ABSTRACT
OBJECTIVES: The objectives of this study were to analyze adverse drug events (ADEs) related to admissions to a pediatric emergency unit and to identify the associated risk factors. METHODS: This was a prospective study. Demographic data and details of medications were collected for each patient admitted. Case studies were performed by clinical pharmacists and the clinical team to discuss whether the admission was due to an ADE and to characterize the ADE. Multivariate logistic regression was used for statistical analysis. RESULTS: In total, 1708 pediatric patients were included in this study. Adverse drug events were the cause of hospital admission in 12.3% of the studied population. The majority of patients presenting with an ADE were in the age group of 0 to 5 years (61.6%), had a mean ± SD age of 4.9 ± 3.9 years, were female (51.2%), were Caucasian (72.0%), and had infectious disorders (49.3%). High frequencies of medication errors (68.8%), use of drugs to treat respiratory disorders (27.7%), and ADEs of mild severity (75.3%) were reported. The risk of being admitted to the pediatric emergency unit for any ADE increased in cases of neurological (odds ratio [OR], 4.63; 95% confidence interval [CI], 2.38-8.99), dermatological (OR, 3.16; 95% CI, 1.93-5.18), and respiratory (OR, 3.02; 95% CI, 1.89-4.83) disorders. CONCLUSIONS: A high frequency of ADE-related admissions to the pediatric emergency unit was observed. The risk of being admitted to the pediatric emergency unit for any ADE increased in cases of neurological, dermatological, and respiratory disorders. Clinical pharmacists play an important role in the identification of ADEs and the education of child caregivers and health care providers concerning pediatric medication.
Subject(s)
Drug-Related Side Effects and Adverse Reactions , Child , Child, Preschool , Drug-Related Side Effects and Adverse Reactions/epidemiology , Emergency Service, Hospital , Female , Hospitalization , Humans , Infant , Infant, Newborn , Male , Medication Errors , Prospective StudiesABSTRACT
INTRODUCTION: There are no published reports on pediatric phenytoin toxicity, resulting from the drug interaction between phenytoin and valproic acid. CASE DESCRIPTION: A 12-year-old patient with refractory epilepsy syndrome presented with phenytoin toxicity, following a concomitant treatment with phenytoin, valproic acid, and lamotrigine. The phenytoin concentration detected in the capsules used by the patient was in accordance with the prescribed dose and was appropriate for the age and weight of the patient. However, a supratherapeutic phenytoin serum concentration was observed (21.92 µg phenytoin/mL of blood). Consequently, the phenytoin dose was reduced, and the patient was monitored; 24 hours later the patient did not present with any signs/symptoms of toxicity. DISCUSSION: Despite the appropriate phenytoin concentration in the capsules, the patient presented with phenytoin toxicity. This toxicity likely resulted from the drug interaction between phenytoin and valproic acid that leads to phenytoin displacement from plasmatic proteins and inhibits phenytoin metabolism, thereby increasing the concentration of free drug in the serum.
Subject(s)
Anticonvulsants/blood , Epilepsy/blood , Epilepsy/drug therapy , Phenytoin/blood , Valproic Acid/blood , Anticonvulsants/therapeutic use , Child , Drug Interactions/physiology , Female , Humans , Phenytoin/therapeutic use , Valproic Acid/therapeutic useABSTRACT
A segurança na utilização de medicamentos tornou-se um tema altamente discutido nas políticas de saúde, em parte devido a pesquisas que demonstram a ocorrência de importantes eventos adversos aos medicamentos (EAM) causados por fármacos comumente utilizados. Poucos estudos em pediatria quantificam os EAM, o que demonstra a necessidade da condução de mais estudos com esta faixa etária. O objetivo deste trabalho foi realizar uma análise prospectiva sobre a incidência de EAM e estabelecer o perfil de adesão à farmacoterapia de uso contínuo em pacientes pediátricos admitidos em uma unidade de emergência. Trata-se, portanto, de um estudo transversal, com duração de um ano (julho/2011 a junho/2012), conduzido na Unidade de Emergência Referenciada Pediátrica do Hospital de Clínicas da (HC) da Universidade Estadual de Campinas (UNICAMP). Os EAM foram identificados, quantificados e caracterizados em 7 categorias (reação adversa ao medicamento; não adesão; inefetividade terapêutica; uso inadequado do medicamento; interação medicamentosa; intoxicação e queixa técnica) e classificados segundo a gravidade obedecendo aos critérios do CTCAE (Common Terminology Criteria for Adverse Events). As reações adversas aos medicamentos foram classificadas pela causalidade, segundo Algoritmo de Naranjo. Para os pacientes em tratamento medicamentoso em regime contínuo, foi avaliado o grau de adesão à terapia proposta utilizando o Teste de Morisky-Green. No período de estudo foram admitidos na unidade de emergência 20.441 pacientes e 1723 (8,4%) foram atendidos pela farmacêutica responsável pelo projeto. Destes, 199 (11,5%) foram admitidos em decorrência de pelo menos um EAM e fazem parte da "População EAM" e 226 (13,2%) relataram o uso de pelo menos um medicamento em regime contínuo e por isso foram incluídos na "População Adesão". O evento de maior frequência foi uso inadequado do medicamento, identificado em 39,3% dos casos...
The safety drug utilization has became a highly visible topic in health politics, due in part to research suggesting that there are important adverse drug events (ADE) caused by commonly used medications. Few pediatric studies quantify the ADE; this fact demonstrates the necessity of conducting further research with this age group. The objective of this study was to realize a prospective analysis on the incidence of ADE and to establish the profile of adherence to pharmacotherapy of continuous use in pediatric patients admitted to an emergency unit. This study was transversal with lasting one year (July/2011 to June/2012), conducted at the Emergency Pediatric Unit, Hospital de Clinicas (HC), State University of Campinas (UNICAMP). The ADE were identified, quantified and characterized in seven categories: (adverse drug reaction, non-compliance, and treatment ineffectiveness, inappropriate use of medication, drug interactions, toxicity, and technical defect) and classified by severity according to the criteria of the CTCAE (Common Terminology Criteria for Adverse Events). The adverse drug reactions were classified by causality, second to Naranjo algorithm, and type (organ involved). For patients under treatment in continuous, the degree of adherence to therapy proposal was evaluated using the Morisky-Green test. During the study period 20,441 patients were admitted and 1,723 (8.4%) were attended by the pharmaceutical responsible for the project. Of these, 199 (11.5%) were admitted with at least one ADE and form part of the "Population ADE"; and 226 (13.2%) were evaluated because of administering at least one drug in continuous and so were included in the "Population Adherence"...
