Health Sector: Life Sciences Industry and the Health Sector (National 5)

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Unit code: F88F 75 Superclass: RH Publication date: August 2013 Source: Scottish Qualifications Authority Version: 4 (September 2017) Unit purpose This unit has been designed as a mandatory of the National 5 Health Sector Course, but can also be taken as a freestanding unit. It is suitable for learners who have no previous experience of the health sector. This unit is designed to introduce learners to the contribution of the life sciences industry in the diagnosis and treatment of illness. Learners will investigate the safety of pharmaceutical products made by the life sciences industry and the health and safety responsibilities of employers and employees in the life sciences industry. Learners will also undertake a risk assessment in relation to production, storage or use of products made by the life sciences industry. The Health Sector includes the National Health Service (NHS) (primary and secondary care), Independent Healthcare, Complementary Therapies, the Life Sciences and Retail Pharmaceutical Industries and the Community and Voluntary Sector. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 1

Outcomes On successful completion of the unit the learner will be able to: 1 Investigate the contribution of the life sciences industry to a specified patient journey. 2 Investigate the safety of pharmaceutical products made by the life sciences industry. 3 Explain health and safety responsibilities in the life sciences industry. 4 Carry out a risk assessment to a given brief. Credit points and level 1 National unit credit at SCQF level 5: (6 SCQF credit points at SCQF level 5) Recommended entry to the unit Entry to this unit is at the discretion of the centre. Core Skills Achievement of this unit gives automatic certification of the following: Complete Core Skill None Core Skill component Critical Thinking at SCQF level 4 There are also opportunities to develop aspects of Core Skills which are highlighted in the support notes for this unit specification. Context for delivery If this unit is delivered as part of a course, it is recommended that it should be taught and assessed within the subject area of the course to which it contributes. The Assessment Support Pack (ASP) for this unit provides assessment and marking guidelines that exemplify the national standard for achievement. Centres wishing to develop their own assessments should refer to the ASP to ensure a comparable standard. A list of existing ASPs is available to download from SQA s website (http://www.sqa.org.uk/sqa/46233.2769.html). F88F 75 Skills for Work Unit Specification September 2017 (version 4) 2

Equality and inclusion This unit specification has been designed to ensure that there are no unnecessary barriers to learning or assessment. The individual needs of learners should be taken into account when planning learning experiences, selecting assessment methods or considering alternative evidence. Further advice can be found on our website www.sqa.org.uk/assessmentarrangements. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 3

National unit specification: Statement of standards Acceptable performance in this unit will be the satisfactory achievement of the standards set out in this part of the unit specification. All sections of the statement of standards are mandatory and cannot be altered without reference to SQA. Outcome 1 Investigate the contribution of the life sciences industry to a specified patient journey. Performance Criteria (a) Identify the main stages of a specified patient journey. (b) Explain the contribution of a product made by the life sciences industry at each appropriate stage of a specified patient journey. Outcome 2 Investigate the safety of pharmaceutical products made by the life sciences industry. Performance Criteria (a) Identify the essential features of pharmaceutical products. (b) Describe the phases of testing a new pharmaceutical product. (c) Describe the responsibilities of consumers when using pharmaceutical products. Outcome 3 Explain health and safety responsibilities in the life sciences industry. Performance Criteria (a) Explain the health and safety responsibilities of employees in the life sciences industry. (b) Explain the health and safety responsibilities of employers in the life sciences industry. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 4

National unit specification: Statement of standards (cont) Outcome 4 Carry out a risk assessment to a given brief. Performance Criteria (a) Identify the main hazards present. (b) Explain the associated risks. (c) Identify a control measure for each risk. Evidence requirements for this unit Evidence is required to demonstrate that learners have achieved all outcomes and performance criteria. Outcome 1 Written and/or oral evidence Evidence for Outcome 1 will be gathered in open-book conditions at appropriate points throughout the unit. Learners will investigate a patient journey for a specified medical condition and the contribution of a product made by life sciences industry at each stage of the journey. The patient journey to be investigated will be negotiated and agreed with the teacher/lecturer. Evidence will be gathered in a learner folio. Learners will be given a brief for the investigation. Learners are required to: identify four stages of one patient journey explain the contribution of one product made by the life sciences industry at each appropriate stage of the specified patient journey The stages of the patient journey will be selected from the range below: prevention screening investigation diagnosis treatment follow up maintenance of health F88F 75 Skills for Work Unit Specification September 2017 (version 4) 5

