Introduction to Pharmaceutical Science 1

PHAR61630 Introduction to Pharmaceutical Science 1 30 Semester 1 Postgraduate Taught Level 7 Philip Macdonald Unit coordinator Ruth Barnes Unit coordinator Mark Oldcorne Unit coordinator Emma Davies Unit coordinator Sue Renn Unit coordinator 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 15.0 Professional Foundations of Healthcare and Clinical ScienceProfessional and personal standards as a practicing healthcare professional:<ul><li>Governance and standards of practice</li><li>Role of the Health and Care Professions Council and Academy for Healthcare Science</li><li>Regulatory and statutory bodies</li><li>Legislation and guidance</li><li>Equality.</li></ul>Safety:<ul><li>Health and safety standards</li><li>Patient safety</li><li>Safeguarding.</li></ul>NHS values and constitution:<ul><li>Duty of care</li><li>Duty of candour.</li></ul>Personal responsibility for your practice:<ul><li>Personal judgement</li><li>Challenging inappropriate behaviour and practice</li><li>Scope of practice</li><li>Knowledge of limitations</li><li>Fitness to practice</li><li>Continued professional development.</li></ul>Confidentiality and information governance:<ul><li>Principles</li><li>Application</li><li>Limitations.</li></ul>Informed Consent:<ul><li>Principles</li><li>Application</li><li>Limitations.</li></ul>Personal Professional Practice:<ul><li>Managing your own health and well being</li><li>Personal effectiveness</li><li>Reflective practice</li><li>Principles of problem solving.</li></ul>Inclusive culture:<ul><li>Unconscious bias</li><li>Protected characteristics</li><li>Respecting differences</li><li>Patient autonomy.</li></ul>Patient pathways:<ul><li>The contribution of Healthcare Science</li><li>Multi-professional working.</li></ul>Effective communication:<ul><li>Negotiation and influencing</li><li>Engaging constructive feedback</li><li>Difficult conversations</li><li>Adapting methods of communication appropriately for the audience</li><li>Social media</li><li>Principles of taking and presenting patient histories</li><li>Sharing knowledge and learning styles.</li></ul>Leadership and followership:<ul><li>Principles and styles</li><li>Culture and values</li><li>Effective teams</li><li>Change and resilience.</li></ul>Patient centred care:<ul><li>Principles</li><li>Culture and values</li><li>Personalised medicine</li><li>Social, psychological and emotional context of care</li><li>Public and patient involvement</li><li>Co-creation of healthcare with patients.</li></ul>Introduction to the structure of the NHS and health services:<ul><li>NHS constitution and values</li><li>Governance</li><li>Accountability</li><li>Principles of health economics.</li></ul>Introduction to population health:<ul><li>Public health</li><li>Social care</li><li>Access to healthcare and health inequalities</li><li>Public health interventions and outcomes</li><li>Environmental impact.</li></ul>Introduction to Regulation and QA<ul><li>Discuss the role of the Clinical Scientist in Pharmaceutical Sciences in ensuring the safety of the patient, related to pharmaceutical preparation, manufacture and quality assurance.</li><li>Evaluate error reports relating to pharmaceutical preparation and describe the impact that these have had on pharmacy regulations and guidance.<ul><li>Devonport Incident (1972) – Clothier Report, then Rosenheim report (1973)</li><li>Manchester Incident (1994) – Farwell Report</li><li>Breckenridge Report (1976)</li><li>London (glucose) Incident (2006)</li><li>Intrathecal Incidents – Woods Report (2001)</li><li>Neonatal PN Report (2011)</li><li>Royal Surrey Incident – Toft Report (2012).</li></ul></li><li>Critically evaluate the application of regulatory controls to pharmaceutical technology and quality assurance.<ul><li>Human Medicines Regulations 2012</li><li>The Medicines Act 1968 and its implication to medicines preparation activities, with particular attention on hospital-based work</li Professional Foundations of Healthcare and Clinical ScienceProfessional and personal standards as a practicing healthcare professional:<ul><li>Governance and standards of practice</li><li>Role of the Health and Care Professions Council and Academy for Healthcare Science</li><li>Regulatory and statutory bodies</li><li>Legislation and guidance</li><li>Equality.