Every company that holds a marketing authorization for a medicine runs a pharmacovigilance system. It collects reports of suspected adverse reactions, assesses them, reports them to regulators within set timelines, looks for new safety signals, prepares periodic safety reports, and manages the risks it identifies.
Reports come from many places: healthcare professionals, patients, clinical trials, medical information inquiries, field conversations and the published literature. Everyone in a pharmaceutical company has an obligation to pass on a possible adverse event they come across, whatever their role.
Literature monitoring is a formal part of the work. In the European Union, good pharmacovigilance practice expects companies to screen the scientific literature for reports on their products at least once a week. In the United States, serious and unexpected adverse experiences found in the scientific literature are subject to expedited reporting, with a copy of the article.
Because medical, commercial and safety teams often read the same publications, a possible case may be spotted first by someone outside drug safety. Making it easy for anyone to route it to the safety team, with a record of the hand-off, closes a common gap.