ArticleBMC pharmacology & toxicology2017
Improved drug safety through intensive pharmacovigilance in hospitalized pediatric patients.
Article in BMC pharmacology & toxicology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.Drug safety · 2024Pooled it
- Article
- Age-stratified pharmacovigilance of azithromycin: a multimethod signal detection analysis in the FAERS database.Journal of pharmaceutical policy and practice · 2025Article
- Analysis of Adverse Drug Reactions in Pediatric Patients with Epilepsy: An Intensive Pharmacovigilance Study.Children (Basel, Switzerland) · 2023Article
- Adverse Drug Reactions in Children: Comparison of Reports Collected in a Pharmacovigilance Project Versus Spontaneously Collected ADR Reports.Paediatric drugs · 2023Article
- Safety of Antibiotics in Hospitalized Children in Romania: A Prospective Observational Study.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Causality and avoidability of adverse drug reactions of antibiotics in hospitalized children: a cohort study.International journal of clinical pharmacy · 2021Article
- Utilization of the Naranjo scale to evaluate adverse drug reactions at a free-standing children's hospital.PloS one · 2021Article
- A 7-Years Active Pharmacovigilance Study of Adverse Drug Reactions Causing Children Admission to a Pediatric Emergency Department in Sicily.Frontiers in pharmacology · 2020Article
- Characterization and preventability of adverse drug events as cause of emergency department visits: a prospective 1-year observational study.BMC pharmacology & toxicology · 2019Observational
- Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review.Paediatric drugs · 2019Article
- Critical assessment of approaches for molecular docking to elucidate associations of HLA alleles with adverse drug reactions.Molecular immunology · 2018Article
- Pharmacovigilance study of amphotericin B for mucormycosis in post-COVID and non-COVID patients at a tertiary care hospital in Eastern India.Indian journal of pharmacologyObservational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of this study was to detect and analyze Adverse Drug Reactions (ADRs) through Intensive Pharmacovigilance (IPV) in hospitalized pediatric patients to improve drug safety.
methodsA prospective 6-month cross-sectional study was performed in the pediatric service of a regional hospital in Mexico in order to assess hospitalized children from 1 day to 18 years old. The inclusion criteria were: both genders, all hospitalization causes, and at least one prescribed medication (indistinct drug group). Notifications were performed through medical visits, phone calls, or spontaneous reports. ADR suspicions were assessed with severity scales: Naranjo algorithm, Schumock & Thornton and Hartwig and Siegel.
resultsFrom a total of 1083 hospital admissions, 19 ADRs were recorded. The average age of patients in years was 7.2 (±5.9). The causality assessment in this study showed that most of the ADRs were probable (68.4%) and 4 certain (8.2%); causality was mainly attributed to antibiotics (AB) and an antiepileptic drug. We found a relationship of AB with ADRs (p < 0.05) with an increased risk at the third day of prescription (p < 0.05). The average severity was level 2 and 21% were classified as "preventable". Lastly, an increase in hospital stay associated with ADRs (p < 0.05) and with concomitant medications (p < 0.05), was also found. The most severe ADRs were hemolysis and toxic epidermal necrolysis.
conclusionsIPV was an effective tool for ADR prevention, detection, and treatment in hospitalized patients. The intensive monitoring approach in pharmacovigilance amplifies ADR detection and this translates into the improvement of drug safety in children.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.