Objective: To review the chemistry, pharmacology, pharmacokinetics, safety, and efficacy of ribociclib (LEE011, Kisqali) in hormone receptor–positive/human epidermal growth factor receptor-2–negative (HR+/HER2−) metastatic breast cancer. Data Sources: A PubMed search was performed using the terms ‘Ribociclib’, ‘Kisqali’, and ‘LEE011’ between May 2018 and November 2018. References of published articles and reviews were also assessed for additional information. Study Selection and Data Extraction: English-language preclinical and clinical studies on the chemistry, pharmacology, pharmacokinetics, safety, and efficacy of ribociclib were evaluated. Data Synthesis: Ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, is Food and Drug Administration (FDA) approved in combination with endocrine therapy for treatment of HR+/HER2− advanced or metastatic breast cancer in premenopausal/perimenopausal and postmenopausal women. Three phase III trials have evaluated ribociclib in combination with endocrine therapy, including letrozole, anastrozole, tamoxifen, and fulvestrant. These studies found that ribociclib 600 mg/d, 21 days on, 7 days off, leads to a significantly greater median progression-free survival (PFS), ranging from 8 to 13 months. Ribociclib is well tolerated in elderly patients, maintains health-related quality of life, and significantly reduces pain scores. The dose-limiting toxicities found in phase I studies were neutropenia, thrombocytopenia, and QTc prolongation. Common adverse effects seen in phase III trials include neutropenia, leukopenia, nausea, diarrhea, vomiting, and fatigue. Relevance to Patient Care and Clinical Practice: Literature on the safety and efficacy of ribociclib as well as its place in therapy in comparison to other FDA-approved CDK4/6 inhibitors for breast cancer is discussed. Conclusions: Ribociclib, when added to endocrine therapy, significantly improves PFS and has manageable toxicity in premenopausal/perimenopausal and postmenopausal women with HR+/HER2− advanced breast cancer.

The impact of clinical pharmacy transitions of care (TOC) services on relevant quality measures (QMs) has been a major focus in the recent biomedical literature. The 2020 ACCP Transitions of Care Task Force was charged with updating a 2012 white paper that focused on process indicators of quality clinical pharmacy services during TOC. The Task Force extensively reviewed the recent literature and regulatory measures relevant to TOC services. Given the wide heterogeneity and apparent uncertainty in these measures, the Task Force identified a need to define broader groupings for QMs so that pharmacy TOC services could more be reliably compared across various institutions and practice settings. The Task Force recommends QMs for the processes used to identify, and ultimately resolve, medication discrepancies (QM‐1) and medication therapy problems (MTPs) (QM‐2). Although interventions through various processes can be used to resolve medication discrepancies and MTPs, the findings of these interventions are closely aligned with the major outcomes from these TOC services. Therefore, the Task Force strongly recommends that the successful resolution of medication discrepancies and MTPs be studied for their potential roles as intermediate, or surrogate, QMs (iQM‐1, iQM‐2, respectively) because these are most likely to directly influence or predict quality related to major outcomes from TOC services. In addition, three QMs related to major outcomes are recommended, which are consistent with the triple aim: QM‐3: Health Care Utilization (HCU), QM‐4: Satisfaction and Engagement, and QM‐5: Economics. QM‐3, QM‐4, and QM‐5 span patient‐centered outcomes to institutional, or clinician‐based, outcomes. Specific metrics used for each QM are recommended. In addition to highlighting confounding variables affecting findings in the recent literature, broader contextual considerations that may support TOC services or span multiple practice settings are summarized. Future studies must adopt standard QMs and seek to understand the potential of iQMs to accurately predict success within major patient‐centered and institutional outcomes.