Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study

Abstract

BackgroundTo describe frequency, preventability and seriousness of adverse drug reactions (ADRs) in children as cause of emergency department (ED) admission and to evaluate the association between specific factors and the reporting of ADRs.MethodsA retrospective analysis based on reports of suspected ADRs collected between January 1st, 2012 and December 31st, 2016 in the ED of Meyer Children’s Hospital (Italy). Demographics, clinical status, suspected drugs, ADR description, and its degree of seriousness were collected. Logistic regression was used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of potential predictors of ADR seriousness.ResultsWithin 5 years, we observed 834 ADRs (1100 drug-ADR pairs), of whom 239 were serious; of them, 224 led to hospitalization. Patients were mostly treated with one drug. Among patients treated with more than one drug, 78 ADRs presented a potential interaction. The most frequently reported ADRs involved gastrointestinal system. The most frequently reported medication class was antinfectives. Risk of serious ADR was significantly lower in children and infants compared to adolescents (ROR 0.41 [95% CI: 0.27–0.61] and 0.47 [0.32–0.71], respectively), and it was significantly increased in subjects exposed to more than one drug (ROR 1.87 [1.33–2.62] and 3.01 [2.07–4.37] for subjects exposed to 2 and 3 or more drugs, respectively). Gender, interactions and off-label drug use did not influence the risk of serious ADRs.ConclusionActive surveillance in pharmacovigilance might represent the best strategy to estimate and characterize the clinical burden of ADRs in children.Electronic supplementary materialThe online version of this article (10.1186/s40360-018-0207-4) contains supplementary material, which is available to authorized users.

Characterization and preventability of adverse drug events as cause of emergency department visits: a prospective 1-year observational study

“…In our study, the higher rates of serious ADEs were observed in ≥65 years group (46.8%) and in patients treated with more than one drug (66.5%). Polytherapy influenced the risk to experience a serious, as well as a certainly preventable ADE, while age ≥ 65 resulted an independent predictor only of serious events, in accordance with previous studies [4,8,10]. It is acknowledged that older age is strongly associated with polytherapy, primarily because of comorbidities (e.g.…”

“…Moreover, women are more likely to use several classes of medications and this could explain the different chance of having ADEs between genders [39]. However, gender did not influence the risk to experience a serious, in accordance with a previous study [4]. On the contrary, in the PSADE study, male gender resulted associated with the occurrence of serious ADEs [10].…”

“…Emergency departments (EDs) constitute an essential part of the healthcare system and an important source of information regarding incidence and characteristics of ADEs, as they are an interface between hospitals and communities [2,3]. Several studies have analysed ED visits potentially related to drug therapy [2,[4][5][6][7][8][9][10]. However, a wide range of ADE-related ED visits was reported and available evidence suggests that 0.6-12% of all visits are due to ADEs [5,7,[10][11][12].…”

“…Other findings are attributable to retrospective study design [21,22], short periods of observation [2,5,6,[23][24][25], or lack of information on preventability [7,10,26]. Moreover, some literature studies reported preventability assessment referred only to therapeutic classes [4,27,28]. Even though several studies were made in different European countries, few data are available especially in a South of Italy setting.…”

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database

“…age, sex etc.) and clinical status; (ii) AE, codified using the Medical Dictionary for Regulatory Activities (MedDRA) classification, and described using the preferred terms (PT) and system organ class (SOC) most frequently reported; (iii) AE degree of seriousness, classified according to the World Health Organisation criteria as fatal, life‐threatening, or requiring hospitalisation of the patient, or causing serious/permanent disability, or causing congenital abnormalities, or other clinically relevant conditions (https://apps.who.int/iris/bitstream/handle/10665/67378/WHO_EDM_QSM_2002.2.pdf;jsessionid=EF4F54EFF6FBD634E21D2C075ADCA3C0?sequence=1; 29661234); (iv) AE outcome; (v) ongoing cannabis therapy (i.e. product type, indication, dosage, length of exposure, and administration route); (vi) concomitant medications.…”