April 19, 2011— -- 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.
The advisory committee of drug, addiction, and pain experts had said it would be inappropriate for drugmakers to tell physicians how to prescribe the drugs.
Woodcock told MedPage Today that the FDA will go through the pharmaceutical company's educational material with a fine-toothed comb to make sure it's scientifically sound and accurately portrays the risks of such drugs.
While the FDA will require drug companies to establish training programs, the REMS will not require physicians to participate in such programs, and it's unclear how many busy physicians will voluntarily take such classes. To add some incentive, expert medical faculty would review the training courses in order to certify them for continuing medical education (CME) credits, Woodcock said.
The REMS would be the most "far-reaching and impactful" imposed by the agency, affecting up to 700,000 physicians who prescribe the drugs, Woodcock said.
But it wouldn't be the most restrictive REMS. In order to prescribe the addiction-treatment drug buprenorphine (Suboxone), physicians must go through an eight-hour training class, and in order to prescribe the acne treatment isotretinoin (Accutane), physicians must obtain negative pregnancy test results from their female patients.
Physicians and nurse practitioners who prescribe certain opioids already have to register with the Drug Enforcement Agency (DEA), and some panelists at the July meeting favored linking that registration to completion of a training program.
However, that approach is out of the FDA's reach and would require an act of Congress. And that's where the hypothetical bill that the officials touted would come in.
The bill would give the DEA authority to require that providers registering with the DEA prove they have undergone training. The training would include specifics on which pain patients need extended-release opioids, how much they need, and when it's a better idea to prescribe a immediate-release opioid or a less potent medication such as a non-steroidal anti-inflammatory drug (NSAID).
That congressionally mandated training would still originate from drug companies, Woodcock said. It would have a large focus on what doctors should tell their patients when they prescribe long-acting narcotics, and include clear explanations of what the drug does, what happens if a patient takes too much, and the importance of locking up the prescription in a secure place.
Kolodny said he worries that even this mandatory education would be a very "watered down" program -- one that pales in comparison to the 8-hour class required for buprenorphine prescribing.
Drugmakers "don't want any kind of system that would limit access" to their product, he said, adding that the buprenorphine course has helped to deter prescribing of the drug.
Seven in 10 people who abuse prescription painkillers got them from a friend or relative, according to a survey from the Substance Abuse and Mental Health Services Administration.
Kerlikowske said the DEA also would crack down on doctors who run so-called "pill mills," illegally doling out narcotics for money.
"Although it's a very small number of doctors who abuse their prescribing privileges, they are responsible for an immense amount of the suffering and death," he said.
Another strategy is to increase the number of state prescription drug monitoring programs (PDMPs).
Currently, 43 states have authorized implementation of such programs, but only 35 are up and running.Florida's governor Rick Scott made headlines recently with his plan to slash the state's PDMP, even though Florida is generally considered as a prime area for abuse of prescription painkillers.
The REMS only deals with extended-release opioids because they are more dangerous when abused. When they are crushed and snorted, they release a high dose of narcotic immediately into the bloodstream -- a dose that was intended to be released slowly.
These include hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine -- affecting a total of 16 brand and generic manufacturers.
The companies will have 120 days to submit their REMS to the FDA for review. Woodcock said the final REMS will likely be completed by early 2012.
Depending on the outcome of the administration's new plan, immediate-release opioids such as hydrocodone (Vicodin) eventually could be targeted as well, Woodcock said.
She added that the agency will be monitoring the success of the REMS, and that it does have other means of accomplishing enforcement if a bill is not drafted or passed.
One person dies from a drug overdose every 19 minutes in the U.S., and more people die from prescription drugs than gunshot wounds, according to the ONDCP.
The overall rate of deaths from drugs -- including heroin, cocaine, and prescription opioids -- is approaching the number of deaths from car crashes each year. Prescription painkiller abuse now matches abuse of illegal drugs, and mortality from the prescription drugs exceeds overdose deaths from cocaine and heroin combined.