Workforce Education and Training Framework for the Safe Use of Cytotoxic Medicines

Workforce Education and Training Framework for the Safe Use of Cytotoxic Medicines

CONTENTS 1 Introduction 2 Rationale for development 3 Who is the framework for? 3 2 Developing the capability framework What are Essential Shared Capabilities? Essential Shared Capabilities 3 Structure and use of the framework 8 How should the framework be used? 8 The workforce education and training framework for the safe use of cytotoxic medicines 10 5 Developing, organising and delivering education and training 2 Practice supervision 2 Who should supervise? 2 Preparation of supervisors 2 Maintaining skills and updating 2 References 25 Key documents 2 Useful websites 27 Appendix 1 2 The Scottish Credit and Qualifications Framework (SCQF) Appendix 2 30 Indicative guide to practice learning outcomes required for roles Appendix 3 32 Steering Group Membership

1 INTRODUCTION Cytotoxic medicines are commonly associated with the treatment of cancer, but are also used to treat a number of other medical conditions in specialties such as dermatology and rheumatology. It is well recognised that while cytotoxic medicines provide significant benefits, they also present potential health hazards for patients and staff and pose risks to the environment. Errors in their administration have resulted in severe, sometimes fatal, consequences (Cambridge Health Authority, 2000; Toft, 2001; National Patient Safety Agency, 200). The roles of doctors, pharmacists and nurses in relation to cytotoxic medicines are well understood. There is less recognition of the important part ancillary staff, such as stores staff, porters and domestic assistants, play in transporting cytotoxic medicines prior to and following reconstitution, disposing of cytotoxic waste and cleaning areas in which cytotoxic medicines are used. It is imperative that everyone involved in prescribing, preparing, dispensing, transporting, administering and disposing of cytotoxic medicines and waste has the knowledge and skills to ensure safe delivery and protect themselves and others from the potential health risks associated with exposure. Oral cytotoxic medicines are no less toxic than those given by other routes. Irrespective of the environment, the need to ensure safe use of cytotoxic medicines remains crucial. Before cytotoxic medicine administration becomes more prevalent in community and home settings, structured and coordinated processes need to be developed to ensure that medicines are prescribed, prepared, dispensed, transported, administered and disposed of safely and appropriately by people who have had the necessary education, training and experience and who possess the knowledge and skills required. The demand for chemotherapy services is increasing. Different and new ways of working are required to meet this demand (SEHD, 200, 2005). Individuals will need to expand their existing roles or take on new roles. A multi-professional approach is required, and increased blurring of role boundaries is envisaged. Healthcare support workers are already expanding their existing roles and nurses and pharmacists are likely to take a greater role in prescribing in the future. 1 All members of the healthcare workforce need access to appropriate and accessible education and training to support existing, new and expanding roles. Much attention has been placed in recent years on centralisation of cytotoxic services and ensuring medicines are administered in specificy designated areas by healthcare professionals who have the appropriate knowledge and skills (Clinical Standards Board for Scotland (CSBS), 2001a, b, c & d). This situation is now changing with increased emphasis on delivering services closer to patients homes (Scottish Executive Health Department (SEHD), 2005) and the rising number of oral chemotherapy agents now available that are suitable for home use. 1 This education and training framework will not prepare individuals for prescribing. Individuals who develop their role to include prescribing will need to undertake an approved prescribing course. 2

Rationale for development The need for a nationy recognised standard of education and competence for members of the healthcare workforce involved in the use of cytotoxic medicines has long been recognised (Royal College of Nursing, 18; CSBS, 2001a, b, c & d). HDL (2005) 2, Guidance for the Safe Use of Cytotoxic Chemotherapy, highlights the need for education and training programmes for staff handling cytotoxic medicines or waste. The changing context of healthcare and role developments referred to above also emphasise the importance of a nationy recognised standard in ensuring those involved with cytotoxic medicines have the necessary knowledge, skills and experience to ensure safe use. Who is the framework for? The framework is intended primarily for those developing education and training for members of the healthcare workforce involved in prescribing, preparing, dispensing, transporting, administering and disposing of cytotoxic medicines and waste. It may also be used as a guide for those wishing to identify appropriate education and training for healthcare staff. The framework provides a basis from which to develop local education and training for individuals involved with cytotoxic medicines use irrespective of medical specialty or place of administration. It is applicable to staff working with adults and children. 2 This workforce education and training framework aims to promote the safe use of cytotoxic medicines and support implementation of national guidelines, particularly HDL (2005) 2 and HDL (200) 30, Safe Administration of Intrathecal Cytotoxic Chemotherapy. It is equy applicable to primary and secondary care settings and provides the foundation for a consistent approach to education and training in Scotland. 2 Additional key content is included for children where appropriate. 3

