Compounded medications for cardiovascular use in neonatology: an integrative review

Greenhalgh, Lucas Louro; Passos, Márcia Maria Barros dos; Agrizzi, Arthur Lopes; Monteiro, Mariana Sato de Souza Bustamante

doi:10.1590/1984-0462/2023/41/2021167

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Brasil

Revista Paulista de Pediatria

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Brasil

Español English

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Review Article • Rev. paul. pediatr. 41 • 2023 • https://doi.org/10.1590/1984-0462/2023/41/2021167 copy

Compounded medications for cardiovascular use in neonatology: an integrative review

Medicamentos manipulados de uso cardiovascular em neonatologia: uma revisão integrativa

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective:

To analyze the profile of the compounded cardiovascular medicines prescribed in neonatology in Brazil.

Data source:

An integrative bibliographic review was carried out, including studies published in the last 20 years. The used descriptors were: Intensive Care Neonatal, Off-Label Use, Pharmaceutical Preparations, in the databases Virtual Health Library (VHL), PubMed, and Scientific Electronic Library Online (SciELO). Review articles and guidelines were excluded. The quality of the evidence was analyzed, and 10 articles were selected to integrate the study.

Data synthesis:

The profile of routine prescrption in the neonatal unit was evaluated. The main cardiovascular medications prescribed as compounding formulation were: Spironolactone, Captopril, Furosemide, Hydrochlorothiazide, Propranolol, Amiodarone, Nifedipine, Carvedilol, Digoxin, Enalapril, Epinephrine, and Hydralazine. The drugs were obtained from adaptations of dosage forms, through the transformation of capsules or tablets into liquid formulations, as a solution, suspension, or syrup, as well as in the form of solutions prepared from active pharmaceutical ingredients. The compounding of medications made drug therapy possible in neonatology, considering that such medications do not have registration of the oral liquid dosage form in the country, despite being part of the List of Essential Medicines for Children of the Word Health Organization.

Conclusions:

It was possible to analyze the profile of compounded cardiovascular medicines prescribed in neonatology in Brazil. The results showed the need for the development of medications suitable for the neonatal population, and the standardization of operational procedures for preparing extemporaneous formulations in neonatology to increase drug safety.

Keywords:
Drugs utilization; Infant, newborn; Pharmaceutical preparations; Off-label use; Intensive care units, neonatal

