Background Owing to complex treatment,critically ill children may experience alterations in their vital parameters.We investigated whether such hemodynamic alterations were temporally and causally related to drug ther...Background Owing to complex treatment,critically ill children may experience alterations in their vital parameters.We investigated whether such hemodynamic alterations were temporally and causally related to drug therapy.Methods In a university pediatric intensive care unit,we retrospectively analyzed hemodynamic alterations defined as values exceeding the limits set for heart rate(HR)and blood pressure(BP).For causality assessment,we used the World Health Organization–Uppsala Monitoring Center(WHO–UMC)system,which categorizes the probability of causality as“certain,”“probable,”“possible,”and“unlikely.”Results Of 315 analyzed patients with 43,200 drug prescriptions,59.7%experienced at least one hemodynamic alteration;39.0%were affected by increased HR,19.0%by decreased HR,18.1%by increased BP,and 16.2%by decreased BP.According to drug information databases,83.9%of administered drugs potentially lead to hemodynamic alterations.Overall,88.3%of the observed hemodynamic alterations had a temporal relation to the administration of drugs;in 80.2%,more than one drug was involved.Based on the WHO–UMC system,a drug was rated as a“probable”causing factor for only 1.4%of hemodynamic alterations.For the remaining alterations,the probability ratings were lower because of multiple potential causes,e.g.,several drugs.Conclusions Critically ill children were frequently affected by hemodynamic alterations.The administration of drugs with potentially adverse effects on hemodynamic parameters is often temporally related to hemodynamic alterations.Hemodynamic alterations are often multifactorial,e.g.,due to administering multiple drugs in rapid succession;thus,the influence of individual drugs cannot easily be captured with the WHO–UMC system.展开更多
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 Nov...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/Q753%/20%)of their pediatric patients were afected 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 of-label use(P<0.001).Altogether,16%(20/127)stated they rather prescribe new medicines as they hope for better efectiveness;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 infuenced their parent counseling and drug prescribing;yet,they struggled to estimate the impact of ADRs on their patients and were not aware of specifc pharmacovigilance measures.展开更多
文摘Background Owing to complex treatment,critically ill children may experience alterations in their vital parameters.We investigated whether such hemodynamic alterations were temporally and causally related to drug therapy.Methods In a university pediatric intensive care unit,we retrospectively analyzed hemodynamic alterations defined as values exceeding the limits set for heart rate(HR)and blood pressure(BP).For causality assessment,we used the World Health Organization–Uppsala Monitoring Center(WHO–UMC)system,which categorizes the probability of causality as“certain,”“probable,”“possible,”and“unlikely.”Results Of 315 analyzed patients with 43,200 drug prescriptions,59.7%experienced at least one hemodynamic alteration;39.0%were affected by increased HR,19.0%by decreased HR,18.1%by increased BP,and 16.2%by decreased BP.According to drug information databases,83.9%of administered drugs potentially lead to hemodynamic alterations.Overall,88.3%of the observed hemodynamic alterations had a temporal relation to the administration of drugs;in 80.2%,more than one drug was involved.Based on the WHO–UMC system,a drug was rated as a“probable”causing factor for only 1.4%of hemodynamic alterations.For the remaining alterations,the probability ratings were lower because of multiple potential causes,e.g.,several drugs.Conclusions Critically ill children were frequently affected by hemodynamic alterations.The administration of drugs with potentially adverse effects on hemodynamic parameters is often temporally related to hemodynamic alterations.Hemodynamic alterations are often multifactorial,e.g.,due to administering multiple drugs in rapid succession;thus,the influence of individual drugs cannot easily be captured with the WHO–UMC system.
基金The study was conducted according to the guidelines of the Declaration of Helsinki,and approved by the Ethics Committee of Medical Faculty of Rostock University,Germany(Ethics approval number:A2020-0065).
文摘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/Q753%/20%)of their pediatric patients were afected 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 of-label use(P<0.001).Altogether,16%(20/127)stated they rather prescribe new medicines as they hope for better efectiveness;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 infuenced their parent counseling and drug prescribing;yet,they struggled to estimate the impact of ADRs on their patients and were not aware of specifc pharmacovigilance measures.