2 DEVELOPING THE CAPABILITY FRAMEWORK Many competency frameworks have been developed in recent years but despite being valued by healthcare workers, the sheer volume of frameworks has been found to be confusing (Hendry et al, 2005). It has also been argued that competencies do not take into account complexity (Wilson & Holt, 2001), and that effective healthcare workers need more than a prescribed set of competencies to carry out their roles effectively (Sainsbury Centre for Mental Health, 2001). The concept of capability combines current competence needed to do the job with the potential to develop future competence (Price, 200). A capability framework facilitates flexibility and adaptability in education and training, owing individuals to develop to meet the future demands of healthcare delivery (Price, 200). A framework based on capabilities therefore lends itself well to a workforce education and training framework for the safe use of cytotoxic medicines. This capability framework has been informed by, and is adapted from, previous capability frameworks (Sainsbury Centre for Mental Health, 2001; Department of Health, 200; Combined Sheffield Universities Interprofessional Learning Unit, 200). The framework has also been used to underpin the Working with People with Cancer: Professional Development Framework for Nurses and Allied Health Professionals - Core Level document developed by NHS Education for Scotland (NES, 2007). Capability is associated with healthcare workers abilities and potential and is considered an essential element of lifelong learning and personal and professional development. It differs from competence in that: Capability frameworks provide a broad outline of what healthcare workers should be able to do in practice. They focus on: realising people s full potential; developing the ability to adapt and apply knowledge and skills; learning from experience; envisaging the future and contributing to making it happen. These elements are congruent with continuing professional development, lifelong learning and personal development goals, each of which is a vital part of the make-up of current and future healthcare workers. Capabilities incorporate several components (Sainsbury Centre for Mental Health, 2001): a performance component identifies what knowledge and skills people need to possess and what they need to achieve in the workplace; an ethical component concerned with integrating knowledge of culture, values and social awareness into professional practice; a component that emphasises reflective practice in action; the capability to effectively implement evidence-based interventions in the changing context of health services; a commitment to working with new models of professional practice and accepting responsibility for lifelong learning. competence describes what individuals know or are able to do in terms of knowledge, skills and attitudes at a particular point in time; capability describes the extent to which an individual can apply, adapt and synthesise new knowledge from experience and continue to improve his or her performance (Fraser & Greenhalgh, 2001).

Capability frameworks are usuy supported by discipline-specific competency frameworks detailing the level of expertise required; existing competency frameworks relating to the use of cytotoxic medicines, however, do not encompass the level of detail considered essential for this framework. To overcome the limitations of existing frameworks, prevent duplication of effort and attempt to capture the notion of capability as current competence combined with the development of future potential competence, this framework incorporates practice learning outcomes to detail what healthcare workers should be able to achieve in practice as a result of education and training. Each practice learning outcome has been matched to the Scottish Credit and Qualifications Framework (SCQF). The SCQF is outlined in Appendix1. The framework provides a basis for comparing learning and qualifications achieved in different contexts, such as in the workplace and in formal study at an education institution (NES, 2007). SCQF levels have been used in this framework to assist those providing education to determine the minimum education level required. Practice learning outcomes can also be incorporated into education and training programmes at a higher level, as required. The levels indicate that any education and training offered should be assessed at a particular level; they do not mean that an individual has to achieve a specific qualification. 5

What are Essential Shared Capabilities? The Ten Essential Shared Capabilities (DoH, 200) have been adapted for cancer care to reflect the core values of nursing, midwifery and the ied health professions described in Delivering Care, Enabling Health (SEHD, 200). They describe the values and principles that should underpin practice, are relevant to healthcare workers irrespective of professional group or role, and represent the minimum requirements. It is anticipated that they will be appropriate for healthcare workers involved in cytotoxic drug use, irrespective of professional discipline and specialist area of practice. Essential Shared Capabilities There is no implied ranking of importance in the way the Essential Shared Capabilities are presented are equy important. Healthcare workers involved in cytotoxic medicine use as part of multiprofessional teams are expected to develop their ability in the following areas. Working in partnership. Developing and maintaining constructive working relationships with individual patients, their families and carers and multiprofessional colleagues to design, deliver and evaluate care and treatment across organisational, geographical and professional boundaries. Respecting diversity. Providing care and treatment in ways that respect and value diversity in, for example, age, race, culture, disability, gender, spirituality and sexuality. Practising ethicy. Recognising the rights of individual patients, their families and carers and providing information to increase understanding, inform choices and support decision making. Providing care and treatment based on professional, legal and ethical codes of practice. Chenging inequality. Identifying where care could be improved and devising solutions to ensure individual patients and their families and carers have access to the best quality care, irrespective of the type and stage of their disease, their personal circumstances or geographical location. Identifying the needs of individual patients, their families and carers. Working in partnership to identify health, well-being and social care needs of individuals, their families and carers. Providing safe and responsive patient-centred care. Providing safe, effective and responsive care and interventions that meet the identified holistic needs of individual patients, their families and carers within the parameters of the role and in accordance with professional codes of conduct and clinical governance.

