| CODE | CPH5406 | ||||||||
| TITLE | Risk Assessment and Management in the Clinical Pharmacotoxicology Setting | ||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||
| MQF LEVEL | 7 | ||||||||
| ECTS CREDITS | 5 | ||||||||
| DEPARTMENT | Clinical Pharmacology and Therapeutics | ||||||||
| DESCRIPTION | Pharmacotoxicological risk assessment is firmly based on toxicological sciences with input from other public health disciplines. This study-unit will provide an overview of the methodology required for the different steps in risk assessment (hazard identification, hazard characterisation, exposure assessment, risk characterisation); uncertainty in risk assessment; use of Adverse Outcome Pathways and mode of action frameworks in risk assessment. The applications of these principles will be discussed in the context of management and decision making in the context of pharmatoxicological events. Study-unit Aims: This study-unit aims to: - To review the risk paradigm components of hazard assessment, dose-response analysis, exposure assessment, and risk characterization, and the toxicological concepts on which they are based; - To provide approaches to managing risk, such as the precautionary principle; - To appreciate newer challenges ranging from nanotechnology to the health impacts of global climate change; - To provide a more systematic thinking on how best to protect human health and the environment. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - Apply risk-management principles by identifying, assessing and reporting hazards, and potential risks in complex and multi/inter-disciplinary healthcare and other settings; - Outline how to (i) identify the risk; (ii) assess the frequency and severity of the risk; (iii) reduce or eliminate the risk; and (iv) assess the costs saved by reducing the risk or the costs if the risk eventuates; - Appreciate the role of human factors and operating systems when reviewing alerts in risk management related to toxicology; - Integrate knowledge and skills on information systems to support patient safety and clinical risk management. 2. Skills By the end of the study-unit the student will be able to: - Apply risk paradigm components of hazard assessment, dose-response analysis, exposure assessment, and risk characterization, and the toxicological concepts on which they are based; - Chose approaches to managing risk, such as the precautionary principle; - Explain newer challenges ranging from nanotechnology to the health impacts of global climate change; - Plan information systems to support patient safety and clinical risk management. Main Text/s and any supplementary readings: Main readings - Helmut Greim, Robert Snyder Toxicology and Risk Assessment A Comprehensive Introduction. 2018 2nd edition Wiley 978-1119135913 - Torres, Jose, Bobst, Sol Toxicological Risk Assessment for Beginners 2015 Springer ISBN 978-3-319-12751-4 - Ira S Richards Marie Bourgeois. Principles and Practice of Toxicology in Public Health - 2nd edition 2014 Jones and Bartlett Publishers ISBN 9781449645267. Supplementary readings - Lewis Nelson, Robert Hoffman,Mary Ann Howland, Neal Lewin), Lewis Goldfrank, Silas W Smith Goldfrank's toxicologic emergencies. 11th edition New York McGraw Hill Medical 2019 ISBN 978-1259859618 (Health Sciences Library Reference RA1224.5 .G6 2019) - Klaassen, Curtis D. Casarett and Doull's toxicology: the basic science of poisons. 9th edition New York McGraw-Hill Education 2019 ISBN 978-1-259-86374-5 - Curtis Klaassen, John Watkins. Casarett & Doull's Essentials of Toxicology, Third Edition. 2015. McGraw Hill ISBN 978-0071847087. Journals (available in Main Library and Health Sciences Library and as e-journals subscribed by UM) Toxicology Environmental toxicology Journal of toxicology Comments on toxicology Archives of toxicology International journal of toxicology Critical reviews in toxicology Toxicology mechanisms and methods Toxicology and applied pharmacology Environmental toxicology and pharmacology Chemical research in toxicology Forensic toxicology. |
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| STUDY-UNIT TYPE | Lecture and Independent Study | ||||||||
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| LECTURER/S | Robert Geller Ziad Kazzi Audrey Ann Anastasi Sophie Briffa Ingrid Busuttil Derian Debattista Suzanne Magri Demajo Janet Mifsud (Co-ord.) |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2024/5. It may be subject to change in subsequent years. |
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