ABSTRACT

The study aimed to analyze the quality of the database regarding antimicrobials from the Brazilian National Controlled Products Management System (SNGPC) available in the public domain and propose improvements. This was an exploratory and descriptive study of antimicrobial sales records from Brazilian private pharmacies, conducted from June 2017 to 2020. Three quality dimensions were considered: completeness, methodological clarity, and validity. Data was analyzed using descriptive statistics. Although the database offers valuable information on antimicrobial consumption, it also poses several challenges that hinder or complicate the analysis. The main obstacles found were: a lack of standardization of the name and description of antimicrobials, the presence of different information in the presentation description field, and the absence of anonymized individualized data. The SNGPC is a key data source on antimicrobial consumption in Brazil, as private pharmacies and drugstores are the population’s primary sources of access to these medications. However, the SNGPC requires improvements to facilitate its use by researchers, policymakers, and healthcare professionals. These improvements would enable more comprehensive studies and support the systematic monitoring of antimicrobial consumption, contributing to strategies to tackle antimicrobial resistance (AMR).

KEYWORDS
Health Information Systems; Database; Public health surveillance; Drug utilization; Antiinfective agents

Introduction

Health Information Systems (HIS) are important sources of secondary data that can portray the health situation of a population, and aspects involving the functioning of the health system. This requires valid and reliable databases that can guide and support decision-making and the planning of health actions based on evidence¹1 Rede Interagencial de Informações para a Saúde. Indicadores básicos para a saúde no Brasil: conceitos e aplicações. 2. ed. Brasília, DF: Organização Pan-Americana da Saúde, Escritório Regional para as Américas da Organização Mundial da Saúde; 2008. 349 p..

Following the creation of the Unified Health System (SUS) and the decentralization of health services to local levels, the demand for information to support SUS managers increased. In this context, the SUS Information Technology Department (DATASUS) and the Interagency Health Information Network (RIPSA) were established to improve the quality of HIS in Brazil.

Brazil has a vast nationwide HIS network that continuously generates a great volume of data, most of which is accessible online. This broad availability of HIS makes it easier for managers, health professionals, and researchers to access data, which can be used to support their practices, while also enabling civil society empowerment for social participation²2 Correia LOS, Padilha BM, Vasconcelos SML. Métodos para avaliar a completitude dos dados dos sistemas de informação em saúde do Brasil: uma revisão sistemática. Ciênc saúde coletiva. 2014;19(11):4467-78. DOI: https://doi.org/10.1590/1413-812320141911.02822013.
https://doi.org/10.1590/1413-81232014191... ,³3 Lima CRA, Schramm JMA, Coeli CM, et al. Revisão das dimensões de qualidade dos dados e métodos aplicados na avaliação dos sistemas de informação em saúde. Cad Saúde Pública. 2009;25(10):2095-109. DOI: https://doi.org/10.1590/S0102-311X2009001000002.
https://doi.org/10.1590/S0102-311X200900... .

Despite the progress that has been made, there is still fragmentation among existing systems, which leads to the underutilization of the available data for decision-making. The main users of SIS, therefore, are researchers. While the role of academia in producing scientific knowledge in the health field is crucial, it should be emphasized that the main purpose of HIS is to generate the necessary and timely information to support the management of healthcare services⁴4 Ministério da Saúde (BR). A experiência brasileira em sistemas de informação em saúde. Brasília, DF: MS; 2009. 148 p. (Série B. Textos Básicos em Saúde)..

Quality is essential if HIS is to be fully utilized and provide truly useful information for solving public health problems. Therefore, understanding the strengths and limitations of the data made available through systematic evaluations is fundamental if HIS is to be continually improved¹1 Rede Interagencial de Informações para a Saúde. Indicadores básicos para a saúde no Brasil: conceitos e aplicações. 2. ed. Brasília, DF: Organização Pan-Americana da Saúde, Escritório Regional para as Américas da Organização Mundial da Saúde; 2008. 349 p.,³3 Lima CRA, Schramm JMA, Coeli CM, et al. Revisão das dimensões de qualidade dos dados e métodos aplicados na avaliação dos sistemas de informação em saúde. Cad Saúde Pública. 2009;25(10):2095-109. DOI: https://doi.org/10.1590/S0102-311X2009001000002.
https://doi.org/10.1590/S0102-311X200900... .

One of the most important public health concerns in the world today is the growing risk of deaths associated with antimicrobial resistance (AMR). AMR is a complex and multifactorial problem associated with the use of antimicrobials in humans and animals, as well as their presence in the environment⁵5 World Health Organization. Global Action Plan on Antimicrobial Resistance. Geneva: WHO; 2015. 28 p..

