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National Nursing Standards for Antineoplastic Drug Administration in New Zealand National Nursing Standards Working Group National standards for Chemotherapy Administration Version 10 Page 1 Contents Introduction Background Process How to use 3 4 4 Standard 1.0 Informed consent 5 Standards 2.0 Patient Education 6 Standard 3.0 Patient Assessment 7 Standard 4.0 Administration 8 Standard 5.0 Staff Education 10 Standard 6.0 Staff safety 11 Standard 7.0 Waste Management 11 Appendix I Working Group Appendix II References 14 Appendix III Patient Assessment Tool Time out tool 15 16 Appendix IV Glossary 17 National standards for Chemotherapy Administration Version 10 Page 2 INTRODUCTION Background The New Zealand Nurses Organisation Cancer Nurses College (CNC) has recognised the need to develop a national certification process for anti-neoplastic drug administration since 2009. In 2014, in collaboration with Nursing in Cancer Care Collaborative Steering Group (now disestablished) a proposal for a nationwide chemotherapy education programme for nurses was discussed with the Medical Oncology Working Group (MOWG). It was acknowledged that there are difficulties 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 CNC leadership, a national working group was formed to develop national standards for antineoplastic drug administration (now known as The Standards). It is well recognised that antineoplastic drugs are complex, with a narrow therapeutic window, and are associated with significant risk for those people receiving them. They also have mutagenic, teratogenic and carcinogenic properties which have the potential to cause harm to those handling and administering these drugs. In New Zealand, most antineoplastic drugs will be administered by nurses. It is essential to ensure adequate precautions are in place to protect people both administering and receiving antineoplastic drugs. New Zealand has six tertiary cancer centres but a significant amount of antineoplastic agents are administered in regional and rural centres across the country. The Standards will ensure that all staff administering chemotherapy have achieved a minimum level of training and education. The Standards Working Group (refer Appendix I) agreed The Standards should: Reflect nursing involvement in antineoplastic drug administration. The working group acknowledge that standards encompassing prescribing, dispensing, storage and transportation should be developed. However given the time frame of this project it was decided that the scope should be focused on anti-neoplastic 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. It is not intended to replace policies and procedures within each antineoplastic drug administration area but provide a tool to guide practice. The Standards are applicable to all anti neoplastic and immunotherapy modalities within cancer care. These will now be referred to as antineoplastic drugs. The Standards will be applicable to all cancer treatment areas in New Zealand regardless of geographic location and/or sub-speciality groups within cancer care. National standards for Chemotherapy Administration Version 10 Page 3 Process Cancer nurses throughout New Zealand were asked to volunteer to be part of this working group to ensure a geographic representation. This has resulted in most District Health Board’s (DHB’s) being represented. Colleagues in private cancer care, the New Zealand Hospital Pharmacist Association and the New Zealand Society of Oncology were also invited to be involved in developing The Standards. The reference group identified five (Refer Appendix 2) published international standards for antineoplastic administration. The Standards were developed from these. A literature review was also undertaken. How to use the standards These standards are to be utilised when developing and auditing the current policies and procedures within each clinical area. They are not designed to replace current policies but to inform practice, and ensure a safe minimal standard is maintained while providing the opportunity to use best practice points to develop an even higher quality of delivery of antineoplastic drugs. An assessment tool is provided (to be included when document finalised), which can be used to measure your current policy against The Standard. It is recommended that each clinical area (DHB and private care delivery centres) review their current policies against the standard. National standards for Chemotherapy Administration Version 10 Page 4 Standard 1.0 Informed consent Standard 1.1 All patients must sign informed written consent prior to initiation of a chemotherapy regime. The consent process should follow appropriate professional and legal guidelines and meet requirements within their DHB. Standard 1.2 Although nursing is not legally accountable for informed consent, nurses play an integral role within the consent process. Nurses have a professional and ethical responsibility to ensure patients are appropriately informed and aware of their rights under the NZ Health and Disability code. Good Practice Points 1.1 Informed consent is a continuous process of communication between healthcare providers and people affected by cancer (principle of Te Whai Mana Painga). This is not limited to the completion of a consent form. 1.2 Consent is central to the relationship between patients, whanau and healthcare providers because it allows people affected by cancer to make autonomous decisions about their treatment. Healthcare providers need to be open, receptive, and responsive to patient questions. People affected by cancer should receive a copy of signed consent. 