PM2A2-Therapeutics and medicines optimisation A2: Molecules and Medicines

Module Provider: Pharmacy
Number of credits: 30 [15 ECTS credits]
Level:5
Terms in which taught: Autumn / Spring / Summer module
Pre-requisites: PM1A Fundamentals of Physiology and PM1B Medicines Discovery, Design, Development and Delivery and PM1C Introduction to Professionalism and Practice
Non-modular pre-requisites:
Co-requisites: PM2B Therapeutics and Medicines Optimisation B: A Journey Through the GI Tract and PM2C2 Therapeutics and medicines optimisation C2: Therapeutics and Patient care and PM2D Delivering Pharmacy Services
Modules excluded:
Current from: 2023/4

Module Convenor: Dr Sam Bizley
Email: s.c.bizley@reading.ac.uk

Type of module:

Summary module description:
PM2A2 (30 credits): With an emphasis on the therapeutic areas of infection and infection control, this module takes the student through the journey of drug discovery, drug action, design of medicines and patient-centred care. The module looks at how chemical structure impacts on activity and on medicine stability, choice of dosage form and advice given to patients by practising pharmacists. Drug design and discovery is discussed for both synthetic and natural products and includes metal-based medicines. Students are taught about the safe handling of materials, including aseptic preparations and quality assurance. Basic statistics is taught and its relevance exemplified with respect to understanding clinical trial data and research papers. Analytical science skills, initially introduced in Part 1, are developed further to introduce more advanced analytical methods and their use in drug discovery and quality control processes. Practical classes cover a breadth of skills from across all cognate disciplines and our Part 2 practical class programme is fully integrated across all modules.

Aims:
This module aims to provide students with an introduction to aspects of medicines development. Students will gain an understanding of drug design, modes of action on a molecular level and drug development using selected drug examples of disease states taught in Part 2. As part of this module, students will also gain an understanding of how the quality of medicines can be assured and controlled. The module aims to teach core science and practice concepts as listed in the summary above using an integrated learning approach.

Assessable learning outcomes:

Students will be able to:

• Discuss ethical dilemmas and respond in accordance with relevant codes of conduct in relation to clinical trials


• Demonstrate how the science of pharmacy is applied in the design and development of drugs by analysing case studies in the area of drug discovery


• Use peer review and assessment in the training of other members of the team within their practical assignment


• Explain the basic concepts of statistics. Use statistics to inform experimental design and critical assessment of evidence. Use common statistical tests to determine significant differences between data sets.


• Access and critically evaluate evidence to support the safe use of medicines


• Critically evaluate a recent research article • Apply knowledge of pharmacy related policies within the design of practical experiments


• Identify and employ appropriate diagnostic orphysiological testing techniques in order to monitor and promote health


• Instruct patients in the safe and effective use and storage of their medicines and devices using science knowledge to aid communication


• Explain the terms “Quality Assurance” and “Quality Control” and how this supports the safe provision of medicines in line with legal requirements and best professional practice


• Ensure the ingredients used to produce medicines comply with quality standards by applying knowledge gained in the problem-based practical classes


• Apply pharmaceutical principles to formulation and preparation by integrating knowledge from PM2B into the practical assignment


• Analyse prescriptions (from community and hospital settings)
  
  
  
  • Assess for legal and contractual validity and clarity
  
  
  • Assess for clinical appropriateness
  
  
  • Where necessary, make suggestions for modifications to maximise outcomes
  
  
  
  


• Undertake pharmaceutical calculations


• Develop, manage and maintain quality records as part of Quality Assurance


• Explain how to safely store and distribute medicines and pharmaceutical products


• Undertake risk assessments and explain their use in minimizing risk associated with practical/laboratory work


• Take responsibility for Health and Safety and work as teams within the practical assignment


• Explain the role of pharmacy technical services and the processes and techniques used in the aseptic preparation of medicinal products


• Use a variety of analytical methods and explain their application as diagnostic testing techniques

Additional outcomes:

Outline content:

• Introduction to the module: The role of chemistry within the context of the design of medicines and provision of information to patients with the emphasis on the therapeutic areas covered in this module and in Part 2 in general.


• Case studies in drug design and drug development to market: Using appropriate molecular examples methods of drug discovery will be discussed that link to drugs and drug classes discussed through years 1 and 2 including infection control.


• An introduction to drug discovery covering ‘me-too’ compounds, screening for natural products, mineral drugs, ethnopharmacology, emphasizing the difference between a single chemical entity (drug) of natural origin and a plant extract (herbal medicine) and its influence on therapeutic activity.


• The role of synthesis, combinatorial methods, high throughput screening and molecular modelling/computational design


• The use of bioisosteres in drug development and the use of feedback from pharmacokinetics data.


• Molecules of medical significance: An overview of the diversity of molecular structures that are used as therapeutic agents with reference drugs and drug classes introduced in years 1 and 2 and infection control.


