From law to practice: Analyzing regulatory challenges in the context of Brazilians commercial pharmacies
DOI:
https://doi.org/10.33448/rsd-v13i6.45990Keywords:
Pharmacy; Law enforcement; Pharmacy legislation; Health care coordination and monitoring.Abstract
In the world of commercial pharmacies, the intersection between legislation and daily practice is a constant challenge. While laws and regulations aim to ensure the quality, safety, and efficacy of pharmaceutical products, the enforcement of these regulations often presents obstacles in the commercial environment. This study aims to analyze the regulatory challenges faced by Brazilian commercial pharmacies. The methodological approach in the development of this study was integrative literature review, a method that allows the integration of knowledge through a methodical and rigorous process. Thus, 17 articles were selected as the basis for the production of this integrative review. Regulations require pharmacies to meet a series of technical, structural, and safety criteria, which can be challenging for commercial establishments. Therefore, the need to comply with all legal requirements, as well as to stay updated with the constant changes in regulations, makes the process of regularizing commercial pharmacies a complex task that demands constant attention and care from those responsible for the establishment. In conclusion, the process of regulating commercial pharmacies in Brazil is inherently complex and challenging, requiring a continuous commitment to regulatory compliance, education of professionals, and adaptation to legislative changes. Overcoming these challenges is crucial to ensure patient safety and the effectiveness of pharmaceutical services, promoting ethical and quality practice in the sector.
References
Alves, T. L., Costa, A. C., & Guerra Júnior, A. A. (2019). Medicines Information and the Regulation of the Promotion of Pharmaceuticals: Challenges for Brazil. Sci Eng Ethics. 25, 1167–1192. https://doi.org/10.1007/s11948-018-0041-5
ANVISA. (2009). Resolução da Diretoria Colegiada - RDC nº 71, de 22 de dezembro de 2009. Ministério da Saúde. Agência Nacional de Vigilância Sanitária (ANVISA). https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/res0071_22_12_2009.html
ANVISA. (2013a). Resolução da Diretoria Colegiada (RDC) nº 585, de 29 de agosto de 2013. Dispõe sobre as atribuições clínicas do farmacêutico. Diário Oficial da União, Brasília, DF. Agência Nacional de Vigilância Sanitária (ANVISA) https://www.cff.org.br/userfiles/file/resolucoes/585.pdf
ANVISA. (2013b). Resolução da Diretoria Colegiada (RDC) nº 586, de 29 de agosto de 2013. Regula a prescrição farmacêutica e dá outras providências. Agência Nacional de Vigilância Sanitária (ANVISA). https://www.cff.org.br/userfiles/file/resolucoes/586.pdf
Bezerra, T. M., Filho, N. A. M., & Soler, O. (2022) Marcos regulatórios e a atuação do farmacêutico no mercado de medicamentos veterinários para animais de companhia: revisão integrativa. Research, Society and Development, 11(4): e36411427604, 1-18. http://dx.doi.org/10.33448/rsd-v11i4.27604
Brasil. (1973). Lei nº 5.991, de 17 de dezembro de 1973. Dispõe sobre o Controle Sanitário do Comércio de Drogas, Medicamentos, Insumos Farmacêuticos e Correlatos, e dá outras Providências. Presidência da República. https://www.planalto.gov.br/ccivil_03/leis/l5991.htm#:~:text=LEI%20No%205.991%2C%20DE%2017%20DE%20DEZEMBRO%20DE%201973.&text=Disp%C3%B5e%20sobre%20o%20Controle%20Sanit%C3%A1rio,Correlatos%2C%20e%20d%C3%A1%20outras%20Provid%C3%AAncias
Brasil. (2014). Lei nº 13.021, de 8 de agosto de 2014. Dispõe sobre o exercício e a fiscalização das atividades farmacêuticas. Presidência da República. https://www.planalto.gov.br/ccivil_03/_ato2011-2014/2014/lei/l13021.htm
Carvalho, A. C. B., Lana, T. N., Perfeito, J. P. S., & Silveira, D. (2018). The Brazilian market of herbal medicinal products and the impacts of the new legislation on traditional medicines. Journal of Ethnopharmacology. 15(212), 29-35. https://doi.org/10.1016/j.jep.2017.09.040
Costa, E. A., Souza, G. S., Araújo, P. S., Alencar, T. O. S., Barros, R. D., Souza, M. K. B. & Lima, Y. O. R. (2016) Medicamento, assistência farmacêutica e vigilância sanitária na atenção integral à saúde. In: Teixeira, C. F. (2016). Observatório de análise política em saúde: abordagens, objetos e investigações. Salvador: EDUFBA, pp. 369-396. https://doi.org/10.7476/9788523220211.0012.
