Freeman Maisha Kelly, White Whitney, Iranikhah Maryam
Samford University Global Drug Information Service, McWhorter School of Pharmacy, Birmingham, AL, USA.
Consult Pharm. 2012 May;27(5):341-52. doi: 10.4140/TCP.n.2012.341.
To describe the product integrity and ethical/ legal issues associated with tablet splitting.
PubMed (1966-June 2011), International Pharmaceutical Abstract (1975-June 2011), and bibliographic searches were conducted.
All studies that evaluated the weight/dose variations (N = 13) of split tablets were included.
The American Pharmacists Association guidelines, recommendations from the Food and Drug Administration, and clinical studies evaluating product integrity of split tablets were used to provide an overview of issues related to this practice. Legal considerations from various sources were also included.
The practice of tablet splitting is increasing and is associated with variations in drug distributions related to the tablet-splitting technique and other causes. The first part of this two-part series will evaluate the product integrity and practice-related issues associated with tablet splitting.
The majority of the studies associated with tablet splitting reveal large fluctuations in weight/dosage, but few studies evaluate variability with narrow therapeutic index medications. Therefore, the clinical impact of these variations is not globally applicable across medication classes. Although tablet splitting has the potential to save patients and health care organizations a significant amount of money, appropriateness of tablet splitting should be determined for individual medications and individual patients. Assessments should include an evaluation of patient understanding and physical abilities for tablet splitting.
描述与片剂分割相关的产品完整性及伦理/法律问题。
检索了PubMed（1966年至2011年6月）、国际药学文摘（1975年至2011年6月）并进行了文献检索。
纳入所有评估分割片剂重量/剂量差异的研究（N = 13）。
采用美国药剂师协会指南、食品药品监督管理局的建议以及评估分割片剂产品完整性的临床研究，以概述与此做法相关的问题。还纳入了来自各种来源的法律考量。
片剂分割的做法正在增加，并且与片剂分割技术及其他原因导致的药物分布差异有关。这个两部分系列的第一部分将评估与片剂分割相关的产品完整性及实践相关问题。
大多数与片剂分割相关的研究显示重量/剂量存在较大波动，但很少有研究评估窄治疗指数药物的变异性。因此，这些差异的临床影响并非在所有药物类别中都普遍适用。尽管片剂分割有可能为患者和医疗保健机构节省大量资金，但应针对个别药物和个别患者确定片剂分割的适宜性。评估应包括对患者理解能力和片剂分割身体能力的评估。
