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DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: There is a growing number of specialty medications with accompanying requirements that exceed standard characteristics, which may be referred to as "ultra complex." This article details examples of ultra-complex specialty medications, including the characteristics that make them ultra complex, and strategies implemented by an integrated health-system specialty pharmacy (IHSSP) to maintain an optimal patient journey. SUMMARY: Before therapy initiation, ultra-complex specialty medications often require additional steps that go beyond what is required of traditional specialty treatments, such as ensuring patients have appointments scheduled and attended and coordinating medical procedures. At the time of initiation, ultra-complex therapy might require additional immunizations or dosing based on specific tests. Finally, specialty pharmacists managing ultra-complex medications often have to dedicate more time and effort to medication monitoring to ensure patients are able to stay on appropriate doses without treatment interruption. Manufacturers of ultra-complex medications must consider the resources and requirements that will be needed to ensure the success of these medications in the real world. Health systems must be aware of resource and staffing requirements necessary to ensure the success of ultra-complex medications. One consideration is the addition of a dedicated risk evaluation and mitigation strategy (REMS) pharmacist whose primary role is to ensure compliance with REMS requirements. CONCLUSION: Ultra-complex specialty medications provide unprecedented therapeutic advancements but demand multidisciplinary resources and workflows to enable safe medication initiation, appropriate dosing and monitoring, and achievement of desired therapeutic goals. IHSSPs are integrated into the care team and provide advanced monitoring capabilities, making them an ideal setting for managing ultra-complex specialty medications. External IHSSP partnerships working together before and after the launch of ultra-complex specialty medications allow for an optimal patient and provider journey from medication initiation through ongoing care coordination and monitoring.
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BACKGROUND: Patient-reported outcomes (PROs) are often used by clinicians to evaluate patient response to specialty medications used to treat multiple sclerosis (MS) and rheumatologic conditions. Identifying associations among PROs and patient characteristics could inform patient-centered treatment monitoring. OBJECTIVE: To examine the association among patient characteristics and PROs, including patient-reported adherence (defined as no missed doses), medication tolerance, patient perceived effectiveness, and health care resource utilization (HCRU; defined as emergency department visits or hospitalizations), for patients prescribed specialty medications in 2 health system specialty pharmacies. METHODS: A dual-center, retrospective review of monthly medication assessments completed by Vanderbilt Specialty Pharmacy and University of Illinois Hospital and Health Sciences System specialty pharmacy was conducted. Patients were included if they received at least 3 fills of a specialty medication from rheumatology or MS clinics from October 2019 to March 2022, excluding patients with more than a 30-day supply. Primary outcomes were the PROs of patient-reported adherence, medication tolerability, perceived effectiveness, and HCRU. For each of the 2 primary outcomes (adherence and tolerability), a mixed-effects logistic regression model was used to test for associations with age, sex, race, clinic, site, and the other PROs. RESULTS: A total of 61,926 assessments were completed from 3,677 patients (Site 1 = 3,346; 91.0% and Site 2 = 331; 9.0%). Patients were predominantly White (75.6%) and female (71.7%) with a median age of 50 years (IQR = 37-61). Assessments most frequently originated from rheumatology (76.0%). Nonadherence was reported 4.0% of the time, with the most common explanations being forgetfulness (33.1%) and medication being held because of a procedure or illness (29.5%). Most responses indicated perceived effectiveness as good/excellent (93.9%), with 98.5% of responses indicating no issues with tolerability. Patients who reported tolerability issues were 2.5 times more likely to report a missed dose (95% CI = 1.87-3.23, P < 0.001). An effectiveness rating of fair was associated with a 61% increase in the odds of a missed dose compared with a rating of good/excellent (95% CI = 1.33-1.94). CONCLUSIONS: Patients filling rheumatology or MS specialty medications within health system specialty pharmacies reported high rates of medication effectiveness and adherence and low rates of issues with tolerability and HCRU. Patients who report tolerability issues or lower perceived effectiveness may benefit from additional monitoring to prevent nonadherence.