Promoting best practice. Continuy reviewing and evaluating to ensure best quality, evidence-based, values-based care designed to meet the individual needs of individual patients, their families and carers is offered. Promoting rehabilitation approaches. Recognising the relevance of rehabilitation for individuals, working in partnership with individuals, families and carers and multi-professional colleagues to set realistic goals, foster hope, and develop and evaluate realistic, sustainable programmes of rehabilitation that emphasise self care. Promoting self care and empowerment. Taking active steps to work with, involve and support people in addressing their own healthcare needs, maximising their potential within the limits of their illness and enabling them to live as independently as possible. Pursuing personal development and learning. Keeping up to date with changes in practice, seeking opportunities to extend knowledge, skills and experience and participating in lifelong learning activity. Pursuing personal and professional development for self and others through supervision and reflection on practice. 7

3 STRUCTURE AND USE OF THE FRAMEWORK The framework is presented under eight domains: Knowledge for Practice The Multi-Professional Approach Prescribing Verification, Preparation and Dispensing Safe Handling Administration Care and Intervention Practising Ethicy How should the framework be used? The framework can be used: as a means of planning personal development; as a means of identifying training needs; as a guide to developing education and training; to benchmark existing education and training; as a guide to developing work-based learning; for quality assurance monitoring; in induction programmes for staff. There is no implied ranking of importance in the way the domains are presented are equy important. Each of the domains contains: capabilities - broad statements of intent; practice learning outcomes - detailing the knowledge, skills, attitudes and behaviours members of the healthcare workforce should be capable of demonstrating in practice; minimum Scottish Credit and Qualifications Framework (SCQF) level each of the practice learning outcomes has been matched to a SCQF level, which are described in Appendix 1; Different members of the healthcare workforce have different education and training needs depending on their role and level of involvement with cytotoxic medicines. Changes in professional roles and role boundaries make it difficult to align practice learning outcomes to specific groups of healthcare workers and the framework intentiony does not address outcomes for individual professional groups. It is anticipated that those developing education and training programmes based on the framework will choose the appropriate practice learning outcomes relevant to their intended participants. To support this process, an indicative guide to mapping practice learning outcomes to specific roles is presented in Appendix 2. key content - a broad outline of the knowledge required to achieve the practice learning outcomes. The Essential Shared Capabilities are incorporated within and are reflected throughout the framework. 8

Examples of how two groups of workers porters and community pharmacy technicians may be involved in cytotoxic medicines use and the practice learning outcomes appropriate to them are shown below. Example 1: Porters Porters may be involved in transporting cytotoxic medicines and waste and need education and training on safe handling. This might take the form of a short training session familiarising participants with the potential dangers of the medicines and relevant policies and procedures. The following practice learning outcomes might be chosen as being appropriate for porters. Domain Practice learning outcomes Knowledge for Practice 1,2 The Multi-Professional Approach 3,5 Safe handling 5.1 3 Safe handling 5.2 2, 5, 7, 10 Example 2: Community pharmacy technician involved with dispensing oral cytotoxic medicines Community pharmacy technicians involved in dispensing oral cytotoxic medicines would require a greater depth and breadth of education and training on the safe use of oral cytotoxic medicines, side-effects and the relevant policies and procedures governing their use. Practice learning outcomes might include the following. Domain Practice learning outcomes Knowledge for Practice 1,2 The Multi-Professional Approach 3,7 Verification, Preparation & Dispensing 5,7 Safe handling 5.1 1, 2, Safe handling 5.2 2,, 5,, 10 Administration Oral 2, 3 Care & Intervention 7.1 1 Practising Ethicy 1, 7, 8

THE WORKFORCE EDUCATION AND TRAINING FRAMEWORK FOR THE SAFE USE OF CYTOTOXIC MEDICINES Domain 1 Knowledge for Practice Capability 1.1 The healthcare worker develops and maintains knowledge and understanding of the actions of cytotoxic medicines and national/local guidelines associated with their use to promote safe and effective care Practice learning outcomes 1. Knows how to access relevant local and national policies/guidelines and continuy develops and updates his/her knowledge to promote safe and effective practice. 2. Is aware of the potential hazards of cytotoxic medicines to self and others. 3. Can explain the physiology of the cell, phases of the cell cycle and the mode of action of specific cytotoxic medicines.. Understands the process of cytotoxic drug development through clinical trials. 5. Can explain common drug regimens delivered in own area of practice in relation to underlying disease.. Can explain the side-effects associated with specific cytotoxic medicines. 7. Is aware of pharmacokinetic and pharmacodynamic factors which may inhibit or enhance the effects of cytotoxic medicines. 8. Is aware of treatment intent and sensitively and appropriately communicates this information to patients, their families and carers.. Can explain the rationale for combining different medicines for specific conditions within individual treatment plans. 10. Can explain the rationale for scheduling cytotoxic medicines. 11. Can explain why cytotoxic medicines are administered by different routes and advises patients, their families and carers accordingly. Minimum SCQF level Key content Key national and local policies and guidelines relevant to the use of cytotoxic medicines. Potential hazards to health. Physiology of the cell and cell cycle. Principles of chemotherapy, cell-kill hypothesis, mode of action of medicines. Drug development and role of phase I, II, III and IV clinical trials. Specific drug regimens and disease processes relevant to own area of practice, side-effects of cytotoxic medicines. Indications for use of cytotoxic medicines and treatment intent. Metabolism, absorption, distribution, secretion and excretion. Common drug, food and complementary therapy interactions. Scheduling of cytotoxic regimens, single agent/ combination chemotherapy, drug resistance. Minimising risk of side-effects and dehydration. Rationale for use of specific routes of administration, including oral, intravenous, subcutaneous, intramuscular, topical, intravesical, intrathecal, intracavity. Benefits and limitations of specific routes. 10

