We are pleased to announce the release of the 'Best Practice In Reporting of Individual Case Safety Reports (ICSRs)'. The guide sets the MHRA's position on how to code adverse drug reactions (ADRs) to a high-quality standard for entry into our Sentinel database.
Data quality of ICSRs is an important issue that affects all stakeholders, particularly to support accurate detection and analysis of drug safety signals. Furthermore, errors in reports create a large volume of enquiries, resulting in a significant administrative burden for both industry and the MHRA in updating cases. The need to develop a guide was identified as a Better Regulation of Medicines Initiative (BROMI), combining ideas from both the MHRA and UK industry trade associations to address differences that occur in classification and coding practices across companies.
Industry colleagues may be aware that in parallel to producing this guide we have been conducting quality audits on a company by company basis. The selection for audit may be based upon concerns raised through review of reports at signal assessment, compliance data or intelligence gathered from pharmacovigilance inspections.
Companies with a high error rate are invited to discuss the findings. It is hoped the guide will contribute to delivering high standards in classification by highlighting common findings from audits of ICSRs and providing specific examples of good practice. We see the guide as a useful way to improve quality without the need for face-to-face meetings with companies.
We hope you find this guidance helpful and are able to implement the best practice within your pharmacovigilance system. If you have any comments or questions, please send them to the Pharmacovigilance Service Desk by email pharmacovigilanceservice@mhra.gsi.gov.uk
Best Practice in Reporting of Individual Case Safety Reports (ICSRs) 
