Subject(s)
Humans , Laboratories , Drug Dispensaries , Drug Dosage Calculations , Pharmaceutical PreparationsABSTRACT
Objetivo desse estudo foi avaliar os efeitos da batata de purga (O. macrocarpa) oferecida em blocos multinutricionais sobre ovinos naturalmente infectados por helmintos gastrintestinais. O trabalho foi desenvolvido de acordo com um delineamento inteiramente casualizado, com quatro tratamentos e seis repetições de um animal. Os tratamentos foram: T1 = apenas BMs; T2 = BMs + batata de purga (1g/Kg/peso vivo); T3 = BMs + batata de purga (0,5g/Kg/pv) e T4 = BMs + anti-helmíntico químico. Nos tratamentos com batata de purga 1g/Kg/pv, 0,5g/Kg/pv e químico o OPG diminuiu aos sete dias com 767, 516, 267 e eficácia de 53, 68, e 84% respectivamente. Os valores médios das hemácias, hemoglobina, hematócrito e leucócitos foram menores para o tratamento apenas com BMs, porém se mantiveram dentro dos valores de referência. Para globulina, proteínas totais, creatinina os valores médios ficaram discretamente abaixo da referência para ovinos. Conclui-se que a O. macrocarpa adicionada aos blocos multinutricionais nas doses e período estudado não provocaram respostas fisiorgânicas características de toxicidade.(AU)
This study evaluates the effects of purge potato (Operculina macrocarpa) in multi-nutritional blocks (MBs) on sheep naturally infected with gastrointestinal helminths. The experimental design was completely randomized, with four treatments and six replicates per animal. Treatments were: T1 = only MBs; T2 = MBs + purge potato (1g/Kg/lw); T3 = MBs + purge potato (0.5/Kg/lw); and T4 = MBs + chemical anthelmintic. In the treatments with 1g/Kg/lw and 0.5g/Kg/lw purge potato and with chemical anthelmintic, eggs per gram (EPG) counts decreased to 767, 516, and 267 at seven days, with an effectiveness of 53, 68, and 84%, respectively. The mean values of red blood cells, hemoglobin, hematocrit, and leukocytes were lower for the treatment with only MBs; however, they were maintained within the reference values. For globulin, total protein, and creatinine, the mean values were discretely below the reference for sheep. It is concluded that adding O. macrocarpa to the multi-nutritional blocks in the studied doses and period did not cause physiological responses characteristic of toxicity.(AU)
Subject(s)
Animals , Convolvulaceae/toxicity , Sheep/parasitology , Helminths , Helminthiasis, Animal/therapy , Anthelmintics/administration & dosage , Anthelmintics/analysis , Gastrointestinal Tract/parasitology , Drug Dosage Calculations , BrazilABSTRACT
OBJECTIVE: Evaluate the appropriateness of acetaminophen dosing by caregivers seeking care for their children/wards at the emergency department of a pediatric hospital. METHODS: Design: Cross-sectional descriptive study. Setting: The emergency department of the University Pediatric Hospital in San Juan, Puerto Rico. Participants: Eighty-eight caregivers who had, in the past 24 hours, administered a known quantity of acetaminophen to a pediatric patient under their care and were visiting the emergency room with that patient. Intervention: The caregivers were interviewed by the investigators, using a standardized questionnaire. Main outcome measures: The appropriateness of the acetaminophen doses administered by caregivers. The product's dosage form and strength, measurement device used (if any), and demographic data (of the caregiver and child) were also collected. Doses of 10 to 15 mg/kg of acetaminophen were considered appropriate. RESULTS: Overall, 45% of the caregivers had administered an inappropriate dose. Of these, 70% were subtherapeutic and 30% were supratherapeutic. Although 74% of the caregivers knew their child's/ward's weight, only 50% had used it to determine the dose. Caregivers with previous experience (as caregivers) were most likely to have administered an inappropriate dose (P = 0.03). Physicians were the source most consulted (40%) by caregivers, followed by the product's label (35%). Only 9% of the caregivers consulted a pharmacist for dosing recommendations. CONCLUSION: Nearly half of all the caregivers administered an incorrect acetaminophen dose, suggesting that there is a need for better caregiver education. Due to their accessibility at the point of sale of OTC medications and pharmacotherapy knowledge, pharmacists could have an active role in promoting the safe and effective use of acetaminophen.
