BMSC304 - Drug Regulation

Year

Credit points

Campus offering

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. Students will also be exposed to the National Medicines Policy and the National Strategy for the Quality Use of Medicines in order to further enhance and apply their understanding of government and industry policies in relation to drug promotion in the post-marketing period. The aim of this unit is to 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 you will be able to demonstrate you have achieved the learning outcomes (LO) detailed in the below table.

Each outcome is informed by a number of graduate capabilities (GC) to ensure your work in this, and every unit, is part of a larger goal of graduating from ACU with the attributes of insight, empathy, imagination and impact.

Explore the graduate capabilities.

On successful completion of this unit, students should be able to:

LO1Identify and describe the role of key partners for achieving Quality Use of Medicines in Australia (GA2, GA5, GA8, GA10) 

LO2Compare and contrast the post-marketing regulatory controls and reporting requirements that exist for pharmaceutical and complementary medicines in Australia (GA4, GA5, GA6, GA8) 

LO3Extrapolate the importance of evidence-based medicine to drug safety in the post-marketing period (GA4 GA5, GA6, GA8) 

LO4Critique a range of information resources and services for health professionals and for consumers related to pharmaceutical medicines (GA2, GA4, GA5, GA6, GA8, GA10) 

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 (Consumer Medicines Information, Patient Information, MIMS and the Australian Medicines Handbook) 
• Role of key partners in the monitoring and reporting of drug safety – Therapeutic Goods Administration (TGA), sponsors, health departments, hospitals, health professionals, consumers, carers 
• 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. This blended learning approach allows flexibility for students and draws upon the opportunities of group and social experiences for essential skill development with expert support. 

Assessment strategy and rationale

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

The first assessment task for this unit is a critique of a Consumer Medicines Information (CMI) leaflet. Students will be given a CMI to annotate and critically analyse in the form of a short essay (1000 words). The assessment is structured in this way as it closely mimics typical tasks required in professional circumstances pertaining to drug promotion (e.g., creating and analysing documents).

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 to develop proficiency in communication of ideas to a novice audience. 

The final assessment task for this unit is an electronic portfolio (e-Portfolio). Students will be allocated one of two historical events that occurred within the pharmaceutical industry and will be required to develop a portfolio of information that highlights key areas of drug promotion in the post-marketing period. This task assesses integration and application of central ideas covered in this unit.

Overview of assessments

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