Changes to the TIRF REMS Implemented on March 29, 2021 The U.S. Food and Drug Administration (FDA) has become aware of concerns from stakeholders regarding the implementation of the December 2020 Transmucosal Immediate-release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategies (REMS) modification. The TIRF REMS modification was approved in December 2020 and fully implemented on March 29, 2021. Due to changes in the requirements, providers that were previously certified in the REMS to prescribe TIRF medicines for outpatient use, and pharmacies that were previously certified to dispense TIRF medicine are required to complete new training, complete the knowledge assessment, and re-certify into the modified REMS. Since the modification was implemented, some prescribers and pharmacies have had difficulties re-certifying in the modified REMS, and consequently, some patients have had difficulties filling their prescriptions. FDA is working with manufacturers of TIRF medicines to address these concerns. For example, manufacturers of TIRF medicines have added additional staff and hours to the TIRF REMS Call Center to better address and resolve issues. We encourage stakeholders to re-certify so that they can continue providing TIRF medicines to patients in need of these medications. For information on how to re-certify, as well as additional information about the TIRF REMS program, visit www.TIRFREMSaccess.com or contact the TIRF REMS program at 1-866-822-1483. | 
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