Neddylation orchestrates the complex transcriptional and posttranscriptional program that drives Schwann cell myelination.

Myelination is essential for neuronal function and health. In peripheral nerves, >100 causative mutations have been identified that cause Charcot-Marie-Tooth disease, a disorder that can affect myelin sheaths. Among these, a number of mutations are related to essential targets of the posttranslational modification neddylation, although how these lead to myelin defects is unclear. Here, we demonstrate that inhibiting neddylation leads to a notable absence of peripheral myelin and axonal loss both in developing and regenerating mouse nerves. Our data indicate that neddylation exerts a global influence on the complex transcriptional and posttranscriptional program by simultaneously regulating the expression and function of multiple essential myelination signals, including the master transcription factor EGR2 and the negative regulators c-Jun and Sox2, and inducing global secondary changes in downstream pathways, including the mTOR and YAP/TAZ signaling pathways. This places neddylation as a critical regulator of myelination and delineates the potential pathogenic mechanisms involved in CMT mutations related to neddylation.

A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.

BACKGROUND: Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments. OBJECTIVE: This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries. METHOD: This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage. RESULTS: Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2). CONCLUSION: The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.

[Concordance between essential medicines lists and diabetes guidelines in Latin America and the CaribbeanConcordância entre as listas de medicamentos essenciais e diretrizes para diabetes na América Latina e no Caribe]. / Concordancia entre las listas de medicamentos esenciales y las guías para diabetes en América Latina y el Caribe.

Objective: Conduct an analysis to determine the existence and updating of national essential medicines lists (EMLs) and clinical practice guidelines (CPGs) for the treatment of diabetes in Latin America and the Caribbean (LAC); and compare the medicines included in each country's list and guidelines both with each other and with those of the World Health Organization (WHO). Methods: Cross-sectional study. EMLs and CPGs for diabetes were found on the websites of the Pan American Health Organization and national health authorities. Medicines were noted and analyzed according to pharmacological group, based on the fourth level of nomenclature of the Anatomical Therapeutic Chemical (ATC) classification system. F1 scoring was used to assess the proximity of EMLs to the WHO Model List of Essential Medicines (MLEM). Results: Of the total number of countries, 87.2% have EMLs, and 91% have CPGs (78% and 45% updated in the last five years, respectively). Compared to the six hypoglycemic groups of the MLEM, the EMLs had a median (range) of 6 (4-13) and an F1 score of 0.80; This indicates proper alignment. CPGs had a median (range) of 12 (1-12) hypoglycemic drugs compared to eight in the WHO guidelines. CPGs had a median of 15 more drugs than their respective EMLs. Conclusions: While most LAC countries have EMLs and CPGs for diabetes, the lack of concordance among them limits their effectiveness. It is necessary to align the processes and criteria for the development of these two tools for policymaking on medicines.

Objetivos: Analisar a existência e a atualização das listas nacionais de medicamentos (LNMs) e guias de prática clínica (GPCs) para o tratamento do diabetes na América Latina e no Caribe (ALC). Comparar os medicamentos incluídos nas listas e nas diretrizes de cada país entre si e com as da Organização Mundial da Saúde (OMS). Métodos: Estudo transversal. Foram identificadas LMNs e GPCs para o diabetes nos sites da Organização Pan-Americana da Saúde e das autoridades sanitárias nacionais. Os medicamentos foram pesquisados e analisados por grupo farmacológico de acordo com o quarto nível da classificação ATC. A pontuação F1 foi utilizada para avaliar o grau de proximidade das LMNs com a lista-modelo de medicamentos essenciais (LMME) da OMS. Resultados: Do total de países, 87,2% dispõem de uma LNM e 91%, de GPCs (78% e 45%, respectivamente, atualizadas nos últimos 5 anos). Em comparação com os seis grupos de agentes hipoglicemiantes da LMME, as LMNs tinham uma mediana (intervalo) de 6 (4 a 13) e uma pontuação F1 de 0,80, o que indica uma conformidade adequada. As GPCs tinham uma mediana (intervalo) de 12 (1 a 12) agentes hipoglicemiantes, em comparação com 8 nos guias da OMS. As GPCs tinham uma mediana de 15 medicamentos a mais do que as respectivas LNMs. Conclusões: Embora a maioria dos países da América Latina e do Caribe disponha de LNMs e GPCs para o diabetes, a falta de concordância entre elas limita sua eficácia. É necessário alinhar os processos e os critérios de desenvolvimento dessas duas ferramentas da política de medicamentos.

Concordancia entre las listas de medicamentos esenciales y las guías para diabetes en América Latina y el Caribe / Concordance between essential medicines lists and diabetes guidelines in Latin America and the Caribbean / Concordância entre as listas de medicamentos essenciais e diretrizes para diabetes na América Latina e no Caribe

[RESUMEN]. Objetivo. Analizar la existencia y actualización de las listas de medicamentos nacionales (LMN) y guías de práctica clínica (GPC) para el tratamiento de la diabetes en América Latina y el Caribe (ALC). Comparar los fármacos incluidos en las listas y guías de cada país, entre sí y con los de la Organización Mundial de la Salud (OMS). Métodos. Estudio de corte transversal. Se identificaron las LMN y GPC para diabetes en los sitios web de la Organización Panamericana de la Salud y de las autoridades sanitarias nacionales. Se relevaron los fármacos y se analizaron por grupo farmacológico según el cuarto nivel de la nomenclatura ATC. Se utilizó el puntaje F1 para evaluar la proximidad de las LMN con la lista modelo de medicamentos esenciales (LMME) de la OMS. Resultados. Del total de países, 87,2% cuentan con LMN, y 91% con GPC (78% y 45% actualizadas en los últimos 5 años, respectivamente). En comparación con los 6 grupos de hipoglucemiantes de la LMME, las LMN tenían una mediana (rango) de 6 (4-13) y un puntaje F1 de 0,80; esto indica una consonancia adecuada. Las GPC tenían una mediana (rango) de 12 (1-12) hipoglucemiantes frente a los 8 de las guías de la OMS. Las GPC tuvieron una mediana de 15 fármacos más que las respectivas LMN. Conclusiones. Si bien la mayoría de los países de ALC cuentan con LMN y GPC para diabetes, la falta de concordancia entre ellas limita su eficacia. Es necesario alinear los procesos y criterios de elaboración de estas dos herramientas de la política de medicamentos.

