FDA's new plan for opioid misuse

Change in dealing with the risk of opioid drugs is coming

Concerns over 33 million Americans 12 or older misusing extended-release/long acting opioids (strong medicines related to opium-such as derived morphine) have prompted the White House and FDA and several agencies to work in concert to try to address this growing problem.

Opioids as a term covers a lot of ground, including:

Chemicals that work by holding on to (binding) with opioid receptors that are in the peripheral nerves and brain
Naturally occurring poppy derived (alkaloids) chemicals that come from the resin of the opium poppy (Papaver somniferum).
Some experts consider semi-synthetic chemicals derived from these alkaloids to be opiates. Examples here include oxycodone, hydromorphone and others
Fully synthetic opioids like fentanyl and tramadol
Substances that our own bodies make called endogenous opioid peptides that we know as endorphins.

Long-acting versions of opioids specifically mentioned include: OxyContin, Avinza, Dolophine, Duragesic and eight others (12 total brands) and 17 generics. The White House/FDA plan involves the DOJ, Health and Human Services, Department of Defense, Veterans Affairs and others and is called Epidemic” Responding to America’s Prescription Drug Abuse Crisis. Four cornerstones of the plan include:

1)      Supporting education for patients and health care providers

2)      Reducing the number of “pill mills” and doctor-shopping through law enforcement

3)      Recommending convenient and environmentally responsible ways to remove unused medicines from homes

4)      Expanding state-based prescription drug monitoring programs.

One broad brush approach the FDA will take is to encourage drug manufacturers to work together to develop a single system for starting the Risk Evaluation and Mitigation Strategies (REMS). The FDA is notifying the companies that they must have a REMS plan in 120 days.

Added steps such as physician training, risk reduction based on the initial steps taken and patient counseling are expected to be required/become effective by 2012. These will cover hydromorphone, oxycodone, morphine, oxymorphone, transdermal fentanyl and transdermal buprenorphine.

The challenge of course will be to help patients with moderate to severe pain get the medicines that they require, while controlling and identifying people who are simply seeking to abuse the drugs.

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