Comparative Effectiveness of Vedolizumab vs. Infliximab Induction Therapy in Ulcerative Colitis: Experience of a Real-World Cohort at a Tertiary Inflammatory Bowel Disease Center.

BACKGROUND: Vedolizumab (VDZ), an adhesion molecule inhibitor and infliximab (IFX), a tumor necrosis factor (TNF) blocker, are both approved as first-line induction agents in moderately to severely active ulcerative colitis (UC). However, there are no head-to-head studies comparing the relative effectiveness of the two agents. Here we provide a real-world comparison of these two agents. METHODS: We conducted an ambidirectional cohort study of adult UC patients seen at our tertiary inflammatory bowel disease (IBD) center from 2012 to 2017. Each patient had moderately to severely active UC via partial Mayo score and was induced with IFX or VDZ. They were followed until assessment of clinical response. Poisson regression was used to calculate clinical response rates and rate ratios. RESULTS: Of 59 patients who met inclusion criteria, 27 and 32 patients were induced with IFX and VDZ, respectively. Totally, 18/27 (66.7%) patients induced with IFX vs. 24/32 (78.1%) patients induced with VDZ were clinical responders. Response rates per 100 person-weeks (PW) were similar for VDZ (5.21) and IFX (5.38). The effectiveness in terms of induction of clinical response (incidence rate ratio, IRR) was not statistically significant for VDZ vs. IFX (IRR 0.97, 95% confidence interval (CI) 0.53 - 1.77). Among TNF blocker naive patients, IRR was also not statistically significant between VDZ (6.74/100 PW) and IFX (6.48/100 PW) (IRR 1.04, 95% CI 0.47 - 2.29). Among TNF blocker experienced patients, there was a higher response rate for VDZ (4.52) vs. IFX (2.29) per 100 PW, but the IRR did not reveal statistical significance (IRR 1.97, 95% CI 0.45 - 8.63) due to small sample size of TNF blocker experienced patients who received IFX. Five patients developed severe infection or adverse reaction during IFX induction requiring exclusion, whereas no VDZ patients were excluded for this reason. CONCLUSIONS: Our study revealed a higher proportion of patients who responded to VDZ vs. IFX; however when accounting for period between induction and assessment of clinical response, rates of clinical response were similar. A key difference between the two groups was the higher response rate in the VDZ group among TNF blocker experienced patients; however, a larger cohort is needed to further elaborate on this difference. VDZ held its own against IFX and this study strengthens its standing as a first-line agent among TNF blocker naive as well as TNF blocker experienced UC patients.

Impact of an open enrollment service on costs for Medicare Part D beneficiaries.

OBJECTIVE: The primary objective was to determine total estimated cost savings based on a patient's current medication regimen after comparing available Medicare Part D plans for the upcoming year by using a plan comparison platform. The secondary objective was to determine patient-centered concerns when considering a change in Part D plans. DESIGN: Review of an open enrollment service that included a patient survey and a Part D plan comparison. SETTING: This study took place at a single independent community pharmacy in northwest Alabama. PARTICIPANTS: Fifty-four patients eligible for Medicare Part D were included in this study. MAIN OUTCOME MEASURES: The study was a review of an open enrollment service that aids Medicare beneficiaries in selecting a Part D plan that best fits their needs. It included a patient survey and plan comparison using a plan comparison platform, during the 2015 Medicare open enrollment period (October 15 to December 7). The survey assessed patient demographics, pharmacy preferences, and cost concerns. Survey data were used to aid in plan selection and analysis to determine the most common patient-centered concerns when considering a change in plans. RESULTS: During the open enrollment period, 54 patients compared Medicare Part D plans. The majority of participants were female (57%) and ranged in age from 65-69 years (37%) to 70-74 years (25.9%). The majority of patients reported a preference for independent pharmacies (92.6%). Deductible (40.7%) was the biggest concern for patients when comparing the main cost variables for medication insurance. The average total cost difference per patient per year showed that each patient saved an average of $1166.46. CONCLUSION: The analysis of an independent pharmacy's open enrollment service determined that a plan comparison platform is a valuable tool in helping patients to compare and select cost-effective Medicare Part D prescription plans and in helping patients save money.

Pharmacy technician-to-pharmacist ratios: a state-driven safety and quality decision.

OBJECTIVE: To discuss the policy of pharmacy technician-to-pharmacist ratios by comparing Florida as an example of legislative-led authority versus Tennessee as an example of board of pharmacy-led ruling. SUMMARY: Over the past 2 years, the Florida legislature has debated the issue of pharmacy staffing ratios, initially leaving the Florida Board of Pharmacy with little authority to advocate for and enact safe technician staffing ratios. Anticipating this situation, the Tennessee Board of Pharmacy created rules to meet pharmacy staffing needs while protecting the authority of the pharmacist-in-charge and promoting patient safety. Before enacting rules, members of the board toured the state and talked about proposed rule changes with pharmacists. The final rule sets the pharmacy technician-to-pharmacist ratio at 2:1 but permits a 4:1 ratio based on public safety considerations and availability of at least two Certified Pharmacy Technicians. CONCLUSION: Pharmacists and leaders within the profession should conduct further research on appropriate and safe ratios of pharmacy technicians to pharmacists, with a focus on safety and quality of care.