Best Practices for Improving the Quality of Individual Case Safety Reports in Pharmacovigilance. (July 2016)

• Record Type: Journal Article
• Authors: Kumar, Rishi; Kumar, Pranay; Kalaiselvan, Vivekanandan; Kaur, Ismeet; Singh, G. N.
• Is Part Of: Therapeutic innovation & regulatory science. Volume 50:Number 4(2016:Jul.)
• Page Start: 464
• Page End: 471
• Publication Date: 2016-07
• Subjects: pharmacovigilance -- Completeness score -- adverse drug reactions -- safety signals; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479016634766
• Languages: English
• ISSNs: 2168-4790

Abstract

Background: The quality of individual case safety reports (ICSRs) plays a vital role in identifying new safety signals in pharmacovigilance. This article focuses on establishing a method for ensuring the quality data. Objective: To develop an in-house method for assessing the documentation grading and completeness score of ICSRs. Methods: In the proposed method, 16 parameters, from report title to case narrative, are adopted to assess the quality of ICSRs. The in-house method ensures the completeness of the data and enhances the quality of ICSRs. Results: The in-house method was found effective in calculating the completeness score of ICSR ranges from 0.05 to 1. Indian ICSR completeness scores significantly improved after the implementation of the proposed method in the third quarter of 2013. In 2014 and until the third quarter of 2015, the score was found to be 0.91 and 0.93 out of 1, respectively. Conclusion: The higher quality ICSRs aids in more effective identification of new drug safety alerts and provides evidence-based information for regulating the drug safety.