Department of Pharmaceuticals, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan.
Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan.
Eur J Pharm Biopharm. 2020 Oct;155:122-127. doi: 10.1016/j.ejpb.2020.08.016. Epub 2020 Aug 24.
Compounding of medications, such as crushing tablets and dispersing the contents of capsules, is a common practice in pharmacies and hospitals worldwide and is often done to provide age-appropriate formulations for oral use in pediatric patients. In the present study, a retrospective, descriptive, questionnaire-based survey was conducted to clarify the current status of drug compounding for pediatric patients in Japan. An electronic questionnaire was distributed to 740 hospitals in Japan with pediatric beds, and 208 (28.1%) of these hospitals responded. The total instances of compounding numbered 14,864 (9.6% of the total pediatric oral prescriptions) and comprised 266 active pharmaceutical ingredients (APIs), one-third of which (98 APIs) were compounded even though flexible dosage forms were available. The three most frequently compounded drugs were dantrolene sodium capsules (1152 prescriptions), ramelteon tablets (726 prescriptions), and hydrocortisone tablets (652 prescriptions), all of which were prescribed and administered in powder form. Although compounding of medications frequently varied by the patients' age, steroids such as prednisolone, dexamethasone, and hydrocortisone were commonly compounded in all age groups. To ensure the quality and safety of these compounded medications, developing a standard protocol for compounding methods is urgently needed in Japan.
药物配制，如压碎片剂和分散胶囊内容物，是全球范围内药房和医院的常见做法，通常用于为儿科患者提供适合年龄的口服制剂。在本研究中，进行了一项回顾性、描述性、基于问卷的调查，以阐明日本儿科患者药物配制的现状。向日本有儿科床位的 740 家医院分发了电子问卷，其中 208 家（28.1%）做出了回应。共配制了 14864 例（占儿科口服处方总数的 9.6%），涉及 266 种活性药物成分（APIs），其中三分之一（98 种 APIs）即使有灵活的剂型也进行了配制。配制最多的三种药物是丹曲林钠胶囊（1152 剂）、雷美替胺片（726 剂）和氢化可的松片（652 剂），均以粉末形式开具和给药。尽管药物配制经常因患者年龄而异，但泼尼松龙、地塞米松和氢化可的松等类固醇在所有年龄段都经常配制。为了确保这些配制药物的质量和安全性，在日本迫切需要制定配制方法的标准协议。
