New restrictions should be applied to widely used narcotic painkillers, because of an alarming increase in addiction and overdose deaths, an FDA Drug Safety and Risk Management Advisory Committee (The Panel) recommended.
The Drug Safety Advisory Panel voted 19 to 10, recommending that drugs containing hydrocodone should be reclassified as Schedule II controlled substances, together with other narcotic painkillers, including oxycodone.
Products containing hydrocodone are currently in Schedule III. The painkiller Vicodin contains hydrocodone.
Tens of millions of people in the USA receive prescriptions for painkillers containing hydrocodone. If the Panel's recommendation becomes law, doctors' prescribing patterns will change considerably, experts say. Hydrocodone-containing drugs will be subject to more rigorous storage and handling rules.
Even though the FDA does not have to go along with what the Panel members recommended, it nearly always does. In this case, with a 19 to 10 majority in favor of limits, it is highly unlikely that the Agency will go against it.
U.S. Senator Joe Manchin Thanks the FDA Panel
U.S. Senator Joe Manchin (D-W.Va.), a proponent of changing the scheduling for hydrocodone-containing drugs, announced that he is grateful for the FDA Drug Safety and Risk Management Advisory Committee's vote to reschedule such medications. The Panel listened to his testimony at a public meeting last Thursday.
"Today was a huge step forward in fighting to help curb the prescription drug abuse epidemic that has ravaged our state and our country. Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands. I want to sincerely thank the committee for listening to West Virginians' heart-wrenching stories that I shared today.
Every city, town and home I've visited across West Virginia is affected by this critical problem in some way, shape and form. It seems that any 18 to 25 year old can go to any doctor, claim they have chronic pain, and get a recurring prescription for 120+ of these pills per month. The high price people are willing to pay for these drugs on the street inevitably gives our young, drug dealing citizens more incentive to continue in their illegal behavior than to earn an honest living.
With that being said, it is now in the FDA's hands to help stop this epidemic. It is my hope that the FDA implements the committee's recommendations and reschedules these addictive drugs immediately."
Several experts say that the problem of narcotic painkiller abuse will need much more than a change in its schedule status in order to address it. The Generic Pharmaceutical Association, which says it will abide with whatever the FDA dictates, reiterated this viewpoint during the weekend.
New York City took steps to control opioid painkiller abuse
He said the guidelines will be used in all the city's public hospitals. Emergency departments at New York City's public hospitals will not be allowed to prescribe long-acting opioid painkillers. Emergency department doctors will only be authorized to prescribe three-days' worth of such drugs. Anybody whose medication supply has been destroyed, lost or stolen will not be able to get repeat/new prescription from emergency departments.
In 2004, there were 55 painkiller-related emergency department visits per 100,000 people in New York City, compared to 143 per 100,000 in 2010 - a nearly threefold increase in six years.
Painkiller abuse and associated deaths, a public health issue
The majority of people who abuse painkillers obtain them from leftover medications.
The CDC (Centers for Disease Control and Prevention) says that over 16,500 people died from opioid-based painkiller overdoses in 2010 in the USA. No other type of drugs, including illegal drugs, kills so many people.
In a Position Statement, the American Academy of Pain Medicine (AAPM) explained that Schedule II substances face more stringent manufacturing and distribution regulations, as well as stricter prescribing rules, including a new written prescription for each refill, no call-in refills, and limits on who can prescribe.
Changing these painkillers to Schedule II status would probably result in the following changes:
There would be more frequent patient visits
Doctors who prescribe improperly would face greater penalties
Pharmacists, and possibly doctors too, would face additional paperwork
There would be a requirement to secure pills
Medicare and insurance companies would incur higher costs
Access to pain medications would be reduced
Probably, there would be less non-medical use of narcotic painkilling medications, fewer deaths from overdoses, and some related cost savings
More stringent regulations on narcotic painkillers would result in fewer prescriptions. This would be good for some people and bad for others.
Medical populations: Who is being prescribed hydrocodone medications?
Non-specialists commonly prescribe drug combinations which include hydrocodone for acute, trauma-related and post-surgical pain, including dental procedures. Any change in scheduling status will impact on much more than just the specialty of pain medicine.
Hydrocodone-combination medications are also commonly prescribed for patients with chronic pain, either on their own or together with other opioids, or in combination with non-opioid adjuvants, such as:
For conditions where intermittent pain is common. Examples include sickle cell disease, interstitial cystitis, and endometriosis
For long-term continuous pain when long-acting opioids are not advisable, not indicated, or simply not available
For sudden flares of pain that occur in patients who suffer with chronic pain
Nonmedical populations at risk for harm
As hydrocodone products are widely prescribed, they become more widely available for unintentional misuse, recreational abuse and diversion. This leads to higher rates of death from overdose and addiction.
If a patient experiences acute pain and needs painkillers just for one or two days but receives a prescription for a 10-to-30 day supply of hydrocodone, the risk of abuse, overdosing and addiction is much greater, the AAPM explained.
Lynn Webster, president-elect of the AAPM, said "I hope people in pain won't suffer as a result (if narcotic painkillers are rescheduled)."
The benefits of changing hydrocodone-containing drugs to Schedule II
Some doctors and other providers may rethink their current prescribing practices. They may lean towards prescribing fewer pills for shorter periods.
If people who had been treated with short-acting hydrocodone products were switched to long-acting opioids, there will be stricter monitoring guidelines, which is good for the patients.
If the new schedule results in a drop in exposures, fewer people who are vulnerable to addiction will come into contact with the substance through legal prescriptions.
