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

UID: 46

Author(s): Peter Doshi*, Jan Sieluk, Anna Hung * Corresponding Author
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 are regulated by the FDA and provided by drug manufacturers. PIs are written for health care professionals and PPIs for both practitioners and patients. Pharmacy leaflets are not regulated, typically produced by vendors, and intended for patient use. The statin documents were searched for language associated with 7 adverse events: diarrhea, arthralgia, dyspepsia, confusion, memory loss, rhabdomyolysis, and kidney failure. Data were collected verbatim and coded according to the statements describing the relationship between the drug and specific harm. Consistency of language was calculated comparing PIs and PPIs, PPIs and pharmacy leaflets, and PIs and leaflets. This dataset includes all prescribing information (drug labels), patient package inserts, and pharmacy leaflets used in the study as well as the extraction sheets.
Timeframe
2015
Subject Domain
Keywords
Access via Zenodo

All data including extraction sheets

Access Restrictions
Free to All
Access Instructions
Available to download from the Zenodo site
Associated Publications
Data Type
Software Used
Microsoft Excel
Microsoft Word
Study Type
Observational
Dataset Format(s)
PDF, Spreadsheet
Dataset Size
119.6 MB
Grant Support
AACP New Investigator Award/American Association of Colleges of Pharmacy