[ABSTRACT]. Objective. Conduct an analysis to determine the existence and updating of national essential medicines lists (EMLs) and clinical practice guidelines (CPGs) for the treatment of diabetes in Latin America and the Carib- bean (LAC); and compare the medicines included in each country's list and guidelines both with each other and with those of the World Health Organization (WHO). Methods. Cross-sectional study. EMLs and CPGs for diabetes were found on the websites of the Pan Amer- ican Health Organization and national health authorities. Medicines were noted and analyzed according to pharmacological group, based on the fourth level of nomenclature of the Anatomical Therapeutic Chemical (ATC) classification system. F1 scoring was used to assess the proximity of EMLs to the WHO Model List of Essential Medicines (MLEM). Results. Of the total number of countries, 87.2% have EMLs, and 91% have CPGs (78% and 45% updated in the last five years, respectively). Compared to the six hypoglycemic groups of the MLEM, the EMLs had a median (range) of 6 (4–13) and an F1 score of 0.80; This indicates proper alignment. CPGs had a median (range) of 12 (1–12) hypoglycemic drugs compared to eight in the WHO guidelines. CPGs had a median of 15 more drugs than their respective EMLs. Conclusions. While most LAC countries have EMLs and CPGs for diabetes, the lack of concordance among them limits their effectiveness. It is necessary to align the processes and criteria for the development of these two tools for policymaking on medicines.

[RESUMO]. Objetivos. Analisar a existência e a atualização das listas nacionais de medicamentos (LNMs) e guias de prática clínica (GPCs) para o tratamento do diabetes na América Latina e no Caribe (ALC). Comparar os medicamentos incluídos nas listas e nas diretrizes de cada país entre si e com as da Organização Mundial da Saúde (OMS). Métodos. Estudo transversal. Foram identificadas LMNs e GPCs para o diabetes nos sites da Organização Pan-Americana da Saúde e das autoridades sanitárias nacionais. Os medicamentos foram pesquisados e analisados por grupo farmacológico de acordo com o quarto nível da classificação ATC. A pontuação F1 foi utilizada para avaliar o grau de proximidade das LMNs com a lista-modelo de medicamentos essenciais (LMME) da OMS. Resultados. Do total de países, 87,2% dispõem de uma LNM e 91%, de GPCs (78% e 45%, respectivamente, atualizadas nos últimos 5 anos). Em comparação com os seis grupos de agentes hipoglicemiantes da LMME, as LMNs tinham uma mediana (intervalo) de 6 (4 a 13) e uma pontuação F1 de 0,80, o que indica uma con- formidade adequada. As GPCs tinham uma mediana (intervalo) de 12 (1 a 12) agentes hipoglicemiantes, em comparação com 8 nos guias da OMS. As GPCs tinham uma mediana de 15 medicamentos a mais do que as respectivas LNMs. Conclusões. Embora a maioria dos países da América Latina e do Caribe disponha de LNMs e GPCs para o diabetes, a falta de concordância entre elas limita sua eficácia. É necessário alinhar os processos e os critérios de desenvolvimento dessas duas ferramentas da política de medicamentos.

Concordancia entre las listas de medicamentos esenciales y las guías para diabetes en América Latina y el Caribe / Concordance between essential medicines lists and diabetes guidelines in Latin America and the Caribbean / Concordância entre as listas de medicamentos essenciais e diretrizes para diabetes na América Latina e no Caribe

RESUMEN Objetivo. Analizar la existencia y actualización de las listas de medicamentos nacionales (LMN) y guías de práctica clínica (GPC) para el tratamiento de la diabetes en América Latina y el Caribe (ALC). Comparar los fármacos incluidos en las listas y guías de cada país, entre sí y con los de la Organización Mundial de la Salud (OMS). Métodos. Estudio de corte transversal. Se identificaron las LMN y GPC para diabetes en los sitios web de la Organización Panamericana de la Salud y de las autoridades sanitarias nacionales. Se relevaron los fármacos y se analizaron por grupo farmacológico según el cuarto nivel de la nomenclatura ATC. Se utilizó el puntaje F1 para evaluar la proximidad de las LMN con la lista modelo de medicamentos esenciales (LMME) de la OMS. Resultados. Del total de países, 87,2% cuentan con LMN, y 91% con GPC (78% y 45% actualizadas en los últimos 5 años, respectivamente). En comparación con los 6 grupos de hipoglucemiantes de la LMME, las LMN tenían una mediana (rango) de 6 (4-13) y un puntaje F1 de 0,80; esto indica una consonancia adecuada. Las GPC tenían una mediana (rango) de 12 (1-12) hipoglucemiantes frente a los 8 de las guías de la OMS. Las GPC tuvieron una mediana de 15 fármacos más que las respectivas LMN. Conclusiones. Si bien la mayoría de los países de ALC cuentan con LMN y GPC para diabetes, la falta de concordancia entre ellas limita su eficacia. Es necesario alinear los procesos y criterios de elaboración de estas dos herramientas de la política de medicamentos.