• Knowledge and understanding of common methods used in their synthesis of peptides, carbohydrates and nucleic acids (and their analogues), and heterocycles, including the concepts of pKa and enolate chemistry.


• Knowledge and understanding of the mechanisms of action, uses, and limitations of the major groups of metallotherapeutic drugs and diagnostic agents, with reference to the key issues relating to the quality assurance, handling, and reconstitution of drugs and diagnostic agents.


• With the use of case studies it will be discussed how the chemical aspects of medicines impacts on their clinical performance and where a knowledge of molecular properties of the medicine formulation is needed to fully support the patient.


• The importance of chemical interactions and drug development tools will be emphasised and relevant biological pathways will be discussed, including the concept of drug interactions from a clinical point of view.


• Mode of Action at the Molecular Level: The mode of action of pharmaceutical compounds with reference to infection control, and the chemical basis behind their therapeutic use will be presented. This will include a discussion of the mode of action of selected drugs as seem from the point of view of a chemist, a pharmacologist, and how the knowledge is used by a pharmacist both within an industrial and practice setting.


• Introduction to Infection Control: This includes an introduction to infection control and covers topics such as aetiology, symptoms and infection transmission of infections. The management of common bacterial, viral, fungal and parasitic conditions are discussed. Antibacterial agent chemistry, formulation and route of administration, mechanism of action and clinical aspects of their use, to control infection are introduced (e.g. disinfectants). Mechanisms that underpin bacterial resistance to antibiotics and discuss the role of pharmacists in reducing the spread of resistant organisms are discussed. Methods of preventing microbial contamination of products are discussed.


• The industrial pharmacist: Quality assurance and quality control in the process of medicine manufacturing: These sessions develop students’ analytical skills and provide students with knowledge and skills in manufacturing methods with reference to GIT, renal, cardiovascular and respiratory disease states, with the emphasis on quality assurance and quality control. Students will learn about :
  
  
  
  • Roles that pharmacists may undertake within the pharmaceutical industry o Quality assurance: the use of Pharmacopoeial monographs.
  
  
  • Statistics and their correct use in a pharmacy and scientific setting.
  
  
  
  

Brief description of teaching and learning methods:

Teaching and learning methods are through lectures, workshops, seminars, practical classes, problem based learning and directed private study. Critical opinion article: Students will write a short 2-page article critically assessing a recent research article. This activity will aid the students to develop their critical skills and their ability to succinctly discuss a topic. Practical classes involve techniques taught in all Part 2 modules and use problem-based learning. Two two-hour sessions are timetabled to support students in preparation of their activity (Certificate of Analysis) for their Personal and Academic Development (PAD) portfolio.

Contact hours:

��	Autumn	Spring	Summer
Lectures	40	23	10
Seminars	8	4
Tutorials	2	5
Practicals classes and workshops	8	10
Guided independent study:	��	��	��
�� �� Wider reading (independent)	5	5	10
�� �� Wider reading (directed)	10	10
�� �� Exam revision/preparation	10	10	30
�� �� Advance preparation for classes	5	5
�� �� Preparation for tutorials		20
�� �� Preparation of practical report	10	10
�� �� Completion of formative assessment tasks	5	5
�� �� Revision and preparation	5	5
�� �� Group study tasks	10	10
�� �� Reflection	2	2	6
��	��	��	��
Total hours by term	120	124	56
��	��	��	��
Total hours for module	300

Summative Assessment Methods:

Method	Percentage
Written exam	70
Report	30

Summative assessment- Examinations:

There will be a three-hour examination.

The examination for this module will require a narrowly defined time window and is likely to be held in a dedicated exam venue.

Summative assessment- Coursework and in-class tests:

1 x API chemical analysis report (12%)

1 x Formulation physical testing report (9%)

1 x Pharmaceutical care-plan test (9%)

Formative assessment methods:

Formative assessment and associated feedback form a large proportion of the module, tutorials and problem classes will offer in class verbal feedback. The module also contains open and closed book tests with verbal feedback to the group to help them prepare for the final examination.

Critical opinion article

Penalties for late submission:

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

• 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 five working days;
• where the piece of work is submitted more than five working days after the original deadline (or any formally agreed extension to the deadline): a mark of zero will be recorded.

The University policy statement on penalties for late submission can be found at: /cqsd/-/media/project/functions/cqsd/documents/cqsd-old-site-documents/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.

Assessment requirements for a pass:
Students must obtain an overall module mark of 40% and obtain at least 40% in the written examination.

Reassessment arrangements:

Re-examination of the end of year exam will be in August and will be by written examination.



Failed coursework may be reassessed by an alternative piece of work, before or during the August examination period.��

Additional Costs (specified where applicable):

1. Required text books:


2. Specialist equipment or materials:


3. Specialist clothing, footwear or headgear:


4. Printing and binding:


5. Computers and devices with a particular specification:


6. Travel, accommodation and subsistence:

Last updated: 30 March 2023