Transplant Coordinators' Perceived Impact of Availability of Multiple Generic Immunosuppression Therapies on Patients, Workload, and Posttransplant Maintenance Therapy
Background. No studies have evaluated the impact of multiple generic immunosuppression medications on transplant coordinators (TCs) and patients. Methods. A cross-sectional, multicenter online survey of TCs managing transplant recipients' outpatient immunosuppression was undertaken to assess TCs' perceptions of the impact of multiple generic immunosuppression therapies on patients and workload. Results. Forty-six of 106 transplant centers contacted (43%) completed the survey, with usable information from 34 TCs (53% in centers performing >100 solid organ transplants annually, 82% registered nurses, and 68% with >5-year experience working with transplant patients). TCs indicated that “change in strength,” “switching from branded to generics,” “heavy pill burden,” and “switching from one generic to another” were the four most frequent reasons for patient confusion regarding immunosuppression. TCs reported increased patient confusion over the previous year for patients on generic immunosuppression therapy: 44% answered ≥3 patient calls/day regarding confusion over immunosuppression therapy. Most TCs indicated increased workload since the introduction of generic immunosuppression therapy. TCs perceived “acute rejection rates,” “rate of graft loss,” and “poor patient adherence” as the three most likely consequences of multiple generic immunosuppression therapy. Conclusion. TCs associated availability of multiple generic immunosuppression therapy with increased patient confusion and time spent addressing patient concerns. 1. Introduction Immunosuppression regimens containing mycophenolate mofetil (MMF) and tacrolimus (TAC) have demonstrated effectiveness to prevent acute rejection in solid organ transplant recipients [1, 2]. Furthermore, MMF and TAC are listed as preferred agents in solid organ transplant clinical practice guidelines such as the Kidney Disease Improving Global Outcomes (KDIGO) [3, 4]. Since the approval of the first generic MMF and TAC in July 2008 and August of 2009, respectively, there have been 10 generic manufacturers of MMF and 4 generic manufacturers of TAC that have emerged [5]. The American Society of Transplantation (AST) supports the use of generic immunosuppressants in transplant patients but stresses the need for bioequivalence testing in this patient population. Furthermore, AST has expressed caution regarding the currently unquantified risk that may be associated with switching immunosuppressive agents under uncontrolled circumstances and the need for clear labeling and patient education regarding any switch to or between
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