Pain Management: FDA to Tighten Regulation of Extended-Release and Patch Opioid Meds
The Food & Drug Administration (FDA) is beginning a "massive new program" to reduce overdoses, diversion, and inappropriate use of powerful opioid pain relievers, especially targeting extended-release and patch formulations of fentanyl, methadone, morphine, oxycodone, and oxymorphone. On Monday, the FDA announced it had sent letters to 16 drug companies who produce the 24 listed products informing them they would now have to create a Risk Evaluation and Management Strategy (REMS) "to ensure that the benefits of the drugs continue to outweigh the risks."
That means physicians are likely to face new procedures in prescribing the drugs, and patients are likely to face more hurdles in obtaining them, an FDA official said at a Monday press conference. But pain patients already face serious obstacles in obtaining relief. The FDA action comes in the context of a campaign by the DEA to crack down on doctors it deems to have improperly prescribed large amounts of opioid pain medication -- even though prescribing what at first glance appear to be extremely large amounts is well with standard pain relief practice. Physician's fears of being prosecuted have contributed to what pain patient advocates describe as a crisis in chronic pain relief.
"Pain patients aren't drug abusers looking for a prescription fix," said Gregory Conko, senior fellow at the Competitive Enterprise Institute, which teamed up with the Pain Relief Network last May to create the Politics of Pain campaign to fight for patients' access to sufficient pain medications. "It's a genuine tragedy that the DEA often treats them and their doctors as if they were. It's as though the agency just doesn't care whether its single-minded waging of the war on drugs imposes collateral damage."
The Politics of Pain campaign has collected personal stories from physicians and patients who have explained firsthand how difficult it can be to either offer or find sufficient treatment for pain conditions. In one video interview, Gulf War veteran James Fernandez and his wife tell their story of how he, once a robustly healthy US Marine, is now virtually confined to his home because of severe, ongoing pain that has been under-treated for years.
In another interview, Dr. Alexander DeLuca, a board-certified specialist in addiction medicine, describes the obstacles faced by a physician trying to deliver the "standard of care" called for by his own medical training. According to DeLuca, virtually no patients in the country today receive proper treatment for chronic pain.
Still, there are a lot of pain pills out there. Last year, US pharmacies dispensed 21 million prescriptions for the 24 medications listed to 3.7 million patients. "This is a very extensively used group of medications," said Dr. John Jenkins, director of the FDA's Office of New Drugs at its Center for Drug Evaluation and Research. "This will be a massive new program."
Jenkins said that abuse, misuse, and accidental overdoses involving those products had been on the rise over the last decade, and the agency is concerned about doctors inappropriately prescribing them for patients who are not suffering moderate or severe chronic pain.
"We continue to see case reports where someone with a sprained ankle receives a fetanyl patch or extended-release opioid," Jenkins said.
Dr. Bob Rappaport, director of FDA's division of anesthesia, analgesia, and rheumatology products, told the press conference the agency was also deeply concerned with the rising non-medical use of the opioids. He cited a Substance Abuse and Mental Health Services Administration (SAMHSA) report released Monday that showed some 5.2 million people said they had used prescription opioids for non-medical purposes in the past month, and that the figure among 18-to-24-year-olds had increased from 4.1% in 2002 to 4.6% in 2007.
"This is an ongoing problem, and it's getting worse," Rappaport said.
Forcing the drug manufacturers to submit REMS plans is "our attempt to ensure the benefits outweigh the risks," Jenkins said. The agency will seek to find an "appropriate balance between legitimate patient need for such drugs and the threats caused by the abuse and misuse," he added.
But tighter regulation isn't going to happen right away; a series of meetings with various stakeholders over the coming months are being set up to arrive at final regulations, said Jenkins. They will include patient advocates, health care professionals, the pharmaceutical companies, and law enforcement. The first meeting with manufacturers is set for March 3. Hopefully the concerns of patient advocates get heeded and successfully addressed, but it's not clear whether that is even possible with a venture of this nature given the current enforcement climate.
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Comment posted by mlang52 on Fri, 02/13/2009 - 5:13pmJust tightening down the screws a little more! I never did disagree with trying to keep the diversion to a minimum when it came to pain meds.
But, to destroy the lives of the 97% or more, of real pain patients, that have been shown to never become addicted to their pain medications, is just plain moronic! I think I speak for all pain patients when I say I wish these "people" could suffer what we do daily, for just a day. Then, maybe, they would learn the terrible injustice they do to pain patients in the name of fighting the drug war. Why is it they still can't decrease the abuse of prescription drugs, after so many years of the drug war? Just another sign of failure. The people who are hurt most are the honest chronic pain patients! And its not only the pain patients lives, who are destroyed. Their doctors fair no better under the present war on pain doctors.
Just another sad day in this person's life, who suffers chronic pain, 24/7.
I find it ironic, that I now suffer with chronic pain, and cannot afford to get it treated! I know both sides of the disaster.
It could drive one to drink!
FDA ! Walk in someone else's shoes, damn it!
Comment posted by Dianne Shatin on Fri, 02/13/2009 - 10:22pmI wish each FDA official would undergo two hip replacements, experience bone cancer, or any one of the chronic debilitating painful conditions that tens of millions of Americans suffer day in day out....let them experience the miracle pain killing of the patch or oxycotin....and then have their doctor withdraw it permanently....and then see what they would do.... these morons are f'ing clueless what it is like to live in chronic pain...opioids are the least expensive and most effective pain killer available....I tell you after two hip replacements I wouldn't have made it through the pain and it infuriates me how patients are treated like either infants or criminals! A pox on them all!
FDA! The Three Stooges Would Do A Better Job!
Comment posted by Dianne Shatin on Fri, 02/13/2009 - 10:29pmmore on the proposed restrictions and hoops for prescribing pain killers to people who need them;
medically necessary medicine being withheld because the FDA actually believes in doing so recreational or addicted users will all of a sudden disappear? really...because heroin is saturating US high schools, then with holding medically needed medicines and making physicians jump through impossible hoops to try to provide such medicines to their patients means no more drug addition in the USA?
maybe these guys need psychopharmaceuticals to think clearly and logically and deduce their proposal is illogical and moronic.
FDA to tighten regulations
Comment posted by billy396 on Fri, 02/13/2009 - 1:29pmI have suffered from chronic pain for years. Degenerative Disc Disease exacerbated by Osteoporosis caused me to have a compression fracture of my L4 vertebrae several years ago. I also get frequent migraines. My last bone scan shows that the fractured vertebrae healed and now it's 30% shorter than the other vertebrae. Fortunately, I have a doctor that believes in taking care of her patients as needed. The law-enforcement community may have a job to do in preventing certain idiots from diverting their pain medication and causing overdose deaths and addiction. But for a government agency to try to pressure my doctor into not treating or under-treating her patients who are in constant pain in intolerable.
This failure of a so-called "drug war" has been an on-going bad joke for over 40 years that has cost the tax-payers of this country billions of dollars with no upside. The crime surrounding drug abuse is virtually always caused by the drug laws, not drug use. It's simply a very convenient crutch for failed law-enforcement policies to always automatically be labelled as "drug-related". The crimes and the law enforcement failures should be labelled as "drug-law-related", because that's much closer to the truth.
It is unconstitutional for a Federal law enforcement agency to go after doctors for treating their patients. If a crooked doctor is violating the law and the standards and ethics of his or her profession, that's a different case altogether.
The Federal government is violating states' rights in prosecuting these doctors, as the doctors are licensed by the states to practice medicine.
The mail-order pharmacy that my health insurance uses for long-term prescriptions has repeatedly harassed my doctor and tried to justify this by saying that she is exceeding the recommended dosage. How does a pharmacy have any right to judge what the correct dosage is for any patient when they aren't physicians and also have very little or no knowledge of any particular patients' physical problems?
I have forced myself to lower my dosage out of fear that the pharmacy will one day refuse to fill my prescriptions. Is this right or just in any way? If I were to lose my job, I would never be able to afford the medications that I take on a daily basis. I have been on Fentanyl patches constantly and on Oxycodone for break-through pain for several years, and the cost of the patches is unbelievable. Luckily, I have a prescription-drug plan. What happens to the people in my situation who have no such drug plan? The drug companies have been overpricing their products to enhance their bottom line for years. The difference between the cost of production and the price they charge is staggering. If the Federal government is going to bail-out the banks and insurance companies, they should also help people who have medical problems and can't afford their medications. Alas, I don't believe that will ever happen, because there are no lobbyists in Washington to bring this plight to their attention, let alone the money to guarantee a response.
I would like to thank StopTheDrugWar.Org for trying to right some of these terrible wrongs.