Adverse drug reactions in children: a ten-year review of reporting to the Portuguese Pharmacovigilance System

Guerra, Leonor Nogueira; Herdeiro, María Teresa; Vaz-Luís, I.; Clérigo, Maria Inês Pinto; Rocha, C.; Araújo, A. M.; Pêgo, Alexandra; Gomes, Eva

doi:10.1517/14740338.2015.1105214

Cited by 11 publications

(6 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Concerning the therapeutic substances involved in ADRs, our results confirm previously reported data ( Clavenna et al, 2009 ; Piovani et al, 2013 ; Nogueira Guerra et al, 2015 ; Ferrajolo et al, 2019 ). In fact, vaccines were the drug class involved in ADRs occurrence, especially in infants.…”

Section: Discussionsupporting

confidence: 91%

A 7-Years Active Pharmacovigilance Study of Adverse Drug Reactions Causing Children Admission to a Pediatric Emergency Department in Sicily

et al. 2020

View full text Add to dashboard Cite

Children represent one of the most susceptible groups to adverse drug reactions (ADRs), as a consequence of physiological growth and maturation of different organ systems. The aim of this study was to characterize the frequency, preventability and seriousness of ADRs recorded in the Pediatric Emergency Department (ED) of the University hospital of Messina, in Sicily. All the suspected adverse reactions to drugs and vaccines collected from 2012 to 2018 were selected and then analyzed. Only adverse drug reactions (ADRs) with a probable or possible causality assessment were included, according to the Naranjo Algorithm and the World Health Organization criteria; the preventability assessment using Schumock and Thornton criteria was also carried out. The Medical Dictionary for Regulatory Activities (MedDRA) was used to group ADRs. Of 75,935 admissions to the Pediatric ED, 120 were due to suspected ADRs. The rate of hospital admission due to ADRs (75.8%) was significantly greater than that of patients without ADRs (11.9%). Among pediatric patients with ADRs the median (Q1-Q3) age was 29.5 (12-73.25) months. Most of ADRs were observed in infants and children (43.3% and 41.7%, respectively vs adolescents, 15%). In addition, in children with ADRs, females [41 (14-105)] were older than males [23 (11-45)] (p=0.044). Most adverse reactions were serious (75.8%) and 20.8% were preventable or probably preventable; however, the majority of serious ADRs (93.4%) resulted without sequelae. The reactions were found to be as probable (54.2%) or possible (45.8%). Vaccines (n=63), antibacterials (n=31) and antiinflammatory medicines (n=14) were the most frequently drugs involved. Organ toxicity mapping due to vaccines was general disorders and administration site conditions (65.1%), nervous disorders (50.2%), cutaneous disorders (35%), followed by gastrointestinal disorders (20.6%). Cutaneous disorders (76%) gastrointestinal (20.7%),

show abstract

Section: Discussionsupporting

confidence: 91%

A 7-Years Active Pharmacovigilance Study of Adverse Drug Reactions Causing Children Admission to a Pediatric Emergency Department in Sicily

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Our findings are largely consistent with several previous studies investigating pediatric reporting patterns in other national and international SRSs [ 25 , 35 – 37 , 43 , 44 ]. In accordance with findings from VigiBase [ 37 ] and the Italian SRS database [ 25 ], most child ICSRs corresponded to children aged 2 up to 17 years and about 52% of all ICSRs concerned boys, mainly from 28 days to 17 years of age.…”

Section: Discussionsupporting

confidence: 93%

“…During the 10-year period covered by our analysis, after exclusion of duplicates, vaccines, and ICSRs containing missing age data, reporting of suspected ADRs in the pediatric population of the Calabria region represented about 6% of all ICSRs collected in the Calabrian Pharmacovigilance database. This proportion was lower than that reported in the EudraVigilance database (11.2%) [ 34 ] and the Portuguese pharmacovigilance database (9.7%) [ 35 ], but it was similar to the percentage of pediatric ICSRs reported in the whole RNF database (6.8%) [ 25 ], in the Spanish pharmacovigilance database (7%) [ 36 ], and in VigiBase (7.7%) [ 37 ]: similar to our study, the RNF database and VigiBase analyses excluded vaccine-related reports.…”

