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F.D.A. Likely To Add Limits On Hydrocodone Painkillers

By Calliope, Jan 26, 2013 | Updated: Jan 26, 2013 | | |
  1. Calliope
    Trying to stem the scourge of prescription drug abuse, an advisory panel of experts to the Food and Drug Administration voted on Friday to toughen the restrictions on painkillers like Vicodin that contain hydrocodone, the most widely prescribed drugs in the country.

    The recommendation, which the drug agency is likely to follow, would limit access to the drugs by making them harder to prescribe, a major policy change that advocates said could help ease the growing problem of addiction to painkillers, which exploded in the late 1990s and continues to strike hard in communities from Appalachia and the Midwest to New England.

    But at 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse. Oxycodone, another highly abused painkiller and the main ingredient in OxyContin, has been in the more restrictive category since it first came on the market, they pointed out in testimony at a public hearing. They also said the change could create unfair obstacles for patients in chronic pain.

    Painkillers now take the lives of more Americans than heroin and cocaine combined, and since 2008, drug-induced deaths have outstripped those from traffic accidents. Prescription drugs account for about three-quarters of all drug overdose deaths in the United States, with the number of deaths from painkillers quadrupling since 1999, according to federal data.

    The change would have sweeping consequences for doctors, pharmacists and patients. Refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed. Distributors would be required to store the drugs in special vaults.

    The vote comes after similar legislation in Congress failed last year, after aggressive lobbying by pharmacists and drugstores.

    “This is the federal government saying, ‘We need to tighten the reins on this drug,’ ” said Scott R. Drab, associate professor of pharmacy and therapeutics at the University of Pittsburgh’s School of Pharmacy. “Pulling in the rope is a way to rein in abuse, and, consequently, addiction.”

    But at the panel’s two-day hearing at F.D.A. headquarters in Silver Spring, Md., many spoke against the change, including advocates for nursing home patients, who said frail residents with chronic pain would have to make the trip to a doctor’s office. The change would also ban nurse practitioners and physician assistants from prescribing the drugs, making it harder for people in underserved rural areas.

    Panelists also cautioned that the change would produce a whack-a-mole effect, pushing up abuse of other drugs, like heroin, which has declined in recent years.

    “Many of us are concerned that the more stringent controls will eventually lead to different problems, which may be worse,” said Dr. John Mendelson, a senior scientist at the Addiction and Pharmacology Research Laboratory at the California Pacific Medical Center Research Institute in San Francisco.

    The F.D.A. convened the panel, made up of scientists, pain doctors and other experts, after a request by the Drug Enforcement Administration, which contends that the drugs are among the most frequently abused painkillers and should be more tightly controlled.

    If the F.D.A. accepts the panel’s recommendation, it will be sent to officials at the Department of Health and Human Services, who will make the final determination. The F.D.A. denied a similar request by the D.E.A. in 2008, but the law enforcement agency requested that the F.D.A. reconsider its position in light of new research and data.

    While hydrocodone products are the most widely prescribed painkillers, they make up a minority of deaths, because there is less medication in each tablet than some of the other more restricted drugs, like extended-release oxycodone products, said Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston. Oxycodone and methadone products account for about two-thirds of drug overdose deaths, he said, despite accounting for only a fraction of hydrocodone prescriptions.

    The importance of Friday’s vote was more symbolic, he said, a message to doctors that they will need to think twice before prescribing hydrocodone, and to patients that the days of “unbridled access” are coming to an end. The tide has been turning against easy opioid prescriptions, as the medical system and federal regulators slowly make adjustments to reduce the potential for abuse.

    “It will help shape thinking,” said Dr. Katz, whose clinical research company, Analgesic Solutions, is trying to develop other treatments for pain. “It’s an important marker in the progressively more conservative swing of the pendulum in opioid prescribing.”

    He cautioned that patients who need the medications for pain should not suffer inappropriate barriers to access because of the change, a concern that the dissenters shared. Medical professionals battling the prescription drug abuse epidemic applauded the change.

    “This may be the single most important intervention undertaken at the federal level to bring the epidemic under control,” said Dr. Andrew Kolodny, chairman of psychiatry at Maimonides Medical Center in New York and president of Physicians for Responsible Opioid Prescribing, a New York-based advocacy group. “This is about correcting a mistake made 40 years ago that’s had disastrous consequences.”

    Testimony at the hearing included emotional appeals from parents who had lost their children to painkiller addiction. Senator Joe Manchin III, a Democrat from West Virginia, a state that has been hit hard by the prescription drug epidemic, pleaded for tougher restrictions.

    “When I go back to West Virginia, I hear how easy it is for anybody to get their hands on hydrocodone drugs,” Mr. Manchin said. “For under-age children, these drugs are easier to get than beer or cigarettes.”



