Currently, most of the global work for signal research in the post marketing phase is based on data from the Individual case safety reports (Icsr). However, the tendency is to use big data for pharmacovigilance studies more and more massively.

Post marketing drug safety analysis are used now a huge numbers of data related to reporting of adverse reactions from disparate sources. What are the potentials and the critical points?

Health Database network

The growing use of health database networks led to development of new analytical methodologies through the elaboration of large volumes of heterogeneous data, as done by the Observational health data sciences and informatics (Ohdsi), which developed
methods and tools for building network infrastructures database. Similarly, the Protect initiative showed how it is possible to conduct analysis on multiple databases, through
the adoption of common protocols rather than through analysis centralized data. Moreover, EMA has coordinated a network of centers of Pharmacoepidemiology and pharmacovigilance (Encepp) consisting of about 200 public institutions and Contract research organization (Cro) involved in activities related to pharmacoepidemiology and pharmacovigilance. In the context of database networks used for pharmacovigilance, two are the initiatives of reference implemented internationally:

  • Sentinel (FDA)
  • EU-Adr (EU)

Other international networks have been established in recent years, with the aim of increasing the power of the post marketing studies on drugs and vaccines, including Aritmo, Safeguard, Advance, Sos, Euromedicat in Europe, Cnodes in Canada and Asian pharmacoepidemiology network (Aspen) in Asia and Australia.

Social media

Social media are heterogeneous data source. The use of these data for pharmacovigilance is full of challenges, not least the fact that the main purpose of most publications is different from reporting a suspected link between one specific health intervention and an adverse event. Clearly, when clinical or patient concerns come expressed on social media about the perceived damage associated to a health intervention, these should be treated
as such. Furthermore, the way in which patients and health professionals consider the effectiveness of treatments or define needs dissatisfied is important for those who develop drugs. However the potential adverse event posted on Social Media often do not meet the basic regulatory definitions of an Individual case safety report (ICSR). In fact, an Icsr is considered valid if it contains at least:
a. an identifiable patient;
b. an identifiable marker;
c. a suspicious drug;
d. an event / negative result.