Evaluation of pediatric hydroxyurea prescriptions for patients with sickle cell disease
10.15343/0104-7809.202246369379I
Keywords:
Sickle cell disease. Sickle Cell Anemia. Hydroxyurea. Pediatrics. Dose.Abstract
Hydroxyurea (HU) was one of the main advances in the treatment of sickle cell disease. The use of the drug in children in Brazil is still off-label and is only available in solid pharmaceutical form. The objective of the present study is to evaluate the strategies for adapting the solid dosage form for use in children with sickle cell disease. This is a descriptive study, with the analysis of pediatric HU prescriptions and the application of questionnaires to those responsible in the period from January to March 2018. 43 prescriptions were analyzed, and two forms of adaptation were identified, 1) conventional dilution: dilution of the drug in a pre-prescribed quantity - determined amount of water, followed by administration of part of the solution obtained (22) (51%), and 2) use of the holiday or intermittent dose recommendation (21) (49%). All patients using the conventional dilution strategy discarded the remainder of the drug from the domestic sewage system. In addition, incorrect administration of the drug was identified in one patient. The lack of an appropriate pharmaceutical form for the pediatric population can lead to risks of incorrect administration and unnecessary expenses with drug disposal, in addition to improper disposal that compromises environmental factors. This study reinforces the need to develop pharmaceutical forms that are more suitable for children.
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References
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2. Silva-Pinto AC, Ângulo IL, Brunetta DM, Neves FIR, Bassi SC, Santis GC, et al. Clinical and hematological effects of hydroxyurea therapy in sickle cell patients: a single-center experience in Brazil. São Paulo Med J. 2013; 131(4): 238-243. https://doi.org/10.1590/1516-3180.2013.1314467.
3. Brasil. Doença falciforme: condutas básicas para tratamento. Ministério da Saúde, 2012. Acessado em: 18 de junho de 2022. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/doenca_falciforme_condutas_basicas.pdf.
4. Araujo OMR, Ivo ML, Junior MAF, Pontes ERJC, Bispo IMGP, Oliveira ECL. Survival and mortality among users and non-users of hydroxyurea with sickle cell disease. Rev Latino-Am Enfermagem. 2015; 23(1): 67-73. doi.org/10.1590/0104- 1169.3385.2526.
5. Heeney MM, Ware RE. Hydroxyurea for children with sickle cell disease. Hematol Oncol Clin North Am. 2010; 24(1): 199- 214. https://doi.org/10.1016/j.hoc.2009.11.002.
6. Estepp JH, Melloni C, Thornburg CD, Wiczling P, Rogers Z, Rothman JA, et al. Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia. J Clin Pharmacol. 2016; 56(3): 298- 306. https://doi. org/10.1002/jcph.598.
7. Wang WC, Ware RE, Miller ST, Iyer RV, Casella JF, Minniti CP, et al. A multicenter randomised controlled trial of hydroxyurea (hydroxycarbamide) in very young children with sickle cell anaemia. Lancet. 2011; 377(9778): 1663-1672. https://doi. org/10.1016/S0140-6736(11)60355-3.
8- Heeney MM, Whorton MR, Howard TA, Johnson CA, Ware RE. Chemical and functional analysis of hydroxyurea oral solutions. J Pediatr Hematol Oncol. 2004; 26(3): 179-184. https://doi.org/10.1097/00043426-200403000-00007.
9- Hydrea®. Sermoneta: Corden Pharma Latina. 2020; Acessado em 11 de julho de 2022. https://www.bms.com/assets/bms/ brazil/documents/bulas-pacientes-otimizadas/HYDREA_CAP_VP_Rev0818.pdf
10- Brasil. Protocolo Clínico e Diretrizes Terapêuticas, Doença Falciforme. Ministério da Sáude. 2018; Acessado em 03 de agosto de 2022. http://conitec.gov.br/images/Consultas/Relatorios/2016/Relatorio_PCDT_DoencaFalciforme_CP_2016_ v2.pdf.
11- Oliveira PH, Pinheiro MG, Isquierdo LA, Sukiennik R, Pellanda LC. Brazilian pediatric research groups, lines of research, and main areas of activity. J Pediatr. 2015; 91: 299-305. https://doi.org/10.1016/j.jped.2014.09.002>.
12- Brasil. Assistência Farmacêutica em Pediatria no Brasil: recomendações e estratégias para a ampliação da oferta, do acesso e do Uso Racional de Medicamentos em crianças. Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos, Departamento de Assistência Farmacêutica e Insumos Estratégicos. Ministério da Saúde. 2017; Acessado em 18 de junho de 2022 https://bvsms.saude.gov.br/bvs/publicacoes/assistencia_farmaceutica_pediatria_brasil_recomendacoes. pdf.
