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配制临时制剂的药房操作规范。

Practices of pharmacies that compound extemporaneous formulations.

作者信息

Treadway Angela K, Craddock Deeatra, Leff Richard

机构信息

Department of Pharmacy Practice, School of Pharmacy, Texas Tech University Health Sciences Center, Dallas, TX 75216, USA.

出版信息

Am J Health Syst Pharm. 2007 Jul 1;64(13):1403-9. doi: 10.2146/ajhp060251.

Abstract

PURPOSE

A survey was conducted to characterize the standard of practice for extemporaneous pharmaceutical compounding within community and institutional pharmacies.

METHODS

Extemporaneous compounding practices vary among pharmacies. Because of this, the survey inquired specifically about a single pharmaceutical product (caffeine citrate 20 mg/mL) to minimize variability among respondents. Survey questions were written to identify compounding practice variations with (1) policies and procedures, (2) process validation, (3) personnel education, training, and evaluation, (4) expiration dating, (5) storage and handling of compounded prescriptions within the pharmacy, (6) labeling, (7) facilities and equipment, (8) end-product evaluation, (9) handling of sterile products outside of the pharmacy, (10) aseptic technique and product preparation, and (11) documentation.

RESULTS

A total of 522 surveys were mailed; 117 completed surveys were returned and included in the analyses. Over half of the pharmacies surveyed were large institutional pharmacies with daily prescriptions exceeding 300. Almost 71% of pharmacies reported having policies and procedures for compounding and providing compounding training for staff. Almost one third of the pharmacies that responded did not have compounding policies and procedures and did not provide staff training. For those pharmacies that provided training, the methods used were diverse (e.g., lectures and videotapes, external certificate programs). Formulations used to compound caffeine appeared to be diverse as evidenced by the varied addition of inactive ingredients.

CONCLUSION

A survey of compounding pharmacies found variability in overall compounding practices and training and in practices specifically related to compounding preparations of caffeine citrate.

摘要

目的

开展一项调查,以描述社区药房和机构药房中临时调配药品的实践标准。

方法

各药房的临时调配实践存在差异。因此,该调查专门询问了单一药品(枸橼酸咖啡因20mg/mL),以尽量减少受访者之间的差异。调查问题旨在识别在以下方面的调配实践差异:(1)政策与程序;(2)工艺验证;(3)人员教育、培训与评估;(4)有效期;(5)药房内调配处方的储存与处理;(6)标签;(7)设施与设备;(8)终产品评估;(9)药房外无菌产品的处理;(10)无菌技术与产品制备;以及(11)文件记录。

结果

共邮寄了522份调查问卷;117份完成的调查问卷被收回并纳入分析。超过半数接受调查的药房是大型机构药房,每日处方量超过300份。近71%的药房报告有调配政策与程序,并为员工提供调配培训。近三分之一做出回应的药房没有调配政策与程序,也未提供员工培训。对于那些提供培训的药房,所采用的方法多种多样(例如讲座、录像带、外部认证项目)。从辅料添加的多样性可以看出,用于调配咖啡因的配方似乎也各不相同。

结论

对调配药房的一项调查发现,总体调配实践、培训以及与枸橼酸咖啡因调配制剂具体相关的实践存在差异。

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