How Do Risk Evaluation and Mitigation Strategies Impact Clinical Practice? A National Survey of Physicians.
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
20 Feb 2024
20 Feb 2024
Historique:
received:
01
11
2023
accepted:
11
01
2024
medline:
20
2
2024
pubmed:
20
2
2024
entrez:
20
2
2024
Statut:
aheadofprint
Résumé
The US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs for prescription drugs to ensure the benefits of use outweigh the risks. We conducted a national survey of physicians' experiences prescribing eight REMS-covered drugs: (1) ambrisentan; (2) bosentan; (3) clozapine; (4) isotretinoin; (5-7) the multiple myeloma (MM) drugs lenalidomide, pomalidomide, thalidomide; and (8) sodium oxybate. Between May 2022 and January 2023, we surveyed 5,331 physician prescribers of these drugs, and 1,295 (24%) returned surveys (range: 149 for bosentan to 226 for MM drugs). Although 765 (68%) respondents thought the certification process provided useful drug information, 757 (67%) wanted materials to include benefit data and 944 (84%) non-REMS-related risk data. A majority (704, 63%) thought the safe use requirements facilitated discussion with patients, but a similar number (637, 57%) attributed delayed medication access to these requirements. In multivariable modeling, MM drug and isotretinoin respondents were less likely than sodium oxybate respondents to agree that the certification process provided useful drug information (MM drug: odds ratio (OR) = 0.37, 95% confidence interval (CI) = 0.25-0.55; isotretinoin: OR = 0.39, 95% CI = 0.25-0.61), and isotretinoin, clozapine, and bosetan respondents were more likely than sodium oxybate respondents to agree that the safe use requirements often delayed medication access (isotretinoin: OR = 5.83, 95% CI = 3.70-9.19; clozapine: OR = 1.65, 95% CI = 1.08-2.54; bosentan: OR = 1.78, 95% CI = 1.12-2.85). Most physicians believe REMS programs convey useful drug safety information and facilitate discussion with patients but also seek information on benefits and non-REMS-related risks and better integration of REMS processes into clinical workflows.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 The Authors. Clinical Pharmacology & Therapeutics © 2024 American Society for Clinical Pharmacology and Therapeutics.
Références
Pub L No 110-85, 121 Stat 823 (September 27, 2007) .
Avorn, J., Kesselheim, A. & Sarpatwari, A. The FDA amendments act of 2007 - assessing its effects a decade later. N. Engl. J. Med. 379, 1097-1099 (2018).
US Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies <https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm>. Accessed December 19, 2023.
US Department of Health and Human Services Office of Inspector General. FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety <https://oig.hhs.gov/oei/reports/OEI-04-11-00510.asp> (2023). Accessed December 19, 2023.
Sarpatwari, A., Franklin, J.M., Avorn, J., Seeger, J.D., Landon, J.E. & Kesselheim, A.S. Are risk evaluation and mitigation strategies associated with less off-label use of medications? The case of immune thrombocytopenia. Clin. Pharmacol. Ther. 97, 186-193 (2015).
Fleischman, W., Auth, D., Shah, N.D., Agrawal, S. & Ross, J.S. Association of a risk evaluation and mitigation strategy program with transmucosal fentanyl prescribing. JAMA Netw. Open 2, e191340 (2019).
Sarayani, A., Donahoo, W.T., Hampp, C., Brown, J.D. & Winterstein, A.G. Assessment of the risk evaluation and mitigation strategy (REMS) for phentermine-topiramate to prevent exposure during pregnancy. Ann. Intern. Med. 176, 443-454 (2023).
Blanchette, C.M. et al. Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function. Drugs 4, 4-10 (2015).
Sarpatwari, A., He, M., Tessema, F.A., Gagne, J.J. & Kesselheim, A.S. Changes in erythropoiesis stimulating agent use under a risk evaluation and mitigation strategy (REMS). Drug Saf. 44, 327-355 (2021).
Sarpatwari, A., Brown, B.L., McGraw, S.A., Dejene, S.Z., Abdurrob, A. & Kesselheim, A.S. Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use. PLoS One 18, e0288008 (2023).
Flynn, A.N., Shorter, J.M., Roe, A.H., Sonalkar, S. & Schreiber, C.A. The burden of the risk evaluation and mitigation strategy (REMS) on providers and patients experiencing early pregnancy loss: a commentary. Contraception 104, 29-30 (2021).
Kaye, J., Reeves, R. & Chaiten, L. The mifepristone REMS: a needless and unlawful barrier to care. Contraception 104, 12-15 (2021).
Frysh, P. Schizophrenia: is the FDA hindering the most effective med? WebMD <https://www.webmd.com/schizophrenia/features/schizophrenia-fda-hindering-clozapine> (2021). Accessed December 19, 2023.
American Association for Public Opinion Research. Standard definitions <https://aapor.org/standards-and-ethics/standard-definitions/>. Accessed December 19, 2023.
Sarpatwari, A. et al. A multi-modal approach to evaluate the impact of risk evaluation and mitigation strategy (REMS) programs. Drug Saf. 44, 743-751 (2021).
Bahri, P. & Harrison-Woolrych, M. Focusing on risk communication about medicines: why now? Drug Saf. 35, 971-975 (2012).
Brown, B.L., Kesselheim, A.S. & Sarpatwari, A. Analysis of risk evaluation and mitigation strategies for teratogenic drugs: variation in primary and secondary prevention measures. PLoS Med. 20, e1004190 (2023).
Kovitwanichkanont, T. & Driscoll, T. A comparative review of the isotretinoin pregnancy risk management programs across four continents. Int. J. Dermatol. 57, 1035-1046 (2018).
FDA briefing document: risk evaluation and mitigation strategy (REMS) for isotretinoin products “iPLEDGE REMS”. Combined Meeting of the Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee <https://www.fda.gov/media/166485/download>. Accessed December 19, 2023.
Stocum, L. Nearly two-thirds still locked out of iPLEDGE. Dermatology Times <https://www.dermatologytimes.com/view/nearly-two-thirds-still-locked-out-of-ipledge> (2022). Accessed December 19, 2023.
American Academy of Dermatology Association. AADA Keeps pressure on IPMG to fix ipledge REMS program <https://www.aad.org/member/publications/impact/2022-issue-3/academy-pressures-ipmg-to-fix-ipledge>. Accessed December 19, 2023.
March 28-29. Joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee meeting announcement <https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-28-29-2023-joint-meeting-drug-safety-and-risk-management-advisory-committee-and-dermatologic>. Accessed December 19, 2023.
Sarpatwari, A. et al. Patient and caregiver experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use. JAMA Netw. Open 5, e2144386 (2022).
US Food and Drug Administration. Challenges and opportunities for REMS integration, innovation, and modernization <https://www.fda.gov/drugs/news-events-human-drugs/challenges-and-opportunities-rems-integration-innovation-and-modernization-10112022> (2022). Accessed December 19, 2023.
Schwartz, L.M. & Woloshin, S. Lost in transmission-FDA drug information that never reaches clinicians. N. Engl. J. Med. 361, 1717-1720 (2009).
US Food and Drug Administration. Policy for certain REMS requirements during the COVID-19 public health emergency guidance for industry and health care professionals <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-certain-rems-requirements-during-covid-19-public-health-emergency-guidance-industry-and> (2023). Accessed December 19, 2023.