Additional Risk Minimization Measures are invaluable for mitigating drug-related risks that are both severe and preventable. Having aRMMs in place often improves patient outcomes, yet aRMMs are notorious for creating challenges in operations and during inspections.
So why are RM Teams struggling with additional RMMs?
While Module XVI is an EMA regulation, it is applied on a granular and localized scale, requiring decentralized negotiations. The exact contents of the aRMM and its implementation must be negotiated with the local health authority.
There are differences in the local versions of the aRMM and the Core version, preventing apples-to-apples comparisons. Once a company has implemented their aRMM, they must then evaluate how effective the activity was—a grim prospect when each activity varies based on location.
Most RM experts agree that defining parameters upfront is the most organized way to manage this data. Of course, sharing those definitions and then collecting the local affiliates’ responses introduces another layer of complexity. The result of these efforts is often unclear effectiveness outcomes, so companies are taking ‘one step forward, and two steps back.’
Finding the differences or deviations and understanding the status of every local version is key. The more versions of an activity or a submission there are, the greater the risk that something will be missed in the crosshairs.
Additional RMMs mitigate what are often extreme risks and provide great benefit to public health. Therefore, keeping track of both their implementation and effectiveness is imperative in improving patient outcomes. It is no secret that the combined complexity and necessity of aRMMs make them a target for increased scrutiny during inspections and audits. Proactive management of these processes is central to the success of your product and your organization.