The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy

Carnovale, Carla; Brusadelli, Tatiana; Zuccotti, Gian Vincenzo; Beretta, Silvia; Sullo, Maria Giuseppa; Capuano, Annalisa; Rossi, Francesco; Mihalj, Martina; Mugelli, Alessandro; Vannacci, Alfredo; Laterza, Marcella; Clementi, Emilio; Radice, Sonia

doi:10.1517/14740338.2014.928692

Cited by 29 publications

(23 citation statements)

References 36 publications

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“…Among medication related-ADRs dermatological manifestation after beta-lactam antibacterial use is the most common disorder which is consistent with the findings of the major national ADRs overview conducted in Italy from 2001 to 2012, collecting data from the Italian Pharmacovigilance Network database [45, 66]. …”

Section: Discussionsupporting

confidence: 78%

“…The Italian active pharmacovigilance project ‘Monitoring of the adverse effects in pediatric population’ (MEAP), aimed to assess pediatric ADRs, provided a valid strategy to identify previously unknown ADRs, reduce underreporting and increase awareness in pediatric clinical practice [45]. This project however is focused exclusively on pediatric ADRs, therefore little is known about pediatric ADEs [46–48] and no study has previously explored pediatric MREs, in Italy.…”

Section: Introductionmentioning

confidence: 99%

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Medication-related visits in a pediatric emergency department: an 8-years retrospective analysis

et al. 2017

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BackgroundThere are limited data on the characterization of medication-related visits (MRVs) to the emergency department (ED) in pediatric patients in Italy. We have estimated the frequency, severity, and classification of MRVs to the ED in pediatric patients.MethodsWe retrospectively analyzed data for children seeking medical evaluation for a MRV over an 8 years period. A medication-related ED visit was identified by using a random pharmacist assessment, emergency physician assessment, and in case of conflicting events, by a third investigators random assessment.ResultsIn this study, regarding a single tertiary center in Italy, on a total of 147,643 patients from 0 to 14 years old, 497 medication-related visits were found, 54% of which occurred in children from 0 to 2 years of age. Severity was classified as mild in 21.6% of cases, moderate in 67.2% of cases, and severe in 11.2% of cases. The most common events were related to drug use without indication (51%), adverse drug reactions (30.3%), supratherapeutic dosage (13.2%) and improper drug selection (4.5%).The medication classes most frequently implicated in an ADE were anti-infective drugs for systemic use (28.9%), central nervous system agents (22.3%) and respiratory system drugs (10.8%).The most common symptom manifestations were dermatologic conditions (46.1%), general disorder and administration site conditions (29.7%) and gastrointestinal symptoms (16.0%).ConclusionsTo our knowledge, this is the first study in Italy evaluating the epidemiologic characteristics of MRVs confirming a significant cause of healthcare contact resulting in ED visits and hospital admissions with associated resource utilization. Our results suggests further future prospective, large-sample sized, and multicenter research is necessary to better understand the impact of MRVs and to develop strategies to provide care plans and monitor patients to prevent medication-related visits.Trial registrationNot applicable.

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Section: Discussionsupporting

confidence: 78%

Section: Introductionmentioning

confidence: 99%

Medication-related visits in a pediatric emergency department: an 8-years retrospective analysis

et al. 2017

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“…The crucial role of active pharmacovigilance in stimulating AEs reporting has been already demonstrated in several Italian studies including pediatric [ 29 ] and elderly patients [ 30 ]. Recently, an observational study (BIO-Cam) investigated the occurrence of AEs in naïve patients receiving biologic drugs in several settings (including rheumatology), supporting our findings that pharmacovigilance programs may represent a winning strategy to improve the knowledge of safety profile of these new drugs [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

Implementing a simple pharmacovigilance program to improve reporting of adverse events associated with biologic therapy in rheumatology: Preliminary results from the Calabria Biologics Pharmacovigilance Program (CBPP)

