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Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India

AIM: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India. MATERIALS AND METHODS: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR o...

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Autores principales: Tandon, Vishal R., Mahajan, Vivek, Khajuria, Vijay, Gillani, Zahid
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4375822/
https://www.ncbi.nlm.nih.gov/pubmed/25821314
http://dx.doi.org/10.4103/0253-7613.150344
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author Tandon, Vishal R.
Mahajan, Vivek
Khajuria, Vijay
Gillani, Zahid
author_facet Tandon, Vishal R.
Mahajan, Vivek
Khajuria, Vijay
Gillani, Zahid
author_sort Tandon, Vishal R.
collection PubMed
description AIM: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India. MATERIALS AND METHODS: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance. RESULTS: 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. CONCLUSION: UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting.
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spelling pubmed-43758222015-03-27 Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India Tandon, Vishal R. Mahajan, Vivek Khajuria, Vijay Gillani, Zahid Indian J Pharmacol Research Article AIM: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India. MATERIALS AND METHODS: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance. RESULTS: 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. CONCLUSION: UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting. Medknow Publications & Media Pvt Ltd 2015 /pmc/articles/PMC4375822/ /pubmed/25821314 http://dx.doi.org/10.4103/0253-7613.150344 Text en Copyright: © Indian Journal of Pharmacology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Tandon, Vishal R.
Mahajan, Vivek
Khajuria, Vijay
Gillani, Zahid
Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India
title Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India
title_full Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India
title_fullStr Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India
title_full_unstemmed Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India
title_short Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India
title_sort under-reporting of adverse drug reactions: a challenge for pharmacovigilance in india
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4375822/
https://www.ncbi.nlm.nih.gov/pubmed/25821314
http://dx.doi.org/10.4103/0253-7613.150344
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