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Background Physicians identify from 45.7 to 96.2 % of Adverse Drug Reactions (ADRs) in their patients, with under-reporting ranging from 6 to 100 %. In order to improve ADR reporting, several interventions have been evaluated in different studies, but not with regard to ADR identification. In addition, it is not known whether some patient characteristics might influence on ADR identification and reporting by physicians. Objectives (a) To assess the effectiveness of a comprehensive intervention directed to Emergency Department physicians and coordinated by a pharmacist in a tertiary care pediatric hospital on ADR identification and reporting. (b) To assess if some of the children’s characteristics might influence on ADR identification and reporting. Setting The Emergency Department of the Hospital Infantil de México “Federico Gómez”, which is a national pediatric institute of health in México. Methods A Quasi-experimental, pre-post test trial was designed. During the intervention, the pharmacist gave talks on Pharmacovigilance and on the program for electronic capture of data, took part in patient visits, left reminders, improved accessibility to ADR report format and performed feedback activities. To classify and quantify correctly identified ADRs and ADRs reported to the Institutional Pharmacovigilance Center (IPC), 1136 clinical records were reviewed. The models were adjusted for patient variables. Main outcome measures Total ADRs, ADRs correctly identified by physicians, ADRs reported to the IPC by physicians. Results Before the intervention, 97 % of ADRs were correctly identified and 6.1 % reported by physicians. During the intervention, 99.6 % were correctly identified and 41.2 % were reported, and after the intervention, 99.6 and 41.7 %, respectively. Identification during the intervention showed a sevenfold increase with regard to preintervention and was maintained post-intervention. ADR reporting during the intervention showed a 14-fold increase with regard to pre-intervention and was maintained during post-intervention. Conclusion Physicians do identify ADRs, but fail to report them. The intervention increased ADR correct identification and reporting. The effect was maintained after the intervention.

Healthcare-associated adverse events represent a heavy burden of symptoms for pediatric oncology patients. Their description allows knowing the safety and quality of the care processes in countries with limited resources. This study aimed to describe the incidence, types, severity, and preventability of adverse events occurring in pediatric patients with acute lymphoblastic leukemia during the induction phase in a tertiary care pediatric hospital in Mexico. This study analyzed a cohort based on medical records of between 2015 and 2017. Initially, information on patients and adverse events was collected; subsequently, two pediatric oncologist reviewers independently classified adverse events, severity and preventability. Agreement between reviewers was evaluated. Adverse events incidence rates were estimated by type, severity, and preventability. One-hundred and eighty-one pediatric patients pediatric patients with acute lymphoblastic leukemia were studied. An overall adverse events rate of 51.8 per 1000 patient-days was estimated, involving 81.2% of patients during induction. Most adverse events were severe or higher (52.6%). Infectious processes were the most common severe or higher adverse event (30.5%). The presence of adverse events caused 80.2% of hospital readmissions. Of the adverse events, 10.5% were considered preventable and 53.6% could be ameliorable in severity. Improving the safety and quality of the care processes of children with acute lymphoblastic leukemia is possible, and this should contribute to the mitigation and prevention of adverse events associated morbidity and mortality during the remission induction phase.

Drug-drug interactions (DDIs) detected in a patient may not be clinically apparent (potential DDIs), and when they occur, they produce adverse drug reactions (ADRs), toxicity or loss of treatment efficacy. In pediatrics, there are only few publications assessing potential DDIs and their risk factors. There are no studies in children admitted to emergency departments (ED). The present study estimates the prevalence and describes the characteristics of potential DDIs in patients admitted to an ED from a tertiary care hospital in Mexico; in addition, potential DDI-associated risk factors are investigated. A secondary analysis of data from 915 patients admitted to the ED of the Hospital Infantil de México \"Federico Gómez\" was conducted. The Medscape Drug Interaction Checker software was used to identify potential DDIs. The results are expressed as number of cases (%), means (95% CI) and medians (25-75th percentiles). Count data regressions for number of total and severity-stratified potential DDIs were performed adjusting for patient characteristics, number of administered drugs, days of stay, presence of ADRs and diagnoses. The prevalence of potential DDIs was 61%, with a median of 4 (2-8). A proportion of 0.2% of potential DDIs was \"Contraindicated\", 7.5% were classified as \"Serious\", 62.8% as \"Significant\" and 29.5% as \"Minor\". Female gender, age, days of stay, number of administered drugs and diagnoses of Neoplasms (C00-D48), Congenital malformations (Q00-Q99), Diseases of the Blood, Blood-forming Organs and Immunity (D50-D89) and Diseases of the nervous system (G00-G99) were significantly associated with potential DDIs. The prevalence of potential DDIs in the ED is high, and strategies should therefore be established to monitor patients' safety during their stay, in addition to conducting investigations to estimate the real harm potential DDIs inflict on patients.

In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children. To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico. A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package. Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs. ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary.

