Validation of procedure for checking and releasing antineoplastics medications in an intravenous mixing center in southern Brazil

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DOI:

https://doi.org/10.30968/rbfhss.2024.151.1030

Abstract

Objective: Considering Collegiate Board Resolution 220 of 2004, which describes the minimum requirements required for the operation of antineoplastic therapy services, the objective of this work was to propose and validate a process for checking and releasing antineoplastics medications manipulated in the Intravenous Mixture Center in a high complexity hospital in southern Brazil. Methods: Prospective descriptive observational study, carried out from January to March 2023 at the Intravenous Mixture Center of a public hospital in Porto Alegre. A pilot study was carried out over a three-week period in which 50% of the antineoplastic preparations produced underwent a final visual check and completion of a checklist with the following points: colors, existence of perforations and/or leaks, foreign bodies or precipitation in the solution, medication compatibility with bag and equipment used and volume in the syringe. The results were presented to the unit’s professionals and validated electronically, applying the Content Validity Index, which calculates the proportion of evaluators who agree with individual and total aspects of the instrument. Subsequently, the process was described in a Standard Operating Procedure (SOP) and made available to the sector team. Results: A total of 427 syringe/pouch preparations were visually checked with the final product over the course of three weeks. During this pilot, three handling errors were identified, as well as the need to adapt work processes. The topics observed using the checklist were evaluated and validated by the sector’s oncology pharmacists. Conclusions: The procedure for checking and releasing antineoplastics medications proved to be a necessary procedure for patient safety due to its ability to prevent errors in the production and handling order from reaching the patient. In addition, it is necessary to keep the SOPs and supporting material constantly updated, together with ongoing staff education.

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References

Instituto Nacional de Câncer (INCA). O que é câncer? 2020. Available in: https://www.inca.gov.br/o-que-e-cancer. Accessed on: 16 Jul. 2022.

Instituto Nacional de Câncer (Brasil). Estimativa 2023: incidencia de câncer no Brasil / Instituto Nacional de Câncer. – Rio de Janeiro: INCA, 2022. 160 p.: il. color. Available in: https://www.inca.gov.br/sites/ufu.sti.inca.local/files//media/document//estimativa-2023.pdf. Accessed on 22 December. 2023.

Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021: 71: 209- 249. DOI: 10.3322/caac.21660.

Jemal A, Kantelhardt EJ, Mathewos A. Management and treatment. In: Jemal A, Torre L, Soerjomataram I, et al. (Ed). The Cancer Atlas, 3. ed. Atlanta: American Cancer Society Inc., 2019: 80-1. Available in: https://canceratlas.cancer.org/wp-content/uploads/2019/10/ACS_CA3_Book.pdf. Accessed on: 18 June. 2022.

Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies Press, 2000. DOI: 10.17226/9728.

Ranchon F, Salles G, Späth HM, et al. Chemotherapeutic errors in hospitalised cancer patients: attributable damage and extra costs. BMC Cancer. 2011;11(478). DOI: 10.1186/1471-2407-11-478.

Instituto para Práticas Seguras no Uso de Medicamentos (ISMP). Antineoplásicos parenterais: erros de medicação, riscos e práticas seguras na utilização. 2014; 3(3). Available in: https://www.ismp-brasil.org/site/wp-content/uploads/2015/07/V3N3.pdf. Accessed on: 10 Jul. 2023.

Brasil. ANVISA. Resolução - RDC n° 220, de 21 de setembro de 2004. Brasil: Aprova Regulamento Técnico de funcionamento dos Serviços de Terapia Antineoplásica. Available in: https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2004/rdc0220_21_09_2004.html. Access: 16 Jul. 2022.

Cardoso ASF, Muller S, Echer IC, Rabelo-Silva ER, Boni FG, Ribeiro AS. Elaboração e validação de checklist para administração de medicamentos para pacientes em protocolos de pesquisa. Rev. Gaúcha de Enferm. 2019;40(spe): e20180311. DOI: 10.1590/1983-1447.2019.20180311.

10. Alexandre NC, Coluci MO. Validade de conteúdo nos processos de construção e adaptação de instrumentos de medidas. Cien Saude Colet. 2011;16(7):3061-8. DOI: 10.1590/s1413-81232011000800006.

Pan American Health Organization. Safe Handling of Hazardous Chemotherapy Drugs in Limited-Resource Settings. Washington, DC: PAHO, 2013.

Empresa Brasileira de Serviços Hospitalares. Boas Práticas de Manipulação de Antineoplásicos da Rede EBSERH, 1st ed. São Paulo: EBSERH, 2021. Available in: https://www.gov.br/ebserh/pt-br/acesso-a-informacao/boletim-de-servico/sede/2021/anexos/manualebserh.pdf. Accessed on: 3 April. 2023.

Ashokkumar R, Srinivasamurthy S, Kelly JJ, et al. Frequency of Chemotherapy Medication Errors: a systematic review. J Pharmacol Pharmacother. 2018; 9(2):86-91. DOI: 10.4103/jpp.jpp_61_18.

World Health Organization. Conceptual Framework for the International Classification for Patient Safety, Version 1.1. Geneva: WHO, 2009. Available in: https://apps.who.int/iris/bitstream/handle/10665/70882/WHO_IER_PSP_2010.2_eng.pdf?sequence=1&isAllowed=y. Access: 12 Jul. 2022.

Dias NM, Silva LL, Castro KS, Lima AB. Validação de conteúdo de uma tecnologia sobre cateter de inserção periférica em unidades neonatais. Nursing. 2023; 26(300): 9596-9605. DOI: 10.36489/nursing.2023v26i300p9596-9605.

Miranda LHD, Reis JS, Oliveira SR de. Construção e validação de ferramenta educativa sobre insulinoterapia para adultos com diabetes mellitus. Ciênc saúde coletiva. 2023 May; 28(5):1513–24. DOI: 10.1590/1413-81232023285.09502022.

Campos FAAC, Ventura CAA, Mion ABZ, Rodríguez TDM, Feitosa FB. Validação do protocolo de terapia familiar aplicado à saúde mental (PTF-SM1). J. Health NPEPS. 2023 jan-jun; 8(1):e11095. DOI: 10.30681/2526101011095.

Conselho Federal de Farmácia. Resolução CFF nº 288, de 21 de março de 1996. Dispõe sobre a competência legal para o exercício da manipulação de drogas antineoplásicas pelo farmacêutico. Brasil, 21 de março de 1996.

Camerini FG, Colcher AP, Moraes DS, et al. Fatores de risco para ocorrência de erro no preparo de medicamentos endovenosos: uma revisão integrativa. Cogitare Enfermagem. 2014; 19 (2): 368-74. DOI:10.5380/ce. v19i2.37362.

Published

2024-03-26

How to Cite

1.
SCHAAB EE, SCHWAMBACH KH, WERLANG MC. Validation of procedure for checking and releasing antineoplastics medications in an intravenous mixing center in southern Brazil. Rev Bras Farm Hosp Serv Saude [Internet]. 2024Mar.26 [cited 2024Jul.20];15(1):1030. Available from: https://rbfhss.org.br/sbrafh/article/view/1030

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ORIGINAL ARTICLES