1.3 1.4 People affected by cancer should receive written information when consenting to treatment 1.5 Changes to treatment regimen require a re-consent. 1.6 Consent can be withdrawn by people affected by cancer at any point in their treatment. The consent process should include: Diagnostic information Treatment options, including no treatment and other therapeutic modalities (e.g. radiation) Treatment intent Prognosis Planned duration of treatment Drugs/ regimen specific information Schedule of treatment administration Information on possible short and long-term adverse effects, When and how to notify health care team Standards 2.0 Patient Education National standards for Chemotherapy Administration Version 10 Page 5 Standard 2.1 Before initiation of an antineoplastic regimen, each person affected by cancer is provided an opportunity for a formal education session supported by written information. Where desired by the people affected by cancer this should include whanau/family. Education should be tailored to the individual – taking into account age, language, culture and health literacy. Good Practice points 2.1 Consideration should be given to using multiple media methods to support principles of effective learning. 2.2 Nurses should have an understanding of health literacy and its relevance to health equity in New Zealand. Key components of chemotherapy education for people affected by cancer should include: An assessment of patient/family/whanau prior knowledge and experience supporting the principle of Ako Family/whanau or significant others Short term side effects specific to drug regime Long term and delayed side effects of drug regime Access to supportive care including NGO e.g. Cancer Society Eating, nutrition and hydration Maintaining healthy life choices Sexuality and intimacy; relationship changes Toxicities and an action plan in event of emergency Waste and spill management How Complementary and Alternative Medicine (CAM) can affect chemotherapy Education is an initial planned event however education should be a continuous process of reviewing people affected by cancer understanding and providing information throughout treatment and beyond. Standard 3.0 Patient Assessment National standards for Chemotherapy Administration Version 10 Page 6 Standard 3.1 Prior to the administration of anti-neoplastic drug therapy nurses should complete a comprehensive holistic assessment. Assessment findings should be documented within the permanent health record. Refer to Appendix III Good Practice points 3.1 Assessment should be tailored to the individual – taking into account the age, language, culture and health literacy of people affected by cancer and their whanau. Assessment should include: Holistic assessment including physical, psychological and social assessment Review of the patient’s diagnosis, treatment plan, health history (including allergies/sensitivities) Height, weight and body surface area – changes in weight should be evaluated in relation to the impact upon Body Surface Area (BSA), where used, and drug dose calculation. Physical and Performance status e.g. Eastern Cooperative Oncology Group performance status (ECOG) Response to previous treatment including toxicities and complications and adverse reactions Current medication being taken to manage symptoms and side effects including both supportive medications and complementary medications. Evaluation of educational needs – the understanding of provided information by people affected by cancer should also be assessed. Other medications (not treatment related) and CAM Baseline observations, tests or investigations specific to the treatment protocol Standard 4.0 Administration National standards for Chemotherapy Administration Version 10 Page 7 Standard 4.1 The nurse who is administering the antineoplastic drugs confirms with the person affected by cancer his/her planned treatment prior to each cycle. Two nurses certified to administer antineoplastic drugs should check medication as per local policy. This should include a “Time Out” procedure and verify all critical information including: • Identify the patient using name and one other identifier (preferably NHI) • Drug • Dose, including BSA check • Volume and rate • Route This is to be checked against the medication order and the label on the antineoplastic syringe/bag See Appendix III Prior to administering an intravenous antineoplastic, the intravenous access device in use must be assessed for patency i.e. flushes freely and blood return present. Standard 4.2 Standard 4.3 Standard 4.4 Extravasation management procedures, including antidotes are defined and aligned with current literature and guidelines. Antidotes are accessible. Standard 4.5 Emergency equipment and spill kits should be available within the administration area. Standard 4.6 Any incidents where antineoplastic medication were used incorrectly should be documented as an incident as per local policy. Best Practice points 4.1 Prior to administration the nurse should National standards for Chemotherapy Administration Version 10 review the Page 8 documentation ensuring the cancer diagnosis and treatment plan confirms appropriate treatment is being administered. Consent should also be sighted. 4.2 Documentation of a comprehensive assessment (as per Standard 3.1) should be reviewed and relevant interventions completed prior to administration of treatment. 