National unit specification: Statement of standards (cont) Outcome 2 Written and/or oral evidence Evidence for Outcome 2 will be gathered at appropriate points throughout the unit. Evidence will be gathered under supervision in open-book conditions with learners having access to notes. Learners are required to: identify four essential features of pharmaceutical products describe three phases of testing of a new pharmaceutical product describe three responsibilities of consumers when using pharmaceutical products Examples of essential features of pharmaceutical products made by the life sciences industry and the responsibilities of consumers when using pharmaceutical products are given in the support notes. Outcome 3 Written and/or oral evidence Evidence for Outcome 3 will be gathered at an appropriate point in the unit. Evidence will be gathered under supervision in open-book conditions with learners having access to notes. Learners are required to: explain two health and safety responsibilities of employees in the life sciences industry explain four health and safety responsibilities of employers in the life sciences industry Outcome 4 Written and/or oral evidence Evidence for Outcome 4 will be gathered under supervision in open-book conditions at appropriate points in the unit. Learners will be provided with a brief specifying the context within which the risk assessment will be carried out. The context must be in relation to production, storage or use of products made by the life sciences industry. Learners are required to: identify three hazards explain one risk associated with each hazard identify one control measure for each risk F88F 75 Skills for Work Unit Specification September 2017 (version 4) 6

National unit specification: Statement of standards (cont) The evidence for Outcome 4 must be presented in the form of a completed risk assessment. The risk assessment will be carried out in a real or simulated setting under supervision at an appropriate point in the unit. Guidance on appropriate settings is provided in the support notes. Learners must organise and present findings in an appropriate format. A template for the risk assessment will be provided. The Assessment Support Pack (ASP) provided for this unit illustrates the standard that should be applied. It contains an investigation pro forma, learner brief, series of structured questions and a risk assessment template. If a centre wishes to design its own assessments for this unit, they should be of a comparable standard. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 7

National unit specification: Statement of standards (cont) Development of skills for learning, skills for life and skills for work It is expected that learners will develop broad, generic skills through this unit. Employability is a key aspect of Skills for Work and is present throughout the unit. In addition, there are a number of other skills that learners will be expected to improve on and develop as they undertake this unit, these can be drawn from the main skills areas listed below. These must be built into the unit where there are appropriate opportunities. 1 Literacy 1.1 Reading 1.2 Writing 5 Thinking skills 5.1 Remembering 5.2 Understanding 5.3 Applying 5.4 Analysing and evaluating Amplification of these is given in SQA s Skills Framework: Skills for Learning, Skills for Life and Skills for Work. The level of these skills should be at the same SCQF level as the unit and be consistent with the SCQF level descriptor. Further information on building in skills for learning, skills for life and skills for work is given in the National unit support notes. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 8