Although AMR is expected and occurs naturally from the exposure of microorganisms to antimicrobial drugs, their indiscriminate use has led to an accelerated advance of AMR, placing it in the ranking of the top 10 threats to global public health, according to the World Health Organization (WHO)⁶6 World Health Organization [Internet]. Geneva: WHO; 2021. Antimicrobial Resistance, 2023 nov 21 [acesso em 2022 out 25]. Disponível em: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-re-sistance.
https://www.who.int/news-room/fact-sheet... . Considering the pillar of antimicrobial use in humans, the consumption pattern of these drugs by outpatients represents an important area for analysis and intervention, since the vast majority of antimicrobial prescriptions are aimed at this public, with a significant portion deemed inappropriate⁷7 Centers for Disease Control and Prevention. Antibiotic use in the United States, 2017: progress and opportunities. Atlanta: CDC; 2017. 40 p.,⁸8 Smieszek T, Pouwels KB, Dolk FCK, et al. Potential for reducing inappropriate antibiotic prescribing in English primary care. J Antimicrob Chemother. 2018;73(supl2):ii36-43. DOI: https://doi.org/10.1093/jac/dkx500.
https://doi.org/10.1093/jac/dkx500.... ,⁹9 Smith DRM, Dolk FCK, Pouwels KB, et al. Defining the appropriateness and inappropriateness of antibiotic prescribing in primary care. J Antimicrob Chemother. 2018;73(supl2):ii11-8. DOI: https://doi.org/10.1093/jac/dkx503
https://doi.org/10.1093/jac/dkx503... ,¹⁰10 Pan American Health Organization; Florida International University. Recommendations for implementing antimicrobial stewardship programs in latin america and the caribbean: manual for public health decision-makers. Washington, D.C.: PAHO; 2018. 144 p..

In Brazil, the population predominantly accesses antimicrobials through private pharmacies and drugstores, through direct disbursement¹¹11 Ministério da Saúde (BR), Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Componente populacional: resultados. Brasília, DF: Ministério da Saúde; 2016. 52 p. (Série Pnaum – Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil).. Until 2021, those establishments were obliged to submit monthly antimicrobial sales data to the National Health Surveillance Agency (ANVISA) via the National System of Controlled Products Management (SNGPC)¹²12 Agência Nacional de Vigilância Sanitária (BR). Dados abertos. Venda de medicamentos industrializados sujeitos à escrituração no SNGPC. documentação e dicionário de dados [Internet]. Brasília, DF: ANVISA; 2020 [acesso em 2022 jun 26]. Disponível em: https://dados.anvisa.gov.br/dados/
https://dados.anvisa.gov.br/dados/... . This makes the SNGPC an important data source for monitoring outpatient antimicrobial consumption in the country.

The SNGPC has been recently the subject of scientific literature¹³13 Ferreira TDJN, Morais JHDA, Caetano R, et al. Tratamento de dados do Sistema Nacional de Gerenciamento de Produtos Controlados para estudos de utilização de medicamentos com antimicrobianos. Cad Saúde Pública. 2023;39(5):e00173922. DOI: https://doi.org/10.1590/0102-311XPT173922
https://doi.org/10.1590/0102-311XPT17392... ; however, it is relevant to consider this database through quality dimensions focused on the managerial use of such data. As highlighted by Feliciano et al.¹⁴14 Feliciano M, Damázio SL, Medeiros KR, et al. Avaliação da cobertura e completitude de variáveis de Sistemas de Informação sobre orçamentos públicos em saúde. Saúde debate. 2019;43(121):341-53. DOI: https://doi.org/10.1590/0103-1104201912104
https://doi.org/10.1590/0103-11042019121... , Health Information Systems (HIS) play a crucial role in decision-making processes, where ensuring data quality is fundamental. Furthermore, since the National Action Plan for the Prevention and Control of Antimicrobial Resistance within the One Health framework (PAN-BR) expired in 2022 and the updated plan had not yet been published as of the closing date of this text, we believe that this discussion is highly opportune.

As such, this study aimed to describe aspects of the quality of SNGPC data available in open access, focusing on antimicrobials. It is an extension of a broader study, conducted in 2021, which analyzed outpatient consumption of antimicrobials in Brazil’s private sector and identified several issues in the use of the SNGPC.

To improve the effective use of this database for both regulation and research, it is necessary to identify its obstacles. Thus, this study also set out to identify the main challenges in using the SNGPC and as opportunities for improvement to support managers in constantly refining this important national database on medication consumption.

Material and methods

An exploratory and descriptive study was carried out on the quality of SNGPC data from June 2017 to 2020, focusing on antimicrobials, considering three dimensions of quality: completeness, methodological clarity, and validity. These dimensions were selected because they are part of the list of quality dimensions of a Health Information System (HIS) described by Lima et al.³3 Lima CRA, Schramm JMA, Coeli CM, et al. Revisão das dimensões de qualidade dos dados e métodos aplicados na avaliação dos sistemas de informação em saúde. Cad Saúde Pública. 2009;25(10):2095-109. DOI: https://doi.org/10.1590/S0102-311X2009001000002.
https://doi.org/10.1590/S0102-311X200900... The completeness and validity dimensions are among the most addressed in HIS evaluation studies, along with the coverage and reliability, although variations occur depending on the HIS being evaluated¹⁵15 Carvalho SC, Mota E. A qualidade dos dados dos sistemas de informação em saúde aplicados em atenção à saúde materno-infantil [tese na Internet]. Salvador: Universidade Federal da Bahia; 2016 [acesso em 2023 dez 20]. Disponível em: https://repositorio.ufba.br/bitstream/ri/21636/1/Tese%20Suzana%20Costa%20Carvalho.%202016.pdf.
https://repositorio.ufba.br/bitstream/ri... , based on the information made available by ANVISA on the Brazilian Open Data Portal (PBDA)¹⁶16 Governo Federal (BR) [Internet]. Brasília, DF: Gov. BR; [Sem data]. Portal Brasileiro de Dados Abertos. 2023 [acesso em 2023 mar 12]. Disponível em: https://dados.gov.br/home
https://dados.gov.br/home... . As for the period covered, the last full year of data availability from the database was used.

