[Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the AmericasAlertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas]. / Alertas sanitarias de productos médicos subestándares, falsificados y no registrados al inicio de la pandemia de COVID-19 en las Américas.

Objective: Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods: Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results: A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions: A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

Objetivo: Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos: Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados: Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões: Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.

Alertas sanitarias de productos médicos subestándares, falsificados y no registrados al inicio de la pandemia de COVID-19 en las Américas / Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the Americas / Alertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas

[RESUMEN]. Objetivo. Identificar y analizar los incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia de COVID-19. Métodos. Búsqueda detallada en los sitios web de las autoridades reguladoras de las Américas. Identificación de los incidentes de medicamentos y dispositivos médicos (incluidos los de diagnóstico in vitro) subestándares falsificados, no registrados y robados. Se determinaron los tipos de productos, las etapas de la cadena de suministro en las que se detectaron y las medidas tomadas por las autoridades. Resultados. Se identificaron 1 273 incidentes en 15 países (1 087 productos subestándares, 44 falsificados, 123 no registrados y 19 robados). La mayor cantidad de incidentes corresponden a dispositivos médicos, desinfectantes y antisépticos. El punto en la cadena de suministro con mayor frecuencia de informes fue la adquisición a través de internet. Las medidas tomadas por las autoridades reguladoras corresponden en su mayoría a: alerta, prohibición de uso, prohibición de publicidad y fabricación, retiro del mercado y seguimiento de eventos adversos. Conclusiones. Se evidenció un número destacable de incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia por COVID-19. La escasez de insumos, la flexibilización en los requisitos regulatorios y el aumento de la demanda son factores que pueden favorecer el incremento del número de incidentes. Las autoridades reguladoras nacionales de referencia presentaron mayores frecuencias de detección de incidentes y de aplicación de medidas sanitarias. Se observó que se debe abordar el canal de venta por internet con alguna estrategia reguladora para garantizar la distribución segura de productos médicos.

[ABSTRACT]. Objective. Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods. Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results. A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unreg- istered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions. A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

[RESUMO]. Objetivo. Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos. Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados. Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões. Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.

Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case-control analysis of the immunization-associated risk: A study protocol.

INTRODUCTION: COVID-19 is associated with higher morbimortality in pregnant people compared with non-pregnant people. At present, the benefits of maternal immunisation are considered to outweigh the risks, and therefore, vaccination is recommended during pregnancy. However, additional information is needed on the safety of the vaccines in this population. METHODS AND ANALYSIS: This a retrospective cohort nested case-control study in pregnant people who attended maternity hospitals from eight Latin American and Caribbean countries. A perinatal electronic clinical history database with neonatal and obstetric information will be used. The proportion of pregnant people immunised with COVID-19 vaccines of the following maternal and neonatal events will be described: preterm infant, small for gestational age, low birth weight, stillbirth, neonatal death, congenital malformations, maternal near miss and maternal death. Moreover, the risk of prematurity, small for gestational age and low birth weight associated with exposure to COVID-19 vaccines will be estimated. Each case will be matched with two groups of three randomly selected controls. Controls will be matched by hospital and mother's age (±3 years) with an additional matching by delivery date and conception time in the first and second control groups, respectively. The estimated required sample size for the main analysis (exposure to any vaccine) concerning 'non-use' is at least 1009 cases (3027 controls) to detect an increased probability of vaccine-associated event risk of 30% and at least 650 cases (1950 controls) to detect 30% protection. Sensitivity and secondary analyses considering country, type of vaccine, exposure windows and completeness of immunisation will be reported. ETHICS: The study protocol was reviewed by the Ethical Review Committee on Research of the Pan American Health Organization. Patient informed consent was waived due to the retrospective design and the utilisation of anonymised data (Ref. No: PAHOERC.0546.01). Results will be disseminated in open access journals.

The Boomerang Effect of Suppression of Emotional Expression: Relationship Power, Affectivity and Adolescent and Youth Male-To-Female Dating Violence.

