure that all staff administering antineoplastic have achieved a minimum
level of training and education.
The National Nursing Standards Working Group (refer Appendix I) agreed on the
following:

The Standards should reflect nursing involvement in antineoplastic drug
administration. The working group acknowledged that standards encompassing
prescribing, dispensing, storage and transportation should be developed. However,
given the timeframe of this project, it decided that the scope should focus on
antineoplastic administration. The Standards are designed to fit within a larger,
multi-disciplinary document.

The Standards will be an overview of best and/or evidenced-based practice. They
are intended to provide a tool to guide practice rather than to replace policies and
procedures within each health care facility.
National Standards for Antineoplastic Drug Administration
Page 1

The Standards will apply to all cancer treatment areas in New Zealand regardless of
geographic location and/or sub-speciality groups within cancer care.

The Standards will apply to patients being treated within clinical trials and the staff
caring for them. There may be additional requirements in the clinical trial protocol
that relevant staff should be aware of.
How The Standards were developed
Cancer nurses throughout New Zealand were asked to volunteer to be part of this working
group to ensure it had a widespread geographical representation. As a result, most District
Health Boards (DHBs) were represented. Colleagues in private cancer care, the New
Zealand Hospital Pharmacists’ Association and the New Zealand Society of Oncology were
also invited to be involved in developing The Standards.
The working group identified five published international standards for antineoplastic
administration. The Standards were developed from these.
A literature review was also undertaken. (Refer to Appendix II for a list of both the
international standards and the other publications reviewed.)
How to use The Standards
These Standards are to be used when developing and auditing the current policies and
procedures within each health care facility. They are not designed to replace current
policies. Instead, their purpose is to inform practice and ensure a safe minimal standard is
maintained while providing the opportunity to use good practice points to develop an
even higher quality of service delivery.
Although the NZNO Cancer Nurses College cannot mandate a continuous process of
auditing, it is hoped that the DHB Lead Nurses will support a biannual audit from each
District Health Board. The Cancer Nurses College should review and collate these audits
and provide its findings to the relevant DHB Lead Nurse who holds the Cancer portfolio.
The DHB Lead Nurse will then present any recommendations to the DHB Lead Nurses’
Nurse Executive of New Zealand for review and decisions on future action.
Appendix V offers an assessment tool that can be used to measure current policy against
The Standards.
National Standards for Antineoplastic Drug Administration
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Standard 1.0: Informed consent
Standard 1.1
There is evidence that all patients have signed informed written
consent before an antineoplastic regime begins. The consent process
will follow appropriate professional and legal guidelines and meet
the requirements of the administering nurse’s organisation.
Rationale

Nurses have a professional and ethical responsibility to ensure patients are
appropriately informed and aware of their rights under the New Zealand Code of
Health and Disability Services Consumers’ Rights. Although nursing is not legally
accountable for informed consent, nurses play an integral role within the consent
process.

Informed consent is a continuous process of communication between health care
providers and people affected by cancer (reflecting the principle of Te Whai Mana
Painga). This process is not limited to the completion of a consent form.

Consent is central to the relationship between patients, whānau and health care
providers because it allows patients to make autonomous decisions about their
treatment. Health care providers need to be open, receptive and responsive to
patient questions.
Good practice points
GPP 1.1
Provide patients with a copy of the signed consent.
GPP 1.2
If a treatment regimen changes, you must go through another
consent process.
National Standards for Antineoplastic Drug Administration
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Standard 2.0: Patient education
Standard 2.1
Each patient is provided with an opportunity for a formal education
session supported by written information. Where the patient desires
it, this session should include whānau.
Standard 2.2
Education should be tailored to the individual – taking into account
age, language, culture and health literacy.
Good practice points
GPP 2.1
Consider using multiple media methods to support principles of
effective learning.
GPP 2.2
Understand health literacy and its relevance to health equity in
New Zealand.
National Standards for Antineoplastic Drug Administration
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Standard 3.0: Patient assessment
Standard 3.1
Assessment findings will be documented within the permanent
health record. Refer to Appendix III for an example of a patient
assessment tool.
Good practice points
GPP 3.1
Undertake a comprehensive health assessment before administering
antineoplastic drugs.
GPP 3.2
Tailor the assessment to the individual – taking into account the age,
language, culture and health literacy of the patient and their whanau.
National Standards for Antineoplastic Drug Administration
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Standard 4.0: Administration
Standard 4.1
Two health care professionals who hold current certification of
competency in antineoplastic drug administration will check
antineoplastic drugs before they are administered.
Standard 4.2
Each health facility will have a policy on administration of oral
antineoplastic drugs.
Standard 4.3
Extravasation management procedures, including antidotes, are
defined and aligned with current literature and guidelines, and are
available in clinical areas. Antidotes are accessible.
Standard 4.4
Emergency equipment and spill kits are available and visible within
the clinical area.
Standard 4.5
Any errors in administration or documentation of antineoplastic
medication will be documented as an incident as per local policy.
Good practice points
GPP 4.1
Before administering antineoplastic drugs, the nurse should review:

