PM1B-Medicines Discovery, Design, Development and Delivery

Module Provider: Pharmacy
Number of credits: 50 [25 ECTS credits]
Level:4
Terms in which taught: Autumn / Spring / Summer module
Pre-requisites:
Non-modular pre-requisites:
Co-requisites: PM1A Fundamentals of Physiology and PM1C Introduction to Professionalism and Practice
Modules excluded:
Current from: 2022/3

Module Convenor: Dr John Brazier
Email: j.a.brazier@reading.ac.uk

Type of module:

Summary module description:
This module introduces students to the chemical and pharmaceutical science concepts that underpin the design and formulation of medicines; how medicines are sourced, developed and manufactured, and how the quality of these medicines is assured, as part of ensuring patient safety. This includes an introduction to natural and synthetic products, structural and synthetic chemistry for organic and inorganic drug discovery, and aspects affecting the physical and chemical properties of drugs. Students gain practical skills in the extemporaneous formulation of medicines and performing pharmaceutical calculations. The theme of quality and safety in the manufacture of medicines and their delivery to the patient is continued as students are introduced to the processes of dispensing medicines, using knowledge and skills relating to prescription assessment and patient consultation developed in PM1C.

Aims:
To introduce students to the fundamental concepts of science that underpin the discovery, design, development and delivery of drugs. The module will develop students£ understanding of where drugs come from, their development in terms of drug formulation, and the importance of quality and safety in these processes and the dispensing of the final medicinal product to the patient. Students will also be able to apply consultation skills developed in PM1C to provide patients with advice about their prescribed medicines.

Assessable learning outcomes:
Students should be able to:
£ Identify a range of sources of medicinal products.
£ Explain the fundamentals of molecular structure and chemical properties and how this is important to the development and delivery of drugs.
£ Apply fundamental principles of reactivity to the design and development of molecules for use in medicinal products.
£ Describe how the chemical properties of molecules are linked to their formulation into medicines.
£ Describe and use basic analytical techniques integral to the quantitative and qualitative analysis of medicinal products.
£ Apply simple mathematical expressions within pharmaceutical calculations, including those relevant to extemporaneous dispensing, dosing, administration rates and drug pharmacokinetics.
£ Use a range of practical skills related to drug design and development, along with formulation and dispensing.
£ Analyse prescriptions from community settings and take appropriate action to rectify problems:
o assess for legal and contractual validity and clarity;
o assess for clinical appropriateness;
o where necessary, make suggestions for modifications to maximise outcomes.
£ Accurately label and dispense community pharmacy-based prescriptions, with appropriate processing of documentation.
£ Extemporaneously prepare medicines:
o identify required formulae using appropriate reference sources;
o select appropriate constituent ingredientsand calculate necessary quantities;
o follow safe and effective work processes;
o package the preparation appropriately;
o make appropriate records of the preparation.
£ Write and follow standard operating procedures in dispensing and the production of extemporaneous preparations.
£ Conduct a self-check to identify errors in extemporaneous preparation and dispensing, reporting and reflecting upon any errors made to support prevention of their recurrence.
£Conduct effective consultations to support patients in the safe and effective use of their prescribed medicines.

Additional outcomes:
Students should develop:
- independent learning skills;
- reflective skills through the development of the Personal & Academic Development portfolio (e.g. inclusion of reflections on errors made during dispensing and extemporaneous preparation);
- problem solving skills;
- communication and time management skills;
- IT skills, including the use of pharmacy dispensing software;
- professional behaviour.

Outline content:
Outline content:
- Introduction to the history of medicines and drug discovery;
- Development of both organic and inorganic based medicines from natural products to synthetic molecules.

Structure and bonding
-Introduction to bonding within medicines, covering the periodic table and electronic configuration, electronegativity, shape of orbitals and formation of bonds.

Stereochemistry
-Introduction to 3 dimensional structures of medicines, and the importance of stereochemistry.

Structure and function of medicines
-Introduction to the importance of structure of drug molecules to their mechanism of action. Structure of functional groups present in common drug molecules, and their potential interactions with biomolecules (linked with the structure of biomolecules within PM1A). Understanding of molecular interactions to agonist/antagonist activity etc.

Design of drug molecules
-Understanding fundamental reaction mechanisms, and the use of curved arrows. Knowledge of the reactivity of pharmaceutically important functional groups, and how this can be utilised within drug design.

Pharmaceutical science in medicine development
-Introduction to the relationship between molecular properties and physicochemical properties of drugs. Understanding thermodynamics and kinetics of drug molecules, chemical equilibria and pKa/pH, and how this relates to development of formulations. Investigating ways of using solubility, interfacial phenomena and colloidal formation in developing suitable strategies to deliver drugs in the most beneficial way. Understanding the science behind the preparation of liquids, suspensions and ointments.

