Adverse drug reactions in a pediatric oncology unit of a university hospital
Keywords:Farmacovigilância, Serviço Hospitalar de Oncologia, Pediatria, Efeitos Colaterais e Reações Adversas Relacionadas a Medicamentos, Sistemas de Notificação de Reações Adversas a Medicamentos, Serviço de Farmácia Clínica
Objectives: Conduct descriptive analysis of adverse drug reactions (ADRs) occurred in a pediatric oncology unit. Methods: retrospective cross-sectional study of patients admitted to a pediatric oncology unit in June 2014 to May 2015. Reactions were identified by active search in medical records and reports from the medical and nursing staff. ADRs were classified as causality of Naranjo algorithm, predictability, and severity. Data were tabulated and codified in SPSS software for analysis. Results: 87 ADRs were reported. The mean age of patients presenting reactions was 9.57 years and the average number of medications in the prescription was 17.47. Antimicrobials were the drug class with most reports, 19 (21.84%) of the cases. The skin was the site where the greatest number of reactions occurred, 46 (52.9%) of occasions. The ADR was considered severe in 26.4% of cases (antineoplastics being the drug class more related with this severity) and moderate in 61.6 % of cases. The reaction was classified as probable in 56 (64.4%) of occasions and predictability was considered as type A in 63 (82.4%) of the events. Conclusion: the reactions occurred more frequently with the use of antimicrobial, antifungal and antineoplastic drugs. Most of the events had cutaneous manifestations and were moderate, allowing easier recognition and less complex management by the multidisciplinary team. The clinical pharmacist assumed an important role in the prevention, detection, reporting and monitoring of ADRs in pediatric oncology, becoming responsible for actions that promote safe use of medicines.
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