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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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6 Drug Labels
Pages 40-47

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From page 40...
... Leander Fontaine of Pharmiceutics LLC noted that the drug label uses precisely defined regulatory terms such as adverse events or adverse reactions that might not be interpreted correctly by physicians and patients. Ed Staffa of the National Association of Chain Drug Stores stated that pharmacists worry that they will miss major drug interactions by having to sift through all the minor or theoretical ones.
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From page 41...
... Staffa. New LabeL RequiRemeNts The FDA estimates that 300,000 preventable adverse events occur each year in the United States because of confusing medical information (FDA, 2006)
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From page 42...
... • Coronary Stenting: 50 mg once daily with food, with antiplatelet doses • See 17 for PATIENT COUNSELING INFORMATION and FDA of aspirin, for up to 30 days following stent implantation (2.2) approved patient labeling Discontinue in renally impaired patients if hemorrhagic or hematopoietic Revised: 5/200X problems are encountered (2.3, 8.6, 12.3)
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From page 43...
... . Tables of mere adverse events from clinical trials, to the extent they are considered valuable information for prescribers, should be provided in a scientific background document to the labeling, comparable to the scientific section of Canadian drug labels.
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From page 44...
... dRuG LabeLiNG aNd dRuG-dRuG iNteRaCtioNs Labels are not being utilized effectively to communicate a drug's potential side effects or interactions with other substances. "We need to think about putting information in formats that are more clinically directed and useful, although a way of testing such formats .
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From page 45...
... as a good medium for developing an official list of drug interactions derived from its official monograph for content. USP has already defined medication error through its National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)
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From page 46...
... The certificate holder can use practice improvement models (PIMs) to meet this requirement; although current PIMs do not address drug safety explicitly, they include a survey of practice and the infrastructure directly relevant to safe medication management.
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From page 47...
... Dr. Drazen concluded that in order to improve the system, clear, accurate, and immediately accessible prescribing information should be made available and should be accompanied by expanded data standards, improved passive surveillance, and robust postmarket active surveillance efforts.
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Key Terms

  • drug labels
  • ncc merp
  • drug safety
  • adverse events
  • adverse drug

  • adverse reaction
  • drug interactions
  • hematological adverse
  • suspected adverse
  • potential adverse

  • adverse event
  • prescribing information
  • medication error
  • drug label
  • drug labeling

  • chain drug
  • address drug
  • drug stores
  • patient information
  • patient safety

  • specific patient
  • aplastic anemia
  • thrombotic thrombocytopenic
  • safety surveillance
  • information contained

  • thrombotic stroke
  • causal certainty
  • boxed warning
  • certificate holder
  • inform consumers


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