{"title":"巴西国家管制产品管理系统放松管制对抗抑郁药销售数据的影响","authors":"Vanessa Gomes Lima, Marcus Tolentino Silva, Tayanny Margarida Menezes Almeida Biase, Taís Freire Galvão","doi":"10.1002/pds.70136","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To assess the effect of deregulating the national sales reporting system on Brazilian pharmacoepidemiologic data on antidepressants.</p><p><strong>Methods: </strong>This was a time series analysis to assess the trends in antidepressant sales in Brazilian drugstores from January 2014 to December 2022 using the Brazilian National Controlled Products Management System (SNGPC) and to predict sales records for 2022 after the deregulation of the mandatory record in December 2021. Antidepressant sales were converted to defined daily doses per 1000 inhabitants per day (DID). The seasonal autoregressive integrated moving average (SARIMA) was used to predict sales records for 2022. All analyses were conducted in Stata v.14.2.</p><p><strong>Results: </strong>Sales of patients taking antidepressants increased significantly from 2014 (mean: 14.7 DID/month) to 2020 (mean: 33.5 DID/month; β = 0.231; p < 0.001). After the start of the COVID-19 pandemic, the increasing trend continued, but the change was not significant (β = 0.330; p = 0.130). After the deregulation, a sharp decrease was observed (β = -1.032; p < 0.001). The monthly antidepressant sales forecasted for 2022 were 36.5 DID, while the observed value was 2.5 DID.</p><p><strong>Conclusion: </strong>Deregulation of SNGPC registration significantly decreased the number of antidepressant sales records. This measure affected the availability of pharmacoepidemiological data and research in Brazil.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70136"},"PeriodicalIF":2.4000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of Deregulation of the Brazilian National Controlled Products Management System on Antidepressants' Sales Data Deregulation of a Brazilian Drug Electronic System.\",\"authors\":\"Vanessa Gomes Lima, Marcus Tolentino Silva, Tayanny Margarida Menezes Almeida Biase, Taís Freire Galvão\",\"doi\":\"10.1002/pds.70136\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To assess the effect of deregulating the national sales reporting system on Brazilian pharmacoepidemiologic data on antidepressants.</p><p><strong>Methods: </strong>This was a time series analysis to assess the trends in antidepressant sales in Brazilian drugstores from January 2014 to December 2022 using the Brazilian National Controlled Products Management System (SNGPC) and to predict sales records for 2022 after the deregulation of the mandatory record in December 2021. Antidepressant sales were converted to defined daily doses per 1000 inhabitants per day (DID). The seasonal autoregressive integrated moving average (SARIMA) was used to predict sales records for 2022. All analyses were conducted in Stata v.14.2.</p><p><strong>Results: </strong>Sales of patients taking antidepressants increased significantly from 2014 (mean: 14.7 DID/month) to 2020 (mean: 33.5 DID/month; β = 0.231; p < 0.001). After the start of the COVID-19 pandemic, the increasing trend continued, but the change was not significant (β = 0.330; p = 0.130). After the deregulation, a sharp decrease was observed (β = -1.032; p < 0.001). The monthly antidepressant sales forecasted for 2022 were 36.5 DID, while the observed value was 2.5 DID.</p><p><strong>Conclusion: </strong>Deregulation of SNGPC registration significantly decreased the number of antidepressant sales records. This measure affected the availability of pharmacoepidemiological data and research in Brazil.</p>\",\"PeriodicalId\":19782,\"journal\":{\"name\":\"Pharmacoepidemiology and Drug Safety\",\"volume\":\"34 3\",\"pages\":\"e70136\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacoepidemiology and Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/pds.70136\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70136","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Effect of Deregulation of the Brazilian National Controlled Products Management System on Antidepressants' Sales Data Deregulation of a Brazilian Drug Electronic System.
Purpose: To assess the effect of deregulating the national sales reporting system on Brazilian pharmacoepidemiologic data on antidepressants.
Methods: This was a time series analysis to assess the trends in antidepressant sales in Brazilian drugstores from January 2014 to December 2022 using the Brazilian National Controlled Products Management System (SNGPC) and to predict sales records for 2022 after the deregulation of the mandatory record in December 2021. Antidepressant sales were converted to defined daily doses per 1000 inhabitants per day (DID). The seasonal autoregressive integrated moving average (SARIMA) was used to predict sales records for 2022. All analyses were conducted in Stata v.14.2.
Results: Sales of patients taking antidepressants increased significantly from 2014 (mean: 14.7 DID/month) to 2020 (mean: 33.5 DID/month; β = 0.231; p < 0.001). After the start of the COVID-19 pandemic, the increasing trend continued, but the change was not significant (β = 0.330; p = 0.130). After the deregulation, a sharp decrease was observed (β = -1.032; p < 0.001). The monthly antidepressant sales forecasted for 2022 were 36.5 DID, while the observed value was 2.5 DID.
Conclusion: Deregulation of SNGPC registration significantly decreased the number of antidepressant sales records. This measure affected the availability of pharmacoepidemiological data and research in Brazil.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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