From association to alert—a revised approach to international signal analysis

Decision making in drug safety—a literature review of criteria used to prioritize newly detected safety issues

“…Some organizations developed lists of ‘drug related events’ and ‘targeted medical events’, based on event seriousness and its likelihood to be drug induced. Examples are: targeted medical events developed by Food and Drug administration (FDA), the critical terms list developed by UMC and the important medical events list developed and maintained by EudraVigilance Expert Working Group in collaboration with MedDRA®. It was demonstrated that ADR being a critical term was predictive of a true signal …”

Signal Detection for Recently Approved Products: Adapting and Evaluating Self-Controlled Case Series Method Using a US Claims and UK Electronic Medical Records Database

“…those with biological plausibility, common ADRs, outcomes listed in risk management plans as potential safety concerns etc.). One example is using the SNIP criteria proposed for filtering spontaneous reports [45], focusing on WHO Critical terms [46] or those proposed as of particular value to screen for in previous longitudinal observation data research initiatives [9].…”

A pipeline to extract drug-adverse event pairs from multiple data sources

“…The UK Medicines Control Agency adopts Proportional Reporting Ratio (PRR) and Chi-square statistic to identify AE signals [45]. The Netherlands Pharmacovigilance Centre Lareb uses the Reporting Odds Ratio [46] and the Uppsala Monitoring Center employs Bayesian Confidence Propagation Neural Network (BCPNN) as its signal detection method on the WHO database [47]. While all these different methods have the ability to detect potential AE pairs, BCPNN is seen to have the best performance when compared to PRR and MGPS [48].…”