During the coronavirus disease 2019 (COVID-19) pandemic, pediatric inpatients frequently received at least one antibiotic, and several antimicrobial stewardship programs (ASPs) strategies were disrupted. In Mexico, no published data are available on antibacterial consumption in children. The aim of this study was to evaluate antibacterial consumption levels and trends before, during, and after the COVID-19 pandemic in a tertiary care pediatric hospital in Mexico, and to forecast future antibacterial consumption. This was a secondary analysis based on time series data of monthly antibacterial consumption from January 2016 to June 2024 in a tertiary care pediatric hospital. Antibacterial consumption was retrospectively measured for the pre-pandemic, pandemic, and post-pandemic periods. Consumption was expressed as days of therapy (DOT) per 1000 patient-days (pd). The mean antibacterial consumption at the Hospital Infantil de México Federico Gómez (HIMFG) from 2016 to 2024 was 789.3 (95% CI, 756.1-822.5) DOT/1000 pd. In the medical pediatric intensive care unit (M-PICU) and surgical pediatric intensive care unit (S-PICU), mean consumption was 1305.3 DOT/1000 pd (95% CI: 1119.1-1491.6) and 1634.5 DOT/1000 pd (95% CI: 1444.2-1824.9), respectively. Before the pandemic, the hospital-wide mean consumption was 848.8 DOT/1000 pd (95% CI: 811.3-886.2); during the pandemic, it was 709.6 DOT/1000 pd (95% CI: 650.3-769.0); and after the pandemic, 799.2 DOT/1000 pd (95% CI: 698.1-900.3). Overall, consumption rates oscillated around the mean, and no patterns were observed. The COVID-19 pandemic did not affect trends of antibacterial consumption across the hospital or in the pediatric intensive care unit. Although the prior authorization component of the ASP maintained antibacterial consumption around the mean, the implementation of additional ASP strategies -such as education and persuasive interventions- alongside current restrictive measures may help further optimize antibacterial consumption in pediatric units.

Introduction Medication errors (MEs) are the main type of preventable adverse events in medical care, as well as safety indicators in the medication processes. Advances in the quality of care in pediatric acute lymphoblastic leukemia (ALL) have enabled to improve clinical outcomes. However, ME epidemiology in pediatric oncology is still incipient in developing countries. In view of this, the objectives of this study were to estimate the incidence of MEs, determine their types and consequences, as well as their preventability in the induction treatment of children with ALL at Hospital Infantil de Mexico Federico Gómez. Methods We reviewed the remission‐induction chemotherapy records of children with ALL between January 2015 and December 2017. A two‐phase review was carried out for ME identification and verification. The consequences of errors were determined by agreement between reviewers. Results We reviewed 1762 chemotherapy orders involving 181 children. MEs were observed in 16.9% of orders and in 57.5% of patients. Prescription errors were the most common (93.3%), with wrong dose errors (90.2%) being predominant. Only 3.7% of wrong dose errors were intercepted, while 12.2% of the children experienced adverse drug events (ADEs) preceded by some wrong dose error. Conclusions MEs were common, since they occurred in 57.5% of children with ALL on induction treatment and involved 16.5% of chemotherapy orders. Only 3.7% of MEs were intercepted, while 12.2% of children had ADEs related to overdose. Measures are required to prevent calculation error in prescriptions, as well as training of the nursing staff to intercept MEs. This study is a retrolective cohort whose aim is estimates the incidence and consequences of medication errors in children with acute lymphoblastic leukemia on remission induction therapy in a tertiary care hospital in Mexico. Medication errors were observed in 16.9% of orders and in 57.5% of patients, while 12.2% of the children experienced adverse drug events preceded by some wrong dose error. Preventive measures are required to build a safer medication process.

Objectives Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the evidence of educational interventions (EIs) efficacy in health professionals to increase ADR reporting, attitudes, and knowledge of pharmacovigilance. Evidence acquisition A systematic literature review was carried out to identify randomized clinical trials evaluating the efficacy of EI in pharmacovigilance in health professionals to improve ADR reports, knowledge, and attitude toward pharmacovigilance. ADR reports were pooled by calculating Odds Ratio (OR) with a 95% confidence interval (95%CI), while pharmacovigilance knowledge and attitude were pooled by calculating a mean difference (MD) with 95%CI. In addition, the subanalysis was performed by EI type. Meta-analysis was performed with RevMan 5.4 software. PROSPERO registry CRD42021254270. Results Eight hundred seventy-five articles were identified as potentially relevant, and 11 were included in the systematic review. Metanalysis showed that EI increased ADR reporting in comparison with control group (OR = 4.74, [95%CI, 2.46 to 9.12], I 2  = 93%, 5 studies). In subgroup analysis, the workshops (OR = 6.26, [95%CI, 4.03 to 9.73], I 2  = 57%, 3 studies) increased ADR reporting more than telephone-based interventions (OR = 2.59, [95%CI, 0.77 to 8.73], I 2  = 29%, 2 studies) or combined interventions (OR = 5.14, [95%CI, 0.97 to 27.26], I 2  = 93%, 3 studies). No difference was observed in pharmacovigilance knowledge. However, the subanalysis revealed that workshops increase pharmacovigilance knowledge (SMD = 1.85 [95%CI, 1.44 to 2.27], 1 study). Only one study evaluated ADR reporting attitude among participants and showed a positive effect after the intervention. Conclusion EI improves ADR reports and increases pharmacovigilance knowledge. Workshops are the most effective EI to increase ADR reporting. Graphical abstract