National unit support notes Unit support notes are offered as guidance and are not mandatory. While the exact time allocated to this unit is at the discretion of the centre, the notional design length is 40 hours. Guidance on the content and context for this unit This unit has been designed as a mandatory unit of the National 5 Health Sector Course, but can also be taken as a freestanding unit. It is suitable for learners who have no previous experience of the health sector. This unit is designed to introduce learners to the contribution of the life sciences industry in the diagnosis and treatment of illness. Learners will investigate the safety of pharmaceutical products made by the life sciences industry and the health and safety responsibilities of employers and employees in the life sciences industry. Learners will also undertake a risk assessment in relation to production, storage and use of products made by the life sciences industry. The Health Sector includes the National Health Service (NHS) (primary and secondary care), Independent Healthcare, Complementary Therapies, the Life Sciences and Retail Pharmaceutical Industries and the Community and Voluntary Sector. The unit will involve learner research which will encourage the development of time management, information retrieval and research skills. Outcome 1 A patient journey describes the route taken by a patient from screening or initial symptoms through a variety of tests to confirm the presence of a specific disease or condition to treatment, discharge and follow up and monitoring of the condition. Learners will investigate a typical patient journey for a specified medical condition and outline the contribution of the life sciences industry to that journey. The stages of the patient journey are specified within the evidence requirements. Examples of patient journeys are provided in the guidance on approaches to delivery of this unit. The folio could be produced in a variety of formats, eg a presentation, display, poster or leaflet. The language and materials used throughout should promote equality and diversity and avoid cultural stereotypes. Learners should be encouraged to identify ways in which their folio or presentation of information reflects and promotes equality and diversity. This could include the use of signs, symbols, pictures etc. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 9

National unit support notes (cont) Outcome 2 Drug discovery is the discovery, development and approval of new chemical compounds or biological products that can be used to treat human disease. The life sciences industry develops and produces pharmaceutical products including drugs. The essential features of pharmaceutical products include the requirements that they should be: safe to use for patients and staff effective reliable acceptable to use for patients and staff cost effective have minimal side effects be comfortable to use have no adverse effects ethically produced and tested Drug trials refer to the process by which medicines are developed. Before a drug is tested on humans, it would have been through laboratory and/or animal testing. Medicines are also tested for toxicity before being given to people. There are then three stages of drug testing on humans and any such trials have to be approved by the ethics committee. Phase one this stage tests for safety. A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects. Phase two the drug is given to people who have the condition to see if it does indeed help them. Phase three large scale studies usually involving tens or thousands of people. Participants are often randomly allocated to either get the drug or a dummy version. In most cases neither the scientists nor the patients know who has got the real drug so that the results cannot be skewed by expectations. Learners should be encouraged to discuss and debate issues around the development of new drugs and vaccines to treat and prevent illness and disease. They should research current stories in the news and media about trials of new drugs and vaccines and issues around animal testing. Consumers of pharmaceutical products are responsible for ensuring that pharmaceutical products are used and stored correctly. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 10

National unit support notes (cont) The responsibilities of consumers when using pharmaceutical products include: take medicines only as prescribed by a doctor or pharmacist keep all medicines in their original containers store medicines and biomedical devices according to instructions use biomedical devices as instructed discard used medicines as instructed do not take medication or use biomedical devices prescribed for another person keep out of the reach of children report any adverse effects to a doctor do not take medication during pregnancy unless approved by a doctor ensure biomedical devices are stored, cleaned and maintained according to instructions Outcome 3 The health and safety of employees in the life sciences industry is ensured by risk assessment. Teachers/lecturers should ensure that learners are informed that the Health and Safety at Work Act is the main piece of legislation covering health and safety in the workplace. Both employers and employees have responsibilities in relation to health and safety. The responsibilities of employees in relation to health and safety include: to co-operate with the employer, attend relevant training and follow the company's health and safety policies to take care of own health and safety and the safety of others to report any injuries to tell your employer if anything happens that might affect your ability to do the job The responsibilities of employers in relation to health and safety include: to make the workplace safe to prevent risks to health to ensure machinery is safe to use and safe working practices are set up and followed ensure materials are handled, stored and used safely to tell employees about any potential hazards from the work they do, chemicals and other substances used by the firm, and give information, instructions, training and supervision as needed to provide protective clothing or equipment free of charge if risks can't be removed or adequately controlled by any other means to ensure that the right warning signs are provided F88F 75 Skills for Work Unit Specification September 2017 (version 4) 11

