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  1. Terrapinzflyer
    A new national strategy being unveiled Tuesday by the White House drug czar to combat prescription drug abuse aims to cut misuse of powerful painkillers like oxycodone by 15 percent within five years through education, stepped-up law enforcement and pill-tracking databases.

    The effort will target pill mills that are dispensing thousands of painkillers, a growing drug abuse epidemic centered in Florida.

    Under one part of the plan, more than 1 million doctors would be required to undergo training on proper prescription practices as a condition for their ability to prescribe the highly addictive drugs known as opioids.

    "The key is that everyone realizes there is no magic answer to this," Gil Kerlikowske, President Barack Obama's national drug policy director, said in an interview with The Associated Press. "It's a really complex problem."

    The first-ever comprehensive federal plan focuses on four main areas: education for prescribing physicians and the public, including a media campaign about the drugs' dangers; pushing for tracking databases in all 50 states; better methods of throwing out unused or expired prescriptions; and more intense training and focus by law enforcement on illegal pill mill clinics.

    Florida is the epicenter of the deadly rise in abuse of oxycodone and similar addictive painkillers, with doctors in the Sunshine State prescribing far more of the drugs than all other states combined, according to the Drug Enforcement Administration. And Florida's pill mills are the supplier of choice for much of the eastern U.S., causing a ripple effect of drug overdoses and addiction to the north — a phenomenon dubbed the "OxyContin Express."

    A recent report by Florida medical examiners found that in the first six months of 2010 — the most recent data available — 1,268 deaths in the state were caused by prescription drugs, or about seven fatalities a day during that span. Kentucky's governor says 82 people die of overdoses each month in his state.

    Renee Doyle, a Fort Lauderdale mother whose son Blayne was in an oxycodone haze when he was struck and killed by a car in 2009, said he was able to get 240 pills on each monthly visit to a local pain clinic by doing little more than asking for them. More than 850 pain clinics are currently registered in Florida, where doctors prescribe 85 percent of all such pills in the nation.

    "I think people were just not paying attention and then greed took over," she said. "They are legal drug dealers and they should be outlawed."

    Although the DEA and local police recently arrested more than 20 people, including five doctors, in a crackdown on South Florida pill mills, Kerlikowske said it's not strictly a law enforcement issue.

    "It's a real collaboration. It's not just a prosecutor and DEA. It isn't just the medical profession. It's everybody," he said.

    Each part of the strategy has several goals. For example, on physician education, the plan calls for Congress to enact a law requiring a certain amount of training on responsible prescription practices of the most-abused drugs for medical practitioners who seek DEA registration to prescribe certain controlled substances. The Food and Drug Administration proposal would be the largest of its kind.

    "There has been a flood of new medicines and many of the physicians out there weren't trained in using them, so there's a big gap in understanding how to manage these drugs," said Dr. Janet Woodcock, who directs the agency's Center for Drug Evaluation and Research.

    Another piece would be a national education campaign featuring ads like the famous frying-egg "this is your brain on drugs" ad used in past antidrug efforts. Key to that is making sure parents keep prescription drugs out of the hands of their children, who are now abusing them more than any illegal drug except marijuana.

    At the state level, the plan envisions prescription drug monitoring programs in all 50 states. Currently, 35 have such programs up and running, and they are authorized but not yet operational in eight more states, including Florida. The databases can help detect abuses and illegal diversion of pills by tracking physicians' prescriptions and how much pharmacies are dispensing.

    The plan also calls for continued aggressive law enforcement efforts and better training. In Florida, Miami DEA chief Mark R. Trouville said he expects a number of physicians to be indicted based on a recent undercover probe involving 340 undercover pill purchases.

    "We're trying to make a statement that if you think you're sliding by in a gray area, you're not, and we're coming," Trouville said.

    By CURT ANDERSON, AP Legal Affairs Writer
    Associated Press writer Matthew Perrone in Washington contributed to this story.
    Tuesday, April 19, 2011



  1. davestate
    Feds Launch Plan to Fight Prescription Drug Epidemic

    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," 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 planis locatedat 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.

    Deborah Brauser
  2. Herbal Healer 019
    Re: Feds Launch Plan to Fight Prescription Drug Epidemic

    It will be funny when the statistics come out showing how grossly ineffective this along with any other effort to curb prescription drug use for recreation is.

    UGH i wish the damn government would just wake up and realize the war on drugs is a huge detriment to society and a waste of money. Always has been, always will be.
  3. davestate
    Re: Feds Launch Plan to Fight Prescription Drug Epidemic

    I uploaded the feds plan to the file archive:
    Epidemic: responding to America's prescription drug abuse crisis

  4. zerozerohero
    Re: Feds Launch Plan to Fight Prescription Drug Epidemic

    hmmm.... interresting... the state shooting one of its major cash cows huh?
    That's obviously just another media-attracting scarecrow thing - i'd never have expected that this administration would go even further in the 'war on drugs' scaremongering than the previous one... how stupid, expensive and useless...especially since in this case the guys on the other side of the fence go sell their stuff to the 'dealer' completely legally and will even offer bonuses and other compensations, again, legally, to the doctor who play ball and prescribe as much as they can...
  5. davestate
    Federal Crack Down on Prescription Drug Abuse Gets Thumbs Up

    Federal Crack Down on Prescription Drug Abuse Gets Thumbs Up

    April 27, 2011 — Several national organizations, including the American Psychiatric Association (APA), have released statements of strong support for the new collaborative action plan to fight prescription drug abuse developed by the White House Office of National Drug Control Policy (ONDCP) in conjunction with the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the US Department of Health and Human Services (HHS).

