Evidence map›Paper›PMID 41593404›Full record

ArticleDrug safety2026

Physician Awareness of FDA's Relaxation of REMS-Required Laboratory Testing Requirements and Changes in Prescribing Practices During the COVID-19 Pandemic.

Catherine S Hwang, Zhigang Lu, Massimiliano Russo, Heidi Zakoul, Gita A Toyserkani, Esther H Zhou, Cynthia LaCivita, Gerald J Dal Pan, Aaron S Kesselheim, Ameet Sarpatwari

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Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Catherine S HwangDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. hwangca@ohsu.edu.ORCID http://orcid.org/0009-0004-0185-3256
Zhigang LuDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Massimiliano RussoDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Heidi ZakoulDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Gita A ToyserkaniOffice of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.
Esther H ZhouOffice of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.
Cynthia LaCivitaOffice of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.
Gerald J Dal PanOffice of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.
Aaron S KesselheimDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Ameet SarpatwariDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

Funding

U.S. Food and Drug Administration 75F40120C0044
6 · The paper itself

Abstract

backgroundThe US Food and Drug Administration (FDA) requires pharmaceutical manufacturers to implement Risk Evaluation and Mitigation Strategy (REMS) programs for certain medications that carry serious safety risks. One possible REMS requirement is routine monitoring via laboratory tests. However, in March 2020, the FDA issued a temporary enforcement discretion policy enabling prescribers to apply medical judgment for completing REMS-required laboratory testing.

objectiveWe aimed to assess whether physicians were aware of the FDA's temporary policy and if they changed their laboratory testing practices during the coronavirus disease 2019 pandemic.

methodsWe designed a survey of US physicians prescribing one of seven medications: ambrisentan, bosentan, clozapine, isotretinoin, lenalidomide, pomalidomide, and thalidomide. The study was conducted over two waves, May 2022 to October 2022 and October 2022 to January 2023. Multivariable logistic regression modeling was used to examine predictors of each outcome.

resultsThe combined response rate between the two waves of survey administration was 21%. Among 949 physician respondents, 438 (47%; 927 question respondents) reported awareness and 192 (21%; 926 question respondents) reported changing practices. Among the 438 physicians who reported awareness, 176 (40%) reported changing practices. Characteristics associated with awareness included sex (female vs male, odds ratio [OR] = 1.92, 95% confidence interval [CI] 1.37-2.69); recency of medical school graduation (25-34 vs ≤ 15 years, OR = 0.50, 95% CI 0.31-0.81); practice setting (academic hospital vs outpatient group, OR = 0.58, 95% CI 0.37-0.88); prescribing experience (≥ 21 vs ≤10 patients, OR = 2.92, 95% CI 2.06-4.14); and timing of survey completion (wave 2 vs wave 1, OR = 0.47, 95% CI 0.34-0.66). Characteristics associated with practice changes included race (Asian vs White, OR = 0.62, 95% CI 0.38-0.99) and awareness of FDA's policy (yes vs no, OR = 14.07, 95% CI 7.93-24.96), in addition to sex (female vs male, OR = 1.99, 95% CI 1.31-3.01), recency of medical school graduation (≥  35 vs <  15 years: OR = 0.53, 95% CI 0.30-0.93), and timing of survey completion (wave 2 vs wave 1: OR = 0.58, 95% CI 0.34-0.99).

conclusionsAlthough policy awareness was correlated with laboratory practice changes, fewer than half of physicians who were aware of the FDA's policy reported changing their practices.

Indexed as

COVID-19PhysiciansPractice Patterns, Physicians'Risk Evaluation and MitigationUnited States Food and Drug AdministrationAdultFemaleHumansMaleMiddle AgedSurveys and QuestionnairesUnited States

Identifiers

PMID41593404

What Socratic holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.