Diagnosis

Treatment plan

Consent
GPP 4.2
Each health facility should use a “Time Out” procedure at the bedside
immediately before antineoplastic drugs are administered. See an
example in Appendix III.
GPP 4.3
Electronic or printed prescriptions of antineoplastic medications are
gold standard and are known to reduce administration errors. Where
possible, these should be used.
GPP 4.4
Nurses who are novice at administration of antineoplastic drugs
should be working under supervision.
National Standards for Antineoplastic Drug Administration
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Standard 5.0: Staff education
Standard 5.1
All nursing staff who administer and manage antineoplastic therapy
will hold current certification of competency by completing an
evidence-based education programme that is recognised by the
NZNO Cancer Nurses College.
Standard 5.2
Each health care facility will ensure that the antineoplastic education
programme undergoes review within its own service every three
years.
Standard 5.3
Each programme will have a mechanism for reassessing competence.
This could be a competency reassessment or an audit process that
documents outcomes.
National Standards for Antineoplastic Drug Administration
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Standard 6.0: Staff safety
Standard 6.1
Each health care facility will have policies in place for safe
administration of the different classes of antineoplastic medication,
in accordance with evidence-based risk assessments of the agents.
Standard 6.2
Closed system administration sets will be used to minimise drug
exposure.
Standard 6.3
Use of personal protective equipment (PPE) is mandatory for
administering antineoplastic drugs.
Standard 6.4
Health care facilities will have a documented process to ensure that
all staff unfamiliar with the clinical area are aware of who is receiving
antineoplastic therapy.
Good practice points
GPP 6.1
Staff who are pregnant or breastfeeding should avoid handling
antineoplastic drugs.
GPP 6.2
PPE requirements vary depending on the risk profile of the medicine.
Examples include gloves, gowns, N95/P2 respirators, face shields
and/or goggles, as per legislation or local policy.
National Standards for Antineoplastic Drug Administration
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Standard 7.0: Waste management
Standard 7.1
All clinical areas administering antineoplastic agents must have
waste and spill management policies.
Standard 7.2
All clinical areas administering antineoplastic agents must have
access to a spill kit and be appropriately trained in how to manage a
spill.
Standard 7.3
All clinical areas administering antineoplastic agents must have a
policy on managing accidental exposure to antineoplastic agents.
Good practice points
GPP 7.1
Wear personal protective equipment when dealing with any
potentially contaminated body fluid waste.
GPP 7.2
Dispose of all waste and non-reusable equipment and products in a
designated cytotoxic waste bin or bag.
GPP 7.3
Where possible, avoid transporting patients between areas or
services with intravenous antineoplastic drugs infusing should be
avoided. However, if this measure is necessary, a health care
professional who holds current certification of antineoplastic drug
administration and a spill kit must accompany the patient.
GPP 7.4
Treat a cytotoxic spill a clinical incident and document it in line with
the local health care facility policy.
GPP 7.5
A shower should be available within the clinical areas for staff and
carers in the event of accidental exposure.
GPP 7.6
All clinical areas should have a policy of surveillance for staff.
National Standards for Antineoplastic Drug Administration
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Appendix I: National Nursing Standards Working
Group membership
Chair
Angela Knox, Clinical Nurse Specialist Haematology, Counties Manukau District Health
Board
Members
Cathie Teague, Clinical Nurse Specialist Medical Oncology, Capital and Coast District
Health Board
Kathryn McWatt, Cancer Nurse Educator, Counties Manukau District Health Board
