PM3CSIP: Clinical and Societal Impact of Pharmacology

Module code: PM3CSIP

Module provider: Pharmacy; School of Chemistry, Food and Pharmacy

Credits: 40

Level: Level 3 (Honours)

When you'll be taught: Semester 1 / 2

Module convenor: Dr Darius Widera, email: d.widera@reading.ac.uk

Pre-requisite module(s): This module is only available to Associated Pharmacy students. (Open)

Co-requisite module(s): IN THE SAME YEAR AS TAKING THIS MODULE YOU MUST TAKE PM3RP (Compulsory)

Pre-requisite or Co-requisite module(s):

Module(s) excluded:

Placement information: NA

Academic year: 2024/5

Available to visiting students: No

Talis reading list: Yes

Last updated: 21 May 2024

Overview

Module aims and purpose

This module expands from core principles of drug action and molecular drug target modules in Part 1 and Part 2 to focus on clinical aspects of drug discovery and translation from preclinical studies to the human situation and associated potential human toxicology. The module focuses on molecular drug targets in the peripheral and central nervous system, the musculoskeletal system and in cancer and pain. It will also provide advanced knowledge on drug pharmacokinetics, drug development and using higher risk drugs (e.g. for cancer, pain), or novel therapies (e.g. gene therapy).  In addition, students will develop a knowledge of so-called ‘lifestyle’ drugs and the effects misuse of these drugs can have on human physiology. The module will also expand the knowledge on drugs used in healthcare and how organisations such as the National Institute for Health and Care Excellence (NICE) provide guidelines for the use of medicines. The module will also consider the basic principles of toxicology, poisons from animals, microorganisms and plants, how chemicals adversely affect embryonic development, and the principles behind the use of pharmacology/toxicology in the development of new medicines. The module will be taught with the aid of lectures, case studies, practicals and workshops which will provide students with opportunities to take part to an ‘experimental’ clinical trial, handle and analyse the data obtained as well as being able to design their own study. This module also covers the ethical principles of research, including clinical trials (design, implementation, and reporting) and the principles of reduction, refinement, and replacement in the use of animals in research. The module will also cover how pharmacology relates to social challenges and public health; the role of the pharmaceutical industry; the impact of pharmacology on patient care and regulation with respect to the safe and effective use of medicines; the pharmacoeconomics of drug provision; and an appreciation of the value of public engagement and outreach. 

Aims 

The module aims to provide further insight into clinical aspects of drug discovery and translation from preclinical studies to the human situation. The module aims to: 

• Introduce students to the molecular drug targets in the peripheral and central nervous system, the musculoskeletal system, and in cancer and pain 
• Further knowledge and understanding of how the body handles drugs and what factors affect pharmacokinetic processes  
• Provide knowledge and understanding on how drugs are discovered and developed as medicines and thus how trials are designed, research data generated, handled, analysed and interpreted. How information from clinical trials and drug development is used to guide the use of medicines for patients in clinical practice. 
• To provide students with opportunities to design and take part in an ‘experimental’ clinical trial, generate, handle, analyse and interpret data obtained.  
• To familiarize students with current concepts of mechanisms by which cells are killed by toxic chemicals with particular emphasis on drugs. 
• To develop in students' knowledge and understanding in toxicology in relation to drug development 
• To provide students with a deeper understanding of how pharmacology plays a major role in today’s society, in terms of economic impact and health and well-being The module will focus on the ethical questions that this input raises including the use of animals, pharmacoeconomic questions, and safe testing and use of pharmacological products to contribute to public health. The module will also consider aspects of scientific integrity, following ethical working practices and developing a willingness to engage with developments across science, the pharmaceutical industry and healthcare. 

Module learning outcomes

By the end of the module, it is expected that students will be able to:

1. Describe molecular drug targets in the peripheral and central nervous system, the musculoskeletal system, musculoskeletal system and cancer and pain
2. Discuss how drugs are discovered and developed as medicines and thus how clinical trials including those using higher risk drugs (e.g. for cancer, pain) and novel therapies (e.g. gene therapy) are designed, research data generated, handled, analysed and interpreted
3. Discuss and debate principles of reduction, refinement, and replacement in the use of animals in research and the ethical use of animals in research
4. Discuss and debate how pharmacology relates to social challenges and public health
5. Understand the impact of pharmacology on patient care with respect to the safe and effective use of medicines and vaccines
   

