An article found on the FDA website dated April 19, 2011, states that The toll our nation’s prescription drug abuse epidemic has taken in communities nationwide is devastating, says Gil Kerlikowske, director of the White House Office of National Drug Control Policy. We share a responsibility to protect our communities from the damage done by prescription drug abuse.
The White House on Tuesday unveiled a multi-agency plan aimed at reducing the epidemic of prescription drug abuse in the U.S. including an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.
Key elements of the plan which is called Responding to America’s Prescription Drug Abuse Crisis are expanding the state based prescription drug monitoring programs, nature friendly ways to remove the unused drugs from homes, giving patients and providers education on these drugs, and cutting down on the number of pill manufacturers.
With the White House plan, the Food and Drug Administration (FDA) is announcing a new risk reduction program. It is called a Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid medications. Drugs like OxyContin, Avinza, Dolophine, Duragesic, and eight other brand names are often mis-prescribed, misused, and abused. These tend to lead to overdoses, addiction, and even deaths across the United States.
The new REMS plan focuses primarily on educating doctors about proper pain management, patient selection, and other requirements and improving patient awareness
about how to use these drugs safely. As part of the plan, FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.
FDA wants drug makers to work together to develop a single system for implementing the REMS strategies. Toward that goal, FDA is now notifying opioid makers that they must propose a REMS plan within 120 days.
The Director of FDA’S Center for Drug Evaluation and Research, Janet Woodcock, says this plan is designed to improve pain management, while still allowing patient access to these needed medications. This will be an important step toward addressing what has become a critical public health problem she says.
This REMS plan will be in effect by early 2012, doctor training, patient counseling, and other risk reduction measures developed by opioid makers should be in full swing. They will be required for various brand name products known under the generic names, as hydromorphone, oxycodone, morphine, xylophone, methadone, transdermal fentanyl, transdermal buprenorphine.
The education for physicians is not mandatory under the REMS plan, other federal agencies are diligently working to get Congress to link mandatory physician training to the already required Drug Enforcement Administration registration number that doctors must have to prescribe controlled substances.
The FDA wants the plan to include a way to keep track of whether the numbers of misuse, addiction, and mis-prescribed are coming down. FDA has had the power to request companies to develop REMS since 2007. The plans may also include medication guides and patient package inserts to further educate those who are prescribed these medications.