Amber Conley, Charge Nurse Paediatrics, Auckland District Health Board
Bridget Smith, Cancer Nurse Educator Paediatrics, Auckland District Health Board
Karen Palmer, Clinical Nurse Specialist Oncology, Northland District Health Board
Paul Smith, Charge Nurse Manager, Ambulatory Care, Capital and Coast District Health
Board
Theresa MacKenzie, Charge Nurse Manager, Auckland District Health Board
Wendy Jar, Clinical Nurse Specialist Bone Marrow Transplant, Canterbury District Health
Board
Sarah Ellery, Nurse Practitioner Oncology, Canterbury District Health Board
Sharyn Pilkington, Registered Nurse Haematology, Waikato District Health Board
Anita Wootton, Clinical Nurse Specialist, Hawke’s Bay District Health Board
Anna Saua, Cancer Nurse Educator, MidCentral District Health Board
Annie Walker, Clinical Speciality Nurse Oncology, Nelson Marlborough District Health
Board
Bronwyn Ward, Charge Nurse Manager, St George’s Cancer Care Centre, Christchurch
Advisors and stakeholders
Karyn Sangster Director of Nursing – Cancer, Nurse Executives of New Zealand
Andrew Simpson, National Clinical Director Cancer, Ministry of Health
Garry Forgeson, Chair, Medical Oncology Working Group
National Standards for Antineoplastic Drug Administration
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Appendix II: Bibliography
International standards for administration of antineoplastic drugs
Alexander M, King J, Bajel A, et al. 2014. Australian consensus guidelines for the safe handling
of monoclonal antibodies for cancer treatment by healthcare personnel. Internal Medicine
Journal 44(10): 1018–26. doi: 10.1111/imj.12564. Available from
http://onlinelibrary.wiley.com/doi/10.1111/imj.12564/pdf
Full guidelines available at:
http://www.wcmics.org/guidelines/20140422_MABs_Guidelines.pdf
Canadian Association of Nurses in Oncology. 2011. Standards and Competencies for Cancer
Chemotherapy Nursing Practice. Available at:
https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=156524
Clinical Oncology Society of Australia. 2008. Guidelines for the Safe Prescribing, Dispensing and
Administration of Cancer Chemotherapy.
https://www.cosa.org.au/media/1093/cosa_guidelines_safeprescribingchemo2008.pdf
National Institute for Occupational Safety and Health. 2014. List of Antineoplastic and Other
Hazardous Drugs in Healthcare Settings, 2014. Available from:
http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf
UK Oncology Nursing Society. 2015. Guidance on the Safe Handling of Monoclonal Antibody
(mAb) Products. 5th edition. Available from: http://www.ukons.org
Literature reviewed
Clinical Oncology Society of Australia – Cancer Pharmacists Group. 2013. Position Statement:
Safe handling of monoclonal antibodies in healthcare settings. Available from:
https://www.cosa.org.au/media/173517/cosa-cpg-handling-mabs-position-statement_november-2013_final.pdf
eviQ Cancer Treatments Online. Supporting Document: Safe Administration of Antineoplastic
Drugs. Available from:
https://www.eviq.org.au/Protocol/tabid/66/categoryid/217/id/5/Resource+Document++Safe+Administration+of+Antineoplastic+Drugs+.aspx
eviQ Cancer Treatments Online. Supporting Document: Safe Handling and Waste Management
of Hazardous Drugs. Available from:
https://www.eviq.org.au/Protocol/tabid/66/id/188/view/Fullview/Supporting%20Docume
nt%20%20Safe%20Handling%20and%20Waste%20Management%20of%20Hazardous%20Drugs%
20%20.aspx
Jacobson J, Polovich M, McNiff K, et al. 2009. American Society of Clinical Oncology, Oncology
Nursing Society chemotherapy administration standards. Oncology Nursing Forum 36(6).
Kullberg A, Larsen J, Sharp L. 2013. Why is another person’s name on my infusion bag? Patient
safety in chemotherapy care – a review of the literature. European Journal of Oncology Nursing
17: 228–235.
National Standards for Antineoplastic Drug Administration
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Lester L. 2012. Safe handling and administration consideration of oral anticancer agent in the
clinical and home setting. Clinical Journal of Oncology 16(6): E192–E197.
National Cancer Action Team, National Health Service. 2011. National Cancer Peer Review
