Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs.[1] The REMS program was formalized in 2007.
The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program.[2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name drug.[1] The FDA may remove the REMS requirement if it is found to not improve patient safety.[3]
The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as the Accutane, which causes serious birth defects, Clozaril, which can cause agranulocytosis, and Thalidomide, which is used to treat leprosy but causes serious birth defects.[4] The 2007 Food and Drug Administration Amendments Act created section 505-1 of the Food, Drug, and Cosmetic Act which allowed for the creation of the REMS program for applying individual monitoring restrictions to medications.[5]
Some of the provisions required by the REMS program are training and certification of physicians allowed to prescribe the drug, requiring that the drug be administered in a hospital setting, requiring pharmacies to verify the status of patients receiving REMS drugs, requiring lab testing of patients to ensure that health status is satisfactory, or requiring that patients be entered into a registry.[6]
As of 2018, there are 74 medications subject to REMS monitoring. 62% of these include "elements to assure safe use". These typically require clinicians or health care institutions to become certified prior to prescribing. 12% include only a "communication plan" REMS element which is informational in nature. These communication plans are typically composed of letters, websites, and fact sheets describing the specific safety risks identified in the REMS. 26% include only the "medication guide" REMS element.[7]
Communication aspectedit
In 2020, clinical settings enrolled in the REMS program asked the FDA to make their reviews of REMS compliance public so that they can more easily view the records and adjust to feedback.[8] Between 2014 and 2017, the FDA stated they did not have enough data to determine whether the REMS program was sufficiently preventing opioid abuse.[9] The Health and Human Services Office of the Inspector General recommended that parties in the REMS program provide the FDA more data.[10] The FDA was habitually late in evaluating that data, reportedly leaving those parties with inadequate time to react to the review before their next assessment.[10] In November 2020, the FDA planned to create a “Summary of the REMS Assessment” document that would publicize their assessments of clinical settings and manufacturers in the REMS program.[8] The FDA made a public request for comment on the idea of publishing the Summary of the REMS Assessment.[11] Without the publication of the Summary, parties in the REMS program must request it using the Freedom of Information Act.[8]
Referencesedit
^ abBrennan, Z. (31 May 2018). "REMS Draft Guidance: FDA Looks to Deal With Exploited Requirements". Retrieved 22 June 2018.
^Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - Frequently Asked Questions (FAQs) about REMS". www.fda.gov. Retrieved 22 June 2018.
^. ASCO. 13 April 2017. Archived from the original on 23 June 2018. Retrieved 22 June 2018.
^Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - FDA's Role in Managing Medication Risks". www.fda.gov. Retrieved 22 June 2018.
^Dabrowska, A. (26 March 2018). "FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development" (PDF). Retrieved 22 June 2018.
^Research, Center for Drug Evaluation and. "Risk Evaluation and Mitigation Strategies (REMS) - What's in a REMS?". www.fda.gov. Retrieved 22 June 2018.
^"Approved Risk Evaluation and Mitigation Strategies (REMS)". www.accessdata.fda.gov. Retrieved 22 June 2018. This article incorporates text from this source, which is in the public domain.
^ abc"FDA seeks comment on plan to increase REMS transparency". www.raps.org. Retrieved 2020-11-15.
^Brooks, Marta J. (2014-12-01). "Mitigating the Safety Risks of Drugs With a Focus on Opioids: Are Risk Evaluation and Mitigation Strategies the Answer?". Mayo Clinic Proceedings. 89 (12): 1673–1684. doi:10.1016/j.mayocp.2014.09.003. ISSN 0025-6196. PMID 25441401.
^ ab"Report: FDA REMS program ineffective at curbing opioid misuse". www.raps.org. Retrieved 2020-11-15.
^"FDA Seeks Public Comment on REMS Program". www.fdanews.com. Retrieved 2020-11-15.
