Department of Pharmacy, COMSATS University Islamabad-Abbottabad Campus, Abbottabad, Pakistan.
Faculty of Pharmaceutical Sciences, UCSI University, Kuala Lumpur, Malaysia.
Curr Med Res Opin. 2022 Apr;38(4):595-605. doi: 10.1080/03007995.2022.2042992. Epub 2022 Mar 3.
Spontaneous Adverse drug reactions (ADRs) reporting is a cornerstone for a successful pharmacovigilance program as under-reporting of ADRs remains a major issue around the globe. The current study aimed to assess the knowledge attitude and practices of health care professionals regarding pharmacovigilance along with barriers and factors to encourage ADR reporting at tertiary care hospitals of Khyber-Pakhtunkhwa, Pakistan.
A questionnaire-based cross-sectional survey was conducted, using the convenience sampling method to collect the data from doctors, nurses, and pharmacists working in seven tertiary care hospitals from seven districts of Khyber-Pakhtunkhwa province, Pakistan, between July 2019 and March 2020.
During the study, a total of 830 questionnaires were distributed, out of which 669 were returned (response rate 80.6%). Overall, Healthcare professionals exhibited poor knowledge (79.5%) about ADR reporting and pharmacovigilance however, 73.5% of pharmacists were more knowledgeable as compared to 18.7% doctors and 13.8% nurses ( < .001). Moreover, poor reporting practices were displayed by 95.6% doctors, 94.4% nurses, 94.4 and 75.5% pharmacists ( < .001). However, the majority of healthcare professionals showed an overall positive attitude (94%) toward ADR reporting. The most frequently cited barriers were unavailability of reporting forms (92.5%), absence of a professional environment to discuss ADRs (82.5%), and lack of training (81.8%) whereas, most common factors to encourage ADR reporting were obligatory reporting (85.9%) and provision of ADR management guidelines and training (84.3%). A significant relation was found between the healthcare professionals and their professional status with the overall knowledge, attitude, and practice (KAP) scores ( < .001) whereas a medium, positive correlation was found between the knowledge and practice of pharmacovigilance and ADR reporting by the healthcare professionals ( = 0.321, = 669, < .001).
There is an overall lack of knowledge and poor reporting practices among health care professionals on ADR reporting and pharmacovigilance. Hence the study suggests that strategies should be devised by all the stakeholders to properly educate and train the healthcare professionals in this area to enhance overall patient safety and safe use of medicines.
自发药物不良反应(ADR)报告是成功药物警戒计划的基石,因为全球范围内的 ADR 报告仍然存在主要问题。本研究旨在评估巴基斯坦开伯尔-普赫图赫瓦省七个地区的七家三级保健医院的医疗保健专业人员在药物警戒方面的知识、态度和实践,以及鼓励药物不良反应报告的障碍和因素。
采用便利抽样法,于 2019 年 7 月至 2020 年 3 月期间从巴基斯坦开伯尔-普赫图赫瓦省七个地区的七家三级保健医院中收集数据,进行了一项基于问卷的横断面调查。
在研究过程中,共发放了 830 份问卷,其中 669 份(回复率为 80.6%)。总体而言,医疗保健专业人员对 ADR 报告和药物警戒的了解程度较差(79.5%),但药剂师的知识水平较高(73.5%),而医生的知识水平较低(18.7%),护士的知识水平最低(13.8%)(<0.001)。此外,95.6%的医生、94.4%的护士、94.4%的药剂师和 75.5%的药剂师表现出不良的报告实践(<0.001)。然而,大多数医疗保健专业人员对 ADR 报告持总体积极态度(94%)。最常提到的障碍是缺乏报告表格(92.5%)、缺乏讨论 ADR 的专业环境(82.5%)和缺乏培训(81.8%),而最常见的鼓励 ADR 报告的因素是强制性报告(85.9%)和提供 ADR 管理指南和培训(84.3%)。医疗保健专业人员及其专业地位与总体知识、态度和实践(KAP)评分之间存在显著关系(<0.001),而医疗保健专业人员在药物警戒和 ADR 报告方面的知识与实践之间存在中等程度的正相关关系(=0.321,=669,<0.001)。
医疗保健专业人员在 ADR 报告和药物警戒方面总体上缺乏知识和不良的报告实践。因此,研究建议所有利益相关者制定策略,在这方面对医疗保健专业人员进行适当的教育和培训,以提高整体患者安全和药物安全使用。