Scarce research has been performed on the role of power, affectivity, and suppression of emotional expression in the use of dating violence by adolescents and young men. This study aims to analyze a model of the associations between perceived power (control and dominance), affectivity (positive and negative affect), suppression of emotional expression and the frequency of use of male-to female dating violence. Participants in this cross-sectional and correlational study were 786 Spanish students aged between 13 and 25 years (M = 18.80; SD = 2.93) divided in two groups: 13-18 (316 adolescents, M = 15.58; SD = 1.02) and 18-25 (462 young men, M = 20.79; SD = 1.98) with 8 participants not stating their age. Different sequential mediation models confirmed that, only in young men, affectivity (negative and positive affect) and suppression of emotional expression mediate the relationship between power and the use of dating violence. Fostering equal relationships, associating them with positive emotional states, avoiding the frustration derived from low power perception, and providing young men with strategies for appropriately expressing their emotions may help decrease the use of dating violence.

Alertas sanitarias de productos médicos subestándares, falsificados y no registrados al inicio de la pandemia de COVID-19 en las Américas / Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the Americas / Alertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas

RESUMEN Objetivo. Identificar y analizar los incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia de COVID-19. Métodos. Búsqueda detallada en los sitios web de las autoridades reguladoras de las Américas. Identificación de los incidentes de medicamentos y dispositivos médicos (incluidos los de diagnóstico in vitro) subestándares falsificados, no registrados y robados. Se determinaron los tipos de productos, las etapas de la cadena de suministro en las que se detectaron y las medidas tomadas por las autoridades. Resultados. Se identificaron 1 273 incidentes en 15 países (1 087 productos subestándares, 44 falsificados, 123 no registrados y 19 robados). La mayor cantidad de incidentes corresponden a dispositivos médicos, desinfectantes y antisépticos. El punto en la cadena de suministro con mayor frecuencia de informes fue la adquisición a través de internet. Las medidas tomadas por las autoridades reguladoras corresponden en su mayoría a: alerta, prohibición de uso, prohibición de publicidad y fabricación, retiro del mercado y seguimiento de eventos adversos. Conclusiones. Se evidenció un número destacable de incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia por COVID-19. La escasez de insumos, la flexibilización en los requisitos regulatorios y el aumento de la demanda son factores que pueden favorecer el incremento del número de incidentes. Las autoridades reguladoras nacionales de referencia presentaron mayores frecuencias de detección de incidentes y de aplicación de medidas sanitarias. Se observó que se debe abordar el canal de venta por internet con alguna estrategia reguladora para garantizar la distribución segura de productos médicos.

ABSTRACT Objective. Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods. Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results. A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions. A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

RESUMO Objetivo. Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos. Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados. Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões. Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.

Effectiveness of nirmatrelvir-ritonavir for the treatment of patients with mild to moderate COVID-19 and at high risk of hospitalization: Systematic review and meta-analyses of observational studies.

OBJECTIVE: To assess the effectiveness of nirmatrelvir-ritonavir in the treatment of outpatients with mild to moderate COVID-19 who are at higher risk of developing severe illness, through a systematic review with meta-analyses of observational studies. METHODS: A systematic search was performed, in accordance with the Cochrane search methods, to identify observational studies that met the inclusion criteria. The outcomes of mortality and hospitalization were analyzed. Search was conducted on PubMed, EMBASE, and The Cochrane Library. Two reviewers independently screened references, selected the studies, extracted the data, assessed the risk of bias using ROBINS-I tool and evaluated the quality of evidence using the GRADE tool. This study followed the PRISMA reporting guideline. RESULTS: A total of 16 observational studies were finally included. The results of the meta-analysis showed that in comparison to standard treatment without antivirals, nirmatrelvir-ritonavir reduced the risk of death by 59% (OR = 0.41; 95% CI: 0.35-0.52; moderate certainty of evidence). In addition, a 53% reduction in the risk of hospital admission was observed (OR = 0.47; 95% CI: 0.36-0.60, with very low certainty of evidence). For the composite outcome of hospitalization and/or mortality, there was a 56% risk reduction (OR = 0.44; 95% CI: 0.31-0.64, moderate certainty of evidence). CONCLUSION: The results suggest that nirmatrelvir-ritonavir could be effective in reducing mortality and hospitalization. The results were valid in vaccinated or unvaccinated high-risk individuals with COVID-19. Data from ongoing and future trials may further advance our understanding of the effectiveness and safety of nirmatrelvir-ritonavir and help improve treatment guidelines for COVID-19.

