A therapeutic risk management system is defined as a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimize risks relating to medicinal products. Regulators also require the system to be capable of determining the effectiveness of individual interventions and of the system as a whole. The resulting risk management plan (RMP) in the EU and the risk evaluation and mitigation strategy (REMS) in the US details all the activities, interventions and evaluation methods.
Unfortunately it has been demonstrated that data from some common evaluation methods such as measuring: distribution, awareness, utilisation, knowledge and behaviour don’t always correlate with the desired objective of the tool. Furthermore, the reporting of effectiveness often occurs over a long time period and for potentially ineffective tools that fail to address important safety risks this is unacceptable.
A mobile solution (validated mobile phone/tablet and app) offers an innovative way to address most of these problems. For instance, mobile devices allow: direct-to-user communications, the co-existence of multiple evaluation tools and for evaluation tools to be quickly updated from a central location and if necessary in any language.
But the unique selling point of any mobile device is that because it is “always on and always with you” real-time data evaluation becomes possible and where necessary a poorly performing risk minimization tool can be quickly removed or updated with the obvious benefit for patient safety.
If you want to hear more about developing mobile apps to determine the effectiveness of risk management tools or anything else relating to apps in pharmaceutical development then please email us at: firstname.lastname@example.org