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.

Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics

“…As a result, physicians are confronted with a dilemma when it comes to making treatment decisions, in which both the demand for evidence-based treatment and liability issues have to be taken into account. However, it is not only about legal consequences: In a survey among physicians treating pediatric patients, more than 80% of physicians reported that it is very important to them to talk to parents about potential adverse drug reactions when a drug is used off-label compared to 38% of physicians who reported this for commonly used authorized drugs [ 43 ].…”

Pharmacovigilance practice among pediatric neurologists from Poland and Germany

“…It was similar to previous observations [ 12 , 13 ]. Despite having such a good knowledge of PV and ADR, the neurologists participating in our study were unaware of the existence of pharmacotherapy safety monitoring centers responsible for PV in their countries [ 14 ]. Similar conclusions were reached by researchers from Malaysia, who confirmed that this was the main reason (40%) for not reporting ADRs [ 15 – 18 ].…”

Antikonvulsiva

“…In einer deutschlandweiten Onlinebefragung von Ärzten, die Kinder und Jugendliche behandeln, berichteten 23 % der Befragten, dass sie nicht einschätzen können, bei wie vielen ihrer pädiatrischen Patienten unter einer Arzneimitteltherapie UAW auftreten [12]. Als häufigste Ursachen für UAW wurden von den Teilnehmern das Wirkstoffprofil (65 %) sowie Disposition des Patienten (genetisch/ zugrundeliegende Erkrankung, 35 %) genannt.…”

“…Als häufigste Ursachen für UAW wurden von den Teilnehmern das Wirkstoffprofil (65 %) sowie Disposition des Patienten (genetisch/ zugrundeliegende Erkrankung, 35 %) genannt. Auffällig war, dass sich die Antworten der Ärzte, die in der Neuro-und Sozialpädiatrie arbeiten und daher häufig Antikonvulsiva verordnen, von denen der anderen Teilnehmer unterschieden: Dosiserhöhung (68 %) und Arzneimittelinteraktionen (47 %) wurden von dieser Ärztegruppe deutlich häufiger als von den restlichen Befragten als Ursachen für UAW genannt [12]. Dies spiegelt auch die Tatsache wider, dass in der Neuropädiatrie häufig aufgrund von Therapieversagen statt einer Monotherapie eine Kombinationstherapie angesetzt werden muss [13].…”