FDA Creates Shared REMS System for TIRF Medicines - - BioPharm International

ADVERTISEMENT

FDA Creates Shared REMS System for TIRF Medicines


BioPharm Bulletin

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.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Launches Human Safety Study of Ebola Vaccine Candidate
August 29, 2014
Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
USP Awards Analytical Research
August 15, 2014
Author Guidelines
Source: BioPharm Bulletin,
Click here