FIGURE 5-1 Learning about benefits and risks is a continuous process, creating a tremendous challenge with respect to updating benefit–risk assessments as postmarketing data accumulate.

SOURCE: From the presentation of discussion leaders Marc Berger, M.D., and Paul Seligman, M.D., MPH.

collect postmarketing safety data and the lack of confidence by many in the ability to monitor drugs in the postmarketing environment.

Dr. Strom discussed three primary postmarketing surveillance data sources and their limitations:

1. The Adverse Event Reporting System (AERS) has been the primary source of postmarketing information about drugs since the 1950s. Hundreds of thousands of adverse reaction reports are collected and analyzed annually. The system has seen very little improvement over time other than becoming computerized. Its major limitation is that it remains a collection of case reports that can signal problems, but cannot be used to draw conclusions.

2. Computerized claims or medical record systems, which are widely used and have been in existence since the late 1970s, include pharmacy, hospital, and physician claims reports sent to insurance carriers. Common identification numbers are increasingly being used to maximize the use of claims databases for research purposes. The Achilles heel of this type of system is physician reimbursement, which is based on visits rather than diagnosis. While hospitals and pharmacies must include diagnostic or drug identification information in claims forms, there is no incentive for physicians to do so.