ABSTRACT Objective. Conduct an analysis to determine the existence and updating of national essential medicines lists (EMLs) and clinical practice guidelines (CPGs) for the treatment of diabetes in Latin America and the Caribbean (LAC); and compare the medicines included in each country's list and guidelines both with each other and with those of the World Health Organization (WHO). Methods. Cross-sectional study. EMLs and CPGs for diabetes were found on the websites of the Pan American Health Organization and national health authorities. Medicines were noted and analyzed according to pharmacological group, based on the fourth level of nomenclature of the Anatomical Therapeutic Chemical (ATC) classification system. F1 scoring was used to assess the proximity of EMLs to the WHO Model List of Essential Medicines (MLEM). Results. Of the total number of countries, 87.2% have EMLs, and 91% have CPGs (78% and 45% updated in the last five years, respectively). Compared to the six hypoglycemic groups of the MLEM, the EMLs had a median (range) of 6 (4-13) and an F1 score of 0.80; This indicates proper alignment. CPGs had a median (range) of 12 (1-12) hypoglycemic drugs compared to eight in the WHO guidelines. CPGs had a median of 15 more drugs than their respective EMLs. Conclusions. While most LAC countries have EMLs and CPGs for diabetes, the lack of concordance among them limits their effectiveness. It is necessary to align the processes and criteria for the development of these two tools for policymaking on medicines.

RESUMO Objetivos. Analisar a existência e a atualização das listas nacionais de medicamentos (LNMs) e guias de prática clínica (GPCs) para o tratamento do diabetes na América Latina e no Caribe (ALC). Comparar os medicamentos incluídos nas listas e nas diretrizes de cada país entre si e com as da Organização Mundial da Saúde (OMS). Métodos. Estudo transversal. Foram identificadas LMNs e GPCs para o diabetes nos sites da Organização Pan-Americana da Saúde e das autoridades sanitárias nacionais. Os medicamentos foram pesquisados e analisados por grupo farmacológico de acordo com o quarto nível da classificação ATC. A pontuação F1 foi utilizada para avaliar o grau de proximidade das LMNs com a lista-modelo de medicamentos essenciais (LMME) da OMS. Resultados. Do total de países, 87,2% dispõem de uma LNM e 91%, de GPCs (78% e 45%, respectivamente, atualizadas nos últimos 5 anos). Em comparação com os seis grupos de agentes hipoglicemiantes da LMME, as LMNs tinham uma mediana (intervalo) de 6 (4 a 13) e uma pontuação F1 de 0,80, o que indica uma conformidade adequada. As GPCs tinham uma mediana (intervalo) de 12 (1 a 12) agentes hipoglicemiantes, em comparação com 8 nos guias da OMS. As GPCs tinham uma mediana de 15 medicamentos a mais do que as respectivas LNMs. Conclusões. Embora a maioria dos países da América Latina e do Caribe disponha de LNMs e GPCs para o diabetes, a falta de concordância entre elas limita sua eficácia. É necessário alinhar os processos e os critérios de desenvolvimento dessas duas ferramentas da política de medicamentos.

Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.

CHLOROQUINE INDUCED MACULAR TOXICITY IN A PATIENT LATER DEVELOPING SECTOR RETINITIS PIGMENTOSA: A CASE REPORT.

PURPOSE: To describe how underlying retinal diseases, such as retinitis pigmentosa, increase the risk of chloroquine-induced macular toxicity. METHODS: Observational case report. RESULTS: We present the case of a 57-year-old woman being annually followed-up in the Ophthalmology service due to a systemic treatment with chloroquine (CQ). The explorations were successive normal, until a 10:2 visual field (VF) shows central defects in both eyes. Despite CQ treatment is discontinued, 10:2 VF reveal slowly progressive macular defects. During follow-up, fundus examination disclosed bone spicules in the inferonasal middle periphery: the electroretinogram (ERG) shows slow amplitude responses under scotopic conditions and the electrooculogram (EOG) also shows pathological responses. Therefore, the diagnosis of sector retinitis pigmentosa plus chloroquine maculopathy is made. Currently, the slow but constant progression of both peripheral and central defects is evident, despite having discontinued CQ treatment more than 15 years ago. CONCLUSION: Underlying retinal diseases seem to increase the risk of photoreceptor damage when undergoing a toxic insult. Thus, we hypothesize a potential interplay between retinal dystrophies and toxic maculopathy induced by CQ, and the influence of each of them in the evolution and prognosis of the other.

Hepatic levels of S-adenosylmethionine regulate the adaptive response to fasting.

There has been an intense focus to uncover the molecular mechanisms by which fasting triggers the adaptive cellular responses in the major organs of the body. Here, we show that in mice, hepatic S-adenosylmethionine (SAMe)-the principal methyl donor-acts as a metabolic sensor of nutrition to fine-tune the catabolic-fasting response by modulating phosphatidylethanolamine N-methyltransferase (PEMT) activity, endoplasmic reticulum-mitochondria contacts, ß-oxidation, and ATP production in the liver, together with FGF21-mediated lipolysis and thermogenesis in adipose tissues. Notably, we show that glucagon induces the expression of the hepatic SAMe-synthesizing enzyme methionine adenosyltransferase α1 (MAT1A), which translocates to mitochondria-associated membranes. This leads to the production of this metabolite at these sites, which acts as a brake to prevent excessive ß-oxidation and mitochondrial ATP synthesis and thereby endoplasmic reticulum stress and liver injury. This work provides important insights into the previously undescribed function of SAMe as a new arm of the metabolic adaptation to fasting.