Study	Study design	Objectives	Mentions of cardiovascular medicines
Passos et al., 2020²⁵25 Passos MM, Andrade AC, Villa AL, Fonseca R, Monteiro MS. Manipulated drugs for newborns. Rev Ped SOPERJ. 2020;20:37-43. https://doi.org/10.31365/issn.2595-1769.v20i2p37-43 https://doi.org/10.31365/issn.2595-1769....	Retrospective descriptive study	To describe the prescriptions of compounded medications for neonate patients and verify their pharmacotechnical preparation	NICU: Spironolactone, Captopril, Furosemide, Hydrochlorothiazide, Propranolol
Costa et al., 2018¹³13 Costa HT, Costa TX, Martins RR, Oliveira AG. Use of off-label and unlicensed medicines in neonatal intensive care. PLoS One. 2018;13:e0204427. https://doi.org/10.1371/journal.pone.0204427 https://doi.org/10.1371/journal.pone.020...	Prospective cohort study	To evaluate the use of off-label and unlicensed medicines in a NICU of a maternity teaching hospital specialized in high-risk pregnancy	NICU: Spironolactone, Furosemide, and Hydrochlorothiazide
Britto et al., 2017²⁶26 Britto JF, Messias GC, Souza EP, Prado NM. Use of extemporaneous magistral preparations in pediatric patients of a public hospital. Saúde.com. 2017;13:797-805. https://doi.org/10.22481/rsc.v13i1.374 https://doi.org/10.22481/rsc.v13i1.374...	Descriptive study	To describe the use profile of pediatric magistral formulations in a public maternal and child hospital, reference in southwest Bahia (Brazil).	P+N: Captopril, Spironolactone, Hydrochlorothiazide
Gonçalves et al., 2017²⁷27 Gonçalves AC, Reis AM, Marçal AC, Bouzada MC. Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital. Braz J Pharm Sci. 2017;53:e00252. https://doi.org/10.1590/s2175-97902017000300252 https://doi.org/10.1590/s2175-9790201700...	Prospective study	To investigate the use of off-label drugs in NICUs according to ANVISA and the FDA	NICU: Amiodarone, Captopril, Carvedilol, Spironolactone, Furosemide, Hydrochlorothiazide, Nifedipine
Pereira et al., 2016²⁸28 Pereira AC, Miranda ES, Castilho SR, Futuro DO, Teixeira LA, Paula GR. Magistral drugs in hospitalized newborns and children. Rev Paul Pediatr. 2016;34:403-7. https://doi.org/10.1016/j.rpped.2016.02.002 https://doi.org/10.1016/j.rpped.2016.02....	Descriptive study	To study the use of magisterial oral solutions and suspensions in newborns and children at a university hospital	P+N: Amiodarone, Captopril, Enalapril, Spironolactone, Furosemide, Hydralazine, Hydrochlorothiazide, Propranolol
Souza Junior et al., 2016²⁹29 Souza Junior AS, Santos DB, Rey LC, Medeiros MG, Vieira MG, Coelho HL. Off-label use and harmful potential of drugs in a NICU in Brazil: a descriptive study. BMC Pediatr. 2016;16:13. https://doi.org/10.1186/s12887-016-0551-8 https://doi.org/10.1186/s12887-016-0551-...	Retrospective cohort study	To describe the drugs prescribed for different groups of neonates admitted to the NICU and to analyze the off-label use and the harmful potential of the drugs	NICU: Spironolactone, Captopril, Furosemide, Propranolol, Epinephrine (the type of transformation is not mentioned in the study)
Dos Santos et al., 2012³⁰30 Dos Santos L, Heineck I. Drug utilization study in pediatric prescriptions of a university hospital in southern Brazil: off-label, unlicensed and high-alert medications. Farm Hosp. 2012;36:180-6. https://doi.org/10.1016/j.farma.2010.12.008 https://doi.org/10.1016/j.farma.2010.12....	Cross-sectional study	To describe and determine the extent of use of unlicensed, off-label, and high-risk drugs in the general pediatric units of a university hospital in southern Brazil	P+N: Spironolactone, Furosemide
Ferreira et al., 2012³¹31 Ferreira AL, Ibiapina CC, Machado MG, Fagundes ED. High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit. Rev Assoc Med Bras (1992). 2012;58:82-7. https://doi.org/10.1016/S2255-4823(12)70159-5 https://doi.org/10.1016/S2255-4823(12)70...	Cross-sectional study	To describe the use and determine the prescription prevalence of off-label and unlicensed medicines in a pediatric intensive care unit of a hospital in southeastern Brazil	P+N: Captopril, Furosemide, Hydrochlorothiazide
Costa et al., 2009³3 Costa PQ, Lima JE, Coelho HL. Prescrição e preparo de medicamentos sem formulação adequada para crianças: um estudo de base hospitalar. Braz J Pharm Sci. 2009;45:57-66. https://doi.org/10.1590/S1984-82502009000100007 https://doi.org/10.1590/S1984-8250200900...	Descriptive study	To identify drugs whose dosage form or formulation represents a problem in pediatrics (problem medication)	P+N: Captopril, Digoxin, Spironolactone, Furosemide, Hydrochlorothiazide, Nifedipine
Costa et al., 2009³²32 Costa PQ, Rey LC, Coelho HL. Lack of drug preparations for use in children in Brazil. J Pediatr. 2009;85:229-35. https://doi.org/10.2223/JPED.1896 https://doi.org/10.2223/JPED.1896...	Descriptive study	To identify drugs that present difficulties for their pediatric use in Brazil	P+N: Captopril, Spironolactone, Hydrochlorothiazide, Propranolol

Medicines	ATC code	Registration of the oral liquid dosage form in the United Kingdom	Registration of the oral liquid dosage form in Brazil
Spironolactone	C03DA01	Yes	No
Hydrochlorothiazide	C03AA03	No	No
Furosemide	C03CA01	Yes	No
Captopril	C09AA01	Yes	No
Propranolol	C07AA05	Yes	No
Enalapril	C09AA02	No	No
Carvedilol	C07AG02	No	No
Hydralazine	C02DB02	No	No

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E-mail: rpp@spsp.org.br

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[1] *Corresponding author. E-mail: mmbpassos@gmail.com (M. M. Barros dos Passos).