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

Article Details

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

Article Type
Original Research

DOI
10.7573/dic.212272

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Abstract

Background: Risk evaluation and mitigation strategies (REMS), as mandated by the US Food and Drug Administration (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. Despite the inherent limitations, data on administrative claims may provide an opportunity to investigate adherence to these programs.

Methods: We assessed adherence to liver function test (LFT) requirements included in the REMS program for bosentan through use of administrative claims. Patients observed in the Optum Research Database who were initiators of bosentan from November 20, 2001 to March 31, 2013 were included. Adherence to LFTs was calculated using pharmacy claims for bosentan dispensation and medical claims for laboratory services, and was assessed at the time of drug initiation and within specified time intervals throughout follow-up.

Results: Of 742 patients, 523 (70.5%) had ≥1 qualifying LFT. Among patients with ≥12 dispensations, claims for LFTs at individual dispensations were 53.2–64.0%. Median proportion of dispensations with ≥1 LFT was 0.8 among patients with ≥6 (interquartile range, 0.7–1.0) or ≥12 (0.7–0.9) dispensations. Adherence was 90–100% for 33.3% of all initiators, whereas 29.3% of initiators were non-adherent (defined as <50% of on-therapy LFTs).

Conclusions: Analyses of administrative claims suggest that the REMS program for bosentan may not have adequately guaranteed adherence to the program’s monthly monitoring of LFTs. Such investigations of existing REMS programs may provide insight on how to accomplish more successful evaluation of REMS.

Keywords: risk evaluation, REMS, liver function test, adherence, compliance, FDA, patient assessment, administrative claims.

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ETASU, elements to ensure safe use; FDA, Food and Drug Administration; IQR, interquartile range; LFT, liver function test; ORD, Optum Research Database; PAH, pulmonary arterial hypertension; REMS, risk evaluation and mitigation strategies; SD, standard deviation; TAP, Tracleer (bosentan) Access Program

Citation
Blanchette CM, Nunes AP, Lin ND, Mortimer KM, Noone J, Tangirala K, Johnston S, Gutierrez B. Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function. Drugs in Context 2015; 4: 212272. doi: 10.7573/dic.212272

Copyright
Copyright © 2015 Blanchette CM, Nunes AP, Lin ND, Mortimer KM, Noone J, Tangirala K, Johnston S, Gutierrez B. Distributed under the terms of the Creative Commons License Deed CC BY NC ND 3.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No other uses without permission.

Correct attribution
Copyright © 2015 Blanchette CM, Nunes AP, Lin ND, Mortimer KM, Noone J, Tangirala K, Johnston S, Gutierrez B. http://dx.doi.org/10.7573/dic.212272. Published by Drugs in Context under Creative Commons Attributions License Deed CC BY NC ND 3.0.

Article URL
https://www.drugsincontext.com/adherence-risk-evaluation-mitigation-strategies-rems-requirements-monthly-testing-liver-function

Correspondence
Christopher M Blanchette, Associate Dean for Research & Public Engagement, Director of Data Sciences & Business Analytics, Associate Professor of Public Health Sciences, College of Health & Human Services, University of North Carolina at Charlotte, 9201 University City Boulevard, CHHS 476, Charlotte, NC 28223, USA. cblanche@uncc.edu

Provenance
Submitted, externally peer reviewed

Dates
Submitted: 2 December 2014
Accepted, subject to peer review: 8 December 2014
Revised manuscript submitted: 29 December 2014
Publication date: 10 February 2015

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