Adverse Event Processing

Adverse Event management in Pharmacovigilance plays a crucial role in ensuring the safety and efficacy of medicinal products. Therefore, it also plays an important role in the continuous monitoring of their potential side effects.

Adverse Event vs Adverse Reaction

An adverse event is any unfavorable medical occurrence in a patient or clinical trial subject who has been prescribed a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

An adverse reaction is an unintended unfavorable reaction of the body associated with the use of a medicinal product and suggesting a relationship with the use of the suspect medicinal product.

A key component of pharmacovigilance is the individual case safety report (ICSR). ICSR consists of detailed information about adverse events (AEs) to medicines or other problems associated with medicines reported by patients, healthcare professionals or pharmaceutical companies. Moreover, these adverse event reports serve as a valuable source of data for national competent authorities, allowing them to continuously assess and manage the benefit-risk profiles associated with medicinal products.

Adverse event management and processing are essential aspects of pharmacovigilance activities: from data collection and entry to assessment and clinical analysis. In addition, ensuring the quality and accuracy of the ICSR is essential for identifying new safety signals and making informed decisions on the safety of medicinal products.

Importance of Adverse Event Processing

Ensuring Patient Safety: Effective AE processing allows healthcare professionals to identify and minimize risks associated with medications, ensuring safer patient outcomes.

Regulatory Compliance: Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate comprehensive reporting of adverse events to monitor drug safety post-marketing. Non-compliance can result in significant penalties.

Pharmaceutical Innovation: By identifying and understanding adverse events, pharmaceutical companies can improve their products, leading to safer and more effective medications.

Public Trust: Transparent adverse event reporting enhances public confidence in healthcare systems and the safety of medications.

Challenges in Adverse Event Processing

Underreporting: A significant challenge in AE processing is the tendency for healthcare providers and patients to underreport adverse events. This limits the data available for comprehensive analysis and understanding of the safety profile of medications.

Data Quality and Consistency: Variability in reporting formats, terminologies, and interoperability among various healthcare systems complicates data aggregation and analysis.

Complexity of Medical Products: As therapeutic options expand to include biologics, biosimilars, and combination therapies, understanding the interactions and potential adverse events becomes increasingly complex.

Resource Constraints: Pharmacovigilance departments often face resource limitations, both in terms of personnel and technology, hindering their ability to process adverse events swiftly and effectively.

What We Do?

In accordance with the agreement with the Marketing Authorization (MA) holders, PharmExpert LLC takes appropriate measures to collect and collate all reports of suspected adverse reactions (ARs) received from various sources without prior request and received upon request in authorized markets.

The PharmExpert pharmacovigilance (PV) system is designed to ensure that the collected ARs are reliable, legible, accurate, consistent, verifiable and as complete as possible for their clinical assessment.

Furthermore, all notifications containing PV data record and archive are in compliance with the applicable data protection requirements.

The company PV system allows reports of suspected ARs to be validated in a timely manner. Also, it is applicable to exchange reports between national competent authority and MAHs within the legal submission time frame.

ICSR Processing Stages by PharmExpert PV Team