Every one of us at some point will take a medication and likely suffer some sort of adverse reaction. However, while some of us will actually read the product label and identify the possible adverse reactions, only a handful of us will ever report our experiences to the manufacturer. This lack of adverse event reporting software solution handcuffs drug manufacturers from fully understanding the safety profile and potential risks of a drug.
As such, companies and regulators are looking for a new approach to solving the challenges of reporting, resulting in a number of initiatives around direct patient reporting that leverage the internet and other communication channels to provide an easy way of submitting adverse event reports.
Of course, while we try to make adverse event reporting software easier for the patient, every company representative, including sales representatives and Medical Science Liaisons (MSLs), also have an obligation to report adverse events in accordance with company SOPs; this requires training to identify and report any potential adverse drug reactions in a timely fashion. The regulatory clock starts ticking the moment the company is aware of an adverse event and is one of the key areas of an inspection and a common reason companies suffer from incomplete or under-reporting. A common reason for under-reporting is partly due to education, but also typical reporting processes have been cumbersome and time consuming, discouraging staff from going through the process. On the other hand, license partners, distributors and healthcare professionals who have an obligation to report are simply looking for solutions to make the reporting process easier and faster.
But there is hope. There are 2.32 billion people using smartphones1 and 61% using smartphones for mobile banking2 , so it is safe to assume that in today’s world, mobile technology is widely accepted. By providing tools based on technology that we are all familiar with, the assumption is that we can increase reporting, awareness and therefore public safety.
And mobile reporting can be made easy. How? By making it simple to report adverse events without the need to register, by providing simple and intuitive reporting on any device, by offering wizard-based entry based on your contact profile, and by giving registered/specialist users access to more information (product leaflets, FAQs, etc.). Clearly nowadays, access needs to be available via smartphones, tablets or PC’s, and should offer off-line support – particularly useful for those annoying times when internet access is not available.
Demand more from your adverse event reporting software today.
Learn more about how to simplify your adverse event reporting process with LifeSphere Reporter™.