At the end of February 2017, the Italian Agency of Medicines, AIFA, announced on its website (http://www.agenziafarmaco.gov.it/) the launch of a new modality for reporting suspect adverse reactions to drugs and vaccines. Healthcare professionals and citizens in Italy can now report directly from the Internet, using the website www.vigifarmaco.it. Once filled, the report reaches the person responsible for pharmacovigilance in the local health authorities and, from there, the Pharmacovigilance National Network.
The system not only allows to send the reports much quicker (there is no need to look for the form, the address or the fax number to whom the report needs to be sent to), but it also reduces substantially the workload related to the management and the upload of the reports in the AIFA database.
The platform has been developed for AIFA by the University of Verona in collaboration with the Pharmacovigilance Centre of Veneto. AIFA’s collaboration with the University research world arises from the necessity of experimenting new methods for gathering and analysing spontaneous report data. The recent European regulation focuses both on citizens spontaneous reporting and on the use of digital instruments for reporting adverse drug reactions. In fact, the European directive (art. 107b) states that the adverse reactions can be reported by using national web portals. The equivalent Italian implementing decree (decree April 30, 2015 art. 22) states that practitioners and citizens can report by using the AIFA web portal.
Online reporting is now a reality in every European country and it is widely used. In Italy, Veneto firstly introduced Vigifarmaco in January 2014 and, after about one year, once the system had been tested by other regions, it was launched on a national level.
The number of web reports has been raising quickly and in Veneto, in some structures, the number of web reports is now higher that the hard-copy ones. The type and number of people reporting adverse drug reactions has not changed substantially though, highlighting the shift from paper to web for those healthcare professionals already actively reporting, but also showing that the new reporting modality has not involved new subjects yet, especially among the citizens. It should be underlined, however, that Vigifarmaco was launched by the AIFA website only at the end of February 2017, before it did not appear in the first pages of any search engine, which surely limited its use.
Several different aspects concerning adverse reaction reporting by using the Internet have been object of studies over the last years. One of these regards how the subject reporting the adverse drug reaction describes it. Almost every online reporting system requires choosing the words for describing the adverse drug reaction from a drop-down menu or from an autocomplete textbox. The person who is reporting the adverse drug reaction has to choose from a list that usually includes terms from the MedDRA terminology, the point of reference for all spontaneous reporting systems. This structure reduces the workload for the pharmacovigilance centre that has to decode the adverse reaction, but complicates the choice for the person reporting it, whom has to choose the right words from a list of over 70,000 words. In some cases, a simplified version of MedDRA has been developed, but the number of terms is still very high and they are also difficult to distinguish. This might induce mistakes, especially when citizens are reporting an adverse reaction. In fact, they tend to describe it more in detail compared to the healthcare professionals, also using non-scientific terms.
In Vigifarmaco, the user describes the adverse reaction writing in a blank textbox, to allow full freedom to the person reporting it. The pharmacovigilance responsible of the Health Local Authorities, however, can use a software that assigns automatically MedDRA codes to the description.
Another important aspect concerns the possibility of reporting adverse reactions through mobile devices (e.g. smartphones), widely used by the population. In 2016, in Italy, the number of internet users connected by smartphone and tablet overtook the number of internet users by PC or laptop. It is therefore essential to facilitate the use of mobile devices for reporting adverse reactions. In this context, it is possible to adapt the website visualisation for the smartphone screen or to develop specific Apps for reporting adverse reactions. The Apps must be adapted to the dispositive operative system (Android o iOS) and allow the use of several functions largely employed in different contexts. With an App, it might be possible to take a picture of a rash, talk instead of writing to describe a reaction, take a picture of the package of the suspected drug or send the report to the competent person according to the location of whom is reporting the adverse reaction (geolocalization). The Apps could also provide information from the Pharmacovigilance Centre back to the person whom reported the adverse reaction.
In Europe, a specific project (WEB-RADR) that involves among others EMA and some European agencies is working also on reporting through Apps. Within the project (consultable from the website www.web-radr.eu), a first version of the App has been developed, even though it does not include many of the described features yet. The App, available for Android and iOS, has been launched in the United Kingdom, in the Netherlands and in Croatia. In the UK, the App has become available since August 2016 and has gathered less than one thousand reports so far. This modest amount underlines the challenges of getting more people involved in reporting adverse reactions despite the modality in use. On one hand, the patients taking the most drugs and therefore at higher risk of adverse reactions are the elderly, usually less comfortable with technology. On the other hand, healthcare professionals (e.g. practitioners) already use other systems for the management of their patients, including adverse drug reactions, and have little time left for reporting, even through an App.
In regard to Vigifarmaco, both the mobile device version and the App will become available shortly. In the meantime, however, a link between the System and one software used by the general practitioners (Momed by Videopress) has already been activated. By means of this link, a practitioner who would like to report an adverse reaction already registered in the patient clinical file could upload the necessary information adding to the data already available on the System and with a simple click, send the report to Vigifarmaco. A similar link is about to be launched with the Informative System of the Vaccine Regional Register in Veneto, for reporting adverse events after the vaccination. It would be desirable that other software houses decided to implement the link to Vigifarmaco with their systems.
An e-learning course about Vigifarmaco
Between December 2015 and December 2016, the first distance learning course dedicated to Vigifarmaco was launched within the programme FaViFAD on www.saepe.it. The aim of the course was to explain the use of the platform Vigifarmaco to the healthcare professionals in order to simplify and increase their accurateness when filling the fields for reporting an adverse drug reaction.
The course, structured with daily practice cases to make the use of the platform more direct, invited the participants to use Vigifarmaco later on for their reporting.
Ten Regions (Basilicata, Campania, Emilia-Romagna, Lazio, Lombardy, Marche, Piedmont, Puglia, Sicily, Veneto) and the Autonomous Province of Bolzano supported the course, granting free access to their healthcare professionals.
In total, there has been a participation of 6,089 healthcare professionals, with peaks in Lombardy (1,431), Veneto (1,277) and Emilia-Romagna (1,056).
Customer satisfaction data showed that the course was highly appreciated, with percentages of effectiveness and usefulness between 98 and 99% from the participant answers, data confirmed also by the comments left by the users in the platform, positive in 98.5% of the cases.