Shared REMS Approved for all Transmucosal Immediate-release Fentanyl Products


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3.3.02_fda-logo.jpgThe FDA has approved a new transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy (REMS) access program. The REMS is a single shared system for all transmucosal immediate-release fentanyl products. Among the goals of the REMS access program are to mitigate the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors by prescribing and dispensing such medicines only to appropriate patients; preventing inappropriate conversion between fentanyl products; and preventing accidental exposure to children and others for whom the drug was not prescribed.

Transmucosal immediate-release fentanyl products are available only through REMS programs, which require enrollment by prescribers, their patients, pharmacies, and distributors. Currently, manufacturers of these drugs have separate REMS programs, and a health-care provider and pharmacy must enroll in multiple REMS programs to prescribe or dispense each product.

Program Live in March 2012

The shared REMS will go live in March 2012, when prescribers, pharmacies, patients, and distributors may all be enrolled in a single program for these products. All stakeholders currently enrolled in any of the individual REMS programs will be automatically enrolled in the shared system in March. For more information, visit fda.gov. ■



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