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Tag "LFT"

Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function

Authors: Christopher M Blanchette, Anthony P Nunes, Nancy D Lin, Kathleen M Mortimer, Joshua Noone, Krishna Tangirala, Stephen Johnston, Benjamin Gutierrez

Risk evaluation and mitigation strategies (REMS), as mandated by the FDA for medications with the potential for harm, are increasingly incorporating rigid protocols for patient evaluation, but little is known about compliance with these programs. This study assessed adherence to liver function test (LFT) requirements included in the REMS program for bosentan and the results suggest that the program may not have adequately guaranteed adherence to monthly monitoring of LFTs.

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