Deprescribing clonazepam in primary care older patients: a feasibility study.

Background Inappropriate use of clonazepam by older adults is associated with cognitive impairment, delirium, and falls. Strategies to optimize its use are important to increase patient safety. Objective To evaluate the feasibility of a clonazepam deprescription protocol in the elderly. Methods This is a quasi-experimental study. Elderly people with chronic use of clonazepam and attended in primary care units in two Brazilian municipalities were selected. A deprescription protocol was used, which included five fortnightly meetings between the older adults and the research team, to reduce the dose by 25%. Patients received instructions on sleep hygiene behaviors and the advantages of clonazepam deprescription; family physicians followed a flowchart for gradual dose reduction. In the 1st and 5th meetings, there were medical appointments for anamnesis and discharge. The monitoring of patients and the application of tests were carried out by the research team. Results Of the 35 elderly people included in the study, 27 reached the end; 81.5% achieved deprescription: 22.2% stopped completely and 59.3% decreased the dose. At the last meeting, 20% of elderly patients reported an increase in blood pressure. Conclusion The high rate of deprescription and the little relevance of clonazepam withdrawal reactions, showed that the use of the protocol was effective. However, the increase in blood pressure and the worsening of sleep quality in the last meeting show the need for adjustment in the last stage of the deprescription process.

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.

Drug utilization research in Peru: Is real-world data available?

Background: Drug utilization research (DUR) is used to provide evidence-based data to inform policies and make decisions. The aim of this study was to map and describe available data sources for drug utilization research in Peru. Methods: We performed a search of data sources providing information on medication use on the website of governmental organizations. We also conducted a literature review using PubMed, LILACs, and BVS. Independently, researchers screened eligible data sources. Data characterization included accessibility, coverage data provider, type of data sources, and setting. We performed a descriptive analysis. Results: We identified seven data sources, CENAFyT, ICI, IDI (SISMED), and ENSUSALUD from MINSA, and CRI-ESSALUD, SGSS/ESSI, and ENSSA from ESSALUD. These presented information on adverse drug reactions (n = 2), drug consumption, and distribution (n = 2), prescription and drug dispensing (n = 1), and surveys addressed to medication users (n = 2). ENSUSALUD was the only data source publicly available. VIGIFLOW and ENSUSALUD have a national granularity from the public and private sectors. The setting of the data sources was both hospital and ambulatory care. Two data sources have individual-level data on adverse drug reactions and one on prescriptions. Four studies on drug utilization research in Peru were derived from ENSUSALUD. Conclusion: In Peru, few data sources are available for drug utilization research. There is an increased need to monitor medications for decision-making purposes. Local and international initiatives and partnerships of the government with academic institutions and the private sector might be a good strategy to increase the transparency of health data and for supporting decision-making using drug utilization research.

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.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries.

OBJECTIVE: To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. METHODS: Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. RESULTS: Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. CONCLUSIONS: Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

Efficacy, feasibility and acceptability of the OptiMEDs tool for multidisciplinary medication review in nursing homes.

AIM(S): Exploring efficacy, feasibility and acceptability of a complex multifaced intervention (OptiMEDs) supporting multidisciplinary medication reviews in Belgian nursing homes (NHs). METHODS: A pilot study in 2 intervention, 1 control NH was held, involving dementia and non-dementia NH residents (>65 years). OptiMEDs provided automated assessment of possible inappropriate medications (PIMs) and patient-specific nurse observation lists of potential side-effects. Medication changes were evaluated one month after the medication review. Feasibility and acceptability was collected via surveys among the health-care professionals. Trial registration NCT04142645, 31/10/2019. RESULTS: Participants (n = 148, n = 100 in the intervention NHs) had a mean age of 87.2 years, with 75.0% females and 49.3% non-dementia patients. Prevalence of PIM use was 84.7% and of potential medication side-effects 84.5%, (range 1-19 per resident). One month after the intervention, the medication use decreased in 35.8% and PIM use in 25.9% of surviving intervention NHresidents (n = 88). GPs changed more medications when side-effects were observed (42% when side-effects present versus 12% when no side-effects, p = 0.019). Median workload for nurses was 45 min, 20 for pharmacists, and 8 for GPs. User satisfaction for the OptiMEDs tool was high (n = 33, median score of 8, IQR 6 -8), with GPs (n = 19) showing the highest appreciation. Nurses (n = 9) reported a median score on the System Usability Scale of 70 (IQR 55 - 72), with lower scores for learnability aspects. CONCLUSION: The OptiMEDs intervention was feasible and user-friendly, showing decreases in the medication and PIM use; without affecting patient safety. A cluster-randomized trial is needed to explore impact on patient-related outcomes.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

[ABSTRACT]. Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators’ websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

[RESUMEN]. Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

[RESUMO]. Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

Data Sources for Drug Utilization Research in Brazil-DUR-BRA Study.

Background: In Brazil, studies that map electronic healthcare databases in order to assess their suitability for use in pharmacoepidemiologic research are lacking. We aimed to identify, catalogue, and characterize Brazilian data sources for Drug Utilization Research (DUR). Methods: The present study is part of the project entitled, "Publicly Available Data Sources for Drug Utilization Research in Latin American (LatAm) Countries." A network of Brazilian health experts was assembled to map secondary administrative data from healthcare organizations that might provide information related to medication use. A multi-phase approach including internet search of institutional government websites, traditional bibliographic databases, and experts' input was used for mapping the data sources. The reviewers searched, screened and selected the data sources independently; disagreements were resolved by consensus. Data sources were grouped into the following categories: 1) automated databases; 2) Electronic Medical Records (EMR); 3) national surveys or datasets; 4) adverse event reporting systems; and 5) others. Each data source was characterized by accessibility, geographic granularity, setting, type of data (aggregate or individual-level), and years of coverage. We also searched for publications related to each data source. Results: A total of 62 data sources were identified and screened; 38 met the eligibility criteria for inclusion and were fully characterized. We grouped 23 (60%) as automated databases, four (11%) as adverse event reporting systems, four (11%) as EMRs, three (8%) as national surveys or datasets, and four (11%) as other types. Eighteen (47%) were classified as publicly and conveniently accessible online; providing information at national level. Most of them offered more than 5 years of comprehensive data coverage, and presented data at both the individual and aggregated levels. No information about population coverage was found. Drug coding is not uniform; each data source has its own coding system, depending on the purpose of the data. At least one scientific publication was found for each publicly available data source. Conclusions: There are several types of data sources for DUR in Brazil, but a uniform system for drug classification and data quality evaluation does not exist. The extent of population covered by year is unknown. Our comprehensive and structured inventory reveals a need for full characterization of these data sources.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries / Utilización de decisiones de autoridades regulatorias de otras jurisdicciones para aprobar nuevos productos medicinales en países de América Latina y el Caribe / Uso de decisões regulatórias de outras jurisdições para aprovação de novas especialidades farmacêuticas em países da América Latina e Caribe

ABSTRACT Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

RESUMEN Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

RESUMO Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

Transparencia de datos para construir un sistema de salud más sólido: estudio de caso de bases de datos administrativas argentinas sobre utilización de medicamentos / Data transparency for building a stronger healthcare system: A case study from Argentinean administrative drug utilization data sources

RESUMEN 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.

ABSTRACT 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.

Development and validation of an assessment tool for nursing workload in emergency departments.

AIMS: To develop the Workload Assessment of Nurses on Emergency (WANE) tool and to test its validity and reliability to measure nursing workload in the emergency departments. BACKGROUND: Ensuring safe nursing staffing in emergency departments is a worldwide concern. There is no valid tool to measure emergency nursing workload in order to determine the needed nurse staffing in the emergency departments. DESIGN: A two-year, cross-sectional, multicenter study. METHODS: Workload was operationalised as the time nurses spent with nursing activities, classified into direct and indirect care. A board of experts provided content validity. Construct validity was evaluated by examining the WANE's correlations and group-discriminations patterns within the network of variables known to determine nursing workload. Reliability was assessed by the tool's ability to yield consistent results across repeated measurements. Reporting of this research adheres to STROBE guidelines. RESULTS: Seven emergency departments, including 3,024 patients, were involved in the first year and 18 emergency departments and 7,442 patients in the second year. Direct care time correlated positively and significantly with patient dependency on nursing care, age and length of emergency department stay and discriminated between the categories of dependency on nursing care, age and hospitalisation. Both direct and indirect care time discriminated between the emergency departments according to different patient care profiles and unit characteristics. WANE showed consistent results across measurements. CONCLUSIONS: Results support the WANE's reliability and validity to measure emergency nursing workload. This tool could be used to determine, on patient and unit, a baseline nurse staffing and the nursing skill mix in the emergency departments. WANE is also an evidence-based management tool for benchmarking purposes. RELEVANCE TO CLINICAL PRACTICE: The use of an evidence-based workload tool in making staffing decisions in emergency departments is crucial to ensure safe patient care and prevent work overload in nursing staff.

Reducing Psychotropic Drug Use in Nursing Homes in Belgium: An Implementation Study for the Roll-Out of a Practice Improvement Initiative.

BACKGROUND AND OBJECTIVE: Psychotropic drug use is high in nursing homes in Belgium. A practice improvement initiative (including education, professional support and the transition towards person-centred care) achieved significant reductions in psychotropic drug use. The initiative outline was transcribed into a general intervention template, and consequently implemented in five nursing homes (in mixed locations and with a mixed character) in preparation for a future broader roll-out in Belgium. The impact of the intervention on the use of psychotropic drugs in these five nursing homes is reported in this paper. METHODS: The general intervention template was fitted into the individual nursing home setting. Education for the nursing home personnel on psychotropic drugs and non-pharmacological alternatives, as well as details for a transition to person-centred care was provided. Psychotropic drug use was recorded using a dynamic cohort study design with cross-sectional observations (November 2016-November 2017). RESULTS: At baseline, participants' (n = 677) mean age was 85.6 years (range 54-109 years), with 72.6% female. Mean medication intake was 8.5 (range 1-22), predominantly central nervous system drugs (Anatomic Therapeutic Chemical classification N, 88.8%). Long-term (> 3 months) psychotropic drug use (62.0%) and concomitant psychotropic drug use (31.5% taking two or more medications) were high. After 12 months, the prevalence of long-term psychotropic drug use decreased significantly (from 62.0 to 52.9%, p < 0.001), likewise the combined use of psychotropic drugs (from 31.5 to 24.0%, p = 0.001). The decrease in the prevalence of antidepressant and hypnosedative use was significant (respectively, from 32.2 to 23.4%, p < 0.001, and from 35.3 to 28.7%, p = 0.006) in contrast to antipsychotic use (from 17.1 to 15.9%, p = 0.522). CONCLUSIONS: The stand-alone adaptation of the previously reported initiative using a general template was possible. This intervention resulted in a significant decrease in psychotropic drug use (predominantly hypnosedatives and antidepressants) among nursing home residents after 12 months.

Cancer events in Belgian nursing home residents: An EORTC prospective cohort study.

OBJECTIVES: This prospective multicenter cohort study aimed to describe new cancer events in nursing home residents (NHR). MATERIALS AND METHODS: The study was performed in 39 nursing homes from the Armonea network in Belgium, covering 4262 nursing home beds. All NHR in these homes were prospectively followed during 1 year for occurrence of cancer events (diagnosis or clinical suspicion of a new cancer or progression of a known cancer). After training, each site's local staff identified NHR with cancer events in collaboration with the treating general practitioner (GP). NHR with cancer events were included after informed consent, and data about general health and cancer status were collected every 3 months up to 2 years. RESULTS: In only nine NHR (median age 87 years, range 72-92), a cancer event was recorded during follow-up including five new (suspected or diagnosed) cancer events (incidence rate = 123/100.000 NHR per year) and four NHR with (suspected or diagnosed) progressive disease. In four NHR with suspected cancer, no diagnostic procedure was performed, and in five no anticancer treatment was started. CONCLUSION: Clinically relevant cancer events (potentially requiring diagnostic or therapeutic action) occur at a much lower frequency in NHR than expected from cancer incidence data in the general older population. Although some underreporting of cancer events cannot be excluded, this prospective study supports several previous retrospective observations that cancer events are rare in very frail older persons. Moreover, diagnostic and therapeutic actions for (suspected) cancer events are often not undertaken in this population.

Balancing medication use in nursing home residents with life-limiting disease.

PURPOSE: Balancing medications that are needed and beneficial and avoiding medications that may be harmful is important to prevent drug-related problems, and improve quality of life. The aim of this study is to describe medication use, the prevalence of deprescribing of medications suitable for deprescribing, and the prevalence of new initiation of potentially inappropriate medications (PIMs) in nursing home (NH) residents with life-limiting disease in Flanders. METHODS: NH residents aged ≥ 65, suffering from end stage organ failure, advanced cancer, and/or dementia (n = 296), were included in this cross-sectional study with retrospective analyses of medication use at the time of data collection (t2) and 3 to 6 months before (t1). The appraisal of appropriateness of medications was done using a list of medications documented as suitable for deprescribing, and STOPPFrail criteria. RESULTS: Residents' (mean age 86 years, 74% female) mean number of chronic medications increased from 7.4 (t1) to 7.9 (t2). In 31% of those using medications suitable for deprescribing, at least one medication was actually deprescribed. In 30% at least one PIM from the group of selected PIMs was newly initiated. In the subgroup (n = 76) for whom deprescribing was observed, deprescribing was associated with less new initiations of PIMs (r = - 0.234, p = 0.042). CONCLUSION: Medication use remained high at the end of life for NH residents with life-limiting disease, and deprescribing was limited. However, in the subgroup of 76 residents for whom deprescribing was observed, less new PIMs were initiated.

Discontinuation of medications at the end of life: A population study in Belgium, based on linked administrative databases.

AIMS: The aim of this study was to examine the use of potentially inappropriate medication (PIM) in relation to time before death, to explore whether PIMs are discontinued at the end of life, and the factors associated with this discontinuation. METHODS: We conducted a retrospective register-based mortality cohort study of all deceased in 2012 in Belgium, aged at least 75 years at time of death (n = 74 368), using linked administrative databases. We used STOPPFrail to identify PIMs received during the period from 12 to 6 months before death (P1) and the last 4 months (P2) of life. RESULTS: Median age was 86 (IQR 81-90) at time of death, 57% were female, 38% were living in a nursing home, and 16% were admitted to hospital between 2 years and 4 months before death. Overall, PIM use was high, and increased towards death for all PIMs. At least one PIM was discontinued during P2 for one in five (20%) of the population, and 49% had no discontinuation. Being hospitalized in the period before the last 4 months of life, living in a nursing home, female gender and a higher number of medications used during P1 were associated with discontinuation of PIMs (respective aOR [95% CI]: 2.89 [2.73-3.06], 1.29 [1.23-1.36], 1.26 [1.20-1.32], 1.17 [1.16-1.17]). CONCLUSION: Initial PIM use was high and increased towards death. Discontinuation was observed in only one in five PIM users. More guidance for discontinuation of PIMs is needed: practical, evidence-based deprescribing guidelines and implementation plans, training for prescribers and a better consensus on what inappropriate medication is.

Associations of potentially inappropriate medication use with four year survival of an inception cohort of nursing home residents.

BACKGROUND: Survival in older adults has a high variability. The possible association of length of survival with potentially inappropriate medication (PIM) use remains unclear. AIM: To examine the four-year survival rate, the prevalence of polypharmacy and PIM use at admission, and the association between the two, in an inception cohort of newly admitted nursing home residents METHODS: Data were used from ageing@NH, a prospective observational cohort study in nursing homes. Residents (n = 613) were followed for four years after admission or until death. PIM use was measured at admission, using STOPPFrail. The Kaplan-Meier method was used to estimate survival, using log-rank tests for subgroup analyses. Cox regression analyses was used to explore associations with PIM use and polypharmacy, corrected for covariates RESULTS: Mean age was 84, 65% were females. After one, two, three and four years the survival rates were respectively 79%, 60.5%, 47% and 36%. At admission, 47% had polypharmacy and 40% excessive polypharmacy, 11% did not use any PIMs, and respectively 28%, 29%, and 32% used one, two and three or more PIMs. No difference in survival was found between polypharmacy and no polypharmacy, and PIM use and no PIM use at admission. Neither polypharmacy nor PIM use at admission were associated with mortality. CONCLUSION: Residents survived a relatively short time after NH admission. Polypharmacy and PIM use at admission were relatively high in this cohort, although neither was associated with mortality.

Electronic assessment of cardiovascular potentially inappropriate medications in an administrative population database.

AIM: To explore the feasibility of the electronic assessment of potentially inappropriate medication (PIM) criteria in a large administrative database and to explore the validity of the cardiovascular subset of PIM criteria, by studying the association with relevant outcome. METHOD: A cohort study using administrative data from Stockholm County, Sweden (VAL database). Eligible for inclusion were community-dwelling older people (≥65 years), alive in Stockholm County on 31 December 2015. We applied PIM criteria pertaining to the cardiovascular medication group (first-level ATC C group), and we assessed the association between PIM use and mortality and hospitalisation. RESULTS: Patients' (n = 315 120) mean age was 74.0 years (range 65-114), and 54.7% were women. There were 111 cardiovascular PIM criteria in the repository, from which 44 were not registered or prescribed in our population. We excluded another 43 requiring information not available in the database, or duplicates, resulting in 24 applicable criteria. The prevalence of polypharmacy (≥ five medications) was 25.5% and the prevalence of at least one PIM use was 8.3%, including 2.8% underuse and 5.3% misuse. Patients with intake of ≥10 medications had 38% increased mortality risk compared to those with 0-4 medications. Unplanned hospitalisation and emergency department visits were positively associated with underuse (12% and 25%, respectively) and misuse (13% and 12%, respectively). CONCLUSION: It was feasible to select a subset of cardiovascular PIM criteria originating from different PIM lists and to apply this subset in an administrative database. Additionally, by applying this subset, we showed significant associations with clinical outcome.

Barriers and enablers to deprescribing in people with a life-limiting disease: A systematic review.

BACKGROUND:: Knowing the barriers/enablers to deprescribing in people with a life-limiting disease is crucial for the development of successful deprescribing interventions. These barriers/enablers have been studied, but the available evidence has not been summarized in a systematic review. AIM:: To identify the barriers/enablers to deprescribing of medications in people with a life-limiting disease. DESIGN:: Systematic review, registered in PROSPERO (CRD42017073693). DATA SOURCES:: A systematic search of MEDLINE, Embase, Web of Science and CENTRAL was conducted and extended with a hand search. Peer-reviewed, primary studies reporting on barriers/enablers to deprescribing in the context of explicit life-limiting disease were included in this review. RESULTS:: A total of 1026 references were checked. Five studies met the criteria and were included in this review. Three types of barriers/enablers were found: organizational, professional and patient (family)-related barriers/enablers. The most prominent enablers were organizational support (e.g. for standardized medication review), involvement of multidisciplinary teams in medication review and the perception of the importance of coming to a joint decision regarding deprescribing, which highlighted the need for interdisciplinary collaboration and involving the patient and his family in the decision-making process. The most important barriers were shortages in staff and the perceived difficulty or resistance of the nursing home resident's family - or the resident himself. CONCLUSION AND IMPLICATIONS OF KEY FINDINGS:: The scarcity of findings in the literature highlights the importance of filling this gap. Further research should focus on deepening the knowledge on these barriers/enablers in order to develop sustainable multifaceted deprescribing interventions in palliative care.

Initiation of advance care planning in newly admitted nursing home residents in Flanders, Belgium: A prospective cohort study.

AIM: To describe (i) the timing of initiation of advance care planning (ACP) after nursing home admission; (ii) the association of dementia and physical health with ACP initiation; and (iii) if and how analgesic use and use of lipid modifying agents is related to ACP, in a cohort of newly admitted residents. METHODS: A prospective, observational cohort study of nursing home residents was carried out. Data were collected 3 months, 15 months (year 1) and 27 months (year 2) after admission, using a structured questionnaire and validated measuring tools. RESULTS: ACP was never initiated during the 2-year stay for 38% of the residents, for 22% ACP was initiated at admission, for 21% during year 1 and for 19% during year 2 (n = 323). ACP initiation was strongly associated with dementia, but not with physical health. Residents without dementia were more likely to have ACP initiation at admission or not at all, whereas ACP initiation was postponed for residents with dementia. Between admission and year 2, analgesic use increased (from 34% to 42%), and the use of lipid-modifying agents decreased (from 28% to 21%). Analgesic use increased more in residents with ACP initiation during year 1 and year 2. The use of lipid-modifying agents was not associated with ACP. CONCLUSIONS: The timing of ACP initiation differed significantly for residents with and without dementia, which highlights the importance of an early onset of ACP before residents lose their decision-making capacity. ACP conversations might create opportunities to discuss adequate pain and other symptom treatment, and deprescribing at the end of life. Geriatr Gerontol Int 2019; 19: 141-146.