Impacto económico de medicamentos de alto precio/costo en la seguridad social de Argentina. El caso del instituto de obra social para las Fuerzas Armadas y de Seguridad / Economic impact of high-price/cost medicines on social security in Argentina. The case of the Institute for the Armed and Security Forces

Resumen Introducción: En Argentina, los medicamentos de alto costo (MAC) generan una carga económica elevada que deben afrontar las instituciones sanitarias. Sin embargo, no existe a la fecha un estu dio en Argentina que indique la magnitud del real problema de los MAC para la Seguridad Social. El presente trabajo, explora cuál es su impacto económico para una de las principales Obras Sociales del país. Métodos: Se realizó un estudio descriptivo con etapa analítica a partir de datos obtenidos en gerencia de prestaciones, área farmacia y área contable de la institución. Cada medicamento fue clasificado según recomendación de OMS (clasificación Anatómica-Terapéutica- Química-ATC). Los precios fueron consignados en tres valores: nominal al momento de adquisición, actualizado a pesos fin de 2021 utilizando el CER (coeficiente de estabilización de referencia), y en dólares (USD). Se evaluaron 105 324 dispensas de MAC, correspondientes a 258 011 unidades para 10 450 afiliados. Resultados: El gasto total anualizado fue 57 millones de dólares (USD), y por usuario 6220 USD. Solo 1.9% de los afiliados requirieron MAC, aunque el gasto fue del 21.9% de los ingresos (aportes + contribuciones). Los primeros 5 medicamentos que generaron el mayor gasto fueron enzalutamida, bevacizu mab, nivolumab, palbociclib, pembrolizumab. Las enfermedades oncológicas y reumatológicas representaron el 62.8% del gasto. Conclusión: A la luz de los resultados, se deduce que los MAC constituyen un riesgo potencial de desfinanciación del sistema de salud si son abordados de manera atomizada por cada subsector. Los MAC requieren de políticas globales de carácter nacional y/o regional.

Abstract Introduction: In Argentina, high-cost drugs (HCD) induce a high economic burden for all the health system sec tors. However, it does not exist in Argentina any data that indicates the real problem of HCD for Social Security. That is why, the present study explores the economic impact of the HCD for one of the main Institutions of the country. Methods: A descriptive study with an analytical stage was carried out based on data obtained from management, pharmacy and accounting area. Each drug was classified according to WHO recommendation (Anatomical-Therapeutic-Chemical-ATC classification). The prices were expressed in three ways: nominal value at the time of acquisition in local currency, updated using the CER (reference stabilization coefficient), and in US dollars. A total of 105 324 HCD dispensed were evaluated, which corresponded to 258 011 units destined to 10 450 patients. Results: Total annualized spend was US$57 million (US$6220 per patient). Only 1.9% of affiliates required HCD, although those expenses represented 21.9% of the institutions´ total income. The first 5 drugs associated to the highest expenditure were enzalutamide, bevacizumab, nivolumab, palbociclib, pembrolizumab. Oncological and rheumatological diseases represented 62.8% of the HCD costs. Conclusion: Considering the results obtained, it can be deduced that if the HCD problem is approached in a scattered way by each subsec tor, it will become a potential risk for health system defund. The HCD topic requires of global policies at national or even regional level.

[Economic impact of high-price/cost medicines on social security in Argentina. The case of the Institute for the Armed and Security Forces]. / Impacto económico de medicamentos de alto precio/costo en la Seguridad Social de Argentina. El caso del Instituto de Obra Social para las Fuerzas Armadas y de Seguridad.

INTRODUCTION: In Argentina, high-cost drugs (HCD) induce a high economic burden for all the health system sectors. However, it does not exist in Argentina any data that indicates the real problem of HCD for Social Security. That is why, the present study explores the economic impact of the HCD for one of the main Institutions of the country. METHODS: A descriptive study with an analytical stage was carried out based on data obtained from management, pharmacy and accounting area. Each drug was classified according to WHO recommendation (Anatomical-Therapeutic-Chemical-ATC classification). The prices were expressed in three ways: nominal value at the time of acquisition in local currency, updated using the CER (reference stabilization coefficient), and in US dollars. A total of 105 324 HCD dispensed were evaluated, which corresponded to 258 011 units destined to 10 450 patients. RESULTS: Total annualized spend was US$57 million (US$6220 per patient). Only 1.9% of affiliates required HCD, although those expenses represented 21.9% of the institutions' total income. The first 5 drugs associated to the highest expenditure were enzalutamide, bevacizumab, nivolumab, palbociclib, pembrolizumab. Oncological and rheumatological diseases represented 62.8% of the HCD costs. CONCLUSION: Considering the results obtained, it can be deduced that if the HCD problem is approached in a scattered way by each subsector, it will become a potential risk for health system defund. The HCD topic requires of global policies at national or even regional level.

Introducción: En Argentina, los medicamentos de alto costo (MAC) generan una carga económica elevada que deben afrontar las instituciones sanitarias. Sin embargo, no existe a la fecha un estudio en Argentina que indique la magnitud del real problema de los MAC para la Seguridad Social. El presente trabajo, explora cuál es su impacto económico para una de las principales Obras Sociales del país. Métodos: Se realizó un estudio descriptivo con etapa analítica a partir de datos obtenidos en gerencia de prestaciones, área farmacia y área contable de la institución. Cada medicamento fue clasificado según recomendación de OMS (clasificación Anatómica-Terapéutica- Química-ATC). Los precios fueron consignados en tres valores: nominal al momento de adquisición, actualizado a pesos fin de 2021 utilizando el CER (coeficiente de estabilización de referencia), y en dólares (USD). Se evaluaron 105 324 dispensas de MAC, correspondientes a 258 011 unidades para 10 450 afiliados. Resultados: El gasto total anualizado fue 57 millones de dólares (USD), y por usuario 6220 USD. Solo 1.9% de los afiliados requirieron MAC, aunque el gasto fue del 21.9% de los ingresos (aportes + contribuciones). Los primeros 5 medicamentos que generaron el mayor gasto fueron enzalutamida, bevacizumab, nivolumab, palbociclib, pembrolizumab. Las enfermedades oncológicas y reumatológicas representaron el 62.8% del gasto. Conclusión: A la luz de los resultados, se deduce que los MAC constituyen un riesgo potencial de desfinanciación del sistema de salud si son abordados de manera atomizada por cada subsector. Los MAC requieren de políticas globales de carácter nacional y/o regional.

