Microbiological control of adapted liquid dosage forms in a pediatric hospital from Manaus

Authors

  • Felipe Mota Tashiro
  • Adriana da Silva Carvalho
  • Igor Rafael dos Santos Magalhães
  • Karen Regina Carim da Costa Magalhães Universidade Federal do Amazonas

DOI:

https://doi.org/10.17058/reci.v14i3.19484

Keywords:

Farmacopeia Brasileira, Hospitais Pediátricos, Preparações Farmacêuticas

Abstract

Background and Objectives: Ideal dosage forms for pediatric use are liquid because this population has difficulty swallowing. However, the pharmaceutical market does not have a large arsenal. To solve this situation, it is necessary to adapt drugs intended for the adult public in the form of oral solutions that allow the use of pediatric patients. Such practice changes the physicochemical and microbiological properties of these drugs. Most studies on pharmaceutical adaptations are directed to the physicochemical stability. Therefore, this study aimed to perform microbiological control of liquid pharmaceutical forms adapted in a pediatric hospital. Methods: Microbiological analysis was performed according to the specifications of the Brazilian Pharmacopoeia for non-sterile products. The total number of mesophilic microorganisms and the presence of pathogenic microorganisms were counted. Results: During the study period, 36 pharmaceutical adaptations were prepared in the hospital and then, after applying exclusion criteria, 16 samples were selected for microbiological analysis. The most common classes were diuretics, antihypertensives and psycholeptics. No preservatives were used in the preparation of the analyzed pharmaceutical adaptations. Half of the adaptations had a total number of mesophilic microorganisms above the allowed limit on the day of manipulation, 43.75% in the middle of the shelf life and 62.5% in the end of the shelf life. Conclusion: Only 03 (18.75%) adaptations were within the acceptable microbial limits established throughout the study. Regarding the presence of pathogens, all were free from the pathogens Escherichia coli, Salmonella sp., Pseudomonas aeruginosa and Staphylococcus aureus during the study period.

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References

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

Published

2024-11-11

How to Cite

Mota Tashiro, F., da Silva Carvalho, A., dos Santos Magalhães, I. R., & Carim da Costa Magalhães, K. R. (2024). Microbiological control of adapted liquid dosage forms in a pediatric hospital from Manaus. Revista De Epidemiologia E Controle De Infecção, 14(3). https://doi.org/10.17058/reci.v14i3.19484

Issue

Section

ORIGINAL ARTICLE