Objectives: To implement the PSUR system in all wards of hospital. Reporting of PSURs for all the running newly launched drugs since 2011 in hospital periodically to DCG (I), New Delhi and assessment of the PSUR system functioning in the hospital. Methods: Prospective observational study. Drug safety reporting either manual or through online portal. Preparation and submission of PSURs as per Schedule Y of drugs and Cosmetics act, India. Results: To implement the DCG (I) initiative PSUR program, one PSUR committee, one drug safety review panel and one Delphi panel for PSUR system assessment has been constituted. Drug safety reporting and assessment tools are prepared and validated. A manual reporting system of drug safety has been set up and one link on hospital intranet website will be very soon available for online drug safety reporting through each ward and departments of hospital. Necessary training on drug safety reporting is provided to all health care professionals. Online hospital information services are in use to track the prescription of these drugs to the in-patients and then, these patients are extensively followed for any drug related problem during their hospital stay. All the associated drug safety reports routed through wards to PSUR work station. The collected reports are assessed and coded using various scales, tools and softwares, e. g. Naranjo Scale, Hartwig severity scale and MedDRA coding software etc. PSUR system functioning in the hospital is assessed at regular time intervals through tool which is prepared and validated using Delphi technique. So far, since its inception two PSURs has been successfully submitted to DCG (I) at six months regular interval and third one is ready to report for next phase. Conclusions: The present pioneering hospital based PSUR setup will create an environment for healthy safety reporting and helps the regulatory authorities for safety related decisions.
Lokhande, A. K., Unnikrishnan, M. K., Prabhu, M. M., Thunga, G., & Mallayasamy, S. R. (2014). Implementation and Assessment of Periodic Safety Update Reporting System at Tertiary Care Teaching Hospital, Karnataka, India: A Drug Controller General of India Initiative. Value in Health, 17(7), A793. https://doi.org/10.1016/j.jval.2014.08.447