Chaney R F, Summerfield M R
Am J Hosp Pharm. 1984 Jun;41(6):1150-2.
A national survey was conducted to determine the policies of hospital pharmacies regarding expiration dates for repackaged pharmaceuticals. A cover letter, questionnaire, and self-addressed stamped envelope were mailed to the directors of pharmacy of 360 randomly selected hospitals. Definitions of bulk and extemporaneous repackaging were provided. The response rate was 57%. Less than one third of the responding institutions followed the current FDA recommendations for dating oral solids repackaged in bulk. Almost one quarter used the manufacturer's date. Only 5.6% of the hospitals used more conservative dating. Similar percentages were found for the dating of oral liquids. One third of the hospitals used 30-90 days to date repackaged injectables ; however, a large range of expiration dates was reported. Almost one third of the hospitals applied the current FDA bulk repackaging dating recommendations to extemporaneous repackaging . A large percentage (29% for oral solids and 31% for oral liquids) used the manufacturer's date. A wide variety of arbitrarily assigned expiration dates are being used by hospital pharmacists in the bulk and extemporaneous repackaging of oral solids, liquids, and injections.
开展了一项全国性调查,以确定医院药房关于重新包装药品有效期的政策。一封附信、问卷以及回邮信封被寄给了随机挑选的360家医院的药房主任。提供了批量和临时重新包装的定义。回复率为57%。不到三分之一的回复机构遵循美国食品药品监督管理局(FDA)目前关于批量重新包装口服固体制剂有效期标注的建议。近四分之一的机构使用制造商标注的日期。只有5.6%的医院采用更保守的有效期标注。口服液体剂有效期标注的情况类似。三分之一的医院对重新包装的注射剂标注30至90天的有效期;然而,报告的有效期范围很大。近三分之一的医院将FDA目前关于批量重新包装的有效期标注建议应用于临时重新包装。很大比例(口服固体制剂为29%,口服液体剂为31%)的医院使用制造商标注的日期。医院药剂师在口服固体制剂、液体剂和注射剂的批量及临时重新包装中使用了各种各样任意设定的有效期。