Abstract
Aim: Patient-reported outcomes associated with adverse events (AEs) reported with generics have not been evaluated. To map AEs associated with generics to the NIH Patient-reported Outcomes Measurement Information System. Methods: We mapped 381 AEs from 148 case reports of generic tamsulosin, levothyroxine and amphetamine/dextroamphetamine to the physical, mental and social domain of the NIH Patient-Reported Outcomes Measurement Information System after reviewing 1237 case reports in the US FDA's Adverse Event Reporting System (FAERS; 2011-2013). Results: 75%, 76% and 71% reports were classified under the physical domain for tamsulosin, levothyroxine and amphetamine/dextroamphetamine, while 9%, 9% and 18% reports were classified under the mental domain, respectively. Conclusion: FAERS reveals several domains of patient-relevant concerns associated with generic drugs.
Original language | English (US) |
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Pages (from-to) | 437-447 |
Number of pages | 11 |
Journal | Journal of Comparative Effectiveness Research |
Volume | 6 |
Issue number | 5 |
DOIs | |
State | Published - Jul 2017 |
Keywords
- FAERS database
- PROMIS outcome
- amphetamine
- levothyroxine
- patient-relevant outcomes
- tamsulosin
ASJC Scopus subject areas
- Health Policy