Or off-label use of antimicrobials in pediatrics
Keywords:
Off-Label use; Antibacterials; Pediatrics.Abstract
To investigate, through an integrative review about the off-label use of antimicrobials in pediatrics. The data survey was consolidated by searching the Virtual Health Library (VHL) for articles indexed in the MEDLINE, LILACS and IBECS databases based on the guiding question: “which reasons and contexts lead to the choice of using off-label antimicrobials? within pediatrics? ” For that, the Health Sciences Descriptors (DeCS) were used: Off-Label Use, Anti-Bacterial Agents, Pediatrics in English and Portuguese. As an inclusion, we adopted publications from 2012-2019 cross-sectional, retrospective, observational, comparative studies and review of clinical trials. Incomplete publications were excluded and they escaped the theme. The application of the descriptors led to 18 articles, which after reading the titles, abstracts and applying the exclusion and inclusion criteria were reduced to a final sample of 6 works to be interpreted to extract the most relevant information on the topic. The analysis of the studies showed that most of the drugs prescribed for children and neonates lack labeling on safety, efficacy and dosage for such public. This stems from the difficulty in carrying out children's pharmacological tests, since the rapid physiological changes make it difficult to determine an appropriate dosage and there are still many ethical challenges for conducting the studies. Therefore, with the present study, it was possible to evidence the wide off-label use of antimicrobial drugs within pediatrics, since clinical trials of drugs for this age group are scarce and adaptation for applicability within the hospital environment is necessary.
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ARÉS ÁLVAREZ, F.; MARTÍNEZ DE LA OSSA SÁENZ-DIEL, J. A. C et al. Uso off-label de medicamentos segundo a idade em crianças brasileiras: um estudo populacional. Rev. bras. epidemiol., Rio de Janeiro, v. 23, e200030, 2020 . Available from <http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1415-790X2020000100419&lng=en&nrm=iso>. access on 12 May 2021. Epub May 11, 2020. https://doi.org/10.1590/1980-549720200030.
BERTHOD, C.; KASSAÏ, B.; BOUSSAGEON, R.; ADELAIDE, L.; JACQUET-LAGRÈZE, M.; LAJOINIE, A. Justification de la prescription hors-AMM d’antibiotiques chez l’enfant hospitalisé. Therapies, v. 72, n. 6, p. 649-658, 2017. https://doi.org/10.1016/j.therap.2017.04.002.
CARNOVALE, C.; CONTI, V.; PERRONE, V. et al. Uso de drogas pediátricas com foco em prescrições off-label na Lombardia e implicações para abordagens terapêuticas. Eur J Pediatr, v. 172, p. 1679–1685, 2013. https://doi.org/10.1007/s00431-013-2111-7
COPPINI, R.; SIMONS, S.H.P.; MUGELLI, A.; ALLEGAERT, K. Clinical research in neonates and infants: Challenges and perspectives. Pharmacological Research, v. 108, p. 80-87, 2016. https://doi.org/10.1016/j.phrs.2016.04.025.
CORNY, J.; BAILEY, B.; LEBEL, D.; BUSSIÈRES, J. F. Unlicensed and of-label drug use in paediatrics in a mother–child tertiary care hospital. Paediatr Child Health, v. 21, n. 2, p. 83–7, 2016.
DAVIS, S. A.; SANDOVAL, L. F.; GUSTAFSON, C. J.; FELDMAN, S. R.; CORDORO, K. M. Treatment of preadolescent acne in the United States: An analysis of nationally representative data. Pediatric Dermatology, vol. 30, no. 6, p. 689–694, 2013. https://doi.org/10.1111/pde.12201.
FERREIRA, L. de A.; IBIAPINA, C. da C.; MACHADO, M. G. P.; FAGUNDES, E. D. T. A alta prevalência de prescrições de medicamentos off-label e não licenciados em unidade de terapia intensiva pediátrica brasileira. Revista da Associacao Medica Brasileira, vol. 58, no. 1, p. 82–87, 2012. https://doi.org/10.1590/S0104-42302012000100019.
GARNER, S. E.; EADY, A.; BENNETT, C.; NEWTON, J. N.; THOMAS, K.; & POPESCU, C. M. Minociclina para acne vulgar: eficácia e segurança. Banco de Dados Cochrane de Revisões Sistemáticas, 2012. doi: 10.1002 / 14651858.cd002086.pub2
LÓPEZ, R.; ALFAYATE MIGUÉLEZ, S. Revisión Quinolonas en Pediatría. Pediatría Atención Primaria, vol. 19, no. 74, p. e83–e92, 2017.
GONCALVES, M. G & HEINECK, Isabela. Frequência de prescrições de medicamentos off-label e não aprovados para uso pediátrico na atenção primária à saúde em município do sul do Brasil. Rev. paul. pediatr., São Paulo, v. 34, n. 1, pág. 11 a 17 de março de 2016. Disponível em <http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0103-05822016000100011&lng=en&nrm=iso>. acesso em 12 de maio de 2021. https://doi.org/10.1016/j.rppede.2015.06.023 .
MACÊDO, A. L de S. A importância do farmacêutico no preparo e manipulação das doses de medicamentos pediátrico. Comunicação científica e técnica em medicina 4, Ponta Grossa, PR: Atena, p. 1-6, 2020. DOI 10.22533/at.ed.941201609
OSHIKOYA, K. A.; WHARTON, G. T.; AVANT, D.; VAN DRIEST, S. L.; FENN, N. E.; LARDIERI, A.; DOE, E.; SOOD, B. G.; TAKETOMO, C.; LIEU, P.; YEN, L.; MCMAHON, A. W. Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review. Pediatric Drugs, vol. 21, no. 1, p. 47–58, 2019. DOI 10.1007/s40272-018-0318-9. Available at: https://doi.org/10.1007/s40272-018-0318-9.
MENDES, K. D. S.; SILVEIRA, R. C. C. P.; GALVÃO, C. M. Revisão integrativa: método de pesquisa para a incorporação de evidências na saúde e na enfermagem. Texto contexto – enferm., Florianópolis, v. 17, n. 4, p. 758-64, 2008. Acesso em: 2 jun. 2020.
TEIXEIRA, E. et al. Integrativeliteraturereviewstep-by-step&convergenceswithothermethodsofreview. RevEnferm UFPI, Teresina, v. 2, n. spe, p. 3-7, 2013. Acesso em: 2 jun. 2020.
SOUZA, M. T.; SILVA, M. D.; CARVALHO, R. Integrative review: whatis it? How to do it? Einstein, São Paulo, v. 8, n. 1, p. 102-6, 2010. Acesso em: 2 jun. 2020.
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