Ultra-complex specialty medications: Meeting the challenges of significant medication requirements through an integrated specialty pharmacy model.

ABSTRACT

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.