V A Bach1, M P Neininger2, U P Spindler1, L C Hotopp1, F Hornemann1, S Syrbe3, A Merkenschlager1, W Kiess1, M K Bernhard1, T Bertsche2, A Bertsche4. 1. University Hospital for Children and Adolescents, Center for Pediatric Research, Liebigstraße 20a, 04103 Leipzig, Germany. 2. Drug Safety Center and Department of Clinical Pharmacy, Leipzig University, Brüderstraße 32, 04103 Leipzig, Germany. 3. University Hospital for Children and Adolescents, Center for Pediatric Research, Liebigstraße 20a, 04103 Leipzig, Germany; Department of General Paediatrics, Division of Child Neurology and Inherited Metabolic Diseases, Centre for Paediatrics and Adolescent Medicine, University Hospital Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany. 4. University Hospital for Children and Adolescents, Center for Pediatric Research, Liebigstraße 20a, 04103 Leipzig, Germany; University Hospital for Children and Adolescents, Neuropediatrics, Ernst-Heydemann-Straße 8, 18057 Rostock, Germany. Electronic address: Astrid.Bertsche@medizin.uni-leipzig.de.
Abstract
BACKGROUND: The main source of knowledge on adverse drug events (ADE) are physicians' reports in controlled clinical trials. In contrast, little is known about the parents' perception of ADE of anticonvulsants their children receive. METHODS: After approval by the local ethics committee, we performed a survey in a neuropediatric outpatient clinic of a university hospital. Based on a structured questionnaire, we interviewed parents of children with current anticonvulsant treatment regarding (i) their fears about potential ADE, (ii) experienced ADE according to parents, and (iii) implications of ADE on the child's life. RESULTS: Parents of 150 patients took part in the interview. (i) 95 (63.3%) parents expressed fears concerning ADE, mostly liver injury/liver failure (33 [22%]). (ii) 129 (86%) parents reported experienced ADE, mostly sedation (65 [43.3%]) and abnormal behavior (54 [36%]). (iii) Parents reported substantial implications of ADE on the child's daily life for 84 (56%) children, and 63 (42%) parents expressed a negative impact on the child's development. CONCLUSION: We recognized a great discrepancy between those ADE that were feared and those that were experienced. Parents feared life-threatening ADE and experienced less severe ADE that nevertheless have a negative impact on the child's daily life.
BACKGROUND: The main source of knowledge on adverse drug events (ADE) are physicians' reports in controlled clinical trials. In contrast, little is known about the parents' perception of ADE of anticonvulsants their children receive. METHODS: After approval by the local ethics committee, we performed a survey in a neuropediatric outpatient clinic of a university hospital. Based on a structured questionnaire, we interviewed parents of children with current anticonvulsant treatment regarding (i) their fears about potential ADE, (ii) experienced ADE according to parents, and (iii) implications of ADE on the child's life. RESULTS: Parents of 150 patients took part in the interview. (i) 95 (63.3%) parents expressed fears concerning ADE, mostly liver injury/liver failure (33 [22%]). (ii) 129 (86%) parents reported experienced ADE, mostly sedation (65 [43.3%]) and abnormal behavior (54 [36%]). (iii) Parents reported substantial implications of ADE on the child's daily life for 84 (56%) children, and 63 (42%) parents expressed a negative impact on the child's development. CONCLUSION: We recognized a great discrepancy between those ADE that were feared and those that were experienced. Parents feared life-threatening ADE and experienced less severe ADE that nevertheless have a negative impact on the child's daily life.
Authors: Martina P Neininger; Sarah Jeschke; Lisa M Kiesel; Thilo Bertsche; Astrid Bertsche Journal: World J Pediatr Date: 2021-11-13 Impact factor: 2.764
Authors: Laurent M Willems; Felix Rosenow; Susanne Schubert-Bast; Gerhard Kurlemann; Johann Philipp Zöllner; Thomas Bast; Astrid Bertsche; Ulrich Bettendorf; Daniel Ebrahimi-Fakhari; Janina Grau; Andreas Hahn; Hans Hartmann; Christoph Hertzberg; Frauke Hornemann; Ilka Immisch; Julia Jacobs; Karl Martin Klein; Kerstin A Klotz; Gerhard Kluger; Susanne Knake; Markus Knuf; Klaus Marquard; Thomas Mayer; Sascha Meyer; Hiltrud Muhle; Karen Müller-Schlüter; Felix von Podewils; Susanne Ruf; Matthias Sauter; Hannah Schäfer; Jan-Ulrich Schlump; Steffen Syrbe; Charlotte Thiels; Regina Trollmann; Adelheid Wiemer-Kruel; Bernd Wilken; Bianca Zukunft; Adam Strzelczyk Journal: CNS Drugs Date: 2021-07-17 Impact factor: 5.749