</li></ul>Safety:<ul><li>Health and safety standards</li><li>Patient safety</li><li>Safeguarding.</li></ul>NHS values and constitution:<ul><li>Duty of care</li><li>Duty of candour.</li></ul>Personal responsibility for your practice:<ul><li>Personal judgement</li><li>Challenging inappropriate behaviour and practice</li><li>Scope of practice</li><li>Knowledge of limitations</li><li>Fitness to practice</li><li>Continued professional development.</li></ul>Confidentiality and information governance:<ul><li>Principles</li><li>Application</li><li>Limitations.</li></ul>Informed Consent:<ul><li>Principles</li><li>Application</li><li>Limitations.</li></ul>Personal Professional Practice:<ul><li>Managing your own health and well being</li><li>Personal effectiveness</li><li>Reflective practice</li><li>Principles of problem solving.</li></ul>Inclusive culture:<ul><li>Unconscious bias</li><li>Protected characteristics</li><li>Respecting differences</li><li>Patient autonomy.</li></ul>Patient pathways:<ul><li>The contribution of Healthcare Science</li><li>Multi-professional working.</li></ul>Effective communication:<ul><li>Negotiation and influencing</li><li>Engaging constructive feedback</li><li>Difficult conversations</li><li>Adapting methods of communication appropriately for the audience</li><li>Social media</li><li>Principles of taking and presenting patient histories</li><li>Sharing knowledge and learning styles.</li></ul>Leadership and followership:<ul><li>Principles and styles</li><li>Culture and values</li><li>Effective teams</li><li>Change and resilience.</li></ul>Patient centred care:<ul><li>Principles</li><li>Culture and values</li><li>Personalised medicine</li><li>Social, psychological and emotional context of care</li><li>Public and patient involvement</li><li>Co-creation of healthcare with patients.</li></ul>Introduction to the structure of the NHS and health services:<ul><li>NHS constitution and values</li><li>Governance</li><li>Accountability</li><li>Principles of health economics.</li></ul>Introduction to population health:<ul><li>Public health</li><li>Social care</li><li>Access to healthcare and health inequalities</li><li>Public health interventions and outcomes</li><li>Environmental impact.</li></ul>Introduction to Regulation and QA<ul><li>Discuss the role of the Clinical Scientist in Pharmaceutical Sciences in ensuring the safety of the patient, related to pharmaceutical preparation, manufacture and quality assurance.</li><li>Evaluate error reports relating to pharmaceutical preparation and describe the impact that these have had on pharmacy regulations and guidance.<ul><li>Devonport Incident (1972) – Clothier Report, then Rosenheim report (1973)</li><li>Manchester Incident (1994) – Farwell Report</li><li>Breckenridge Report (1976)</li><li>London (glucose) Incident (2006)</li><li>Intrathecal Incidents – Woods Report (2001)</li><li>Neonatal PN Report (2011)</li><li>Royal Surrey Incident – Toft Report (2012).</li></ul></li><li>Critically evaluate the application of regulatory controls to pharmaceutical technology and quality assurance.<ul><li>Human Medicines Regulations 2012</li><li>The Medicines Act 1968 and its implication to medicines preparation activities, with particular attention on hospital-based work</li><li>The rules governing medicinal products in the European Community</li><li>European Commission Directives</li><li>Statutory Instruments</li><li>Medicines Act leaflets</li><li>Clinical Trials directive and UK implementation</li><li>Quality management standards (e.g. ISO9000)</li><li>International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)</li><li>Specifications and standards (e.g. British Pharmacopoeia)</li><li>Official reports (e.g. Farwell, Clothier, Rosenheim) of relevance and importance</li><li>Yellow Cover Documents.</li></ul></li><li>Critically appraise the principles of quality assurance and EU GMP and quality management systems.