Gupta Sandeep Kumar, Nayak Roopa P, Shivaranjani R, Vidyarthi Surendra Kumar
Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India.
Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India.
Perspect Clin Res. 2015 Jan-Mar;6(1):45-52. doi: 10.4103/2229-3485.148816.
The primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Perambalur (Tamil Nadu), a tertiary care teaching hospital. The second primary objective was to assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India. The secondary objective was to compare the findings of this study with the results of the published studies from India on evaluation of the KAP of pharmacovigilance among healthcare professional.
A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the DSMCH, Perambalur (Tamil Nadu) during the study period were included. Only those who gave their consent to participate were included in the study. The data was analyzed by using the Statistical Package for Social Sciences (SPSS) statistical software, version 16.
One hundred and fifty pretested questionnaires were distributed among the healthcare professionals and 101 responded. 62.4% healthcare workers gave correct response regarding the definition of pharmacovigilance. 75.2% of healthcare workers were aware regarding the existence of a National Pharmacovigilance Program of India. 69.3% healthcare professional agreed that ADR reporting is a professional obligation for them. Among the participants, 64.4% have experienced ADRs in patients, but only 22.8% have ever reported ADR to pharmacovigilance center. Unfortunately only 53.5% healthcare workers have been trained for reporting adverse reactions. But, 97% healthcare professionals agreed that reporting of ADR is necessary and 92.1% were of the view that pharmacovigilance should be taught in detail to healthcare professional.
This study demonstrated that knowledge and attitude towards pharmacovigilance is gradually improving among healthcare professionals, but unfortunately the actual practice of ADR reporting is still deficient among them.
本研究的主要目的是评估位于坦米尔纳德邦佩兰巴卢尔的达纳拉克希米·斯里尼瓦桑医学院及医院(DSMCH)(一家三级护理教学医院)的医护人员关于药物警戒的知识、态度和实践(KAP)。第二个主要目的是评估药品不良反应(ADR)报告不足的原因,因为这在印度需要得到充分评估。次要目的是将本研究的结果与印度已发表的关于医护人员药物警戒KAP评估研究的结果进行比较。
采用预先测试的问卷进行横断面研究。该问卷旨在评估关于药物警戒的KAP。纳入了研究期间在坦米尔纳德邦佩兰巴卢尔的DSMCH工作的医护人员(医生、护士和药剂师)。只有那些同意参与的人员才被纳入研究。使用社会科学统计软件包(SPSS)统计软件16版对数据进行分析。
向医护人员发放了150份预先测试的问卷,101人做出了回应。62.4%的医护人员对药物警戒的定义给出了正确回答。75.2%的医护人员知晓印度国家药物警戒计划的存在。69.3%的医护人员同意ADR报告是他们的职业义务。在参与者中,64.4%曾在患者中经历过ADR,但只有22.8%曾向药物警戒中心报告过ADR。不幸的是,只有53.5%的医护人员接受过不良反应报告培训。但是,97%的医护人员同意ADR报告是必要的,92.1%的人认为应该向医护人员详细讲授药物警戒。
本研究表明,医护人员对药物警戒的知识和态度正在逐渐改善,但不幸的是,他们在ADR报告的实际实践方面仍然存在不足。