The importance of a World Health Organization international pharmacovigilance database (VigiBase): novel methods for safety monitoring and surveillance of medical products

Abstract

Pharmacovigilance and medical product safety issues are important for all global citizens. Previous studies have analyzed the disaster caused by thalidomide in 1961. In 1963, the 16 th World Health Assembly was determined to create the World Health Organization (WHO) Pilot Research Project for International Drug Monitoring in order to develop and understand adverse effects of medical products. In 1968, this pilot research project developed into the WHO Programme for International drug Monitoring (earlier versions of VigiBase) coordinated by the Uppsala Monitoring Center (Uppsala, Sweden) which expanded in scale to include 153 member countries, 22 associates, and many regional reporting centers as of March 2022. The main goal of the WHO Global ICSR Database System (VigiBase) is detecting, understanding, assessing, and preventing adverse effects of medical products (herbals, complementary medicines, biologic products, blood products, medical devices, and vaccines). This article aims to provide appropriate and strong reference of adverse reactions in specific drugs and novel method to identify specific features of adverse drug reactions through data and information achieved by VigiBase.

Global burden of vaccine‐associated multiple sclerosis, 1967–2022: A comprehensive analysis of the international pharmacovigilance database

“…20 The IC has been validated and its effectiveness to identify signals has been confirmed in several studies. 14,15 The statistical formula for calculating the IC is as follows: IC = log 2 ([N observed +0.5]/[N expected +0.5]). N expected is the number of cases expected for the combination of vaccine and AEs and is calculated as [N vaccine × N adverse event ]/N total ; N observed refers to the number of case reports for a certain AE associated with a specific vaccine; N vaccine refers to the number of case reports for a specific vaccine regardless of AEs; N adverse event refers to the number of case reports for a given AE regardless of the vaccines; and N total represents the total number of case reports in the database.…”

“…All spontaneous reports included at least one vaccine suspected to be involved in the occurrence of AEs following immunization. According to the WHO definition, each AE is characterized as “non‐serious” or “serious.” 14,15 Fatal outcome was defined as fatal or death among serious AE. Physicians who submitted the ICSR determined the severity of the MS. Concomitant AEs were reported with vaccine‐associated MS.…”

“…The IC was calculated for case‐non‐case analysis using a Bayesian confidence propagation neural network, developed and validated by the Uppsala Monitoring Centre as the indicator value for disproportionate reporting 20 . The IC has been validated and its effectiveness to identify signals has been confirmed in several studies 14,15 . The statistical formula for calculating the IC is as follows: IC = log 2 ([ N observed +0.5]/[ N expected +0.5]).…”

“…The database consists of ICSR from over 150 countries, involving 25 000 drugs and vaccines, and includes 120 715 116 reports submitted from national pharmacovigilance centers since 1967 17 . Physicians, healthcare professionals, pharmacists, pharmaceutical companies, and patients spontaneously notify the ICSR database, and they are checked for quality of report, regularly reviewed, and analyzed based on predefined criteria 14,15 . ICSR is coded into preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA) 18 .…”

“…We conducted a comprehensive analysis of international pharmacovigilance studies focusing on vaccine-associated MS reported in VigiBase, which is the global postmarketing pharmacovigilance database maintained by the Swedish WHO Collaborating Centre for International Drug Monitoring, branded as the Uppsala Monitoring Centre (UMC), and has accumulated individual case safety reports (ICSR). [14][15][16] Individual reports include basic health data of the patient, adverse effect data, and drug data. The database consists of ICSR from over 150 countries, involving 25 000 drugs and vaccines, and includes 120 715 116 reports submitted from national pharmacovigilance centers since 1967.…”