3105.0: Monday, November 13, 2000: 2:30 PM-4:00 PM

Strategies for Post-Marketing Surveillance

Post-marketing surveillance programs are extremely important to ensure that medications used by populations cause no harm and improve the health of the public. These studies address assorted aspects of beneficial and detrimental drug effects, including the existence of causal effects, risk factors, economic consequences, and characterization of drug use in clinical practice. Dr. Hennessy will expand on the reasons and methods for post-marketing studies to establish the framework of the discussion topic. Technological advances have provided health maintenance organizations with the ability to create comprehensive databases. In the past, important contributions to pharmacoepidemiology have been provided by these databases. Dr. Platt has recently put together multicenter databases from a number of HMO’s. The multicenter nature of these databases offer new possibilities for post-marketing surveillance programs, which will be the basis of his presentation. General Practice Automated Databases cover a wide spectrum of data, and therefore, provide a closer look at the impact of medications at the population level. Dr. García will share the experience of using population based registries of large communities and will illustrate the seminal role they have played to characterize the adverse events of medications. Medications with abuse potential (e.g. analgesics) require special methodologies to determine to what extent these are abused and the temporal changes using time of introduction in the market as the time scale. Dr. Cicero will illustrate innovative methods for post-marketing surveillance programs for medications with potential for abuse. Overall, the symposium will provide the participants with the opportunity to become familiar with different strategies and methodologies for post-marketing surveillance programs
See individual abstracts for presenting author's disclosure statement.
Learning Objectives: Refer to the individual abstracts for learning objectives
Presider(s):Alvaro Munoz, PhD
Eric Strain, MD
2:30 PMPost-marketing surveillance: Objectives and methods
Sean Hennessy, PharmD
2:50 PMSurveillance of safety using multicenter Health Maintenance Organizations’ data
Richard Platt, PhD
3:10 PMA post-marketing surveillance program to monitor abuse liability of new medications
Theodore J. Cicero, PhD
3:30 PMUse of general practice automated databases for studies of drug effects
Luis A. Garcia-Rodriguez, PhD

The 128th Annual Meeting of APHA