Prescribing Pattern and Safety of Immunosuppressants in Renal Transplant Patients: An Observational Study.

BACKGROUND: Renal transplantation is a life-saving procedure and contributes to a better quality of life in patients with end-stage renal disease. The discovery and use of immunosuppressants to prevent and treat allograft rejection are responsible for the improved outcome after the transplant. Long-term usage of these drugs warrants special monitoring and follow-up of the adverse drug reactions developed during the post-transplant period. This study analyzes the prescribing pattern and severity and outcome of adverse drug reactions of immunosuppressants in renal transplant patients.

MATERIALS AND METHODS: A cross-sectional, observational study was done in patients more than 18 years of age who have undergone renal transplantation and receiving immunosuppressants in the Department of Nephrology in a tertiary care hospital.

RESULTS: During the two-month study period, 150 post-transplant patients were screened for adverse drug reactions, and the prescription pattern was also studied. Immunosuppressive therapy was given as induction and maintenance therapy. The short-term induction therapy regimen was based on the type of donor (injection basiliximab or anti-thymocyte globulin). The long-term maintenance therapy comprises triple therapy of tacrolimus, mycophenolate mofetil, and prednisolone in 102 (68%) patients and cyclosporine, mycophenolate mofetil, prednisolone in 37 (25%) patients. A total of 116 adverse drug reactions were reported in 82 patients. The pattern of the adverse drug reactions showed urinary tract infections in 26 (17.3%) patients on tacrolimus-based regimen and hypertension in 20 (13.3%) patients on tacrolimus and cyclosporine-based regimen. Causality assessment using the World Health Organization causality assessment scale showed that the observed reactions were of probable 42 (36%) and possible 74 (64%) categories.

CONCLUSIONS: Long-term intake of immunosuppressive drugs is essential to improve the quality of life in renal transplant individuals and it is essential to monitor adverse drug reactions of these drugs through vigilant self-reporting and pharmacovigilance practices.