Feds Launch Plan to Fight Prescription Drug Epidemic

REMS Requires Manufacturers to Initiate and Pay for Physician Training Programs

Deborah Brauser

April 19, 2011

April 19, 2011 — White House officials from the Office of National Drug Control Policy (ONDCP), along with the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA), today announced the release of the first national action plan to fight a "prescription drug abuse epidemic."

The collaborative "Obama Administration action plan" urges prescriber education on opioid risks and benefits, recommends monitoring programs for all states, and suggests easier ways to dispose of unwanted or unused drugs in the home. The joint-agency group is also calling for new laws to turn these recommendations into requirements.

In conjunction with the new action plan, the FDA announced a new Risk Evaluation and Mitigation Strategy (REMS) program and reports that it has already contacted the manufacturers of the extended-release and long-acting opioid medications hydromorphone, oxycodone, morphine, oxymorphine, morphone, methadone, and transdermal fentanyl.

The new REMS program will require these manufacturers to develop and pay for programs to educate doctors on proper pain management, patient selection, and ensuring that their patients understand how to use these drugs safely.

 

I don't use the word 'epidemic' lightly, but that's what this country is in the midst of now and the facts are devastating. We set a goal of reducing this abuse by 15% over the next 5 years. But the severity of this issue requires a sustained national effort.

"I don't use the word 'epidemic' lightly, but that's what this country is in the midst of now and the facts are devastating. We set a goal of reducing this abuse by 15% over the next 5 years. But the severity of this issue requires a sustained national effort," said Gil Kerlikowske, director of the ONDCP, during a press conference.

"Today we are making an unprecedented commitment to combat the growing problem of prescription drug abuse," said Vice President Joe Biden in a release.

"The Government, as well as parents, patients, healthcare providers, and manufacturers all play a role in preventing abuse. This plan will save lives and will substantially lessen the burden this epidemic takes on our families, communities, and workforce."

The new action plan was published April 19 on the ONDCP Web site. Information on the new REMS plan is located on the FDA's Web site.

Nation's Fastest Growing Drug Problem

Calling prescription drug abuse "our Nation's fastest growing drug problem," Mr. Kerlikowske reported that approximately 27,000 people died of unintentional drug overdoses in 2007, "driven to a large degree by prescription drug abuse." Deaths from unintentional prescription drug overdoses now exceed deaths from gunshot wounds.

Mr. Gil Kerlikowske

In addition, the Substance Abuse and Mental Health Services Administration reports that hospital emergency department visits involving prescription drug abuse have doubled just over the past 5 years.

"Overdoses that we have talked about in the past, historically crack cocaine and others, are not even at the same level of problem that we are seeing with prescription drugs today," said Mr. Kerlikowske.

"From day 1, the Obama administration has been focused like a laser on this particular issue. This new plan will build upon our already unprecedented efforts to coordinate a national response to this public health crisis by addressing the threat at the federal, state, and local level."

The 4 key goals of the new action plan are to:

  • Expand awareness and education to physicians, researchers, and the public;

  • Expand efforts to monitor the prescribing of these drugs, including calling upon every state to set up a program;

  • Make it easier to dispose of drugs; and

  • Shut down "pill mills" and reduce doctor shopping.

"Too many Americans are not aware of how dangerous these drugs can be, particularly compared to illegal drugs, which get a lot of attention. That's why we need to raise awareness," said Mr. Kerlikowske.

He reported that prescription drug monitoring programs have already been successfully implemented in 35 states, noting that "they are saving lives by tracking prescriptions and immediately alerting prescribers to those who may be engaged in doctor shopping."

In addition to expanding this effort to the remaining states, the action plan recommends the sharing of patient data between all states.

"Until now, we have tried to respond to this abuse problem as individuals and as individual organizations. But this plan now gives us an opportunity to provide a broad partnership to tackle these issues from a public health and public safety approach," said Howard Koh, MD, MPH, assistant secretary for health at the Department of Health and Human Services (HHS).

He "pledged full support" of the HHS for all components of the plan, especially in the area of helping with drug monitoring programs.

Eliminating Pill Mills

According to Mr. Kerlikowske, as much as 40% of all prescription go unused, and 7 of 10 prescription medication abusers get their drugs from friends or family.

Although it is a very small number of doctors who abuse their prescribing privileges, they are responsible for an immense amount of the addiction and deaths. And we have a responsibility to do everything we can to bring these criminals to justice.

"The DEA hosted the first national Take Back Program last September, collecting over 121 tons of prescription drugs in 1 day alone. Then in October, the President signed into law historic federal legislation that will make it easier for communities to collect dangerous and expired drugs," he reported.

The new action plan recommends convenient and environmentally responsible disposal methods to remove these pain killers from the home, requires more Take Back Programs from the DEA, and recommends that "new Federal rules be created" so local communities can host their own Take Back days.

Regarding the so-called pill mills, Mr. Kerlikowske said that physicians who "contribute to this suffering" should be punished.

"Although it is a very small number of doctors who abuse their prescribing privileges, they are responsible for an immense amount of the addiction and deaths. And we have a responsibility to do everything we can to bring these criminals to justice," he explained.

"As a result, this action plan increases resources, training, and support for federal agencies and state medical boards to take action against these rogue pain clinics and prescribers."

REMS Requirements

Dr. Margaret Hamburg

The new opioids REMS program was created in support of the new national action plan, reported FDA commissioner Margaret A. Hamburg, MD.

She noted that when used properly, opioids do have benefit and "are a necessary component" of pain management for certain patients — but they pose serious risks when used improperly.

"We face an ongoing challenge and a dual responsibility. We must ensure that patients have access to the medications they need while also preventing use and abuse," said Dr. Hamburg.

She reported that the new REMS program will require manufacturers to develop risk-benefit plans and education programs for health professionals, as well as education programs for patients.

New REMS program will require manufacturers to develop risk-benefit plans and education programs for health professionals, as well as education programs for patients.

"We think this should be accomplished through 2 key features: medication guides and new tools for both prescriber and patients," explained Dr. Hamburg.

"Our focus above all is to ensure that health professionals have the knowledge and training to deliver effective pain management care and that patients understand the risks of opioid products."

Dr. Hamburg said that the FDA will approve all materials before they can be implemented and expects that all training will be done by accredited continuing education providers. They also plan to conduct periodic assessments "to ensure our program is indeed effective."

"The ONDCP is going to build on this joint effort by pursuing legislation that would amend the Controlled Substances Act to require mandatory education on the sale and appropriate use of opioids for all prescribers of controlled substances," reported Mr. Kerlikowske.

Dr. Hamburg added that the FDA "strongly supports the Administration's call" for mandatory opioid education for prescribers.

Pooling Resources

When asked about the costs for the new action plan, Mr. Kerlikowske said that "very little money" is actually involved.

"We understood that we wanted to come together as a group and pool our assets and knowledge and resources, the ability to have administrative actions taken, and the ability to use local law enforcement in this volunteer way across the country."

"In this austere budget climate, this is what the American citizen expects of us — to be smart and work together to be strategic. I am incredibly optimistic that almost everything in this plan can be accomplished and that over the next year we are going to make a big dent in this problem," he said.

"The abuse of prescription drugs is an alarming public health crisis that is suffocating our society. This new national plan offers tremendous promise of health and hope to our country. And it gives us a chance to celebrate a healthcare system that delivers prevention early instead of treatment too late," said Dr. Koh.

The new national action plan is located at the ONDCP's Web site.

The new opioids REMS program is located at the FDA's Web site.

The next national Take Back Day is April 30. More information on this program is posted on the DEA's Web site.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....