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Effect of Deregulation of the Brazilian National Controlled Products Management System on Antidepressants’ Sales Data Deregulation of a Brazilian Drug Electronic System

Pharmacoepidemiol Drug Saf. 2025 Mar;34(3):e70136. doi: 10.1002/pds.70136.

ABSTRACT

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.

PMID:40107838 | DOI:10.1002/pds.70136

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