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An Algorithm to Identify Generic Drugs in the FDA Adverse Event Reporting System
Geetha Iyer1, Sathiya Priya Marimuthu2,3, Jodi B Segal2,4,5
1Department of Epidemiology, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA, USA.
Drug Safety
|June 9, 2017
Summary
A new algorithm reliably identifies generic drugs in the US FDA Adverse Event Reporting System (FAERS), improving drug safety analysis. This method enhances the accuracy of identifying generic medications within adverse event reports.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Regulatory Science
Background:
- Generic drugs comprise a significant majority of US prescriptions.
- Current methods for identifying generic drugs in the US FDA Adverse Event Reporting System (FAERS) are unreliable.
- Accurate identification of generic drugs in FAERS is crucial for comprehensive drug safety monitoring.
Purpose of the Study:
- To develop and validate an algorithm for accurately identifying generic drugs within the FAERS database.
- To address the existing gap in reliable generic drug identification in adverse event reporting.
Main Methods:
- Utilized adverse event reports for tamsulosin, levothyroxine, and amphetamine/dextroamphetamine from FAERS (2011-2013).
- Developed a three-item algorithm based on manufacturer name, NDA/ANDA number, and explicit 'generic'/'brand' terms.
- Compared algorithm-based classifications against original source case narratives for validation.
Main Results:
- The algorithm achieved high inter-rater reliability (kappa=0.89) in classifying generic drugs.
- A significant proportion of cases (37%) could not be classified due to incomplete FAERS data.
- The algorithm correctly identified 95.3% of generics when validated against original reports, with 20.9% reclassified from non-generic.
Conclusions:
- The developed algorithm demonstrates high reliability and moderate internal consistency for identifying generic drugs in FAERS.
- Improving data completeness in FAERS is essential for enhancing the reliability and validity of generic drug identification.
- This algorithm offers a valuable tool for more accurate pharmacovigilance and drug safety research.
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