Domain 2 The Multi-Professional Approach Capability 2.1 The healthcare worker actively contributes to a multi-professional approach to promote effective communication and continuity and consistency of safe and effective patient-focused treatment and care within and across care settings. Practice learning outcomes 1. Works collaboratively with other members of the multi-professional team to ensure that appropriate procedures and policies are in place for areas in which cytotoxic medicines are administered. 2. Works collaboratively with other members of the multi-professional team to criticy analyse local policies and procedures to ensure consistency with current research evidence and national guidelines. 3. Is aware of own role and the role of other relevant members of the multi-professional team and knows how and when to access specialist advice and who to contact in an emergency.. Uses recognised communication channels to consistently and clearly communicate relevant information about the treatment plan to other members of the multi-professional team within and across care settings. 5. Effectively communicates, verby and in writing, pertinent information about individuals care and preferences with other members of the multi-disciplinary team.. Continuy reflects on practice and identifies where services could be improved to better meet patient needs. 7. Works collaboratively with other members of the multi-professional team to improve equity of access and quality of services. Minimum SCQF level Key content Policies and procedures for aspects of cytotoxic drug use. Best practice guidelines. Contact details of key people in the multiprofessional team. Formal and informal communication channels. Service development. 11

Domain 3 Prescribing Capability 3.1 The healthcare worker continuy practices in a way that demonstrates his or her clinical knowledge and understanding of the legislative requirements and professional guidance associated with prescribing cytotoxic medicines. Practice learning outcomes 1. Consistently prescribes within the parameters of own role, competence and local frameworks for practice by applying knowledge of national and local protocols/guidelines for initiating a cytotoxic regimen and prescribing chemotherapy regimens. 2. Consistently applies specific prescribing guidelines in completing cytotoxic prescriptions for intrathecal cytotoxic medicines. 3. Applies knowledge of national and local guidelines for prescribing in the development and implementation of individual clinical management plans.. Assesses symptom history, clinicy examines the patient and accurately interprets relevant clinical data to assess the individual s fitness for treatment and appropriateness of initial and subsequent cycles of treatment. 5. Applies knowledge of food, medicine and complementary therapy interactions to promote effective prescribing.. Consistently prescribes cytotoxic medicines and associated supportive treatments in accordance with recognised treatment protocols (including clinical trials) and clinical management guidelines for own area of practice. 7. Uses in-depth knowledge and professional judgement to act within parameters of own role and national/local frameworks for practice in any deviation from recognised protocols and clinical management guidelines. 8. Consistently calculates accurate drug dosage according to specific patient parameters and in-depth knowledge of treatment toxicities.. Promotes safe and effective treatment by consistently completing cytotoxic prescriptions clearly and accurately. 10. Applies knowledge of national/local prescribing guidelines to the development and implementation of Patient Group Directions for supportive treatments. 11. Promotes consistency and continuity of treatment and care by succinctly recording information regarding the treatment regimen in the patient record. Minimum SCQF level Key content National/local guidelines for prescribing cytotoxic medicines. Specific prescribing guidelines for intrathecal medicines. National guidelines for supplementary and independent prescribing, clinical management plans, Patient Group Directions. Normal haematological and biochemical parameters, including hepatic and renal function, radiological results, tumour markers, performance status. Common treatment protocols (including clinical trials) used in specific areas, patient eligibility criteria, number of cycles, intervals between cycles, maximum cumulative doses, side-effects and contra-indications, route and duration of administration, and supportive treatments such as sodium bicarbonate, calcium leucovorin, mesna. Drug calculations, surface area, area under the curve e.g. carboplatin. Criteria for dose reduction/modification. Completion of standard chemotherapy prescription and electronic prescribing forms in line with legislative frameworks and national/ local guidelines. 12 National guidance related to prescribing is included in the key documents section.

Domain Verification, Preparation and Dispensing Capability.1 The healthcare worker continuy practices in a way that demonstrates his or her knowledge and understanding of the legislative requirements and professional guidance associated with verifying, preparing and dispensing cytotoxic medicines. Practice learning outcomes 1. Accurately interprets clinical data in assessing individual prescriptions for validity, safety and clinical appropriateness. 2. Applies knowledge of food, medicine and complementary therapy interactions in verifying the prescription. 3. Applies knowledge of associated supportive treatments in verifying the prescription.. Consistently applies national standards for aseptic preparation within parameters of own role. 5. Consistently dispenses oral medicines according to legislation and national guidelines.. Consistently dispenses intrathecal medicines according to legislation and national guidelines. 7. Uses knowledge of cytotoxic medicines to provide patients, their families and carers with information about safe handling of dispensed medicines. 8. Consistently undertakes final check and release of asepticy prepared cytotoxic medicines according to parameters of own role, competence and local guidelines.. Consistently undertakes final check and release of non-asepticy prepared cytotoxic medicines according to parameters of own role, competence and local guidelines. Minimum SCQF level Key content Patient assessment data, normal dose ranges, drug interactions, diluents, stability, storage requirements, maximum doses, relevant clinical management guidelines and cytotoxic protocols, toxicities, drug, food and complementary therapy interactions, associated supportive treatments. Aseptic dispensing standards. Out-of-hours preparation, oral and intrathecal medicines. Legislation, national guidelines and standard operating procedures for verifying, checking and dispensing cytotoxic medications. Safe handling of individual medicines. National/local guidelines for check and release of cytotoxic medicines. 13