    As reported by Medscape Medical News, the new action plan calls for healthcare provider training and increased patient education on these medications, expanded monitoring of their use, better disposal of unwanted and/or unused drugs, the shut-down of so-called pill mills, and doctor shopping.

    "I am very pleased to support the administration in addressing the problems related to the abuse of prescription medications," said John A. Renner, MD, chair of the APA's Council on Addiction Psychiatry, in a release.
    "It is important for all clinicians to recognize that we share a major professional responsibility to ensure that prescriptions for opioids and other abuseable medications are prescribed only for appropriate indications, that patients are followed closely, and both patients and their families understand the risks associated with these drugs," he added.

    Also applauding the new federal recommendations are representatives from the American Osteopathic Academy of Addiction Medicine (AOAAM) and the American Academy of Addiction Psychiatry (AAAP).
    "The administration's action plan to address the growing problem of prescription drug abuse in our nation, especially among our youth, is an unprecedented step forward in helping to reduce the morbidity and mortality associated with addiction," Joseph Liberto, MD, president of the AAAP, said in the same release.
    He noted that the plan's call for prescriber education "is consistent with the educational missions of the AAAP, APA, and AOAAM."

    Much Needed Plan
    Dr. Renner, who is also an associate professor of psychiatry at Boston School of Medicine in Massachusetts and runs the Addiction Psychiatry Residency at the Boston VA, told Medscape Medical News that the new action plan is "a very well-organized approach" and much needed right now.
    [​IMG] Dr. John A. Renner "The abuse of opioid pharmaceuticals has been growing steadily for 10 years and has gotten to a point where it now overshadows all the other drug problems in the United States, certainly more so than heroin and cocaine. So it's important and necessary that we address it for the type of problem it is, that it involves elements of medical practice. It's not going to be resolved unless we pay attention to that," said Dr. Renner.
    "I think that for physicians, learning how to use new medications, what the risks are and what the benefits are, this is all an important part of ongoing medical training."

    During the press conference announcing the new national action plan, Howard K. Koh, MD, MPH, assistant secretary for health at the HHS, said that, based on his experience, clinician training on this topic is sorely needed.
    "As a physician who has spent over 30 years caring for patients, I am very aware that providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication."

    Meeting Expectations
    Dr. Renner noted that the new plan tells physicians that they "can no longer take for granted" that they can get their license and their DEA registration and certificate automatically.
    "I think the public, the professional societies, and the regulating groups expect that we are maintaining a level of competence in our practice. And I think there are a number of areas where physicians are going to be watched a little more carefully."
    However, he added that clinicians should not be concerned that the new plan's recommendations will mean a much bigger time investment.
    "In most circumstances, physicians are already required to do a number of hours of continuing medical education [CME] in order to renew their state licenses. And I suspect this type of training will count toward CME requirements that already exist."

    Dr. Renner said that although drug manufacturers are now in charge of designing the initial training and education efforts, he is not concerned with their involvement. This is due to the FDA's plan for reviewing all content to make sure it meets their standards and covers the topics they want taught. "I'm confident that that will guarantee a quality product."
    In addition, he opined that the ONDCP's call for new legislation to make physician training mandatory "is a good thing" — although he admits that some in the field might not agree.
    "I suspect that there will be some physicians and some elements of organized medicine that will not be comfortable with that. But I think we live in an era where physicians are expected to demonstrate that they're keeping up with the state of medical practice."
    However, he noted that the training does not guarantee that participants will become experts — especially because the number of hours that are going to be required have not yet been specified.
    "I imagine that it would be anywhere from 2 to 8 hours," said Dr. Renner. "That would be very helpful, but it's not a medical school curriculum. It will improve people's level of knowledge, but I would hope that if someone is working in this area, is directing their practice towards the management of chronic pain, than participation in a whole range of ongoing training courses should be routine and expected."

    Better Balance Needed
    "The abuse of [prescription] drugs, especially abuse of opioids, is a public health crisis that takes a tremendous toll on individuals, families, the healthcare system, and communities," said Margot L. Waitz, DO, president of the AOAAM, in a release.
    Dr. Koh reported that prescription drug abuse now accounts for 1 million emergency department visits a year, matching the number of visits attributable to illegal drugs.
    "These facts alarm me as a father, as a physician, and as the assistant secretary for health. All parents try to protect their children and create safe, healthy environments. So it's important they realize that prescription drugs are beneficial only when used appropriately."
    In a recent survey reported by WebMD, the opioid hydrocodone combined with acetaminophen was currently ranked as the number one most prescribed medication in the United States. Dr. Renner said this finding does not surprise him.
    "Initially, I think some of these meds were marketed aggressively. And I just think physicians need to realize you don't need a powerful opiate for every headache. Instead, we need to get a better understanding of the range of options for managing acute and chronic pain. Frankly, I don't think medical schools have or are currently doing a good job training physicians on how to do that effectively," he said.

    "On the one hand, these medications have been wonderful additions to medical care. We're now able to control serious pain in ways we could not before. And I don't think anyone wants to interfere with the appropriate treatment of patients with legitimate pain. I think we just want to establish a better balance between guaranteeing that patients get the care they need and to make sure we don't generate secondary problems because of misuse of the medications," concluded Dr. Renner.

    Deborah Brauser
    April 27, 2011
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