Pharmacovigilance Increasing Adverse Event Reporting subproject

December 3, 2018

The ICMRA Pharmacovigilance working group was formed to examine gaps in current pharmacovigilance practices. The ICMRA Pharmacovigilance Increasing Adverse Event Reporting (IAER) subproject was tasked in September 2017 to examine the opportunities, challenges, good practice and to facilitate international collaboration in this area, where feasible. The IAER subproject has a focus on increasing suspected adverse drug reaction (ADR) reporting and improving the quality of reports received by national PV systems. Led by the Medicines and Healthcare products Regulatory Agency in the UK, the subproject team has small group of 7 ICMRA members. The World Health Organisation are observers of the subproject. A project plan was developed with a key set of objectives (see context and scope within the survey report) for implementation through a phased approach endorsed by ICMRA.

Over a series of meetings, a survey was developed and then circulated to ICMRA members. The results are presented within the report below. The report contains case studies of various approaches and initiatives taken by individual ICMRA members. It also includes recommendations from the IAER subproject team; endorsed by ICMRA. It must be noted that the report represents a snapshot in time with information collected up to March 2018 that informed the discussions of the subproject group and the report.

ICMRA PhV Increasing Adverse Event Reporting subproject Survey Report

One of the IAER objectives was to explore the appetite and encourage ICMRA members to participate in the 3rd annual social media ADR awareness week campaign taking place from 19-23 November 2018. In a joint global effort, 36 medicines regulatory authorities participated in this social media campaign from the EU, Australasia, Latin America and the Middle East. For more information on this please see here.