Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2023 Apr 28;4(2):91-93.
doi: 10.36518/2689-0216.1558. eCollection 2023.

Leveraging Technology in Risk Evaluation and Mitigation Strategy Programs

Sondra Davis  1 , Katie Reynolds  1 , Charles Ulrich  1
Affiliations
Editorial

Leveraging Technology in Risk Evaluation and Mitigation Strategy Programs

Sondra Davis et al. HCA Healthc J Med. .

Abstract

Description Medication safety is improved through REMS programs. Multidisciplinary teams and front-line staff are vital in setting up a REMS program and should be included in any discussions surrounding REMS programs. Certain components of the REMS requirements may be replaced with CDS screens. Utilizing technology can help advance patient safety and aid in regulatory compliance.

Keywords: FDA; REMS; drug safety; medication safety; pharmacy technology; risk mitigation.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest The authors declare that they have no conflicts of interest.

References

    1. Food US, Administration Drug.Approved risk evaluation and mitigation strategies (REMS) [Accessed October 7, 2022]. https://www.accessdata.fda.gov/Scripts/Cder/Rems/index.cfm .
    1. Tsapepas DS, McKeen JT, Martin ST, et al. Risk evaluation and mitigation strategy programs in solid organ transplantation: the promises of information technology. J Am Med Inform Assoc. 2014;21(e2):e358–e362. doi: 10.1136/amia-jnl-2013-002446. - DOI - PMC - PubMed
    1. Quffa LH, Panna M, Jr, Kaufmann MR, McKillop M, Dietrich NM, Franck AJ. Impact of a pharmacy-cardiology collaborative practice on dofetilide safety monitoring. Ann Pharmacother. 2017;51(1):39–43. doi: 10.1177/1060028016669962. - DOI - PubMed
    1. Brandenburg NA, Bwire R, Freeman J, Houn F, Sheehan P, Zeldis JB. Effectiveness of risk evaluation and mitigation strategies (REMS) for lenalidomide and thalidomide: patient comprehension and knowledge retention. Drug Saf. 2017;40(4):333–341. doi: 10.1007/s40264-016-0501-2. - DOI - PMC - PubMed
    1. Chan HW, Russell AM, Smith MY. What is the quality of drug safety information for patients: an analysis of REMS educational materials. Pharmacoepidemiol Drug Saf. 2018;27(9):969–978. doi: 10.1002/pds.4614. - DOI - PMC - PubMed

Publication types

LinkOut - more resources