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Introduction: Adverse symptoms experienced by solid organ transplant recipients remain largely unexplored despite their purported frequency.Objective: To characterize patient perspectives on adverse symptoms, identifying the most problematic symptoms and the perceived cause and treatability, and to evaluate their impact on quality of life (QoL) and medication adherence.Methods: An electronic survey was distributed to members of the Canadian Transplant Association, to characterize perceptions on symptom experience (Modified Transplant Symptom Occurrence and Distress Scale), and QoL (Short Form-12), medication adherence (Basel Assessment of Adherence to Immunosuppressive Medications Scale), demographics, and clinical situation.Results: The questionnaire was distributed to 249 solid organ transplant recipients and achieved a 51% response rate (N = 127). Respondents reported a mean of 25 (standard deviation 10) adverse symptoms each. In women, the most prevalent and distressing symptoms were tiredness, lack of energy, sleep difficulties, difficulty concentrating or memory problems, diarrhea, joint pain, and depression. In men, they were tiredness, flatulence, lack of energy, sleep difficulties, and erectile problems. With the exception of flatulence, these symptoms were more often perceived to be caused by medical conditions rather than by immunosuppressants or other medications. Quality of life was similar to the general public, with mean physical and mental component scores of 47.4 (9.9) and 52.1 (8.2), respectively (relative to a US average of 50 [10]). However, QoL scores inversely correlated to the number of symptoms reported and were higher in patients who perceived all symptoms to be treatable.Conclusion: Adverse symptoms may impact patient well-being. Perceived cause and treatability should be further explored.

In order to evaluate change in knowledge about transplantation, satisfaction and adherence, the authors report on a randomized controlled trial in 246 de novo SOTR receiving standard teaching with or without post discharge computer-based education at home. No significant improvement occurs in the intervention group suggesting barriers to this intervention has to be worked on. Supplemental digital content is available in the text.

The introduction of generic immunosuppressant medications may present an opportunity for cost savings in solid organ transplantation if equivalent clinical outcomes to the branded counterparts can be achieved. An interprofessional working group of the Canadian Society of Transplantation was established to develop recommendations on the use of generic immunosuppression in solid organ transplant recipients (SOTR) based on a review of the available data. Under current Health Canada licensing requirements, a demonstration of bioequivalence with the branded formulation in healthy volunteers allows for bridging of clinical data. Cyclosporine, tacrolimus, and sirolimus are designated as “critical dose drugs” and are held to stricter criteria. However, whether this provides sufficient guarantee of therapeutic equivalence in SOTR remains controversial, and failure to maintain an appropriate balance of immunosuppression may have serious consequences, including rejection, graft loss, and death. Published evidence supporting therapeutic equivalence of generic formulations in SOTR is lacking. Moreover, in the setting of multiple generic formulations the potential for uncontrolled product switching is a major concern, since generic preparations are not required to demonstrate bioequivalence with each other. Although close monitoring is recommended with any change in formulation, drug product switches are likely to occur without prescriber knowledge and may pose a significant patient safety risk. The advent of generic immunosuppression will require new practices including more frequent therapeutic drug and clinical monitoring, and increased patient education. The additional workload placed on transplant centers without additional funding will create challenges and could ultimately jeopardize patient outcomes. Until more robust clinical data are available and adequate regulatory safeguards are instituted, caution in the use of generic immunosuppressive drugs in solid organ transplantation is warranted.