<ul><li>Pharmaceutical Quality Systems</li><li>Risk assessment</li><li>Data Integrity</li><li>Product Quality Review</li><li>Pharmaceutical Quality Systems Review</li><li>Validation and Validation Master Plans</li><li>Change Control</li><li>Specifications and Standards</li><li>Errors and deviations</li><li>CA/PA</li><li>Root cause analysis</li><li>Capacity and contingency planning</li><li>Management of defects and recalls</li><li>Maintenance of facilities and equipment</li><li>Audit and self-inspection</li><li>Contamination control strategies</li><li>Governance and controls assurance, risk management and critical point control analysis.</li></ul></li><li>Critique documentation relating to pharmaceutical preparation, manufacturing, quality assurance and quality control.<ul><li>Document design principles</li><li>Document control</li><li>Data Integrity.</li></ul></li><li>Discuss the health and safety aspects of pharmaceutical technology and quality assurance.<ul><li>COSHH</li><li>Health and Safety at Work Act.</li></ul></li><li>Critique the requirements for outsourcing and purchasing of pharmaceutical products.</li></ul> This unit will provide trainees with context and foundations to their practice in healthcare as a Clinical Scientist. Central to this, the module provides students with an essential grounding in pharmaceutical quality assurance which underpins all GMP activities, and the means to ensure the provision of safe, effective, high quality patient centred care.<ul><li>Students will engage with lecturers and reading material to gain a full understanding of the regulatory framework governing pharmaceutical preparation and manufacture within the NHS, with a fundamental understanding of Pharmaceutical Quality Systems (PQS).</li><li>Trainees will develop a framework of skills and knowledge to evaluate and evolve practice in the context of the wider healthcare landscape. Throughout this module trainees will have opportunities to develop their professional skills.</li></ul>The unit provides the students with an essential grounding in pharmaceutical quality assurance which underpins all GMP activities. Students will engage with lecturers and reading material to gain a full understanding of the regulatory framework governing pharmaceutical preparation and manufacture within the NHS.It will also provide a fundamental understanding of Pharmaceutical Quality Systems (PQS) and the operational benefits and challenges of a robust system. The key documents of a PQS will be defined. Professional Foundations of Healthcare and Clinical ScienceStudents will be able to:<ol><li>Critically evaluate your personal responsibilities, challenges and limitations of your practice as a healthcare scientist in respect to the standards and ethical boundaries including confidentiality, informed consent and safeguarding.</li><li>Critically appraise the contribution of healthcare science and multi-professional working in the provision of patient care within the structure and function of health and social care including effective communication and leadership.</li><li>Critically evaluate the principles of methodologies which ensure the quality of practice in healthcare science.</li><li>Critically evaluate the principles of patient centred care applied to healthcare in the NHS including approaches to managing health which aim to promote wellbeing and reduce health inequalities.</li><li>Critically appraise the requirements for continuous development, evolution and improvement of services and standards in healthcare and innovations which impact healthcare science and healthcare.</li></ol>Introduction to Regulation and QAStudents will be able to:<ol><li>Discuss the role of the Clinical Scientist in Pharmaceutical Sciences in ensuring the safety of the patient, related to pharmaceutical preparation, manufacture and quality assurance.</li><li>Evaluate error reports relating to pharmaceutical preparation and the impact that these have had on pharmacy regulations and guidance.</li><li>Critically evaluate the application of regulatory controls to pharmaceutical technology and quality assurance.</li><li>Critically appraise the principles of quality assurance and EU good manufacturing practice (GMP) and quality management systems.</li><li>Critique documentation relating to pharmaceutical preparation, manufacturing, quality assurance and quality control.