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1. Status of documentation grading and completeness score for Indian individual case safety reports.

Author

Vivekanandan, Kalaiselvan, Rishi, Kumar, Prasad, Thota, Arunabh, Tripathi, and Singh, G. N.

Subjects
*MEDICATION safety, *DRUG side effects, *COMPLETENESS theorem, *HEALTH outcome assessment
Abstract

The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour. [ABSTRACT FROM AUTHOR]

Published
2015
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