Programme: Manual for Cancer Service: Chemotherapy antineoplastic measures. Available from:
http://www.mycancertreatment.nhs.uk/wpcontent/themes/mct/uploads/2012/09/resources_measures_ChemotherapyAntineoplastic_M
easures_June2011.pdf
Neuss N, Polovich M, McNiff K et al. 2013. 2013 Updated American Society of Clinical
Oncology/Oncology Nursing Society chemotherapy administration safety standards including
the standards for the safe administration and management of oral chemotherapy. Journal of
Oncology Practice 9(2 Suppl): 5s–13s. Available from: http://www.jop.ascopubs.org
The Quality Unit, Scottish Government. 2012. Guideline for the Safe Delivery of Systemic Anticancer Therapy. Available at: http://www.scotland.gov.uk
SA Health, Government of South Australia. 2015. Safe Handling of Cytotoxic Drugs and Related
Wastes: Guidelines for South Australian Health Services 2012. Available at:
http://www.sahealth.sa.gov.au/wps/wcm/connect/f8aa68004b3f6cf6a340afe79043faf0/Safe
HandlingOfCytotoxicDrugsRelatedWastesGuideline-PHCS-120515.pdf?MOD=AJPERES
Treleaven J, Gadd J, Cullis J et al. 2012. Guidelines on obtaining consent for systemic anticancer
therapy in adults. Haematology 17(5): 249–254.
Vioral A, Kenniham H. 2012. Implementation of the American Society of Clinical Oncology and
Oncology Nursing Society chemotherapy safety standards: A multidisciplinary approach.
Clinical Journal of Oncology Nursing 16(6): E226–E230.
National Standards for Antineoplastic Drug Administration
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Appendix III: Assessment tool
National Standards for Antineoplastic Drug Administration
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National Standards for Antineoplastic Drug Administration
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Appendix IV: Glossary
Accidental exposure (to cytotoxic drugs): Can occur at any time during or after the
administration of the drugs. This includes both direct drug exposure and exposure to
contaminated body fluid waste.
Antibody–drug conjugate: An antibody linked to a cytotoxic chemotherapy drug that
targets cancer cells, limiting the impact on normal, healthy cells.
Antineoplastic therapy: An agent used to control or kill cancer cells. Includes cytotoxic,
hormonal, immune-system-modifying (immunotherapy), some biological and molecular
targeted therapies.
Biologic therapy: A treatment that uses substances made from living organisms, which
either occur naturally in the body or are made in the laboratory.
Cytotoxic chemotherapy: Medicines that attack and kill rapidly growing cells, including
both cancer cells and normal cells.
Cytotoxic spills: Spills involving any formulation of antineoplastic drugs, which can occur
wherever cytotoxic drugs and waste are being handled, stored, transported or disposed.
Spills may contaminate the environment, including floors, work surfaces, equipment,
bedding and clothing as well as the patient and carer or staff member.
Health literacy: A person’s capacity to find, interpret and use information and health
services to make effective decisions for health and wellbeing.
Hormonal therapy: Some cancers that are hormone-sensitive or hormone-dependent.
Hormone therapies can slow down or stop the growth of cancers by preventing the
hormones either from being produced or from stimulating the cancer to grow.
Immunotherapy: An agent that interacts in some way with the immune system either to
stimulate it to recognise and attack cancer cells or to inhibit the production of abnormal
immune system cells or molecules present as a result of cancer.
Monoclonal antibodies (mAbs): A type of biologic medicine designed to target specific
proteins on cell receptors and help the body fight cancer. All currently available mAbs
have a low risk of internalisation at occupational exposure levels. Dermal absorption of
mAbs across intact skin during dose preparation or administration is unlikely due to their
high molecular weight; however, the use of gloves and effective hand hygiene are
recommended to minimise risks of contamination and infection.
Radiolabelled drugs: A radio-isotope linked to a mAb that targets cancer cells, limiting