May 08, 2024
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Risk Evaluation and Mitigation Strategies REMS is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects REMS applies only to specific prescription drugs but can apply to brand name or generic drugs 1 The REMS program was formalized in 2007 The FDA determines as part of the drug approvals process that a REMS is necessary and the drug company develops and maintains the individual program 2 REMS applies only to specific prescription drugs but can apply to brand name or generic drugs REMS for generic drugs may be created in collaboration with the manufacture of the brand name drug 1 The FDA may remove the REMS requirement if it is found to not improve patient safety 3 The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high risk drugs such as the Accutane which causes serious birth defects Clozaril which can cause agranulocytosis and Thalidomide which is used to treat leprosy but causes serious birth defects 4 The 2007 Food and Drug Administration Amendments Act created section 505 1 of the Food Drug and Cosmetic Act which allowed for the creation of the REMS program for applying individual monitoring restrictions to medications 5 Some of the provisions required by the REMS program are training and certification of physicians allowed to prescribe the drug requiring that the drug be administered in a hospital setting requiring pharmacies to verify the status of patients receiving REMS drugs requiring lab testing of patients to ensure that health status is satisfactory or requiring that patients be entered into a registry 6 Contents 1 Usage 2 Communication aspect 3 ReferencesUsage editAs of 2018 there are 74 medications subject to REMS monitoring 62 of these include elements to assure safe use These typically require clinicians or health care institutions to become certified prior to prescribing 12 include only a communication plan REMS element which is informational in nature These communication plans are typically composed of letters websites and fact sheets describing the specific safety risks identified in the REMS 26 include only the medication guide REMS element 7 Communication aspect editIn 2020 clinical settings enrolled in the REMS program asked the FDA to make their reviews of REMS compliance public so that they can more easily view the records and adjust to feedback 8 Between 2014 and 2017 the FDA stated they did not have enough data to determine whether the REMS program was sufficiently preventing opioid abuse 9 The Health and Human Services Office of the Inspector General recommended that parties in the REMS program provide the FDA more data 10 The FDA was habitually late in evaluating that data reportedly leaving those parties with inadequate time to react to the review before their next assessment 10 In November 2020 the FDA planned to create a Summary of the REMS Assessment document that would publicize their assessments of clinical settings and manufacturers in the REMS program 8 The FDA made a public request for comment on the idea of publishing the Summary of the REMS Assessment 11 Without the publication of the Summary parties in the REMS program must request it using the Freedom of Information Act 8 References edit a b Brennan Z 31 May 2018 REMS Draft Guidance FDA Looks to Deal With Exploited Requirements Retrieved 22 June 2018 Research Center for Drug Evaluation and Risk Evaluation and Mitigation Strategies REMS Frequently Asked Questions FAQs about REMS www fda gov Retrieved 22 June 2018 FDA Removes Risk Evaluation Management Strategies REMS for ESAs ASCO 13 April 2017 Archived from the original on 23 June 2018 Retrieved 22 June 2018 Research Center for Drug Evaluation and Risk Evaluation and Mitigation Strategies REMS FDA s Role in Managing Medication Risks www fda gov Retrieved 22 June 2018 Dabrowska A 26 March 2018 FDA Risk Evaluation and Mitigation Strategies REMS Description and Effect on Generic Drug Development PDF Retrieved 22 June 2018 Research Center for Drug Evaluation and Risk Evaluation and Mitigation Strategies REMS What s in a REMS www fda gov Retrieved 22 June 2018 Approved Risk Evaluation and Mitigation Strategies REMS www accessdata fda gov Retrieved 22 June 2018 nbsp This article incorporates text from this source which is in the public domain a b c FDA seeks comment on plan to increase REMS transparency www raps org Retrieved 2020 11 15 Brooks Marta J 2014 12 01 Mitigating the Safety Risks of Drugs With a Focus on Opioids Are Risk Evaluation and Mitigation Strategies the Answer Mayo Clinic Proceedings 89 12 1673 1684 doi 10 1016 j mayocp 2014 09 003 ISSN 0025 6196 PMID 25441401 a b Report FDA REMS program ineffective at curbing opioid misuse www raps org Retrieved 2020 11 15 FDA Seeks Public Comment on REMS Program www fdanews com Retrieved 2020 11 15 Retrieved from https en wikipedia org w index php title Risk Evaluation and Mitigation Strategies amp oldid 1144916686, wikipedia, wiki, book, books, library,
