From the *Department of Pharmacy Practice, Kulliyyah of Pharmacy, Kuantan; †Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia; and ‡College of pharmacy, Qatar University, Doha, Qatar.
J Patient Saf. 2014 Jun;10(2):81-7. doi: 10.1097/PTS.0000000000000051.
This study was designed to explore awareness and attitudes of community pharmacists toward the national ADR reporting system activities in the northern states of Malaysia.
A cross-sectional survey using a validated self-administered questionnaire was used in this study. The questionnaire was delivered to all community pharmacists (N = 470) practicing in the four northern states of Malaysia (Perlis, Kedah, Pulau Pinang and Perak) during the study period.
A total of 470 survey forms were sent with one wave of reminders. Only 116 pharmacists responded to the survey (response rate of 25.2%). The total number of usable responses was 104 (24.7%). The survey findings revealed that nearly three-quarters of pharmacists (n = 75; 72.1%) were not aware of the pharmacovigilance activities run by the drug regulatory authority in Malaysia. Although more than half (n = 65, 61.5%) of the surveyed pharmacists emphasized the importance of ADR reporting, only 13 pharmacists (12.9%) claimed that they submitted ADR reports to the Malaysia Adverse Drug Reaction Advisory Committee (MADRAC) before this survey. Barriers which prevent community pharmacists from ADR reporting were identified. These included lack of knowledge on how to report (n = 36; 34.7%), the unavailability of reporting forms (n = 44; 42.6%), and ignorance of where the report should be sent to (n = 46; 44.6%).
Despite the unfamiliarity and the common misconceptions, the study results show that community pharmacists in the northern states of Malaysia have a very positive attitude toward the ADR reporting system in the country. However, the study findings highlight the urgent need for special education programs to establish continuous efforts to promote ADR reporting among community pharmacists. Further studies at the national level aimed at identifying and removing barriers that prevent community pharmacists from performing ADR reporting are required.
本研究旨在探讨马来西亚北部各州社区药剂师对国家不良反应报告系统活动的认知和态度。
本研究采用了经过验证的自填式问卷进行横断面调查。在研究期间，向马来西亚北部四个州（玻璃市、吉打、槟城和霹雳）的所有社区药剂师（N=470）分发了问卷。
共发出 470 份问卷，并进行了一轮提醒。只有 116 名药剂师对调查做出回应（回应率为 25.2%）。可使用的有效回复总数为 104 份（24.7%）。调查结果显示，近四分之三的药剂师（n=75；72.1%）不知道马来西亚药品监管机构开展的药物警戒活动。尽管超过一半（n=65，61.5%）的被调查药剂师强调不良反应报告的重要性，但在此调查之前，只有 13 名药剂师（12.9%）声称他们向马来西亚不良反应药物咨询委员会（MADRAC）提交了不良反应报告。确定了阻碍社区药剂师进行不良反应报告的障碍。这些障碍包括缺乏报告方法的知识（n=36；34.7%）、缺乏报告表（n=44；42.6%）和不知道报告应寄往何处（n=46；44.6%）。
尽管不熟悉和普遍存在误解，但研究结果表明，马来西亚北部各州的社区药剂师对该国的不良反应报告系统持非常积极的态度。然而，研究结果强调，迫切需要开展特别教育计划，以促使社区药剂师持续努力进行不良反应报告。需要在全国范围内开展进一步的研究，以确定和消除阻碍社区药剂师进行不良反应报告的障碍。