4.3 When administering bolus vesicant antineoplastic drugs, it is advisable to: • Administer with fast flowing compatible fluids • Administer vesicants first unless otherwise indicated • Wherever possible, use a newly inserted cannula for peripheral administrations 4.4 For people affected by cancer who are enrolled on a clinical trial, clinical trial information should be available within the clinical treatment area. 4.5 Electronic or printed prescriptions of neoplastic medications are gold standard and are known to reduce administration errors. Where possible these should be used. 4.6 Administration of oral antineoplastic medications Refer to Standard 2.1 Patient Education for required information. Patients receiving oral antineoplastic drugs should also receive information on: • How and when to take each medicine • What to do if doses are missed • What to do if patient vomits after taking a dose. • The need to swallow tablets/capsules whole and not chew • Risks of crushing tablets and mixing with food or emptying the contents of capsules into food or drink • To store all medications appropriately i.e. refrigeration as needed and secure away from children • Avoid or minimise the handling of tablets/capsules by family members/carers i.e. using a non-touch technique • Where to return empty anti-neoplastic medication containers or any left-over medication • How to manage waste • How to manage a spill Standards 5.0 Staff Education National standards for Chemotherapy Administration Version 10 Page 9 Standard 5.1 All staff engaged in the administration and management of antineoplastic therapy must be certified to do so by completion of an appropriate training program. Competency should be a measurable indicator of an individual's ability to perform the associated clinical duties. ___________________________________________________________________________________________ Good practice points 5.1 Each health care facility should have a documented training program which is evidenced based and includes competency assessment tools based on effective learning methodology. 5.2 The training programme should undergo a robust review for relevancy every 2 – 3 years. 5.3 Each program should have a mechanism for competency evaluation. This could be a competency reassessment or an audit process which documents outcomes. 5.4 Competency includes the professional expectation that certified staff maintain ongoing competence within the reassessment timeframe by recognizing their own ongoing education needs and demonstrating a commitment to evidence based practice and legislative updates. 5.5 Nurses who are novice at antineoplastic drug administration should be working under the appropriate supervision (either indirect/direct) of an allocated preceptor who is fully certified in antineoplastic drug administration and management. The components within an education program for developing nursing staff to be competent handling antineoplastic drugs should include: • The basic principles of antineoplastic therapy including mechanism of action, dosing methods, scheduling and administration and treatment intent • Antineoplastic protocols commonly used and how to access and refer to the protocols • Adverse effects and toxicities associated with antineoplastic therapy including, early identification, ongoing monitoring, principles of prevention and management • Principles of safe handling and waste management of antineoplastic drugs. • Antineoplastic medication preparation, storage and transportation • Information and support needs of patients and their families including psychological support for persons receiving treatment for cancer • Ethical and legal issues associated with the use of antineoplastic therapy • Local policy and procedures as they relate to cancer treatment • Managing infusion reactions, extravasation and spills • Principles content of education for the person affected by cancer. Standard 6.0 Staffand safety • Assessment of IV access considerations National standards for Chemotherapy Administration Version 10 Page 10 Standard 6.1 Staff should be aware of relevant legislation and guidelines pertaining to administration of anti-neoplastic drugs and associated waste management. Standard 6.2 Closed system administration sets should be utilised to minimise drug exposure. Standard 6.3 Personal Protective Equipment (PPE) is mandatory for personnel administrating antineoplastic drugs. PPE consists of chemotherapy approved gloves and gowns. N95/P2 Respirators, face shields and/or goggles can be worn as per legislation or local policy. PPE must be available in each administration area. Standard 6.4 All clinical areas administering antineoplastic agents should have a process to ensure that staff unfamiliar to the clinical area is aware who is receiving chemotherapy. Standard 6.5 Staff who are pregnant, actively trying to get pregnant or breastfeeding should not be handling antineoplastic drugs Standard 7.0 Waste Management Standards 7.1 All clinical areas administering antineoplastic agents must have a waste management policy 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 documented policy on managing accidental exposure to antineoplastic agents Standard 7.4 A cytotoxic spill must be regarded as a clinical incident and documentation completed as per the local health care facility policy. Best Practice Points 7.1 Personal protective equipment should be worn when dealing with any National standards for Chemotherapy Administration Version 10 Page 11 potentially contaminated body fluid waste. 