Objective: To describe the product integrity and ethical/ legal issues associated with tablet splitting.
Data sources: PubMed (1966-June 2011), International Pharmaceutical Abstract (1975-June 2011), and bibliographic searches were conducted.
Study selection: All studies that evaluated the weight/dose variations (N = 13) of split tablets were included.
Data extraction: 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.
Data synthesis: 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.
Conclusion: 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.