Subject(s)
Acetaminophen/administration & dosage , Caregivers , Emergency Service, Hospital/statistics & numerical data , Fever/drug therapy , Nonprescription Drugs/administration & dosage , Acetaminophen/adverse effects , Adult , Analgesics, Non-Narcotic/administration & dosage , Child , Child, Preschool , Cross-Sectional Studies , Drug Dosage Calculations , Female , Hospitals, Pediatric , Hospitals, University , Humans , Infant , Male , Puerto Rico , Self CareABSTRACT
BACKGROUND: In patients co-infected with HIV and tuberculosis, antiretroviral therapy options are limited due to drug-drug interactions with rifampicin. A previous phase 2 trial indicated that raltegravir 400 mg twice a day or efavirenz 600 mg once a day might have similar virological efficacy in patients given rifampicin. In this phase 3 trial, we assessed the non-inferiority of raltegravir to efavirenz. METHODS: We did a multicentre, open-label, non-inferiority, randomised, phase 3 trial at six sites in Côte d'Ivoire, Brazil, France, Mozambique, and Vietnam. We included antiretroviral therapy (ART)-naive adults (aged ≥18 years) with confirmed HIV-1 infection and bacteriologically confirmed or clinically diagnosed tuberculosis who had initiated rifampicin-containing tuberculosis treatment within the past 8 weeks. Using computerised random numbers, we randomly assigned participants (1:1; stratified by country) to receive raltegravir 400 mg twice daily or efavirenz 600 mg once daily, both in combination with tenofovir and lamivudine. The primary outcome was the proportion of patients with virological suppression at week 48 (defined as plasma HIV RNA concentration <50 copies per mL). The prespecified non-inferiority margin was 12%. The primary outcome was assessed in the intention-to-treat population, which included all randomly assigned patients (excluding two patients with HIV-2 infection and one patient with HIV-1 RNA concentration of <50 copies per mL at inclusion), and the on-treatment population, which included all patients in the intention-to-treat population who initiated treatment and were continuing allocated treatment at week 48, and patients who had discontinued allocated treatment due to death or virological failure. Safety was assessed in all patients who received at least one dose of the assigned treatment regimen. This study is registered with ClinicalTrials.gov, NCT02273765. FINDINGS: Between Sept 28, 2015, and Jan 5, 2018, 460 participants were randomly assigned to raltegravir (n=230) or efavirenz (n=230), of whom 457 patients (230 patients in the raltegravir group; 227 patients in the efavirenz group) were included in the intention-to-treat analysis and 410 (206 patients in the raltegravir group; 204 patients in the efavirenz group) in the on-treatment analysis. At baseline, the median CD4 count was 103 cells per µL and median plasma HIV RNA concentration was 5·5 log10 copies per mL (IQR 5·0-5·8). 310 (68%) of 457 participants had bacteriologically-confirmed tuberculosis. In the intention-to-treat population, at week 48, 140 (61%) of 230 participants in the raltegravir group and 150 (66%) of 227 patients in the efavirenz had achieved virological suppression (between-group difference -5·2% [95% CI -14·0 to 3·6]), thus raltegravir did not meet the predefined criterion for non-inferiority. The most frequent adverse events were HIV-associated non-AIDS illnesses (eight [3%] of 229 patients in the raltegravir group; 21 [9%] of 230 patients in the efavirenz group) and AIDS-defining illnesses (ten [4%] patients in the raltegravir group; 13 [6%] patients in the efavirenz group). 58 (25%) of 229 patients in raltegravir group and 66 (29%) of 230 patients in the efavirenz group had grade 3 or 4 adverse events. 26 (6%) of 457 patients died during follow-up: 14 in the efavirenz group and 12 in the raltegravir group. INTERPRETATION: In patients with HIV given tuberculosis treatment, non-inferiority of raltegravir compared with efavirenz was not shown. Raltegravir was well tolerated and could be considered as an option, but only in selected patients. FUNDING: National French Agency for AIDS Research, Ministry of Health in Brazil, Merck. TRANSLATIONS: For the Portuguese and French translations of the abstract see Supplementary Materials section.
Subject(s)
Alkynes/therapeutic use , Anti-HIV Agents/therapeutic use , Benzoxazines/therapeutic use , Coinfection/drug therapy , Cyclopropanes/therapeutic use , HIV Infections/drug therapy , Raltegravir Potassium/therapeutic use , Tuberculosis/drug therapy , Adult , Aged , Aged, 80 and over , Brazil , Cote d'Ivoire , Drug Dosage Calculations , Female , France , Humans , Male , Middle Aged , Mozambique , Treatment Outcome , Vietnam , Young AdultABSTRACT
Objetivo desse estudo foi avaliar os efeitos da batata de purga (O. macrocarpa) oferecida em blocos multinutricionais sobre ovinos naturalmente infectados por helmintos gastrintestinais. O trabalho foi desenvolvido de acordo com um delineamento inteiramente casualizado, com quatro tratamentos e seis repetições de um animal. Os tratamentos foram: T1 = apenas BMs; T2 = BMs + batata de purga (1g/Kg/peso vivo); T3 = BMs + batata de purga (0,5g/Kg/pv) e T4 = BMs + anti-helmíntico químico. Nos tratamentos com batata de purga 1g/Kg/pv, 0,5g/Kg/pv e químico o OPG diminuiu aos sete dias com 767, 516, 267 e eficácia de 53, 68, e 84% respectivamente. Os valores médios das hemácias, hemoglobina, hematócrito e leucócitos foram menores para o tratamento apenas com BMs, porém se mantiveram dentro dos valores de referência. Para globulina, proteínas totais, creatinina os valores médios ficaram discretamente abaixo da referência para ovinos. Conclui-se que a O. macrocarpa adicionada aos blocos multinutricionais nas doses e período estudado não provocaram respostas fisiorgânicas características de toxicidade.
