On the 2nd July 2012 , changes to European Union pharmacovigilance legislation (Directive 2010/84/EU; Regulation 1235/2010) were brought into effect. Amongst these changes was one key new requirement for pharmaceutical companies, to now capture information about potential ‘off-label’ use of medicines within their product portfolio.
In one amendment, to Article 24(1), the significance of the changes are clear:
“The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.”
The key words here are “…as well as from uses outside the terms of the marketing authorisation…”
It has been noted by some in the past, that some pharmaceutical companies have felt reluctance toward social media, in part due to the perceived increase in volume of potentially reportable adverse events. With these recent legislative changes, it may on first glance appear that the new requirements create even more of a challenge to being involved in social media conversations.
On the contrary, whilst this does increase the requirement to have a thorough strategy and process for approaching social media monitoring, the many advances in social media listening technology mean that this level of capturing information does not need to be laborious or difficult.
Creation Healthcare have been training companies in social listening techniques for many years, having helped propagate the now commonly used terms ‘Active’ and ‘Passive’ listening. In recent times, we have been working with the frontier of natural language processing technologies to help develop semantic analysis of online conversation for pharmaceutical use.
Natural language processing systems in healthcare are something that readers of the Healthcare Engagement Strategy e-Journal should be familiar with to some extent. For the uninitiated, to summarise, they are not simply traditional key word searching tools – but intelligent analysis engines that are able to perceive the importance and context of information, rather than just the number of times a word or phrase is mentioned. In this way they can sort information into buckets and follow a workflow to make sure business critical intelligence is seen by the right people within the organisation.
For pharmaceutical companies, we believe this can be a strategic asset for achieving more through social listening. Moving beyond ‘buzz-monitoring’ into natural language processing can ideally serve to reduce human resource requirements, and could in some cases help to increase the quality of compliance visibility and reporting.
Rather than being a burden for a pharmaceutical company, well documented cases of efficacious off-label produce use may inspire the consideration of additional marketing authorisation in a new market or new indication. This is the power of crowd-sourced media, potentially leveraged to inform and drive new business objectives and therapeutic expansion.
Again, having such a system ‘trained’ on your product brand names can provide early warning of previously undetected issues so that you can mitigate corporate risk. Yet the more exciting possibility is that these could also identify new opportunities that are not just about marketing or reputation management, but about the core business proposition.
We probably all acknowledge that more and more people are coming online every day, in many more languages. We know that people are talking about health and wellness, and treatment and products. Perhaps the industry has shied away in the past from social media due to pharmacovigilance requirements, however this could be the era in which we get the proverbial ‘ducks in a row’ and develop a strategy for embracing social media listening and more.
Perhaps these recent changes in EU legislation will be a catalyst for the next level of advanced social media monitoring systems and resourcing. Only time will tell.
In the meantime, Creation Healthcare provides training for digital teams and brand managers, to help them understand and respond to changes in legislation around pharmacovigilance. Additionally, we can help you set up and run a monitoring system or command centre which takes the company from a position of watching at a distance, to being totally informed about real-time trends and changes in the way your products are mentioned. Potentially, the science of natural language processing has the power to produce evidence for entirely new marketing authorisation, as well as safer medicines for all.