Automatic Assessment of Transcatheter Aortic Valve Implantation Results on Four-Dimensional Computed Tomography Images Using Artificial Intelligence.

Transcatheter aortic valve implantation (TAVI) is a procedure to treat severe aortic stenosis. There are several clinical concerns related to potential complications after the procedure, which demand the analysis of computerized tomography (CT) scans after TAVI to assess the implant's result. This work introduces a novel, fully automatic method for the analysis of post-TAVI 4D-CT scans to characterize the prosthesis and its relationship with the patient's anatomy. The method enables measurement extraction, including prosthesis volume, center of mass, cross-sectional area (CSA) along the prosthesis axis, and CSA difference between the aortic root and prosthesis, all the variables studied throughout the cardiac cycle. The method has been implemented and evaluated with a cohort of 13 patients with five different prosthesis models, successfully extracting all the measurements from each patient in an automatic way. For Allegra patients, the mean of the obtained inner volume values ranged from 10,798.20 mm3 to 18,172.35 mm3, and CSA in the maximum diameter plane varied from 396.35 mm2 to 485.34 mm2. The implantation of this new method could provide information of the important clinical value that would contribute to the improvement of TAVI, significantly reducing the time and effort invested by clinicians in the image interpretation process.

Acceptability of short message service (SMS) as a tool for malaria treatment adherence in the Brazilian Amazon: a qualitative study.

BACKGROUND: Malaria is one of the leading causes of morbidity worldwide, and patient adherence to prescribed antimalarials is essential for effective treatment. METHODS: This cross-sectional study, with in-depth telephone interviews, analyzed participants' perceptions of short message service (SMS) in adherence to treatment. RESULTS: Five thematic categories emerged: decreased forgetfulness, the novelty of the tool, easy-to-understand language, the impact of SMS messages during treatment, and suggestions for improvement and complaints. CONCLUSIONS: SMS could assist patients in adhering to prescribed antimalarials.

[Regulation of the online sale of medical products: experiences and strategies for Latin AmericaRegulamentação da venda de produtos médicos pela internet: experiências e estratégias para a América Latina]. / Regulación de la venta de productos médicos por Internet: experiencias y estrategias para Latinoamérica.

The objective of this special report is to present the advances in Latin America on regulation of the online sale of medical products and to offer guidance to national regulatory authorities (NRAs) on planning and implementing strategies to regulate and oversee the e-commerce of medical products. The regulatory advances and the programs and initiatives implemented in four Latin American countries to control the online sale of medical products are presented, including complementary reviews of the literature and reviews of e-commerce control programs of agencies of reference. Based on this review, the following strategies are proposed: strengthening the regulatory and policy framework; strengthening the capacity for oversight; collaboration with national and international authorities and other key players; and communication and awareness-raising with the community and health care professionals. Each of these strategies should be accompanied by specific actions that can serve as guidelines for NRAs in the Americas and in countries with similar contexts, to strengthen their regulatory frameworks and patient and consumer protections.

O objetivo deste relatório especial é apresentar os avanços na regulamentação da comercialização de produtos médicos pela internet na América Latina e oferecer orientações às Autoridades Reguladoras Nacionais (ARN) sobre planejamento e execução de estratégias de regulamentação e fiscalização do comércio eletrônico de produtos médicos. São apresentados avanços regulatórios e programáticos, bem como iniciativas realizadas por quatro países latino-americanos para controlar a venda de produtos médicos pela internet, incluindo revisões complementares da literatura e programas de controle do comércio eletrônico por agências reguladoras de referência. Com base nesta revisão, propõem-se as seguintes linhas estratégicas: fortalecimento do marco regulatório e normativo; fortalecimento da capacidade de fiscalização; colaboração com autoridades e outros atores-chave nacionais e internacionais; e comunicação e sensibilização da comunidade em geral e dos profissionais de saúde. Cada uma dessas estratégias deve ser acompanhada de ações específicas, que podem servir de diretrizes para as ARN das Américas ­ e de países com contextos semelhantes ­ para fortalecer seus marcos regulatórios e a proteção de pacientes e consumidores.

Regulación de la venta de productos médicos por Internet: experiencias y estrategias para Latinoamérica

[RESUMEN]. El objetivo de este informe especial es presentar los avances en Latinoamérica sobre la regulación de la venta de productos médicos a través de internet y ofrecer orientación a las Autoridades Reguladoras Nacionales (ARN) en la planificación y ejecución de estrategias para la regulación y fiscalización del comercio electró- nico de productos médicos. Se presentan los avances regulatorios y de programas, e iniciativas efectuadas por cuatro países de América Latina para el control de la venta de productos médicos a través de Internet, incluyendo revisiones complementarias de la literatura y de programas para el control del comercio elec- trónico de agencias de referencia. A partir de esta revisión, se proponen las siguientes líneas estratégicas: fortalecimiento del marco regulatorio y normativo; fortalecimiento de la capacidad fiscalizadora; colaboración con autoridades y otros actores clave nacionales e internacionales; y comunicación y sensibilización con la comunidad y los profesionales de salud. Cada una de estas estrategias deben ir acompañadas con acciones específicas, que pueden servir como orientaciones para las ARN de las Américas, y de países con contextos similares para el fortalecimiento de sus marcos regulatorios y la protección de los pacientes y consumidores.

[ABSTRACT]. The objective of this special report is to present the advances in Latin America on regulation of the online sale of medical products and to offer guidance to national regulatory authorities (NRAs) on planning and implemen- ting strategies to regulate and oversee the e-commerce of medical products. The regulatory advances and the programs and initiatives implemented in four Latin American countries to control the online sale of medical products are presented, including complementary reviews of the literature and reviews of e-commerce control programs of agencies of reference. Based on this review, the following strategies are proposed: strengthening the regulatory and policy framework; strengthening the capacity for oversight; collaboration with national and international authorities and other key players; and communication and awareness-raising with the community and health care professionals. Each of these strategies should be accompanied by specific actions that can serve as guidelines for NRAs in the Americas and in countries with similar contexts, to strengthen their regula- tory frameworks and patient and consumer protections.

[RESUMO]. O objetivo deste relatório especial é apresentar os avanços na regulamentação da comercialização de pro- dutos médicos pela internet na América Latina e oferecer orientações às Autoridades Reguladoras Nacionais (ARN) sobre planejamento e execução de estratégias de regulamentação e fiscalização do comércio eletrô- nico de produtos médicos. São apresentados avanços regulatórios e programáticos, bem como iniciativas realizadas por quatro países latino-americanos para controlar a venda de produtos médicos pela internet, incluindo revisões complementares da literatura e programas de controle do comércio eletrônico por agências reguladoras de referência. Com base nesta revisão, propõem-se as seguintes linhas estratégicas: fortaleci- mento do marco regulatório e normativo; fortalecimento da capacidade de fiscalização; colaboração com autoridades e outros atores-chave nacionais e internacionais; e comunicação e sensibilização da comuni- dade em geral e dos profissionais de saúde. Cada uma dessas estratégias deve ser acompanhada de ações específicas, que podem servir de diretrizes para as ARN das Américas – e de países com contextos seme- lhantes – para fortalecer seus marcos regulatórios e a proteção de pacientes e consumidores.

Myopericarditis Associated with the Novavax COVID-19 Vaccine (NVX-CoV2373): A Retrospective Analysis of Individual Case Safety Reports from VigiBase.