SNGPC data is available in files for download on the PBDA website. The files are organized in such a way that each one refers to a month of sales of industrialized medicines subject to record-keeping in private pharmacies and drugstores. On the web portal, you can find records of sales made from January 2014 to November 2021. After that date, there was a temporary suspension on the use of the SNGPC as a way of recording transactions of drugs under special control¹⁷17 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC No 586, de 17 de dezembro de 2021. Dispõe sobre a suspensão temporária, por tempo indeterminado, dos prazos previstos nos §3º e §4º do art. 10 da Resolução de Diretoria Colegiada - RDC nº 22, de 29 de abril de 2014, que estabelece a utilização do Sistema Nacional de Gerenciamento de Produtos Controlados - SNGPC, por farmácias e drogarias, como um sistema de informação de vigilância sanitária para a escrituração de dados de produção, manipulação, distribuição, prescrição, dispensação e consumo de medicamentos e insumos farmacêuticos. Diário Oficial da União, Brasília, DF. 2021 dez 17; Seção I:2..

The completeness dimension is understood as the degree to which a variable is filled out in the database, i.e. the proportion of non-null records for a given variable. Methodological clarity refers to the extent to which the instructions for using and filling out the HIS describe the necessary data in a clear and accessible way. Finally, the validity dimension deals with the degree to which the data is capable of measuring what it is intended to measure, i.e. it refers to the internal validity of the data within the variable itself³3 Lima CRA, Schramm JMA, Coeli CM, et al. Revisão das dimensões de qualidade dos dados e métodos aplicados na avaliação dos sistemas de informação em saúde. Cad Saúde Pública. 2009;25(10):2095-109. DOI: https://doi.org/10.1590/S0102-311X2009001000002.
https://doi.org/10.1590/S0102-311X200900... .

A series of steps were taken to process the data before analysis. Initially, the medicines were classified as: antimicrobials; controlled; and not applicable to the SNGPC. The latter refers to medication mistakenly included in the system, as they are not part of the medication list under special control by ANVISA.

Next, only the antimicrobials were filtered, which were classified into systemic use of antimicrobials (ATC group J01) and topical use of them (not J01). The data selected for the quality study were only those relating to sales of systemic-use antimicrobials.

Descriptive statistics were used to analyze the data quality, which allowed for the definition of exclusion criteria for the study titled ‘Antimicrobial consumption in Brazilian private pharmacies and drugstores in the light of the PAN-BR and the COVID-19 pandemic’. The objective was to analyze the antimicrobial consumption in the private pharmacy network in Brazil, from 2017 to 2020¹⁸18 Caetano MC, Campos MR, Emmerick ICM, et al. Consumo de antimicrobianos nas farmácias e drogarias privadas brasileiras à luz do PAN-BR e da pandemia de COVID-19. BJDV. 2022;8(1):645-69. DOI: https://doi.org/10.34117/bjdv8n1-043
https://doi.org/10.34117/bjdv8n1-043... . In addition, the analysis of data quality enabled the identification of cut-off points for case exclusions to reduce information bias due to loss of internal validity.

THE SNGPC

The National System of Controlled Products Management (SNGPC) was developed and implemented in 2007 by ANVISA, to electronically manage and monitor the movement of medications subject to compulsory recordkeeping in private pharmacies and drugstores in Brazil¹⁹19 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC no 44, de 26 de outubro de 2010. Dispõe sobre o controle de medicamentos à base de substâncias classificadas como antimicrobianos, de uso sob prescrição médica, isoladas ou em associação e dá outras providências. Diário Oficial da União, Brasília, DF. 2010 out 26; Seção I:78-79.,²⁰20 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC no 22, de 29 de abril de 2014. Dispõe sobre o Sistema Nacional de Gerenciamento de Produtos Controlados – SNGPC, revoga a Resolução de Diretoria Colegiada nº 27, de 30 de março de 2007, e dá outras providências. Diário Oficial da União, Brasília, DF. 2014 abr 29; Seção I:76.. The submission of data was the responsibility of the pharmacist in charge or their legal substitute¹²12 Agência Nacional de Vigilância Sanitária (BR). Dados abertos. Venda de medicamentos industrializados sujeitos à escrituração no SNGPC. documentação e dicionário de dados [Internet]. Brasília, DF: ANVISA; 2020 [acesso em 2022 jun 26]. Disponível em: https://dados.anvisa.gov.br/dados/
https://dados.anvisa.gov.br/dados/... .

The SNGPC gradually replaced physical record-keeping with electronic record-keeping, allowing data to be transmitted directly to ANVISA, making this process more efficient and secure for pharmacies¹²12 Agência Nacional de Vigilância Sanitária (BR). Dados abertos. Venda de medicamentos industrializados sujeitos à escrituração no SNGPC. documentação e dicionário de dados [Internet]. Brasília, DF: ANVISA; 2020 [acesso em 2022 jun 26]. Disponível em: https://dados.anvisa.gov.br/dados/
https://dados.anvisa.gov.br/dados/... . Among the list of drugs subject to SNGPC recording are: psychotropic drugs, narcotics, and other products regulated in the same ordinance²¹21 Agência Nacional de Vigilância Sanitária (BR). Portaria No 344, de 12 de maio de 1998. Aprova o Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial. Diário Oficial da União, Brasília, DF. 1998 maio 12; Seção I:3-43.; antimicrobial, included in 2013²²22 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC no 20, de 5 de maio de 2011. Dispõe sobre o controle de medicamentos à base de substâncias classificadas como antimicrobianos, de uso sob prescrição, isoladas ou em associação. Diário Oficial da União, Brasília, DF. 2011 maio 5; Seção I:39-41.; and drugs containing chloroquine, hydroxychloroquine, nitazoxanide, and ivermectin, included in 2020, after the onset of the COVID-19 pandemic²³23 Ministério da Saúde (BR). Resolução RDC no 405, de 22 de julho de 2020. Estabelece as medidas de controle para os medicamentos que contenham substâncias constantes do Anexo I desta Resolução, isoladas ou em associação, em virtude da Emergência de Saúde Pública de Importância Internacional (ESPII) relacionada ao novo Coronavírus (SARS-CoV-2). Diário Oficial da União, Brasília, DF. 2020 jul 22; Seção I:91.,²⁴24 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC No 351, de 20 de março de 2020. Dispõe sobre a atualização do Anexo I (Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial) da Portaria SVS/MS nº 344, de 12 de maio de 1998, e dá outras providências. Diário Oficial da União, Brasília, DF. 2020 mar 20; Seção I:117.. The latter two were excluded from the list of controlled substances in September 2020²³23 Ministério da Saúde (BR). Resolução RDC no 405, de 22 de julho de 2020. Estabelece as medidas de controle para os medicamentos que contenham substâncias constantes do Anexo I desta Resolução, isoladas ou em associação, em virtude da Emergência de Saúde Pública de Importância Internacional (ESPII) relacionada ao novo Coronavírus (SARS-CoV-2). Diário Oficial da União, Brasília, DF. 2020 jul 22; Seção I:91..

The SNGPC enables the identification of patterns and deviations in the prescription and consumption of medications as well as potential health risks to the population²⁵25 Agência Nacional de Vigilância Sanitária (BR). Relatório de Atividades 2016. Brasília, DF: ANVISA; 2017. 200 p.,²⁶26 Oliveira MG, Mota DM, Cunha TRP. Sistema Nacional de Gerenciamento de Produtos Controlados (SNGPC): inovando na qualidade do monitoramento e controle de medicamentos no Brasil. Brasília, DF: Red PARF; 2011.. This system has already been used to analyze the consumption and prescription of appetite suppressants²⁶26 Oliveira MG, Mota DM, Cunha TRP. Sistema Nacional de Gerenciamento de Produtos Controlados (SNGPC): inovando na qualidade do monitoramento e controle de medicamentos no Brasil. Brasília, DF: Red PARF; 2011.; identify deviations in the use of fluoxetine²⁷27 Agência Nacional de Vigilância Sanitária (BR). Relatório de Atividades 2009. Brasília, DF: ANVISA; 2010. 169 p.; and explore the consumption of benzodiazepines, including their relation with users’ sociodemographic and social characteristics²⁸28 Azevedo ÂJP, Araújo AA, Ferreira MÂF. Consumo de ansiolíticos benzodiazepínicos: uma correlação entre dados do SNGPC e indicadores sociodemográficos nas capitais brasileiras. Ciênc saúde coletiva. 2016;21(1):83-90. DOI: https://doi.org/10.1590/1413-81232015211.15532014
https://doi.org/10.1590/1413-81232015211... ,²⁹29 Zorzanelli RT, Giordani F, Guaraldo L, et al. Consumo do benzodiazepínico clonazepam (Rivotril®) no estado do Rio de Janeiro, Brasil, 2009-2013: estudo ecológico. Ciênc saúde coletiva. 2019;24(8):3129-40. DOI: https://doi.org/10.1590/1413-81232018248.23232017
https://doi.org/10.1590/1413-81232018248... .

Therefore, the information generated by the SNGPC has effectively supported health surveillance agencies in inspection and control actions. It has also provided data to assist managers in developing strategic policies to curb the abusive use of this group of medications, including antimicrobials²⁸28 Azevedo ÂJP, Araújo AA, Ferreira MÂF. Consumo de ansiolíticos benzodiazepínicos: uma correlação entre dados do SNGPC e indicadores sociodemográficos nas capitais brasileiras. Ciênc saúde coletiva. 2016;21(1):83-90. DOI: https://doi.org/10.1590/1413-81232015211.15532014
https://doi.org/10.1590/1413-81232015211... ,²⁹29 Zorzanelli RT, Giordani F, Guaraldo L, et al. Consumo do benzodiazepínico clonazepam (Rivotril®) no estado do Rio de Janeiro, Brasil, 2009-2013: estudo ecológico. Ciênc saúde coletiva. 2019;24(8):3129-40. DOI: https://doi.org/10.1590/1413-81232018248.23232017
https://doi.org/10.1590/1413-81232018248... .

