Adverse drug event reporting systems: a systematic review.

ABSTRACT:

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

SUBMITTER: Bailey C 

PROVIDER: S-EPMC4917803 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature