Systematic screening of gender violence and domestic violence among HIV-positive patients: the VIHOLETA study.

We conducted a multicentre observational study in people living with HIV (PLHIV) on antiretroviral therapy in Alicante (Spain) from 2019 to 2020 aiming to analyse the prevalence of abuse and assess treatment adherence according to this variable. We used the Abuse Assessment Screen tool, the simplified medication adherence questionnaire and the medication possession ratio to assess outcomes.. Of the 161 included PLHIV, 53 (32.9%) had suffered abuse (27 emotional abuse, 6 physical abuse, 3 sexual abuse, 13 emotional and physical abuse, 4 unknown type). Seven (4.3%) had suffered abuse in the last year (5 emotional, 2 physical). Abuse had lasted a median of 48 months (interquartile range 12-81). HIV status was considered as a cause of violence by 9.4% of victims. In the multivariable analysis, only abuse was independently associated with non-adherence [adjusted odds ratio (aOR) 3.92; 95% confidence interval (CI) 1.80-8.84; p = 0.0007]. Abuse (aOR 6.14; 95% CI 1.63-27.70; p = 0.001) and previous incarceration (aOR 15.08 95% CI 2.71-104.71; p = 0.003) were associated with detectable viral load. In conclusion, the prevalence of abuse is high in PLHIV, hampering adherence and virological success. Abuse screening tools should be incorporated into routine HIV care.

Six months multicentre pilot open label single-arm study to evaluate patient experience, acceptability and satisfaction of switching certolizumab pegol from a prefilled syringe or autoinjection pen to an AVA® e-Device in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis patients.

WHAT IS KNOWN AND OBJECTIVE: The study aimed to assess acceptability and patient experience of Certolizumab (CZP) self-injection with AVA® and clarify patient device preference after switching CZP from the syringe or auto-injection pen to AVA® in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients. METHOD: A multicentre open-label, cross-sectional and prospective study among four Spanish hospitals was performed. Adult RA, PsA, axSpA patients treated for at least 6 months with the CZP syringe or pen were recruited. At the first visit, patients completed Pre-AVA® questionnaire. Patients were instructed on proper administration of CZP by AVA®. After 2 and 6 months of CZP self-injections using the AVA®, patient experience, adherence, preference and safety of each administration was assessed using post-AVA® questionnaire. RESULTS AND DISCUSSION: Thirty four patients were included (28 women). All patients self-administered CZP AVA® the full dose of CZP was injected. Patients reported >90% adherence to CZP AVA® assessed with the injection log. Pain at the injection site was reduced after switching to AVA®. Twenty nine patients preferred CZP AVA® and five patients preferred the CZP pen. No safety-related findings related to AVA® CZP administration were identified. WHAT IS NEW AND CONCLUSION: The AVA® is an advantageous delivery option for CZP in patients with RA, PsA, axSpA.

Filgrastim use in the emergency department of a Spanish general hospital.

BACKGROUND: Febrile neutropenia is a cause of dose reduction in hematological cancer treatments, with patient risk of infection proportional to duration and severity. In addition, colony-stimulating factors have been shown to be beneficial in a patient subgroup, although they are probably overused in the clinical setting. OBJECTIVE: Evaluation of compliance with American Society of Clinical Oncology 2006 criteria when it comes to filgrastim use in the Emergency Department of a Spanish general hospital. METHODS AND MATERIALS: A prospective observational study from August 2011 to February 2012 in a tertiary Spanish General Hospital. We included all patients prescribed with filgrastim in the Emergency Department. Data was collected on demographics, the pharmacotherapy history, the administered chemoprophylaxis, and the destination after discharge from a clinical department, the complete blood count, and the presence of fever >= 38 °C. RESULTS: 51 patients were recorded over the period of the study. 27.45% of prescriptions complied with the clinical practice guideline criteria given the risk of febrile neutropenia, whereas 72.34% of prescriptions did not comply with the criteria, 17.65% of which did not fulfil any requirements. CONCLUSIONS: A high percentage of colony-stimulating factors use in the Emergency Department does not comply with the medical practice guideline.

