Control microbiológico de formas farmacéuticas líquidas adaptadas en un hospital pediátrico de Manaus
DOI:
https://doi.org/10.17058/reci.v14i3.19484Palabras clave:
Farmacopeia Brasileira, Hospitais Pediátricos, Preparações FarmacêuticasResumen
Justificación y Objetivos: Las formas farmacéuticas líquidas son ideales para pacientes pediátricos, ya que esta población presenta dificultades para deglutir. Sin embargo, el mercado farmacéutico no dispone de un amplío arsenal terapéutico. Para superar esta situación, es necesaria la adaptación de medicamentos destinados al público adulto a laforma de soluciones orales, que permitan su uso en pacientes pediátricos. No obstante, esto puede alterar las propiedades físico-químicas y microbiológicas de estos fármacos. De acuerdo con la literatura, gran parte de los estudios sobre adaptaciones farmacéuticas están dirigidos a la estabilidad físico-química, y los parámetros microbiológicos son menos evaluados. Por lo tanto, el objetivo de este estudio fue realizar el control microbiológico de las formas farmacéuticas líquidas adaptadas en un hospital pediátrico. Métodos: El análisis microbiológico se realizó conforme a las especificaciones de la Farmacopea Brasileña para productos no estériles. Se realizaron pruebas de recuentos del número total de microorganismos mesófilos y de la presencia de microorganismos patógenos. Resultados: Durante el período delestudio, se seleccionaron 16 muestras para el análisis microbiológico. Entre los medicamentos, las clases más frecuentes fueron: diuréticos, antihipertensivos y psicolépticos. No se utilizaron conservantes en la preparación de las adaptaciones farmacéuticas analizadas. La mitad de las adaptaciones presentaron un recuento del número total de microorganismos mesófilos por encima del límite permitido el día de la manipulación, el 43,75% en la mitad del período de validez y el 62,5% en el período de validez. Conclusión: Solo 03 (18,75%) adaptaciones estaban dentro de los límites microbianos aceptables establecidos a lo largo del estudio. En cuanto a la presencia de patógenos, todos extensas de los patógenos Escherichia coli, Salmonella sp., Pseudomonas aeruginosa y Staphylococcus aureus durante el período de estudio.
Descargas
Citas
Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr. 2005;164(9):552-558. https://doi.org/10.1007/s00431-005-1698-8
Binson G, Sanchez C, Waton K, et al. Accuracy of dose administered to children using off-labelled or unlicensed oral dosage forms. Pharmaceutics. 2021;13(7). https://doi.org/10.3390/pharmaceutics13071014
Tukayo BLA, Sunderland B, Parsons R, et al. High prevalence of off-label and unlicensed paediatric prescribing in a hospital in Indonesia during the period Aug.—Oct. 2014. Vol. 15, PLoS ONE. Public Library of Science; 2020. https://doi.org/10.1371/journal.pone.0227687
Petkova V, Georgieva D, Dimitrov M, et al. Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022. Vol. 15, Pharmaceutics. Multidisciplinary Digital Publishing Institute (MDPI); 2023. https://doi.org/10.3390/pharmaceutics15122652
Visser JC, Woerdenbag HJ, Hanff LM, Frijlink HW. Personalized Medicine in Pediatrics: The Clinical Potential of Orodispersible Films. AAPS PharmSciTech. 2017;18(2):267-272. https://doi.org/10.1208/s12249-016-0515-1
Belayneh A, Tadese E, Molla F. Safety and biopharmaceutical challenges of excipients in off-label pediatric formulations. Vol. 13, International Journal of General Medicine. Dove Medical Press Ltd; 2020. p. 1051–66. https://doi.org/10.2147/IJGM.S280330
da Silva MRM, Dysars LP, Dos Santos EP, Ricci Júnior E. Preparation of extemporaneous oral liquid in the hospital pharmacy. Brazilian Journal of Pharmaceutical Sciences. 2020;56:1-15. https://doi.org/10.1590/S2175-97902019000418358
Van der Zanden TM, Smeets NJL, de Hoop-Sommen M, et al. Off-Label, but on-Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy. Clinical Pharmacology and Therapeutics. 2022 Dec 1;112(6):1243–53. https://doi.org/10.1002/cpt.2736
Hunea I, Luca C, Eșanu I, et al. Ethical Issues Regarding Off - Label Administration of Antibiotics. Journal of Intercultural Management and Ethics. 2020 Mar 31;3(1):29–38. https://doi.org/10.35478/jime.2020.1.04
Tang L, Zhao K, Hou N. Off-label use of antimicrobials among hospitalized children: a retrospective study of 3,406 patients. Frontiers in Microbiology. 2023;14. https://doi.org/10.3389/fmicb.2023.1173042
Villaca VC, Asami KD, Bueno FG, et al. Estabilidade físico-química e microbiológica de suspensão oral de omeprazol 10 mg/mL manipulada em uma farmácia escola. Brazilian Journal of Health Review. 2023 Nov 28;6(6):30090–108. https://doi.org/10.34119/bjhrv6n6-269
Palmeira De Oliveira R, Luís C, Gaspar C, et al. Microbiological quality control of non-sterile compounded medicines prepared in a Portuguese hospital centre. European Journal of Hospital Pharmacy. 2016;23(4):228-232. https://doi.org/10.1136/ejhpharm-2015-000769
Yuliani SH, Putri DCA, Virginia DM, et al. Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review. Pharmaceutics. 2023 Mar 4;15(3):840. https://doi.org/10.3390/pharmaceutics15030840
Meng M, Zhou Q, Lei W, et al. Recommendations on Off-Label Drug Use in Pediatric Guidelines. Frontiers in Pharmacology. 2022 Jun 9;13. https://doi.org/10.3389/fphar.2022.892574
Poy MJC, Ramirez CC, Lauro SXG, et al. Microbiological quality of pediatric oral liquid formulations. Farmacia Hospitalaria, 2016, 40(5):427-35. https://doi.org/10.7399/fh.2016.40.5.10541
Gomes VP, Silva KM, Chagas SO, et al. Off-label and unlicensed utilization of drugs in a Brazilian pediatric hospital. Farmacia Hospitalaria, 2015, 39(3):176-80. https://dx.doi.org/10.7399/fh.2015.39.3.847217.
