WASHINGTON -- Responding to what they say is an epidemic worse than the crack cocaine problem in the 1980s and the heroin epidemic of the 1990s combined, public health and law enforcement officials in the Obama administration have released a national anti-abuse plan for prescription drugs.
"We are in the midst of a public health crisis driven by prescription drug abuses," Gil Kerlikowske, White House Director of the Office of National Drug Control Policy (ONDCP) said at a Tuesday morning press conference at the National Press Club.
In 2007, there were 28,000 deaths from prescription drug overdoses -- five times the number in 1990, Kerlikowske said. Those deaths were driven largely by the abuse of prescription painkillers.
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One of the main goals of the plan is to cut the rate of abuse of these drugs by 15 percent within five years.
As part of the plan, the FDA announced it will enact a risk-mitigation strategy to educate patients and doctors on proper use and prescribing of extended-release prescription pain pills, such as oxycodone (Oxycontin).
The overall plan -- called "The Administration's Epidemic: Responding to America's Prescription Drug Abuse Crisis" -- supports state-based prescription drug monitoring programs; take-back programs that safely dispose of prescription narcotics; and an education program aimed at patients and healthcare providers.
Administration officials at the press conference said a bill would be introduced in Congress that would require physicians to undergo training provided by drug companies in order to write prescriptions for extended-release prescription narcotics.
But they were mum on who would introduce the bill and when. Kerlikowske said he wouldn't be touting a sweeping plan to combat prescription drug abuse if he wasn't confident Congress would pass such a bill.
On another front, the FDA will develop what is known as a risk evaluation and mitigation strategy (REMS) for the problem. Oddly, the REMS unveiled on Tuesday is essentially the same plan that an advisory panel rejected in a 25-10 vote in July, 2010. The panel felt the FDA's proposal didn't go nearly far enough to prevent drug abuse, overdose, and death.
The FDA will go ahead with the plan, despite the panel's lack of confidence in it.
"It appears to me they were convinced by 'stakeholders' that ready access to opioids is necessary for the millions of Americans with chronic pain," said Dr. Andrew Kolodny, director of psychiatry at Maimonides Medical Center in Brooklyn, N.Y., who has been following the REMS issue closely.
On an FDA telebriefing that followed the morning press conference, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER) emphasized that the purpose of the REMS is not to make it harder for pain patients who need these medications to be prescribed them.
The REMS will require drug companies to provide education programs to doctors who prescribe extended-release prescription narcotics, and also require the companies to provide materials prescribers can use when counseling patients about the risks and benefits of opioid use.
On the call, Woodcock said this would include the use of pain contracts- agreements between patient and physicians that put down on paper how exactly the patient should and shouldn't use the drug.