Pharmacovigilance in pediatrics

Bouquet, Emilie; Star, Kristina; Jonville-Béra, Annie Pierre; Durrieu, Geneviève

doi:10.1016/j.therap.2017.11.012

Cited by 19 publications

(14 citation statements)

References 94 publications

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“…635 (87%) NOM were found, occurred to infants (237; 38%) and children (117; 19%) and 318 (51%), referred as non-quantitative ineffectiveness. These results could be explained by the higher medicine use in pre-schoolers [42], lack of knowledge of medicines in those ages [43,44] off-label high prevalence use, lack of reliable safety and pharmacokinetic data from clinical trials, drug-induced growth and development disorders as delayed ADRs not ndable in adults [10,45]. To overcome this, authors recommended conducting paediatric pharmacoepidemiological studies on top of spontaneous reporting [10,45].…”

Section: Discussionmentioning

confidence: 99%

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Social media as a source of drug safety information in the paediatric population

Vilimelis-Piulats

Pérez-Ricart

Calvo

et al. 2022

Preprint

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Purpose: Children are vulnerable to suffer negative outcomes due to medication (NOM), social media (SM) can be a non-interventional tool to gather safety data. The aim of this study is to assess paediatric Adverse Events (AE) or suspected Adverse Drug Reaction (ADR) detected in SM. Secondary objectives are the assessment of NOM, Drug Related Problems (DRP) and Medication Errors (ME). Methods: Observational, ambispective study assessing NOM in Public Parenting Forums (PPF) using data mining software. Entries that mentioned a medicine administered to children were analyzed and, if NOMs were detected, DRP, ME and AE were categorized. ME and ADR seriousness were assessed. ADR causality according Liverpool Causality Assessment (LCAT) and prevalence compared with those reported in Summary of Product Characteristics (SmPC) of each product. Results: Two forums (mumsnet.uk; socpetit.cat 2733 (81%)) were analyzed. Of 3375 entries, 635 contained a NOM and a DRP, 214 in English, 6 in Spanish and 217 in Catalan. 161 ADR were detected, including Serious AEs (SAEs), unknown, rare or very rare ADR. 29(16%) were not reported in SmPC. 95 ME were found, caused parents or caregivers (40; 42%) and healthcare professionals (HCP) (55; 58%). Severity ranged from no harm up to harm required intervention. Conclusion: ADR were found in PPF, including SAEs and ADR with low or unknown prevalence and suspect ADRs not included in the SmPC. ME that reached children were also found. As consequence, despite that the overall number of entries is not high, forums are a source of valuable pharmacovigilance information.

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Section: Discussionmentioning

confidence: 99%

“…Children's NOM vulnerability is due to their immaturity and non-pharmacological causes [9][10][11] . The use of SM has been considered paediatric-speci c topics such as vaccine hesitancy 12 , adherence [13], ADR [14].…”

Section: Introductionmentioning

confidence: 99%

Social media as a source of drug safety information in the paediatric population

Vilimelis-Piulats

Pérez-Ricart

Calvo

et al. 2022

Preprint

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“…In addition, children are particularly susceptible to unwanted and toxic drug effects because of significant pathophysiological developmental changes resulting in dramatic effects on pharmacokinetics and pharmacodynamics [ 6 , 11 ]. Consequently, this type of prescribing in children is potentially associated with a greater risk of adverse drug reactions (ADRs) and/or a lack of therapeutic effectiveness, as suggested by many studies both in hospital and outpatient care [ 12 – 17 ].…”

Section: Introductionmentioning

confidence: 99%

Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy

et al. 2022

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Introduction The paucity of pediatric clinical trials has led to many medicines frequently prescribed to children without a license for use in pediatrics, resulting in an increased risk of adverse drug reactions. Pharmacovigilance databases remain, among others, a valuable tool for evaluating pediatric drug safety in the real-life setting. Objective We aimed to characterize pediatric adverse drug reactions reported in the Italian Pharmacovigilance database coming from the Calabria region (Southern Italy) over 10 years. Methods All Individual Case Safety Reports (ICSRs) concerning individuals aged under 18 years were extracted from 2010 to 2019. Duplicate and vaccine ICSRs were excluded. The remaining ICSRs were analyzed with respect to patients’ demographic data, suspected drugs, and category of adverse drug reactions across different age groups. Results Among 6529 selected ICSRs, 395 pediatric ICSRs corresponding to 556 adverse drug reactions were analyzed. From 2010 to 2015, an increasing number of ICSRs were observed, but the reporting rate decreased after 2015. The highest proportion of ICSRs concerned children and adolescents. Around 52% of ICSRs involved boys: a trend observed in all age groups excluding newborns. Sixty ICSRs were serious and among them, 75% required hospitalization mainly in children and adolescents. Most of the ICSRs were issued by physicians (64.1%), followed by other healthcare professionals (22.5%) and pharmacists (9.9%). Anti-infective agents for systemic use and skin disorders were, respectively, the most frequently reported drug group and adverse drug reaction category. Conclusions This study provides an overview of adverse drug reactions reported in the pediatric population of the Calabria region and emphasizes the need for strengthening the surveillance in specific age subgroups and on given drugs in relation to their pattern of use. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-022-01232-w.

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“…O uso de medicamentos que não produzidos especificamente para a população pediátrica dificulta a determinação da dose adequada e reforça a vulnerabilidade dessa população pediátrica, impondo desafios às atividades de farmacovigilância 52 . A OMS define a farmacovigilância como a "ciência e atividades relacionadas à detecção, avaliação, compreensão e prevenção das reações adversas e outros problemas relacionados ao uso do medicamento" 22 .…”

Section: Erros De Medicação Em Pediatriaunclassified

“…Melhorar a qualidade da informação dos relatos de RAM em pediatria é um dos objetivos da farmacovigilância. Mas, com exceção de algumas áreas clínicas, os ensaios clínicos na população pediátrica permanecem escassos quando comparados com os testes clínicos realizados em adultos26,48,52 .Existem poucos mecanismos para se coletar dados relacionados a EM na população pediátrica que ocorrem no ambiente domiciliar. Os registros das notificações dos atendimentos realizados no Centro de Assistência Toxicológica representam valiosa fonte de dados para a detecção e análise de EM 1,53 .…”

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Erros de medicação domiciliares notificados a um Centro de Assistência Toxicológica

Castro¹

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INTRODUCTION: Medication errors (MEs) are preventable events and common causes of harm and hospital admissions. In Brazil, there is a scarcity of data on MEs in the pediatric population in the home environment. Knowledge about the types of ME, characteristics and causes of MEs may help preventive strategies involving the pediatric population. OBJECTIVES: To describe the characteristics of the MEs in the pediatric population in the home environment. METHODS: A cross-sectional study about MEs in the pediatric population in the home environment of the reported cases to Centro

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Pharmacovigilance in pediatrics

Cited by 19 publications

References 94 publications

Social media as a source of drug safety information in the paediatric population

Social media as a source of drug safety information in the paediatric population

Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy

Erros de medicação domiciliares notificados a um Centro de Assistência Toxicológica

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