Course description
Postgraduate Professional Development Short Course (30 credits)
The global pandemic of COVID-19 has focused huge attention on the importance of pharmacoepidemiology. Speculation about the role of prescribed drugs such as ACE inhibitors, NSAIDs and hydroxychloroquine, followed by often poorly conducted studies of association with COVID-19, has caused anxiety globally. Development of Coronavirus vaccines will result in the need for intensive surveillance of subsequent safety profiles internationally. Having the skills to conduct and interpret such studies to a high standard has never been more important.
The global challenge of maximising drug safety yet maintaining public confidence has become increasingly complex. Health authorities are tasked to provide quality care while managing a growing drug budget. Regulatory authorities must balance the potential benefits of new drugs with the perception of their potential harm.
This Postgraduate Professional Development Short Course addresses the need for well-informed professionals to work in all areas related to the assessment of drug safety and the management of risks and benefits of medications, including vaccines.
This course is run in collaboration with University of London, and applications must be made via the University of London website.
Course objectives
This course aims to equip you with a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance, and to apply these skills to a currently unresolved drug safety issue.
By the end of this course, you will be able to:
- Demonstrate an understanding and critically evaluate issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs), the manner in which these are detected and monitored, and the related historic and legal frameworks
- Understand and critically compare fundamental statistical, economic and epidemiological concepts and methods
- Understand and critically reflect upon important pharmacoepidemiological concepts and methods and how these methods can be applied to specific drug issues
- Assess and critically analyse the results of pharmacoepidemiological studies, including critical appraisal of the study question, study design, methods and conduct, statistical analyses and interpretation
- Understand how new medicines are assessed for their cost-effectiveness as well as efficacy and safety, before being recommended for use
- Apply the techniques and approaches covered in the taught element of the course, plus your own experience, to evaluate issues presented to you in the format of a project, and where relevant, develop recommendations for the best option or options
Key course topics
Pharmacoepidemiology - you will learn about the fundamentals of pharmacoepidemiology, its conduct, practical uses and limitations in determining the effects of medications in large groups of people. The statistical basis underpinning pharmacoepidemiology will also be introduced, and you will integrate statistics and epidemiology to gain competence in critically appraising pharmacoepidemiology studies.
Pharmacovigilance - you will be introduced to the key elements of pharmacovigilance and its basis within drug regulation. Within the risk management elements of the course, you will gain insight into how pharmacoepidemiology and pharmacovigilance are combined in the investigation of the effects of medicines. Principles will largely be demonstrated within the European legislative context, whilst recognizing these general principles apply more broadly throughout the world.
Health economics - you will be introduced to the fundamental concepts involved in assessing the cost effectiveness of health technologies and methodologies used to assess the health related quality of life. Real world examples will be used to illustrate concepts.
Who is it for?
This course is aimed at personnel involved in the safe use of medicines, particularly in developed countries. This includes those working (or intending to work) in: the pharmaceutical industry who are involved in drug development, licensing and surveillance; regulatory bodies who are involved in licensing and surveillance; the health service who are involved in drug policy; and health policy decision-making agencies.