National unit support notes (cont) Outcome 4 Learners should be made aware of the difference between a hazard and a risk. A definition is provided below: a hazard is something with the potential to cause harm a risk is the likelihood of harm from that hazard Learners should learn about risk assessments and how these are carried out using current health and safety guidelines. The five steps in a risk assessment are: identify the hazards decide who might be harmed and how evaluate the risks and decide on precautions record your findings and implement them review your assessment and update if necessary Learners will learn how to carry out a risk assessment in relation to production, storage or use of products made by the life sciences industry for use in the health sector. The risk assessment could be in relation to: the storage of biomedical devices in a practical room or health sector environment a visit by the class to a life sciences facility a medicine cabinet and contents the use of products made by the life sciences industry in the health sector Learners will be given a brief specifying the risk assessment to be carried out. The risk assessment will be carried out in a real or simulated environment. Employability Skills In this unit learners will generate evidence for the following employability skills: positive attitude to learning and the workplace self respect and respect and consideration for others understanding of roles and responsibilities in the workplace understanding of health and safety understand and seek clarification of instructions demonstrate an awareness of organisational standards for appearance and behaviour understanding of organisational principles and values in the health sector F88F 75 Skills for Work Unit Specification September 2017 (version 4) 12

National unit support notes (cont) Although not directly assessed in this unit, there may be opportunities to develop the following employability skills: awareness of equality and diversity reflecting on own abilities contribute to team work implementation of infection control procedures These skills can be practised in real or simulated workplace environments and individual or group classroom activities. Guidance on approaches to delivery of this unit Outcome 1 Learners must identify the stages of the patient journey they are investigating. Evidence could be presented in the form of a diagram illustrating the involvement of the life sciences industry throughout the patient journey. The following are examples of the beginning of patient journeys: A woman being called for a routine mammogram as part of the breast cancer screening programme A woman who thinks she may be pregnant A young man in an accident resulting in a broken leg A man being told he may have diabetes A man complaining of toothache An elderly person needing a hip replacement An elderly person being investigated for Alzheimer s Disease A young person having a test for HIV The needs of patients and their health problems differ as they move through their journey from diagnosis through care and treatment to recovery. Visiting speakers and workplace visits can provide valuable insight into the contribution of the life sciences industry to the treatment of patients. Learners should be encouraged to work in groups and share information. Outcome 2 Visiting speakers and workplace visits can provide valuable insights into the ways that the life sciences industry ensures the safety of its products. Learners should be encouraged to discuss topical issues in relation to the testing of new drugs such as vaccines for the H1N1 virus, Human Papilloma virus or new cancer treatments. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 13

National unit support notes (cont) Outcome 3 Teachers/lecturers should ensure that learners understand that the health and safety responsibilities of employers and employees in the life science industry are the same as in any other industry. Outcome 4 As part of learning and teaching a range of scenarios could be devised demonstrating the hazards and risks associated with the manufacture, storage and use of products made by the life sciences industry for use in the Health Sector. The scenarios could be presented to learners in the form of written descriptions, multimedia presentations, illustrations, computer simulations, real work environments and classroom mock ups. It is essential that learners experience health and safety as an interactive process and delivery should be based on practical scenarios wherever possible. Delivery of this unit could incorporate a variety of teaching and learning methods including: Teacher/lecturer presentations and demonstrations Group work and discussions Handouts Visiting speakers Workplace visits Practical activities Individual and group research Internet searches DVD presentations Interviews with health professionals/patients/relatives/workers Guidance on approaches to assessment of this unit Evidence can be generated using different types of assessment. The following are suggestions only. There may be other methods that would be more suitable to learners. Centres are reminded that prior verification of centre-devised assessments would help to ensure that the national standard is being met. Where learners experience a range of assessment methods, this helps them to develop different skills that should be transferable to work or further and higher education. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 14

