scholarly journals Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jumpei Saito ◽  
Naomi Nadatani ◽  
Makoto Setoguchi ◽  
Masahiko Nakao ◽  
Hitomi Kimura ◽  
...  
Keyword(s):  
Observational Study ◽  
Benzyl Alcohol ◽  
Propylene Glycol ◽  
Demographic Data ◽  
Daily Intake ◽  
Package Insert ◽  
Prescription Data ◽  
Polysorbate 80 ◽  
Nationwide Observational Study ◽  
Harmful Excipients

Abstract Background A multicenter investigation of neonate exposure to potentially harmful excipients (PHEs) in neonatal intensive care units (NICUs) in Japan has not been conducted. Methods A multicenter nationwide observational study was conducted. Neonate patient demographic data and information on all medicines prescribed and administered during hospitalization on 1 day between November 2019 and March 2021 were extracted from the medical records. Nine PHEs, paraben, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol, benzalkonium chloride, and aspartame, were selected. PHEs were identified from the package insert and the Interview Form. The quantitative daily exposure was calculated if quantitative data were available for each product containing the PHE. Results Prescription data was collected from 22 NICUs in Japan. In total, 343 neonates received 2360 prescriptions for 426 products containing 228 active pharmaceutical ingredients. PHEs were found in 52 (12.2%) products in 646 (27.4%) prescriptions for 282 (82.2%) neonates. Benzyl alcohol, sodium benzoates, and parabens were the most common PHEs in parenteral, enteral, and topical formulations, respectively. Quantitative analysis showed that 10 (10%), 38 (42.2%), 37 (94.9%), and 9 (39.1%) neonates received doses exceeding the acceptable daily intake of benzyl alcohol, polysorbate 80, propylene glycol, and sorbitol, respectively. However, due to the lack of quantitative information for all enteral and topical products, accurate daily PHE exposure could not be quantified. Conclusions Neonates admitted to NICUs in Japan were exposed to PHEs, and several of the most commonly prescribed medicines in daily clinical practice in NICUs contained PHEs. Neonate PHE exposure could be reduced by replacing these medicines with available PHE-free alternatives.

Potentially harmful excipients in neonatal medicines: a pan-European observational study

2015 ◽  
Vol 100 (7) ◽  
pp. 694-699 ◽  
Author(s):  
Georgi Nellis ◽  
Tuuli Metsvaht ◽  
Heili Varendi ◽  
Karolin Toompere ◽  
Jana Lass ◽  
...  
Keyword(s):  
Propylene Glycol ◽  
Anatomical Therapeutic Chemical ◽  
Demographic Data ◽  
Active Pharmaceutical Ingredient ◽  
Geographical Region ◽  
Polysorbate 80 ◽  
Free Products ◽  
Saccharin Sodium ◽  
Anatomical Therapeutic Chemical Class ◽  
Harmful Excipients

ObjectivesWe aimed to describe administration of eight potentially harmful excipients of interest (EOI)—parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride—to hospitalised neonates in Europe and to identify risk factors for exposure.MethodsAll medicines administered to neonates during 1 day with individual prescription and demographic data were registered in a web-based point prevalence study. Excipients were identified from the Summaries of Product Characteristics. Determinants of EOI administration (geographical region, gestational age (GA), active pharmaceutical ingredient, unit level and hospital teaching status) were identified using multivariable logistical regression analysis.ResultsOverall 89 neonatal units from 21 countries participated. Altogether 2095 prescriptions for 530 products administered to 726 neonates were recorded. EOI were found in 638 (31%) prescriptions and were administered to 456 (63%) neonates through a relatively small number of products (n=142; 27%). Parabens, found in 71 (13%) products administered to 313 (43%) neonates, were used most frequently. EOI administration varied by geographical region, GA and route of administration. Geographical region remained a significant determinant of the use of parabens, polysorbate 80, propylene glycol and saccharin sodium after adjustment for the potential covariates including anatomical therapeutic chemical class of the active ingredient.ConclusionsEuropean neonates receive a number of potentially harmful pharmaceutical excipients. Regional differences in EOI administration suggest that EOI-free products are available and provide the potential for substitution to avoid side effects of some excipients.

Temporal trends in the epidemiology, management and outcome of sepsis – a nationwide observational study

2022 ◽  
Author(s):  
Edda Vesteinsdottir ◽  
Martin Ingi Sigurdsson ◽  
Magnus Gottfredsson ◽  
Asbjorn Blondal ◽  
Sigurbergur Karason
Keyword(s):  
Observational Study ◽  
Temporal Trends ◽  
Nationwide Observational Study

scholarly journals Associations between COVID-19 Incidence Rates and the Exposure to PM2.5 and NO2: A Nationwide Observational Study in Italy

2020 ◽  
Vol 17 (24) ◽  
pp. 9318
Author(s):  
Fabiana Fiasca ◽  
Mauro Minelli ◽  
Dominga Maio ◽  
Martina Minelli ◽  
Ilaria Vergallo ◽  
...  
Keyword(s):  
Population Density ◽  
Observational Study ◽  
Air Pollutants ◽  
Regression Models ◽  
Positive Relationship ◽  
The Elderly ◽  
Incidence Rates ◽  
Multiple Factors ◽  
Epidemic Period ◽  
Nationwide Observational Study

The COVID-19 outbreak disproportionately affected the elderly and areas with higher population density. Among the multiple factors possibly involved, a role for air pollution has also been hypothesized. This nationwide observational study demonstrated the significant positive relationship between COVID-19 incidence rates and PM2.5 and NO2 levels in Italy, both considering the period 2016–2020 and the months of the epidemic, through univariate regression models, after logarithmic transformation of the variables, as the data were not normally distributed. That relationship was confirmed by a multivariate analysis showing the combined effect of the two pollutants, adjusted for the old-age index and population density. An increase in PM2.5 and NO2 concentrations by one unit (1 µg/m3) corresponded to an increase in incidence rates of 1.56 and 1.24 × 104 people, respectively, taking into account the average levels of air pollutants in the period 2016–2020, and 2.79 and 1.24 × 104 people during March–May 2020. Considering the entire epidemic period (March–October 2020), these increases were 1.05 and 1.01 × 104 people, respectively, and could explain 59% of the variance in COVID-19 incidence rates (R2 = 0.59). This evidence could support the implementation of targeted responses by focusing on areas with low air quality to mitigate the spread of the disease.

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