Course Title: Extemporaneous Compounding and the Quality Control of Medicines

Part A: Course Overview

Course Title: Extemporaneous Compounding and the Quality Control of Medicines

Credit Points: 12.00

Terms

Course Code

Campus

Career

School

Learning Mode

Teaching Period(s)

CHEM1291

Bundoora Campus

Undergraduate

173H School of Health and Biomed

Face-to-Face

Sem 2 2018,
Sem 2 2019,
Sem 2 2020,
Sem 2 2021

Course Coordinator: Dr Ayman Allahham

Course Coordinator Phone: +61 3 9925 7998

Course Coordinator Email: ayman.allahham@rmit.edu.au

Course Coordinator Location: 201.08.025


Pre-requisite Courses and Assumed Knowledge and Capabilities

Required prior study (Pre-requisites)



Course Description

You will advance your knowledge and understanding of essential and advanced medicine formulations considered in PHAR1016 and PHAR1013 to the evaluation, analysis and extemporaneous production of medicines, drugs and excipients.

You will practice the extemporaneous preparation of basic and advanced formulations including pharmacopoeial and non-pharmacopoeial formulations encountered in pharmacy practice, together with requisite documentation, labelling, packaging and counselling requirements. You will consider the manufacture of sterile products, parenteral nutrition and cytotoxic formulations and apply the concepts of regulatory governance, pharmaceutical quality control and good manufacturing practice. You will study the analysis of formulations and their components and relate these to the clinical performance of medicines.

Please note that if you take this course for a bachelor honours program, your overall mark in this course will be one of the course marks that will be used to calculate the weighted average mark (WAM) that will determine your award level.

This applies to students who commence enrolment in a bachelor honours program from 1 January 2016 onwards. See the WAM information web page for more information (http://www1.rmit.edu.au/browse;ID=eyj5c0mo77631).


Objectives/Learning Outcomes/Capability Development

This course contributes to the following program learning outcomes of BH102 - Bachelor of Pharmacy (Hons):

  • PLO 2 Research, critically evaluate and apply evidence in professional practice.
  • PLO 5 Communicate effectively for the delivery of patient-centred care.
  • PLO 7 Apply pharmaceutical, medication and health knowledge and skills to improve patient and population health.
  • PLO 8 Formulate, prepare and supply medicines and therapeutic products.


On successful completion of this course, you should be able to:

  1. Prepare extemporaneous formulations including pharmacopoeial formulations of the APF/BP/EP/USP and non-pharmacopoeial formulations to a standard suitable for administration to a patient including requisite documentation, labelling, packaging and the provision of advice to the patient.
  2. Investigate, evaluate and report the physical characteristics of formulations including release kinetics and relate these to quality control and preformulation requirements.
  3. Relate the application of quality control, quality assurance and the principles of good manufacturing practice to regulation of medicine production in Australia and internationally.
  4. Relate the formulation and preparation of cytotoxic medicines and sterile products to environmental control, risk assessment and the clinical outcome for the patient.


Overview of Learning Activities

This course is presented using a blended learning approach. Key concepts will be presented using flexible learning resources supported by face-to-face workshops or webinars that are integrated with tutorial exercises and practical classes. Practical and tutorial classes will extend your understanding of the extemporaneous production of medicines (including the requisite documentation of the production process, labelling, packaging, and the provision of appropriate advice to the patient) and the analysis of pharmaceutical products. You are expected to supplement these activities with recommended readings and private study.

The learning activities in this course include:

  • Flexible learning resources
  • Tutorials
  • Workshops
  • Practical classes


Overview of Learning Resources

Course materials are distributed online through myRMIT, these may include:

  • Digitized readings.
  • Study notes.
  • Video recordings.
  • Webinars
  • Feedback to assessment tasks and formative exercises.
  • Links to external internet sites.
  • Access to RMIT Library online and hardcopy resources.

You should check myRMIT regularly for updated information and resources. You should purchase the recommended textbook and review recommended readings in addition to study notes and other flexible learning resources before attending related tutorial and practical classes.


Overview of Assessment

Your ability to demonstrate an understanding of the key concepts using appropriate terminology may be assessed in written and oral assessments.

All hurdle requirements for this course are indicated clearly in the assessment regime that follows, against the relevant assessment task(s) and all have been approved by the College Deputy Vice-Chancellor (Learning & Teaching).

Assessment Tasks

Assessment task 1: Applied Case 1
Weighting 30%
This assessment task supports CLOs 3 & 4

Assessment task 2: Applied Case 2
Weighting 30%
This assessment task supports CLOs 3 & 4

Assessment Task 3: Compounding and Quality Control Skills
Weighting 20 %
This assessment task supports CLOs 1 & 2

Assessment task 4: Final practical test
This assessment is a HURDLE
Weighting 20%
This assessment task supports CLOs 1 & 2