This study evaluates the effects of purge potato (Operculina macrocarpa) in multi-nutritional blocks (MBs) on sheep naturally infected with gastrointestinal helminths. The experimental design was completely randomized, with four treatments and six replicates per animal. Treatments were: T1 = only MBs; T2 = MBs + purge potato (1g/Kg/lw); T3 = MBs + purge potato (0.5/Kg/lw); and T4 = MBs + chemical anthelmintic. In the treatments with 1g/Kg/lw and 0.5g/Kg/lw purge potato and with chemical anthelmintic, eggs per gram (EPG) counts decreased to 767, 516, and 267 at seven days, with an effectiveness of 53, 68, and 84%, respectively. The mean values of red blood cells, hemoglobin, hematocrit, and leukocytes were lower for the treatment with only MBs; however, they were maintained within the reference values. For globulin, total protein, and creatinine, the mean values were discretely below the reference for sheep. It is concluded that adding O. macrocarpa to the multi-nutritional blocks in the studied doses and period did not cause physiological responses characteristic of toxicity.
Subject(s)
Animals , Anthelmintics/administration & dosage , Anthelmintics/analysis , Convolvulaceae/toxicity , Helminths , Helminthiasis, Animal/therapy , Sheep/parasitology , Brazil , Drug Dosage Calculations , Gastrointestinal Tract/parasitologyABSTRACT
INTRODUCCIÓN: Los estudiantes de enfermería deben desarrollar habilidades matemáticas para una vez que sean profesionales de esta disciplina no tengan obstáculos con la dosificación de medicamentos, que es una de las funciones que deben desarrollar en el ámbito clínico, y cuya equivocación podría poner en riesgo la seguridad y vida del paciente. OBJETIVO: Analizar de qué manera las habilidades para las matemáticas básicas afecta la realización del cálculo de las dosis de medicamentos por parte de los estudiantes de enfermería en una institución universitaria. MATERIALES Y MÉTODOS: investigación descriptiva transversal realizada a través del instrumento "Habilidad matemática para el cálculo de las dosis de medicamentos" compuesto por 13 preguntas abiertas y aplicado a 256 estudiantes de los ocho semestres que componen un programa de enfermería. RESULTADOS: El estudio evidenció serias deficiencias en la resolución de situaciones que involucran distintas habilidades matemáticas básicas que debe poseer un estudiante de enfermería. Solo el 30,7% de los estudiantes pudo resolver las situaciones clínicas en las cuales tenía que realizar el cálculo de las dosis de medicamentos; también en el manejo de los porcentajes se encontró dificultades, ya que apenas el 42% logró resolver la situación planteada. La interpretación de conceptos matemáticos básicos mediante la utilización de gráficos fue interpretada adecuadamente por el 50,2%. CONCLUSIÓN: Los hallazgos de la presente investigación, mostraron que deben buscar estrategias de aprendizaje que mejoren las habilidades de los estudiantes de enfermería para la dosificación de medicamentos.
INTRODUCTION: Nursing students must develop mathematical skills so that once they are professionals in this discipline, they do not have obstacles with the dosage of medications, which is one of the functions that they must develop in the clinical field, and whose error could put at risk the safety and life of the patient. OBJECTIVE: To analyze how the skills for basic mathematics affect the calculation of medicine doses by nursing students in a university institution. MATERIALS AND METHODS: descriptive cross-sectional research, carried out through the instrument "Mathematical ability to calculate drug doses" made up of 13 open-ended questions and applied to 256 students from the eight semesters that make up a nursing program. RESULTS: The study showed serious deficiencies in the resolution of situations that involve different basic mathematical skills that a nursing student must possess. Only 30.7% of the students were able to resolve the clinical situations in which they had to perform the calculation of the drug doses; Difficulties were also found in managing the percentages, since only 42% managed to resolve the situation. The interpretation of basic mathematical concepts using graphics was adequately interpreted by 50.2%. CONCLUSION: The findings of the present investigation showed that they should seek learning strategies that improve the skills of nursing students for the dosage of medications.
Subject(s)
Humans , Male , Female , Students, Nursing , Pharmaceutical Preparations/administration & dosage , Drug Dosage Calculations , Mathematics/education , Dosage , Patient Safety , Medication Errors/nursingABSTRACT
The aim of this study was to develop a population pharmacokinetic model of rifampicin (RMP) in Mexican patients with tuberculosis (TB) to evaluate the influence of anthropometric and clinical covariates, as well as genotypic variants associated with MDR1 and OATP1B1 transporters. A prospective study approved by Research Ethics Committee was performed at Hospital Central in San Luis Potosí, Mexico. TB patients under DOTS scheme and who signed informed consent were consecutively included. Anthropometric and clinical information was retrieved from medical records. Single nucleotide polymorphisms in MDR1 (C3435T) and SLCO1B1 (A388G and T521C) genes were evaluated. RMP plasma concentrations and time data were assessed with NONMEM software. A total of 71 Mexican TB patients from 18 to 72 years old were included for RMP quantification from 0.3 to 12 h after dose; 329 and 97 plasma concentrations were available for model development and validation, respectively. Sequential process includes a typical lag time of 0.25 h prior to absorption start with a Ka of 1.24 h-1 and a zero-order absorption of 0.62 h to characterize the gradual increase in RMP plasma concentrations. Final model includes total body weight in volume of distribution (0.7 L/kg, CV = 26.8%) and a total clearance of 5.96 L/h (CV = 38.5%). Bioavailability was modified according to time under treatment and generic formulation administration. In conclusion, a population pharmacokinetic model was developed to describe the variability in RMP plasma concentrations in Mexican TB patients. Genetic variants evaluated did not showed significant influence on pharmacokinetic parameters. Final model will allow therapeutic drug monitoring at early stages.
