Syed Akash, Azhar Saira, Raza Muhammad Mohsin, Saeed Humaira, Jamshed Shazia Qasim
Department of Pharmacy, COMSATS Institute of Information Technology, Abbottabad 22060, Pakistan.
Department of Pharmacy Practice, College of Pharmacy, Princess Nourah bint Abdulrahman University, Riyadh 84428, Saudi Arabia.
Pharmacy (Basel). 2018 Mar 31;6(2):29. doi: 10.3390/pharmacy6020029.
Pharmacovigilance in Pakistan needs robust preference in terms of implementation and consistent movement of structured approaches. The objective of this study is to explore the knowledge, attitude and barriers towards adverse drug reaction (ADR) reporting among physicians and pharmacists and to explore the encouraging factors of ADR reporting.
The current research was a cross-sectional study design in which a pre-validated questionnaire was administered to physicians and pharmacists in Abbottabad, Pakistan. The study was conducted for two months from January 2016 to February 2016.
A total of 194 physicians and pharmacists responded with a response rate of 35.3%. All the respondents either strongly agreed or agreed that ADRs reporting is a part of their duty. Half of the respondents agreed that monitoring of drug safety is important. Around three quarters of respondents (74.2%) stated that they did not report ADRs due to unavailability of reporting forms while 70% cited lack of a proper pharmacovigilance center as one of the key barriers. Half of the respondents (52.2%) did not report due to their insufficient knowledge. A large majority (81.8%) said that they would report ADRs if there is pharmacovigilance center. On the point of incentives, opinion seems to be divided. Slightly less than half (47.8%) cited their wish to have few incentives while the remaining 52.2% either preferred to be neutral or disagreed.
Based on the study findings, barriers were mostly related to general unfamiliarity with ADRs reporting guidelines and the non-existence of a pharmacovigilance center. It is highlighted that the regulatory body should carve a niche for a properly functional pharmacovigilance center and initiate educational programs for strengthening knowledge and attitudes towards ADR reporting.
巴基斯坦的药物警戒在实施方面需要大力支持，且要有结构化方法的持续推进。本研究的目的是探究医生和药剂师对药品不良反应（ADR）报告的知识、态度及障碍，并探究ADR报告的促进因素。
本研究采用横断面研究设计，向巴基斯坦阿伯塔巴德的医生和药剂师发放经过预验证的问卷。研究于2016年1月至2016年2月进行了两个月。
共有194名医生和药剂师做出回应，回应率为35.3%。所有受访者均强烈同意或同意ADR报告是他们职责的一部分。一半的受访者同意药物安全监测很重要。约四分之三的受访者（74.2%）表示，由于没有报告表格，他们没有报告ADR，而70%的受访者指出缺乏合适的药物警戒中心是主要障碍之一。一半的受访者（52.2%）由于知识不足而未报告。绝大多数（81.8%）表示，如果有药物警戒中心，他们会报告ADR。在激励措施方面，意见似乎存在分歧。略少于一半（47.8%）的人表示希望有一些激励措施，而其余52.2%的人要么倾向于保持中立，要么不同意。
根据研究结果，障碍主要与对ADR报告指南普遍不熟悉以及缺乏药物警戒中心有关。强调监管机构应为正常运作的药物警戒中心创造空间，并启动教育项目，以加强对ADR报告的知识和态度。
