PrimeVigilance have provided a new page which provides some background summaries of the various definitions of epidemiology and pharmacoepidemiology and some key applications within contemporary drug saftey work. This page provides some further background to the topic by providing defintions from relevant organisations and a bullet point summary of key applications within contemporary drug saftey.
Further Contemporary Definitions Of Epidemiology
Epidemiology is often summarised as considering the “who, where, what and why” of how a particular disease arises and develops within a pre-determined real life population. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (co-ordinated by the European Medicines Agency) provide the following brief definition (which can be found at http://www.encepp.eu/glossary.html ) :
“Epidemiology is the study of factors affecting the health and illness of populations, and serves as the foundation and logic of interventions made in the interest of public health and preventive medicine.”1
Investigations involve larger-scale ‘real life’ populations, meaning patients within particular pre-defined communities, cities, areas, countries, continents, etc. There may be reference to individual details for one particular patient; however, this branch of science concerns itself with studies conducted on a macro-scale.
Further Contemporary Definitions Of Pharmacoepidemiology
This science also concerns itself with macro-scale studies of ‘real life’ populations – they key characteristic being that the population will be one taking a particular medicinal product (or products). The International Society for Pharmacoepidemiology provides a definition which futher notes key characteristics as:
- “the study of the utilization and effects of drugs in large numbers of people.”
- “a bridge science spanning both pharmacology and epidemiology”
- “the application of epidemiological methods to pharmacological issues”2.
Key Applications Within Pharmacovigilance
It should be noted that the types of studies and methodology found within which epidemiology and pharmacoepidemiology are not likely to form part of the routine day to day workload of pharmacovigilance services. However, there are times when the data generated by the former disciplines is vital for the latter:
- Epidemiology data informs the “Safety Specification” for each new medicine (which forms part of the Risk Management Plan prepared by drug safety services)
- Pharmacoepidemiology studies are helpful to follow up patients and determine their progess over longer periods of time
- Pharmacoepidemiology studies may also aid investigations into new saftey signals arising during the post-marketing phase
1. The European Network of Pharmacoepidemiology and Pharmacovigilance Centres (ENCePP). 2012. Glossary Of Terms. [online]. Available from: http://www.encepp.eu/glossary.html [Accessed 19th April 2012]