Subject(s)
Antibiotics, Antitubercular/pharmacokinetics , Liver-Specific Organic Anion Transporter 1/genetics , Models, Biological , Pharmacogenomic Variants , Polymorphism, Single Nucleotide , Rifampin/pharmacokinetics , Tuberculosis/drug therapy , ATP Binding Cassette Transporter, Subfamily B/genetics , ATP Binding Cassette Transporter, Subfamily B/metabolism , Adolescent , Adult , Aged , Antibiotics, Antitubercular/administration & dosage , Bayes Theorem , Biological Availability , Drug Administration Schedule , Drug Dosage Calculations , Female , Humans , Liver-Specific Organic Anion Transporter 1/metabolism , Male , Mexico/epidemiology , Middle Aged , Pharmacogenetics , Prospective Studies , Reproducibility of Results , Rifampin/administration & dosage , Treatment Outcome , Tuberculosis/diagnosis , Tuberculosis/ethnology , Tuberculosis/microbiology , Young AdultABSTRACT
The third trimester of pregnancy is related to physiological changes that can modify the process of absorption, distribution, metabolism, and excretion and, consequently, the efficacy and toxicity of drugs. However, little is known about furosemide pharmacokinetics and placental transfer in pregnancy. This study evaluated the maternal-fetal pharmacokinetics and distribution to amniotic fluid of furosemide in hypertensive parturient women under cesarean section. Twelve hypertensive parturient women under methyldopa (250 mg/8 h) and/or pindolol (10 mg/12 h) treatment received a 40-mg single oral dose of furosemide 1 to 10 hours before delivery by cesarean section. Blood and urine samples were collected for 12 hours after furosemide administration. At delivery, samples were obtained from maternal and umbilical cord blood (n = 8) to assess the transplacental transfer. Amniotic fluid (n = 4) was collected at the time of delivery. The following furosemide pharmacokinetic parameters were obtained as median (interquartile range): Cmax , 403 ng/mL (229 to 715 ng/mL); Tmax , 2.00 hours (1.50 to 4.83 hours); elimination half-life (t1/2 ), 2.50 hours (1.77 to 2.97 hours); AUC0-12 h , 1366 ngâ h/mL (927 to 2531 ngâ h/mL); AUC0-∞ , 1580 ngâ h/mL (1270 to 2881 ngâ h/mL); CL/F 25.3 L/h (13.8 to 31.4 L/h); CLR, 2.50 L/h (1.77 to 2.97 L/h); CLNR, 22.7 L/h (12.1 to 25.6 L/h); and Vd /F 82.8 L (34.4 to 173 L). The transplacental transfer of furosemide was 0.43 (0.10 to 0.73), and the amniotic fluid concentration was 11.0 ng/mL (5.51 to 14.6 ng/mL). From a clinical point of view, these results suggest that substrates of uridine diphosphate-glucuronosyltransferase isoenzymes such as furosemide may have increased clearance during pregnancy and could require dose adjustment in this population.
Subject(s)
Amniotic Fluid/metabolism , Diuretics/pharmacokinetics , Furosemide/pharmacokinetics , Hypertension, Pregnancy-Induced , Hypertension/drug therapy , Maternal-Fetal Exchange/physiology , Administration, Oral , Adult , Cesarean Section , Diuretics/administration & dosage , Diuretics/blood , Diuretics/urine , Drug Dosage Calculations , Drug Elimination Routes , Female , Fetal Blood/metabolism , Furosemide/administration & dosage , Furosemide/blood , Furosemide/urine , Glucuronosyltransferase/metabolism , Humans , Hypertension/blood , Hypertension/urine , Parturition/blood , Parturition/urine , Pilot Projects , PregnancyABSTRACT
In just a few years, immune checkpoint inhibitors have dramatically changed the landscape in oncology, offering durable responses and improved survival for many patients across several tumor types. With more than 3,300 new agents in the immuno-oncology pipeline plus a wide array of combinations being studied, it seems this new era is just getting started. These advances come with a significant caveat: most of the world population does not have access to their benefits, because the yearly cost of a novel anticancer medication can routinely exceed $100,000. There is a large amount of data showing that checkpoint inhibitors have significant activity at doses much lower than those currently approved. We review the evidence for reduced drug dosing as a strategy to increase the number of patients who can be treated and what would be needed to further validate this approach.