BACKGROUND: Myocarditis and pericarditis have been associated most notably with mRNA vaccines, but the association with a recently authorized adjuvated vaccine (NVX-CoV2373) is controversial. OBJECTIVE: The aim was to analyze the cases of myocarditis and pericarditis in association with NVX-CoV2373 reported to the World Health Organization (WHO) global database of individual case safety reports (ICSRs) for drug monitoring (VigiBase), applying disproportionality analyses. PATIENTS AND METHODS: The main characteristics of the ICSRs reporting myopericarditis with NVX-CoV2373 have been summarized. Reporting odds ratios (RORs) as a measure of disproportionality for reported myopericarditis (November 1967-August 2022) have been calculated for NVX-CoV2373; mRNA and adenoviral vector-based vaccines were also included as a reference. RESULTS: In total, 61 ICSRs included NVX-CoV2373. Most of the reports originated in Australia (50; 82.0%); 24 (39.3%) were considered serious. None of them were fatal. The median age of individuals was 35.5 years old, and most were males (38; 62.3%). Chest pain was the most common co-reported event 43 (70.5%). The median induction period was 3 days after immunization. Increased disproportionality for myopericarditis was found for NVX-CoV2373 (ROR 14.47, 95% confidence interval [CI] 11.22-18.67) and mRNA vaccines: BNT162b2 (ROR 17.15, 95% CI 16.88-17.42) and mRNA-1273 (ROR 6.92, 95% CI 6.77-7.08). Higher values were found in males. The adenoviral vector-based vaccine Ad26.COV2.S showed slightly increased disproportionality (ROR 1.83, 95% CI 1.70-1.98), whereas no increased disproportionality was found for ChAdOx1. CONCLUSIONS: NVX-CoV2373 vaccine showed a similar increased disproportionality as mRNA vaccines. More evidence from controlled studies is necessary; however, a precautionary approach is warranted. Healthcare professionals should be aware of the potential occurrence of myopericarditis with this new vaccine.

Psychological withdrawal and mental health during the COVID-19 pandemic: a longitudinal study.

OBJECTIVE: The first objective was to track temporal changes in participants' mental health during the 2020 lockdown in Spain. Second, we tested whether age moderated the association between the use of psychological withdrawal and mental health over time. Design: Participants (N = 396, 74% women) completed three waves of a web-based survey during the lockdown. Age mean was 40.11 (sd = 12.66). MAIN OUTCOME MEASURES: Participants answered a set of sociodemographic data, the General Health Questionnaire (GHQ-12), and the Measures of Affect Regulation Scale (MARS). RESULTS: Disruptions and withdrawal were associated with more mental health symptoms (between 39% and 41% mental distress). Growth models showed that social dysfunction increased over time while dysphoric symptoms decreased. The use of withdrawal aggravated social dysfunction symptoms. Young people who use more withdrawal experienced more social dysfunction and dysphoria over time than those who used less withdrawal strategies. CONCLUSION: The differential trends in social dysfunction versus dysphoria symptoms suggest an adaptation process after the initial stress of the lockdown. Older age was correlated with less mental health problems and reflects age related improvements in emotional regulation.

Barriers of Access to Opioid Medicines within the Context of Palliative Care in Latin America: The Perception of Health Professionals.

Background: Different sets of barriers have been identified to explain the difficulties in the access and availability of opioid analgesics in palliative care, particularly in low- and middle-income countries, including Latin America. Objective: To validate a structured questionnaire for the access to opioid medicines and to investigate the perception of health professionals regarding access barriers to opioid analgesics in 17 countries of the Latin American Region. Design: Survey to identify the domains and barriers of access to opioid medicines according to health professionals, including physicians, nurses, and pharmacists affiliated to institutions that provide palliative care in Latin America between August 2019 and October 2020. Results: We analyzed responses from 426 health professionals. The median age was 44 years old (ranging from 23 to 73 years) with an average experience in palliative care of 10 years (range: 1-35), 71.8% were women, and 49.8% were affiliated to specialized health care facilities of urban areas (94.6%). The main barriers perceived to be extremely relevant by the respondents were "belief that patients can develop addiction" and "financial limitations of patients" for the patient's domain and the "appropriate education, instruction, and training of professionals" for health professional's domain. Conclusions: It is necessary to develop strategies to strengthen less-developed health systems of the region to review legal frameworks, ensure integrated palliative care systems, and deploy multidisciplinary strategies for sensitizing, training, and raising the awareness of patients, caregivers and, particularly, health professionals regarding appropriate prescription and rational use of opioid analgesics.

