Real-time pharmacovigilance with the VigiBase API

Modern technology with mobile apps, online reporting, and integrated pharmacovigilance systems open up efficient medicines safety processes. The VigiBase API is an important building block to achieve real-time reporting of adverse effects.

Tightly connected pharmacovigilance systems are not only possible within a country but also on a global scale, and a quicker reporting process has the potential for faster intervention when adverse drug reaction (ADR) events take place.

“The sooner data is shared – from the event occurring to the report being available for analysis – the sooner we will be able to detect emerging safety issues, also on a global level,” Anki Hagström, the head of Uppsala Monitoring Centre’s Global Services department, said.

Imagine the following scenario: A patient suffers from a serious adverse reaction after taking a medicine. The patient recollects the latest TV awareness campaign about the importance of reporting ADRs. Via the website of the regulatory agency in the patient’s country, an online ADR reporting form is available. In addition, a medicinal dictionary is linked to the online form for easy selection of the specific, correct medicine that the patient was exposed to. The completed report is automatically uploaded in the national pharmacovigilance system with all available information, including correct medicine according to the dictionary.

Since the reaction was reported as serious it is automatically highlighted and therefore quickly handled by pharmacovigilance staff, who only have to code reactions from any free text and to perform causality assessment. As soon as the ADR report is completed, a copy of the report is automatically submitted to VigiBase, the WHO global ICSR (Individual Case Safety Report) database. Within a week, the ADR report is available in the VigiLyze and VigiAccess tools for signal detection and analysis. The picture show VigiAccess data on adverse event statistics presented in a mobile app.

The above scenario is already available today with existing technology. However, to make the process tighter, better connections between disparate pharmacovigilance systems are required to minimise the need for manual interventions and to integrate international standards from the start.

One of the building blocks needed in this scenario is the functionality that allow automatic and real-time reporting of ICSRs from national pharmacovigilance centres to VigiBase. This is achieved with the newly released VigiBase API service. The API has been developed with simplicity in mind, yet it satisfies the demands of security and audit trail.

Connecting national pharmacovigilance systems directly to VigiBase will eliminate the need for error-prone manual interactions, thereby allowing reports to be shared one by one as they are completed, and not in batches every week, month, or quarter as is common today.

All regulatory agencies in the process of developing a new system, re-building an old system, or that have an old system in place that could be easily modified, should consider connecting to the VigiBase API. The API is already used by VigiFlow and by one national pharmacovigilance centre’s system. It will also be used by the European Medicines Agency from the end of 2017 according to current plans. A guideline on how to connect to the VigiBase API is available upon request.

Real-time data sharing via the VigiBase API will make safety data rapidly available to the global community, thereby improving patient safety and public health.

This blog post is also published in Uppsala Reports #75 page 16.