Domain 5 Safe Handling Capability 5.1 The healthcare worker works collaboratively with other members of the healthcare team and within the parameters of own role to promote consistency, safety and security in the storage and transport of cytotoxic medicines. Practice learning outcomes 1. Applies knowledge of guidelines and procedures to ensure cytotoxic medicines, including (where appropriate) those for intrathecal use, are received and stored safely, securely and in the most appropriate conditions in pharmacy/clinical areas. 2. Applies knowledge of guidelines and procedures to the packaging of cytotoxic medicines to ensure they are safely and securely transported in the most appropriate conditions. 3. Applies safe handling guidelines in safely transporting cytotoxic medicines.. Consistently contributes to accurate record keeping within the parameters of own role. Minimum SCQF level Key content National and local guidelines/policies on safe storage. Labelling of storage facilities. National and local guidelines/policies on packaging and transporting medicines, including medicines for intrathecal use. Assessment of risk. Maintaining cold chain. Special precautions for specific medicines. Packaging of medicines. Receipt of medicines. Roles of members of the healthcare team in storage and transport of cytotoxic medicines. 1

Domain 5 Safe Handling Capability 5.2 The healthcare worker consistently uses knowledge of the potential hazards of cytotoxic medicines to promote a safe environment and protect the health and well-being of patients and staff by demonstrating safe handling practices. Practice learning outcomes 1. Participates in and, where appropriate, initiates a risk assessment in areas where cytotoxic medicines are to be administered (including in patients homes) to ensure medicines can be administered safely and effectively. 2. Consistently applies safe handling practices to activities associated with cytotoxic drug use. 3. Protects the health of patients, their families and carers, colleagues and self when administering cytotoxic medicines by acting to assess and minimise the risk of exposure and spillage.. Protects the health of patients, colleagues and self when disposing of unused cytotoxic medicines by acting to minimise the risk of exposure and spillage. 5. Protects the health of patients, colleagues and self when disposing of used equipment by acting to minimise the risk of exposure and spillage.. Understands the need for national/local policies and procedures and takes appropriate precautions to protect the health of patients, colleagues and self when disposing of patient excreta. 7. Is aware of national/local policies and procedures and acts in accordance with these in removing and transporting cytotoxic waste. 8. Is aware of the environmental hazards of cytotoxic medicines and acts in accordance with national and local policies to protect self and others by effectively cleaning areas in which cytotoxic medicines are prepared/administered.. Teaches patients, their families and carers procedures to promote safe storage and disposal of cytotoxic medicines, equipment (such as medicine measures, oral syringes) and waste at home. 10. Uses knowledge of national/local policies and procedures in managing and reporting spillage of cytotoxic medicines. Minimum SCQF level 8 8 Key content Risk assessment, factors affecting safe use, including environment, resources and equipment (such as hazardous waste containers), spillage and extravasation packs, staff education and training. Potential hazards to health and environmental contamination. Control of Substances Hazardous to Health (COSHH) guidelines. Occupational health and safety (health surveillance, guidelines for pregnancy). Common causes of exposure. Reducing potential for airborne, skin or eye contamination, splashing or spillage, including personal protective equipment and specific precautions for different routes of administration (safe handling of oral medicines, intravenous infusion sets, urinary catheters). Disposal of cytotoxic waste and equipment. Disposal of excreta. Labelling, packaging and transporting cytotoxic waste. Care and cleaning of environment, drug preparation areas and reusable equipment. Management of spillage. Disposal of wet/soiled linen. 15