Acceptability of short message service (SMS) as a tool for malaria treatment adherence in the Brazilian Amazon: a qualitative study

ABSTRACT Background: Malaria is one of the leading causes of morbidity worldwide, and patient adherence to prescribed antimalarials is essential for effective treatment. Methods: This cross-sectional study, with in-depth telephone interviews, analyzed participants' perceptions of short message service (SMS) in adherence to treatment. Results: Five thematic categories emerged: decreased forgetfulness, the novelty of the tool, easy-to-understand language, the impact of SMS messages during treatment, and suggestions for improvement and complaints. Conclusions: SMS could assist patients in adhering to prescribed antimalarials.

Regulación de la venta de productos médicos por Internet: experiencias y estrategias para Latinoamérica / Regulation of the online sale of medical products: experiences and strategies for Latin America / Regulamentação da venda de produtos médicos pela internet: experiências e estratégias para a América Latina

RESUMEN El objetivo de este informe especial es presentar los avances en Latinoamérica sobre la regulación de la venta de productos médicos a través de internet y ofrecer orientación a las Autoridades Reguladoras Nacionales (ARN) en la planificación y ejecución de estrategias para la regulación y fiscalización del comercio electrónico de productos médicos. Se presentan los avances regulatorios y de programas, e iniciativas efectuadas por cuatro países de América Latina para el control de la venta de productos médicos a través de Internet, incluyendo revisiones complementarias de la literatura y de programas para el control del comercio electrónico de agencias de referencia. A partir de esta revisión, se proponen las siguientes líneas estratégicas: fortalecimiento del marco regulatorio y normativo; fortalecimiento de la capacidad fiscalizadora; colaboración con autoridades y otros actores clave nacionales e internacionales; y comunicación y sensibilización con la comunidad y los profesionales de salud. Cada una de estas estrategias deben ir acompañadas con acciones específicas, que pueden servir como orientaciones para las ARN de las Américas, y de países con contextos similares para el fortalecimiento de sus marcos regulatorios y la protección de los pacientes y consumidores.

ABSTRACT The objective of this special report is to present the advances in Latin America on regulation of the online sale of medical products and to offer guidance to national regulatory authorities (NRAs) on planning and implementing strategies to regulate and oversee the e-commerce of medical products. The regulatory advances and the programs and initiatives implemented in four Latin American countries to control the online sale of medical products are presented, including complementary reviews of the literature and reviews of e-commerce control programs of agencies of reference. Based on this review, the following strategies are proposed: strengthening the regulatory and policy framework; strengthening the capacity for oversight; collaboration with national and international authorities and other key players; and communication and awareness-raising with the community and health care professionals. Each of these strategies should be accompanied by specific actions that can serve as guidelines for NRAs in the Americas and in countries with similar contexts, to strengthen their regulatory frameworks and patient and consumer protections.

RESUMO O objetivo deste relatório especial é apresentar os avanços na regulamentação da comercialização de produtos médicos pela internet na América Latina e oferecer orientações às Autoridades Reguladoras Nacionais (ARN) sobre planejamento e execução de estratégias de regulamentação e fiscalização do comércio eletrônico de produtos médicos. São apresentados avanços regulatórios e programáticos, bem como iniciativas realizadas por quatro países latino-americanos para controlar a venda de produtos médicos pela internet, incluindo revisões complementares da literatura e programas de controle do comércio eletrônico por agências reguladoras de referência. Com base nesta revisão, propõem-se as seguintes linhas estratégicas: fortalecimento do marco regulatório e normativo; fortalecimento da capacidade de fiscalização; colaboração com autoridades e outros atores-chave nacionais e internacionais; e comunicação e sensibilização da comunidade em geral e dos profissionais de saúde. Cada uma dessas estratégias deve ser acompanhada de ações específicas, que podem servir de diretrizes para as ARN das Américas - e de países com contextos semelhantes - para fortalecer seus marcos regulatórios e a proteção de pacientes e consumidores.

[Adverse reactions to drugs used for COVID-19 in five Latin American countriesReações adversas a medicamentos utilizados para a COVID-19 em cinco países da América Latina]. / Reacciones adversas a medicamentos utilizados para la COVID-19 en cinco países de América Latina.

