Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, PO Box 30001, 9700, Groningen, RB, The Netherlands.
MedDRA® Maintenance and Support Services Organization, McLean, VA, USA.
Drug Saf. 2019 Jul;42(7):881-886. doi: 10.1007/s40264-019-00800-x.
When reporting adverse drug reactions to pharmacovigilance centres, patients and consumers can describe adverse drug reactions experienced in free-text format. Recently, a patient-friendly adverse drug reaction terms list was introduced in the adverse drug reaction report form in the UK to facilitate this reporting.
The objective of this study was to evaluate the actual use of the patient-friendly terms list in the adverse drug reaction report form and its association with the type of adverse drug reactions reported.
We conducted a database study in which we reviewed the list's use for all reported adverse drug reactions by patients and consumers to the pharmacovigilance centre in the UK via the online report form between August and September 2017. Descriptive statistics were used. In addition, for adverse drug reactions reported more than 20 times, Chi-squared tests were used to test for differences in the number of reports in which the patient-friendly terms list was used and those in which the adverse drug reaction was entered as free text.
In total, 888 reports were received. In 185 reports (21%), the patient-friendly terms list was used to enter an adverse drug reaction. In total, the reports contained 3227 adverse drug reactions. Nausea, headache, diarrhoea, dizziness, insomnia, anxiety, depression, fatigue, tiredness, vomiting, appetite lost, joint pain, chest pain, constipation and pain were reported more than 20 times. Five of these adverse drug reactions (i.e. nausea, diarrhoea, dizziness, insomnia and constipation) were reported significantly more often in reports where the adverse drug reactions were selected from the patient-friendly terms list.
Most people chose to describe adverse drug reactions in their own words rather than selecting adverse drug reactions from a patient-friendly terms list. Although the patient-friendly terms list may be a useful feature for some patients or for some adverse drug reactions, it should not replace the option for patients to describe adverse drug reactions in their own words.
当向药物警戒中心报告药物不良反应时，患者和消费者可以用自由文本格式描述所经历的药物不良反应。最近，英国在药物不良反应报告表中引入了便于报告的患者友好型药物不良反应术语列表。
本研究旨在评估该患者友好型术语列表在药物不良反应报告表中的实际使用情况及其与报告的药物不良反应类型的关系。
我们开展了一项数据库研究，其中我们回顾了 2017 年 8 月至 9 月期间通过英国在线报告表向药物警戒中心报告的患者和消费者报告的所有药物不良反应中该列表的使用情况。使用描述性统计。此外，对于报告超过 20 次的药物不良反应，使用卡方检验检验使用患者友好型术语列表和以自由文本形式输入药物不良反应的报告数量差异。
共收到 888 份报告。在 185 份报告（21%）中，使用患者友好型术语列表输入药物不良反应。报告共包含 3227 种药物不良反应。恶心、头痛、腹泻、头晕、失眠、焦虑、抑郁、疲劳、乏力、呕吐、食欲丧失、关节痛、胸痛、便秘和疼痛报告超过 20 次。其中五种药物不良反应（即恶心、腹泻、头晕、失眠和便秘）在从患者友好型术语列表中选择药物不良反应的报告中报告的频率明显更高。
大多数人选择用自己的话描述药物不良反应，而不是从患者友好型术语列表中选择药物不良反应。尽管患者友好型术语列表对于某些患者或某些药物不良反应可能是有用的功能，但它不应替代患者用自己的话描述药物不良反应的选项。