Module content

• Molecular drug targets in the peripheral and central nervous system, the musculoskeletal system, and cancer and pain 
• Factors including age, pregnancy, diseases and genetics that affect drugs’ pharmacokinetic, effects and side effects.  
• Neonatology & Paediatrics: Diseases affecting the new-born/prematurely born; drug use and pharmaceutical care considerations in neonates and children; how drugs are tested in children and pregnant women. 
• Main multi-organ disorders of old age; co-morbidities in elderly and multi-organ disease:   
• Cancer: Detecting and staging metastatic cancer; routes of metastasis; resistance to chemo- and radiotherapy; emerging anti-cancer drug discovery programmes, advances in personalised medicines, the localized delivery of anti-cancer agents, anti-angiogenic agents 
• Novel trial designs, trials using high risk drugs (e.g. for cancer, pain), trials using novel therapies (e.g. nanomedicine, cancer vaccines, gene therapy) 
• Effects of drugs of abuse on human physiology 
• Genetics, responses to drugs and personalised medicine  
• Hot topics in clinical pharmacology and advances in therapeutics 
• Key stages in clinical trials and the importance of pharmacology in these  
• Clinical trial design, data handling collection and interpretation  
• Processes and regulation required to get a drug to market and how data about drugs is processed and used to decide how to treat patients in healthcare 
• Basic principles of toxicology including common adverse drug reactions and cellular effects of chemical poisons  
• Mode of action of animal, microorganism and plant toxins acting in humans. 
• Relationship between safety toxicology studies and drug development  
• The ethical use of animals in research  
• Reduction, refinement, and replacement in the use of animals in research  
• The societal impact of the pharmaceutical industry and how pharmacology relates to social challenges and public health. 
• The impact of pharmacology on patient care with respect to the safe and effective use of medicines. 
• An appreciation of the value of public engagement and outreach.  
• Personal development in terms of development of the skills for lifelong learning e.g. independence, time management, organisation and planning, initiative, knowledge transfer; and the ability to self-assess performance will also be covered.  
• Study skills in relation to pharmacology

Student will also develop the following: 

Working in small groups during laboratory practical classes and workshops students will develop self-learning, time management & communication skills. Students will learn how communicate effectively within a team and communicate findings to a wider audience. Students will also improve team-working skills, such as leadership, motivating and working with others, and contribute to identifying the learning and development needs of team members through coaching and feedback. 

Working in small groups during debates and engaging in a multidisciplinary team-based working will: 

• Improve team-working skills, such as leadership, motivating and working with others, and contribute to identifying the learning and development needs of team members through coaching and feedback 
• Communicate effectively within a team and communicate findings to a wider audience. 
• Improve self-directed learning 

Structure

Teaching and learning methods

The course content will be provided through a mixture of formal lectures, practical sessions, supported by interactive tutorial sessions. Attendance to all teaching sessions is required and poor attendance will be recorded in the student’s personal file. 

Study hours

At least 93 hours of scheduled teaching and learning activities will be delivered in person, with the remaining hours for scheduled and self-scheduled teaching and learning activities delivered either in person or online. You will receive further details about how these hours will be delivered before the start of the module.

Please note the independent study hours above are notional numbers of hours; each student will approach studying in different ways. We would advise you to reflect on your learning and the number of hours you are allocating to these tasks.

Semester 1 The hours in this column may include hours during the Christmas holiday period.

Semester 2 The hours in this column may include hours during the Easter holiday period.

Summer The hours in this column will take place during the summer holidays and may be at the start and/or end of the module.

Assessment

Requirements for a pass

Students need to achieve an overall module mark of 40% to pass this module.

Summative assessment

Penalties for late submission of summative assessment

The Support Centres will apply the following penalties for work submitted late:

Assessments with numerical marks

• where the piece of work is submitted after the original deadline (or any formally agreed extension to the deadline): 10% of the total marks available for that piece of work will be deducted from the mark for each working day (or part thereof) following the deadline up to a total of three working days;
• the mark awarded due to the imposition of the penalty shall not fall below the threshold pass mark, namely 40% in the case of modules at Levels 4-6 (i.e. undergraduate modules for Parts 1-3) and 50% in the case of Level 7 modules offered as part of an Integrated Masters or taught postgraduate degree programme;
• where the piece of work is awarded a mark below the threshold pass mark prior to any penalty being imposed, and is submitted up to three working days after the original deadline (or any formally agreed extension to the deadline), no penalty shall be imposed;
• where the piece of work is submitted more than three working days after the original deadline (or any formally agreed extension to the deadline): a mark of zero will be recorded.

Assessments marked Pass/Fail

• where the piece of work is submitted within three working days of the deadline (or any formally agreed extension of the deadline): no penalty will be applied;
• where the piece of work is submitted more than three working days after the original deadline (or any formally agreed extension of the deadline): a grade of Fail will be awarded.

The University policy statement on penalties for late submission can be found at: https://www.reading.ac.uk/cqsd/-/media/project/functions/cqsd/documents/qap/penaltiesforlatesubmission.pdf

You are strongly advised to ensure that coursework is submitted by the relevant deadline. You should note that it is advisable to submit work in an unfinished state rather than to fail to submit any work.

Formative assessment

Formative assessment is any task or activity which creates feedback (or feedforward) for you about your learning, but which does not contribute towards your overall module mark.

Formative assessment and associated feedback form a large proportion of the module, with students being provided with workshops, tutorials and online assessments to prepare for the final examination. Formative assessment is provided through compulsory small group tutorials and workshops, instructor-, self-, and peer-led assessment and feedback. 

Reassessment

Additional costs