Spontaneous Reporting Systems

Systems of spontaneous reporting were developed in the 1960s. Nowadays, there are worldwide systems for processing millions of individual case safety reports per year. Despite the significant underreporting bias, the amount and quality of information collected through spontaneous reporting are sufficient for justification of the large number of regulatory actions taken to minimise risks associated with medicinal products. Spontaneous reports still represent an irreplaceable source of information for pharmacovigilance. They have been significantly strengthened by the new technology of mobile phone apps, social media, and artificial intelligence applications in healthcare. Essential rules of implied causality and acceptance of patient reports, paired with the emphasis on the quality of reports and their validation at source, have further improved the usefulness of the collected information for signal detection, assessment, and regulatory decision-making. Efforts to integrate data from spontaneous reports with other types of reports and available data in healthcare systems are ongoing on a larger scale. Data science techniques are also being further developed to improve the quality of data and its interpretation. This may lead to even quicker risk minimisation, including predicting adverse drug reactions to new medicinal products. Clinicians benefit from the lower thresholds for reporting and quicker sharing of new knowledge.