PharmExpert LLC

Infographic illustrating the process of adverse event processing in pharmacovigilance, including data collection, evaluation, and regulatory reporting.

Adverse Event Processing

Efficient adverse event processing is critical in ensuring patient safety and regulatory compliance in the healthcare and pharmaceutical industries. By streamlining how adverse events are identified, reported, and managed, organizations can minimize risks while adhering to strict guidelines. Explore the best practices, tools, and solutions to enhance your adverse event processing systems for optimal results.

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

One of the main roles of MI is to ensure that healthcare professionals have access to accurate and up-to-date medical knowledge. This includes creating comprehensive responses to inquiries from physicians, pharmacists, and other stakeholders regarding a specific product or therapy.

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

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

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

1

Case Intake/receipt

2

Triage

3

Data Entry and Case Pocessing

4

Quality Review

5

Medical Review

6

Regulatory Submission

Procedure-Demo for processing of adverse event reports occurring during Clinical Trials (CT) and Post-Marketing Safety Studies (PASS) information 

Standard Operating Procedure (SOP) for Adverse Event Processing in Clinical Trials

Procedure-Demo for processing of post-marketing Adverse Event (AE) reports and other safety related information

Standard Operating Procedure (SOP) for Adverse Event Processing in Pharmacovigilance

Procedure-Demo for assessment of safety data

Standard Operating Procedure (SOP) for Case Assessment in Pharmacovigilance