Proton pump inhibitor leaflets: Is there information on deprescribing?

Marcus Vinícius Lopes  Campos; Farah Maria Drumond  Chequer; Luanna Gabriella Resende da  Silva; André Oliveira  Baldoni

doi:10.1590/

Authors

Marcus Vinícius Lopes Campos Federal University of São João del-Rei (UFSJ), Divinópolis, MG, Brazil https://orcid.org/0009-0004-9129-2025
Farah Maria Drumond Chequer Federal University of São João del-Rei (UFSJ), Divinópolis, MG, Brazil https://orcid.org/0000-0003-3514-2132
Luanna Gabriella Resende da Silva Federal University of São João del-Rei (UFSJ), Divinópolis, MG, Brazil https://orcid.org/0000-0003-1879-5166
André Oliveira Baldoni Federal University of São João del-Rei (UFSJ), Divinópolis, MG, Brazil https://orcid.org/0000-0001-6379-0415

DOI:

https://doi.org/10.1590/

Keywords:

Leaflet, Deprescription, Rational Use of Medicines, Proton Pump Inhibitors, Brazilian Health Regulatory Agency (ANVISA), Food and Drug Administration (FDA)

Abstract

This study aims to analyze the existence of information about deprescription in the leaflets of proton pump inhibitor (PPI) medications. The leaflets available on the Brazilian Health Regulatory Agency (ANVISA) and Food and Drug Administration (FDA) websites for the following medications were analyzed: omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, and rabeprazole. The variables collected in each leaflet were the existence: a) about deprescribing; b) of guidance on the deprescription process; c) maximum recommended time for use; and d) risk of prolonged use. This information was analyzed in accordance with the PPI deprescription guideline, from Canada. Regarding the medication leaflets, 83.33 % from ANVISA and 100 % from the FDA did not present explicit and systematic guidance on deprescribing. Regarding the maximum time of use, 100 % of the leaflets from both agencies contained this information. Regarding the risks of prolonged use of the medication, 33.33 % of the ANVISA leaflets and 33.3 % of the FDA leaflets did not report the increased risks described in the guideline. The results highlight a large gap in information about deprescribing in PPI leaflets; this highlighting is necessary to contribute to the promotion of the rational use of medicines.

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References

Aquino JA, Oliveira CL, Otoni A, Sanches C, Guedes JVM, Morais DB, et al. Progression of chronic kidney disease in nondialysis patients: a retrospective cohort. Brazilian Journal of Pharmaceutical Sciences. Braz J Pharm Sci. 2022;58:e20249.

Araújo LS, Araujo BM, Guimarães CS, Fróes DNS, Maia ECS, Hoffmann G, et al. Inibidores de Bomba de Prótons: vantagens e desvantagens do uso prolongado. REAC. 2021;34:e8662.

Brasil. Ministério da Saúde. RDC no 47 de 8 de setembro de 2009. Estabelece regras para elaboração, harmonização, atualização, publicação e disponibilização de bulas de medicamentos para pacientes e para profissionais de saúde. Diário Oficial da União Brasília, DF, 9 de set. 2009. Available: Available: https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/rdc0047_08_09_2009.pdf Accessed 13 jan. 2024.

» https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/rdc0047_08_09_2009.pdf

Coelho VF, Pessoa G de O, Magalhães ECC, Coelho AM, Amorim ML de O, Ribeiro FM, et al. Principais riscos do uso de omeprazol ao longo prazo Braz J Health Rev. 2023;6(6):30810-30818.

Costa MP, Damascena RS. Perfil de Usuários de Omeprazol e Considerações Sobre Seu Uso Racional. Id On line Rev Mult Psiq. 2020;14(50):1-12.

Cunha N, Machado AP. Inibidores da bomba de protões e o risco de eventos adversos graves-uma bomba cardiovascular? Ver Port Cardiol. 2018;37(10):859-863.

Farrell B, Pottie K, Thompson W, Boghossian T, Pizzola L, Rashid FJ, et al. Deprescribing proton pump inhibitors. Evidence-based clinical practice guideline. Can Fam Physician. 2017;63(5):354-364.

