Skip to main content

Understanding the Benefits and Risks of Pharmaceuticals Workshop Summary (2007) / Chapter Skim
Currently Skimming:

5 Patient Experience with Drugs over Time
Pages 52-58

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 52...
... While computerized patient and pharmacy order entry systems and other information technologies have the potential to improve the way we conduct postmarketing surveillance, the comments of participants suggest that these technologies have not yet lived up to that potential. There were repeated calls for integrating postmarketing data into the regulatory component of the life cycle (represented by the box in the lower left corner of Figure 5-1)
Read the entire page →
From page 53...
... 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.
Read the entire page →
From page 54...
... In the future, with better electronic systems and a more comprehensive national healthcare information infrastructure (e.g., the Medicare system that links health outcomes with prescribing data) , our dependence on AERS will decrease.
Read the entire page →
From page 55...
... However its signal is low, with only about 10 percent of adverse events detected. 2 Active surveillance produces a stronger signal, and its larger numbers allow for relative risk calculations, better precision, and comparisons within or between drugs.
Read the entire page →
From page 56...
... The signals can also be used to conduct nonrandomized observational studies designed to test prespecified hypotheses.3 Dr. Overhage was asked about the limitations of using postmarketing observational data to update benefit profiles, as well as risk profiles, for various therapies, compared to data collected from randomized control trials.
Read the entire page →
From page 57...
... Leiden had proposed a new paradigm for drug development that depends in large part on our ability to collect robust information in the postmarketing arena and be able to do experimental studies that involve randomization, or in some way classifying individuals into different groups, so that we can continue to collect good efficacy as well as safety information. Yet are the kinds of databases that Dr.
Read the entire page →
From page 58...
... In its most recent report to Congress Validating Regulatory Analysis, OMB assembled all 47 published case studies (out of more than 20,000 new regulations since 1981) in which benefit and cost estimates had been validated after the rule was promulgated (OMB 2005)
Read the entire page →

Key Terms

  • active surveillance
  • adverse events
  • observational studies
  • postmarketing data
  • adverse reactions

  • clinical data
  • health information
  • observational data
  • adverse event
  • spontaneous reporting

  • chart review
  • information exchange
  • overhage described
  • proposed therapy
  • claims reports

  • regulatory component
  • regulatory analysis
  • computerized surveillance
  • postmarketing safety
  • nonrandomized observational

  • epidemiological data
  • data improves
  • prescribing data
  • robust information
  • postmarketing information

  • statewide health
  • data reuse
  • rare adverse
  • safety information
  • detailed clinical


    • 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.