Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

Gonçalves, Adriana Cristina de Souza; Reis, Adriano Max Moreira; Marçal, Ana Carolina Gusmão; Bouzada, Maria Cândida Ferrarez

doi:10.1590/s2175-97902017000300252

Cited by 12 publications

(29 citation statements)

References 30 publications

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“…Accordingly, the overall off-label medicine use in ACSH NICU was found to be 67.58%. This was higher compared to several study findings elsewhere in the globe which reported off-label medicine use in the range of 23 to 62% [3,4,9,11,13,14,[20][21][22][23]. However, it was slightly lower compared to a study from India which reported an off-label prescription of 70% [2].…”

Section: Discussioncontrasting

confidence: 75%

“…Of the total (364) prescribed medicines only 23.63% of them were unlicensed for neonatal use. This is higher compared to reports of many studies conducted elsewhere which reported unlicensed medicine use in the range of 1.9-19% [3,11,13,22,23]. However, lower compared to a study done in India in which 56% of the prescriptions were unlicensed for neonatal use [4].…”

Section: Discussioncontrasting

confidence: 59%

“…The same reason was also reported from a study conducted in Iran [3]. However our finding were different from studies conducted in Germany, Brazil and India which reported the commonest reason for being off-label as frequency of administration, dosage form difference, and dose respectively [4,9,13]. This is expected since such difference might be atributed to differences in medicines licensing policy across the countries, disease pattern difference or difference in definitions of off-label medicines used.…”

Section: Discussioncontrasting

confidence: 52%

“…This is slightly higher compared to studies conducted in Germany, Ireland and Iran which reported 69.7-89.9% [3,9,11]. But, this was slightly lower compared to other studies which reported 95.5-99.5% exposure to off-label medicines [12][13][14]. This can be due to lack of evidence on safety and efficacy of the medicines for neonatal use due to their limited data from premarketing studies.…”

Section: Discussionmentioning

confidence: 56%

“…Despite the increased risk of medication error and ADRs, the incidence of off-label/unlicensed medicine is highest among neonates admitted to NICU. For instance many studies reported off-label/unlicensed drug exposure in NICU patients in the range of 38 to 99.5% [3,9,[11][12][13][14] and 1.9% up to 24% [3,11,[14][15][16] respectively.…”

Section: Introductionmentioning

confidence: 99%

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Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit

et al. 2020

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Background: Off-label drug use refers to the use of medicines outside of their marketing authorization with respect to dose, dosage form, route of administration, indication or age. Off-label/unlicensed drug use significantly associated with adverse drug reactions and medication errors in neonates and critically ill neonates are more vulnerable to these problems. Objective: To assess the prevalence and associated factors with off-label and unlicensed drug use in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital. Methods: A cross-sectional study was conducted from March 01,2019 to April 30, 2019 in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital. Neonates admitted for 24 h and took at least one medicine were included in the study. Data was collected from prescription and medical charts. The off-label and license status of the medicine was verified based on European medicine Agency electronic medicine compendium. Data was analyzed by SPSS version 21.0. Binary and multivariate logistic regression was done to assess the predictors of offlabel/unlicensed medicine use at p-value ≤0.05 significance level. Result: A total of 364 medicines prescribed for 122 neonates were analyzed. The prevalence of off-label and unlicensed drug use was 246 (67.58%), and 86 (23.63%) respectively. Of the total 122 neonates, 114(93.44%), and 57(46.72%) of them were exposed to at least one off-label and unlicensed drug respectively. Antibiotics were the most commonly prescribed off-label and unlicensed drugs. No statistically significant association was found between demographic as well as health related variables with off-label/unlicensed medicine use at p-value of ≤0.05 significance level. Conclusion: Off-label and unlicensed medicine use was high among neonates admitted to intensive care unit of the hospital. Selecting the safest medicines for such vulnerable patients is crucial to promote rational prescribing and better therapeutic benefit.

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Section: Discussioncontrasting

confidence: 75%

Section: Discussioncontrasting

confidence: 59%

Section: Discussioncontrasting

confidence: 52%

Section: Discussionmentioning

confidence: 56%

Section: Introductionmentioning

confidence: 99%

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Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit

et al. 2020

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Use of Off-Label Medications in a Neonatal Intensive Care Unit

Koszma

Bispo

Santana

et al. 2021

Rev. paul. pediatr.

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Objective: This paper aims to analyze the use of off label (OL) medicines, according to the National Regulatory Agency, in a neonatal intensive care unit of a high-risk maternity hospital in Northeast Brazil. Methods: A cross-sectional study was carried out, using a convenience sample of newborns that used mechanical ventilation at the Intensive Care Unit. As a reference, OL medications were considered for those without an approval for newborn usage by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) and by the Food and Drugs Administration (FDA). Results: The sample consisted of 158 newborns, 58.3% male, 87.7% premature, and 70.2% of low or very low birth weight. According to ANVISA, 440 out of the 1,167 prescriptions analyzed were OL, with 98.1% of newborns exposed to at least one of these drugs. According to the FDA, 484 prescriptions were OL, with 75.8% of newborns exposed to at least one of them. Anti-infectives were the most prescribed OL medications. Neonates who presented respiratory failure and pneumonia used these drugs more often; and there was no relation between their use and the number of deaths. Conclusions: Nearly all newborns at the Intensive Care Units, mainly preterm infants, are exposed to at least one off-label (OL) medication during hospital stay, according to the national and international regulatory agencies. No association was found between off-label prescriptions and the frequency of complications or neonatal deaths.

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Compounded medications for cardiovascular use in neonatology: an integrative review

Greenhalgh

Passos

Agrizzi

et al. 2023

Rev. paul. pediatr.

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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.

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Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

Cited by 12 publications

References 30 publications

Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit

Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit

Use of Off-Label Medications in a Neonatal Intensive Care Unit

Compounded medications for cardiovascular use in neonatology: an integrative review

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