the impact on normal, healthy cells.
Te Whai Mana Painga: Empowerment with knowledge, skills and resources to make an
informed choice about care and treatment.
National Standards for Antineoplastic Drug Administration
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Appendix V: Standards assessment tool
National Standards Antineoplastic Administration: Review Tool 2016
Prepared by NZNO CNC
Contributors / reviewers
National Standards for Antineoplastic Drug Administration
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Cluster 1: Consent
#
Standard statement
1.1
Patients have signed
informed written consent
Monitoring requirements
Findings
(Include current activity, areas of good practice and source
of evidence)
Standard
met
☐ Yes
☐ Partial
☐ No
☐ NA
Cluster 2: Patient education
#
Standard statement
Monitoring requirements
Findings
(Include current activity, areas of good practice and source
of evidence)
2.1
Standard
met
☐ Yes
Formal education session
provided
☐ Partial
☐ No
☐ NA
2.2
☐ Yes
Education session is
tailored to needs of the
individual
☐ Partial
☐ No
☐ NA
National Standards for Antineoplastic Drug Administration
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Cluster 3: Patient assessment
#
Standard statement
3.1
Assessment documented in
patient’s health record
Monitoring requirements
Findings
(Include current activity, areas of good practice and source
of evidence)
Standard
met
☐ Yes
☐ Partial
☐ No
☐ NA
Cluster 4: Administration of antineoplastic
#
Standard statement
Monitoring requirements
Findings
(Include current activity, areas of good practice and source
of evidence)
4.1
4.2
Standard
met
Prior to administration
antineoplastic are checked
by two health care
professionals
☐ Yes
Policy for antineoplastic
administration
☒ Yes
☐ Partial
☐ No
☐ NA
☐ Partial
☐ No
☐ NA
National Standards for Antineoplastic Drug Administration
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Cluster 4: Administration of antineoplastic
#
Standard statement
4.3
Policy for extravasation
management
Monitoring requirements
Findings
(Include current activity, areas of good practice and source
of evidence)
Standard
met
☒ Yes
☐ Partial
☐ No
☐ NA
4.4
☒ Yes
Emergency equipment and
spill kits available
☐ Partial
☐ No
☐ NA
4.5
☒ Yes
Policy for documenting and
tracking errors
☐ Partial
☐ No
☐ NA
National Standards for Antineoplastic Drug Administration
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Cluster 5: Staff education
#
Standard statement
5.1
All nursing staff engaged in
administration and
management of
antineoplastic drugs are
component
☐ Yes
The education program
used will undergo a review
every three years
☐ Yes
5.2
Monitoring requirements
Findings
(Include current activity, areas of good practice and source
of evidence)
Standard
met
☐ Partial
☐ No
☐ NA
☐ Partial
☐ No
☐ NA
5.3
The education program will
have a mechanism for
reassessing competent
☐ Yes
☐ Partial
☐ No
☐ NA
National Standards for Antineoplastic Drug Administration
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Cluster 6: Staff safety
#
Standard statement
6.1
Administration policy
based on different classes
of antineoplastic
Monitoring requirements
Findings
(Include current activity, areas of good practice and source
of evidence)
Standard
met
☐ Yes
☐ Partial
☐ No
☐ NA
6.2
☐ Yes
Utilising closed
administration systems
☐ Partial
☐ No
☐ NA
6.3
☐ Yes
Utilisation and availability
of personal protective
equipment
☐ Partial
☐ No
☐ NA
6.4
☐ Yes
Process to ensure all
unfamiliar staff are aware
who is receiving
antineoplastic
National Standards for Antineoplastic Drug Administration
☐ Partial
☐ No
☐ NA
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Cluster 7: Treatment
#
Standard statement
7.1
Policy of waste and spill
management
Monitoring requirements
Findings
(Include current activity, areas of good practice and source
of evidence)
Standard
met
☐ Yes
☐ Partial
☐ No
☐ NA
7.2
Training re using the spill
kit safety
☐ Yes
☐ Partial
☐ No
☐ NA
7.3
Policy on management of
accidental exposures
☐ Yes
☐ Partial
☐ No
☐ NA
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