UMB Data Catalog

A project of the Health Sciences and Human Services Library

Filter by

of 1 Next >
Results Found: 2
  • UMB Dataset

    Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling

    Authors
    Peter Doshi
    Bansri Desai
    Kyungwan Hong
    John H. Powers, III
    Description

    Clinicians prescribing therapeutic agents newly approved by the FDA must rely on the information reported through drug labels (also known as “package inserts”). Ideally, labels should incorporate details regarding key efficacy information, including the magnitude of treatment benefit, and measures of precision and random error (confidence intervals and p values). This study assessed the degree to which...

    Subject
    Drug Labeling/standards
    Access Rights
    Unrestricted access
  • UMB Dataset

    The Possible Harms of Statins: What do Product Labels, Patient Package Inserts, and Pharmacy Leaflets Tell Us?

    Authors
    Peter Doshi
    Jan Sieluk
    Anna Hung
    Description

    This cross-sectional study evaluated three sources of written medical documents for consistency of language with regard to the adverse effects of 8 single-agent statins. Full prescribing information (PI’s, also called package inserts or drug labels), patient package inserts (PPIs), and pharmacy leaflets differ according to regulatory status, issuing body, and intended audience. The first two sources...

    Subject
    Consumer Health Information/standards
    Drug Labeling/standards
    Timeframe
    2015
    Access Rights
    Unrestricted access