Faria Júnior, E., & Ferreira, A. (2021). Desafios da atuação farmacêutica diante das atribuições comerciais inerentes aos estabelecimentos farmacêuticos. Revista Saúde dos Vales, 1 (1), 1-13. https://revistas.unipacto.com.br/storage/publicacoes/2022/823_desafios_da_atuacao_farmaceutica_diante_das_atribuicoes_comerciais_ine.pdf
Mattos, L. V., Silva, R. M., Silva, F. R. P., & Luiza, V. L. (2022). Das farmácias comunitárias às grandes redes: provisão privada de medicamentos, sistema de saúde e financeirização no varejo farmacêutico brasileiro. Cadernos De Saúde Pública, 38, e00085420. https://doi.org/10.1590/0102-311X00085420
Melo, M. do S., Silva, M. B., & Silva, R. M. (2017). Pharmacy in Brazil: Progress and Challenges on the Road to Expanding Clinical Practice. Canadian Journal of Health-System Pharmacy, 70 (5), 8-10. https://doi.org/10.4212/cjhp.v70i5.1700
Moraes, G. C. (2022). Farmácia como estabelecimento de saúde: uma leitura das coalizões de defesa para a discussão da implementação da lei 13.021/2014. [Dissertação de mestrado, Universidade de Brasília]. Repositório Institucional da Universidade de Brasília. http://icts.unb.br/jspui/handle/10482/44087.
Mota, K. F., Baldoni, A. O., Baptista, E. C. C., Reis, T. M., Pereira, L. R. L., Nascimento, M. M. G., & Pereira, M. L. (2020). Profile of activities developed by community pharmacists: do they corroborate the precepts of the pharmaceutical profession? Brazilian Journal of Pharmaceutical Sciences, 56, e18472. http://dx.doi.org/10.1590/s2175-97902020000118472
Peruchi, A.. (2020). O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista. História, Ciências, Saúde-manguinhos, 27 (3), 933–965. https://doi.org/10.1590/S0104-59702020000400013
Pons, E. S., Moraes, C. G., Falavigna, M., Webster, G., & Pizzol, T. S. D. (2019). Users’ preferences and perceptions of the comprehensibility and readability of medication labels. PLoS ONE. 14 (2): e0212173. https://doi.org/10.1371/journal.pone.021217
Rezende, A. (2019). Businessplan for a pharmacy in Brazil. [Tese de mestrado] Universidade de Ciências Aplicadas da Carélia. Programa de Graduação em Negócios Internacionais. https://www.theseus.fi/bitstream/handle/10024/160798/AdrianaRezende-IB-1402036.pdf;jsessionid=50C5574D13DFB68A EEA068B3620F0119?sequence=1
Rezende, M. D. A. (2020). An update in regulatory of the Brazilian herbal medicines and medicinal plants professional prescribers. Pharmacol Int J, 8 (2), 73-77. 10.15406/ppij.2020.08.00282.
Sakeena, M. H. F., Bennett, A. A., & McLachlan, A. J. (2018) Non-prescription sales of antimicrobial agents at community pharmacies in developing countries: a systematic review. International Journal of Antimicrobial Agents, 52 (6):771-782. https://doi.org/10.1016/j.ijantimicag.2018.09.022
Saavedra, P. A. E., Galato, D., de Souza Silva, C. M., Rodrigues da Silva, I. C., & da Silva, E. V. (2022). Dispensing of psychotropic drugs in the Brazilian capital city before and during the COVID-19 pandemic (2018–2020). Front. Pharmacol., 13:1028233. 10.3389/fphar.2022.1028233
Santos, L. R. S. S. (2022) Assistência e Atenção Farmacêutica: os desafios encontrados pelo profissional farmacêutico que atua em drogarias e farmácias de Porto Alegre, RS: um relato de experiência. Research, Society and Development, 11(13): e245111334544, 1-15. http://dx.doi.org/10.33448/rsd-v11i13.34544
Souza, C. M. A. de., Paranhos, J., & Hasenclever, L. (2021). Comparativo entre preço máximo ao consumidor de medicamentos e preços praticados na internet no Brasil: desalinhamentos e distorções regulatórias. Ciência & Saúde Coletiva, 26 (11), 5463–5480. https://doi.org/10.1590/1413-812320212611.44082020
Varallo, F. R., Forgerini, M., Herdeiro, M. T., & Mastroianni, P. C. (2019). Harmonization of Pharmacovigilance Regulation in Brazil: Opportunities to Improve Risk Communication. Clinical Therapeutics, 41(3), 600-602. https://doi.org/10.1016/j.clinthera.2019.01.013
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Alexandre Alves Maciel; Anna Thalita Nunes de Barros; Maysa Boaventura Oliveira; Gustavo José Vasco Pereira
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
1) Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
2) Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
3) Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.