Subject(s)
Antibodies, Monoclonal/administration & dosage , Antineoplastic Agents/administration & dosage , Neoplasms/drug therapy , Antibodies, Monoclonal/economics , Antibodies, Monoclonal/therapeutic use , Antineoplastic Agents/economics , Antineoplastic Agents/therapeutic use , Clinical Trials as Topic , Combined Modality Therapy , Drug Dosage Calculations , Female , Humans , Male , Neoplasms/economics , Neoplasms/immunology , Survival Analysis , Treatment OutcomeABSTRACT
AIMS: Pregnancy is associated with physiological changes that alter the pharmacokinetics (PK) of drugs. The aim of this study was to predict the PK of ziprasidone in pregnant women. METHODS: A full physiologically-based pharmacokinetic (PBPK) model of ziprasidone was developed and validated for the non-pregnant population (healthy adults, paediatrics, geriatrics), and this was extended to the pregnant state to assess the change in PK profile of ziprasidone throughout pregnancy. RESULTS: The PBPK model successfully predicted the ziprasidone disposition in healthy adult volunteers, wherein the predicted and observed AUC, Cmax and tmax were within the fold-difference of 0.94-1.09, 0.89-1.40 and 0.80-1.08, respectively. The paediatric and geriatric population, also showed predicted AUC, Cmax and tmax within a two-fold range of the observed values. The simulated exposure in pregnant women using a p-PBPK model showed no significant difference when compared to non-pregnant women. CONCLUSIONS: The PBPK model predicted the impact of physiological changes during pregnancy on PK and exposure of ziprasidone, suggesting that dose adjustment is not necessary in this special population.
Subject(s)
Antipsychotic Agents/pharmacokinetics , Computer Simulation , Models, Biological , Piperazines/pharmacokinetics , Thiazoles/pharmacokinetics , Adult , Age Factors , Aged , Antipsychotic Agents/administration & dosage , Area Under Curve , Caco-2 Cells , Child , Dose-Response Relationship, Drug , Drug Dosage Calculations , Female , Healthy Volunteers , Humans , Mental Disorders/drug therapy , Piperazines/administration & dosage , Pregnancy , Pregnancy Complications/drug therapy , Thiazoles/administration & dosageABSTRACT
Introducción: Un requisito en la conducción de la anestesia intravenosa total, en modo manual, radica en la necesidad de realizar ajustes de dosificación temporales para evitar la acumulación plasmática del fármaco. Desde hace algunos años existe el interés de emplear otros fármacos como la ketamina. Objetivos: Comparar la variación temporal de la concentración plasmática de ketamina al aplicar una variante de cálculo de decrecimiento de la velocidad de infusión (Vinf) con una velocidad de infusión invariable. Métodos: Se realizó un estudio analítico que describe el cálculo de dosificación para TIVA manual, la simulación farmacocinética del comportamiento de la concentración plasmática de la ketamina en caso de administrarse invariablemente con esos regímenes de dosificación, en un paciente virtual, de 70 Kg, según el modelo de Domino y el análisis de la variante de cálculo de decrecimiento de la Vinf del medicamento. Se estimó una significación estadística de un 95 por ciento (p<0.05). Resultados: la variante de cálculo de decrecimientode la velocidad de infusión: Vinf (tn) = Vinf (tn-1) _ [(Vinf (tn-1) x e(1 + 1/t)t)/100] = Vinf (t n-1) x 0,85 permitió valores más estables de la concentración plasmática, aproximadas a la del modelo ideal (p>0,05), por espacio de 6 h. Conclusiones: es probable que el decrecimiento de la dosis de ketamina, establecido por la variante de cálculo e infusión propuesta, posibilite una mejor estabilidad de la concentración plasmática(AU)
Introduction: A requirement in the manual conduction of total intravenous anesthesia is the need to make temporary dosage adjustments to avoid drug accumulation in plasma. For some years there has been interest in using other drugs such as ketamine. Objectives: To compare the temporal variation of ketamine concentration in plasma when applying a variant for calculating the decrease in the infusion rate (Vinf) with an invariable infusion rate. Methods: An analytical study was carried out describing the dosage calculation for manual total intravenous anesthesia, the pharmacokinetic simulation of the behavior of ketamine concentration in plasma in case of being invariably administered with these dosing regimens, in a virtual patient, of 70 kg, according to the Domino model and the analysis of the variant for calculating the decrease of ketamine infusion rate. A statistical significance of 95 percent was estimated (p<0.05). Results: The variant for calculating the decrease of the infusion rate: Vinf (tn) = Vinf (tn-1) _ [(Vinf (tn-1) x e (1+1/t) t)/100] = Vinf (tn -1) x 0.85 allowed more stable values of plasma concentration, which approximate that of the ideal model (p>0.05), for a time of 6 hours. Conclusions: Probably, the decrease of the ketamine dose, established by the proposed calculation and infusion variant, allows better stability of plasma concentration(AU)
Subject(s)
Humans , Ketamine/administration & dosage , Anesthesia, Intravenous/methods , Infusions, Intravenous/methods , /methods , Drug Dosage Calculations , Ketamine/analysisABSTRACT
OBJECTIVE: To analyze suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups. METHODS: A descriptive study of drugs with pediatric indication included in a retrospective cohort of new drugs registered in Brazil. The evaluation of drug suitability for the pediatric age group was performed using the following criteria: suitability of dosage form and capacity to deliver the recommended dose. The drugs were considered adequate for the pediatric age groups when they met both criteria. The statistical analysis included calculation of frequencies and proportions. RESULTS: Suitability due to the drug capacity to deliver the recommended dose was greater than 80% across all age groups. Regarding suitability of the dosage form, we identified that the older the age group, the greater suitability for pediatric use. Concerning the drugs presented in solid dosage form, we showed that half were classified as inadequate for one or more pediatric age groups to whom they were indicated. The adequacy of drugs to the pediatric age group was 64.3% for preschool children, 66.7% for full-term newborns, 66.7% for premature newborns, and over 70% for other age groups. CONCLUSION: Drugs for children aged under 6 years were less often adequate, considering the dosage form and capacity to provide the recommended dose. The availability and proportional suitability of medicines for pediatric use are greater for older age groups, according to age groups the drug is registered for.