</li><li>Discuss the health and safety aspects of pharmaceutical technology and quality assurance.</li><li>Critique the requirements for outsourcing and purchasing of pharmaceutical products.</li></ol> Professional Foundations of Healthcare and Clinical ScienceStudents will be able to:<ol><li>Critically reflect professional and personal behaviour.</li><li>Present scientific and clinical information appropriately.</li><li>Formulate a critical argument.</li><li>Evaluate scientific and clinical information.</li><li>Compare and contrast a range of leadership models.</li><li>Appraise the ethical foundations of professionalism, including critical reflection, and how these relate to the clinical scientist, the patient, the practice of healthcare. science and the wider healthcare environment. </li></ol>Introduction to Regulation and QAStudents will be able to:<ol><li>Follow regulatory standards and guidance. </li><li>Evaluate scientific and clinical literature and present appropriately.</li><li>Critically appraise concepts and measures of quality and quality assurance and their links with the effective and efficient management of resources and improvement of service delivery.</li></ol> Professional Foundations of Healthcare and Clinical ScienceThe students will be able to:<ol><li>Present information clearly in the form of verbal and written reports.</li><li>Communicate complex ideas and arguments in a clear and concise and effective manner to both clinical professional and lay individuals.</li><li>Work effectively as an individual or part of a team. </li><li>Demonstrate Leadership.</li><li>Take a patient history.</li></ol>Introduction to Regulation and QAThe students will be able to:<ol><li>Prepare technical documents; product specifications, investigation reports.</li><li>Prepare risk assessments using a variety of tools and techniques.</li><li>Interpret complex data and report on the findings.</li><li>Prepare for an internal or external audit.</li><li>Identify shortcoming in existing procedure and recommend change.</li><li>Assess the impact of change.</li></ol> Professional Foundations of Healthcare and Clinical ScienceThe students will be able to:<ol><li>Be able to communicate effectively with professional colleagues and service users.</li><li>Consistently operate within sphere of personal competence and level of authority.</li><li>Manage personal workload and objectives to achieve quality of care.</li><li>Work in partnership with colleagues, other professionals, patients and their carers to maximise patient care.</li></ol>Introduction to Regulation and QAThe students will be able to:<ol><li>Read, interpret and apply standards and guidance to working practices.</li><li>Demonstrate professionalism and ethical awareness.</li><li>Communicate effectively with professional colleagues and service users.</li><li>Select and apply appropriate analysis or assessment techniques and tools.</li></ol> <ol><li>A teaching block including face-to-face and online lectures and workshops.</li><li>E-learning: evidence-based learning supported by course notes, video/audio lectures, and discussion boards.</li></ol> 0 Other 100% <figure class="table"><table style="width:500px;" border="1" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Assessment</th><th scope="col">Length</th><th scope="col">Feedback</th><th scope="col">Weighting</th></tr></thead><tbody><tr><td colspan="4">Professional Foundations of Healthcare and Clinical Science</td></tr><tr><td>Reflective written assignment</td><td>3,000 words</td><td>3 weeks after submission deadline</td><td>50%</td></tr><tr><td colspan="4">Regulation and QA</td></tr><tr><td>Discussion board on the e-learning materials</td><td>1,000 words</td><td>3 weeks after submission deadline</td><td>Formative</td></tr><tr><td>Online e-assessment x 5 (at the start of each teaching day)  </td><td>15 minutes</td><td>Online –immediately following quiz</td><td>Formative</td></tr><tr><td>Written assignment (group of 4-6)</td><td>3,000 words</td><td>3 weeks after submission deadline</td><td>25%</td></tr><tr><td>Written assignment (individual reflection)  </td><td>1,000 words</td><td>3 