Data sources for drug utilization research in Latin American countries—A cross‐national study: <scp>DASDUR‐LATAM</scp> study

Lopes, Luciane Cruz; Salas, Maribel; Osório-de-Castro, Claudia Garcia Serpa; Leal, Lisiane Freitas; Doubova, Svetlana Vladislavovna; Cañás, Martín; Dreser, Anahí; Acosta, Ángela; Baldoni, André Oliveira; Bergamaschi, Cristiane Cássia; Mota, Daniel Marques; Gómez-Galicia, Diana Lizbeth; Sepúlveda‐Viveros, Dino; Delgado, Edgard Narvaez; Lima, Elisângela da Costa; Vera, Felipe Daniel; Ferré, Felipe; Marín, Gustavo Horacio; Olmos, Ismael; Zimmermann, Ivan Ricardo; Fulone, Izabela; Roldán-Saelzer, Juan; Sánchez-Salgado, Juan Carlos; Castro‐Pastrana, Lucila I.; Souza, Luiz Júpiter Carneiro de; Beltrán, Manuel Machado; Silva, Marcus Tolentino; Mena, María Belén; Fonteles, Marta Maria de França; Urtasun, Martín; Tarapués, Mónica; Hernández, Mario; Medero, Natalia; Comoglio, Raquel Herrera; Barberato‐Filho, Silvio; Galvão, Taís Freire; Luiza, Vera Lúcia; Santa‐Ana‐Téllez, Yared; Rodríguez-Tanta, Yesenia; Elseviers, Monique

doi:10.1002/pds.5404

Cited by 6 publications

(6 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The methods were based on the DASDUR-LATAM Study which was sponsored by ISPE ( Lopes et al, 2022 ). DASDUR-LATAM is a cross-sectional comparison study that aimed to compile an inventory of available national drug data sources from nine countries.…”

Section: Methodsmentioning

confidence: 99%

“…Indeed, a study that compiled information on drug data sources in Latin American (LA) found 124 potential data sources for DUR from nine countries, being Brazil and Argentine the countries with the major number of data sources. Unfortunately, accessibility to those databases is limited and only aggregate-level data was available, given this situation, the DUR implementation is scarce in LA ( Lopes et al, 2022 ).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

et al. 2023

Self Cite

View full text Add to dashboard Cite

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.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2023

Self Cite

View full text Add to dashboard Cite

show abstract

“…This project was derived from the “Publicly Available Data Sources for Drug Utilization Research in Latin American (LatAm) Countries—DASDURLATAM study,” which is an initiative supported by the International Society for Pharmacoepidemiology (ISPE) to make an inventory for all LatAm countries ( Lopes et al, 2021 ).…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2022

Self Cite

View full text Add to dashboard Cite

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.

show abstract

“…These issues are intensified in the context of Argentina, Brazil, and Colombia, three populous countries in South America, where there are deep endemic inequalities, technological and import dependence on biopharmaceutical products and active pharmaceutical ingredients, and other obstacles such as pricing and government budgets ( Vargas et al, 2022 ). To date, little quantitative evidence has been reported related to the transparency of the pharmaceutical market and policies in South America ( Lopes et al, 2022 ). Moreover, transparency levels have not been determined.…”

Section: Introductionmentioning

confidence: 99%

“…Latin American countries experience shortages and failures, including a “lack of linked data and cross-validated secondary data” ( Leal et al, 2022 ) and “transparent, feasible, affordable, and protocol-driven data” ( Lopes et al, 2022 ) on data sources related to quality, safety, purchases, medication use, and treatment adherence ( Acosta et al, 2018 ; Lopes et al, 2022 ; Leal et al, 2022 ). This context may worsen due to the imminent recession and drastic increases in unemployment, poverty, and despondency.…”

Section: Introductionmentioning

confidence: 99%

Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia

et al. 2023

Self Cite

View full text Add to dashboard Cite

Introduction: The transparency of data on the value chain of medicines is crucial for the study and monitoring of the pharmaceutical system. These data may impact medicine pricing negotiations, contribute to patient access to pharmaceutical products, and strengthen health systems.Objective: This study analyzed the national strategies to ensure the transparency of data from medicine cost development to marketing in Argentina, Brazil, and Colombia.Method: A descriptive study was carried out by searching databases, reports, documents, and scientific articles published between January and August 2022 related to rules on transparency and databases, including 1) marketing authorization; 2) pricing; 3) intellectual property; 4) clinical trials; 5) research and development (R&D); and 6) health technology assessment (HTA) of selected biopharmaceuticals.Results: Transparency data, rules, and information are not uniform. The infostructures (organizational capacity for collecting and distributing information) regarding the pharmaceutical value chain in these three countries face limitations in appropriate measures to publicly share data and evidence, including pre-clinical data, clinical data, and costs. None of the countries require transparency about data on research and development costs. All three countries present similar publicization of data on marketing authorization and intellectual property, with some differences. The significant limitations in Argentina include the absence of formal price regulation and data on the volume of medicine purchased and respective amounts paid. Among the three countries, Brazil showed a higher degree of information transparency, perhaps due to the legal regulation that guarantees citizens access to information of public interest. Brazil also stands out in terms of the public availability of HTA reports and pricing, in addition to the highest volume of information. In contrast, Colombia has in place a decree that allows 5 years of trial data exclusivity for new medicines, an act contrary to data transparency. Despite the different stages of transparency, no country has evidenced a robust use of these data in public policy decision-making.Conclusion: The results reinforce the presence of information asymmetry between stakeholders, data fragmentation, data gaps and overlap, and difficulty in comparing available data across the three countries and the use of these data nationally to produce evidence.

show abstract

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

Cited by 6 publications

References 23 publications

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

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

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

Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia

Contact Info

Product

Resources

About