7.2 All waste and non-reusable equipment/products should be disposed of in a designated cytotoxic waste bin or bag. 7.3 Transporting patients between areas/services with intravenous chemotherapy infusing should be avoided. However, if this is necessary, they must be accompanied by a cytotoxic certified person and a spill kit. 7.4 If a staff member or carer is accidentally exposed to antineoplastic drugs: • Remove contaminated clothing • Wash the affected area with copious amounts of soap and water for 10-15 minutes. Consider doing this in a shower • If eyes have been contaminated, irrigate them with copious amounts of water or saline. • For needlestick injuries, follow local procedure • Inform appropriate personnel and complete documentation as per local area • Medical attention may be required 7.5 A shower should be available within the clinical areas for staff /carers in the event of accidental exposure 7.6 All clinical areas should have a policy of surveillance for staff and/or visitors who are accidentally exposed to antineoplastic drugs. APPENDIX I National standards for Chemotherapy Administration Version 10 Page 12 Chair Angela Knox, Clinical Nurse Specialist – Counties Manukau District Health Board Members Cathie Teague, Clinical Nurse Specialist 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, CNE paediatrics - Auckland District Health Board Karen Palmer, Clinical Nurse Specialist Oncology – Northland District Health Board Paul Smith, Charge Nurse Manager, Capital and Coast District Health Board Theresa MacKenzie, Nurse Manager, Auckland District Health Board Wendy Jar, Clinical Nurse Specialist Bone Marrow Transplant, Canterbury District Health Board Sarah Ellery, Clinical Nurse Specialist CNS Oncology, Canterbury District Health Board Sharyn Pilkington, Registered Nurse Haematology, Waikato District Health Board Anita Wootton, Clinical Nurse Specialist – Hawkes Bay District Health Board Anna Saua, Cancer Nurse Educator -Mid Central 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- New Zealand Nurse Executives Andrew Simpson , National Clinical Director Cancer Ministry of Health Garry Forgeson, Chair - Medical Oncology Working Group National standards for Chemotherapy Administration Version 10 Page 13 Appendix II References 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_safeprescribingchemo2 008.pdf National Cancer Action Team: National Health Service (2011) National cancer peer review programme. Manual for cancer Service: Chemotherapy measures. http://www.mycancertreatment.nhs.uk/wpcontent/themes/mct/uploads/2012/09/resources_measures_Chemotherapy_M easures_June2011.pdf Neuss, N. Polovich, M. McNiff, K. Esper, P.Gilmore, T. LeFebvre, K. Schulmeister, L. Jacobson, J. 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. www.jop.ascopubs.org The Quality Unit: Scottish Government. 2012. Guideline for the safe delivery of systemic anti-cancer therapy. http://www.scotland.gov.uk Canadian Association of Nurses in Oncology. 2011. Standards and competencies for cancer chemotherapy nursing practice. https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=156524 Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012 http://www.sahealth.sa.gov.au/wps/wcm/connect/f8aa68004b3f6cf6a340afe7 9043faf0/SafeHandlingOfCytotoxicDrugsRelatedWastesGuideline-PHCS120515.pdf?MOD=AJPERES Jacobson, J. Polovich, M. McNiff, K. LeFebvre, K. Cumming, C. Galioto, M. Bonelli, K. McCorkle, M. 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 Chemotherapy Administration Version 10 Page 14 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. Treleaven, J. Gadd, J. Cullis, J. Favre, A. McLeod, A. Meller, S. Milligan, D. Neilson, R. Quinn, B. Webb, A. Wimperis, J. 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): E226E230. National standards for Chemotherapy Administration Version 10 Page 15 Appendix III Assessment tool National standards for Chemotherapy Administration Version 10 Page 16 Timeout Checklist Appendix IV Glossary Antineoplastic therapy - Encompasses biological therapies and cytotoxic chemotherapy National standards for Chemotherapy Administration Version 10 Page 17 Ako - The concept of ako describes a teaching and learning relationship, where the educator is also learning from the student and where educators’ practices are informed by the latest research and are both deliberate and reflective. Ako is grounded in the principle of reciprocity and also recognises that the learner and whānau cannot be separated Certified Staff – where a nurse has been professionally certified as being able to competently complete a task or skill. Cytotoxic spills - Involve any formulation of the drug and can occur wherever cytotoxic drugs and waste are being handled, stored, transported or disposed. Spills may result in the contamination of the environment including floors, work surfaces, equipment, bedding and clothing as well as the patient and carer/staff member Accidental exposure - to cytotoxic drugs can occur at any time during and after the administration process. This includes both direct drug exposure and exposure to contaminated body fluid waste. Health literacy - The capacity to find, interpret and use information and health services to make effective decisions for health and wellbeing. Te Whai Mana Painga - Empowerment of knowledge, skills and resources, to make an informed choice of care and treatment. NGO - Non government Organisation offering supportive services, in this case for people affected by cancer e.g. Cancer Society, Leukaemia and Blood Cancer New Zealand. People affected by cancer - People affected by all types of cancer, including those at risk of developing cancer, people living with cancer, cancer survivors, carers, family and whānau members and significant others. National standards for Chemotherapy Administration Version 10 Page 18