Peymani Payam, Tabrizi Reza, Afifi Saba, Namazi Soha, Heydari Seyed Taghi, Shirazi Mohammad Khabaz, Nouraei Hasti, Sadeghi Elham, Lankarani Kamran B, Maharlouei Najmeh
Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Clinical Pharmacy Departments, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
Int J Risk Saf Med. 2016 Mar 16;28(1):25-31. doi: 10.3233/JRS-160670.
An adverse drug reaction (ADRs) is linked with the use of medications and unpredictable negative consequences. The Iranian Pharmacovigilance center (IPC) has reported that the rate of ADR is very low.
Thus, this study was performed to find the reasons for this under-reporting, and investigate the level of knowledge, attitude and practice (KAP) of General Practitioners (GPs) about spontaneous reporting system in Shiraz.
The present cross-sectional study was conducted on 350 general practitioners (GPs) working in Shiraz, Iran from Oct 2014 to March 2015. A semi-structured questionnaire was used which included demographic features, and evaluated KAPs of GPs regarding ADRs, Pharmacovigilance, and yellow card reporting. Statistical analysis was done by descriptive and analytical statistics (frequency, Mean±SD, Student t-test, Chi-square) using SPSS version 16.
Of 350 (95.1%) GPs, 333 completed the questionnaire. The respondents aged from 26 to76 years, of whom 176 (52.9%) were males with mean age 39.6±8.8 SD years. In regard to work place, 85 (25.5%) had their own office, and 112 (33.7%), 101 (30.9%), and 35 (10.5%) worked in private hospitals, in governmental hospitals, and in more than one place, respectively. Work experience mean was 13.3±8.2SD years and median was 12 years (range 1-50 years). Although, less than half of the participants (n = 151; 45.3%) described ADR correctly, 215 (64.6%) respondents claimed that they were not familiar with physician's responsibility regarding ADR reporting. Overall, few of the participants were aware of the steps in either ADR reporting or using Yellow Card System. On the whole, 100 (30%) respondents achieved acceptable knowledge score, while the median score was 9 out of 14 and minimum and maximum being 5 and 14, respectively.
The physicians in Shiraz have poor knowledge of the pharmacovigilance system; however self-education leads to a better knowledge and positive attitude regarding ADRs reporting system. National Pharmacovigilance center should play a more active role in improving physicians' adherence to the ADRs reporting systems and the comprehensive educational pack can be used in local and national meetings. The main factor for low ADR reporting rates is lack of information about ADRs and how to report an ADR. Otherwise, obligatory education and training courses should be designed for general practitioners on reporting ADRs during and after graduation.
药物不良反应（ADR）与药物使用及不可预测的负面后果相关。伊朗药物警戒中心（IPC）报告称ADR发生率很低。
因此，本研究旨在找出报告率低的原因，并调查设拉子地区全科医生（GP）对自发报告系统的知识、态度和实践（KAP）水平。
本横断面研究于2014年10月至2015年3月对在伊朗设拉子工作的350名全科医生进行。使用了一份半结构化问卷，其中包括人口统计学特征，并评估了全科医生关于ADR、药物警戒和黄卡报告的KAP。使用SPSS 16版进行描述性和分析性统计（频率、均值±标准差、学生t检验、卡方检验）。
350名（95.1%）全科医生中，333人完成了问卷。受访者年龄在26至76岁之间，其中176人（52.9%）为男性，平均年龄39.6±8.8标准差岁。关于工作地点，85人（25.5%）有自己的办公室，112人（33.7%）、101人（30.9%）和35人（10.5%）分别在私立医院、公立医院和多个地点工作。工作经验均值为13.3±8.2标准差年，中位数为12年（范围1至50年）。虽然不到一半的参与者（n = 151；45.3%）正确描述了ADR，但215名（64.6%）受访者声称他们不熟悉医生关于ADR报告的责任。总体而言，很少有参与者了解ADR报告或使用黄卡系统的步骤。总体而言，100名（30%）受访者获得了可接受的知识分数，而中位数分数为14分中的9分，最低和最高分数分别为5分和14分。
设拉子的医生对药物警戒系统了解不足；然而，自我教育会带来对ADR报告系统更好的了解和积极态度。国家药物警戒中心应在提高医生对ADR报告系统的依从性方面发挥更积极的作用，并且综合教育包可用于地方和全国会议。ADR报告率低的主要因素是缺乏关于ADR以及如何报告ADR的信息。否则，应为全科医生在毕业期间和毕业后设计关于报告ADR的强制性教育和培训课程。
