Correction: Del Valle-Moreno et al. Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review. Pharmaceutics 2023, 15, 1859.

There was an error in the original publication [...].

Electronic Medication Reconciliation Tools Aimed at Healthcare Professionals to Support Medication Reconciliation: a Systematic Review.

The development of health information technology available and accessible to professionals is increasing in the last few years. However, a low number of electronic health tools included some kind of information about medication reconciliation. To identify all the electronic medication reconciliation tools aimed at healthcare professionals and summarize their main features, availability, and clinical impact on patient safety. A systematic review of studies that included a description of an electronic medication reconciliation tool (web-based or mobile app) aimed at healthcare professionals was conducted. The review protocol was registered with PROSPERO: registration number CRD42022366662, and followed PRISMA guidelines. The literature search was performed using four healthcare databases: PubMed, EMBASE, Cochrane Library, and Scopus with no language or publication date restrictions. We identified a total of 1227 articles, of which only 12 met the inclusion criteria.Through these articles,12 electronic tools were detected. Viewing and comparing different medication lists and grouping medications into multiple categories were some of the more recurring features of the tools. With respect to the clinical impact on patient safety, a reduction in adverse drug events or medication discrepancies was detected in up to four tools, but no significant differences in emergency room visits or hospital readmissions were found. 12 e-MedRec tools aimed at health professionals have been developed to date but none was designed as a mobile app. The main features that healthcare professionals requested to be included in e-MedRec tools were interoperability, "user-friendly" information, and integration with the ordering process.

Combined or Sequential Treatment with Immune Checkpoint Inhibitors and Car-T Cell Therapies for the Management of Haematological Malignancies: A Systematic Review.

The aim of this paper was to review the available evidence on the efficacy and safety of combined or sequential use of PD-1/PD-L1 immune checkpoint inhibitors (ICI) and CAR-T cell therapies in relapsed/refractory (R/R) haematological malignancies. A systematic literature review was performed until 21 November 2022. Inclusion criteria: cohort studies/clinical trials aimed at evaluating the efficacy and/or safety of the combination of CAR-T cell therapy with PD-1/PD-L1 inhibitors in R/R haematological malignancies, which had reported results. Those focusing only on ICI or CAR-T separately or evaluating the combination in other non-hematological solid tumours were excluded. We used a specific checklist for quality assessment of the studies, and then we extracted data on efficacy or efficiency and safety. A total of 1867 articles were identified, and 9 articles were finally included (early phase studies, with small samples of patients and acceptable quality). The main pathologies were B-cell acute lymphoblastic leukaemia (B-ALL) and B-cell non-Hodgkin's lymphoma (B-NHL). The most studied combination was tisagenlecleucel with pembrolizumab. In terms of efficacy, there is great variability: the combination could be a promising option in B-ALL, with modest data, and in B-NHL, although hopeful responses were received, the combination does not appear better than CAR-T cell monotherapy. The safety profile could be considered comparable to that described for CAR-T cell monotherapy.

Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review.

BACKGROUND: Pharmacokinetic nomograms, equations, and software are considered the main tools available for Therapeutic Drug Monitoring (TDM). Model-informed precision dosing (MIPD) is an advanced discipline of TDM that allows dose individualization, and requires a software for knowledge integration and statistical calculations. Due to its precision and extensive applicability, the use of these software is widespread in clinical practice. However, the currently available evidence on these tools remains scarce. OBJECTIVES: To review and summarize the available evidence on MIPD software tools to facilitate its identification, evaluation, and selection by users. METHODS: An electronic literature search was conducted in MEDLINE, EMBASE, OpenAIRE, and BASE before July 2022. The PRISMA-ScR was applied. The main inclusion criteria were studies focused on developing software for use in clinical practice, research, or modelling. RESULTS: Twenty-eight software were classified as MIPD software. Ten are currently unavailable. The remaining 18 software were described in depth. It is noteworthy that all MIPD software used Bayesian statistical methods to estimate drug exposure and all provided a population model by default, except NONMEN. CONCLUSIONS: Pharmacokinetic software have become relevant tools for TDM. MIPD software have been compared, facilitating its selection for use in clinical practice. However, it would be interesting to standardize the quality and validate the software tools.

Gender bias in clinical trials of biological agents for migraine: A systematic review.

Migraine is considered one of the most disabling diseases. Currently, there are few studies on clinical migraine treatment based on sex-related differences, despite the important role of sex in migraine. Our aim was to evaluate gender bias in published clinical trials on monoclonal antibodies (erenumab, galcanezumab, fremanezumab and eptinezumab). We performed a systematic review of controlled clinical trials of erenumab, galcanezumab, fremanezumab and eptinezumab, searching the PubMed/MEDLINE database for articles published before December 2021. The search identified 760 articles, 25 of which met the inclusion criteria. Of all the patients included in these trials, 85.1% were women. Only one study had female lead authors. Two of the 25 studies included a sex-based analysis of the primary endpoint. None of the articles discussed the results separately for men and for women. The proportion of men recruited in trials is scarce and more studies are needed to guarantee the safety and tolerability of monoclonal antibodies used in male migraine. As observed in our study, despite the high number of women recruited, only 2 studies analysed the results separately by sex. Thus, a potential risk of gender bias was found in these clinical trials.

