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


Course Code

Campus

Career

School

Learning Mode

Teaching Period(s)


Course Coordinator: Associate Professor Simon Young

Course Coordinator Phone: +61 3 9925 7309

Course Coordinator Email: simon.young@rmit.edu.au

Course Coordinator Location: 201.9.11


Pre-requisite Courses and Assumed Knowledge and Capabilities

Enforced prerequisites

PHAR1006 Pharmacy Practice 3

PHAR1013 Advanced Medicine Formulations

 

Assumed Knowledge and Capabilities An understanding of the Australian healthcare system is assumed. An understanding of chemistry and the application of physicochemical principles to formulation design is required. A comprehensive understanding of the formulation of medicines and their operation is essential. An understanding of the provision of medicine advice appropriate to the patient for a broad range of formulations is required.


Course Description

You will advance your knowledge and understanding of essential and advanced medicine formulations considered in PHAR1013 and CHEM1291 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, labeling, packaging and counseling 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.


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, labeling, 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 in blended learning. Key concepts will be developed in flexible learning resources supported by face-to-face workshops or webinars integrated with tutorial exercises and practical classes. In practical and tutorial classes you will extend your understanding to the extemporaneous production of medicines (including the requisite documentation of the production process, labeling, 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.

  • Flexible learning resources Resources are organized into learning modules and provide the theoretical basis required for the successful completion of tutorials, workshops, practical classes and assessment tasks.
  • Workshops/webinars Workshops/webinars provide a forum to give, receive and discuss theoretical concepts and applications to reinforce knowledge and understanding developed in the study of flexible learning resources.
  • Tutorials Tutorials provide the opportunity to work through example puzzles (both individual and group) in a guided environment. Attendance at tutorials is expected; these classes may include summative assessments related to the extemporaneous production of medicines and the analysis of medicines, drugs or excipients.
  •  Practical analysis and extemporaneous preparation classes In practical classes you will apply theoretical understanding to the extemporaneous production and evaluation of medicines, drugs or excipients. Attendance is expected; practical classes may include summative assessments related to your production of extemporaneous preparations and your analysis of medicines, drugs or excipients.


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 Pro Vice-Chancellor (Learning & Teaching).

 

Summative assessments include:

Mid-semester test(s)

Weighting 20%

This assessment task supports CLOs 1-4

Practical/tutorial assessments

Weighting 30%

The extemporaneous compounding of medicines for an individual patient based upon a prescription is a fundamental skill of pharmacists practising in Australia.  Throughout the practical series you will be guided through new production processes meeting the legal and ethical responsibilities of the pharmacist. The final practical test is a hurdle requirement for this course.

This assessment task supports CLOs 1-4

End of course exam

              Weighting 50%

              This assessment task supports CLOs 1-4