The sale of antimicrobials in Brazil was regulated in 2010¹⁹19 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC no 44, de 26 de outubro de 2010. Dispõe sobre o controle de medicamentos à base de substâncias classificadas como antimicrobianos, de uso sob prescrição médica, isoladas ou em associação e dá outras providências. Diário Oficial da União, Brasília, DF. 2010 out 26; Seção I:78-79. and updated in 2011²²22 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC no 20, de 5 de maio de 2011. Dispõe sobre o controle de medicamentos à base de substâncias classificadas como antimicrobianos, de uso sob prescrição, isoladas ou em associação. Diário Oficial da União, Brasília, DF. 2011 maio 5; Seção I:39-41. and 2021²³23 Ministério da Saúde (BR). Resolução RDC no 405, de 22 de julho de 2020. Estabelece as medidas de controle para os medicamentos que contenham substâncias constantes do Anexo I desta Resolução, isoladas ou em associação, em virtude da Emergência de Saúde Pública de Importância Internacional (ESPII) relacionada ao novo Coronavírus (SARS-CoV-2). Diário Oficial da União, Brasília, DF. 2020 jul 22; Seção I:91., requiring the presentation and retention of a prescription at the time of purchase to prevent indiscriminate access to antimicrobials by the population, minimizing self-medication and the consequent risk of inducing antimicrobial resistance (AMR). The list of substances classified as antimicrobial subject to control is published in specific legislation²³23 Ministério da Saúde (BR). Resolução RDC no 405, de 22 de julho de 2020. Estabelece as medidas de controle para os medicamentos que contenham substâncias constantes do Anexo I desta Resolução, isoladas ou em associação, em virtude da Emergência de Saúde Pública de Importância Internacional (ESPII) relacionada ao novo Coronavírus (SARS-CoV-2). Diário Oficial da União, Brasília, DF. 2020 jul 22; Seção I:91..

In 2020, ANVISA provided open access to data on sales of industrialized medicines subject to record-keeping in the SNGPC, from 2014 onwards, in private pharmacies and drugstores throughout the country. This expands the possibilities for conducting studies in the field of drug use.

The SNGPC database includes the following variables (table 1): year of sale, month of sale, State of the sale, municipality where the sale was made, active ingredient of the antimicrobial sold, product presentation description, quantity of units sold, unit of measurement of the product, prescribing council of the professional who prescribed the antimicrobial, State of the prescribing professional’s council, type of prescription, ICD-10, sex and age of the patient and unit of age (months or years). It should be noted that the variables ICD-10, sex, age, and age unit are only applicable to antimicrobial sales.

Quality and challenges in using SNGPC data

The SNGPC provides several variables of interest to analyze antimicrobial consumption in Brazil. Its data allows for the generation of information on the profile and trends of antimicrobial use over time by the Brazilian population. It also enables to understanding of antimicrobial users’ characteristics, such as gender, age, and consumption patterns according to municipal size, regions of the country, and prescribing professionals (physician, dentist, and veterinarian).

Nevertheless, a set of problems related to filling out and systematizing the data in the SNGPC were identified, with some examples of inconsistencies found during the exploratory analysis shown in table 1.

Regarding the completeness dimension, it was observed that the field referring to the patient’s age was not filled out for around 2% of the analyzed sales (206,871 records). The ICD-10 field was not filled out in any of the antimicrobials sales records until June 2019 and was present in less than 1% of sales by June 2020. This incompleteness concerning ICD-10 is likely related to the absence of this information on the prescription presented by patients at the time of purchase.

As for the methodological clarity dimension, we observed that the codes for the variables ‘SEX’, ‘RECEIPT_TYPE’, and ‘AGE_UNIT’ were not described in the dictionary of SNGPC variables, which is available on the PBDA website. The lack of code descriptions for these variables makes it impossible to translate the meaning of the record in the database and therefore prevents these variables from being used in any kind of analysis.

In the case of the variable ‘AGE_UNIT’, it was possible to deduce which code corresponded to months and years units, based on the number of records and the corresponding values in the ‘AGE’ variable. Regarding the ‘SEX’ variable, it was only possible to identify its codes through direct contact with the ANVISA professional responsible for the system at the time.

The field relating to the unit of packaging sold (‘UNIT_MEASURE’), described as a box or bottle, showed inconsistencies in its entries. Sometimes oral solutions or suspensions were classified as boxes, while oral solids were determined as bottles in some records. In addition, topical formulations, such as dermatological creams, were also defined as boxes. Methodological clarity was thus compromised, making it impossible to use this variable. If better classified and filled out correctly, it could serve as a useful filter between liquid, solid, and topical antimicrobials.

The alternative for obtaining information on the unit of packaging sold was to use the ‘PRESENTATION_DESCRIPTION’ field. The use of this variable is complex and labor-intensive as it is an open-text field with no standardized format for data entry. The same is true of the ‘ACTIVE_INGREDIENT’ field, which represents the main challenge in analyzing SNGPC data, also related to the methodological clarity dimension.

Considering that the analyzed sample contained only systemic-use antimicrobials, 58 active ingredients were selected, for which 108 different descriptions were used. In other words, 46.2% of the names did not correspond to actual variations of active ingredients. Amoxicillin was chosen as an example to illustrate the challenge encountered. For this drug, four different forms of notation were identified: ‘amoxicillin’, ‘amoxicillin base’, ‘amoxicillin trihydrate’, and ‘amoxicillin trihydrate’. The antimicrobials with the highest number of variations in this variable were: amoxicillin/clavulanate (9), ciprofloxacin (6), amoxicillin (4), ampicillin/sulbactam (4), and ampicillin (4)).

In the presentation description field, the variability of description types was much more significant. Of the total of 1,370 presentations of systemic-use antimicrobials registered in the SNGPC, only 30% (411) corresponded to different products. This means that the number of variations identified in the database is incompatible with the variety of antimicrobial presentations available on the pharmaceutical market and sold by Brazilian pharmacies and drugstores.

