@article{5c68d56a51424daba9a1b6969c9e4a4f,
title = "Rates of, and factors associated with, switching among generic levothyroxine preparations in commercially insured American adults",
abstract = "Importance: Some practice guidelines warn against generic L-thyroxine preparation switching. Objective: To examine the rates of generic L-thyroxine preparation switching within one year of initiating L-thyroxine, and to examine factors associated with switching. Design and setting: Retrospective study using national data from a large administrative claims database from January 2008 through November 2018. Patients: Medicare or commercially insured adults (≥18 years) who filled a generic L-thyroxine preparation. Main outcome measures: At least one switch from one generic L-thyroxine preparation to another within 1 year of L-thyroxine initiation defined by prescription fills. Results: From January 2008 to November 2018, we included 483,390 patients who initiated generic L-thyroxine: mean (SD) age was 61.4 years (15.2), 75.2% were female, 72.6% were white. Within 1 year of initiating therapy, 98,013 (20%) switched to another L-thyroxine generic preparation at least once. In a multivariate logistic regression analysis, factors associated with switching included the number of pharmacies visited to fill L-thyroxine (>2 vs 1 adjusted OR [aOR] 7.15, 95% confidence interval [CI] 6.97–7.34), age ≥75 vs. <45 years (aOR 1.29, 95% CI 1.26–1.33), history of thyroid surgery (aOR 1.22, 95% CI 1.13–1.31), and first L-thyroxine fill date in 2018 vs. 2008 (aOR 3.32, 95% CI 3.14–3.51). Conclusions and relevance: One in five patients switched among generic L-thyroxine manufacturers within one year of treatment initiation. Generic L-thyroxine switching occurred more often when more pharmacies were used to fill L-thyroxine. Given existing guideline recommendations, additional studies should clarify the impact of generic L-thyroxine switching on thyroid hormone values.",
keywords = "Generic, Hypothyroidism, Levothyroxine",
author = "Brito, {Juan P.} and Yihong Deng and Ross, {Joseph S.} and Choi, {Nam Hee} and Graham, {David J.} and Yandong Qiang and Elena Rantou and Zhong Wang and Liang Zhao and Shah, {Nilay D.} and Lipska, {Kasia J.}",
note = "Funding Information: JSR has received research support through Yale University from Johnson and Johnson, from Medtronic, Inc., the Food and Drug Administration (FDA) (U01FD004585), from the Blue Cross Blue Shield Association, from the Centers of Medicare and Medicaid Services (CMS) (HHSM-500-2013-13018I), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164), and from the Laura and John Arnold Foundation. NDS has received research support through Mayo Clinic from the Centers of Medicare and Medicaid Innovation, from the Agency for Healthcare Research and Quality (R01HS025164; R01HS025402; R03HS025517; U19HS024075), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496; R01HL131535), National Science Foundation, and from the Patient Centered Outcomes Research Institute (PCORI). KJL receives support from the Centers of Medicare and Medicaid Services (CMS) and the National Institute on Aging and the American Federation of Aging Research through the Paul Beeson Career Development Award (K23AG048359). RCS receives support from the Alfred D. and Audrey M. Petersen Professorship in Cancer Research. J.P.B., Y.D., N.H.C., D.J.G., Y.Q., E.R., Z.W., L.Z. have nothing to declare. Funding Information: This project was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [Center of Excellence in Regulatory Science and Innovation grant to Yale University and Mayo Clinic, U01FD005938] totaling $158,430 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government. Publisher Copyright: {\textcopyright} 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.",
year = "2022",
month = may,
doi = "10.1007/s12020-022-02987-z",
language = "English (US)",
volume = "76",
pages = "349--358",
journal = "Endocrine",
issn = "1355-008X",
publisher = "Humana Press",
number = "2",
}