Alectinib - induced acute renal failure.

Introduction: Alectinib is a potent and selective orally active tyrosine kinase inhibitor used for anaplastic lymphoma kinase-positive non-small cell lung cancer, which has a better safety profile than other inhibitors of anaplastic lymphoma kinase. We report a case of a mixed pattern of acute interstitial nephritis and acute tubular necrosis proven by renal biopsy upon starting alectinib therapy. Case report: A 68-year-old man with diabetes, hypertension, and dyslipidaemia, diagnosed with anaplastic lymphoma kinase-positive non-small cell lung cancer stage IV, had 27 days previously started alectinib 600 mg twice daily. He presented at the emergency room due to vomiting, nausea, and more dyspnoea than usual. A high creatinine level and metabolic imbalances were detected in laboratory tests. Management and outcomes: After a diagnosis of acute renal failure, the patient was admitted to hospital. Nephrotoxic drugs were suspended, and haemodialysis was required. After dismissing other causes, a probable diagnosis of acute interstitial nephritis due to alectinib was established. Corticotherapy was initiated and renal function returned to baseline levels. Renal biopsy showed a mixed pattern of acute interstitial nephritis and acute tubular necrosis. The patient was discharged, and alectinib therapy was modified to lorlatinib. No polymorphisms were found in a pharmacogenetic test. After 10 months with lorlatinib, renal function remains stable. Discussion: The relationship between acute renal failure and alectinib initiation is considered probable in this patient. Although it is an adverse effect reported in less than 1% of cases, it would be advisable to monitor renal function in this kind of patient.

Gender bias in clinical trials of biological agents for severe asthma: A systematic review.

Asthma is one of the most common chronic diseases characterized by sex disparities. Gender bias is a well-documented issue detected in the design of published clinical trials (CTs). International guidelines encourage researchers to analyze clinical data by sex, gender, or both where appropriate. The objective of this work was to evaluate gender bias in the published CTs of biological agents for the treatment of severe asthma. A systematic review of randomized controlled CTs of the biological agents (omalizumab, benralizumab, reslizumab, mepolizumab or dupilumab) for the treatment of severe asthma was conducted. The literature search was performed using PubMed and EMBASE without language restrictions. This study followed the corresponding international recommendations. We identified a total of 426 articles, of which 37 were finally included. Women represented 60.4% of patients included. The mean percentage of women in these trials was 59.9%, ranged from 40.8% to 76.7%. The separate analysis by sex of the main variable was only performed in 5 of the 37 publications included, and none of the trials analyzed secondary variables by sex. Only 1 of the articles discussed the results separately by sex. No study included the concept of gender in the text or analyzed the results separately by gender. The proportion of women included in CTs was higher compared to publications of other disciplines, where women were under-represented. The analysis of the main and secondary variables by sex or gender, even the discussion separately by sex, was insufficient. This gives rise to potential gender bias in these CTs.

Pharmacokinetic software for therapeutic drug monitoring: A scoping review protocol.

OBJECTIVE: Nomograms, equations and pharmacokinetic software are considered the main tools available for therapeutic drug monitoring. Due to  its great applicability to various groups of drugs, the use of software is widely extended in clinical practice. The main goals of the studies using this  type of software do not normally include the description of its features, therefore, the information about its characteristic is scarce. Moreover,  no review of the literature has been published that brings together  all the information available about these software. The present study aimed to synthesize the available evidence regarding software applied to therapeutic drug monitoring to facilitate its identification, evaluation and  election by users. METHOD: This article describe a scoping review protocol, developed following  the PRISMA-P and PRISMA-ScR guidelines. An electronic literature search was  performed in MEDLINE, EMBASE, OpenAire and BASE (Bielefeld Academic  Search Engine) databases. Only those software for which the following  information was available were included: name of the software,  developer/marketer, type of pharmacokinetic analysis allowed, and drugs  included in the analysis. Results: In this study we will synthesized the most relevant characteristics for  the clinical practice of the pharmacokinetic software available. A critical  ppraisal of the sources if information will be included. Also, if it is possible, a  comparison of the available tools will be carried out  in order to facilitate the  evaluation and selection of pharmacokinetic software. CONCLUSIONS: Pharmacokinetic software has become a relevant tool for  therapeutic drugs monitoring. Currently available evidence on such tools is  scarce, which precludes a rapid and effective comparative analysis between the  different options available. An analysis of the main characteristics and a  comparison between different pharmacokinetic software will be useful to the  users, leading to a greater integration of these tools in healthcare practice.

