[Comparative assessment of off-label and unlicensed drug prescription in neonatal intensive care: FDA versus Brazilian guidelines].

Introduction: Regulatory agencies are responsible for defining the use of off-label (OL) and unlicensed (UL) drug prescription in neonatal intensive care. However, these regulatory criteria may differ between agencies in different countries. The aim of this study was to establish the frequency of OL and UL drug prescription in a sample of patients in a neonatal intensive care unit applying the criteria of the Food and Drug Administration (FDA) of the United States and the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil, analysing the differences observed in the results based on the applied criteria.

Drug-drug interactions in neonatal intensive care: A prospective cohort study.

Background: To characterize the prevalence and profile of drug-drug interactions (DDIs), the drugs most related to major DDIs and risk factors of their prescription in a neonatal intensive care unit (NICU).

Methods: Neonates admitted to a NICU who had at least one medication prescribed and a hospital stay >24 h were included in a prospective cohort study (August 2017 to July 2018). All medications prescribed during the hospitalization were collected from all neonates (n = 220), with the screening for DDIs.

Population Pharmacokinetics of Magnesium Sulfate in Preeclampsia and Associated Factors.

Background And Objective: The pharmacokinetic basis of magnesium sulphate (MgSO) dosing regimens for preeclampsia (PE) prophylaxis and treatment is not clearly established. The aim of study is to develop a population pharmacokinetic (PK) model of MgSO in PE, and to determine key covariates having an effect in MgSO pharmacokinetics in preeclampsia (PE) and to determine key covariates having an effect in MgSO PK.

Methods: A prospective cohort study was conducted from June 2016 to February 2018 in patients with PE administered MgSO as a 4-g bolus followed by continuous infusion at a rate of 1 g/h.

Incidence of Adverse Drug Reactions in High-Risk Pregnancy: A Prospective Cohort Study in Obstetric Intensive Care.

Purpose: To estimate the cumulative incidence of adverse drug reactions (ADRs) in women with high-risk pregnancy hospitalized in an obstetric intensive care unit, then to describe the medicines involved and to identify major risk factors.

Methods: From June 2016 to December 2017, patients admitted to the ICU with high-risk pregnancy were considered eligible in this observational, longitudinal, prospective study. Patients were investigated daily for the occurrence of ADRs through pharmaceutical anamnesis, active search in medical records and questioning of the health team.

Drug related problems in the neonatal intensive care unit: incidence, characterization and clinical relevance.

Background: Any event involving drug therapy that may interfere in a patient's desired clinical outcome is called a drug related problem (DRP). DRP are very common in intensive therapy, however, little is known about DRP in the Neonatal Intensive Care Unit (NICU). The purpose of this study was to determine the incidence of DRPs in NICU patients and to characterize DRPs according to type, cause and corresponding pharmaceutical conducts.

Potential drug incompatibilities in the neonatal intensive care unit: a network analysis approach.

Background: There is little information on the frequency of drug incompatibilities in neonatal intensive care units (NICU) and the agents most commonly involved in them. The objective of the study was to characterize potential Drug Incompatibilities (DI) in the NICU by frequency, type and combination of drugs.

Methods: Between August 2015 and December 2016, all neonates admitted for more than 24 h and who received any drug treatment were included in this cohort study conducted in the NICU of a teaching maternity hospital in Brazil.

Use of off-label and unlicensed medicines in neonatal intensive care.

Purpose: To evaluate the use of off-label and unlicensed medicines in a neonatal intensive care unit (NICU) of a teaching maternity hospital specialized in high risk pregnancy.

Methods: A prospective cohort study was conducted between August 2015 and July 2016. All newborns admitted to the NICU who had at least one medication prescribed and a hospital stay longer than 24 hours were included.

Measuring eosinophiluria, urinary eosinophil cationic protein and urinary interleukin-5 in patients with Lupus Nephritis.

Background: Urine is increasingly becoming an attractive biological fluid in clinical practice due to being an easily obtained, non-invasive sampling method, containing proteins and peptides. The aim of this study was to investigate eosinophiluria, urinary eosinophil cationic protein (uECP) and urinary IL-5 (uIL-5) in patients with Lupus Nephritis.

Methods: Seventy-four patients with SLE-20 with clinical and laboratory evidence of lupus nephritis (LN group) and 54 without evidence of renal involvement (non-LN group)-were analyzed regarding eosinophiluria, uECP and uIL-5.