Clinical Pharmacy, Institute of Pharmacy, Medical Faculty, Leipzig University and Drug Safety Center, Leipzig University and University Hospital, Bruederstrasse 32, 04103, Leipzig, Germany.
University Hospital for Children and Adolescents, Neuropediatrics, Ernst-Heydemann-Str. 8, 18057, Rostock, Germany.
World J Pediatr. 2022 Jan;18(1):50-58. doi: 10.1007/s12519-021-00478-1. Epub 2021 Nov 13.
Children and adolescents are at particular risk for adverse drug reactions (ADRs). We investigated physicians' perceptions on ADRs in pediatric routine care.
In this exploratory study from April to November 2020, we invited physicians treating pediatric patients across Germany to complete an online questionnaire consisting mainly of closed questions.
Completion rate was 98% (127/129). Of all participants, 23% (29/127) stated they were not able to estimate how many of their pediatric patients experienced ADRs during drug therapy. The remaining physicians estimated that 7.5% (median; Q25/Q75 3%/20%) of their pediatric patients were affected by ADRs. Regarding counseling on ADRs, 61% (77/127) stated they do not ask regularly the extent to which parents want to be informed. In total, 26% (33/127) stated they avoid counseling on ADRs concerning commonly used approved therapies, whereas only 4% (5/127) did so concerning off-label use (P < 0.001). Altogether, 16% (20/127) stated they rather prescribe new medicines as they hope for better effectiveness; 72% (91/127) said they are cautious about doing so owing to yet unknown ADRs. Of all respondents, 46% (58/127) stated they do not report ADRs to the authorities. Concerning the black triangle symbol, a European pharmacovigilance measure, 11% (14/127) stated they knew it and 6% (7/127) stated they reported any suspected ADR for drugs with that symbol.
Physicians' perspectives on ADRs were ambivalent: ADRs influenced their parent counseling and drug prescribing; yet, they struggled to estimate the impact of ADRs on their patients and were not aware of specific pharmacovigilance measures.
儿童和青少年特别容易发生药物不良反应（ADR）。我们调查了医生在儿科常规护理中对 ADR 的看法。
在这项从 2020 年 4 月到 11 月进行的探索性研究中，我们邀请了治疗儿科患者的德国医生完成一份主要由封闭问题组成的在线问卷。
完成率为 98%（127/129）。所有参与者中有 23%（29/127）表示，他们无法估计在药物治疗期间有多少儿科患者经历了 ADR。其余医生估计，他们的儿科患者中有 7.5%（中位数；Q25/Q75 为 3%/20%）受到 ADR 的影响。关于 ADR 的咨询，61%（77/127）表示他们没有定期询问父母希望在多大程度上了解信息。总的来说，26%（33/127）表示他们避免就常用批准疗法的 ADR 进行咨询，而只有 4%（5/127）避免就标签外使用进行咨询（P<0.001）。总的来说，16%（20/127）表示他们宁愿开新药，因为他们希望有更好的疗效；72%（91/127）表示他们这样做是因为对未知的 ADR 谨慎。在所有回答者中，46%（58/127）表示他们没有向当局报告 ADR。关于欧洲药物警戒措施的黑三角符号，11%（14/127）表示他们知道它，6%（7/127）表示他们报告了带有该符号的任何可疑 ADR 药物。
医生对 ADR 的看法存在矛盾：ADR 影响了他们对父母的咨询和药物处方；然而，他们难以估计 ADR 对患者的影响，并且不了解特定的药物警戒措施。
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