weeks after submission deadline</td><td>10%</td></tr><tr><td>Presentation (group of 4-6)</td><td>20 minutes plus 5 minutes questions</td><td>3 weeks after submission deadline</td><td>15%</td></tr></tbody></table></figure> Provisional marks and feedback for written assignment returned within 3 weeks after submission.Provisional marks and feedback for online e-assessment returned immediately following quiz.Provisional marks and feedback for presentation returned within 3 weeks after submission.Exam marks and final marks returned after ratification at exam board. N Professional Foundations of Healthcare and Clinical Science<ul><li>Donaldson, Liam J. and Paul Rutter, 2017. Donaldsons’ essential public health. (4th Edition).</li><li>Tony Hope; Medical Ethics A Very Short Introduction: Oxford University Press 2004.</li><li>Chloe Baxter, Mark G Brennan, Yvette Coldicott, Maaike Moller; the practical guide to Medical Ethics & Law 2nd Edition: PasTest (2005).</li><li>Barr J and Dowding L (2019) Leadership in Health Care Sage Publications (London) (4th Edition).</li><li><a href="http://www.healthtalkonline.org/" target="_blank">http://www.healthtalkonline.org/</a></li><li><a href="http://www.england.nhs.uk/2013/03/26/nhs-constitution/">http://www.england.nhs.uk/2013/03/26/nhs-constitution/</a></li></ul>Introduction to Regulation and QA<ul><li>Beaney, A. 2016. Quality Assurance of Aseptic Preparation Services (5th Edition). <a href="http://www.rpharms.com/support-pdfs/rps---qaaps-standards-document.pdf">http://www.rpharms.com/support-pdfs/rps---qaaps-standards-document.pdf</a></li><li>EU Legislation – Eudralex, online at <a href="http://ec.europa.eu/health/documents/eudralex/">http://ec.europa.eu/health/documents/eudralex/</a><ul><li>Volume 1 – EU pharmaceutical legislation for medicinal products for human use; </li><li>Volume 2 – Notice to applicants and regulatory guidelines for medicinal products for human use; </li><li>Volume 3 – Scientific guidelines for medicinal products for human use. </li></ul></li><li>Guidelines for good manufacturing practices for medicinal products for human and veterinary use (Volume 4), online at <a href="http://ec.europa.eu/health/documents/eudralex/">http://ec.europa.eu/health/documents/eudralex/</a><ul><li>Chapter 1 – Pharmaceutical Quality System; </li><li>Chapter 4 – Documentation; </li><li>Chapter 8 – Complaints and Product Recall; </li><li>Chapter 9 – Self Inspection; </li><li>Part III – GMP related documents, Site Master File, Q9 Quality Risk Management, Q10 Note for Guidance on Pharmaceutical Quality System. </li></ul></li><li>Explanatory Memorandum to the Human Medicines Regulations 2012 (2012 No. 1916), online at  <a href="http://www.legislation.gov.uk/uksi/2012/1916/pdfs/uksiem_20121916_en.pdf">http://www.legislation.gov.uk/uksi/2012/1916/pdfs/uksiem_20121916_en.pdf</a></li><li>The Medicines Act 1968, online at <a href="http://www.legislation.gov.uk/ukpga/1968/67/pdfs/ukpga_19680067_en.pdf">http://www.legislation.gov.uk/ukpga/1968/67/pdfs/ukpga_19680067_en.pdf</a></li><li>MHRA Guidance Note 14: The supply of unlicensed medicinal products (“specials”), online at <a href="https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials">https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials</a></li><li>Thalidomide and its sequelae, online  at <a href="http://www.sciencedirect.com/science/article/pii/S0140673612604681">http://www.sciencedirect.com/science/article/pii/S0140673612604681</a></li><li>WHO Quality Assurance of Pharmaceuticals (Volume 2), online at <a href="http://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf">http://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf</a></li></ul> Lectures 50 0 250 30 credits comprised of:<ul><li>20 credits - Professional Foundations of Healthcare and Clinical Science</li><li>10 credits - Introduction to Regulation and Quality Assurance</li></ul>Other Scheduled teaching and learning activities include:<ul><li>Lectures and workshops</li><li>Self-directed study (web-based learning and activities on Blackboard)</li><li>Private study</li><li>Catch-up meetings and online Q&A</li><li>Summative assessment</li><li>Formative assessment.</li></ul>