Publicly Available Pharmacovigilance Databases of Suspected Adverse Drug Reactions Reporting

Publicly Available Pharmacovigilance Databases of Suspected Adverse Drug Reactions (ADRs) Reporting 

Introduction

Pharmacovigilance, defined by the World Health Organisation as 'the science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions (ADRs). The aim of pharmacovigilance is to continuously update and enhance knowledge about the safety of medicines in order to improve patient overall wellbeing.

The most important method of postmarketing drug safety surveillance is the spontaneous reporting system. Spontaneous reporting systems are an important tool in pharmacovigilance and are based on reports of ADRs from treating physicians, other healthcare professionals, patients or patient’s caregiver. These ADRs then final submitted to the regulatory agencies large databases like FDA Adverse Event Reporting System (FAERS), EudraVigilance (EV) and VigiBase.

Table: Worldwide Pharmacovigilance Databases

Country	Database	Description
US	FAERS	Adverse Event Reporting System by the US Food and Drug Administration (US FDA)
Europe	EudraVigilance	System maintained by the European Medicines Agency (EMA)
WHO	VigiBase®	Maintained by the World Health Organization’s (WHO’s) global database of individual case safety reports (ICSRs) maintained by the Uppsala Monitoring Centre, Uppsala, Sweden

1.    FDA Adverse Event Reporting System (FAERS)

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA by reporter. The database is intended to support the FDA's post-marketing safety surveillance program for FDA approved drug and biologic products. Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.   

The intention of FAERS Public Dashboard is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers.

·       Healthcare professionals, consumers, and manufacturers can submit reports to FAERS

·    FDA receives voluntary reports sent by healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). 

Key Highlights of FAERS

·         FAERS Public dashboard is a highly interactive web-based tool

·         Allows for the querying of FAERS data in a user friendly fashion

·         Data can be extracted in Excel spreadsheet and downloadable  

·         Provides raw data consisting of individual case safety reports

2.    EudraVigilance: European Database of Suspected Adverse Drug Reactions Reports   

EudraVigilance (EV) by European Medicines Agency is the database for collecting, managing and analysing suspected adverse drug reactions (ADRs) to medicines authorised in the European Economic Area (EEA). The use of any marketed health product is associated with the risk of an adverse reaction. 

Large databases of suspected adverse drug reactions represent an important source of data for signal detection activities. Different statistical disproportionality methods [e.g., Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR)] are available to facilitate the detection of potential signals from large databases such as EudraVigilance and Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.   

Who Can Access to Data Available in EudraVigilance?

Table: The stakeholders granted access to EudraVigilance data can be grouped as follows:

Stakeholders	Group
Medicines regulatory authorities in EEA Member States, the European Commission and the Agency	Stakeholder Group I
Healthcare Professionals and the Public	Stakeholder Group II
Marketing Authorisation Holders	Stakeholder Group III
Academia	Stakeholder Group IV
WHO – Uppsala Monitoring Centre	Stakeholder Group V
Medicines regulatory authorities in third countries	Stakeholder Group VI

(EudraVigilance Access Policy, 2019)

3.    VigiBase

VigiBase database maintained by the World Health Organization’s (WHO’s) global database of individual case safety reports (ICSRs) maintained by the Uppsala Monitoring Centre, Uppsala, Sweden, containing ICSRs submitted since 1968 by member countries of the WHO.    

The database system includes the

·         ICH E2B compatible ICSR database

·         WHO Drug Dictionaries (WHO-DD and -DDE)

·         Medical terminologies WHO Adverse Reaction Terminology (WHO-ART)

·         International Classification of Diseases (ICD)

·         Medical Dictionary for Regulatory Activities (MedDRA).

Reference:

1. FDA Adverse Event Reporting System (FAERS) Public Dashboard. Accessed from https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard.

2. EudraVigilance - European Database of Suspected Adverse Drug Reactions Reports. Accessed from https://www.adrreports.eu/en/index.html.

3. EU Individual Case Safety Report (ICSR) Implementation Guide, July 2017. 

4.    VigiBase. Accessed from https://who-umc.org/vigibase/.