OBJETIVO: Los nomogramas, ecuaciones y software de contenido  armacocinético se consideran las principales herramientas disponibles para la  monitorización farmacocinética clínica. Debido a su gran aplicabilidad en  numerosos grupos de fármacos, el empleo de software se encuentra  ampliamente extendido en la práctica clínica. Generalmente, el objetivo  principal de los estudios que incluyen el uso de estos software no es la  descripción de los mismos, por lo que la información disponible es escasa y,  además, no se dispone de una revisión que aúne toda la información disponible  referente a este tipo de software El objetivo de este estudio será  sintetizar la evidencia disponible sobre los distintos software de aplicación en la  monitorización farmacocinética para facilitar a los usuarios su identificación,  evaluación y selección.Método: Se realizará una revisión exploratoria de la literatura cuyo protocolo se describe en este artículo, de acuerdo con las recomendaciones PRISMA para la elaboración de revisiones exploratorias y  publicación de protocolos. Se realizará una búsqueda bibliográfica en las bases  de datos Medline, Embase, OpenAire y Bielefeld Academic Search Engine. Se  incluirán en el estudio aquellos software detectados de los que se disponga de  la siguiente información: nombre del software, desarrollador/ comercializador,  tipo de análisis farmacocinético y fármacos incluidos. Resultados: En este  estudio se espera realizar una síntesis de las características más relevantes en  la práctica clínica de los software de contenido farmacocinético disponibles en  el mercado. Se realizará una síntesis narrativa crítica de las fuentes de  información utilizadas. Además, se llevará a cabo, si es posible, una  comparación de los mismos para facilitar la evaluación y selección por parte de  los usuarios. CONCLUSIONES: Los software de contenido farmacocinético se han convertido en un recurso fundamental en la práctica de la monitorización  terapéutica de fármacos. La evidencia disponible en la actualidad es escasa y  no permite a los usuarios realizar de forma rápida y eficiente un análisis comparativo entre los distintos software disponibles. El análisis sobre  las características principales y comparación entre los distintos software de  plicación farmacocinética será de gran utilidad a sus usuarios para una mayor  integración de estas herramientas en la práctica asistencial.

Software de contenido farmacocinético para la monitorización terapéutica de fármacos: Protocolo de revisión exploratoria / Pharmacokinetic software for therapeutic drug monitoring: A scoping review protoco

Objetivo: Los nomogramas, ecuaciones y software de contenido farmacocinético se consideran las principales herramientas disponibles para la monitorización farmacocinética clínica. Debido a su gran aplicabilidad en numerososgrupos de fármacos, el empleo de software se encuentra ampliamente extendido en la práctica clínica. Generalmente, el objetivo principal de los estudiosque incluyen el uso de estos software no es la descripción de los mismos, porlo que la información disponible es escasa y, además, no se dispone de unarevisión que aúne toda la información disponible referente a este tipo de softwareEl objetivo de este estudio será sintetizar la evidencia disponible sobre losdistintos software de aplicación en la monitorización farmacocinética parafacilitar a los usuarios su identificación, evaluación y selección.Método: Se realizará una revisión exploratoria de la literatura cuyo protocolo se describe en este artículo, de acuerdo con las recomendacionesPRISMA para la elaboración de revisiones exploratorias y publicaciónde protocolos. Se realizará una búsqueda bibliográfica en las bases dedatos Medline, Embase, OpenAire y Bielefeld Academic Search Engine.Se incluirán en el estudio aquellos software detectados de los que se disponga de la siguiente información: nombre del software, desarrollador/comercializador, tipo de análisis farmacocinético y fármacos incluidos.Resultados: En este estudio se espera realizar una síntesis de lascaracterísticas más relevantes en la práctica clínica de los software decontenido farmacocinético disponibles en el mercado. Se realizará una síntesis narrativa crítica de las fuentes de información utilizadas. Además,se llevará a cabo, si es posible, una comparación de los mismos parafacilitar la evaluación y selección por parte de los usuarios. (AU)

Objective: Nomograms, equations and pharmacokinetic software areconsidered the main tools available for therapeutic drug monitoring. Dueto its great applicability to various groups of drugs, the use of software iswidely extended in clinical practice. The main goals of the studies usingthis type of software do not normally include the description of its features,therefore, the information about its characteristic is scarce. Moreover, noreview of the literature has been published that brings together all theinformation available about these software. The present study aimed tosynthesize the available evidence regarding software applied to therapeutic drug monitoring to facilitate its identification, evaluation and selectionby users.Method: This article describe a scoping review protocol, developedfollowing the PRISMA-P and PRISMA-ScR guidelines. An electronic literature search was performed in MEDLINE, EMBASE, OpenAire and BASE(Bielefeld Academic Search Engine) databases. Only those software forwhich the following information was available were included: name of thesoftware, developer/marketer, type of pharmacokinetic analysis allowed,and drugs included in the analysis.Results: In this study we will synthesized the most relevant characteristics for the clinical practice of the pharmacokinetic software available.A critical appraisal of the sources if information will be included. Also,if it is possible, a comparison of the available tools will be carried out in order to facilitate the evaluation and selection of pharmacokineticsoftware. (AU)