Pharmacoepidemiology

A sub-discipline of epidemiology concerned with estimating the efficacy, effectiveness and safety of pharmaceutical products.

Briggs and Levy "Pharmacoeconomics and pharmacoepidemiology: curious bedfellows or a match made in heaven?"Pharmacoeconomics, 2006

Pharmacoepidemiology is used to answer these questions:

  • Who uses which medications?
  • How are medications prescribed?
  • What are the benefits associated with a medication or class of medications?
  • What risks are associated with a medication?
  • Are there people who shouldn’t be using a specific medication?

FDA oversees the drug development life cycle – pharmacoepidemiology contributes at all points in drug development.

FDA DESK REFERENCE GUIDE

But it isn’t perfect – the Institute of Medicine report on our drug safety system -

IOM Report

One of our key tasks – understanding Adverse Events.