Physicians’ perspectives on adverse drug reactions in pediatric routine care: a survey

Abstract

Background: Children and adolescents are at particular risk for adverse drug reactions (ADRs). We investigated physicians’ perceptions on ADRs in pediatric routine care. Methods: 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. Results: 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. Conclusions: 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.