Therapeutic Drug Monitoring in Oncohematological Patients: A Fast and Accurate HPLC-UV Method for the Quantification of Nilotinib in Human Plasma and Its Clinical Application.

Nilotinib, a second-generation tyrosine kinase inhibitor, has demonstrated clinical activity in chronic myeloid leukemia. As an exposure-response relationship has been observed for nilotinib, its therapeutic drug monitoring could be a valuable tool in clinical practice. Therefore, the aim of this study was to develop and validate a selective and precise high performance liquid chromatography-ultraviolet method for the measurement of nilotinib in plasma from patients with cancer. After protein precipitation extraction with acetonitrile, nilotinib and rilpivirine were separated using isocratic elution on a Tracer Excel 120 ODS C18 column using a mobile phase consisting of a mixture of potassium dihydrogen phosphate-buffered solution (pH 5.5; 0.037 M)-methanol-acetonitrile (45:45:10, v/v/v), pumped at a flow rate of 1.7 mL·min-1. A wavelength of 254 nm was selected for the quantification of the analyte and the internal standard (IS). The technique was validated following the guidelines for the validation of analytical methods of regulatory agencies (Food and Drug Administration (FDA) and the European Medicines Agency (EMA)). Linearity was established in a concentration range between 125 and 7000 ng/mL. The detection limit was 90 ng/mL, and the lower limit of quantification was 125 ng/mL. For all concentrations in the calibration curve, the intraday and interday coefficients of variation were less than 4.1%. Median recovery of nilotinib from plasma was ≥65.1% (±21.4%). The method described is sensitive, selective, reproducible, and rapid, and can be used for the accurate determination of nilotinib in human plasma for pharmacokinetics studies and for therapeutic drug monitoring (TDM) of nilotinib in routine clinical practice.

Stability and compatibility of ondansetron with haloperidol in parenteral admixtures.

BACKGROUND: The chemical stability of coadministered ondansetron (OND) and haloperidol (HAL) in parenteral admixtures has not been described yet. OBJECTIVE: The aim of the present work is to study the chemical stability and the compatibility of OND and HAL admixtures. METHODS: Normal saline solution and dextrose were used to prepare the admixture solutions of the drugs; the materials of the containers were the original plastic bags of the diluents and the stability was studied at 20°C. Compatibility was studied by visual inspection of no colour change and turbidity or precipitation appearance. The concentration of the drugs was studied by ultraviolet detection high-performance liquid chromatography. The method was validated following the Food and Drug Administration and European Medicines Agency guidelines, and the assay enables the measurement of both drugs with a linear calibration curve (r=0.999) over the concentration range 10-100 µg/mL, with acceptable values of linearity, precision and accuracy. Darunavir was used as internal standard. RESULTS: Most of the admixtures have an adequate concentration until 24 hours(less than 10% of loss). 25% of the samples show a higher loss at 24 hours, and the chemical stability of these samples is 12 hours. CONCLUSIONS: The stability and compatibility of OND and HAL in the coadministered admixtures in Viaflo plastic bags with normal saline or dextrose are suggested at 12 hours.

Chemical stability of ondansetron hydrochloride with other drugs in admixtures via parenteral; a review.

OBJECTIVE: This review was prepared to offer the most complete information about the use of ondansetron in parenteral admixtures with other drugs. METHOD: The search was done from September 2016 to April 2017 by using electronic databases Stabilis® and Micromedex® solutions, Medline/PubMed and Scholar Google searching publications about ondansetron stability in parenteral infusion when is administered by itself or with other medication. RESULTS: 49 studies are included with a total of 53 drugs. 15 drugs were found compatible administered with ondansetron in a clinical routine concentration range in intravenous administration. Also, four ternary blends were found compatible and another one was incompatible. Otherwise, 38 drugs were found incompatible. DISCUSSION: Compatibility of ondansetron offers a broad number of options to be used to avoid nausea and vomiting symptoms in patients with other concomitant medication.