Section: Discussioncontrasting

confidence: 61%

Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy

et al. 2022

View full text Add to dashboard Cite

Introduction The paucity of pediatric clinical trials has led to many medicines frequently prescribed to children without a license for use in pediatrics, resulting in an increased risk of adverse drug reactions. Pharmacovigilance databases remain, among others, a valuable tool for evaluating pediatric drug safety in the real-life setting. Objective We aimed to characterize pediatric adverse drug reactions reported in the Italian Pharmacovigilance database coming from the Calabria region (Southern Italy) over 10 years. Methods All Individual Case Safety Reports (ICSRs) concerning individuals aged under 18 years were extracted from 2010 to 2019. Duplicate and vaccine ICSRs were excluded. The remaining ICSRs were analyzed with respect to patients’ demographic data, suspected drugs, and category of adverse drug reactions across different age groups. Results Among 6529 selected ICSRs, 395 pediatric ICSRs corresponding to 556 adverse drug reactions were analyzed. From 2010 to 2015, an increasing number of ICSRs were observed, but the reporting rate decreased after 2015. The highest proportion of ICSRs concerned children and adolescents. Around 52% of ICSRs involved boys: a trend observed in all age groups excluding newborns. Sixty ICSRs were serious and among them, 75% required hospitalization mainly in children and adolescents. Most of the ICSRs were issued by physicians (64.1%), followed by other healthcare professionals (22.5%) and pharmacists (9.9%). Anti-infective agents for systemic use and skin disorders were, respectively, the most frequently reported drug group and adverse drug reaction category. Conclusions This study provides an overview of adverse drug reactions reported in the pediatric population of the Calabria region and emphasizes the need for strengthening the surveillance in specific age subgroups and on given drugs in relation to their pattern of use. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-022-01232-w.

show abstract

“…In line with our results, data obtained from an analysis of AEFIs reported to the Danish Medicines Agency between 1998 and 2007 revealed that AEFIs most commonly referred to the following SOCs: “general disorders and administration site conditions,” “skin and subcutaneous tissue disorders,” and “nervous system disorders” ( Aagaard et al, 2011 ). Also the results of a further pharmacovigilance study showed that out of 1,742 reports (of which 42% referred to vaccine), ADRs/AEFIs most commonly referred to “general disorders and administration site conditions” and “skin and subcutaneous tissue disorders” ( Nogueira Guerra et al, 2015 ). An analysis of AEFIs’ reports from Switzerland in 2016 showed that, apart from the above mentioned SOCs, AEFIs were also related to SOCs “injury, poisoning, and procedural complications” and “musculoskeletal and connective tissue disorders” ( AEFI, 2018 ).…”

Section: Discussionmentioning

confidence: 99%

Did the New Italian Law on Mandatory Vaccines Affect Adverse Event Following Immunization’s Reporting? A Pharmacovigilance Study in Southern Italy

et al. 2018

View full text Add to dashboard Cite

Despite the well-recognized role of vaccines, coverage is far from optimal especially in children, representing a growing concern also in Italy. In order to reverse this emergency, the Italian Ministry approved in July 2017 the Law 119/2017, which renders mandatory and free of charge 10 vaccinations for patients aged 0–16. We aim to investigate the effects of the new Law 119/2017 on the reporting of adverse events following immunization related to mandatory vaccines into the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza – RNF). Therefore, we analyzed the spontaneous reports of suspected adverse events following immunization recorded in Campania Region (South of Italy) from December 1, 2016, to March 31, 2018. During the study period, 69 reports, covering 179 AEFIs, related to mandatory vaccines were sent to Campania Pharmacovigilance Regional Center. A substantial increase in AEFIs reporting was observed after the adoption of Law 119/2017. Out of 69 reports, 62% reported AEFIs that were considered as not serious and 78% had a favorable outcome. Out of 179 AEFIs, more than half referred to the following SOC: “general disorders and administration site conditions,” “nervous system disorders,” and “psychiatric disorders.” The highest number of reports came from patient/citizen. After the adoption of the Law 119/2017, there was an increase in the number of reports (18 before the adoption of the Law vs. 51 after). According to reported AEFIs during the entire period, no worrying safety data have emerged. In our opinion, the increase in the number of AEFIs’ reports should be related to the increase in vaccination coverage as well as to the intense debate that has followed the new Law. In this context, the continuous monitoring of vaccine safety and the fully implementation of vaccine–vigilance programs play a key role in achieving higher confidence in immunization programs and optimal vaccination coverage rate.

show abstract

Adverse drug reactions in children: a ten-year review of reporting to the Portuguese Pharmacovigilance System

Abstract: Pediatric ADR represents about 10% of the reports received by the PPS. Most ADR were considered serious. Major findings varied according to age groups.

Cited by 11 publications

References 31 publications

A 7-Years Active Pharmacovigilance Study of Adverse Drug Reactions Causing Children Admission to a Pediatric Emergency Department in Sicily

A 7-Years Active Pharmacovigilance Study of Adverse Drug Reactions Causing Children Admission to a Pediatric Emergency Department in Sicily

Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy

Did the New Italian Law on Mandatory Vaccines Affect Adverse Event Following Immunization’s Reporting? A Pharmacovigilance Study in Southern Italy

Contact Info

Product

Resources

About