Stewart Derek, Helms Peter, McCaig Dorothy, Bond Christine, McLay James
Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen, UK.
Br J Clin Pharmacol. 2005 Jun;59(6):677-83. doi: 10.1111/j.1365-2125.2005.02424.x.
To determine the feasibility of a community pharmacy-based parental adverse drug reaction (ADR) reporting system for children.
Prospective study of parent-reported ADRs using a questionnaire issued to the parent or guardians of children 0-11 years of age collecting prescribed medicine for amoxicillin, and/or salbutamol, and collecting prescribed medicine for, or purchasing, paracetamol or ibuprofen suspension.
Seven community pharmacies in Grampian, Scotland.
During a 4-week period 360 prescriptions or purchases for the study medications occurred. Two hundred and sixty-seven parents (85.5%) agreed to participate in the study. One hundred and six participants (40%) returned a total of 122 questionnaires. The demographics of responders and nonresponders including medication, age of child, and social status as assessed by the Depcat score were similar. There was no evidence of under-representation of any socio-economic group. Possible adverse events were detected using a symptom tick list and perceived ADRs using free text entry. Using the symptom tick list approach the most commonly reported symptoms were diarrhoea (28.9%) and tiredness (31.6%) for amoxicillin. The levels of diarrhoea and tiredness reported for ibuprofen, paracetamol and salbutamol were 15% and 20%, 7.4% and 18.5%, and 20% and 0%, respectively. Using the freehand section of the questionnaire 15 specific ADRs were reported by parents (12.3%). Eight children (21.2%) reported ADRs attributed to amoxicilin [diarrhoea (n = 4), fever (n = 1), anorexia (n = 1), hyperactivity (n = 1) and nonspecific (n = 1)], five to paracetamol [diarrhoea (n = 3), anorexia, irritability, crying and very angry (n = 1) and not stated (n = 1)], two to ibuprofen [diarrhoea (n = 1), not stated (n = )]. Only one off-label prescription was identified and this was for salbutamol syrup prescribed to a child under 2 years of age.
The prospective monitoring of paediatric ADRs, using a questionnaire issued to parents or guardians in the community pharmacies, is feasible.
确定基于社区药房的儿童家长药物不良反应（ADR）报告系统的可行性。
采用前瞻性研究，通过向0至11岁儿童的家长或监护人发放问卷，收集阿莫西林和/或沙丁胺醇的处方药，以及收集对乙酰氨基酚或布洛芬混悬液的处方药或购买情况，以了解家长报告的ADR。
苏格兰格兰扁地区的七家社区药房。
在为期4周的时间里，共发生了360次研究药物的处方或购买。267名家长（85.5%）同意参与研究。106名参与者（40%）共返回了122份问卷。应答者和未应答者的人口统计学特征，包括用药情况、儿童年龄以及通过Depcat评分评估的社会地位相似。没有证据表明任何社会经济群体的代表性不足。使用症状勾选清单检测可能的不良事件，并通过自由文本输入了解感知到的ADR。使用症状勾选清单方法，阿莫西林最常报告的症状是腹泻（28.9%）和疲倦（31.6%）。布洛芬、对乙酰氨基酚和沙丁胺醇报告的腹泻和疲倦水平分别为15%和20%、7.4%和18.5%、20%和0%。家长通过问卷的自由填写部分报告了15种特定的ADR（12.3%）。8名儿童（21.2%）报告了归因于阿莫西林的ADR[腹泻（n = 4）、发热（n = 1）、厌食（n = 1）、多动（n = 1）和非特异性（n = 1）]，5名儿童报告了归因于对乙酰氨基酚的ADR[腹泻（n = 3）、厌食、易怒、哭闹和非常生气（n = 1）以及未说明（n = 1）]，2名儿童报告了归因于布洛芬的ADR[腹泻（n = 1）、未说明（n = 1）]。仅识别出一张超说明书用药处方，是给一名2岁以下儿童开具的沙丁胺醇糖浆。
通过向社区药房的家长或监护人发放问卷对儿科ADR进行前瞻性监测是可行的。
