Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital
The pediatric population is a vulnerable group for adverse drug reactions (ADRs), and data on spontaneous reporting of ADRs in the hospital setting are scarce. We conducted a retrospective analysis of ADRs in pediatric patients spontaneously reported by health care professionals to a Pharmacovigilan...
| Authors: | ; ; ; ; ; ; |
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| Format: | Article |
| Publication date: | 2021 |
| Country: | España |
| Institution: | Universitat Autònoma de Barcelona |
| Repository: | Dipòsit Digital de Documents de la UAB |
| Language: | English |
| OAI Identifier: | oai:ddd.uab.cat:264656 |
| Online Access: | https://ddd.uab.cat/record/264656 https://dx.doi.org/urn:doi:10.3390/jcm10235531 |
| Access Level: | Open access |
| Keyword: | Adverse drug reaction Spontaneous reporting Pharmacovigilance Children Pediatrics |
| _version_ | 1878735178834116608 |
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| author | López Valverde, Laura|||0000-0003-2504-6008 |
| author2 | Domènech Marsal, Èlia Roguera, M. Gich, Ignasi|||0000-0003-3975-6588 Farré Albaladejo, Magí|||0000-0001-8338-7543 Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585 Montané Esteva, Eva|||0000-0002-1691-7652 |
| author2_role | author author author author author author |
| author_browse | Domènech Marsal, Èlia Farré Albaladejo, Magí|||0000-0001-8338-7543 Gich, Ignasi|||0000-0003-3975-6588 López Valverde, Laura|||0000-0003-2504-6008 Montané Esteva, Eva|||0000-0002-1691-7652 Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585 Roguera, M. |
| author_facet | López Valverde, Laura|||0000-0003-2504-6008 Domènech Marsal, Èlia Roguera, M. Gich, Ignasi|||0000-0003-3975-6588 Farré Albaladejo, Magí|||0000-0001-8338-7543 Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585 Montané Esteva, Eva|||0000-0002-1691-7652 |
| author_role | author |
| collection | Dipòsit Digital de Documents de la UAB |
| description | The pediatric population is a vulnerable group for adverse drug reactions (ADRs), and data on spontaneous reporting of ADRs in the hospital setting are scarce. We conducted a retrospective analysis of ADRs in pediatric patients spontaneously reported by health care professionals to a Pharmacovigilance Program in a tertiary hospital between 2010 and 2020, and we compared characteristics of ADRs between pediatric age subgroups. From 1787 spontaneously reported ADRs in an 11-year period, 103 (5.85%) were pediatric ADRs. The median age of patients with ADRs was 8.4 years (range 1 day-17 years) and 57.3% were male. The most frequent ADRs reported were nervous system disorders (13.6%) and the most frequently involved drugs were antineoplastics and immunodulators (32.4%). A 59.2% of the ADRs were serious and 55.3% were classified as being type B reactions. Medication errors were involved in 7.8% of the ADRs and 11.9% of the suspected drugs were used off-label. Spontaneous reports of ADRs in newborns, infants, and toddlers were more serious and less often described in the product data sheet than in children and adolescents (p < 0.001 and p = 0.004 respectively). Medication errors were more frequent in patients under two years of age. These results should be interpreted with caution due to under-reporting and biases in spontaneous reporting of ADRs. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_7799c511e596ddf796eb2f97b81a4da2 |
| institution | Universitat Autònoma de Barcelona |
| instname_str | Universitat Autònoma de Barcelona |
| language | eng |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:ddd.uab.cat:264656 |
| publishDate | 2021 |
| publishDateSort | 2021 |
| reponame_str | Dipòsit Digital de Documents de la UAB |
| spelling | Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital López Valverde, Laura|||0000-0003-2504-6008 Domènech Marsal, Èlia Roguera, M. Gich, Ignasi|||0000-0003-3975-6588 Farré Albaladejo, Magí|||0000-0001-8338-7543 Rodrigo Gonzalo de Líria, Carlos|||0000-0003-1140-2585 Montané Esteva, Eva|||0000-0002-1691-7652 Adverse drug reaction Spontaneous reporting Pharmacovigilance Children Pediatrics The pediatric population is a vulnerable group for adverse drug reactions (ADRs), and data on spontaneous reporting of ADRs in the hospital setting are scarce. We conducted a retrospective analysis of ADRs in pediatric patients spontaneously reported by health care professionals to a Pharmacovigilance Program in a tertiary hospital between 2010 and 2020, and we compared characteristics of ADRs between pediatric age subgroups. From 1787 spontaneously reported ADRs in an 11-year period, 103 (5.85%) were pediatric ADRs. The median age of patients with ADRs was 8.4 years (range 1 day-17 years) and 57.3% were male. The most frequent ADRs reported were nervous system disorders (13.6%) and the most frequently involved drugs were antineoplastics and immunodulators (32.4%). A 59.2% of the ADRs were serious and 55.3% were classified as being type B reactions. Medication errors were involved in 7.8% of the ADRs and 11.9% of the suspected drugs were used off-label. Spontaneous reports of ADRs in newborns, infants, and toddlers were more serious and less often described in the product data sheet than in children and adolescents (p < 0.001 and p = 0.004 respectively). Medication errors were more frequent in patients under two years of age. These results should be interpreted with caution due to under-reporting and biases in spontaneous reporting of ADRs. https://ddd.uab.cat/record/264656 https://dx.doi.org/urn:doi:10.3390/jcm10235531 |
| spellingShingle | Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital López Valverde, Laura|||0000-0003-2504-6008 Adverse drug reaction Spontaneous reporting Pharmacovigilance Children Pediatrics |
| title | Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital |
| title_full | Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital |
| title_fullStr | Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital |
| title_full_unstemmed | Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital |
| title_short | Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital |
| title_sort | Spontaneous reporting of adverse drug reactions in a pediatric population in a tertiary hospital |
| topic | Adverse drug reaction Spontaneous reporting Pharmacovigilance Children Pediatrics |
| topic_facet | Adverse drug reaction Spontaneous reporting Pharmacovigilance Children Pediatrics |
| url | https://ddd.uab.cat/record/264656 https://dx.doi.org/urn:doi:10.3390/jcm10235531 |