Veracuity Blog The unbearable cost of pharmacovigilance “Making more informed drug choices using comprehensive and actionable adverse drug events data leads to improved patient safety and outcomes and reduced costs.” Becker’s Hospital Review, 2015 According to Institute of Medicine (IoM) study To Err Is Human (IoM, 2007), adverse drug events are the largest single category…
Veracuity Blog Drug diversion – issues and identification Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks. Spotting drug diversion within the current reporting system…
Veracuity Blog Biases in pharmacovigilance reporting The FDA Adverse Event Reporting System (FAERS) database is often taken as the “gold standard’ to which data gathered from social media is compared. This practice, although useful in a practical sense, has some limitations that need to be considered. Disproportionality calculations rely on comparator incidence as a valid…
Veracuity Blog Detection and annotation of data from social media Manual annotation of vast amounts of data obtained from social media is a costly commitment because the work must be done by experts with domain knowledge. The amount of data required to train the algorithm is in the tens of thousands of records. Extraction of…