et al. 2018

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IntroductionPost-marketing surveillance activities (namely pharmacovigilance) are crucial to favor the early detection of unexpected adverse events (AEs) and/or serious adverse reactions (SAEs). Indeed, spontaneous reporting of AEs has been demonstrated to underestimate the number of events in different clinical settings. Aim of the present study is to report the preliminary data of a Regional (Calabria, Italy) Pharmacovigilance Program (CBPP) aimed at improving AEs’ reporting associated with biologics use in rheumatology.Materials and methodsWe developed a simple, cost-effective pharmacovigilance program based on regular training sessions for physicians (stimulated reporting), periodical phone calls by a clinical pharmacologist aimed at identifying new events and stimulating self-awareness and encouraging reporting to the physician during the subsequent follow-up visit for minor AEs. To test this approach, all consecutive patients undergoing treatment with one biologic agent at eight rheumatology centers during a two-years period were invited to participate. Collected AEs were compared to the number of AEs spontaneously reported for the same molecules in the same centers before starting the protocol.ResultsDuring the study period, 399 patients (245 females; mean age: 58 ± 11 years) were started on treatment with biologics for active RA (n = 211, 52.9%), PsA (n = 119, 29.8%) or AS (n = 69, 17.3%) at eight rheumatology centers. A total of 125 AEs (31.3%) and 9 SAEs (2.3%) were reported during the two-years study period. In the control cohort (comprising 368 consecutive patients started on treatment with bDMARDs during a two-years period before CBPP study) only 42 (11.4%) AEs and no SAEs were reported (p < 0.0001). The most common AEs were injection site reactions and skin disorders.ConclusionsIn conclusion, our study provides further evidence of a critical role of active pharmacovigilance in detection, reporting and analysis of AEs in rheumatology.

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“…Young patients affected by bipolar disorder, psychosis, or schizophrenia have been shown to be particularly prone to experiencing ADRs due to APs (11). Also, children and adolescents seem to present a higher sensitivity to several ADRs such as neurologic disturbances, hyperprolactinemia, cardiovascular-related adverse events, weight gain, and related metabolic features in comparison to adult patients (12)(13)(14). These are consequences of the physiological variations typical of the developmental age, which could interfere with both the pharmacodynamic and pharmacokinetic profiles of the APs (15).…”

Section: Introductionmentioning

confidence: 99%

Safety and Tolerability of Antipsychotic Drugs in Pediatric Patients: Data From a 1-Year Naturalistic Study

Cicala

Santoro

Tata³

et al. 2020

Front. Psychiatry

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Background: Antipsychotic drugs (APs) are increasingly used to treat a variety of psychiatric disorders in children and adolescents. However, their safety and tolerability profiles, when used in a developmental age context, show different characteristics from the ones observed in adult patients. Treatment with APs in pediatric patients is often long-term. However, the tolerability data regarding these patients mostly derive from short-term studies.Methods: Starting from April 2017, for a 1-year period, patients between 4 and 18 years of age followed by five units of developmental age neuropsychiatry, who initiated a treatment with at least an AP (ATC class N05A) were included into the study. Patient-related data have been collected at baseline and regularly thereafter, as allowed by the clinical routine. Changes to continuous variables over time have been analyzed using a linear mixed model in subsamples of our population treated with risperidone or aripiprazole.Results: During the observation period, 158 patients were initially enrolled, but only 116 completed 12 months of therapy with an AP. Risperidone was the most used AP (n = 52) followed by aripiprazole (n = 44) and olanzapine (n = 7). For both the aripiprazole and risperidone groups, the mean body mass index (BMI) (P < 0.001 for both groups) and heart rate (P = 0.026 for aripiprazole group and P < 0.001 for the risperidone one) values significantly increased over time. The mean prolactin concentration value significantly increased over time only in the risperidone group (P = 0.04). Eighty-six patients experienced at least one adverse drug reaction (ADR), accounting for a total of 238 specific reactions, with the most frequent being weight gain (n = 34), increased serum prolactin levels (n = 21), hyperphagia (n = 20), and hypercholesterolemia (n = 14). Among these, only 24 ADRs were classifiable as serious.Cicala et al. Antipsychotic Drugs in Pediatric PatientsConclusions: The results of this study confirm that risperidone and aripiprazole are relatively well-tolerated therapeutic options for the treatment of a variety of psychiatric disorders in pediatric patients. However, in findings such as statistically significant increments of BMI and heart rate mean values, the variations over time in prolactin levels observed with risperidone and the differences between the two drugs remark the necessity of systematic monitoring.

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The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy

Cited by 29 publications

References 36 publications

Medication-related visits in a pediatric emergency department: an 8-years retrospective analysis

Medication-related visits in a pediatric emergency department: an 8-years retrospective analysis

Implementing a simple pharmacovigilance program to improve reporting of adverse events associated with biologic therapy in rheumatology: Preliminary results from the Calabria Biologics Pharmacovigilance Program (CBPP)

Safety and Tolerability of Antipsychotic Drugs in Pediatric Patients: Data From a 1-Year Naturalistic Study

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