Subject(s)
Drug Dosage Calculations , Drug Prescriptions/standards , Off-Label Use/standards , Pharmaceutical Preparations/administration & dosage , Brazil , Child , Child, Preschool , Drug Prescriptions/statistics & numerical data , Humans , Infant , Infant, Newborn , Off-Label Use/statistics & numerical data , Reference Standards , Retrospective StudiesABSTRACT
OBJECTIVES: To evaluate if institutionally established calculations for transitioning continuous IV midazolam to enteral benzodiazepines maintain Withdrawal Assessment Tool-Version 1 scores equal to or less than preconversion values. DESIGN: Retrospective cohort study evaluating the effectiveness and safety of benzodiazepine conversion calculations embedded within an institution-specific clinical pathway for sedation and weaning of mechanically ventilated pediatric patients. SETTING: A 55-bed, mixed-medical, noncardiac surgical PICU in a tertiary care children's hospital. PATIENTS: All patients age 6 months to 18 years who received continuous midazolam for 5 days or longer while mechanically ventilated for 5-21 days and were then converted to either enteral diazepam or lorazepam following extubation (or return to baseline ventilator settings in tracheostomy-dependent patients) between January 1, 2015, and June 30, 2016. INTERVENTIONS: Benzodiazepine conversion calculations were applied according to institutional clinical pathway guidance. MEASUREMENTS AND MAIN RESULTS: Withdrawal Assessment Tool-Version 1 scores were compared pre and post benzodiazepine conversion. Patient demographics, benzodiazepine dose escalations, as needed benzodiazepine requirements, and severe adverse events within 48 hours of conversion were assessed. Seventy-one patient encounters were analyzed (median age, 2.5 yr; interquartile range, 1.2-5.3). The median Withdrawal Assessment Tool-Version 1 scores pre conversion and post conversion were not significantly different (1 [interquartile range, 0.75-2] and 1 [interquartile range, 0.25-2], respectively, p = 0.1). As needed benzodiazepine doses were administered in 38% of encounters post conversion, but escalation of a scheduled enteral benzodiazepine regimen was only required in 2.8% of encounters. Post conversion, one patient (1.4%) had increased seizure activity, and four patients (5.6%) required fluid boluses secondary to tachycardia or dehydration, but not hypotension. CONCLUSIONS: These findings suggest that standardized benzodiazepine conversions successfully achieved consistent Withdrawal Assessment Tool-Version 1 scores compared with preconversion values. Severe adverse events associated with oversedation and/or withdrawal were minimal and confounded by underlying disease states.
