title: Clinical profiles of adverse drug reactions spontaneously reported at a single Korean hospital dedicated to children with complex chronic conditions.
abstract: Children with complex chronic conditions (CCC) are presumed to be vulnerable to adverse drug reactions (ADRs). The clinical profiles of ADRs in CCC are not well known. Herein, we aim to describe the ADR profiles in CCC with regard to typical presentations and vulnerable groups. We accessed the ADR yearly reports at a tertiary children's hospital whose practice is mainly dedicated to CCC and descriptively analyzed their clinical profiles according to the presence of a complex chronic condition, ADR severity, and age groups. A total of 1841 cases were analyzed, among which 1258 (68.3%) were mild, 493 (26.8%) moderate, and 90 (4.9%) cases were severe. A total of 1581 (85.9%) cases of complex chronic condition were reported. The proportion of CCC in each severity group increased as the ADR becomes more severe. In CCC, ADRs were most frequently reported by nurses in the adolescent group and in cases where the symptoms involved the gastrointestinal system. The class of antineoplastic and immunomodulating drugs was the most commonly suspected of causing an ADR, followed by one of the antibiotics. When we focus on the trend across the age groups, the ratio of severe-to-total ADRs decreased with older age. Among severe cases, the ratio of off-label prescription-related cases was the highest in the infant/toddler group and decreased as the groups aged. In conclusion, ADRs of CCCs admitted to a tertiary children's hospital have a unique profile. These groups are vulnerable to ADRs and thus they should be monitored closely, especially when they are infants or toddlers, so that severe ADRs can be identified and treated immediately.
authors.affiliation: Department of Pharmacy, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Bomi
authors.initials: B
authors.lastname: Kim
authors.affiliation: Student in training, Bachelor of Medicine and Bachelor of Surgery (MBBS), Shanghai Medical College of Fudan University, Shanghai, China.
authors.forename: Sunwha Zara
authors.initials: SZ
authors.lastname: Kim
authors.affiliation: Department of Pharmacy, Seoul National University Hospital, Seoul, Republic of Korea.|Regional Drug Safety Monitoring Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Jin
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Pharmacy, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Ae Hee
authors.initials: AH
authors.lastname: Jung
authors.affiliation: Department of Pharmacy, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Sun-Hoi
authors.initials: SH
authors.lastname: Jung
authors.affiliation: Department of Pharmacy, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Hyeon-Joo
authors.initials: HJ
authors.lastname: Hahn
authors.affiliation: Regional Drug Safety Monitoring Center, Seoul National University Hospital, Seoul, Republic of Korea.|Division of Allergy, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Hye Ryun
authors.initials: HR
authors.lastname: Kang
authors.affiliation: Regional Drug Safety Monitoring Center, Seoul National University Hospital, Seoul, Republic of Korea.|Department of Pediatrics, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Dong In
authors.identifier: http://orcid.org/0000-0002-7817-8728
authors.initials: DI
authors.lastname: Suh
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D002648:Child; D002908:Chronic Disease; D016208:Databases, Factual; D006776:Hospitals, Pediatric; D006801:Humans; D056910:Republic of Korea; D012720:Severity of Illness Index; D062606:Tertiary Care Centers
chemical_list: D000900:Anti-Bacterial Agents