{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T10:25:41Z","timestamp":1793787941468,"version":"4.6.1"},"reference-count":30,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T00:00:00Z","timestamp":1785110400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Risk &amp; Safety in Medicine"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Adverse drug reactions (ADRs) are a major cause of medication-related morbidity and contribute significantly to healthcare burden. Systematic evaluation of ADRs is essential for strengthening pharmacovigilance and improving patient safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the severity, predictability, preventability, causality, management, and outcomes of ADRs reported to an Adverse Drug Reaction Monitoring Centre (AMC) in a tertiary care teaching hospital.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>An observational study was conducted using ADR reports submitted to the AMC between January and December 2025. Eligible reports were extracted from the VigiFlow database and analyzed using standardized pharmacovigilance assessment tools. Descriptive statistics were used to summarize the data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 1,994 ADR reports were analyzed. Adults (59.0%) and elderly patients (28.0%) accounted for most reports. Mild ADRs predominated (64.3%), while 77.2% were classified as predictable Type A reactions. Preventability assessment showed that 72.9% of ADRs were either definitely or probably preventable. Most ADRs were non-serious (81.6%) and categorized as probable (65.1%) on causality assessment. Gastrointestinal disorders were the most commonly affected organ class, and anti-invectives were the most frequently implicated drug class.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Most ADRs were mild, predictable, and potentially preventable, highlighting opportunities to enhance medication safety through rational prescribing, therapeutic monitoring, and strengthened pharmacovigilance practices.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/09246479261472658","type":"journal-article","created":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T06:51:56Z","timestamp":1785221516000},"page":"519-528","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Real-world drug safety surveillance in south India: Experience from an ADR monitoring center"],"prefix":"10.1177","volume":"37","author":[{"given":"Pratiksha","family":"Kini","sequence":"first","affiliation":[{"name":"Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mandati Santhosh","family":"Reddy","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.S.","family":"Ganachari","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,7,27]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-023-03457-9"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13601-019-0259-6"},{"issue":"5","key":"e_1_3_4_4_2","first-page":"e60977","article-title":"Exploration and evaluation of adverse drug reactions documented in a tertiary-care hospital in Chennai: an in-depth retrospective observational study","volume":"16","author":"Selva P","year":"2024","unstructured":"Selva P, Durairajan S. Exploration and evaluation of adverse drug reactions documented in a tertiary-care hospital in Chennai: an in-depth retrospective observational study. Cureus 2024; 16(5): e60977. https:\/\/doi.org\/10.7759\/cureus.60977","journal-title":"Cureus"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.5083\/ejcm\/2023"},{"key":"e_1_3_4_6_2","unstructured":"Indian Pharmacopoeia Commission. Handbook of Pharmacovigilance Programme of India (PvPI). Ghaziabad: Indian Pharmacopoeia Commission; 2025 [cited 2026 Jul 19]. Available from: https:\/\/www.ipc.gov.in\/images\/Handbook_PvPI_-_10.3.2025.pdf"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-025-01642-6"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1177\/09246479251364713"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200528010-00002"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.2196\/40080"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-023-01302-7"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare14070930"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1080\/20523211.2024.2378461"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.18203\/2320-6012.ijrms20180310"},{"issue":"9","key":"e_1_3_4_15_2","first-page":"2229","article-title":"Preventability and severity assessment in reporting adverse drug reactions","volume":"49","author":"Hartwig SC","year":"1992","unstructured":"Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49(9): 2229\u20132232.","journal-title":"Am J Hosp Pharm"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.282.6268.974"},{"issue":"5","key":"e_1_3_4_17_2","first-page":"e59975","article-title":"Causality, severity, preventability and predictability assessment scales for adverse drug reactions: a review","volume":"16","author":"Manjhi PK","year":"2024","unstructured":"Manjhi PK, Singh MP, Kumar M. Causality, severity, preventability and predictability assessment scales for adverse drug reactions: a review. Cureus 2024; 16(5): e59975. https:\/\/doi.org\/10.7759\/cureus.59975","journal-title":"Cureus"},{"key":"e_1_3_4_18_2","unstructured":"World Health Organization. The use of the WHO-UMC system for standardised case causality assessment. Geneva: World Health Organization; 2013 [cited 2026 Jul 19]. Available from: https:\/\/www.who.int\/docs\/default-source\/medicines\/pharmacovigilance\/whocausality-assessment.pdf"},{"issue":"9","key":"e_1_3_4_19_2","first-page":"e44984","article-title":"Pharmacovigilance study of anticancer drugs in a tertiary care teaching hospital in North India: a retrospective study","volume":"15","author":"Kumar RS","year":"2023","unstructured":"Kumar RS, Jindal A, Garg P, et al. Pharmacovigilance study of anticancer drugs in a tertiary care teaching hospital in North India: a retrospective study. Cureus 2023; 15(9): e44984. https:\/\/doi.org\/10.7759\/cureus.44984","journal-title":"Cureus"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.18203\/2319-2003.ijbcp20240033"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.3399\/BJGP.2022.0181"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.4103\/jfmpc.jfmpc_2374_20"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1177\/0976500X221130841"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.5530\/ijpi.20250144"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.13040\/IJPSR.0975-8232.14(12).5831-40"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.18203\/2319-2003.ijbcp20194778"},{"key":"e_1_3_4_27_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-052737"},{"key":"e_1_3_4_28_2","doi-asserted-by":"publisher","DOI":"10.1177\/09246479241304316"},{"issue":"9","key":"e_1_3_4_29_2","article-title":"Pattern of adverse drug reactions at a tertiary care hospital, Kerala, India: a cross-sectional study","volume":"18","author":"Sruthi S","year":"2024","unstructured":"Sruthi S, Nair MK, Reshma S. Pattern of adverse drug reactions at a tertiary care hospital, Kerala, India: a cross-sectional study. J Clin Diagn Res 2024; 18(9). https:\/\/doi.org\/10.7860\/JCDR\/2024\/72989.19887","journal-title":"J Clin Diagn Res"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-055551"},{"key":"e_1_3_4_31_2","doi-asserted-by":"publisher","DOI":"10.7324\/JAPS.2024.187314"}],"container-title":["International Journal of Risk &amp; Safety in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/09246479261472658","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/09246479261472658","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/09246479261472658","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T09:37:58Z","timestamp":1793785078000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/09246479261472658"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,27]]},"references-count":30,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,11]]}},"alternative-id":["10.1177\/09246479261472658"],"URL":"https:\/\/doi.org\/10.1177\/09246479261472658","relation":{"has-review":[{"id-type":"doi","id":"10.1177\/09246479261472658\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/09246479261472658\/v2\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/09246479261472658\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/09246479261472658\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1177\/09246479261472658\/v2\/decision1","asserted-by":"object"}]},"ISSN":["0924-6479","1878-6847"],"issn-type":[{"value":"0924-6479","type":"print"},{"value":"1878-6847","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,27]]}}}