Subject(s)
Diazepam/administration & dosage , Drug Dosage Calculations , Drug Substitution , Hypnotics and Sedatives/administration & dosage , Lorazepam/administration & dosage , Midazolam/administration & dosage , Airway Extubation/adverse effects , Child, Preschool , Diazepam/pharmacokinetics , Female , Humans , Hypnotics and Sedatives/adverse effects , Hypnotics and Sedatives/pharmacokinetics , Infant , Infusions, Intravenous/methods , Intensive Care Units, Pediatric , Lorazepam/pharmacokinetics , Midazolam/adverse effects , Midazolam/pharmacokinetics , Quality Improvement , Respiration, Artificial/adverse effects , Retrospective Studies , Substance Withdrawal Syndrome/prevention & controlABSTRACT
Saber o peso real do animal é de suma importância para realização de alguns protocolos como: dosagem de medicamentos, formulação de dietas e acompanhamento do desenvolvimento pondera! Algumas empresas e laboratórios disponibilizam fitas que mostram o peso dos animais pelo perímetro torácico, podendo ser utilizada como medida quando não tem acesso a balança. Visando a necessidade de estimar o peso vivo do animal, o objetivo do estudo é correlacionar o peso real dos animais, com os valores obtidos pelas fórmulas e com os dados das fitas de pesagem. Foram utilizados 40 animais, da raça Quarto de Milha, onde os dados foram obtidos através da balança com capacidade para 3000 kg, fita métrica aprovada pelo INMETRO e 5 tipos de fitas de pesagem comercia!. A pesquisa utilizou os dados obtidos através da balança, fórmula e fitas, e realizou uma análise estatística baseado na porcentagem de precisão dos valores estimados em relação ao peso real, em seguida realizou o desvio padrão e coeficiente de regressão para uma melhor avaliação dos resultados. Os resultados do estudo demonstraram que a precisão dos métodos para estimação de peso encontrado com a fita 1 foi o valor mais próximo do grupo controle (balança), no entanto, nenhuma das metodologias utilizadas evidenciaram diferença estatística (P=0,808). Sendo assim, a utilização da fita de pesagem provou ser eficiente, de baixo custo e prática para a utilização por proprietários, tratadores e médicos veterinários na rotina diária.
Knowing the real weight of the animal it is very important for the accomplishment of some protocols such as: dosage of medicines, formulation of diets and monitoring of weight development. Recently companies and laboratories have already made commercial tapes that show the weight of the animais by the thoracic perimeter, and can be used as a measurement when does not have access to the weighbridge. Aiming at a need to estimate the live weight of the animal, the objective of the study is to correlate the real weight of the animais with the values obtained by the formulas and with the data of the weighing tapes. We used 40 animais, of the Quarter Horse breed, where the data obtained through the weighbridge with capacity for 3000 kg, tape measure approved by INMETRO and 5 types of commercial weighing tapes. The research used the data obtained through the weighbridge, formula and tapes, and performed a statistical analysis on the percentage accuracy ofthe estimated values in relation to the actual weight, instead, the standard deviation and the regression coefficient for a better evaluation of the results. The results of the study demonstrated the accuracy of the methods for weight estimation found with tape 1 was the closest value of the control group (balance), however, none of the methodologies evidenced the statistical difference (P=0.808). Therefore, a use of the weighing tape proved to be efficient, inexpensive and practical for use by owners, handlers and veterinarians in the daily routine.
Saber el peso real del animal es de suma importancia para la realización de algunos protocolos como: dosificación de medicamentos, formulación de dietas y seguimiento dei desarrollo pondera!. Algunas empresas y laboratorios ofrecen cintas que muestran el peso de los animales por el perímetro torácico, pudiendo ser utilizada como medida cuando no tiene acceso a la balanza. Con el objetivo de estimar el peso vivo del animal, el objetivo del estudio es correlacionar el peso real de los animales, con los valores obtenidos por las fórmulas y con los datos de las cintas de pesaje. Se utilizaron 40 animales, de la raza Cuarto de Milla, donde los datos fueron obtenidos a través de la balanza con capacidad para 3000 kg, cinta métrica aprobada por el INMETRO y 5 tipos de cintas de pesaje comercial. La investigación utilizó los datos obtenidos a través de la balanza, fórmula y cintas, y realizó un análisis estadístico basado en el porcentaje de precisión de los valores estimados en relación con el peso real, luego realizó la desviación estándar y coeficiente de regresión para una mejor evaluación de los resultados. Los resultados del estudio demostraron que la precisión de los métodos de estimación de peso encontrados con la cinta 1 fue el valor más cercano del grupo control (balanza), sin embargo, ninguna de las metodologías utilizadas evidenció diferencia estadística (P=0,808). Por lo tanto, la utilización de la cinta de pesaje ha demostrado ser eficiente, de bajo costo y práctica para la utilización por propietarios, cuidadores y médicos veterinarios en la rutina diaria.
