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2016 ; 82
(1
): 17-29
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Adverse drug event reporting systems: a systematic review
#MMPMID27016266
Bailey C
; Peddie D
; Wickham ME
; Badke K
; Small SS
; Doyle-Waters MM
; Balka E
; Hohl CM
Br J Clin Pharmacol
2016[Jul]; 82
(1
): 17-29
PMID27016266
show ga
AIM: Adverse drug events (ADEs) are harmful and unintended consequences of
medications. Their reporting is essential for drug safety monitoring and
research, but it has not been standardized internationally. Our aim was to
synthesize information about the type and variety of data collected within ADE
reporting systems. METHODS: We developed a systematic search strategy, applied it
to four electronic databases, and completed an electronic grey literature search.
Two authors reviewed titles and abstracts, and all eligible full-texts. We
extracted data using a standardized form, and discussed disagreements until
reaching consensus. We synthesized data by collapsing data elements, eliminating
duplicate fields and identifying relationships between reporting concepts and
data fields using visual analysis software. RESULTS: We identified 108 ADE
reporting systems containing 1782 unique data fields. We mapped them to 33
reporting concepts describing patient information, the ADE, concomitant and
suspect drugs, and the reporter. While reporting concepts were fairly consistent,
we found variability in data fields and corresponding response options. Few
systems clarified the terminology used, and many used multiple drug and disease
dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA).
CONCLUSION: We found substantial variability in the data fields used to report
ADEs, limiting the comparability of ADE data collected using different reporting
systems, and undermining efforts to aggregate data across cohorts. The
development of a common standardized data set that can be evaluated with regard
to data quality, comparability and reporting rates is likely to optimize ADE data
and drug safety surveillance.
|*Drug-Related Side Effects and Adverse Reactions
[MESH]
|*Pharmacovigilance
[MESH]
|Adverse Drug Reaction Reporting Systems/*standards/statistics & numerical data
[MESH]
|Databases, Factual/statistics & numerical data
[MESH]