Evaluation of the Conversion from Brand Name to Generic Immunosuppression in Hospitalized Organ Transplant Recipients.
1Department of Pharmacy, Saint Luke's Hospital, Kansas City, MO
2Transplant Quality Department, Saint Luke's Hospital, Kansas City, MO
3Cardiovascular Outcomes Research, Saint Luke's Hospital, Kansas City, MO
4Abdominal Transplant and HPB Surgery, Saint Luke's Transplant Specialists, Kansas City, MO
Meeting: 2017 American Transplant Congress
Abstract number: D111
Keywords: Bioequivalence, Heart transplant patients, Immunosuppression, Kidney/liver transplantation
Session Name: Poster Session D: Kidney Immunosuppression: Novel Regimens and Drug Minimization
Session Type: Poster Session
Date: Tuesday, May 2, 2017
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall D1
Purpose: Safe and effective immunosuppressant medications are critical to accomplish good graft and patient survival rates. The availability of “AB-rated” generic immunosuppression affords the opportunity to lower the cost of therapy without negatively impacting the quality of care provided. The purpose of this study is to evaluate the impact of conversion from brand to generic immunosuppression in hospitalized organ transplant recipients.
Methods: November 4, 2014 formulary conversion from brand name to generic immunosuppression products occurred. Following conversion, a prospective chart review (November 4, 2014 through April 30, 2015) of rehospitalized kidney, liver and heart transplant patients 18 years and older was completed and compared to a retrospective control group (April 1, 2014 through September 30, 2014). The primary endpoint was the percentage of patients with tacrolimus levels that deviated from their goal once converted to the generic product 48-72 hours after admission. Secondary analysis included percentage of patients requiring tacrolimus dosage adjustment, absolute change in tacrolimus dosage, and frequency of biopsy proven rejection within six months of discharge.
Results: 102 patients in the pre- and 157 patients in the post-conversion groups met inclusion criteria. Percentage of patients that met their goal level 48-72 hours after admission was similar (51.5% vs 42.9%, p=0.18; pre- vs post-conversion). Percentage of patients who required a tacrolimus dosage adjustment was 47.2% vs 39.6%, pre- vs post-conversion (p=0.251). Absolute change in tacrolimus dosage after admission was 0.9±1.4 mg in the pre- and 0.6±1.2 mg in the post-conversion groups (p=0.138). Results found no statistically significant difference in frequency of biopsy proven rejection (19.4% vs 10.9%, p=0.063).
Conclusions: Conversion to generic immunosuppression products was not shown to cause a deviation from patient's goal tacrolimus levels and had no impact on frequency of biopsy proven rejection. Utilization of generic immunosuppression upon admission to the hospital was shown to be safe and effective.
CITATION INFORMATION: DeZotell L, Blunck K, Guy J, Woods M, Reffett M, Terrell J, Palermo A, Gosch K, Cummings L. Evaluation of the Conversion from Brand Name to Generic Immunosuppression in Hospitalized Organ Transplant Recipients. Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:DeZotell L, Blunck K, Guy J, Woods M, Reffett M, Terrell J, Palermo A, Gosch K, Cummings L. Evaluation of the Conversion from Brand Name to Generic Immunosuppression in Hospitalized Organ Transplant Recipients. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/evaluation-of-the-conversion-from-brand-name-to-generic-immunosuppression-in-hospitalized-organ-transplant-recipients/. Accessed March 26, 2023.
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