Using amoxicillin as an example, sales were recorded for 39 different presentations of this antimicrobial, 24 of which corresponded to tablets or capsules, and 15 to oral suspensions. However, 227 different descriptions for amoxicillin were registered in the database, which means that 82.8% of the description type variations for this antimicrobial were unnecessary - 75.2% (97) for solid presentations and 88.5% (130) for oral suspensions. This indicates that standardizing the drug description would represent a significant improvement in the clarity of the variable and, consequently, of the database.

Regarding the validity dimension, three issues were identified. The first concerns the presence of records for medication sales that are not subject to record-keeping in the SNGPC (2%) (graph 1). These included corticosteroids, non-steroidal anti-inflammatory drugs, vitamins, antihypertensives, and muscle relaxants, among others. Although the percentage found was small, only 2%, this suggests a need for periodic training of the professionals involved in using the system or validations to prevent incorrect recording.

Another finding was the presence of records for patients over 120 years of age in 13,723 sales (0.11%), indicating data entry errors in these cases. This resulted in the exclusion of these records from the database used for research purposes, as they were inconsistent data.

The same occurred with sales records that contained quantities far exceeding the maximum expected for the treatment of infections for an individua. This suggests that these sales were made to healthcare facilities rather than to specific patients. Some presentations even contained the term ‘hospital packaging’ in the product description. It is noteworthy that the legislation does not mention the possibility of selling antimicrobials to healthcare facilities or other types of healthcare establishments by pharmacies and drugstores, nor does it specify the need for or method of recording such cases in the SNGPC²⁰20 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC no 22, de 29 de abril de 2014. Dispõe sobre o Sistema Nacional de Gerenciamento de Produtos Controlados – SNGPC, revoga a Resolução de Diretoria Colegiada nº 27, de 30 de março de 2007, e dá outras providências. Diário Oficial da União, Brasília, DF. 2014 abr 29; Seção I:76..

Finally, the SNGPC data available through open access is only presented in an aggregate form, which imposed limitations on conducting a more in-depth analysis of outpatient antimicrobial consumption in Brazil.

Opportunities to improve the SNGPC

Given the challenges encountered when using the SNGPC, as previously outlined, some improvement suggestions for improvements are proposed to enhance the speed and efficiency of using this database to produce information on the outpatient consumption of antimicrobials by the Brazilian population. It is important to stress the need to test any suggested changes before widespread implementation, including analyzing the operationality of the information recording procedures and the impact on user service times, considering the workflow of pharmacies and drugstores.

The first and most important suggestion for providing a faster and more accurate analysis of SNGPC data is to include a set of variables that make it possible to identify and standardize the different medications included in the database. This information could be linked to the product registry of pharmacies and drugstores.

Table 2 shows the variables suggested for inclusion in the SNGPC, based on the original variables ‘ACTIVE_INGREDIENT’ and ‘DESCRIPTION_PRESENTATION’, and provides some examples based on antimicrobial sales records in the database. It is suggested to include the variables: Brazilian Common Denomination (DCB), 5th level ATC classification, AWaRe classification, pharmaceutical form, route of administration, dose, dosage unit, and the total number of units in the package. Additionally, it is also recommended to include an identification code for each medication.

The DCB is the nomenclature system adopted in Brazil for standardizing the names of the active ingredients of medications³⁰30 Moretto LD, Mastelaro R. MDCB: Manual das denominações comuns brasileiras. São Paulo: SINDUSFARMA; 2013. 706 p. v. 16 (Manuais SINDUSFARMA)., avoiding duplication of equivalent items. The classifications of antimicrobials into groups – AWaRe and 5th level ATC – aim to facilitate the data analysis by strategic therapeutic groups from the point of view of managing the use of antimicrobial³¹31 World Health Organization. GLASS methodology for surveillance of national antimicrobial consumption [Internet]. Geneva: WHO; 2020 [acesso em 2022 out 8]. Disponível em: https://apps.who.int/iris/handle/10665/336215.
https://apps.who.int/iris/handle/10665/3... .

The other suggested variables refer to the stratification of the information set provided in the presentation description field (dose, pharmaceutical form, unit, and number of units per package). The fact that the description field contains multiple pieces of information about the product makes standardization difficult across the various pharmacies linked to the SNGPC.

It is suggested to break down this information into the following variables, as shown in table 2.

• Pharmaceutical form: tablet; capsule; oral solution or suspension; injectable solution or suspension, cream, ointment or gel; topical solution; ophthalmic solution or ointment; otologic solution; vaginal cream or ovule; capsule or inhalation powder or solution;

• Route of administration: PO (oral), IV (intravenous), IM (intramuscular), TD (transdermal);

• Dose (per dosage unit);

• Dosage unit: tablet, capsule, milliliter, milligram, gram;

• Total number of units (per package).

Creating these variables in the SNGPC would contribute to faster and more effective data analysis, especially for calculating the Defined Daily Dose (DDD), the primary method for measuring medication consumption. In addition, these fields would simplify the database’s use for analyzing the consumption data of controlled medications, encouraging the systematic use of this database by researchers and healthcare managers.

Table 3 encloses the description of all the systemic-use antimicrobials selected in this study, with their respective AWaRe and ATC classifications, which may help researchers or managers when using this data source.

The second proposed improvement is the provision of individualized and anonymized data from SNGPC medication sales records. This would allow an analysis of the number of antibiotic treatments administered to each individual over a given period. The number of times an individual is exposed to antibiotics at short intervals increases the risk of AMR³²32 Costelloe C, Metcalfe C, Lovering A, et al. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010;340:c2096. DOI: https://doi.org/10.1136/bmj.c2096
https://doi.org/10.1136/bmj.c2096... and is therefore also an important indicator of antimicrobial consumption.

The inclusion of a field to distinguish the origin of drug prescriptions – private sector or SUS (Unified Health System) – is another suggested proposal. This would allow for the analysis and comparison of the main sources of antimicrobial prescriptions, as well as the different prescribing patterns in the public and private sectors nationwide.

There is also a need to improve the SNGPC data dictionary by defining the codes for missing variables. Furthermore, this document could include suggestions for data cleaning resources.

The final suggestion for refining the SNGPC is to create a specific prescription model for antimicrobial prescriptions in Brazil, preferably in electronic format. This measure would allow for the definition of mandatory fields and the electronic recording of prescriptions, facilitating qualitative analysis of antimicrobial use in outpatient settings.

Discussion

The SNGPC is a valuable source of research on the outpatient consumption of antimicrobials in Brazil since private pharmacies and drugstores are the primary means for the population to access these drugs¹¹11 Ministério da Saúde (BR), Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Componente populacional: resultados. Brasília, DF: Ministério da Saúde; 2016. 52 p. (Série Pnaum – Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil).. However, this study identified a series of obstacles that hinder the use of this database to produce information on antimicrobial consumption.

The performance of a Health Information System is measured by the quality of its data and its use in decision-making³³33 MEASURE Evaluation. Strengthening health information systems in low- and middle- income countries: a model to frame what we know and what we need to learn [Internet]. Chapell Hill: MEASURE Evaluation; 2019 [acesso em 2023 dez 20]. Disponível em: https://www.measureevaluation.org/resources/publications/tr-17-156/at_download/document
https://www.measureevaluation.org/resour... . The quality of information sources depends primarily on the presence of reliable, valid, and properly compiled data³⁴34 Muzy J. Fontes de informações para indicadores em saúde. In: Marques A, Oliveira A, Romero D, et al. Informação e indicadores: conceitos, fontes e aplicações para a saúde do idoso e envelhecimento. Rio de Janeiro: Edições Livres; 2021. p. 23-41.. According to Carvalho and Mota¹⁵15 Carvalho SC, Mota E. A qualidade dos dados dos sistemas de informação em saúde aplicados em atenção à saúde materno-infantil [tese na Internet]. Salvador: Universidade Federal da Bahia; 2016 [acesso em 2023 dez 20]. Disponível em: https://repositorio.ufba.br/bitstream/ri/21636/1/Tese%20Suzana%20Costa%20Carvalho.%202016.pdf.
https://repositorio.ufba.br/bitstream/ri... , the factors determining the quality of HIS data can be related to technical, behavioral, and organizational aspects.

Technical factors are those associated with data collection tools and the available technological resources. Behavioral ones are related to the knowledge, skills, motivation, commitment, and confidence of the professionals who feed the database. Organizational factors refer to the management of information culture and healthcare service operations¹⁵15 Carvalho SC, Mota E. A qualidade dos dados dos sistemas de informação em saúde aplicados em atenção à saúde materno-infantil [tese na Internet]. Salvador: Universidade Federal da Bahia; 2016 [acesso em 2023 dez 20]. Disponível em: https://repositorio.ufba.br/bitstream/ri/21636/1/Tese%20Suzana%20Costa%20Carvalho.%202016.pdf.
https://repositorio.ufba.br/bitstream/ri... .

Considering all the obstacles faced in using SNGPC data, it can be said that the majority were related to technical factors, involving structural limitations of the system and incomplete information for its adequate use. Behavioral factors also compromised the quality of SNGPC data, as mistakes were made in the inclusion of various medications that are not under special control as well as the failure to fill out user characterization fields, such as gender and age in some of the records.

Gaps in knowledge and lack of motivation among professionals are some of the behavioral factors that can lead to data entry errors in the HIS¹⁵15 Carvalho SC, Mota E. A qualidade dos dados dos sistemas de informação em saúde aplicados em atenção à saúde materno-infantil [tese na Internet]. Salvador: Universidade Federal da Bahia; 2016 [acesso em 2023 dez 20]. Disponível em: https://repositorio.ufba.br/bitstream/ri/21636/1/Tese%20Suzana%20Costa%20Carvalho.%202016.pdf.
https://repositorio.ufba.br/bitstream/ri... . Periodic and systematic training for the professionals who manage SNGPC data is essential to ensure its proper use. It is also essential to raise their awareness of the epidemiological importance of accurate and timely data recording. Lemma et al.³⁵35 Lemma S, Janson A, Persson LÅ, et al. Improving quality and use of routine health information system data in low- and middle-income countries: a scoping review. PLoS One. 2020;15(10):e0239683. DOI: https://doi.org/10.1371/journal.pone.0239683
https://doi.org/10.1371/journal.pone.023... demonstrated that combined interventions targeting both technical and behavioral factors improved the quality and use of HIS data.

