Meeting report: FDA public meeting on patient-focused drug development and medication adherence in solid organ transplant patients

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.

Evaluation of tools for annual capture of adherence to immunosuppressive medications after renal transplantation - a single-centre open prospective trial

“…Both clinician′s score and TacVar are also implementable with standard data capture processes in such registries. Different adherence tools captured to a large degree different patients, so in line with previous studies the current data support the use of combination of tools . The present data also indicate that repeated self‐assessment, for example obtaining BAASIS © forms fortnightly, identifies additional and different patients compared with a single assessment, but did not per se influence patients adherence.…”

Trajectories of health-related quality of life among renal transplant patients associated with graft failure and symptom distress: Analysis of the BENEFIT and BENEFIT-EXT trials

“…Additionally, patient‐reported outcomes could be used to evaluate the effectiveness and tolerability of new treatments or interventions. The US Food and Drug Administration has recognized the need to incorporate transplant recipient perspectives on posttransplant management by introducing the Patient‐Focused Drug Development initiative with the goal of understanding patients’ perceptions of their conditions . Complications associated with immunosuppressive drugs are known to adversely affect the HRQoL of renal transplant recipients, which can trigger medication nonadherence and subsequently increase the risk of poor clinical outcomes and socioeconomic burdens such as rejection, increased health care costs, and mortality .…”

C4 article: Challenges and solutions to appropriate and timely medication access in transplantation in the United States

“…Medication nonadherence has been identified in nearly half of kidney transplant recipients with allograft failure resulting from rejection . To address this issue, in 2016, the FDA led a forum with transplant recipients and caregivers with the primary objective to ascertain factors that contribute to medication nonadherence . Patient‐identified factors included barriers to medication access and medication costs.…”