Costos directos y aspectos clínicos de las reacciones adversas a medicamentos en pacientes hospitalizados en el servicio de medicina interna de una institución de tercer nivel de BogotáGabriel Tribiño, Carlos Maldonado, Omar Segura, Jorge Díaz Departamento de Farmacia, Universidad Nacional de Colombia, Bogotá, D.C., Colombia.Introducción. Las reacciones adversas a medicamentos constituyen un problema clínico frecuente en el ámbito hospitalario y aumentan los costos de la atención en salud. En Colombia son pocos los estudios realizados para evaluarlas desde el punto de vista clínico y económico. Objetivo. Determinar los costos generados por las reacciones adversas a medicamentos en pacientes hospitalizados en el servicio de medicina interna de una institución de tercer nivel e identificar sus principales características clínicas. Materiales y métodos. Se hizo seguimiento intensivo de los pacientes del servicio de medicina interna durante un período de cinco meses para detectar reacciones adversas. La información se recolectó mediante un formulario basado en el formato de reporte del INVIMA. La probabilidad de causalidad se generó mediante el algoritmo de Naranjo. Se calcularon los costos directos desde la perspectiva del pagador teniendo en cuenta la estancia adicional, los medicamentos, los exámenes paraclínicos, los procedimientos, los traslados a la unidad de cuidado intermedio o intensivo y los insumos. Resultados. Se detectaron 268 reacciones adversas en 208 de los 836 pacientes que ingresaron en el servicio (proporción de incidencia, 25,1%; razón de presencia, 0,32). El 74,3% se clasificó como probable; el 92,5% fue tipo A; el 81,3% correspondió a reacciones moderadas. El sistema más frecuentemente afectado fue el hematológico (33,9%). Los medicamentos que actúan en sangre fueron los más frecuentemente relacionados (37,6%). El costo generado por la atención de las reacciones adversas fluctuó entre $93'633.422 y $122'155.406. Conclusiones. Dado el impacto negativo de las reacciones adversas en el bienestar de los pacientes, los recursos que se emplean en su atención y la proporción importante de reacciones adversas prevenibles, se requieren programas operativos de farmacovigilancia institucional.Palabras clave: farmacoepidemiología, efectos adversos, economía de la salud, hospitalización, medicina interna Direct costs and clinical aspects of adverse drug reactions in patients admitted to a level 3 hospital internal medicine ward.Introduction. Adverse drug reactions (ADRs) occur frequently in hospitals and increase costs of health care; however, few studies have quantified the clinical and economic impact of ADRs in Colombia. Objectives. These impacts were evaluated by calculating costs associated with ADRs in patients hospitalized in the internal medicine ward of a Level 3 hospital located in Bogotá, Colombia. In addition, salient clinical features of ADRs were identified and characterized. Material and methods. Intensive follow-ups for a cohort of patients were conducted for a five month period in order to ...

Agriculture first reached the Iberian Peninsula around 5700 BCE. However, little is known about the genetic structure and changes of prehistoric populations in different geographic areas of Iberia. In our study, we focus on the maternal genetic makeup of the Neolithic (~ 5500–3000 BCE), Chalcolithic (~ 3000–2200 BCE) and Early Bronze Age (~ 2200–1500 BCE). We report ancient mitochondrial DNA results of 213 individuals (151 HVS-I sequences) from the northeast, central, southeast and southwest regions and thus on the largest archaeogenetic dataset from the Peninsula to date. Similar to other parts of Europe, we observe a discontinuity between hunter-gatherers and the first farmers of the Neolithic. During the subsequent periods, we detect regional continuity of Early Neolithic lineages across Iberia, however the genetic contribution of hunter-gatherers is generally higher than in other parts of Europe and varies regionally. In contrast to ancient DNA findings from Central Europe, we do not observe a major turnover in the mtDNA record of the Iberian Late Chalcolithic and Early Bronze Age, suggesting that the population history of the Iberian Peninsula is distinct in character.