Domain Administration Capability.1 The healthcare worker continuy reflects on and develops practice to provide evidence- and values-based treatment and care to meet the diverse needs of patients, their families and carers. 1 Practice learning outcomes: Generic 1. Combines effective assessment, clinical examination and communication skills to assess individuals fitness for treatment. 2. Elicits an accurate ergy history and uses knowledge of the hypersensitivity profile of cytotoxic medicines to assess individual potential for ergic and hypersensitivity reactions. 3. Can interpret blood values and uses agreed protocols to decide if cytotoxic medicines should be administered.. Assesses the severity of side-effects using a recognised toxicity grading system and agreed protocols to decide if cytotoxic medicines should be administered. 5. Uses effective communication skills to sensitively engage patients, their families and carers in health related discussions and listens to their views.. Consistently calculates drug doses and infusion rates accurately. 7. Applies knowledge of specific drug protocols and clinical trials commonly used in own area of practice to ensure medicines are checked and administered safely. 8. Is aware of adverse reactions associated with specific cytotoxic medicines, associated supportive therapies and routes of administration and promotes patient safety by taking appropriate precautions based on knowledge and national/local guidelines.. Continuy monitors the patient for signs of adverse reactions throughout administration of medicine and reports occurrence to relevant senior personnel. 10. Actively encourages patients, their families and carers to become involved in their care and report any unusual sensations or side-effects experienced during and after drug administration. 11. Applies knowledge of the side-effects of specific cytotoxic medicines to ensure associated supportive treatments such as anti-emetics and fluids are administered with the chemotherapy regimen. 12. Uses knowledge of common drug and food interactions to provide timely and appropriate advice to patients, their families and carers. 13. Clearly records medicines administered to ensure safety, continuity and consistency of care. Minimum SCQF level 8 Key content Assessment, clinical examination skills, ergy history, cytotoxic medicines commonly causing ergic and hypersensitivity reactions, potential risk factors. Age-related normal blood values, toxicity grading scales, indications for withholding chemotherapy. Calculation of surface area, drug calculations. Dose ranges of commonly used medicines. Local checking procedures and policies, five rights of drug administration (right patient, right drug, right dose, right time, right route). Specific safety issues associated with routes of administration - oral, intravenous, subcutaneous, intramuscular, intracavity, intrathecal and topical, including eye drops. Procedures for reporting adverse drug reactions, including clinical trials. Prevention of ergic and hypersensitivity reactions, monitoring of vital signs and urine. Associated supportive treatments required for specific drug regimens.

Domain Administration Practice learning outcomes: Intravenous 1. Uses knowledge of anatomy and physiology of veins and arteries to consistently choose an appropriate, healthy and viable vein for peripheral cannulation. 2. Uses knowledge of potential insertion sites, types and sizes of cannulae, duration of treatment and method of administration to consistently choose the most appropriate cannula and insertion site for individuals. 3. Consistently cannulates and checks patency and integrity of vein proficiently.. Applies and reflects on local procedures for the care and management of peripheral cannulae, peripheral intravenous central catheters (PICC), central catheters and implantable ports (where applicable). 5. Applies knowledge of functioning of infusion pumps and criteria for use to consistently select appropriate device for the individual and specific medicines.. Uses knowledge of IV fluid compatibility to choose appropriate flush solution for intravenous catheters before, between and after each drug. 7. Consistently anticipates and plans interventions to minimise potential adverse reactions and extravasation. 8. Is proficient in safely administering a cytotoxic medicine via a peripheral line, PICC, central line or implantable port (where applicable).. Continuy monitors for signs of hypersensitivity reaction during administration. 10. Continuy monitors for signs of extravasation during administration. Minimum SCQF level 8 Key content Anatomy and physiology of veins and arteries. Practical issues in administration, including proactive assessment of veins, selection of veins/ cannulae, choice of and management of site. Local procedures and research evidence related to prevention of infection, flushing cannulae and dressings. Criteria for use of specific infusion pumps. Checking line patency before commencing infusion, precautions to be taken with specific medicines, IV fluid compatibility, order of administration, time over which medicines should be administered, potential drug interactions. Vesicant and irritant medicines, potential risk factors preventing extravasation, including extravasation from a central catheter or implanted port. Signs of hypersensitivity reaction. Signs of extravasation. 17

Domain Administration Practice learning outcomes: Intrathecal 1. Is familiar with national and local policies and procedures for administering cytotoxic medicines intrathecy. 2. Is aware of own roles and responsibilities in assisting with the checking and administration of intrathecal medicines. 3. Is aware of the local intrathecal register, designated areas for administration and named individuals who can administer intrathecal medicines to promote safe administration.. Is aware of the specific medicines which may be administered intrathecy. 5. Is aware of the dangers associated with injection of cytotoxic medicines intrathecy.. Uses knowledge to consistently choose appropriate site for lumbar puncture and appropriate type and size of spinal needle. 7. Applies knowledge of the anatomy and physiology of the spinal column and central nervous system (CNS) in proficiently performing lumbar puncture and administering cytotoxic medicines intrathecy. 8. Consistently applies local procedures for monitoring the patient for signs of discomfort, infection and neurotoxicity during and after the procedure. Minimum SCQF level Key content National and local policies and procedures for intrathecal administration of cytotoxic medicines. Local intrathecal register and named individuals. Designated local areas for administration of intrathecal medicines. Specific medicines for intrathecal use, timing for cerebral spinal fluid removal and administration of medicines. Anatomy and physiology of spinal column and central nervous system. Hazards of intrathecal injection. Signs of infection/trauma, neurotoxicity. Monitoring procedures. 18 Practice learning outcomes: Oral 1. Consistently demonstrates non-touch technique in the administration of oral preparations. 2. Teaches patients, their families and carers techniques for the safe handling and administration of oral preparations. 3. Uses effective communication skills to inform patients, their families and carers about the prescribed drug regimen and to check their understanding of the correct dose, times at which medicines should be taken and, where appropriate, when medicines should be stopped. Precautions required with oral preparations, non-touch technique, issues relating to crushing and splitting tablets, liquid preparations. Importance of shared-care pathways and protocols and responsibility for prescribing and monitoring. Importance of adherence to prescribed regimens. Missed doses. Importance of regular monitoring, benefits and risks of medication.

