Safety of medicines and vaccines - building next generation capability

The systematic safety surveillance of real-world use of medicinal products and related activities (pharmacovigilance) started in earnest as a scientific field only in the 1960s. While developments have occurred over the past 50 years, adding to its complexity and sophistication, the extent to which some of these advances have positively impacted the capability for ensuring patient safety is questionable. We review how the conduct of safety surveillance has changed, highlight recent scientific advances, and argue how they need to be harnessed to enhance pharmacovigilance in the future. Specifically, we describe five changes that we believe should and will need to happen globally in the coming years: (i) better, more diverse data used for safety; (ii) the switch from manual activities to automation; (iii) removal of limited value, extraneous transactional activities and replacement with sharpened focus on scientific efforts to improve patient safety; (iv) patient-involved and focussed safety; and (v) personalised safety.