Bhagavathula Akshaya Srikanth, Elnour Asim Ahmed, Jamshed Shazia Qasim, Shehab Abdulla
Department of Clinical Pharmacy, University of Gondar-College of Medicine and Health Sciences, School of Pharmacy, Gondar, Ethiopia.
Department of Clinical Pharmacy, Faculty of Pharmacy, Fatima College of Heath Sciences, FCHS-Al Ain Campus, Al Ain, UAE.
PLoS One. 2016 Mar 24;11(3):e0152221. doi: 10.1371/journal.pone.0152221. eCollection 2016.
Spontaneous or voluntary reporting of suspected adverse drug reactions (ADRs) is one of the vital roles of all health professionals. In India, under-reporting of ADRs by health professionals is recognized as one of the leading causes of poor ADR signal detection. Therefore, reviewing the literature can provide a better understanding of the status of knowledge, attitude and practice (KAP) of Pharmacovigilance (PV) activities by health professionals.
A systematic review was performed through Pubmed, Scopus, Embase and Google Scholar scientific databases. Studies pertaining to KAP of PV and ADR reporting by Indian health professionals between January 2011 and July 2015 were included in a meta-analysis.
A total of 28 studies were included in the systematic review and 18 of them were selected for meta-analysis. Overall, 55.6% (95% CI 44.4-66.9; p<0.001) of the population studied were not aware of the existence of the Pharmacovigilance Programme in India (PvPI), and 31.9% (95% CI 16.3-47.4; p<0.001) thought that "all drugs available in the market are safe". Furthermore, 28.7% (95% CI 16.4-40.9; p<0.001) of them were not interested in reporting ADRs and 74.5%, (95% CI 67.9-81.9; p<0.001) never reported any ADR to PV centers.
There was an enormous gap of KAP towards PV and ADR reporting, particularly PV practice in India. There is therefore an urgent need for educational awareness, simplification of the ADR reporting process, and implementation of imperative measures to practice PV among healthcare professionals. In order to understand the PV status, PvPI should procedurally assess the KAP of health professionals PV activities in India.
自发或主动报告可疑药物不良反应（ADR）是所有卫生专业人员的重要职责之一。在印度，卫生专业人员对ADR报告的漏报被认为是ADR信号检测不佳的主要原因之一。因此，回顾文献可以更好地了解卫生专业人员在药物警戒（PV）活动方面的知识、态度和实践（KAP）状况。
通过PubMed、Scopus、Embase和谷歌学术科学数据库进行系统回顾。纳入2011年1月至2015年7月期间印度卫生专业人员关于PV的KAP以及ADR报告的研究进行荟萃分析。
系统回顾共纳入28项研究，其中18项被选入荟萃分析。总体而言，所研究人群中有55.6%（95%置信区间44.4 - 66.9；p<0.001）不知道印度药物警戒计划（PvPI）的存在，31.9%（95%置信区间16.3 - 47.4；p<0.001）认为“市场上所有可用药物都是安全的”。此外，28.7%（95%置信区间16.4 - 40.9；p<0.001）对报告ADR不感兴趣，74.5%（95%置信区间67.9 - 81.9；p<0.001）从未向PV中心报告过任何ADR。
在印度，卫生专业人员对PV和ADR报告的KAP存在巨大差距，尤其是在PV实践方面。因此，迫切需要提高教育意识，简化ADR报告流程，并在医疗保健专业人员中实施必要措施以开展PV实践。为了解PV状况，PvPI应按程序评估印度卫生专业人员PV活动的KAP。
