Introduction: Spontaneous notification depends on the ability of pediatricians to identify adverse drug reactions (ADRs) along with their habit of reporting these incidents. During the years 2008 and 2009, the frequency of reports of ADRs to the Electronic Program of Pharmacovigilance (SISFAR) in the Hospital Infantil of Mexico Federico Gomez (HIMFG) was low (0.44% and 0.20%, respectively). Because of the above, the ability of pediatricians from the Emergency Department (ED) to identify ADRs using the clinical chart review was evaluated in 2010 in this study.
Methods: A descriptive, observational, cross-sectional retrospective study was conducted in the ED from March 1 to August 31. ADRs were classified and quantified as "ADRs identified by pediatricians" when there was evidence in the clinical chart that pediatricians associated a clinical sign, symptom and laboratory value with an ADR. The numbers of notifications reported in SISFAR were quantified. Descriptive analysis was done using SPSS v.18.
Results: Considering patients who were admitted to the ED, the frequency of ADRs was 21.8%. The frequency of ADRs identified by physicians in clinical charts was 86%. The pharmacist detected 14% of ADRs. The frequency of ADRs reported by physicians was 6.1%.
Conclusions: Although identification of ADRs in the clinical charts by pediatricians was high, it is possible that some ADRs were undetected. Because underreporting was very high, it is necessary to take actions to improve the reporting process.
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http://dx.doi.org/10.1016/j.bmhimx.2015.04.003 | DOI Listing |
BMC Cancer
January 2025
Department of Pharmacy, Hainan Cancer Hospital, Haikou, Hainan, China.
Background: To identify the factors influencing pyrotinib-induced severe diarrhea and to establish a risk prediction nomogram model.
Methods: The clinical data of 226 patients received pyrotinib from two medical institutions from January 2019 to December 2023 were analysed retrospectively. A training set was made up of 167 patients from Hainan Cancer Hospital, and the external validation set was made up of 59 patients from Hainan West Central Hospital.
Clin Kidney J
January 2025
Pharmacoepidemiology Unit, Department of Clinical Pharmacology, Amiens-Picardie University Medical Center, Amiens, France.
Background: We sought to comprehensively describe drug-related components associated with acute kidney injury (AKI) in patients with chronic kidney disease (CKD), describing the incidence of drug-related AKI, the proportion of preventable AKI, identified the various drugs potentially associated with it, explored the risk factors, and assessed the 1-year incidences of the recurrence of drug-related AKI, kidney failure, and death.
Methods: CKD-REIN is a French national prospective cohort of 3033 nephrology outpatients with a confirmed diagnosis of CKD (eGFR <60 ml/min/1.73 m²).
Drugs Real World Outcomes
January 2025
School of Pharmacy, College of Medicine, National Taiwan University, Taipei, 100025, Taiwan.
Background And Objectives: Accumulating pediatric efficacy and safety data on drug use is inherently challenging yet essential. This study aimed to analyze the frequency and compute the odds of pediatric drug-associated liver injury across age groups (early childhood, middle childhood, and adolescence) and therapeutic categories using adverse drug reactions (ADRs) reporting data spanning nearly two decades.
Methods: We analyzed the reports of suspected ADRs occurring in children and adolescents in the Taiwan National Adverse Drug Reaction Reporting System during the period from May 1998 until July 2017.
BMC Neurol
December 2024
Pharmacovigilance, Pharmacoepidemiology and Drug Information Centre, Department of Clinical Pharmacology, Rennes University Hospital, Rennes, 35033, France.
Background: Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe headaches, often thunderclap headaches, and a multifocal constriction of the cerebral arteries. Although RCVS can occur spontaneously, some cases occur after exposure to drugs. We describe the first case of RCVS in which methylphenidate, a drug with vasoconstrictive properties, is the only suspected drug.
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