Domain Administration Practice learning outcomes: Intravesical 1. Uses effective communication skills to inform patients, their families and carers about specific actions to be taken before and immediately following instillation of cytotoxic medicines and to answer their questions. 2. Interprets pre-treatment urinalysis results and uses agreed protocols to decide if cytotoxic medicines should be administered. 3. Uses knowledge of different types and sizes of catheter to choose the most appropriate catheter for individuals.. Uses knowledge of anatomy and physiology of the urethra and bladder to consistently catheterise proficiently and minimise trauma. 5. Consistently acts to prevent skin/mucosal contamination.. Is proficient in administering a cytotoxic drug into the bladder. 7. Continuy monitors patient for signs of adverse reactions. Practice learning outcomes: Intraperitoneal 1. Applies and reflects on local guidelines and procedures for the care and management of intraperitoneal catheters or implanted ports. 2. Is proficient in instilling cytotoxic medicines intraperitoney. 3. Continuy monitors patient for signs of adverse reactions. Minimum SCQF level 8 Key content Local guidelines and procedures for administering cytotoxic medicines intravesicy. Fluid intake before and after instillation, change of position, retention of drug, voiding urine. Relevance of proteinurea or haematuria, symptoms of urinary tract infection. Choice of catheter. Local guidelines and procedures for intraperitoneal administration. Care of exit site, catheter care, prevention of infection. Instillation of drug, volume, temperature, rate of administration. Adverse reactions, including: respiratory distress, abdominal pain, distension or discomfort, diarrhoea, peritonitis, electrolyte imbalance. 1

Domain 7 Care and Intervention Capability 7.1 The healthcare worker participates as part of the multi-professional team and, where appropriate, initiates prompt and effective responses to the management of adverse reactions. Practice learning outcomes Hypersensitivity reactions 1. Is aware of the procedure for reporting drug errors, critical incidents and adverse drug reactions. 2. Can identify and differentiate between signs and symptoms of local and systemic hypersensitivity reactions. 3. Is aware of local/national guidelines for the immediate and ongoing management of hypersensitivity and anaphylactic reactions.. Is aware of procedures for documenting and reporting hypersensitivity and anaphylactic reactions. Extravasation 1. Can distinguish between a flare reaction and extravasation. 2. Can identify the signs and symptoms of extravasation from both peripheral and central venous access devices. 3. Is aware of local/national guidelines for the immediate and ongoing management of extravasation.. Knows who to contact for support and advice in the event of extravasation. 5. Is aware of procedures for documenting and reporting extravasation. Minimum SCQF level Key content Local and national procedures for reporting drug errors and critical incidents. Signs and symptoms of hypersensitivity and anaphylactic reactions. National/ local guidelines for management of hypersensitivity reactions and anaphylaxis. Documenting and reporting. Signs and symptoms of flare reaction and extravasation. National and local guidelines for management of extravasation. Documenting and reporting extravasation. 20

Domain 7 Care and Intervention Capability 7.2 The healthcare worker uses knowledge and professional judgement of the potential consequences of cytotoxic medicines and works in partnership with patients, their families and carers to assess their holistic needs and provide and evaluate evidence-based interventions that promote well-being and self-care abilities. Practice learning outcomes Minimum SCQF level Key content 1. Is aware of the potential physical, psychological, social and financial impact of chemotherapy and demonstrates skills in sensitively assessing the needs and listening to the concerns of patients, their families and carers. 2. Recognises that different individuals have different information and support needs, beliefs and values and uses effective communication skills to assess the information individual patients, their families and carers require before, during and after the administration of chemotherapy. 3. Uses effective communication skills to provide information to patients, their families and carers about the side-effects of cytotoxic medicines and associated supportive treatments and to answer their questions.. Provides patients, their families and carers with information and listens to their concerns to reduce the potential impact of uncertainty and promote return to everyday activities during and following the completion of treatment. 5. Advises patients about the sensory effects that may be experienced during the administration of chemotherapy.. Identifies and responds sensitively and appropriately to verbal and non-verbal cues from individuals, their families and carers that might indicate psychological distress. 7. Plans and delivers evidence-based interventions to prevent or minimise the side-effects of chemotherapy. 8. Identifies symptoms that might indicate disease progression or a developing emergency and promptly informs other members of the multi-professional team to promote timely and responsive intervention. 8 8 8 Psychological support, employment and benefits, returning to everyday life during and following completion of treatment, rehabilitation. Management of immediate, short and long-term side-effects and organ toxicities, including those caused by associated supportive treatments such as anti-emetics: nausea & vomiting, mucositis, constipation, hand/foot syndrome, diarrhoea, nutritional consequences, bone marrow suppression, alopecia, body image, sexuality, sexual activity and contraception following drug administration, sun sensitivity, fatigue, hyperuricaemia, ototoxicity, renal, cardiac, neurological and hepatic toxicity, sexual dysfunction, infertility, haemorrhagic cystitis, pulmonary fibrosis, secondary cancers. Sensory perceptions. Emergencies, such as tumour lysis syndrome, neutropenic sepsis. Intravesical: Specific side-effects: chemical cystitis, haematuria, urinary tract infection, contact dermatitis, bladder spasm, physiological and psychological effects of frequent catheterisation. Fluid intake, disposal of excreta. Paediatric: Education/play specialists, family care. Late effects of treatment. Adolescents. 21

