Chelsea Phillips Renfro

Ustekinumab, approved for the treatment of moderate to severe Crohn disease (CD) and ulcerative colitis (UC), requires a clinic-administered intravenous (IV) induction infusion (loading dose) followed by transition to self-administered, subcutaneous (SC) injection for maintenance every 8 weeks. Many patients need subsequent dose escalations to obtain or maintain effectiveness. As an increasing number of CD and UC therapies require a similar dosing and escalation strategy, research evaluating care coordination requirements and clinical outcomes for patients prescribed ustekinumab can help guide best practices. To describe the care coordination process and response to therapy from decision to treat with ustekinumab through the first 12 months of initiating SC injection and evaluate differences in SC shipment timing between patients filling at a health-system specialty pharmacy (HSSP) compared with a non-HSSP. A single-center, retrospective cohort study was conducted. Patients prescribed ustekinumab for CD or UC between November 1, 2021, and March 31, 2022, were included. Patients were excluded if they never received an infusion or SC dose, received the SC dose at an infusion center, or became lost to follow-up. Outcomes included time between clinical events (decision to treat to IV infusion, prior authorization [PA] submission, PA approval, and SC shipment), the occurrence of SC shipments between 4 and 8 weeks after infusion (most appropriate time frame to prevent waste), and the occurrence of a dose escalation within the first 12 months of therapy. The occurrence of SC shipments within the 4- to 8-week window were analyzed using a multiple logistic regression with the following covariates: age, insurance type, and filling pharmacy type. In the 70 included patients, the median age was 36 (IQR, 28-44) years. Most patients had commercial insurance (79%), and approximately half filled SC doses external to the HSSP (53%). Median time between events was as follows: decision to treat to PA submission: 3 days (IQR, 1-8); decision to treat to PA approval: 6 days (IQR, 3-14); decision to treat to infusion date: 20 days (IQR, 13-25); and PA approval to medication shipment: 49 days (IQR, 34-73). In the 70 SC doses shipped, 64% (n = 45) occurred within the 4- to 8-week window. Prescriptions filled with the HSSP had 2.5 times higher odds of being shipped in the appropriate window compared with non-HSSP prescriptions (95% CI, 0.8-7.8; P = 0.126). Thirty-nine patients (56%) had dose escalations. Ustekinumab initiation and escalation within the first year can be a complex process requiring a high level of care coordination to ensure patients receive timely therapy while reducing potential waste.

Many payers and pharmacy benefit managers (PBMs) use step therapy requirements and formulary alternatives to reduce prescription spending. The clinical utility and ultimate therapy outcomes for patients participating in these programs is an area of needed research. To evaluate medication outcomes and time requirements to access therapy in patients required to use a step therapy or formulary alternative after being prescribed a specialty medication for psoriasis (PsO) or atopic dermatitis (AD). A single-center, retrospective review of data collected from electronic health records and the specialty pharmacy patient management system was conducted. Patients were included if they had a referral for a specialty medication by a dermatology provider for PsO or AD that was discontinued because of the payer/PBM requiring step therapy or formulary alternative use from January 2021 to June 2022. The primary outcome was the number of days from the time of patient referral for specialty medication until the second specialty medication referral. Secondary outcomes included the number of patients that failed step therapy or formulary alternative and were referred back to the specialty pharmacy as well as the number of patients not started on a specialty medication and the reason. The included patients (N = 83) were predominantly White (75%) and female (61%) with a median age of 50 years (interquartile range [IQR] = 37-61 years). 51% of patients had an indication of AD. 62 patients were required to use step therapy, and 21 were required to use a formulary alternative. Of the patients required to use step therapy, 37 (60%) had a second referral for a specialty medication because of failing step therapy requirements, with a median time to a second referral of 75 days (IQR = 27-135). The remaining 25 patients were not started on a specialty medication: 5 patients (8%) benefited from and remained on step therapy, 15 (24%) were lost to follow-up, 3 (5%) decided not to start step therapy, and 2 (3%) were referred for psoriatic arthritis evaluation. All patients required to use a formulary alternative initiated specialty medication with a median time from the initial referral to second referral of 3 days (IQR = 1-9 days). Most patients required to complete nonspecialty step therapy ultimately initiated specialty medications after a lengthy delay, demonstrating the potential impact of step therapy requirements on initiating clinically appropriate treatment for AD and PsO. Further research assessing the financial burden and clinical impact of requiring step therapy before specialty medications is warranted.

Interprofessional education (IPE) activities provide students insight into healthcare teams, shared decision-making, and social determinants of health (SDOH). Virtual IPE activities with large student populations or across multicampus have not been evaluated. The study aimed to explore the interprofessional competency growth in students, across several disciplines, following participation in a large-scale, virtual IPE activity. Students from pharmacy, medicine, social work, and physician assistant programs across Tennessee participated in an IPE patient case and SDOH in fall 2020 and fall 2021. Pre- and postsurveys included Likert ranking of 16 statements based on the 2011 Interprofessional Education Collaborative (IPEC) framework. A total of 607 students completed surveys (overall response rate, 76%). Wilcoxon signed-rank tests were performed on the pre-/postsurvey data, in aggregate and by discipline. Significant increases in all IPEC competency statements were seen, both in aggregate (100% of statements with p < 0.001) and in pharmacy (100% of statements with p < 0.001) and medicine subgroups (94% of statements with p < 0.001). Implementing large virtual IPE activities involving a complex patient case and SDOH significantly increased student IPEC competency outcomes for participating students, whether in aggregate or on a discipline-specific basis.

A 12-question survey instrument was developed, pilot-tested, and administered to 191 pharmacy students in their first professional year after engaging in a learning activity focusing on topics across five categories with clinical relevance to providing care to the LGBTQ+ community. A paired student t-test was performed on survey tool pre-test and post-test survey responses, with p < 0.05 considered significant. A total of 183 usable pre-test and post-test survey responses were received. Statistically significant differences between the pre-test and post-test correct responses were observed for scenarios involving proper pronoun use, hormone therapy (HT) counseling, immunization best practices, and communication hesitancy. The greatest knowledge change was reported in the categories of immunization best practices (48.9%), HT counseling (33.6%), and pronoun use (22.8%). Active learning assignments are effective teaching strategies to promote clinical knowledge in providing inclusive and culturally competent care to LGBTQ+ patients. Clinical topic areas including proper pronoun use, HT counseling, immunization best practices, privacy, risk awareness, and communication hesitancy are effective curricula additions for pharmacy colleges to advance inclusive curricula concerning providing care to the LGBTQ+ community.

Community pharmacies represent a highly accessible and convenient setting for vaccination. However, setting-specific barriers exist which contribute to suboptimal vaccination rates, particularly for pneumococcal vaccinations. One proven quality improvement framework growing in use within healthcare settings is Lean Six Sigma (LSS). This paper describes the application of the LSS framework in select locations of a national pharmacy chain. The implementation of a training program for improved recommendation techniques to promote higher rates of pneumococcal vaccinations in high-risk adult populations is also addressed. A mixed-methods approach including pre/post quasi-experimental design and in-depth key informant interviews was used.