Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan
| العنوان: | Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan |
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| المؤلفون: | Mayumi Torimoto, Mami Obara, Naoki Yoshikawa, Kazuhiro Yamamoto, Takeshi Enokihara, Kanako Iino, Naoki Mitsuya, Hiroaki Nagai, Wakako Sakata, Rie Kihara, Mariko Araki, Hiroki Katsu, Mari Hashimoto, Yuta Takahashi, Ran Watanabe, Yuki Hasegawa, Masahiko Nakao, Jumpei Saito, Tomoya Takeda, Kinuko Imai, Naomi Nadatani, Hitomi Takahashi, Toshimi Kimura, Masaki Wada, Makoto Setoguchi, Keiko Kobayashi, Rina Kishi, Naoko Fujiwara, Sayaka Katayama, Toshihiro Yokoyama, Naoko Akiyama, Mayuri Sameshima, Hiroaki Matsumoto, Ayano Tanzawa, Akimasa Yamatani, Kumiko Fushimi, Hitomi Kimura, Yukihiro Hamada, Mei Suenaga |
| المصدر: | Journal of Pharmaceutical Health Care and Sciences, Vol 7, Iss 1, Pp 1-9 (2021) Journal of Pharmaceutical Health Care and Sciences |
| بيانات النشر: | BMC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, Acceptable daily intake, Package insert, Pharmacology (nursing), RM1-950, 01 natural sciences, Enteral administration, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacotherapy, Neonate, Pharmacy and materia medica, Excipient, Parenteral, 030225 pediatrics, Intensive care, Internal medicine, medicine, Pharmacology (medical), Medical prescription, Enteral, Aspartame, business.industry, 0104 chemical sciences, Paraben, RS1-441, 010404 medicinal & biomolecular chemistry, chemistry, Topical, Comparative study, Therapeutics. Pharmacology, business, Research Article |
| الوصف: | BackgroundA multicenter investigation of neonate exposure to potentially harmful excipients (PHEs) in neonatal intensive care units (NICUs) in Japan has not been conducted.MethodsA 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.ResultsPrescription 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.ConclusionsNeonates 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. |
| اللغة: | English |
| تدمد: | 2055-0294 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f0f2c6776e8c9d840cf24b2708106ba2 https://doaj.org/article/a399b5936e0140ab9d25acaba683ca91 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....f0f2c6776e8c9d840cf24b2708106ba2 |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 20550294 |
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