Sabblah George Tsey, Darko Delese Mimi, Mogtari Hudu, Härmark Linda, van Puijenbroek Eugène
Food and Drugs Authority, P. O. Box CT2783, Accra, Ghana.
Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting, 's-Hertogenbosch, The Netherlands.
Drug Saf. 2017 Oct;40(10):911-921. doi: 10.1007/s40264-017-0563-9.
Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries.
The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana.
A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana. Reasons and opinions on patients' reporting on adverse drug reactions were surveyed using a 5-point Likert scale. The Pearson chi-square test was used to determine associations between background variables and responses on knowledge of adverse drug reaction reporting.
Responses from 434 patients (86.7%) were included in the analysis. Among those interviewed, there was a high level of awareness regarding the existence of the National Pharmacovigilance Centre (81.6%). Approximately half of the respondents (49.5%) were aware that patients were able to report adverse drug reactions associated with medicinal products directly to the National Pharmacovigilance Centre. Of the respondents, 46.3% stated that they had an adverse drug reaction to their medicines in the past; of these, 53.2% reported to healthcare professionals and 36.9% failed to report because they stopped their medication. The three main reasons for patients' reporting were desire for extra information (92.4%), desire to share experiences with other people (91.7%) and expectation for the National Pharmacovigilance Centre to inform others about the possible adverse drug reactions (88.0%). Patients' opinions were to contribute to research/knowledge (96.5%) and improvements in drug safety (96.5%). Patients' behaviour towards adverse drug reaction reporting was affected by the likely consequences of reporting, influence of others and the ease of reporting.
Patients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients' positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted.
近期在药物警戒系统中引入患者直接报告的努力已证明，患者报告对药物安全有重大贡献，但在发展中国家，关于患者对药物不良反应报告的看法的信息却很少。
本研究的目的是探讨加纳患者对自发药物不良反应报告的知识、态度、行为和意见。
2016年8月25日至2016年9月20日，采用通过面对面访谈发放问卷的横断面研究方法，从加纳城乡的两家社区药房通过便利抽样选取了442名18岁及以上的患者。使用5点李克特量表对患者报告药物不良反应的原因和意见进行了调查。采用Pearson卡方检验来确定背景变量与药物不良反应报告知识回答之间的关联。
434名患者（86.7%）的回答纳入了分析。在接受访谈的患者中，对国家药物警戒中心的存在有较高的知晓率（81.6%）。大约一半的受访者（49.5%）知道患者能够直接向国家药物警戒中心报告与药品相关的药物不良反应。在受访者中，46.3%表示他们过去曾对所服用的药物出现过药物不良反应；其中，53.2%向医护人员报告了，36.9%未报告是因为他们停止了用药。患者报告的三个主要原因是渴望获得更多信息（92.4%）、渴望与他人分享经历（91.7%）以及期望国家药物警戒中心告知其他人可能的药物不良反应（88.0%）。患者的意见是为研究/知识做出贡献（96.5%）以及改善药物安全（96.5%）。患者对药物不良反应报告的行为受到报告可能产生的后果、他人的影响以及报告的难易程度的影响。
患者对向国家药物警戒中心报告药物不良反应持积极态度且有较好的了解，报告是因为他们期望获得更多信息并为药物安全做出贡献。通过定期开展宣传活动，宣传药物不良反应报告的重要性，并及时向患者反馈因他们提交的报告而做出的监管决定，可以维持患者对药物不良反应报告的积极态度。
