{"id":43357,"date":"2026-05-29T13:38:20","date_gmt":"2026-05-29T13:38:20","guid":{"rendered":"https:\/\/eurekainfomed.it\/dev\/?p=43357"},"modified":"2026-05-29T13:38:20","modified_gmt":"2026-05-29T13:38:20","slug":"active-and-passive-pharmacovigilance-differences-and-practical-applications","status":"publish","type":"post","link":"https:\/\/eurekainfomed.it\/en\/active-and-passive-pharmacovigilance-differences-and-practical-applications\/","title":{"rendered":"Active and Passive Pharmacovigilance: differences and practical applications"},"content":{"rendered":"

When discussing drug safety, it is important to understand where information on potential adverse effects comes from. Not all safety data are generated in the same way: some arise from spontaneous reports, while others come from structured monitoring programs. In pharmacovigilance, these approaches are broadly classified into two main types: passive pharmacovigilance and active pharmacovigilance.<\/p>\n

Understanding this distinction is essential to correctly interpret safety data and the contribution of each approach to the evaluation of the benefit\u2013risk profile of medicinal products.<\/p>\n

What is passive pharmacovigilance<\/strong><\/h4>\n

Passive pharmacovigilance is based on the spontaneous collection of reports of suspected adverse drug reactions through what are known as Spontaneous Reporting Systems (SRS).<\/p>\n

In this system, healthcare professionals and patients voluntarily report adverse events observed during the use of a medicinal product. These reports are then collected and analyzed at national and international levels through databases managed by regulatory authorities.<\/p>\n

What is active pharmacovigilance<\/strong><\/h4>\n

Active pharmacovigilance is based on a proactive approach. In this case, structured systems are implemented to actively monitor patients exposed to a specific medicinal product. This means that data are collected in a planned and continuous manner, following predefined protocols that determine what information to collect, how often, and in which populations.<\/p>\n

These activities include post-authorisation observational studies, such as Post Authorisation Safety Studies (PASS), disease or drug registries, patient monitoring and follow-up programs, and other initiatives aimed at systematically collecting data over time. Active pharmacovigilance may also involve the analysis of healthcare databases and other structured real-world data sources.<\/p>\n

Differences and practical applications<\/strong><\/h4>\n

Passive pharmacovigilance collects spontaneous reports on a large scale and plays a fundamental role in the early detection of potential safety signals. However, it has limitations, such as underreporting and the inability to accurately estimate the frequency of adverse events.<\/p>\n

Active pharmacovigilance, on the other hand, is based on structured monitoring that enables more in-depth and quantitative analyses, allowing estimation of event incidence and identification of risk factors, although it requires greater resources and may present methodological limitations.<\/p>\n

In practice, the two approaches are complementary: passive pharmacovigilance generates signals that are then further investigated through active approaches, such as PASS or registries. This transition makes it possible to verify the robustness of the signal, estimate its frequency, and assess its clinical relevance in defined populations.<\/p>\n

Active pharmacovigilance can also help identify specific risk factors, vulnerable patient subgroups, and conditions of use associated with an increased likelihood of adverse events, thereby supporting more informed regulatory and clinical decisions.<\/p>\n

Their integration is formalized within Risk Management Plans (RMPs), which are essential for ensuring continuous and proactive monitoring of medicinal product safety throughout their lifecycle.<\/p>\n

Conclusions<\/strong><\/h4>\n

The distinction between active and passive pharmacovigilance helps in correctly interpreting safety data and understanding the role each approach plays in monitoring medicinal products.<\/p>\n

Their effective integration remains essential to support more robust regulatory decisions and to ensure more effective and continuous surveillance of medicines over time.<\/p>\n

References<\/strong><\/p>\n

    \n
  1. World Health Organization. The importance of pharmacovigilance: Safety monitoring of medicinal products.<\/em><\/li>\n
  2. Directive 2010\/84\/EU<\/li>\n
  3. Regulation (EU) No. 1235\/2010<\/li>\n
  4. EMA. Good Pharmacovigilance Practices (GVP): Module V (Risk management systems), Module VI (Collection, management and submission of reports of suspected adverse reactions), Module IX (Signal management)<\/em><\/li>\n<\/ol>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

    When discussing drug safety, it is important to understand where information on potential adverse effects comes from. 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