national nursing standards for antineoplastic drug ... · national standards for antineoplastic...

National Nursing Standards for

Antineoplastic Drug Administration

in New Zealand

National Nursing Standards Working Group

National Standards for Antineoplastic Drug Administration Page ii

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


Standard 3.0: Patient assessment .................................................................................................. 5


Standard 4.0: Administration .......................................................................................................... 6


Standard 5.0: Staff education ........................................................................................................... 7

Standard 6.0: Staff safety ................................................................................................................... 8


Standard 7.0: Waste management ................................................................................................. 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 1

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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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


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.


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/wp-

content/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 Anti-

cancer 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.


Appendix III: Assessment tool


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.


Appendix V: Standards assessment tool

National Standards Antineoplastic Administration: Review Tool 2016 Prepared by NZNO CNC

Contributors / reviewers


Cluster 1: Consent

# Standard statement Monitoring requirements Findings (Include current activity, areas of good practice and source of evidence)

Standard met

1.1 Patients have signed informed written consent

☐ Yes

☐ Partial

☐ No

☐ NA

Cluster 2: Patient education


Standard met

2.1 Formal education session provided

☐ Yes

☐ Partial

☐ No

☐ NA

2.2 Education session is tailored to needs of the individual

☐ Yes

☐ Partial

☐ No

☐ NA


Cluster 3: Patient assessment


Standard met

3.1 Assessment documented in patient’s health record

☐ Yes

☐ Partial

☐ No

☐ NA

Cluster 4: Administration of antineoplastic


Standard met

4.1 Prior to administration antineoplastic are checked by two health care professionals

☐ Yes

☐ Partial

☐ No

☐ NA

4.2 Policy for antineoplastic administration

☒ Yes

☐ Partial

☐ No

☐ NA


Cluster 4: Administration of antineoplastic


Standard met

4.3 Policy for extravasation management

☒ Yes

☐ Partial

☐ No

☐ NA

4.4 Emergency equipment and spill kits available

☒ Yes

☐ Partial

☐ No

☐ NA

4.5 Policy for documenting and tracking errors

☒ Yes

☐ Partial

☐ No

☐ NA


Cluster 5: Staff education


Standard met

5.1 All nursing staff engaged in administration and management of antineoplastic drugs are component

☐ Yes

☐ Partial

☐ No

☐ NA

5.2 The education program used will undergo a review every three years

☐ Yes

☐ Partial

☐ No

☐ NA

5.3 The education program will have a mechanism for reassessing competent

☐ Yes

☐ Partial

☐ No

☐ NA


Cluster 6: Staff safety


Standard met

6.1 Administration policy based on different classes of antineoplastic

☐ Yes

☐ Partial

☐ No

☐ NA

6.2 Utilising closed administration systems

☐ Yes

☐ Partial

☐ No

☐ NA

6.3 Utilisation and availability of personal protective equipment

☐ Yes

☐ Partial

☐ No

☐ NA

6.4 Process to ensure all unfamiliar staff are aware who is receiving antineoplastic

☐ Yes

☐ Partial

☐ No

☐ NA


Cluster 7: Treatment


Standard met

7.1 Policy of waste and spill management

☐ 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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