Selective Focal Laser Therapy as the Primary Treatment for Exudative Perifoveal Vascular Anomalous Complex (ePVAC): Case Series and Literature Review.

Perifoveal anomalous exudative vascular complex (PEVAC) was first described in 2011. Since then, individual clinical cases and a couple of case series have been published, and their characteristics have been studied in multi-modal images. To date, there is no consensus on its treatment. Initially, it was thought that PEVACs could be left to spontaneous evolution because they presented a slow progression. But it has been shown that the growth of the lesion covers a spectrum from non-exudative lesions to PEVAC with vision impairment over time. We present an updated bibliographic review of this pathology. We explain the changes in the diagnostic criteria that have been undergone. And we focus the discussion on selective treatment with focal laser, which has shown an excellent anatomical response and visual improvement or stabilization in the cases described and in our series of three patients systematically treated with focal laser. [Ophthalmic Surg Lasers Imaging Retina 2023;54:43-49.].

Medicines withdrawn in other countries due to safety concerns: should they continue to be available in the Argentine pharmaceutical market? / [Medicamentos retirados en otros países por problemas de seguridad: ¿Deben seguir presentes en el mercado farmacéutico argentino?]

Introduction: Numerous medicines have been withdrawn from the market because of the risks of serious adverse effects. The objective of this study was to identify in the Argentine pharmaceutical market (APM) the presence of medicines withdrawn in other countries due to safety problems, to analyze the information on their risks and to propose recommendations. Method: observational, descriptive study that explored the presence in the APM, until May 2021, of 462 medicines withdrawn in other countries. Those medicines on this list that are present in the APM and that are not currently authorized in countries with high sanitary surveillance were studied. Results: 17 medicines are still present in the APM, one over-the-counter. The package insert for 11 of the 17 medicines does not mention the adverse effects that led to their withdrawal. It was considered that the permanence in the APM of 16 of them should be reassessed. Conclusions: recommendations are made on actions to be taken by the regulatory authorities with the 17 medicines already present in the APM.

Introducción: Numerosos fármacos han sido retirados del mercado por sus riesgos de efectos adversos graves. El objetivo de este trabajo fue identificar en el mercado farmacéutico argentino (MFA) la presencia de medicamentos retirados en otros países por problemas de seguridad, analizar información sobre sus riesgos y proponer recomendaciones. Método: estudio observacional, descriptivo que exploró la presencia en el MFA, hasta mayo de 2021, de 462 medicamentos retirados en otros países. Se estudiaron aquellos medicamentos de esta lista presentes en el MFA y que no estuvieran autorizados actualmente en países de alta vigilancia sanitaria. Resultados: 17 medicamentos siguen presentes en el MFA, uno de venta libre.  El prospecto de 11 de los 17 fármacos no menciona los efectos adversos que motivaron su retiro. Se consideró que la permanencia en el MFA de 16 de ellos debería ser reevaluada. Conclusiones: se realizan recomendaciones sobre acciones a tomar por las autoridades reguladoras con los 17 medicamentos aún presentes en el MFA.

Uso de benzodiazepinas y fármacos relacionados en el seguro social para adultos mayores de Argentina / Use of benzodiazepines and related drugs in social security for older adults in Argentina

Resumen El uso clínico de las benzodiazepinas (BZD) y fármacos relacionados es un tema controversial, especialmente la prescripción prolongada en adultos mayores, que es contraria a las recomendaciones generales. Nuestro objetivo fue describir el uso de BZD y de los hipnóticos denominados fármacos Z (zolpidem, zopiclona y eszopiclona) en los adultos mayores beneficiarios del Instituto Nacional de Servicios Sociales para Jubilados y Pensionados (INSSJP-PAMI) de Argentina. Se realizó un estudio de utilización de medicamentos observacional, descriptivo, de corte transversal, a partir de la base de datos de dispensa de medicamentos del Instituto. Se incluyeron los beneficiarios de ambos sexos de 65 años y más. Se calculó para cada fármaco la prevalencia de uso en 2018 y las dosis diarias definidas (DDD) por cada 1000 habitantes/día (DHD). Se inclu yeron 3 864 949 beneficiarios (77.6 % de la población argentina de esa edad, 61.2 % mujeres), con 184 000 nonagenarios y más de 5000 centenarios. El 30.3 % recibió al me nos una dispensa de BZD o fármacos Z durante 2018, con mayor prevalencia de uso en mujeres (35.6%) que en varones (22.0%) y con aumento progresivo hasta los 85-89 años, y descenso posterior. Las BZD más recetadas fueron alprazolam (41.6%) y clonazepam (41.1%), seguidas por lorazepam (9.9%). La dispensa alcanzó 252.7 DHD, representado un promedio de 0.8 DDD por usuario y por día, valor que disminuyó con la edad. La prevalencia de uso encontrada está entre las más elevadas a nivel internacional, justificando la implementación de intervenciones clínicas y de salud pública para mejorar esta situación.

Abstract The clinical use of benzodiazepines (BZD) and related drugs is a controversial issue, especially prolonged prescription in older adults, which is contrary to general recommendations. Our objective was to describe the use of BZD and the hypnotics called Z drugs (zolpidem, zopiclone and eszopiclone) in elderly beneficiaries of the National Institute of Social Services for Retirees and Pensioners (INSSJP-PAMI) of Argentina. An observational, descriptive, cross-sectional drug use study was conducted based on the Institute's drug dispensing database. Beneficiaries of both sexes aged 65 years and over were included. The prevalence of use in 2018 and the defined daily doses (DDD) per 1000 inhabitants / day (DHD) were calculated for each drug. A total of 3 864 949 benefi ciaries were included (77.6% of the Argentine population of that age, 61.2% women), with 184 000 nonagenar ians and more than 5000 centenarians; 30.3% of whom received at least one dispensation of BZD or "Z drugs" during 2018, with a higher prevalence of use in women (35.6%) than in men (22.0%) and with a progressive increase until 85-89 years, with a subsequent decrease. The most prescribed BZDs were alprazolam (41.6%) and clonazepam (41.1%), followed by lorazepam (9.9%). The dispense drugs reached 252.7 DHD, representing an average of 0.8 DDD per user and per day, a value that decreased with age. The prevalence of use found is among the highest at international level, justifying the implementation of clinical and public health interventions to improve this situation.

