Ozanimod: A First-in-Class Sphingosine 1-Phosphate Receptor Modulator for the Treatment of Ulcerative Colitis.

OBJECTIVE: To review the pharmacological and clinical profile of ozanimod in the treatment of ulcerative colitis (UC). DATA SOURCES: A PubMed search was conducted from inception to July 2021 using the keywords ozanimod, ulcerative colitis, and sphingosine 1-phosphate receptor modulator. Information was also extracted from published abstracts and the package insert. STUDY SELECTION AND DATA EXTRACTION: Phase 2 and 3 studies and relevant literature on ozanimod pharmacological and clinical profiles were reviewed. DATA SYNTHESIS: Ozanimod approval was based on True North, a phase 3 trial evaluating ozanimod's efficacy and safety in the treatment of moderate to severe UC. Compared with placebo, ozanimod led to clinical remission in a significantly higher proportion of patients in both the induction and maintenance phase. Additionally, for secondary end points of clinical response, endoscopic improvement, corticosteroid-free remission, and mucosal healing, ozanimod performed significantly better than placebo. Common adverse events included infections, headaches, hypertension, bradycardia, and liver enzyme elevations. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Ozanimod is the first sphingosine 1-phosphate modulator to be approved for UC and is administered orally. Its efficacy profile is comparable with other UC medications. However, its safety profile is unique, requiring extensive assessments prior to initiation of and during treatment. Thus, it is unclear how ozanimod will be positioned in UC treatment. CONCLUSION: Ozanimod is another option in the growing arsenal of UC treatment. Although it offers a novel mechanism of action and is administered orally, there are important safety, dosing, and pharmacokinetic factors to consider prior to initiation and use.

Development of a screening tool to identify patients likely to benefit from clinical pharmacist review in a home-based primary care population.

OBJECTIVE: To create a novel screening tool that identified patients who were most likely to benefit from pharmacist in-home medication reviews. DESIGN: Single-center, retrospective study. SETTING AND PARTICIPANTS: A total of 25 homebound patients in Forsyth County, NC, aged 60 years or older with physical or cognitive impairments and enrolled in home-based primary care or transitional and supportive care programs participated in the study. Pharmacy resident-provider pairs conducted home visits for all patients in the study. Pharmacy residents assessed the subjective risk (high, medium, low) of medication nonadherence using information obtained from home visits (health literacy, support network, medications, and detection of something unexpected related to medications). An electronic medical record-based risk score was simultaneously calculated using screening tool components (i.e., electronic frailty index score, LACE+ index [length of stay in the hospital, acuity of admission, comorbidity, emergency department utilization in the 6 months before admission], and 2015 American Geriatric Society Beers Criteria). OUTCOME MEASURES: The electronic medical record-based screening tool numerical risk scores were compared with pharmacy resident subjective risk assessments using tree-based classification models to determine screening tool components that best predicted pharmacy residents' subjective assessment of patients' likelihood of benefit from in-home pharmacist medication review. Following the study, satisfaction surveys were given to providers and pharmacy residents. RESULTS: The best predictor of high-risk patients was an electronic frailty index score greater than 0.32 (indicating very frail) or LACE+ index greater than or equal to 59 (at high risk for hospital readmission). Pharmacy residents and providers agreed that homebound patients at high-risk for medication noncompliance benefited from pharmacist time and attention in home visits. CONCLUSION: In homebound older persons, this screening tool allowed for the identification of patients at high-risk for medication nonadherence through targeted in-home pharmacist medication reviews. Further studies are needed to validate the accuracy of this tool internally and externally.

Defining the Roles of Inflammatory Bowel Disease Clinical Pharmacists in the United States: A Systematic Review and National RAND/UCLA Consensus.

BACKGROUND: Given the complexity of inflammatory bowel disease (IBD) care, utilization of multidisciplinary teams is recommended to optimize outcomes. There is a growing recognition that clinical pharmacists should be an integral part of this care model. We sought to define the roles of IBD clinical pharmacists in the United States. METHODS: A national multidisciplinary expert panel of 12 gastroenterologists and clinical pharmacists practicing in IBD clinics was assembled. We used the RAND/University of California, Los Angeles appropriateness method, with a total of 281 statements generated based on a systematic literature review and expert opinion. Each statement was anonymously rated as appropriate, uncertain, or inappropriate in 2 rounds of voting. RESULTS: The number of publications evaluating the clinical pharmacists' roles in IBD is limited, primarily focusing on thiopurine initiation and monitoring, medication adherence, and switching to biosimilars. Medication education; medication initiation and monitoring; therapeutic drug monitoring; biosimilar management; health maintenance review; and transitions of care were deemed by the panel to be appropriate roles for IBD clinical pharmacists. In considering real-world settings, IBD clinical pharmacists should practice clinically under a predefined scope and primarily focus on complex treatments (eg, immunomodulators, biologics, and small molecules). Clinical pharmacists should also be included in practice settings with IBD specialized physicians. Additionally, clinical pharmacists caring for patients with IBD should be residency trained and board certified. CONCLUSIONS: This consensus defines IBD clinical pharmacists' roles and provides a framework for embedded clinical pharmacists in IBD care.