ImportanceA safe and effective treatment for recurrent Clostridioides difficile infection (CDI) is urgently needed. Antibiotics kill toxin-producing bacteria but do not repair the disrupted microbiome, which promotes spore germination and infection recurrence.ObjectivesTo evaluate the safety and rate of CDI recurrence after administration of investigational microbiome therapeutic SER-109 through 24 weeks.Design, Setting, and ParticipantsThis phase 3, single-arm, open-label trial (ECOSPOR IV) was conducted at 72 US and Canadian outpatient sites from October 2017 to April 2022. Adults aged 18 years or older with recurrent CDI were enrolled in 2 cohorts: (1) rollover patients from the ECOSPOR III trial who had CDI recurrence diagnosed by toxin enzyme immunoassay (EIA) and (2) patients with at least 1 CDI recurrence (diagnosed by polymerase chain reaction [PCR] or toxin EIA), inclusive of their acute infection at study entry.InterventionsSER-109 given orally as 4 capsules daily for 3 days following symptom resolution after antibiotic treatment for CDI.Main Outcomes and MeasuresThe main outcomes were safety, measured as the rate of treatment-emergent adverse events (TEAEs) in all patients receiving any amount of SER-109, and cumulative rates of recurrent CDI (toxin-positive diarrhea requiring treatment) through week 24 in the intent-to-treat population.ResultsOf 351 patients screened, 263 were enrolled (180 [68.4%] female; mean [SD] age, 64.0 [15.7] years); 29 were in cohort 1 and 234 in cohort 2. Seventy-seven patients (29.3%) were enrolled with their first CDI recurrence. Overall, 141 patients (53.6%) had TEAEs, which were mostly mild to moderate and gastrointestinal. There were 8 deaths (3.0%) and 33 patients (12.5%) with serious TEAEs; none were considered treatment related by the investigators. Overall, 23 patients (8.7%; 95% CI, 5.6%-12.8%) had recurrent CDI at week 8 (4 of 29 [13.8%; 95% CI, 3.9%-31.7%] in cohort 1 and 19 of 234 [8.1%; 95% CI, 5.0%-12.4%] in cohort 2), and recurrent CDI rates remained low through 24 weeks (36 patients [13.7%; 95% CI, 9.8%-18.4%]). At week 8, recurrent CDI rates in patients with a first recurrence were similarly low (5 of 77 [6.5%; 95% CI, 2.1%-14.5%]) as in patients with 2 or more recurrences (18 of 186 [9.7%; 95% CI, 5.8%-14.9%]). Analyses by select baseline characteristics showed consistently low recurrent CDI rates in patients younger than 65 years vs 65 years or older (5 of 126 [4.0%; 95% CI, 1.3%-9.0%] vs 18 of 137 [13.1%; 95% CI, 8.0%-20.0%]) and patients enrolled based on positive PCR results (3 of 69 [4.3%; 95% CI, 0.9%-12.2%]) vs those with positive toxin EIA results (20 of 192 [10.4%; 95% CI, 6.5%-15.6%]).Conclusions and RelevanceIn this trial, oral SER-109 was well tolerated in a patient population with recurrent CDI and prevalent comorbidities. The rate of recurrent CDI was low regardless of the number of prior recurrences, demographics, or diagnostic approach, supporting the beneficial impact of SER-109 for patients with CDI.Trial RegistrationClinicalTrials.gov identifier: NCT03183141

BackgroundThe antimicrobial resistance is a global problem, probably due to the indiscriminate and irrational use of antibiotics, prescriptions for incorrect medicines or incorrect determinations of dose, route and/or duration. Another consideration is the uncertainty of patients receiving antibiotics about whether the quality of a generic medicine is equal to, greater than or less than its equivalent brand-name drug. The antibiotics behaviors must be evaluated in vitro and in vivo in order to confirm their suitability for therapeutic use.MethodsThe antimicrobial activities of Meropenem and Piperacillin/Tazobactam were studied by microbiological assays to determine their potencies (content), minimal inhibitory concentrations (MICs), critical concentrations and capacity to produce spontaneous drug-resistant mutants.ResultsWith respect to potency (content) all the products fulfill USP requirements, so they should all be considered pharmaceutical equivalents. The MIC values of the samples evaluated (trade marks and generics) were the same for each strain tested, indicating that all products behaved similarly. The critical concentration values were very similar for all samples, and the ratios between the critical concentration of the standard and those of each sample were similar to the ratios of their specific antibiotic contents. Overall, therefore, the results showed no significant differences among samples. Finally, the production of spontaneous mutants did not differ significantly among the samples evaluated.ConclusionsAll the samples are pharmaceutical equivalents and the products can be used in antimicrobial therapy.

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