Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India.
Indian J Pharmacol. 2012 Nov-Dec;44(6):699-703. doi: 10.4103/0253-7613.103253.
Lack of knowledge of pharmacovigilance (PhV) and adverse event (AE) reporting culture among the healthcare providers have been identified as major factors for under reporting of AE in developing countries. Hence, this study was planned to assess and compare the knowledge, attitude, and practices (KAP) of resident doctors and nurses about PhV and AE reporting.
This cross-sectional, questionnaire-based study was conducted to compare KAP of 100 doctors and 100 nurses on PhV and AE reporting.
All the respondents felt that AE reporting is necessary and two-thirds were aware of the existing PhV Program of India. Significantly, higher proportion of doctors had correct understanding regarding PhV (P<0.05) and knew what should be reported (P<0.05) but nurses (75%) knew better about where to report (P<0.001). Significantly (P<0.001), more doctors (98%) felt that the patients are benefited by reporting AE. Nurses (96%) felt the need for information on drugs causing AE and their management strategy (P<0.001). Around 60% of all the respondents were in favor of mandatory PhV and feedback on the submitted AE. Doctors (67%) (P<0.05) had a practice of inquiring patients for any untoward outcome of therapy. Higher proportion (P<0.05) of nurses (55%) mentioned that observed AE are recorded in patient's case record, but random screening of 1000 patients' record did not reveal it. Nurses mentioned that they never reported any AE (P<0.05) and witnessed discussions on ADRs during the ward rounds (P<0.001). All the respondents preferred phone as the convenient method for reporting AE followed by drop box kept in the ward/OPD and felt the need of frequent workshops and continuing medical education.
Resident doctors and nurses had good knowledge and awareness on AE reporting and PhV but their practices need to be improved.
在发展中国家，医疗保健提供者对药物警戒（PhV）和不良事件（AE）报告文化的了解不足是报告 AE 数量不足的主要因素。因此，本研究旨在评估和比较住院医生和护士对 PhV 和 AE 报告的知识、态度和实践（KAP）。
这项基于问卷调查的横断面研究比较了 100 名医生和 100 名护士对 PhV 和 AE 报告的 KAP。
所有受访者都认为 AE 报告是必要的，三分之二的人了解印度现有的 PhV 计划。显著的是，医生对 PhV 的正确理解比例更高（P<0.05），并且知道应该报告什么（P<0.05），但护士（75%）更了解应该报告的地方（P<0.001）。显著的是（P<0.001），更多的医生（98%）认为报告 AE 对患者有益。护士（96%）认为需要了解导致 AE 的药物及其管理策略的信息（P<0.001）。大约 60%的受访者赞成强制性的 PhV 和对提交的 AE 的反馈。医生（67%）（P<0.05）在询问患者任何治疗不良后果时，有实践。更高的比例（P<0.05）的护士（55%）提到在患者病历中记录观察到的 AE，但对 1000 名患者病历的随机筛查并未发现这一点。护士提到他们从未报告过任何 AE（P<0.05），并且在病房巡视期间目睹了关于 ADR 的讨论（P<0.001）。所有受访者都首选电话作为报告 AE 的便捷方式，其次是病房/门诊保留的投件箱，并认为需要频繁举办讲习班和继续教育。
住院医生和护士对 AE 报告和 PhV 有很好的了解和认识，但他们的实践需要改进。
