A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.
Journal
Drug safety
ISSN: 1179-1942
Titre abrégé: Drug Saf
Pays: New Zealand
ID NLM: 9002928
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
accepted:
08
04
2021
pubmed:
28
4
2021
medline:
21
4
2022
entrez:
27
4
2021
Statut:
ppublish
Résumé
Since 2007, the US Food and Drug Administration has had the authority to require risk evaluation and mitigation strategy (REMS) programs for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Such programs can include requirements for patient monitoring, restrictions on dispensing or administration, and physician and pharmacy training and certification. However, there has been only scattered evidence on the impact of REMS programs on informed decision making, medication access, or patient outcomes. The objective of this article was to describe a study that researchers at Brigham and Women's Hospital and Harvard Medical School will conduct in partnership with the Food and Drug Administration's Office of Surveillance and Epidemiology to investigate systematically how REMS programs have operated in practice. Investigations include health insurance claims-based analyses to understand patterns of drug use, adherence to safety requirements, and patient outcomes under REMS programs; surveys and interviews to understand physician and patient experiences with REMS; and REMS program material-based and interview-based analyses to understand the effectiveness of risk communication in REMS programs. These research activities will evaluate the performance of REMS programs, provide information on the benefits and burdens to patients and healthcare providers, and generate recommendations for actionable steps to improve REMS programs overall.
Identifiants
pubmed: 33904111
doi: 10.1007/s40264-021-01070-2
pii: 10.1007/s40264-021-01070-2
doi:
Substances chimiques
Pharmaceutical Preparations
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
743-751Subventions
Organisme : NHLBI NIH HHS
ID : T32 HL007633
Pays : United States
Références
Avorn J, Kesselheim A, Sarpatwari A. The FDA Amendments Act of 2007: assessing its effects a decade later. N Engl J Med. 2018;379(12):1097–9.
doi: 10.1056/NEJMp1803910
Pub L No 110–85, 121 Stat 823 (September 27, 2007).
21 USC § 355-1.
United States Food and Drug Administration. Approved risk evaluation and mitigation strategies (REMS). https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm . Accessed 17 Mar 2021.
United States Department of Health and Human Services Office of Inspector General. FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drugs safety. February 2012. https://oig.hhs.gov/oei/reports/OEI-04-11-00510.asp . Accessed 17 Mar 2021.
Sarpatwari A, He M, Tessema FA, Gagne JJ, Kesselheim AS. Changes in erythropoiesis stimulating agent use under a risk evaluation and mitigation strategy (REMS) program. Drug Saf. 2021;44(3):327–35.
doi: 10.1007/s40264-020-01017-z
Ishihara L, Beck M, Travis S, Akintayo O, Brickel N. Physician and pharmacist understanding of the risk of urinary retention with retigabine (Ezogabine): a REMS assessment survey. Drugs Real World Outcomes. 2015;2(4):335–44.
doi: 10.1007/s40801-015-0042-5
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):969–78.
doi: 10.1002/pds.4614
Sarpatwari A, Franklin JM, Avorn J, Seeger JD, Landon JE, Kesselheim AS. Are risk evaluation and mitigation strategies associated with less off-label use of medications? The case of immune thrombocytopenia. Clin Pharmacol Ther. 2015;97:186–93.
doi: 10.1002/cpt.17
Blanchette CM, Nunes AP, Lin ND, et al. Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function. Drugs Context. 2015;4:212272.
pubmed: 25709706
pmcid: 4335780
Sarayani A, Albogami Y, Elkhider M, Hincapie-Castillo JM, Brumback BA, Winterstein AG. Comparative effectiveness of risk mitigation strategies to prevent fetal exposure to mycophenolate. BMJ Qual Saf. 2020;29(8):636–44.
doi: 10.1136/bmjqs-2019-010098
Sarpatwari A, Curfman G. Mitigating health risks of prescription drugs: lessons from FDA oversight of opioid products. JAMA. 2019;321(7):676–85.
doi: 10.1001/jama.2019.0236
Palmsten K, Huybrechts KF, Mogun H, et al. Harnessing the Medicaid Analytic eXtract (MAX) to evaluate medications in pregnancy: design considerations. PLoS ONE. 2013;8:e67405.
doi: 10.1371/journal.pone.0067405
MacDonald SC, Cohen JM, Panchaud A, McElrath TF, Huybrechts KF, Hernandez-Diaz S. Identifying pregnancies in insurance claims data: methods and application to retinoid teratogenic surveillance. Pharmacoepidemiol Drug Saf. 2019;28(9):1211–21.
doi: 10.1002/pds.4794
Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002;27:299–309.
doi: 10.1046/j.1365-2710.2002.00430.x
Tamariz L, Harkins T, Nair V. A systematic review of validated methods for identifying ventricular arrhythmias using administrative and claims data. Pharmacoepidemiol Drug Saf. 2012;21(Suppl 1):148–53.
doi: 10.1002/pds.2340
Lo Re V, Haynes K, Goldberg D, et al. Validity of diagnostic codes to identify cases of severe acute liver injury in the US Food and Drug Administration’s Mini-Sentinel Distributed Database. Pharmacoepidemiol Drug Saf. 2013;22:861–72.
doi: 10.1002/pds.3470
Barber C, Lacaille D, Fortin PR. Systematic review of validation studies of the use of administrative data to identify serious infections. Arthritis Care Res. 2013;65:1343–57.
doi: 10.1002/acr.21959
Iwashyna TJ, Odden A, Rohde J, et al. Identifying patients with severe sepsis using administrative claims: patient-level validation of the angus implementation of the international consensus conference definition of severe sepsis. Med Care. 2014;52:e39-43.
doi: 10.1097/MLR.0b013e318268ac86
Margulis AV, Setoguchi S, Mittleman MA, Glynn RJ, Dormuth CR, Hernandez-Diaz S. Algorithms to estimate the beginning of pregnancy in administrative databases. Pharmacoepidemiol Drug Saf. 2013;22:16–24.
doi: 10.1002/pds.3284
Andrade SE, Moore Simas TA, Boudreau D, et al. Validation of algorithms to ascertain clinical conditions and medical procedures used during pregnancy. Pharmacoepidemiol Drug Saf. 2011;20:1168–76.
doi: 10.1002/pds.2217