| Affiliation: | 1. Department of Pediatrics, UCLA Mattel Children's Hospital, Los Angeles, CA, USA;2. Division of Transplant and Ophthalmology Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA;3. Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA;4. Colleges of Pharmacy and Medicine, University of Tennessee Health Science Center, Memphis, TN, USA;5. Departments of Psychiatry, Psychology, Epidemiology, Biostatistics, and Clinical and Translational Science, University of Pittsburgh, Pittsburgh, PA, USA;6. Astellas Pharma Global Development Inc, Northbrook, IL, USA;7. Department of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada;8. Office of Program and Strategic Analysis, Office of Strategic Programs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA |
| Abstract: | The Food and Drug Administration (FDA) held a public meeting and scientific workshop in September 2016 to obtain perspectives from solid organ transplant recipients, family caregivers, and other patient representatives. The morning sessions focused on the impact of organ transplantation on patients’ daily lives and the spectrum of activities undertaken to maintain grafts. Participants described the physical, emotional, and social impacts of their transplant on daily life. They also discussed their posttransplant treatment regimens, including the most burdensome side effects and their hopes for future treatment. The afternoon scientific session consisted of presentations on prevalence and risk factors for medication nonadherence after transplantation in adults and children, and interventions to manage it. As new modalities of Immunosuppressive Drug Therapy are being developed, the patient perceptions and input must play larger roles if organ transplantation is to be truly successful. |
