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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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1 Introduction
Pages 7-11

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From page 7...
... Premarket review addresses issues of efficacy and safety of a particular drug, and postmarketing surveillance examines rare adverse reactions, effects that can be appreciated only with long-term use, and off-label uses of FDA-approved drugs.
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From page 8...
... For example, patients taking the medication may differ from the population in which it was studied; the treated population may not be as closely monitored as the patients in the clinical trials; or drugs may be prescribed for off-label use, the common practice in which physicians prescribe a medication for a use other than that for which it was tested and approved. In addition, during the initial period after the introduction of a new drug, the likelihood of inappropriate dosing, failure to follow directions, and contraindicated use is high (Smalley et al., 2000; Graham et al., 2001; Griffin et al., 2004)
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From page 9...
... . In addition to AERS, the FDA requires drug companies to commit to conducting postmarketing studies for new drugs under the Accelerated Approval Program, the Animal Efficacy Rule, and the Pediatric Research 1As of publication, the AERS database contains more than 3.5 million reports (personal communication with Toni Piazza-Hepp, FDA, March 5, 2007)
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From page 10...
... The Animal Efficacy Rule requires postmarket studies when animal data replace human data for ethical reasons. The Pediatric Research Equity Act enables the FDA to require pediatric studies of drugs already approved for adults before the drugs are labeled for children.
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From page 11...
... Section 2 reviews current sources of information on adverse drug events, including the FDA's MedWatch program and the AERS, institutional review boards, and the CMS. Section 3 describes surveillance systems, surveillance technology, and data quality.
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Key Terms

  • adverse events
  • drug safety
  • drug interactions
  • postmarket studies
  • event reporting

  • drug companies
  • drug event
  • drug events
  • independent drug
  • drug reactions

  • reporting adverse
  • serious adverse
  • rare adverse
  • adverse event
  • postmarketing surveillance

  • clinical trials
  • animal efficacy
  • accelerated approval
  • premarket studies
  • pediatric research

  • premarketing studies
  • postmarketing studies
  • jeffrey drazen
  • approval program
  • efficacy rule

  • drug surveillance
  • requires drug
  • particular drug
  • discusses drug
  • drug watch


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