  1. talltom
    I think this is a terrible recommendation. It will mean people who genuinely need the drug, especially those who are handicapped, will have to make difficult trips to a doctor's office. It will also mean the patient will have to pay an additional charge for a doctor's visit. A better solution is for the doctor to closely monitor the patient' drug use, putting the burden on the doctor, where it belongs, rather than needlessly burdening the patient.
  2. kumar420
    It really does suck for people that legitimately need the drugs, but i disagree that doctors should be held entirely responsible for the prescriptions though. After all, its a select few patients that are abusing these drugs and/or are putting them on the streets. Should the legitimate users be penalized? Hell no, but until somebody wakes up and decides to target the problem (stings targeting prescription drug trafficking rings, and so on) it seems they are trying to slap on a band-aid that is a headache for doctors and patients alike. The DEA needs to get off its high horse and stop trying to bust clubs in WA and colorado and focus on a real problem area, like this rise in prescription drug abuse and deaths.
  3. hookedonhelping
    This will come to fruition and then there will be an even bigger problem. The irony of life.
  4. talltom
    I did not mean to imply that the entire burden of preventing misuse of Vicodin and similar Schedule III painkillers should fall on the prescribing physician. At the same time, converting these drugs to Schedule II (if that's the plan that is implemented) places a bigger burden and expense on patients who legitimately need these drugs. For schedule II, patients have to see the doctor and get a written prescription each time they run out. Call-ins and multiple refills are not allowed.

    Instead, registries and other systems should be set up to prevent doctor hopping; many states have such systems now. Also, physicians should be more careful in writing prescriptions. As the lead article said "doctors . . . will need to think twice before prescribing hydrocodone, and patients (need to realize) that the days of 'unbridled access' are coming to an end." As someone with a legitimate need for these products, I strongly believe that's the better approach.
  5. CaptainTripps
    I think this whole thing totally sucks. I frankly think that vicodin should be sold, with some restrictions, over the counter. This is hysterical nonsense. I think the absolutely worst part of this is the part about doctors thinking twice. The last thing I want to see is doctors being inhibited about prescribing what in my opinion is a rather safe opioid drug. The big problem pain patients are facing today is the reluctance of doctors to prescribe. First strong pain meds, now this.

    The big things that the news media have been stressing are that that pharmacies need to have more safe guards and that prescriptions must be hand written. No call in's, no faxes and worse yet, no refills. However, these are largely procedural nuisances . My experience is schedule II does not require a doctors exam every time you need a refill. It simply requires you to go and pick up the written prescription from the doctors receptionist. In this situation the only extra expense would be gas and wasted time.

    I will tell you something that these idiots have failed to consider and that is the backlash to all this. This is in many ways a middle aged and elderly issue. Older Americans need these mild pain relievers and guess what, they vote. The fact is if this is actually put into practice and older Americans find out how it is going to affect them they are going to pitch a fit. The reason that their is any support at all is that they have been led to believe this will only affect young drug seekers. Most of the complaints I have been hearing about this are not from young "druggies", but from mostly straight older folks in legitimate pain. The young folks that want opiates are all chasing the dragon anyway. Pills have simply become too expensive and hard to get. I can see it now, people in retirement homes sitting around with their aluminum foil, straws and lighters.

    I do feel bad about the elderly and disabled who have transportation issues. I don't mean to minimize that. One more thing to consider and I will give a personal example. I was having post surgery pain and needed a refill on my percocet. It was on a Friday afternoon and I did not have enough to make it through the weekend. At this particular time in my life things like percocet got me pretty high. When I called my doctor to call in a refill he said he could not call it in, I had the choice of racing over to his office and picking up a written prescription or he could call in some Vicodin. I was in a lot of pain and Vicodin was not going to come even close to working. By the time my wife got home from work his office would be closed. So in a narcotic haze I had to get into my car and drive to the doctors office. So much for this policy increasing public safety. Fyi, now that I know how these things work I plan ahead for these things and I certainly do not endorse driving under the influence. Besides she is now retired so would be available to drive me.

    If passed this policy it will not last. This is a feel good policy from the good folks at the DEA. The young people hate them already and now the old folks will too. We need to cut the deficit, I suggest we get rid of useless agencies, like the DEA.
  6. talltom
    Right on Captain. Of course, the more dangerous component of Vicodin is acetaminophen which you CAN buy over the counter. That stuff is very dangerous to the liver, especially when taken with alcohol. You can get hydrocodone without acetaminophen, but that is already Schedule II. What good does it do to schedule Vicodin, or similar brand names, which combine the two, as schedule II. As you point out, this is just a procedural change, making it more complicated, but not preventing patients from getting it legally. I hope they just leave it alone. But to leave it alone means "we the people" need to make our views known to our elected officials. Another key step.
  7. Frmrjunkie
    Just a note of experience for people that are worried about a trip to doctors office monthly. My doctor mailed my prescriptions to the pharmacy. About a week before they could be filled, I would call doctors office tell them who I was & ask if they would kindly get my prescription mailed out for me. Doctor was always timely & as I patronized a small, family owned pharmacy instead of big corporation there were never any issues on the pharmacies end either. Although I can't see a large, corporate pharmacy would have problems with this; I just prefer small businesses :) Also probably best not to pharmacy hop.

    Please note that I do not think any further restrictions will solve any abuse issues of pain medications. It will however push another group of people to a harder drug, most likely heroin. Prohibition is not the answer. Throughout history, this has been proven multiple times.
  8. talltom
    Good to know, Frmrjunkie, that there are cooperative doctors like that. I think mine will be, if they do reschedule Vicodin. Also, the pharmacy I use is on the first floor of the medical office building where my doctor has her office. This makes communication easier.

    In fact, a pharmacy staff once took a prescription for a controlled substance up to the doctor's office, while I waited, and had the doctor rewrite it properly so I could pick it up that day. And it was a national chain pharmacy! Would that everyone had access to doctors and pharmacists that are so accommodating. Of course I've been using them for many years; doubt they would do that for an unfamiliar customer.
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