{"id":43398,"date":"2026-07-07T10:44:07","date_gmt":"2026-07-07T10:44:07","guid":{"rendered":"https:\/\/eurekainfomed.it\/dev\/?p=43398"},"modified":"2026-07-07T10:44:07","modified_gmt":"2026-07-07T10:44:07","slug":"pharmacovigilance-is-reporting-an-obligation-or-a-professional-responsibility","status":"publish","type":"post","link":"https:\/\/eurekainfomed.it\/en\/pharmacovigilance-is-reporting-an-obligation-or-a-professional-responsibility\/","title":{"rendered":"Pharmacovigilance: is reporting an obligation or a professional responsibility?"},"content":{"rendered":"

Is reporting an adverse drug reaction a legal obligation, an element of good clinical practice, or an ethical duty?<\/p>\n

Before answering this question, it is useful to focus on two fundamental aspects of pharmacovigilance that are not always fully understood or sufficiently valued in everyday clinical practice: the phenomenon of adverse event under-reporting and the process of identifying potential safety signals.<\/p>\n

These two concepts are closely interconnected and directly linked to the regulatory obligations, clinical responsibilities, and ethical duties of healthcare professionals.<\/p>\n

Under-reporting: a persistent challenge<\/strong><\/h4>\n

Despite the well-recognized importance of pharmacovigilance, under-reporting remains a significant issue worldwide. It is estimated that only about 10% of adverse events that actually occur are reported.<\/p>\n

Several factors contribute to this phenomenon, often overlapping in daily practice. On one hand, there may be limited awareness of the role of pharmacovigilance or a tendency to underestimate the observed event. On the other hand, organizational and cultural factors play a role, including concerns about potential legal implications or the perception that reporting is a time-consuming administrative task.<\/p>\n

In addition, healthcare professionals may assume that the event is already known or not sufficiently relevant to warrant reporting. Limited communication among healthcare professionals and insufficient pharmacovigilance training can further contribute to the problem.<\/p>\n

As a result, under-reporting is not merely a statistical issue. Rather, it directly affects the ability of the pharmacovigilance system to identify emerging drug-related risks at an early stage and ultimately impacts patient safety.<\/p>\n

Reporting and signals: why suspicion matters<\/strong><\/h4>\n

In pharmacovigilance, reporting an adverse reaction does not require certainty of a causal relationship between the medicinal product and the event. Instead, reporting is based on the suspicion that such a relationship may exist.<\/p>\n

This is a key principle. Healthcare professionals are not expected to establish causality with certainty. In line with the precautionary principle, their role is to observe and report events even when only a reasonable suspicion is present.<\/p>\n

The assessment of causality is instead performed by regulatory authorities through structured processes involving the collection and aggregation of cases, statistical analyses, and comparisons with population-level data.<\/p>\n

Through this broader analysis, a pharmacovigilance signal may emerge. A signal represents information suggesting a possible increase in the frequency or severity of an adverse event compared with what was previously known.<\/p>\n

From this perspective, every report contributes to a larger body of evidence. An isolated case may appear insignificant on its own, but when combined with similar reports, it may reveal an important safety concern.<\/p>\n

Without reporting, signals cannot emerge. Consequently, opportunities to identify new risks early and protect patients may be lost.<\/p>\n

Reporting: obligation, good practice, or responsibility?<\/strong><\/h4>\n

In light of these considerations, reporting adverse reactions cannot be viewed from a single perspective. Instead, it should be understood as the integration of three complementary dimensions.<\/p>\n

From a regulatory standpoint, reporting is first and foremost a legal obligation. The European regulatory framework, established through Regulation (EU) No. 1235\/2010 and Directive 2010\/84\/EU, clearly states that healthcare professionals are expected to report adverse reactions. In Italy, this obligation is further reinforced by the Ministerial Decree of April 30, 2015, which assigns healthcare professionals a direct responsibility, particularly in relation to serious adverse reactions. Therefore, reporting should not be regarded as an optional activity but as an integral part of professional duties.<\/p>\n

However, limiting pharmacovigilance reporting to a regulatory requirement would be overly simplistic. Pharmacovigilance is also a fundamental component of good clinical practice. By reporting suspected adverse reactions, healthcare professionals actively contribute to the continuous assessment of a medicine\u2019s benefit-risk profile, the improvement of treatment safety, and the ability to make increasingly informed clinical decisions. Consequently, reporting is not merely an administrative task but a genuine clinical activity that directly influences the quality of patient care.<\/p>\n

Beyond these aspects, there is also an ethical and professional dimension. Reporting a suspected adverse reaction means taking responsibility toward both individual patients and the wider community. It contributes to preventing similar events, improving the understanding of predisposing factors, and supporting more effective risk management strategies. Furthermore, every report expands the collective body of knowledge that enables regulatory authorities to implement monitoring measures, risk minimization activities, or, in the most serious cases, restrictions on use or market withdrawal of a medicinal product.<\/p>\n

Accordingly, pharmacovigilance reporting should be viewed as an activity that combines legal obligation, clinical responsibility, and ethical commitment, making a substantial contribution to patient safety and the overall quality of healthcare systems.<\/p>\n

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

Reducing pharmacovigilance reporting to a simple regulatory obligation provides only a partial view of its true value.<\/p>\n

Legal requirements, good clinical practice, and ethical-professional responsibility are not separate concepts. Instead, they represent complementary components of a single system focused on the safety of healthcare and patient protection.<\/p>\n

Ultimately, the deeper value of reporting lies in the balance between professional competence, accountability, and continuous vigilance.<\/p>\n

Effective pharmacovigilance depends on both the quality and quantity of the data collected. This quality can only be maintained through the active participation of healthcare professionals who contribute directly to the identification, assessment, and monitoring of potential risks associated with medicinal therapies.<\/p>\n

References<\/p>\n

    \n
  1. Regulation (EU) No. 1235\/2010 of the European Parliament and of the Council<\/li>\n
  2. Directive 2010\/84\/EU of the European Parliament and of the Council<\/li>\n
  3. Italian Ministerial Decree of April 30, 2015<\/li>\n
  4. European Medicines Agency (EMA) \u2013 Good Pharmacovigilance Practices (GVP)<\/em><\/li>\n
  5. Italian Medicines Agency (AIFA) \u2013 Pharmacovigilance<\/em><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Is reporting an adverse drug reaction a legal obligation, an element of good clinical practice, or an ethical duty? 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