Improving Pharmacovigilance Beyond Spontaneous Reporting

About forty years ago pharmacovigilance started as a formal public health practice with the setting up of spontaneous reporting schemes. This can be recognised as the first generation of progress in this discipline. Since then, along with the consolidation of such programmes around the world, important new developments have taken place, reinforcing our ability to identify and characterise drug safety issues earlier and on more scientific grounds. The application of pharmacoepidemiological methods to drug safety evaluation has been crucial in this process, marking the second generation of progress. The conceptual evolution has been immense but there is still a lot of work to be done to transfer it into routine practice, in particular when the aim is to be proactive in anticipating and minimising drug safety issues. Patient risk management can be recognised as the third generation of progress and the new challenge for the first decades of the 21st century.