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Update: FDA Announces REMS for Long-Acting Opioids

On April 19, 2011 the Office of National Drug Control Policy (ONDCP) released a plan for education, monitoring, proper disposal, and enforcement, to reduce prescription drug abuse. The FDA supported this by announcing elements of REMS requiring manufacturers of LAOs and ER opioids to ensure training for prescribers and to develop patient information. For more information, click here.

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Welcome to the Ready for REMSSM
Web site, an online portal for information on Risk Evaluation and Mitigation Strategies (REMS) for opioids.


Click here to download the latest Ready for REMS materials for healthcare providers.

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Updated Information on Opioid REMS

To access Path to REMS and find out about the history leading up to opioid REMS click here.

If you want to access Opioid Classifications and see how opioid REMS fit in with the various categories of the opioid family, click here.

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Views on REMS from the Experts

For views from the Ready for REMS expert panel on the current state of opioid REMS, including consultation on a class-wide REMS for long-acting opioids and extended-release opioids, click here.

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QuantiaMD Survey Results
From Your Peers

Your peers responded to a QuantiaMD survey taken before and after viewing Ready For REMS presentations on the goals of opioid REMS and how HCPs can use opioid REMS in pain management.
To see the results, click here.

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Winner of the 2011 Communicator
Awards

ReadyForREMS.com is a winner of the 2011 Communicator Awards. Click here for further information.

To access the REMS Timeline and find out about the history leading up to opioid REMS, click here. If you want to access Opioid Classifications and see how opioid REMS fit in with the various categories of the opioid family, click here.

What are opioid REMS?

Since March 2008, Food and Drug Administration (FDA) may formally require manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) for drugs or biologics that have a known or potential safety risk. This FDA requirement is being applied to many products including certain opioids.

Click here to find out more.

Transmucosal Immediate-Release Fentanyl (TIRF) REMS Update

 
Enrollment in the Actiq® (oral transmucosal fentanyl citrate) and FENTORA® (fentanyl buccal tablet) REMS program opened on 9/16/11. To maintain continuity of care for your patients already taking Actiq or FENTORA, go to http://www.actiqandfentorarems.com/ to enroll.
 
Much of the media coverage has been on the class-wide Long Acting/Extended Release (LA/ER) opioid REMS.  Note that the TIRF product REMS have different requirements than the LA/ER opioids and enrollment in product-specific TIRF REMS programs is mandatory.
 
The following TIRFs launched with their REMS and are also open for enrollment:
Abstral® (fentanyl sublingual tablet) http://www.abstralrems.com/
Lazanda® (fentanyl nasal spray) http://www.lazandarems.com/
OnsolisTM (fentanyl buccal soluble film) http://www.onsolisfocus.com/
 
The trade names listed are registered trademarks of the following companies: Abstral (ProStrakan, Inc.), Actiq (Cephalon, Inc.), FENTORA (Cephalon, Inc.), Lazanda (Archimedes Pharma US, Inc.), and Onsolis (Meda Pharmaceuticals, Inc.).

 
© 2009–2011 Cephalon, Inc. All Rights Reserved. Privacy Statement
 
 
 

Poll

Ready for REMS 3
Do you believe that opioid REMS will impact prescribing of opioids?





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Ready for REMS
resources and downloads

Ready for REMS has resources and downloads designed to help healthcare providers to prepare for opioid REMS. These include posters, slides, webcast presentations, a checklist, patient guide, and information links, among other useful items.