Descripción de la disponibilidad y normas para el uso de las benzodiacepinas en algunos países de América Latina, 2022 / Description of benzodiazepines availability and regulation in several countries of Latin America, 2022 / Descrição da disponibilidade e regulamentação para o uso de benzodiazepínicos em alguns países da América Latina, 2022

Resumen: Introducción: las benzodiacepinas constituyen un grupo farmacológico de amplia prescripción a nivel mundial desde su aparición en la década de 1960. El objetivo del presente estudio fue identificar la disponibilidad, las modalidades de prescripción y dispensación de benzodiacepinas en diferentes países de América Latina, según reglamentación vigente en cada país participante del estudio. Materiales y métodos: estudio observacional, descriptivo y transversal, realizado con los datos disponibles al año 2022 de todos los países miembros de la Red de Centros de Información de Medicamentos de LatinoAmérica y el Caribe (Red CIMLAC) que fueron parte del estudio. Se utilizaron las bases de datos de las agencias regulatorias, la reglamentación vigente y otros documentos necesarios para obtener la información sobre la dispensación y prescripción en cada país. Resultados: doce de los 20 países de la Red CIMLAC completaron el estudio. El total de benzodiacepinas disponible en cada país varió entre 6 y 12 (media: 9). De ellas, en promedio 5 estaban incluidas en listados de medicamentos esenciales nacionales. La mayoría de los países cuentan con combinaciones a dosis fijas con benzodiacepinas. En todos los países se realiza la prescripción por receta especial. Más de la mitad de los países cuentan con recomendaciones nacionales. Conclusiones: la amplia disponibilidad de benzodiacepinas comercializadas, la existencia de combinaciones a dosis fijas y la falta de recomendaciones nacionales pueden ser factores que contribuyan al uso irracional de este grupo terapéutico.

Summary: Introduction: benzodiazepines constitute a widely prescribed group of drugs around the world, since they appeared in the sixties. This study aims to identify the availability, prescription modalities and dispensing of benzodiazepines in different countries around Latin America, as per the legal provisions in force in each of the countries participating in the study. Method: observational, descriptive, transversal study based on the information available in 2022 about all the member countries of the Network Medicines Information Centers of Latin America and the Caribbean (CIMLAC Network) that were part of the study. The databases of regulatory authorities were used and the legal provisions in force and relevant documents were consulted in order to obtain information on benzodiazepines dispensing and prescription in each country. Results: twelve out of the 20 CIMLAC Network member countries completed the study. The total number of benzodiazepines available in the study ranged from 6 to 12 (mean was 9), and 5 of them on average were included in the national essential medications lists. Most countries have benzodiazepines fixed dose combinations and in all countries a special medical prescription is needed. More than half of the countries have national recommendations. Conclusions: the wide availability of benzodiazepines in the market, the existence of fixed-dose combinations and the lack of national recommendations may constitute factors that contribute to the irrational use of this group of drugs.

Resumo: Introdução: os benzodiazepínicos constituem um grupo farmacológico amplamente prescrito em todo o mundo desde seu surgimento na década de 1960. O objetivo deste estudo foi identificar a disponibilidade, prescrição e modalidades de dispensação de benzodiazepínicos em diferentes países da América Latina, de acordo com as regulamentações vigentes em cada país participante do estudo. Materiais e métodos: estudo observacional, descritivo e transversal, realizado com os dados disponíveis até o ano de 2022 dos países membros da Rede de Centros de Informação sobre Medicamentos da América Latina e do Caribe (Red CIMLAC) que faziam parte do estudo. As bases de dados das agências reguladoras, normas vigentes e outros documentos necessários foram utilizados para obter informações sobre dispensação e prescrição em cada país. Resultados: doze dos 20 países da Rede CIMLAC completaram o estudo. O número total de benzodiazepínicos disponíveis em cada país variou entre 6 e 12 (média: 9). Destes, uma média de 5 foram incluídos nas listas nacionais de medicamentos essenciais. A maioria dos países tem combinações de dose fixa com benzodiazepínicos. Em todos os países é necessário prescrição especial. Mais da metade dos países têm recomendações nacionais. Conclusões: a ampla disponibilidade de benzodiazepínicos comercializados, a existência de combinações em doses fixas e a falta de recomendações nacionais podem ser fatores que contribuem para o uso irracional desse grupo terapêutico.

[Use of benzodiazepines and related drugs in social security for older adults in Argentina]. / Uso de benzodiazepinas y fármacos relacionados en el Seguro Social para adultos mayores de Argentina.

The clinical use of benzodiazepines (BZD) and related drugs is a controversial issue, especially prolonged prescription in older adults, which is contrary to general recommendations. Our objective was to describe the use of BZD and the hypnotics called Z drugs (zolpidem, zopiclone and eszopiclone) in elderly beneficiaries of the National Institute of Social Services for Retirees and Pensioners (INSSJP-PAMI) of Argentina. An observational, descriptive, cross-sectional drug use study was conducted based on the Institute's drug dispensing database. Beneficiaries of both sexes aged 65 years and over were included. The prevalence of use in 2018 and the defined daily doses (DDD) per 1000 inhabitants / day (DHD) were calculated for each drug. A total of 3 864 949 beneficiaries were included (77.6% of the Argentine population of that age, 61.2% women), with 184 000 nonagenarians and more than 5000 centenarians; 30.3% of whom received at least one dispensation of BZD or "Z drugs" during 2018, with a higher prevalence of use in women (35.6%) than in men (22.0%) and with a progressive increase until 85-89 years, with a subsequent decrease. The most prescribed BZDs were alprazolam (41.6%) and clonazepam (41.1%), followed by lorazepam (9.9%). The dispense drugs reached 252.7 DHD, representing an average of 0.8 DDD per user and per day, a value that decreased with age. The prevalence of use found is among the highest at international level, justifying the implementation of clinical and public health interventions to improve this situation.

