Streamlining Case Management: The Role of Tiered Case Processing in Pharmacovigilance
The monitoring of the safety of medicinal products is an ongoing and important process throughout their lifecycle. The past decade witnessed a significant increase in the availability of sources for reporting Adverse Events (AEs), providing valuable insights into the safety profile of these products. Market Authorization Holders (MAHs) are now able to collect, evaluate, and report AEs from a variety of sources, including clinical data, electronic patient records, call centers, medical literature, and patient support programs, among others. This expansion of data sources has led to an increase in the number of Individual Case Safety Reports (ICSRs). The volume of Individual Case Safety Reports (ICSRs) is reaching an all-time high. This increase in data presents a challenge for safety operations but also an opportunity for the life sciences industry to optimize resource allocation and develop more efficient methods to manage and utilize these insights.
In 2021, the number of ICSRs related to suspected adverse reactions collected and managed in EudraVigillance2 were 3.5million
Source: 2021annual report on EudraVigillance for the European parliament, the council and the commission.
From 2010 to 2022, adverse events reporting1 has increased at a CAGR of 9.9%
Source: FAERS public data base - AE reports from 2012 to 2022
The Potential of Tiered Case Processing in Pharmacovigilance
To effectively scale, a systematic approach is needed that efficiently allocates resources to serious and clinically important cases, while still allowing for a thorough assessment of all reported AEs. One solution is to group and channel AEs based on complexity, relevance, seriousness, and a variety of other factors. Taking this a step further, leveraging technology such as analytics and Artificial Intelligence based predictors can accelerate the process of systematically codifying cases right from the point of identification. This technology-enabled, tiered case processing approach is the key to the next wave of Pharmacovigilance ICSR case automation, paving the way for the future of pharmacovigilance. This technology-enabled, tiered case processing approach is the key to the next wave of Pharmacovigilance ICSR case automation, paving the way for the future of pharmacovigilance.
This approach can potentially help to address four key challenges faced by pharmacovigilance systems, including:
Managing large volumes of data
Identifying and addressing potential safety concerns
Allocating resources effectively