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Background: Oncology clinicians often struggle with managing medications and vaccinations in older adults with cancer. We sought to demonstrate the feasibility and preliminary efficacy of integrating pharmacists into the care of older adults with cancer to enhance medication management and vaccination administration. Methods: We randomly assigned patients aged ≥65 years with breast, gastrointestinal, or lung cancer receiving first‐line chemotherapy to the pharmacy intervention or usual care. Patients assigned to the intervention met with a pharmacist once during their second or third chemotherapy infusion. We obtained information about patients' medications and vaccinations via patient report and from the electronic health record (EHR) at baseline and week 4. We determined the number of discrepant (difference between patient report and EHR) and potentially inappropriate (Beers Criteria assessed by nonintervention pharmacists blinded to group assignment) medications. We defined the intervention as feasible if >75% of patients enrolled in the study and received the pharmacist visit. Results: From January 17, 2017, to October 27, 2017, we enrolled and randomized 60 patients (80.1% of patients approached). Among those assigned to the intervention, 96.6% received the pharmacist visit. At week 4, intervention patients had higher rates of acquiring vaccinations for pneumonia (27.6% vs. 0.0%, p =.002) and influenza (27.6% vs. 0.0%, p =.002) compared with usual care. Intervention patients had fewer discrepant (5.82 vs. 8.07, p =.094) and potentially inappropriate (3.46 vs. 4.80, p =.069) medications at week 4, although differences were not significant. Conclusion: Integrating pharmacists into the care of older adults with cancer is feasible with encouraging preliminary efficacy for enhancing medication management and improving vaccination rates. Implications for Practice: Results of this study showed the feasibility, acceptability, and preliminary efficacy of an intervention integrating pharmacists into the care of older adults with cancer. Notably, patients assigned to the intervention had fewer discrepant medications and were more likely to acquire vaccinations for pneumonia and influenza. Importantly, this work represents the first randomized controlled trial involving the integration of pharmacists into the outpatient oncologic care of older adults with cancer. In the future, a larger randomized trial is needed to demonstrate the efficacy of this care model to enhance medication management and improve vaccination outcomes for older patients with cancer. Medication management and vaccinations are particularly challenging in an older cancer population, and incorporating clinical pharmacists into the cancer care of older patients represents a potential strategy to enhance clinical outcomes for the geriatric oncology population. This article reports on the feasibility and efficacy of integrating pharmacists into the care of older adults with cancer to improve medication management and vaccination administration. [ABSTRACT FROM AUTHOR]

BACKGROUND: Up to 50% of oncology drug use is considered "off-label," defined as use for a purpose outside of the US Food and Drug Administration-approved indication for that drug. An Off-Label/Exception Order policy was developed at the Massachusetts General Hospital Cancer Center (MGHCC) in Boston that requires advanced review of treatments ordered outside of institution- approved treatment regimens. Clinical pharmacists prospectively review and approve off-label requests for parenteral cancer treatment at MGHCC. OBJECTIVES: To evaluate the role of clinical pharmacists in the off-label drug use review process, and to assess the pharmacist's impact on the facilitation of patient care. METHODS: This retrospective analysis involved review of off-label requests submitted at MGHCC between January 1, 2015, and August 31, 2015. The primary end point was the percentage of off-label requests that had advanced reviews by a clinical pharmacist. The secondary end points were the percentage of off-label requests that complied with the Off-Label/Exception Order policy, the percentage of off-label requests directed to oncology finance, assessment of reimbursement for select high-cost drugs, and the impact of the off-label review and approval process on pharmacy resources. RESULTS: A total of 133 off-label requests were identified during the study period; of these, 99% of requests were reviewed by a clinical pharmacist before administration of the first dose, and 72% of requests fully complied with the policy. A pharmacy approval note, including a treatment plan and references, was documented in the electronic medical record for 93% of the requests; 28% of the requests required additional research or communication by a clinical pharmacist, for reasons such as dosing, monitoring, disease state, and patient-specific considerations. CONCLUSION: Clinical pharmacists play an integral role in the off-label review process at the MGHCC. In light of the increasing number and complexity of off-label drug use requests, additional pharmacy resources may be warranted to ensure timely and appropriate reviews that allow clinical pharmacists to maintain other professional responsibilities. [ABSTRACT FROM AUTHOR]

Aberrations of the cell cycle are pervasive in cancer, and selective cell cycle inhibition of cancer cells is a target of choice for a number of novel cancer therapeutics. Cyclin‐dependent kinases (CDKs) are key regulatory enzymes that control cell cycle transitions and the commitment to cell division. Palbociclib and ribociclib are both orally active, highly selective reversible inhibitors of CDK4 and CDK6 that are approved by the U.S. Food and Drug Administration (FDA) for hormone receptor‐positive metastatic breast cancer in combination with specific endocrine therapies. A third oral CDK4/6 inhibitor, abemaciclib, received Breakthrough Therapy designation status from the FDA and is also being developed in breast cancer. The most common adverse events associated with palbociclib and ribociclib are hematologic, particularly neutropenia. However, the neutropenia associated with CDK4/6 inhibitors is distinct from chemotherapy‐induced neutropenia in that it is rapidly reversible, reflecting a cytostatic effect on neutrophil precursors in the bone marrow. Most hematologic abnormalities seen with CDK4/6 inhibitors are not complicated and are adequately managed with standard supportive care and dose adjustments when indicated. Cytopenias are less prevalent with abemaciclib, although fatigue and gastrointestinal toxicity is more common with this agent. This review focuses on the clinical management of potential toxicities and drug interactions seen with the use of CDK4/6 inhibitors in breast cancer, with a focus on palbociclib and ribociclib, and summarizes practical management strategies for an oncologist. Implications for Practice. The emergence of modern cyclin‐dependent kinase (CDK) inhibitors has changed the treatment paradigm for metastatic hormone receptor (HR)‐positive breast cancer. Palbociclib, ribociclib, and abemaciclib are highly selective reversible inhibitors of CDK4 and CDK6. Palbociclib is U.S. Food and Drug Administration (FDA)‐approved in the first‐ and second‐line settings in combination with endocrine therapy for HR‐positive metastatic breast cancer. Ribociclib is FDA‐approved in the first‐line setting. Abemaciclib has received FDA Breakthrough Therapy designation status. This review focuses on the clinical management of potential toxicities and drug interactions seen with the use of CDK4/6 inhibitors in breast cancer.