13- Falqueto E, Kligerman DC, Assumpção RF. Como realizar o correto descarte de resíduos de medicamentos?. Ciênc Saúde Coletiva. 2010; 15(2): 3283-3293. https://doi.org/10.1590/S1413-81232010000800034.
14- BRASIL. Comissão Nacional de Incorporação de Tecnologia no SUS (CONITEC) – Relatório nº 57. Portaria nº 27, de 12 de junho de 2013. Acesso de 18 de junho de 2022. https://www.gov.br/saude/pt-br/composicao/sctie/dgitis.
15- World Health Organization. WHO. Child growth standards. 2 to 5 years (z-scores). http://www.who.int/childgrowth/ standards/chts_wfa_girls_z/en/. Acesso em 01 de maio de 2018.
16- Agência Nacional de Vigilância Sanitária, Lista de Preços de Medicamentos da CMED, versão de 25/02/2018. Acesso em 18 de junho de 2022. http://portal.anvisa.gov.br/listas-de-precos.
17- Chambers TM, Kahan S, Camanda JF, Scheurer M, Airewele GE. Intermittent or uneven daily administration of low‐dose hydroxyurea is effective in treating children with sickle cell anemia in Angola. Pediatr Blood Câncer. 2018; 65(12): e27365. https://doi.org/10.1002/pbc.27365.
18- Costa PQ, Rey LC, Coelho HLL. Lack of drug preparations for use in children in Brazil. J Pediatr. 2009; 85(3): 229-235. https://doi.org/10.1590/S0021-75572009000300008
19- Kipper DJ. Ética em pesquisa com crianças e adolescentes: à procura de normas e diretrizes virtuosas. Rev Bioé. 2016; 24(1): 37-48. https://doi.org/10.1590/1983-80422016241104.
20- Santana RS, Lupatini EO, Leite SN. Registro e incorporação de tecnologias no SUS: barreiras de acesso a medicamentos para doenças da pobreza?. Ciênc saúde colet. 2017; 22: 1417-1428. https://doi.org/10.1590/1413-81232017225.32762016 .
21- U.S. Food and Drug Administration. FDA. Drug Approvals and Databases. Approved Drugs. FDA approves hydroxyurea for treatment of pediatric patients with sickle cell anemia. Ano???Acesso em: 01 de maio de 2018.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm590096.htm.
22- Siklos®: Hydroxyurea. Pennsylvania: MEDUNIK USA, 2017. Acessado em 11 de julho de 2022. Disponível em: https:// www.ema.europa.eu/en/documents/product-information/siklos-epar-product-information_pt.pdf.
23- Strouse JJ., Heeney MM. Hydroxyurea for the treatment of sickle cell disease: efficacy, barriers, toxicity, and management in children. Pediatr Blood Cancer. 2012; 59(2): 365-371. https://doi.org/10.1002/pbc.24178.
24- Balkrishnan R. Predictors of medication adherence in the elderly. Clin Ther. 1998; 20(4): 764-771. https://doi.org/10.1016/ s0149-2918(98)80139-2.
25- MacLaughlin EJ, Raehl CL, Treadway AK, Sterling TL, Zoller DP, Bond CA. Assessing medication adherence in the elderly. Drugs Aging. 2005; 22(3): 231-255. https://doi.org/10.2165/00002512-200522030-00005.
26- Sanders LM, Federico S, Klass P, Abrams A, Dreyer B. Literacy and child health: a systematic review. Arch Pediatr Adolesc Med. 2009; 163(2): 131-140. https://doi.org/10.1001/archpediatrics.2008.539.
27- Morrison AK, Myrvik MP, Brousseau DC, Hoffmann RG, Stanley RM. The relationship between parent health literacy and pediatric emergency department utilization: a systematic review. Acad Pediatr. 2013; 13(5): 421-429. https://doi. org/10.1016/j.acap.2013.03.001.
28- World Health Organization - WHO. Health promotion glossary. Geneva:
WHO, 1998. Acesso em 03 de agosto de 2022. https://www.who.int/publications/i/item/WHO-HPR-HEP-98.1
29- INAF. Indicador de Analfabetismo Funcional. INAF Brasil 2011 Principais Resultados. Instituto Paulo Montenegro. Acesso em 01 de maio de 2018. http://www.ipm.org.br/relatorios.
30- Fry PH. O significado da anemia falciforme no contexto da política racial do governo brasileiro 1995-2004. Hist Ciênc Saude-Manguinhos. 2005;12(2): 347-70. https://doi.org/10.1590/S0104-59702005000200007.
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2022-11-04
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Tanimoto Duque, F. A., Ferreira Dias, E., Soares Malta, J., Cezarino Rodrigues, P., de Faria Martins Braga, L., & Moreira da Costa, J. (2022). Evaluation of pediatric hydroxyurea prescriptions for patients with sickle cell disease: 10.15343/0104-7809.202246369379I. O Mundo Da Saúde, 46, 369–379. Retrieved from https://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1440
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