Under-reporting of adverse drug reactions A challenge for pharmacovigilance in India (Record no. 23698)
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| fixed length control field | 02741 a2200217 4500 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251203141839.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 251203b |||||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Author | Tandon, Vishal R. |
| 9 (RLIN) | 8222 |
| 245 ## - TITLE STATEMENT | |
| Title | Under-reporting of adverse drug reactions A challenge for pharmacovigilance in India |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.47(1), Jan-Feb |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Mumbai |
| Name of publisher, distributor, etc. | Wolter Kluwer |
| Year | 2015 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 65-71p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India.<br/>Materials and Methods: <br/><br/>A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance.<br/>Results: <br/><br/>At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | PHARMACOLOGY |
| 9 (RLIN) | 4774 |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Co-Author | Mahajan, Vivek |
| 9 (RLIN) | 27645 |
| 773 0# - HOST ITEM ENTRY | |
| Title | Indian Journal of Pharmacology |
| Place, publisher, and date of publication | Andheri - Mumbai Wolters Kluwer India Private Limited |
| International Standard Serial Number | 0253-7613 |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://journals.lww.com/iphr/fulltext/2015/47010/under_reporting_of_adverse_drug_reactions__a.13.aspx |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
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| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 03/12/2025 | 2025-1733 | 03/12/2025 | 03/12/2025 | Articles Abstract Database |