An FDA advisory committee recently met to review the FDA’s proposed plan to create a REMS (Risk Evaluation and Mitigation Strategy) to help deal with opioid abuse and overdoses. In the FDA proposal, manufacturers of extended-release opioids would be responsible for providing educational materials and programs for physicians and nurses. This was to include pamphlets for patients and educational classes to guide physicians’ selection of appropriate patients.
Opioids are narcotic pain medications and are among the most abused drugs in the country. Extended-release opioids have a high incidence of overdose and death. Abuse of opioids can occur when patients claim to have pain solely in order to be prescribed the pain medications or when patients use their prescriptions in a way other than how the doctor prescribes. In extended-release opioids, abuse can occur when a patient modifies the medication to receive all the medication effects at once rather than the designed slow release of the opioid into the body, a potentially dangerous situation. The educational classes for physicians would train them to identify addicted opioid users seeking to abuse the system.
The proposal by the FDA was voted down by the advisory committee 25-10. The committee members felt the proposal was not enough to impact this national medical problem. They were concerned that the educational materials and physician training would only be available, instead of mandatory. They also had an issue with physicians being taught by medication manufacturers on how to prescribe the drugs, preferring a government-regulated system. The FDA could not start their own training program of this sort without legislation from Congress. The committee’s other concern was that creating a REMS for extended-release opioids would only make it necessary to create a REMS for immediate release opioids as well, which they felt should be done all at once to be consistent.
Opioids (narcotic medications) are commonly used to treat back pain over short periods of time (less than two weeks) to relieve acute pain from injury, but are less frequently used to treat chronic back pain due to the risk of developing tolerance to the opioids (where the body needs more of the drug to give the same amount of relief) and addiction concerns.
You have a voice
The FDA is accepting comments until October 19, 2010 about this issue. If you have an opinion on the Advisory Committee's recommendations, you can go to the issue on regulations.gov, click on “Submit Comment” near the top of the page and share your thoughts and/or opinions.