Fujita PL, Machado CJS, Teixeira M de O. The medicine package leaflet and the regulation of its configurations in terms of form and content in Brazil. Saúde Soc São Paulo. 2014; 23(1):277-292.

Guedes JVM, Aquino JA, Castro TLB, Morais FA, Baldoni AO, Belo VS, Otoni A. Omeprazole use and risk of chronic kidney disease evolution. PLoS One. 2020;15:0229344-16.

Gomm W, Von holt K, Thomé F, Broich K, Maier W, Fink A, et al. Association of proton pump inhibitors with risk of dementia: a pharmacoepidemiological claims data analysis. JAMA Neurol. 2016;73(4):410-416.

Nielsen ASB, Mardov-Egvang P, Dave SK. E-labeling and digital transformation in healthcare. Regulatory Focus. 2023;1(2):1-21.

Imparato RR, Toma TS. Depreciação do inibidor da bomba de prótons: uma revisão rápida. Braz J Pharm Sci . 2022;58:e19989.

Kondapalli A, Agarwal S, Germosen C, Bucovsky M, Colon I, Kil N, Walker M. Bone microstructure in proton pump inhibitor users. Bone. 2023;168:116668.

Lee C, Lo A, Ubhi K, Milewski M. “Outcome after Discontinuation of Proton Pump Inhibitors at a Residential Care Site: Quality Improvement Project”. Can J Hop Farm. 2017;70(3):215-223.

Lima MG, Álvares J, Guerra Junior AA, Costa EA, Guibu IA, Soeiro OM, et al. Indicators related to the rational use of medicines and its associated factors. Revi Saúde Pública. 2017;51(2):23.

Macfarlane B. Management of gastroesophageal reflux disease in adults: a pharmacist›s perspective. Integr Pharm Res Pract. 2018;7:41-52.

Martins de P da MSR, Menezes de MF. Efeitos da desprescrição de inibidores de bomba de prótons. An Fac Med Olinda. 2019;1(4):56-60.

Melo I de O, Carvalho THF de, Cassundé MA, Costa RB. Inibidores da bomba de prótons e carcinogênese: uma revisão da literatura. Rev Med (São Paulo). 2021;100(5),479-485.

Morschel CF, Mafra D, Eduardo JCC. Inibidores da bomba de prótons e sua relação com a doença renal. J Bras Nefrol São Paulo. 2018;40(3):301-306.

Mullin JM, Gabello M, Murray LJ, Farrell CP, Bellows J, Wolov KR, et al. Proton pump inhibitors: actions and reactions. Drug Discov Today. 2009;14(13-14), 647-660.

Nguyen-soenen J, Rat C, Gaultier A, Schirr-bonnans S, Tessier P, Fournier JP. Effectiveness of a multi-faceted intervention to deprescribe proton pump inhibitors in primary care: protocol for a population-based, pragmatic, cluster-randomized controlled trial. BMC Health Serv Res. 2022;22(1):219.

Proença AD, Guedes JVM, Aquino J de A, Baldoni A de O, Morais FA, Freitas SB, et al. Associação entre o uso de inibidores de bomba de prótons e a doença renal crônica: uma revisão sistemática. Ciência ET Praxis. 2020;13(25):07-20.

Salgado AL, Palma AL do R, Ramos L de P, Miranda PE, Oliveira FG, Cortelli AFD, et al. Uso indiscriminado de inibidores da bomba de prótons em receituários de medicamentos de uso contínuo/ Uso indiscriminado de inibidores da bomba de prótons em prescrições de medicamentos de uso contínuo Braz J Health Rev . 2019;2(6):5883-5897.

Schnoll-Sussman F, Niec R, Katz PO. Proton pump inhibitors: the good, bad, and ugly. Gastrointest Endosc Clin N Am. 2020;30(2):239-251.

Sgnaolin V, Engroff P. Desprescrição. PAJAR. 2019;7(2):e34609.

Proton pump inhibitor leaflets

Is there information on deprescribing?

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