Skip to main content

Adverse Drug Event Reporting The Roles of Consumers and Health-Care Professionals: Workshop Summary (2007) / Chapter Skim
Currently Skimming:

Summary
Pages 1-6

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 1...
... In order to identify adverse drug events after a drug has been released, the Food and Drug Administration (FDA) relies on a postmarketing surveillance program known as MedWatch.
Read the entire page →
From page 2...
... The Centers for Medicare and Medicaid Services captures data on drug use and clinical services for individual subscribers. And institutional review boards of individual health systems capture many adverse events in clinical trials.
Read the entire page →
From page 3...
... The formation of a crossdisciplinary DDI working group that would create improved tools for communicating interactions and consequences was discussed. This group could identify and prioritize DDIs, develop a public database capable of receiving all new labeling information on drug interactions, perform an ongoing review of data from the FDA and the published literature, and possibly recommend specific interaction studies.
Read the entire page →
From page 4...
... Another concern is that drug labels do not currently communicate the likelihood that a particular adverse event will occur when taking the drug. Participants suggested that labeling should inform consumers and physicians about the level of causal certainty of suspected adverse reactions.
Read the entire page →
From page 5...
... Other suggestions discussed by participants included the formation of a drug safety oversight board with its own regulatory power, composed of consumer representatives and scientists with no industry ties or involvement in the approval process. Increased involvement in reporting ADEs may also be achieved by looking to successful reporting programs, such as the United Kingdom's yellow card system.
Read the entire page →

Key Terms

  • adverse event
  • adverse events
  • drug safety
  • drug events
  • event reporting

  • adverse reactions
  • identify adverse
  • potential adverse
  • drug event
  • drug interactions

  • drug reactions
  • drug labels
  • ade reporting
  • identifying adverse
  • suspected adverse

  • adverse reaction
  • serious adverse
  • monitor drug
  • address drug
  • improve drug

  • file adverse
  • particular adverse
  • drug label
  • participants discussed
  • clinical trials

  • increasing consumer
  • event reports
  • participants included
  • discuss safety
  • successful reporting


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.