Tandon Vishal R, Mahajan Vivek, Khajuria Vijay, Gillani Zahid
Department of Pharmacology and Therapeutics, Government Medical College, Jammu, J and K, India.
Indian J Pharmacol. 2015 Jan-Feb;47(1):65-71. doi: 10.4103/0253-7613.150344.
The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India.
A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance.
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.
UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting.
评估印度药物不良反应（ADR）报告不足（UR）的程度及相关因素。
采用回顾性观察、基于问卷的横断面前瞻性分析，以评估药物警戒中ADR报告不足的程度及因素。
在撰写本报告时，印度有90个ADR监测中心（AMC）在运作。印度AMC的运作率为56.45%。我们中心每月通过VigiFlow报告的个体病例安全报告平均数量为48.038份。在3年期间，报告的ADR总数为3024例。每月平均报告数量为80.08份。主动监测与自发报告分别占ADR总数的66.13%和33.86%（P<0.0001）。门诊（OPD）的报告占总数的76.05%，住院报告占23.94%（P<0.0001）。医学科贡献最大（33%），其次是肿瘤科（19.27%）和胸科疾病科（13.49%）。药理学ADR监测OPD的贡献为16.20%。眼科、耳鼻喉科、外科、私立医学院、周边地区、分区和地区医院均无ADR报告。通过临床表现、生化检查和诊断工具检测到的ADR率分别为84.33%、14.57%和1.09%（P<0.0001）。研究生、住院医师、顾问和护士的报告率分别为72.65%、6.58%、16.56%和4.19%（P<0.0001）。药理学专业的研究生平均每月报告5.61份ADR报告。对印度药物警戒计划（PvPI）缺乏了解和认识、怠惰、冷漠、不安全感、自满、工作量大、缺乏培训是报告不足的常见因素。主要学术活动、考试、论文和摘要提交时间影响研究生报告ADR。
报告不足是印度药物警戒计划（PvPI）关注的问题。需要采取多种干预措施来改善ADR报告。
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