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

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....

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Detalles Bibliográficos
Autores principales: Vivekanandan, Kalaiselvan, Rishi, Kumar, Prasad, Thota, Arunabh, Tripathi, Singh, G. N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Short Communication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4450561/
https://www.ncbi.nlm.nih.gov/pubmed/26069373
http://dx.doi.org/10.4103/0253-7613.157133
Descripción
Sumario: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.

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