Objective: Characterize and describe reports of suspected adverse reactions to a group of drugs used in Colombia, Costa Rica, Cuba, Chile, El Salvador, Mexico, and Peru to treat or prevent coronavirus disease (COVID-19) between 1 March and 31 August 2020. Methods: A list of the 13 drugs used to treat or prevent COVID-19 was prepared, based on official and unofficial sources. Drawing on the databases of the national pharmacovigilance programs of the participating countries, reports of suspected adverse reactions to these drugs were collected for the period from 1 March and 31 August 2020. Results: A total of 3 490 reports of suspected adverse reactions were received from the pharmacovigilance programs of Peru (n = 3 037), Cuba (n = 270), Colombia (n = 108), Chile (n = 72), and El Salvador (n = 3). The drugs with the highest number of reported adverse reactions were azithromycin, ivermectin, and hydroxychloroquine. Diarrhea was the most frequent event (15.0%). Of the total suspected adverse reactions, 11.9% were reported as serious. The most frequent was QT prolongation following use of hydroxychloroquine. Of these suspected serious adverse reactions, 54.5% occurred in people over 65 years of age. Conclusions: While it is not possible to establish a causal relationship from the evaluation of spontaneous reports, the present study confirms the presence of adverse reactions-some of them serious-involving drugs used to treat or prevent COVID-19.

Objetivo: Caracterizar e descrever as notificações de suspeitas de reações adversas a um grupo de medicamentos utilizados na Colômbia, Costa Rica, Cuba, Chile, El Salvador, México e Peru, para tratar ou prevenir a doença do coronavírus (COVID-19), entre 1º de março e 31 de agosto de 2020. Métodos: Foi elaborada uma lista dos 13 medicamentos usados para tratar ou prevenir a COVID-19, segundo fontes oficiais e não oficiais. A partir das bases de dados dos programas nacionais de farmacovigilância dos países participantes, foram coletadas notificações de suspeitas de reações adversas a esses medicamentos, recebidas no período entre 1º de março e 31 de agosto de 2020. Resultados: Foram recebidas 3.490 notificações de suspeitas de reações adversas dos programas de farmacovigilância do Peru (n = 3.037), Cuba (n = 270), Colômbia (n = 108), Chile (n = 72) e El Salvador (n = 3). Os medicamentos com maior número de notificações de reações adversas foram azitromicina, ivermectina e hidroxicloroquina. A diarreia foi o evento mais frequente (15,0%). Do total de suspeitas de reações adversas, 11,9% foram notificadas como graves. A mais frequente foi o prolongamento do intervalo QT após o uso de hidroxicloroquina. Dessas suspeitas de reações adversas graves, 54,5% ocorreram em pessoas com mais de 65 anos. Conclusão: Embora não seja possível estabelecer uma relação causal com base na avaliação de relatos espontâneos, o presente estudo confirma a presença de reações adversas ­ algumas graves ­ a medicamentos que foram usados para tratar ou prevenir a COVID-19.

Reacciones adversas a medicamentos utilizados para la COVID-19 en cinco países de América Latina

[RESUMEN]. Objetivo. Caracterizar y describir las notificaciones de sospechas de reacciones adversas de un grupo de medicamentos que se utilizaron en Colombia, Costa Rica, Cuba, Chile, El Salvador, México y Perú para tratar o prevenir la enfermedad por el coronavirus (COVID-19, por su sigla en inglés) entre el 1 de marzo y el 31 de agosto del 2020. Métodos. Se elaboró una lista de los 13 medicamentos utilizados para tratar o prevenir la COVID-19, según fuentes oficiales y no oficiales. Desde las bases de datos de los programas nacionales de farma- covigilancia de los países participantes, se recopilaron las notificaciones de sospechas de reacciones adversas a estos medicamentos recibidas en el período comprendido entre el 1 de marzo y 31 de agosto de año 2020. Resultados. Se recibieron 3 490 notificaciones de sospechas de reacciones adversas desde los programas de farmacovigilancia de Perú (n = 3 037), Cuba (n = 270), Colombia (n = 108), Chile (n = 72) y El Salvador (n = 3). Los medicamentos con mayor número de notificaciones de reacciones adversas fueron la azitromi- cina, la ivermectina y la hidroxicloroquina. La diarrea fue el evento más frecuente (15,0%). Del total de las sospechas de reacciones adversas, 11,9% fueron notificadas como graves. La más frecuente fue la prolon- gación del intervalo QT posterior al uso de hidroxicloroquina. De estas sospechas de reacciones adversas graves, 54,5% ocurrieron en personas mayores de 65 años. Conclusión. Si bien no es posible establecer una relación causal a partir de la evaluación de informes espon- táneos, el presente estudio confirma la presencia de reacciones adversas, algunas graves, con medicamentos que se utilizaron para tratar o prevenir la COVID-19.