Nóbrega EP, Chagas SO, Magalhães IRS. Evaluation of adaptation of pharmaceutical forms in a pediatric hospital in Manaus. Rev. Bras. Farm. Hosp. Serv. Saúde 2018; 9(1):e091.005. https://rbfhss.org.br/sbrafh/article/view/312/326
WHO - World Health Organization. Anatomical Therapeutic Chemical - ATC. World Health, 2016, disponível em: <https://www.whocc.no/atc_ddd_index/>, acesso em: 28/07/2018 às 01:30.
BRASIL. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Farmacopeia Brasileira. 5ª edição, Volume 1. Brasília: Ministério da Saúde; 2010. disponível em: < https://www.gov.br/anvisa/pt-br/assuntos/farmacopeia/farmacopeia-brasileira/arquivos/8000json-file-1>, acesso em: 28/07/2018 às 02:30.
Yusuff KB. Extent of extemporaneous compounding and pattern of prescribing and use of extemporaneous medicines in a developing setting. Journal of Pharmaceutical Health Services Research. 2019;10(2):255-260. https://doi.org/10.1111/jphs.12297
Mugoyela V, Mugoyela V, Mwambete K.D. Microbial contamination of nonsterile pharmaceuticals in public hospital settings. Ther Clin Risk Manag. Published online September 2010:443. https://doi.org/10.2147/tcrm.s12253
García-López I, Cuervas-Mons Vendrell M, Martín Romero I, de Noriega I, Benedí González J, Martino-Alba R. Off-Label and Unlicensed Drugs in Pediatric Palliative Care: A Prospective Observational Study. J Pain Symptom Manage. 2020;60(5):923-932. https://doi.org/10.1016/j.jpainsymman.2020.06.014
Ratajczak M, Kubicka MM, Kamińska D, Sawicka P, Długaszewska J. Microbiological quality of non-sterile pharmaceutical products. Saudi Pharmaceutical Journal. 2015;23(3):303-307. https://doi.org/10.1016/j.jsps.2014.11.015
Gad G, Aly R, Ashour M. Microbial Evaluation of Some Non-sterile Pharmaceutical Preparations Commonly Used in the Egyptian Market. Tropical Journal of Pharmaceutical Research. 2011;10(4). https://doi.org/10.4314/tjpr.v10i4.9
Rezende CL e, Castania V de P, Rezende-Lago NCM de, et al. Qualidade microbiológica de alimentos. Research, Society and Development. 2021;10(14):e572101422344. https://doi.org/10.33448/rsd-v10i14.22344
Marcena EC de A, Gomes INP, De Araújo MR dos S, Jácome Júnior AT. Avaliação da presença de Pseudomonas aeruginosa como indicador da qualidade bacteriológica da água utilizada na merenda escolar. Revista Contemporânea. 2024;4(1):96-110. https://doi.org/10.56083/RCV4N1-005
Vorlasane L, Luu MN, Tiwari R, et al. The clinical characteristics, etiologic pathogens and the risk factors associated with dehydration status among under-five children hospitalized with acute diarrhea in Savannakhet Province, Lao PDR. PLoS One. 2023;18(3):e0281650. https://doi.org/10.1371/journal.pone.0281650
##submission.downloads##
Publicado
Cómo citar
Número
Sección
Licencia
Derechos de autor 2024 Felipe Mota Tashiro, Adriana da Silva Carvalho, Igor Rafael dos Santos Magalhães, Karen Regina Carim da Costa Magalhães
Esta obra está bajo una licencia internacional Creative Commons Atribución 4.0.
The author must state that the paper is original (has not been published previously), not infringing any copyright or other ownership right involving third parties. Once the paper is submitted, the Journal reserves the right to make normative changes, such as spelling and grammar, in order to maintain the language standard, but respecting the author’s style. The published papers become ownership of RECI, considering that all the opinions expressed by the authors are their responsibility. Because we are an open access journal, we allow free use of articles in educational and scientific applications provided the source is cited under the Creative Commons CC-BY license.