The quality of HIS data has improved globally³⁶36 Nisingizwe MP, Iyer HS, Gashayija M, et al. Toward utilization of data for program management and evaluation: quality assessment of five years of health management information system data in Rwanda. Glob Health Action. 2014;7:25829. DOI: https://doi.org/10.3402/gha.v7.25829
https://doi.org/10.3402/gha.v7.25829... ,³⁷37 Amoakoh-Coleman M, Kayode GA, Brown-Davies C, et al. Completeness and accuracy of data transfer of routine maternal health services data in the greater Accra region. BMC Res Notes. 2015;8:114. DOI: https://doi.org/10.1186/s13104-015-1058-3
https://doi.org/10.1186/s13104-015-1058-... , but low- and middle-income countries still face a range of issues such as incomplete records, inconsistent data, and low levels of accuracy³⁸38 Roomaney RA, Pillay-van Wyk V, Awotiwon OF, et al. Availability and quality of routine morbidity data: review of studies in South Africa. J Am Med Inform Assoc. 2017;24(e1):e194-206. DOI: https://doi.org/10.1093/jamia/ocw075
https://doi.org/10.1093/jamia/ocw075... ,³⁹39 Sharma A, Rana SK, Prinja S, et al. Quality of health management information system for maternal & child health care in Haryana State, India. PLoS One. 2016;11(2):e0148449. DOI: https://doi.org/10.1371/journal.pone.0148449
https://doi.org/10.1371/journal.pone.014... . Moreover, despite the growing availability of health information, its use in decision-making remains limited in many of these countries⁴⁰40 Lippeveld T. Routine health facility and community information systems: creating an information use culture. Glob Health Sci Pract. 2017;5(3):338-40. DOI: https://doi.org/10.9745/GHSP-D-17-00319
https://doi.org/10.9745/GHSP-D-17-00319... . Healthcare professionals report low use of data for planning purposes, often due to a lack of confidence in its quality⁴¹41 Dagnew E, Woreta SA, Shiferaw AM. Routine health information utilization and associated factors among health care professionals working at public health institution in North Gondar, Northwest Ethiopia. BMC Health Serv Res. 2018;18(685):1-8. DOI: https://doi.org/10.1186/s12913-018-3498-7
https://doi.org/10.1186/s12913-018-3498-... .

In the case of high-income countries, major investments have been made in the development of health information technologies. However, they also face challenges, especially in terms of interoperability between different systems⁴²42 Li E, Clarke J, Ashrafian H, et al. The impact of electronic health record interoperability on safety and quality of care in high-income countries: systematic review. J Med Internet Res. 2022;24(9):e38144. DOI: https://doi.org/10.2196/38144
https://doi.org/10.2196/38144... .

Regarding data quality, the SNGPC presented greater challenges in terms of methodological clarity and validity. Completeness, validity, and timeliness were the most frequently assessed attributes in studies involving the quality of Health Information Systems, according to a review conducted by Chen et al.⁴³43 Chen H, Hailey D, Wang N, et al. A review of data quality assessment methods for public health information systems. Int J Environ Res Public Health. 2014;11(5):5170-207. DOI: https://doi.org/10.3390/ijerph110505170
https://doi.org/10.3390/ijerph110505170... .

Finally, it is worth highlighting that since December 2021, due to the significant instability of the SNGPC, ANVISA has temporarily and indefinitely suspended the mandatory submission of electronic files. During the suspension, private pharmacies and drugstores began to keep their records in specific physical or computerized logbooks, which must remain available to the inspection authorities²⁴24 Agência Nacional de Vigilância Sanitária (BR). Resolução RDC No 351, de 20 de março de 2020. Dispõe sobre a atualização do Anexo I (Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial) da Portaria SVS/MS nº 344, de 12 de maio de 1998, e dá outras providências. Diário Oficial da União, Brasília, DF. 2020 mar 20; Seção I:117..

Failure to submit the sales records of prescription medications through the SNGPC will result in a large gap in this database during the suspension period. It will lead to an unparalleled loss in the ability to analyze the longterm trends in the consumption of these drugs. This is even more critical for antimicrobials, considering that monitoring has become an urgent global priority in the fight against the spread of antimicrobial resistance (AMR).

Final considerations

The SNGPC data available in open access is presented in such a way as to enable the extraction of various relevant information for analyzing the consumption pattern of antimicrobials in private pharmacies and drugstores in Brazil.

However, some limitations of this database have been identified, such as the absence of individualized data and the lack of completion of the ICD-10 field. These issues hinder a qualitative analysis of the outpatient use of antimicrobials, including the indications for their use and the number of antibiotic courses taken by each patient in a given period. This information is relevant for managers, healthcare professionals, and researchers committed to controlling AMR in the country.

Moreover, some challenges were faced when using this database, such as the lack of standardization of antimicrobial names and descriptions, the presence of different types of information in the presentation description field, data entry errors, and the presence of null values. There was a considerable increase in the time required to process the data and the need to exclude some of it.

Incorporating variables that can help standardize and classify antimicrobials is crucial for enabling more comprehensive, faster, and efficient analyses of SNGPC data. One way in which ANVISA could improve the database is through a partnership with the DATASUS, from the Ministry of Health, which has expertise in developing systems that support SUS management.

In summary, the SNGPC offers open access to valuable data for analyzing outpatient consumption of antimicrobials. It also serves as a key resource for generating knowledge in this field, given that private pharmacies and drugstores are the primary access to these drugs for the Brazilian population. However, the system’s quality can and should be improved to make it more user-friendly for researchers, healthcare professionals, and managers, thereby increasing the potential for conducting more robust analyses and studies. Thus, the SNGPC could significantly enhance the monitoring of outpatient antimicrobial use in Brazil and support the development of actions and health policies aimed at tackling the advance of microbial resistance in the country.

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