El uso clínico de las benzodiazepinas (BZD) y fármacos relacionados es un tema controversial, especialmente la prescripción prolongada en adultos mayores, que es contraria a las recomendaciones generales. Nuestro objetivo fue describir el uso de BZD y de los hipnóticos denominados fármacos Z (zolpidem, zopiclona y eszopiclona) en los adultos mayores beneficiarios del Instituto Nacional de Servicios Sociales para Jubilados y Pensionados (INSSJP-PAMI) de Argentina. Se realizó un estudio de utilización de medicamentos observacional, descriptivo, de corte transversal, a partir de la base de datos de dispensa de medicamentos del Instituto. Se incluyeron los beneficiarios de ambos sexos de 65 años y más. Se calculó para cada fármaco la prevalencia de uso en 2018 y las dosis diarias definidas (DDD) por cada 1000 habitantes/día (DHD). Se incluyeron 3 864 949 beneficiarios (77.6 % de la población argentina de esa edad, 61.2 % mujeres), con 184 000 nonagenarios y más de 5000 centenarios. El 30.3 % recibió al me nos una dispensa de BZD o fármacos Z durante 2018, con mayor prevalencia de uso en mujeres (35.6%) que en varones (22.0%) y con aumento progresivo hasta los 85-89 años, y descenso posterior. Las BZD más recetadas fueron alprazolam (41.6%) y clonazepam (41.1%), seguidas por lorazepam (9.9%). La dispensa alcanzó 252.7 DHD, representado un promedio de 0.8 DDD por usuario y por día, valor que disminuyó con la edad. La prevalencia de uso encontrada está entre las más elevadas a nivel internacional, justificando la implementación de intervenciones clínicas y de salud pública para mejorar esta situación.

La fijación con tornillo de interferencia tibial cuadrante específico permite un constante desplazamiento de los injertos de tejido dentro de tuneles tibiales mal poscionados: análisis cuantitativo de ligamento cruzado anterior en porcinos / Quadrant specific tibial interference screw fixation allows constant displacement of soft tissue grafts inside misplaced tibial tunnels: a porcine anterior cruciate ligament quantitative assessment study

INTRODUCCIÓN El error técnico más común durante la reconstrucción del ligamento cruzado anterior (LCA) es la ubicación incorrecta del túnel. Es incierto si un túnel tibial mal ubicado puede corregirse en el intraoperatorio. OBJETIVO Medir el desplazamiento del injerto de tejido blando con tornillos de interferencia tibial.MATERIALES Y MÉTODOS Estudio experimental ex vivo en 28 rodillas porcinas. Se cosechó el tendón flexor de la extremidad posterior, que fue duplicado y dimensionado para que pasara a través de un túnel tibial mal posicionado. Las muestras se dividieron en 4 grupos según el cuadrante de entrada (anterior [A], posterior [P], medial [M], o lateral [L]) de un tornillo de interferencia tibial de 9 mm con relación al injerto. Se ubicó una regla milimétrica en la meseta tibial, la cual fue fotografiada con una cámara EOS T6 (Canon Inc., Ota, Tokio, Japón), y la imagen fue digitalizada, y puesta en escala a tamaño. La distancia y dirección de los desplazamientos del injerto se midieron con Adobe Photoshop CC 2019 (San José, CA, EEUU). Se analizaron las diferencias medias entre los grupos por análisis de la varianza (analysis of variance, ANOVA, en inglés) unidireccional. El análisis estadístico se realizó con el programa Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, IBM Corp., Armonk, NY, EEUU), versión 25.0 (p ≤ 0,05)).RESULTADOS La distancias medias de los desplazamientos del injerto fueron similares en todos los grupos: A ­ 4,4 mm; P ­ 4,6 mm; M ­ 4,5 mm; y L ­ 4,3 mm, sin diferencias estadísticamente significativas (p = 0,894). Las direcciones medias de los desplazamientos del injerto también fueron similares entre los 4 grupos: A ­ 176° (desviación estándar [DE]: ± 15,4°); P ­ 165° (DE: ± 16,6°); M ­ 166° (DE: ± 12,1°); y L ­ 169° (DE: ± 10,6°). No se encontraron diferencias estadísticamente significativas (p = 0.42).CONCLUSIONES Independientemente del cuadrante de entrada, se observó un desplazamiento constante del injerto hacia el lado opuesto cuando el tornillo tibial alcanzaba la superficie articular. Relevancia clínica: el tornillo tibial mal posicionado puede corregirse en el intraoperatorio con fijación proximal en cuadrante específico, y debe alcanzar la superficie articular para generar un desplazamiento efectivo del injerto. Sin embargo, no podemos predecir la magnitud de error en todos los túneles mal brocados, que debe ser evaluada caso a caso.