Foundations in numeracy and pharmaceutical calculations
-Consolidation of basic mathematical principles within a pharmacy context.

Analysis of molecules for medicinal use
-Introduction to quality assurance, the British Pharmacopoeia and basic analytical techniques including both qualitative and quantitative approaches.

Delivering medicines to the patient
-Introduction to dispensing, labelling and understanding quality and safety related to these procedures (linking to clinical governance in PM1C)

Introduction to independent learning and reflection
-Understanding the importance of independent learning, and how to undertake reflective statements for use in the development portfolio.

Practical aspects of medicine design, development and delivery
-Introduction to practical chemistry skills, formulation and dispensing. Developing skills and knowledge of drug design and synthesis. Extemporaneous preparation of pharmaceutical suspensions (including those made from licensed tablet and capsule formulations), solutions, creams and ointments. Implications of extemporaneous preparation in relation to patient safety, liability and responsibility. Safe working practice within laboratories and the workplace, including the importance of standard operating procedures and accurate documentation. Knowledge and skills learnt in PM1C regarding prescription assessment and dispensing processes will be applied to the assembly of prescribed licensed medicinal products and extemporaneously prepared products, and instructing patients in the safe and effective use of their medicines through effective consultations.

Integrated workshops and tutorials
-Throughout the module, the students will receive workshops and tutorials to emphasise the links between subjects and the relevance to pharmacy. These sessions will provide the formative assessment and feedback that is integral to the assessment strategy of this module, and will be used to encourage independent learning.

Global context:
This module will develop core knowledge, and show how this knowledge is relevant to the role of a pharmacist. The student will need to develop independent learning skills within this module to progress into Part 2, but should then be suitably equipped to tackle the rigour of an MPharm degree. The topics covered here will link into all 4 modules of Part 2.

Brief description of teaching and learning methods:
Lectures, tutorials, workshops, directed private study, practical classes, preparation of written reports.
4-5 one-hour lectures per week with one tutorial / workshop every week. In addition, students will attend practical sessions over the duration of the module. The workshops will provide the students with the opportunity to work in small groups and develop problem solving skills, with guidance being provided by members of staff. The tutorials will allow students to work independently to solve problems and then present answers in a coherent fashion through written and oral reports. The practical sessions will range from laboratory sessions providing training in basic practical skills as well as in some analytical and purification techniques, in which the importance of COSHH regulations will also be emphasised. Extemporaneous formulation and dispensing classes will develop students£ ability to prepare and safely dispense medicinal products.

Contact hours:

	Autumn	Spring	Summer
Lectures	58	24
Seminars	37	15	15
Tutorials	2	4
Practicals classes and workshops	14	16
Guided independent study:
Exam revision/preparation	20	30
Advance preparation for classes	10	10
Preparation for tutorials	10	10
Preparation for seminars	10	20
Revision and preparation	30	50	70
Reflection	15	30
Total hours by term	206	209	85
Total hours for module	500

Summative Assessment Methods:

Method	Percentage
Written exam	70
Practical skills assessment	20
Class test administered by School	10

Summative assessment- Examinations:

3 hours (written 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:
Summative assessment details:
Knowledge gained throughout the module will be assessed in an end of module exam during the summer exam period.
Pharmaceutical calculations are assessed in a calculations test with a 70% pass mark that represents 10% of the module mark.
A structured practical skills assessment will be carried out to assess laboratory, formulation, dispensing and communication skills (taught as part of PM1C) along with important safety implications and the use of standard operating procedures. This assessment will focus on integration of the practical science with the task of safely dispensing and counselling the patient on the correct use of a medicinal product.

Formative assessment methods:
Students will attend tutorials and workshops. Attendance is compulsory at both.
Tutorial deadlines will be within one week of the tutorial session, and written and verbal feedback will be provided during the timetabled session.
Diagnostic tests will be periodically released through Blackboard, to inform the students on their progress, and help them develop and update their learning needs analysis.

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: https://www.reading.ac.uk/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:
A mark of 40% in the module overall and a mark of 40% in the written exam component. The pharmaceutical calculations test must be passed at 70%.

Reassessment arrangements:
Reassessment of the written exam component is by re-examination in August only, with a pass mark of 40%.
Students who pass the module but fail the pharmaceutical calculations test will be permitted to re-sit the test, before or during the August examination period.

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

Additional Costs (specified where applicable):

Required text books: The University library has a large number of text books and specialised reading material. There are also an excellent number of e-books available to the students. There might be core text books, which the students wish to purchase at varying costs.

Specialist clothing, footwear or headgear: Lab coat and safety glasses during some practical classes. The lab coats are available to purchase during first week of term if the student does not have one, and safety glasses are provided free of charge.

Last updated: 22 September 2022