National unit support notes (cont) Outcome 1 The evidence will be gathered in a learner folio which will include information on a patient journey. The information will include: identification of four stages of the identified patient journey explanation of the contribution of one product made by the life sciences industry at each appropriate stage of the specified patient journey The evidence will be gathered in open-book conditions at appropriate points throughout the unit. Outcome 2 The evidence will be produced in supervised open-book conditions. The evidence will be produced by the learner on their own at an appropriate point during the unit. Evidence could be gathered in response to a series of structured questions, within the time limit of one hour. Outcome 3 The evidence will be produced in supervised open-book conditions. The evidence will be produced by the learner on their own at an appropriate point during the unit. Evidence could be gathered in response to a series of structured questions, within the time limit of one hour. Outcome 4 Learners will be supplied with a brief. The brief will specify the setting within which the risk assessment will be carried out. Learners are required to: identify three hazards explain one risk associated with each hazard identify one control measure for each risk The risk assessment will be carried out in a real or simulated setting under supervision at an appropriate point in the unit. Learners should be supplied with an appropriate template to record the risk assessment. The Assessment Support Pack (ASP) provided for this unit illustrates the standard that should be applied. It contains an investigation pro forma, learner brief, series of structured questions and a risk assessment template. If a centre wishes to design its own assessments for this unit, they should be of a comparable standard. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 15

National unit support notes (cont) Opportunities for e-assessment E-assessment may be appropriate for some assessments in this unit. By e-assessment we mean assessment which is supported by Information and Communication Technology (ICT), such as e-testing or the use of e-portfolios or social software. Centres which wish to use e-assessment must ensure that the national standard is applied to all learner evidence and that conditions of assessment as specified in the evidence requirements are met, regardless of the mode of gathering evidence. The most up-to-date guidance on the use of e-assessment to support SQA s qualifications is available at www.sqa.org.uk/e-assessment. Opportunities for developing Core Skills This unit has the Critical Thinking component of Problem Solving embedded in it. This means that when learners achieve the unit, their Core Skills profile will also be updated to show they have achieved Critical Thinking at SCQF level 4. In this unit learners will be involved in an investigation. There may be opportunities for learners to work with others which would enable them to develop effective communication and interpersonal skills. If the learner uses a computer while undertaking any part of this unit, they will have the opportunity to develop Information and Communication Technology (ICT) skills. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 16

General information for learners This section will help you decide whether this is the unit for you by explaining what the unit is about, what you should know or be able to do before you start, what you will need to do during the unit and opportunities for further learning and employment. In this unit you will investigate the contribution of the life sciences industry in the diagnosis and treatment of illness relating to a specified patient journey. You will also investigate the safety of pharmaceutical products made by the life sciences industry. You will learn about the health and safety responsibilities of employers and employees in the life sciences industry. You will also undertake a risk assessment in relation to production, storage or use of products made by the life sciences industry. The Health Sector includes the National Health Service (NHS) (primary and secondary care), Independent Healthcare, Complementary Therapies, the Life Sciences and Retail Pharmaceutical Industries and the Community and Voluntary Sector. Achievement of this unit gives automatic certification of the Core Skill component, Critical Thinking at SCQF level 4. There may be opportunities for you to work with others which would enable you to develop effective communication and interpersonal skills. If you use a computer while undertaking any part of this unit, you will have the opportunity to develop Information and Communication Technology (ICT) skills. F88F 75 Skills for Work Unit Specification September 2017 (version 4) 17

Administrative information Published: September 2017 (version 4) Superclass: RH History of changes to National unit specification Version Description of change Date 4 Core Skills Component Critical Thinking at SCQF level 4 13/09/17 embedded. 3 Units moved into a new template and re-coded to align with corresponding course 2 code. No change to unit content. Feb 2017 This specification may be reproduced in whole or in part for educational purposes provided that no profit is derived from reproduction and that, if reproduced in part, the source is acknowledged. Additional copies of this unit can be downloaded from SQA s website at www.sqa.org.uk. Note: readers are advised to check SQA s website: www.sqa.org.uk to ensure they are using the most up-to-date version of the unit specification. Scottish Qualifications Authority 2013, 2017 F88F 75 Skills for Work Unit Specification September 2017 (version 4) 18