The US Food and Drug Administration has approved Subsys (fentanyl) sublingual spray. Subsys is a sublingually-administered formulation of fentanyl which provides relief to patients for breakthrough cancer pain
This medication CAN ONLY be prescribed to patients with cancer. The FDA made it clear that only cancer pt's are eligible to receive this medication. The FDA made it clear that pt's with spinal problems and other muscular problems are not eligible to receive this medication. Subsys is available only through a program called the TIRF REMS ACCESS program.
FDA approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.
The TIRF REMS Access Program is aimed to ensure patient access to important medications and mitigate the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors by:
- prescribing and dispensing TIRF medicines only to appropriate patients, including use only in opioid-tolerant patients.
- preventing inappropriate conversion between fentanyl products.
- preventing accidental exposure to children and others for whom TIRF medicines were not prescribed.
- educating prescriber's, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose.
This program sounds good,But it only addresses a very small population of chronic pain patients. I just don't know why they are able to implement such a program for certain types of chronic pain patients and not for others...
Most of this info was received from the FDA medwatch website...
Post Edited (rjbeck) : 1/10/2012 2:50:22 AM (GMT-7)