Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function
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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BioExcel Publishing Ltd
2015-02-01
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| Series: | Drugs in Context |
| Subjects: | |
| Online Access: | http://www.drugsincontext.com/adherence-to-risk-evaluation-and-mitigation-strategies-rems-requirements-for-monthly-testing-of-liver-function/ |
| _version_ | 1818942720069074944 |
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| author | Christopher M Blanchette Anthony P Nunes Nancy D Lin Kathleen M Mortimer Joshua Noone Krishna Tangirala Stephen Johnston Benjamin Gutierrez |
| author_facet | Christopher M Blanchette Anthony P Nunes Nancy D Lin Kathleen M Mortimer Joshua Noone Krishna Tangirala Stephen Johnston Benjamin Gutierrez |
| author_sort | Christopher M Blanchette |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-20T07:15:55Z |
| format | Article |
| id | doaj.art-73c170ca39f74d3bac1caac9f553ca56 |
| institution | Directory Open Access Journal |
| issn | 1740-4398 1740-4398 |
| language | English |
| last_indexed | 2024-12-20T07:15:55Z |
| publishDate | 2015-02-01 |
| publisher | BioExcel Publishing Ltd |
| record_format | Article |
| series | Drugs in Context |
| spelling | doaj.art-73c170ca39f74d3bac1caac9f553ca562022-12-21T19:48:48ZengBioExcel Publishing LtdDrugs in Context1740-43981740-43982015-02-0111010.7573/dic.212272Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver functionChristopher M BlanchetteAnthony P NunesNancy D LinKathleen M MortimerJoshua NooneKrishna TangiralaStephen JohnstonBenjamin GutierrezBackground: 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.http://www.drugsincontext.com/adherence-to-risk-evaluation-and-mitigation-strategies-rems-requirements-for-monthly-testing-of-liver-function/risk evaluationREMSliver function testadherencecomplianceFDApatient assessmentadministrative claims |
| spellingShingle | Christopher M Blanchette Anthony P Nunes Nancy D Lin Kathleen M Mortimer Joshua Noone Krishna Tangirala Stephen Johnston Benjamin Gutierrez Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function Drugs in Context risk evaluation REMS liver function test adherence compliance FDA patient assessment administrative claims |
| title | Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function |
| title_full | Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function |
| title_fullStr | Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function |
| title_full_unstemmed | Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function |
| title_short | Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function |
| title_sort | adherence to risk evaluation and mitigation strategies rems requirements for monthly testing of liver function |
| topic | risk evaluation REMS liver function test adherence compliance FDA patient assessment administrative claims |
| url | http://www.drugsincontext.com/adherence-to-risk-evaluation-and-mitigation-strategies-rems-requirements-for-monthly-testing-of-liver-function/ |
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