Pharmacoepidemiology and drug safety · 2026
Trends in Medicines Discontinuation and Implications for Access in Brazil (2014-2024).
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de Lima Raphaella Oliveira Martins, Silva Esther Ramos, Emmerick Isabel C M, de Souza Serio Dos Santos Danielle Maria, Godói Isabella Piassi Dias, Campos Ana Cristina Viana, Chaves Luisa Arueira
Аннотация
PURPOSE: The World Health Organization (WHO) began recognizing drug shortages as a global issue in 2014, impacting health systems and patient care. Shortages arise from supply chain disruptions, production issues, and mismatches between supply and demand, aggravated by insufficient mechanisms for forecasting and communication.
METHODS: The study analyzed medicine discontinuation notifications in Brazil from 2014 to 2024 from a public secondary database. Data was downloaded, organized, and cleaned using Excel, incorporating ATC classification and verification of medicines listed on the National Essential Medicines List (NEML/RENAME). Statistical analyses included descriptive statistics and association tests (Pearson's χ2, Fisher's exact test) examining discontinuation types, registration categories, reasons, and NEML presence.
RESULTS: Between 2014 and 2024, Brazil had 23, 110 discontinuation notifications, of which 15, 599 (67.5%) were temporary, and 7,511 (32.5%) were definitive discontinuation. The annual distribution was not homogeneous. Generic had the highest proportion of discontinuations (37.2%), surpassing branded generics (33.2%) and originator brands (15.9%). In contrast, biological products, herbal medicines, dynamized medicines, and specific medicines together accounted for only 13.73% of the total. Regarding the reasons for discontinuation, commercial reasons predominated, accounting for 73.4% of notifications. Finally, it was found that the majority of discontinued drugs were not included in NEML (73.9%).
CONCLUSIONS: Medicine discontinuation in Brazil from 2014 to 2024 is mainly temporary and occurs for generics and branded-generics due to commercial decisions. The findings highlight the complexity of supply continuity and the importance of strategies that include diversifying supply sources, strengthening regulatory oversight, and improving monitoring and communication systems.
METHODS: The study analyzed medicine discontinuation notifications in Brazil from 2014 to 2024 from a public secondary database. Data was downloaded, organized, and cleaned using Excel, incorporating ATC classification and verification of medicines listed on the National Essential Medicines List (NEML/RENAME). Statistical analyses included descriptive statistics and association tests (Pearson's χ2, Fisher's exact test) examining discontinuation types, registration categories, reasons, and NEML presence.
RESULTS: Between 2014 and 2024, Brazil had 23, 110 discontinuation notifications, of which 15, 599 (67.5%) were temporary, and 7,511 (32.5%) were definitive discontinuation. The annual distribution was not homogeneous. Generic had the highest proportion of discontinuations (37.2%), surpassing branded generics (33.2%) and originator brands (15.9%). In contrast, biological products, herbal medicines, dynamized medicines, and specific medicines together accounted for only 13.73% of the total. Regarding the reasons for discontinuation, commercial reasons predominated, accounting for 73.4% of notifications. Finally, it was found that the majority of discontinued drugs were not included in NEML (73.9%).
CONCLUSIONS: Medicine discontinuation in Brazil from 2014 to 2024 is mainly temporary and occurs for generics and branded-generics due to commercial decisions. The findings highlight the complexity of supply continuity and the importance of strategies that include diversifying supply sources, strengthening regulatory oversight, and improving monitoring and communication systems.