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There have been significant changes in the way the European Medicines Agency (EMA) expects marketing authorization holders (MAHs) to handle ICSRs from the new EudraVigilance system, creating additional work for already busy pharmacovigilance departments. In the past, the European Medicines Agency (EMA) would push Individual Case Safety Reports (ICSRs) via a gateway-to-gateway connection to the Manufacturer Authorization Holder (MAH)’s pharmacovigilance database. As part of the move towards simplified reporting, required as per the new EU pharmacovigilance legislation, the EMA is now putting more responsibility on MAHs by requiring them to log onto a common portal. Once logged into the EudraVigilance portal, MAHs must download ICSRs, review available files to identify relevant reports, and import those cases into their safety database.

This is an onerous task, made harder by the delivery of ICSRs in the E2B (R3) XML format. To determine relevance, the pharmacovigilance staff must manually review each ICSR. During this review the pool of available ICSRs are categorized into applicable cases and non-relevant cases. The usage of the E2B (R3) XML format means that ICSRs are not easily readable in their raw structure. The overall process is resource-intensive and inefficient.

Understanding the Challenges

During a recent ArisGlobal webcast, “From Push and Pull with EMA: A Modern Take on Triaging Adverse Events, we asked attendees, “What is your greatest challenge when it comes to triaging reports?” Responses were split evenly between handling the high volume of adverse events and time spent downloading files (both 37%). Other concerns were the reconciliation of applicable files and the manual segregation of files were considered priority concerns by fewer respondents (15% and 11% respectively). High volumes and time spent on activities go to the heart of the overarching issue companies face – that of managing a huge and growing workload with fewer resources.

But what if there is a better way to handle the triage and reconciliation of the ICSRs downloaded from EudraVigilance? ArisGlobal has developed a tool called LifeSphere® EV Triage (EudraVigilance triage tool), that automates the manual process of reviewing, triaging and reconciling the downloaded ICSRs. The tool uses an algorithm to filter-out relevant ICSRs from the available files. The algorithm uses the key parameters generally used by pharmacovigilance staff for review. The data elements include local trade name, active substance/active ingredient names, form of administration, route of administration and primary source country. These data points are referenced in the MAHs product dictionary and compared to the data within the ICSR files. The tool, therefore, can address both volume and time constraints associated with this activity.

The tool also provides an option to reconcile and archive downloaded cases. For cases that are determined to be not relevant, the tool archives them for future reference. This local repository eliminates the dependency of the MAH on the EudraVigilance portal to locate and retrieve cases that were initially determined to be non-relevant.

The LifeSphere® EV Triage tool incorporates most advanced automation and artificial intelligence (AI) technologies and is expected to substantially decrease the manual effort involved in ICSR download and triage. The smart analysis and auto-matching features ensure that relevant cases are identified and categorized appropriately. The natural language processing (NLP), employed for narrative analysis in this tool, is a self-learning technology that gets better at determining relevance, as more information on products is available to the safety system.

Addressing Automation Reservations

Any discussion about AI and automation, however, needs to account for industry reticence and uncertainty about the technology. So, in our webcast, we asked attendees, “What is the biggest hindrance in adopting automation technologies?” Perhaps not surprisingly, uncertainty over quality was considered the biggest barrier (48%) followed closely by cost of integrating existing systems (45%). Very few considered perceived ROI not justifying the investment or scarcity of skills major obstacles (4% in both cases). With the most advanced and proven automation technologies incorporated in LS EV triage tool, the performance of this tool is expected to be high. As per the feedback received by our early adopters, the tool has provided efficiency gains of up to 80%.

As there is no definite timeline communicated by EMA on resuming the gateway-to-gateway transmission of ICSRs, using a tool that automates the review and triaging process of ICSRs downloaded from EudraVigilance will relieve MAHs from the current burden of a manual process. Even when the direct transmission is resumed, MAHs would do well to streamline the triaging process so they have complete control over their safety cases.

We invite you to learn more on this topic by viewing our on-demand webcast From Push and Pull with EMA: A Modern Take on Triaging Adverse Events.

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