Domain 7 Care and Intervention Capability 7.3 The healthcare worker works in partnership with patients, their families and carers to optimise well-being by promoting empowerment and the development of self-care abilities. Practice learning outcomes 1. Helps to empower patients, their families and carers by directing them to appropriate sources of information, advice and support. 2. Engages with individuals, their families and carers and creates opportunities to discuss their desire, abilities and role in self care. 3. Teaches appropriate interventions and encourages and supports patients and their families and carers to optimise well-being and reduce the impact of potential side-effects.. Encourages self care by teaching patients, their families and carers interventions to effectively manage anticipated side-effects. 5. Empowers patients, their families and carers by teaching them how to recognise early warning signs of impending side-effects that need the intervention of healthcare professionals.. Provides information about when and how to contact healthcare professionals for specific advice and support. Minimum SCQF level Key content Patient information and education. Self-care interventions. 22

Domain 8 Practising Ethicy Capability 8.1 The healthcare worker continuy develops his or her knowledge of culture, diversity and ethical, professional and legal frameworks to support interactions with patients, their families and carers and promote their participation in treatment and care. Practice learning outcomes 1. Reflects on own values and beliefs and how they may affect his/her attitude towards patients, their families and carers. 2. Provides information to patients, their families and carers to inform choice and decision making and facilitate informed consent to treatment, including clinical trials. 3. Actively listens and uses effective communication skills to ensure patients, their families and carers understand the information they have been given.. Recognises that different value systems and beliefs may impact on the extent to which individuals want to be partners in care and uses effective communication skills to explore issues with patients, their families and carers. 5. Works collaboratively with colleagues to assess the appropriateness of the facilities and available resources in planning service developments to improve effectiveness or equity of access.. Promotes safe and effective care by applying knowledge of legal and professional frameworks in planning role developments. 7. Applies knowledge of personal, professional and legal accountability and responsibility in the use of cytotoxic medicines to ensure safe and effective practice that meets the needs of patients. 8. Continuy reflects on practice to identify areas for own personal/professional development. Minimum SCQF level 7 7 Key content Informed consent, participation in clinical trials, autonomy and decision making, including vulnerable adults. Duty of care, negligence, legal standard of care. Accountability and responsibility for safety in role and service developments, including resources, staff education and availability of policies and procedures for aspects of the prescription, supply and administration of cytotoxic medicines. Paediatric: Informed consent, invasive procedures such as inserting venous access devices, intrathecal chemotherapy, rights of the child, holding and restraint policies. 23

5 DEVELOPING, ORGANISING AND DELIVERING EDUCATION AND TRAINING The potential hazards associated with cytotoxic medicines mean that healthcare workers involved in their use require a high level of knowledge and competence. Clinical expertise is vital to education and training and responsibility for development, organisation and delivery of education and training should be a joint venture involving expert clinicians and educationalists. Practice supervision All those involved in prescribing, preparing, administering and disposing of cytotoxic medicines should be supervised until they are deemed to have the necessary knowledge and skills to practise independently. Local arrangements for supervision will be required and issues such as supervision of those working in community settings will need to be considered. Who should supervise? Supervisors of practice should be carefully selected. They must be experienced and competent in the safe use of cytotoxic medicines, have confidence in their own abilities and be comfortable in supervising others. It is recommended that supervisors have a minimum of six months independent practice experience in the use of cytotoxic medicines. Maintaining skills and updating A refresher programme is recommended for healthcare workers after prolonged sick leave or maternity leave (HDL (2005) 2). It is also recognised that some practitioners may only be involved in cytotoxic drug administration on an intermittent basis and may lose some of their confidence and competence over time. There is a number of ways in which these healthcare workers can be supported to maintain their skills and regain their confidence and competence, including: opportunities to regularly spend time in specialist centres to update skills; supervised practice in own area of work; use of technology such as telemedicine for virtual supervision and confidence building. It is recommended that tripartite agreements between employers, those responsible for education and training and the individual healthcare worker are in place to ensure maintenance of competence and confidence. Preparation of supervisors 2 Supervisors need to be carefully prepared for their supervisory role. At a minimum, they need to be familiar with the education and training being delivered, what learners are expected to know/achieve and the supervisor s role in facilitating learning. It is essential that the supervisor has time within his or her normal work role to supervise others. Formal processes should be in place to support supervisors and enable them to reflect on and evaluate their experiences of supervision.