Subject(s)
Animals , Horses/growth & development , Body Weight/physiology , Drug Dosage Calculations , Statistics as TopicABSTRACT
Saber o peso real do animal é de suma importância para realização de alguns protocolos como: dosagem de medicamentos, formulação de dietas e acompanhamento do desenvolvimento pondera! Algumas empresas e laboratórios disponibilizam fitas que mostram o peso dos animais pelo perímetro torácico, podendo ser utilizada como medida quando não tem acesso a balança. Visando a necessidade de estimar o peso vivo do animal, o objetivo do estudo é correlacionar o peso real dos animais, com os valores obtidos pelas fórmulas e com os dados das fitas de pesagem. Foram utilizados 40 animais, da raça Quarto de Milha, onde os dados foram obtidos através da balança com capacidade para 3000 kg, fita métrica aprovada pelo INMETRO e 5 tipos de fitas de pesagem comercia!. A pesquisa utilizou os dados obtidos através da balança, fórmula e fitas, e realizou uma análise estatística baseado na porcentagem de precisão dos valores estimados em relação ao peso real, em seguida realizou o desvio padrão e coeficiente de regressão para uma melhor avaliação dos resultados. Os resultados do estudo demonstraram que a precisão dos métodos para estimação de peso encontrado com a fita 1 foi o valor mais próximo do grupo controle (balança), no entanto, nenhuma das metodologias utilizadas evidenciaram diferença estatística (P=0,808). Sendo assim, a utilização da fita de pesagem provou ser eficiente, de baixo custo e prática para a utilização por proprietários, tratadores e médicos veterinários na rotina diária.(AU)
Knowing the real weight of the animal it is very important for the accomplishment of some protocols such as: dosage of medicines, formulation of diets and monitoring of weight development. Recently companies and laboratories have already made commercial tapes that show the weight of the animais by the thoracic perimeter, and can be used as a measurement when does not have access to the weighbridge. Aiming at a need to estimate the live weight of the animal, the objective of the study is to correlate the real weight of the animais with the values obtained by the formulas and with the data of the weighing tapes. We used 40 animais, of the Quarter Horse breed, where the data obtained through the weighbridge with capacity for 3000 kg, tape measure approved by INMETRO and 5 types of commercial weighing tapes. The research used the data obtained through the weighbridge, formula and tapes, and performed a statistical analysis on the percentage accuracy ofthe estimated values in relation to the actual weight, instead, the standard deviation and the regression coefficient for a better evaluation of the results. The results of the study demonstrated the accuracy of the methods for weight estimation found with tape 1 was the closest value of the control group (balance), however, none of the methodologies evidenced the statistical difference (P=0.808). Therefore, a use of the weighing tape proved to be efficient, inexpensive and practical for use by owners, handlers and veterinarians in the daily routine.(AU)
Saber el peso real del animal es de suma importancia para la realización de algunos protocolos como: dosificación de medicamentos, formulación de dietas y seguimiento dei desarrollo pondera!. Algunas empresas y laboratorios ofrecen cintas que muestran el peso de los animales por el perímetro torácico, pudiendo ser utilizada como medida cuando no tiene acceso a la balanza. Con el objetivo de estimar el peso vivo del animal, el objetivo del estudio es correlacionar el peso real de los animales, con los valores obtenidos por las fórmulas y con los datos de las cintas de pesaje. Se utilizaron 40 animales, de la raza Cuarto de Milla, donde los datos fueron obtenidos a través de la balanza con capacidad para 3000 kg, cinta métrica aprobada por el INMETRO y 5 tipos de cintas de pesaje comercial. La investigación utilizó los datos obtenidos a través de la balanza, fórmula y cintas, y realizó un análisis estadístico basado en el porcentaje de precisión de los valores estimados en relación con el peso real, luego realizó la desviación estándar y coeficiente de regresión para una mejor evaluación de los resultados. Los resultados del estudio demostraron que la precisión de los métodos de estimación de peso encontrados con la cinta 1 fue el valor más cercano del grupo control (balanza), sin embargo, ninguna de las metodologías utilizadas evidenció diferencia estadística (P=0,808). Por lo tanto, la utilización de la cinta de pesaje ha demostrado ser eficiente, de bajo costo y práctica para la utilización por propietarios, cuidadores y médicos veterinarios en la rutina diaria.(AU)
Subject(s)
Animals , Horses/growth & development , Body Weight/physiology , Statistics as Topic , Drug Dosage CalculationsABSTRACT
BACKGROUND: There was a need for a solid asthma guideline in Mexico to update and unify asthma management. Because high-quality asthma guidelines exist worldwide, in which the latest evidence on asthma management is summarized, the ADAPTE approach allows for the development of a national asthma guideline based on evidence from already existing guidelines, adapted to national needs. OBJECTIVE: To fuse evidence from the best asthma guidelines and adapt it to local needs with the ADAPTE approach. METHODS: The Appraisal of Guidelines for Research and Evaluation (AGREE) II asthma guidelines were evaluated by a core group to select 3 primary guidelines. For each step of asthma management, clinical questions were formulated and replied according to (1) evidence in the primary guidelines, (2) safety, (3) Cost, and (4) patient preference. The Guidelines Development Group, composed of a broad range of experts from medical specialties, primary care physicians, and methodologists, adjusted the draft questions and replies in several rounds of a Delphi process and 3 face-to-face meetings, taking into account the reality of the situation in Mexico. We present the results of the pediatric asthma treatment part. RESULTS: Selected primary guidelines are from the British Thoracic Society and Scottish Intercollegiate Guidelines Network (BTS/SIGN), Global Initiative for Asthma (GINA), and Spanish Guidelines on the Management of Asthma (GEMA) 2015, with 2016 updates. Recommendations or suggestions were made for asthma treatment in Mexico. In this article, the detailed analysis of the evidence present in the BTS/SIGN, GINA, and GEMA sections on the (non) pharmacologic treatment of pediatric asthma, education, and devices are presented for 2 age groups: children 5 years or younger and children 6 to 11 years old with asthma. CONCLUSION: For the pediatric treatment and patient education sections, applying the AGREE II and Delphi methods is useful to develop a scientifically sustained document, adjusted to the Mexican situation, as is the Mexican Guideline on Asthma.