FDA Creates Shared REMS System for TIRF Medicines - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Creates Shared REMS System for TIRF Medicines


ePT--the Electronic Newsletter of Pharmaceutical Technology

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, narcotic pain medicines used by cancer patients to manage pain. The TIRF REMS program is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.

“This TIRF REMS will ensure safe use and access to these drugs for patients who need them,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research in a press release. FDA hopes to limit the risk of misuse, overdose, abuse, and complications related to TIRF medicines, which include the brand names Abstral, Actiq, Fentora, Lazanda, and Onsolis. The program will ensure that TIRF drugs are prescribed and dispensed only to appropriate patients and will prevent inappropriate conversion between fentanyl products.

Prescribers, patients, and pharmacies will begin using the program beginning in March 2012, but until then the current individual REMS programs will continue to be used. Those already enrolled in established individual REMS for TIRF products will automatically be transitioned to the shared program. Patients who receive TIRF medicines in inpatient situations (e.g., hospitals and hospices) will not be required to enroll in the program, nor will the doctors that prescribe TIRF drugs in inpatient situations. However, patients receiving the medicines on an outpatient basis are required to be enrolled.

See related Pharm Tech articles:

Safety Concerns and Shortages Challenge Pharma

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here