[ABSTRACT]. Objective. Characterize and describe reports of suspected adverse reactions to a group of drugs used in Colombia, Costa Rica, Cuba, Chile, El Salvador, Mexico, and Peru to treat or prevent coronavirus disease (COVID-19) between 1 March and 31 August 2020. Methods. A list of the 13 drugs used to treat or prevent COVID-19 was prepared, based on official and unofficial sources. Drawing on the databases of the national pharmacovigilance programs of the participating countries, reports of suspected adverse reactions to these drugs were collected for the period from 1 March and 31 August 2020. Results. A total of 3 490 reports of suspected adverse reactions were received from the pharmacovigilance programs of Peru (n = 3 037), Cuba (n = 270), Colombia (n = 108), Chile (n = 72), and El Salvador (n = 3). The drugs with the highest number of reported adverse reactions were azithromycin, ivermectin, and hydroxychlo- roquine. Diarrhea was the most frequent event (15.0%). Of the total suspected adverse reactions, 11.9% were reported as serious. The most frequent was QT prolongation following use of hydroxychloroquine. Of these suspected serious adverse reactions, 54.5% occurred in people over 65 years of age. Conclusion. While it is not possible to establish a causal relationship from the evaluation of spontaneous reports, the present study confirms the presence of adverse reactions—some of them serious—involving drugs used to treat or prevent COVID-19.

[RESUMO]. Objetivo. Caracterizar e descrever as notificações de suspeitas de reações adversas a um grupo de medica- mentos utilizados na Colômbia, Costa Rica, Cuba, Chile, El Salvador, México e Peru, para tratar ou prevenir a doença do coronavírus (COVID-19), entre 1o de março e 31 de agosto de 2020. Métodos. Foi elaborada uma lista dos 13 medicamentos usados para tratar ou prevenir a COVID-19, segundo fontes oficiais e não oficiais. A partir das bases de dados dos programas nacionais de farmacovigilância dos países participantes, foram coletadas notificações de suspeitas de reações adversas a esses medicamentos, recebidas no período entre 1o de março e 31 de agosto de 2020. Resultados. Foram recebidas 3.490 notificações de suspeitas de reações adversas dos programas de far- macovigilância do Peru (n = 3.037), Cuba (n = 270), Colômbia (n = 108), Chile (n = 72) e El Salvador (n = 3). Os medicamentos com maior número de notificações de reações adversas foram azitromicina, ivermectina e hidroxicloroquina. A diarreia foi o evento mais frequente (15,0%). Do total de suspeitas de reações adversas, 11,9% foram notificadas como graves. A mais frequente foi o prolongamento do intervalo QT após o uso de hidroxicloroquina. Dessas suspeitas de reações adversas graves, 54,5% ocorreram em pessoas com mais de 65 anos. Conclusão. Embora não seja possível estabelecer uma relação causal com base na avaliação de relatos espontâneos, o presente estudo confirma a presença de reações adversas – algumas graves – a medicamen- tos que foram usados para tratar ou prevenir a COVID-19.

Facial Motion Analysis beyond Emotional Expressions.

Facial motion analysis is a research field with many practical applications, and has been strongly developed in the last years. However, most effort has been focused on the recognition of basic facial expressions of emotion and neglects the analysis of facial motions related to non-verbal communication signals. This paper focuses on the classification of facial expressions that are of the utmost importance in sign languages (Grammatical Facial Expressions) but also present in expressive spoken language. We have collected a dataset of Spanish Sign Language sentences and extracted the intervals for three types of Grammatical Facial Expressions: negation, closed queries and open queries. A study of several deep learning models using different input features on the collected dataset (LSE_GFE) and an external dataset (BUHMAP) shows that GFEs can be learned reliably with Graph Convolutional Networks simply fed with face landmarks.