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Background: Disease-modifying therapy (DMT) delays disease progression and improves quality of life for patients with multiple sclerosis (MS), but adherence to DMT is often suboptimal. Vanderbilt Specialty Pharmacy (VSP) embeds pharmacists within an outpatient MS clinic to provide medication management and address barriers to adherence. Objective: We evaluated rates and predictors of adherence to DMT among patients with MS at an integrated specialty pharmacy. Methods: We included patients with MS who filled ≥3 DMT prescriptions from VSP during the study period. Adherence was defined as medication possession ratio (MPR) or proportion of days covered (PDC) ≥0.8. Reasons for nonadherence were collected from pharmacy claims and electronic medical records. Results: The study included 653 patients. Average MPR and PDC were 0.93 and 0.94, respectively. Eighty-eight percent of patients achieved MPR ≥0.8; 89% achieved PDC ≥0.8. Using financial assistance and having $0 out-of-pocket cost were associated with higher odds of achieving MPR and PDC ≥0.8 ( P < .05). Of the 12% of patients who were nonadherent, most were unreachable for refills. Conclusions: Ensuring financial assistance and low out-of-pocket costs are associated with high adherence to DMT within an integrated specialty clinic, but more work is needed to address adherence in unreachable patients.

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Phosphodiesterase-5 inhibitors (PDE-5I) have demonstrated improvement in disease symptoms and quality of life for patients with pulmonary arterial hypertension (PAH). Despite these benefits, reported adherence to PDE-5I therapy is sub-optimal. Clinical pharmacists at an integrated practice site are in a unique position to mitigate barriers related to PAH therapy including medication adherence and costs. The primary objective of this study was to assess medication adherence to PDE-5I therapy within an integrated care model at an academic institution. The secondary objective was to assess the impact of out-of-pocket (OOP) cost, frequency of dosing, adverse events (AE) and PAH-related hospitalizations on medication adherence. We performed a retrospective cohort analysis of adult patients with PAH who were prescribed PDE-5I therapy by the center’s outpatient pulmonary clinic and who received medication management through the center’s specialty pharmacy. We defined optimal medication adherence as proportion of days covered (PDC) ≥ 80%. Clinical data including AEs and PAH-related hospitalizations were extracted from the electronic medical record, and financial data from pharmacy claims. Of the 131 patients meeting inclusion criteria, 94% achieved optimal adherence of ≥ 80% PDC. In this study population, 47% of patients experienced an AE and 27% had at least one hospitalization. The median monthly OOP cost was $0.62. Patients with PDC<80% were more likely to report an AE compared to patients with PDC≥ 80% ( p = 0.002). Hospitalization, OOP cost, and frequency of dosing were not associated with adherence in this cohort. Patients receiving PDE-5I therapy through an integrated model achieved high adherence rates and low OOP costs.

Background The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence. Objective This study aims to determine whether pharmacist interventions improve specialty medication adherence. Methods This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum. Discussion This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent. Registration The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on