BACKGROUND The most common technical error during anterior cruciate ligament (ACL) reconstruction is incorrect tunnel placement. It remains unclear if a misplaced tibial tunnel may be corrected intraoperatively. AIM To measure the displacement of soft-tissue grafts with tibial interference screws. MATERIALS AND METHODS Ex-vivo experimental study in 28 porcine knees. The flexor tendon of the posterior limb was harvested, doubled and sized to fit through a 9-mm misplaced tibial tunnel. The specimens were divided into 4 groups according to the quadrant of entry (anterior [A], posterior [P], medial [M], or lateral [L]) of a 9-mm tibial interference screw in relation to the graft. A millimetric ruler was placed at the tibial plateau, which was photographed with a an EOS T6 (Canon Inc., Ota, Tokio, Japan) camera, and the image was digitalized and scaled to size. The length and direction of the graft displacements were measured with Adobe Photoshop CC 2019 (San José, CA, US). The mean differences among the groups were analyzed through one-way analysis of variance (ANOVA). The statistical analysis was performed using the Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, IBM Corp., Armonk, NY, US) software, version 25.0 (p 0.05) RESULTS The mean lengths of the graft displacements were similar among the groups: A ­ 4.4 mm; P ­4.6 mm; M ­ 4.5 mm; and L ­ 4.3 mm, without statistically significant differences (p » 0.894). The mean directions of the graft displacements were also similar among the groups: A ­ 176° (standard deviation [SD]: 15.4°); P ­ 165° (SD: 16.6°); M ­ 166° (SD: 12.1°); and L ­ 169° (SD: 10.6°). No statistically significant differences were found (p » 0.42). CONCLUSIONS Regardless of the entry quadrant, constant graft displacement to the opposite side was observed when the tibial screw reached the articular surface. Clinical relevance: a misplaced tibial tunnel may be corrected intraoperatively with a quadrantspecific screw, which must reach the articular surface to produce an effective graft displacement. Nevertheless, we cannot predict the magnitude of this error in every poorly-drilled tibial tunnel; it should be assessed case by case.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

[Benzodiazepine and Z-drug consumption in a national social security organization in Argentina: rational or excessive use?] / Consumo de benzodiazepinas y fármacos Z en una organización de la seguridad social nacional argentina: ¿uso racional o excesivo?

Benzodiazepines and "Z-drugs" (BZD/Z) are overprescribed in many countries. This study evaluates their consumption in a social security sector health insurance provider with national coverage in Argentina. With a descriptive and observational approach, outpatient dispensations of BZD/Zs were analyzed for people over 18 years old from April 2020 to March 2021, disaggregated by sex, age, active ingredient, and half-life. An annual prevalence of use of 11.6% was found among the 431,445 adult affiliates, with higher rates in women and in those over age 60. Overall consumption of BZD/Zs was 77.6 defined daily doses (DDD) per 1000 enrollee-days. The average user received 5.1 annual dispensations and the equivalent of 1.4 DDD for each day of the year. BZD/Zs with long half-life were the most used. We found high levels of BZD/Z consumption and for longer periods than recommended. It is necessary to improve the quality of consumption and reduce the negative impact of inappropriate use of these drugs among treated individuals.

Las benzodiazepinas y los "fármacos Z" (BZD-Z) se prescriben en exceso en muchos países. Este estudio evaluó su consumo en una organización de la seguridad social (obra social) de Argentina de alcance nacional. A partir de un diseño observacional descriptivo se analizó la dispensa ambulatoria de BZD-Z, entre abril 2020 y marzo 2021, a mayores de 18 años; desagregada por sexo, edad, principio activo y vida media. Se encontró una prevalencia anual de uso del 11,6% entre los 431.445 afiliados adultos, con valores más elevados en las mujeres y mayores de 60 años. El consumo global de BZD-Z fue de 77,6 dosis diarias definidas (DDD) cada 1.000 afiliados-día. El usuario promedio recibió 5,1 dispensas anuales y el equivalente a 1,4 DDD por cada día del año. Las BZD-Z más usadas fueron las de vida media larga. El consumo de BZD-Z resultó elevado y más prolongado que lo recomendado. Es necesario mejorar la calidad en el consumo y reducir el impacto negativo del uso inapropiado de estos fármacos entre los individuos tratados.

Potential negative impact of reputed regulators' decisions on the approval status of new cancer drugs in Latin American countries: A descriptive analysis.

BACKGROUND: Many new cancer drugs are being approved by reputed regulatory authorities without evidence of overall survival benefit, quality of life improvement, and often based on clinical trials at high risk of bias. In recent years, most Latin American (LA) countries have reformed their marketing authorization (MA) rules to directly accept or abbreviate the approval process in case of earlier authorization by the European Medicines Agency (EMA) and the US Food and Drug Administration, mainly. This study assessed the potential impact of decisions taken by EMA regarding the approval of new cancer drugs based on no evidence of overall survival or in potentially biased clinical trials in LA countries. DESIGN: Descriptive analysis. SETTING: Publicly accessible marketing authorization databases from LA regulators, European Public Assessment Report by EMA, and previous studies accessing EMA approvals of new cancer drugs 2009-2016. MAIN OUTCOME AND MEASURES: Number of new cancer drugs approved by LA countries without evidence of overall survival (2009-2013), and without at least one clinical trial scored at low risk of bias, or with no trial supporting the marketing authorization at all (2014-2016). RESULTS: Argentina, Brazil, Chile, Colombia, Ecuador, Panama and Peru have publicly accessible and trustful MA databases and were included. Of the 17 cancer drugs approved by EMA (2009-2013) without evidence of OS benefit after a postmarketing median time of 5.4 years, 6 LA regulators approved more than 70% of them. Of the 13 drugs approved by EMA (2014-2016), either without supporting trial or with no trial at low risk of bias, Brazil approved 11, Chile 10, Peru 10, Argentina 10, Colombia 9, Ecuador 9, and Panama 8. CONCLUSIONS: LA countries keep approving new cancer drugs often based on poorly performed clinical trials measuring surrogate endpoints. EMA and other reputed regulators must be aware that their regulatory decisions might directly influence decisions regarding MA, health budgets and patient's care elsewhere.

Data transparency for building a stronger healthcare system: A case study from Argentinean administrative drug utilization data sources.

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.

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.