Unlocking the possibilities of Mobile Technologies for Pharmacovigilance

Investigating how mobile technologies can be utilized to collect and leverage important drug safety information is one of the key components of the WEB-RADR project. So far three apps have been developed; how and if they will be used is still to be seen.

Imagine yourself waiting at the bus stop or in a hospital waiting room. In the good old days, people where reading books, newspapers or just relaxing – actually doing nothing – while waiting. Over the past few years this scenery has shifted dramatically. Nowadays it’s hard to find anyone, who is awake, not using their smartphone. The phone is always at hand, for example during dinner parties when discussions about the height of the Eiffel Tower or the size of Sweden is abruptly stopped by someone googling it on their smartphone.

The above reality is something that can and should be used also to improve pharmacovigilance. There are enormous possibilities for collection of information from all kind of resources but also to get information out to those that need it, when they need it.

One ongoing project aiming to explore these opportunities is the WEB-RADR project. The project has two major parts: one is about monitoring/mining social media streams as a new way of finding drug related safety information, while the other is more specifically about using mobile technologies for reporting safety concerns.

So why has the importance of data collection and information spreading increased? To start with, patients and healthcare professionals are much more used to search for information online, and they expect to find the answers. Many are also getting used to share information in different kind of social media forums, both general and more specialized forums. Moreover, the simplified access to medicines via web channels challenges the traditional way of data collection and risk communication (previously often communicated to healthcare professionals in “dear doctor” letters and leaflets).

Scientifically, there is also an increased need for more information. With a drive towards shortened development processes to get drugs out on the market earlier to benefit both patients and generate income earlier, there is an increased need to capture traditional “post marketing” information as part of the safety evaluation of new drugs. This new drive towards “accelerated release of medicines” was the subject of the Uppsala Forum conference arranged by Uppsala Monitoring Centre (UMC) in Uppsala end of May 2016. In the introductory talk Marie Lindquist (UMC) talked about Agile Pharmacovigilance which require deep involvement of all stakeholders throughout the development process of a drug.

What could then mobile technologies deliver that cannot be delivered via traditional channels like for example online web reporting.

As François Houÿez, Director of Treatment Information at EURODIS which is part of the WEB-RADR consortium, presented at Uppsala Forum there are a number of things a mobile device can bring to reporting of adverse events: Pictures taken by camera, bar code scanning for identification of medicines, geographical location (for SSFFC detection), health data collected via wearables, weather information (that could help explain respiratory issues for example), voice recordings, and so on. Especially the voice recording, which translates speech to text, is something that could really speed up and simplify the process of describing the event reported.

But why would anyone like to report an adverse event via a mobile app? Most patients report very rarely. Healthcare professionals should report more frequently, but what is in it for them? The answer to this is that the reporting functionality must be bundled with functionalities that are of use to the reporter. After interviews with users it emerged that reporters generally would like to get information back, such as reporting statistics, targeted news about the drug they take, and feedback on the reporting they do.

The initial app developed in the WEB-RADR project has focused on the latter parts – sending information back to the reporters – and kept the reporting functions simple, without including more advanced features like pictures and so forth. The reason to not include all features is that the project tries to keep to existing reporting standards, like E2B, in order to be able to use existing processes as far as possible, while at the same time getting the app itself interesting to install. Later in the project it is planned to upgrade to the coming E2B (R3) standard. This will allow more information to be embedded in the reports, but it will also require that the receiving systems at the involved authorities can handle this additional information.

E2B is the international standard used to transfer information about adverse events. The standard is quite elaborate and complex, so parallel to the WEB-RADR project, a “Simplified E2B guide for primary reporters” as well as a guide for transfer of such data to authorities have been developed.

Presently, there are three smartphone apps available in both iOS and Android versions delivered by the WEB-RADR project. The authorities behind those apps are Lareb (Netherlands), HALMED (Croatia) and MHRA (UK).

Much remains to be done before it will be as natural to look up drug safety information and report drug-related issues on our mobile devices as it is to google the height of the Eiffel Tower during dinner, at the bus stop, or in the hospital waiting room. The apps being developed in the WEB-RADR project will not take us all the way there, but they are important small steps on the road.