Objetivo: Esta revisión ha sido preparada para recopilar toda la información referente a la estabilidad del ondansetrón en mezclas parenterales junto a otros fármacos.Método: La búsqueda fue realizada entre septiembre de 2016 y abril de 2017 empleando bases de datos electrónicas como Stabilis® y Micromedex® solutions, Medline/PubMed y Google Académico buscando publicaciones sobre la estabilidad del ondansetrón para infusión vía parenteral cuando es administrado en monoterapia o en una mezcla con otros fármacos.Resultados: En este trabajo han sido incluidos 49 artículos con un total de 53 fármacos. 15 fármacos han sido descritos como compatibles con ondansetrón en concentraciones habituales en la clínica práctica para administración intravenosa. Además, cuatro mezclas ternarias han sido descritas como compatibles y una como incompatible. Por otro lado, 38 fármacos han sido descritos como incompatibles para su administración con ondansetrón.Discusión: La compatibilidad del ondansetrón ofrece un amplio rango de opciones para evitar los síntomas de náuseas y vómitos en pacientes con otra medicación concomitante.

[Subcutaneous drug administration in palliative care]. / Administración de medicamentos por vía subcutánea en cuidados paliativos.

OBJECTIVE: Develop a guide that compiles all the information available in the literature for healthcare staff on the administration of drugs subcutaneously in palliative care patients of the Hospital Unit of home. METHOD: It is designed a summary table of drugs likely to be administered subcutaneously in palliative care patients through the revision of the technical reports of the manufacturers and other literature published by scientific organizations, in addition to the literature search on Pubmed® and Micromedex®. RESULTS: We have reviewed 65 drugs and a guide has been developed of recommendations depending on whether there is information of his administration by subcutaneous or, if on the contrary, its use is contraindicated. CONCLUSIONS: Although mainly manufacturers laboratories do not have data, information collected in this guide will allow the management of the subcutaneous route of some of the most commonly used medications in palliative care.

Objetivo: Elaborar una guía que recopile toda la información disponible en la bibliografía para el personal sanitario sobre la administración de medicamentos por vía subcutánea en pacientes de cuidados paliativos de la Unidad de Hospitalización a Domicilio. Método: Se diseña una tabla resumen de fármacos susceptibles de ser administrados por vía subcutánea en pacientes de cuidados paliativos mediante la revisión de los informes técnicos de los laboratorios fabricantes y de otra literatura publicada por organizaciones científicas, además de la búsqueda bibliográfica en Pubmed® y Micromedex®. Resultados: Se han revisado 65 fármacos y se ha elaborado una guía de recomendaciones en función de si existe información de su administración por vía subcutánea o, si por el contrario, esta contraindicado su uso. Conclusiones: Aunque mayoritariamente los laboratorios fabricantes no disponen de datos, la información recopilada en esta guía permitirá el manejo de la vía subcutánea de algunos de los medicamentos más utilizados en cuidados paliativos.

Midazolam and haloperidol for palliative sedation: physicochemical stability and compatibility of parenteral admixtures

This study was done to determine the time while the binary admixtures with midazolam and haloperidol drugs are administered by perfusion to the patients in the clinical routine. Samples with different concentrations of both drugs were prepared following the usual clinical practice. Solvents used were 0.9 % sodium chloride solution and 5% dextrose, and viaflo plastic bags were used as the containers of the admixtures. Samples were not protected from light and were stored at 20 ºC or at 4 ºC. Compatibility and physicochemical stability were studied by visual inspection, turbidity measurement, pH determination and ultraviolet detection high performance liquid chromatography (UV-HPLC) was used to determine midazolam and haloperidol concentrations. The assay was validated following the FDA and EMA guidelines. Darunavir was used as internal standard (IS). For the studied admixtures, turbidity measurements and pH determinations showed little changes in function of the time. Haloperidol and midazolam concentrations determined by HPLC are within the acceptable range of drug concentrations, which are considered stable for four days in case of admixtures stored at 20 ºC and for seven days for refrigerated admixtures. Taking into account the microbiological risk matrix, the compatibility and the chemical and microbiological stability of the midazolam and haloperidol in the co-administered admixtures in viaflo plastic bags with 0.9 % sodium chloride solution and 5% dextrose can be set as 48 hours when samples are stored at 20 ºC and one week if they are refrigerated.