Program Overview

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BMSC304 - Drug Regulation

Year

2022

Credit points

10

Campus offering

No unit offerings are currently available for this unit.

Prerequisites

BIOL205 Pharmacology 1

Unit Rationale, Description, and Aim

In this elective unit, students will be introduced to key policymakers involved in the marketing of medicines and will explore the roles of government, pharmaceutical companies, and independent organisations within the field of drug promotion. Students will explore the importance of drug safety guidelines and associated post-market pharmacovigilance protocols, highlight the difference between evidence-based medicine and hype, and consider current legislation on intellectual property and drug patents. The aim of this unit is to support students in the exploration of the essential knowledge associated with drug promotion in the post-marketing period.

Learning Outcomes

To successfully complete this unit, students will be able to:

• Identify and describe the role of key partners for achieving Quality Use of Medicines in Australia
• Compare and contrast the post-marketing regulatory controls and reporting requirements that exist for pharmaceutical and complementary medicines in Australia
• Extrapolate the importance of evidence-based medicine to drug safety in the post-marketing period
• Critique a range of information resources and services for health professionals and for consumers related to pharmaceutical medicines

Graduate Attributes

• GA2: Recognise their responsibility to the common good, the environment, and society
• GA4: Think critically and reflectively
• GA5: Demonstrate values, knowledge, skills, and attitudes appropriate to the discipline and/or profession
• GA6: Solve problems in a variety of settings taking local and international perspectives into account
• GA8: Locate, organise, analyse, synthesise, and evaluate information
• GA10: Utilise information and communication and other relevant technologies effectively

Content

Topics will include:

• The National Medicines Policy
• The National Strategy for the Quality Use of Medicines
• Australian Register of Therapeutic Goods
• Drug Scheduling
• Medicine labelling and packaging framework
• Resources, tools, and information provided to health professionals and consumers to enhance the safe use of medicines
• Role of key partners in the monitoring and reporting of drug safety
• Intellectual Property protection and drug patents in the post-marketing period
• Evidence-based medicine vs. hype in drug promotion
• Medicines in the media

Learning and Teaching Strategy and Rationale

This unit uses an active learning approach to support students in the exploration of the essential knowledge associated with drug promotion in the post-marketing period. Using a blended learning strategy, students will explore the core ideas underpinning drug promotion in a series of online interactive lessons. Workshops assist students to construct and apply their knowledge of drug promotion with other students, so as to develop skills of collaboration and teamwork, and acquire a level of understanding sufficient to their professional endpoint.

Assessment Strategy and Rationale

The assessment strategy used allows students to evaluate and reflect on various post-marketing protocols relating to medicines, in order to build their understanding of drug promotion in Australia.

• The first assessment task is a critique of a Consumer Medicines Information (CMI) leaflet.
• The second assessment task is a vodcast where students produce an 8-minute voice recording with accompanying visual material based on one of three allocated topics.
• The final assessment task is an electronic portfolio (e-Portfolio) where students develop a portfolio of information that highlights key areas of drug promotion in the post-marketing period.

Overview of Assessments

Brief Description of Kind and Purpose of Assessment Tasks	Weighting	Learning Outcomes	Graduate Attributes
Written assessment (1000 words)	20%	LO2, LO4	GA2, GA4, GA5, GA8
Vodcast presentation	40%	LO1 - 4	GA4, GA5, GA6, GA8, GA10
Portfolio	40%	LO1 - 4	GA4, GA5, GA6, GA8, GA10

Representative Texts and References

• The National Strategy for Quality Use of Medicines (2002) Commonwealth of Australia
• National Medicines Policy (2000) Department of Health and Ageing, Commonwealth of Australia
• Australian Medicines Handbook (2016) Australian Medicines Handbook