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Supplemental material, sj-docx-1-bmi-10.1177_11772719231164528 for The Use of Biomarkers in Pharmacovigilance: A Systematic Review of the Literature by Maribel Salas, Maxine Gossell-Williams, Priyanka Yalamanchili, Sameer Dhingra, Marina A Malikova, Omar Aimer and Toluwalope Junaid in Biomarker Insights

Para realizar un inventario de fuentes de datos nacionales sobre utilización de medicamentos en Argentina y verificar las fuentes de datos disponibles públicamente, llevamos a cabo un estudio transversal que investiga la existencia de bases de datos nacionales y provinciales sobre utilización de medicamentos. En julio de 2020, realizamos una búsqueda en sitios web de instituciones gubernamentales, una búsqueda sistemática en bases de datos bibliográficas sobre “drug utilization research” en Argentina y una encuesta de expertos. Se identificaron 31 fuentes de datos de utilización de medicamentos, solo una era de acceso público y conveniente, cinco publicaban datos agregados y proporcionaban un acceso más detallado mediante solicitud formal, solo siete fuentes (23%) informaban datos nacionales, y la mayoría de ellas (n=29) incluían solo datos del sector público de salud. Aunque se han encontrado fuentes de datos de utilización de medicamentos en Argentina, el acceso a investigadores y legisladores sigue siendo una barrera importante. Aumentar la transparencia de los datos de salud a través de fuentes disponibles públicamente para analizar la información de salud pública es crucial para construir un sistema de salud más sólido., In order to compile an inventory of national data sources for drug utilization research (DUR) in Argentina and to verify publicly available data sources, we performed a cross-sectional study that sought to identify national and provincial databases of drug use. In July 2020, we searched the websites of government institutions, carried out a systematic query of bibliographic databases for "drug utilization research" conducted in Argentina, and conducted a survey with local experts. Data collected included: the institution responsible for the database, population covered, accessibility, source of the data, healthcare setting, geographic information, and whether data were individual or aggregated. Descriptive analyses were then performed. We identified 31 data sources for DUR; only one was publicly and conveniently accessible. Five published aggregated data and provide more detailed access by formal request. Only seven sources (23%) reported national data, and most (n=29) included only data from the public healthcare sector. Although data sources for DUR have been found in Argentina, limited access by researchers and policymakers is still an significant obstacle. Increasing health data transparency by making data sources publicly available for the purpose of analyzing public health information is crucial for building a stronger health system., Facultad de Ciencias Médicas

Additional file 1.

There is data on the World Development Report 2018 where it states that education is still in processes of change in countries with unstable economies, despite this there are constructivist pedagogical models that currently still determine opportunities to promote quality and inclusive teaching, that is It is on this principle that the research is based, where the need for teachers to improve their educational skills and competencies arises as a problem. To develop the document, the objective was to analyze the influence of the constructivist pedagogical model through active methodologies to improve performance and educational quality in education and thus develop teaching skills at work with the constructivist pedagogical model. The methodology used is descriptive with a mixed approach that used the survey in an evaluative way of the teacher's activity in the classroom with the 60 students of the defined grades and then the results were contrasted with the two directors of the Clara Bruno Fiscal Educational Unit of Piana. As a result, it was found that the level of teachers was lower intermediate and that competency training strategies could be applied, which were developed in the proposal......... Existen datos sobre el Informe del desarrollo mundial 2018 donde manifiesta que la educación aún está en procesos de cambios en países de economías inestables, pese a ello existen modelos pedagógicos constructivistas que en la actualidad aún determinan oportunidades para promover una enseñanza de calidad e inclusiva, es en este principio que se fundamenta la investigación, donde se plantea como problema, la necesidad de los docentes de mejorar sus capacidades y competencias educativas. Para desarrollar el documento se trazó como objetivo es analizar la influencia del modelo pedagógico constructivista para la atención a la diversidad. La metodología utilizada es descriptiva con un enfoque mixto que utilizó la encuesta de forma valorativa de la actividad del docente en el aula con los 60 estudiantes de los grados delimitados y luego se contrastaron los resultados con los dos directivos de la Unidad Educativa Fiscal Clara Bruno de Piana. Se encontró como resultado que el nivel de los docentes era intermedio inferior y que se podían aplicar estrategias de capacitación en competencias las cuales se desarrollaron en la propuesta........

Kathryn Duensing,1 Robert Twillman,1– 3 Stephen Ziegler,4,5 M Soledad Cepeda,6 David Kern,6 Maribel Salas,7,8 Gregory Wedin9 1RKT Consulting, LLC, Lenexa, KS, USA; 2Behavioral Health Section, Saint Luke’s Health System, Kansas City, MO, USA; 3Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine, Kansas City, KS, USA; 4Center for Effective Regulatory Policy and Safe Access, Denver, CO, USA; 5College of Professional Studies, Purdue University, Fort Wayne, IN, USA; 6Department of Epidemiology, Janssen Research & Development, Titusville, NJ, USA; 7Department of Epidemiology, Clinical Safety and Pharmacovigilance, Daiichi Sankyo, Basking Ridge, NJ, USA; 8University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA; 9Upsher-Smith Laboratories, LLC, Pharmacovigilance and Risk Management, Maple Grove, MN, USACorrespondence: Robert TwillmanSaint Luke’s Health System, Kansas City, MO, USATel +1 913-205-3746Email Bob.Twillman@gmail.comIntroduction: Opioid overdose deaths in the United States have climbed sharply over the past two decades. Simultaneously, increased awareness of inadequately treated chronic pain has resulted in increased opioid analgesic prescribing. The correlation between these two phenomena has led policymakers to posit that they are causally linked, and to implement policy changes supporting safe opioid prescribing.Purpose: To evaluate the impact of its Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program, the US Food and Drug Administration (FDA) requested the opioid manufacturers responsible for implementing that program provide information regarding opioid policy changes from 2016 to 2018. FDA also requested a survey of state requirements for pain and opioid prescribing continuing education (CE), the number of prescribers affected by those requirements, the extent to which a REMS-compliant CE program would meet each state’s requirements, and the number of relevant CE programs available.Results: Results indicate that 527 federal and state opioid-related policies (statutes, rules/regulations, and guidelines) were approved during the 2016– 2018 study period. While the largest number of these policies focused on prescription drug monitoring programs, 170 specifically imposed limits on opioid prescribing and an additional 35 specifically referred to, or incorporated, the Centers for Disease Control and Prevention opioid prescribing guideline. We also found that 46 states and the District of Columbia mandated some amount of pain or opioid prescribing CE for prescribers renewing their licenses. These mandates potentially affected as many as 1.7 million prescribers. In 69% of cases, a REMS-compliant CE program would fully meet the state mandates for various types of prescribers.Conclusion: The severity and complexity of the problems of pain management and opioid overdose have led to large-scale intervention by policymakers. Assessing the impact of these changes is difficult, at best, but will be necessary if interventions are to be refined to increase their effectiveness.Keywords: opioids, FDA blueprint, prescribing, law, policy, CDC, REMS