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Adverse Drug Event Reporting The Roles of Consumers and Health-Care Professionals: Workshop Summary (2007) / Chapter Skim
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2 Current Adverse Event Reporting Systems
Pages 12-17

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From page 12...
... Reports of adverse drug events (ADEs) make their way to the FDA through various means -- through pharmaceutical companies, which collect and report adverse events on their drugs; directly from providers and patients through the FDA's MedWatch system; from patient databases of payers such as the Centers for Medicare and Medicaid Services and managed care companies; and from hospitals.
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From page 13...
... : • Events associated with drug use in a professional practice • Events resulting from accidental or intentional overdose • Events occurring from drug abuse • Events occurring from drug withdrawal • Any failure of expected pharmacological action The analysis of serious adverse events identifies issues that should result in changes to drug labels or that require physician notification of adverse events. This information, as Anne Trontell, deputy director of the FDA's Office of Drug Safety, noted, allows the FDA, in collaboration with the manufacturer, to ensure that there is effective product labeling to alert health-care practitioners and patients to possible safety risks and areas of risk prevention.
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From page 14...
... medWAtch The FDA's program for collecting data on ADEs is known as MedWatch. It has an outreach component, designed to facilitate public reporting of adverse events, and a reporting component, which provides the actual means for reporting, including an Internet portal for reporting drug event information.
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From page 15...
... Databases are particularly useful when combined with review of the full-text medical records of a very small number of people to confirm the database information and to gather additional data." reporting Adverse events to institutionAl revieW BoArds Current systems for reporting adverse events to institutional review boards (IRBs) are problematic because these reports rarely contain adequately detailed information and the data are reported sporadically and are not easily aggregated for analysis.
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From page 16...
... It is intended to assist IRBs, investigators, research institutions, HSS agencies that conduct or sponsor human subjects research, and other interested parties. OHRP believes that there will be more collaborative efforts by federal agencies that are involved in human subjects research to create a new approach to handling adverse events (HHS Office for Human Research Protections, 2005)
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From page 17...
... . neW ApproAches For improving reporting systems Alastair Wood of Vanderbilt Medical School discussed new approaches to improve the current adverse event reporting systems.
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Key Terms

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

  • current adverse
  • report adverse
  • drug event
  • medicaid services
  • drug safety

  • institutional review
  • events occurring
  • human subjects
  • guidance document
  • quality improvement

  • review boards
  • serious adverse
  • reviewing adverse
  • handling adverse
  • vaccine adverse

  • examine adverse
  • regarding adverse
  • monitoring adverse
  • unknown adverse
  • adverse reaction

  • reporting drug
  • drug manufacturers
  • approved drug
  • monitor drug
  • drug withdrawal


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