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Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases
- Source :
- Drug Safety, 36(8), 617-625. Adis
- Publication Year :
- 2013
- Publisher :
- Adis, 2013.
-
Abstract
- Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from small differences in the manufacturing process. Detailed exposure information should be readily available in systems for postmarketing safety surveillance of biopharmaceuticals, including spontaneous reporting systems (SRSs), in which reports of ADRs are collected. The aim of this study was to explore the current status of traceability of biopharmaceuticals in the US and the EU up to patient level in SRSs. A cross-sectional study was conducted over the period 2004–2010, including ADR reports from two major SRSs: the FDA Adverse Event Reporting System (FAERS) in the US and EudraVigilance (EV) in the EU. The availability of batch numbers was determined for biopharmaceuticals, and compared with small molecule drugs. For biopharmaceuticals for which a biosimilar has been approved for marketing in the EU, the identifiability of the product (i.e. the possibility of distinguishing the biosimilar from the reference biopharmaceutical) was determined. A total of 2,028,600 unique ADR reports were identified in the FAERS, reporting a total of 591,380 biopharmaceuticals (of which 487,065 were suspected). In EV there were 2,108,742 unique ADR reports, reporting a total of 439,971 biopharmaceuticals (356,293 suspected). Overall, for 24.0 % of the suspected biopharmaceuticals in the FAERS and 7.4 % of the suspected small molecule drugs (p
- Subjects :
- medicine.medical_specialty
Prescription Drugs
Traceability
Databases, Pharmaceutical
Cross-sectional study
Pharmacology
Toxicology
Biological Factors
Adverse Event Reporting System
medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
Intensive care medicine
Drug Labeling
Safety surveillance
United States Food and Drug Administration
business.industry
Biosimilar
United States
Europe
Cross-Sectional Studies
Biopharmaceutical
Spontaneous reporting
Batch Number
business
Subjects
Details
- ISSN :
- 11791942 and 01145916
- Volume :
- 36
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Drug Safety
- Accession number :
- edsair.doi.dedup.....a1d159f61063acdd752486ecbb9b69de