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动物患者的药物配制:当代问题

Compounding for animal patients: contemporary issues.

作者信息

Lust Elaine

机构信息

Department of Pharmacy Sciences, School of Pharmacy and Health Professions, Creighton University, 2500 California Plaza, Omaha, NE 68178, USA.

出版信息

J Am Pharm Assoc (2003). 2004 May-Jun;44(3):375-84; quiz 384-6. doi: 10.1331/154434504323064011.

Abstract

OBJECTIVES

To provide background information relating to the growth observed in veterinary compounding, discuss positive contributions made to animal health via compounding, present compounding practices that are in the best interest of patient care, present documents available to pharmacists to use for guidance when practicing veterinary pharmacy, and emphasize the need for education among stakeholders on the subject of veterinary compounding.

DATA SOURCES

The Animal Medicinal Drug Use Clarification Act of 1994, compliance policy guide section 608.400, the American Veterinary Medical Association Position Statement on Compounding and Extralabel Drug Use Algorithm; supporting data from veterinary and pharmacy literature documenting the practice of veterinary compounding are referenced (SilverPlatter Medline 1966-2002 and International Pharmaceutical Abstracts; 1970 through December 2002; no restrictions; search terms, veterinary AND compounding).

STUDY SELECTION

By the author.

DATA EXTRACTION

By the author.

DATA SYNTHESIS

Requests for compounding of products for veterinary uses are common in community pharmacy, and these preparations fill many clinical, dosing, and drug-administration needs in the care of companion animals. However, like other elements of pharmacy compounding, preparation of veterinary products falls into a legally gray area that is the subject of current scrutiny by the U.S. Food and Drug Administration (FDA). Pharmacists involved in this practice should keep the best interests of the animal in mind; recognize limitations about safety, effectiveness, and stability of compounded formulations; and avoid preparing products similar in ingredients and purpose as commercially available, FDA-approved products. Situations in which compounding becomes manufacturing invites enforcement action by FDA. The dispensing of compounded products should be based on a valid veterinarian-client-patient relationship and comply with federal acts, FDA's compounding compliance policy guide, and other such resources.

CONCLUSION

All pharmacists and pharmacies engaged in any type of veterinary pharmacy practice must be aware of the contemporary issues facing their profession. Best patient care practices, education, and open communication among stakeholders will play a critical role in the practice and future regulation of veterinary compounding.

摘要

目标

提供与兽用复方制剂增长相关的背景信息,讨论复方制剂对动物健康的积极贡献,介绍符合患者护理最佳利益的复方制剂操作方法,展示可供药剂师在从事兽用药学实践时用于指导的文件,并强调利益相关者之间就兽用复方制剂主题进行教育的必要性。

数据来源

1994年《动物医药使用澄清法案》、合规政策指南第608.400节、美国兽医医学协会关于复方制剂和超说明书用药算法的立场声明;引用了来自兽医和药学文献的支持数据,这些数据记录了兽用复方制剂的实践情况(SilverPlatter Medline 1966 - 2002年以及《国际药学文摘》;1970年至2002年12月;无限制;检索词:兽医与复方制剂)。

研究选择

由作者完成。

数据提取

由作者完成。

数据综合

在社区药房中,兽用产品的复方制剂需求很常见,这些制剂满足了伴侣动物护理中的许多临床、给药和药物管理需求。然而,与药学复方制剂的其他方面一样,兽用产品的制备处于法律灰色地带,目前正受到美国食品药品监督管理局(FDA)的审查。参与此项实践的药剂师应牢记动物的最佳利益;认识到复方制剂在安全性、有效性和稳定性方面的局限性;避免制备成分和用途与市售的、FDA批准的产品相似的产品。复方制剂变成生产行为的情况会招致FDA的执法行动。复方制剂产品的调配应基于有效的兽医 - 客户 - 患者关系,并符合联邦法律、FDA的复方制剂合规政策指南及其他此类资源的要求。

结论

所有从事任何类型兽用药学实践的药剂师和药房都必须了解其职业面临的当代问题。最佳的患者护理实践、教育以及利益相关者之间的开放沟通将在兽用复方制剂的实践和未来监管中发挥关键作用。

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