There will be fewer leftover hydrocodone pills, resulting in fewer opportunities from accidental overdose or illicit use.
The risks of changing hydrocodone-containing drugs to Schedule II
Patients who currently have a legitimate clinical need for hydrocodone-containing medications may find it harder to get their drugs, especially if they live out in the country or other underserved areas. They may have to face more co-pays, more frequent clinic visits, and a higher price for their newly-scheduled medication.
There will be no more telephone refills. The AAPM wrote "Even under FDA rules that allow three consecutive 30-day Schedule II prescriptions to be written, clinic visits are likely to increase with the stricter medical monitoring accorded Schedule II opioids. Costs to private and government payers, including Medicare, may also increase. Some physicians, particularly in primary care, would decrease prescribing rather than face increased regulatory scrutiny that accompanies Schedule II controlled substances. This could have grave consequences in pain left untreated."
If hydrocodone-containing drugs are replaced with less regulated ones, there could be further consequences. Examples include:
Codeine - there is a risk of overdose, lack of efficacy
Tramadol - a higher risk of seizures and serotonin syndrome
Benzodiazepines - non-medical use leads to a higher risk of overdosing and addiction
If a patient is switched from a short-acting hydrocodone medication to a long-acting opioid, the risk of harm may increase. Most deaths related to opioids involve long-acting formulations. Some may even be switched to methadone, another Schedule II drug, because it is cheaper.
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posted by Rodney on 30 Apr 2013 at 9:21 am
I am a disabled vet back fusion multi disc issues in lumbar and cervical and T1-12 I have been on narcotics mediation since 1979, having chronic pain, muscle pain, spasms in legs and arms, weakness lower body, I was on 240mg morphine and 30mg hydrocodone per day, I have been on this much for at lest 5 years with no side effects, and now they are reducing the medication to 90mg morphine and 5mg hydrocodone and I don't think I will not be able to function or move from all the pain I will be in. we will have to see.
pain relief - not fair for people with chronic pain
posted by rod gandy on 29 Apr 2013 at 12:33 pm
This is not fair to us with chronic pain due to an injury that i recieved by serving my country in june of 1987, i have L5 - S1 fusin, degenitive disk from L1-L4, T1-T12, C3-4.
I dont take the meds because i want to but to help with the pain. Now i have to look to other types of drugs not legal like marijuana where it iis legal in my state of az, and go back to drinking beer with my medication to help with the pain.
You people that has never been in pain dont have a clue how much it hurts to be in pain 24 hours a day 7 days week, and 365 days a year without pain, it must be nice to have no pain, i wish i had a higher pain tolerance level than i do, but I'm a wimp when it comes to constant pain.
if I have to live this way long i will ask the VA TO INSTALL A ROD OF STEAL FROM MY ASS TO MY NECK so that the pain will stop. but the VA will not do it because it is not feasible or cost effective, but they reather see there veterans in pain and seat behind that desk and LAUGH at you and say have a nice day, but there is nothing i can do for you, but here is a aspirin for your chronic pain.
You all watch and see whats going to happen. The veterans will rise up and take action to make a point at all the va hosiptals and it will not be pretty. And people in pain will rise up and take those pills that you took without seeing or going to see the serviceman and women service person that did what they were asked to do for there country and when you return to your state after serving your country they tell you have to live with it without our help, you're on your own.
And that is the truth. after you serve your country you have to prove to the VA that you were there and you served your country, show paperwork, photos of you and your service buds and friends, letters from commanders and any type of medical records showing that you were injured in the line of duty.
If you cannot show that information your out of luck. I see a lot of veterans fighting for there rights for benefits and getting turned down because they don't have the paperwork. I have some paperwork.
Now they want to take your medication away, next they will want to reduce your disability pay, then your SSI check or give you a choice either recieve disaility pay or SSI but not both!!!!!!!!!!!!!!!!!!!!!!!
Beware of what maybe coming vets AND disabled personings.
I'm a 54 year old male with moderate to severe Degenerative Disc Disease in the Lumbar. 5 years ago my doctor began prescribing 7.5 Norcos three times a day, and the pain relief and other benefits were immediate and lasting. I had been self medicating with as much as ten aspirin a day and quite bit of alcohol, which was leading to ulcers and worse, but couldn't sit in one place or sleep without them. I now get by with just the Norco, 1-3 aspirin, and no booze at all. That low a dosage of the Hydrocodone doesn't relieve all the pain (I'm a very large guy), but it's enough to function and sleep with no major problems.
It sounds like, if this becomes law, doctors are going to prescribing Hydrocodone less to people with legitimate needs, but it won't even dent the illegal trade going on. This sounds like exactly the wrong way to address the problem.
The changes the government wants to make is life changing for many .Myself ,I have Rheumatoid Arthritis ,Undifferentiated Connective Tissue Disease and fibromyalgia .Plus restless leg,migraines ,etc..After struggling the last few years I was told by my doctors I needed to quit.I worked 32 years and I am 51.The medication I need daily is a great amount.But without my pain meds my option would be sitting and lying down mostly.And sleep would be difficult.I am NOT addicted but I am dependent .Please don't allow the addicts to take away our lives.Why is it the people in the wrong hurt those who have not broken the law?It rains on the just and unjust.I hope for everyone a pain free day. Sharron from Florida
If opiod painkillers become harder to obtain or not able to obtain at all, people will only turn to Heroine, the next closest thing! Those addicted to painkillers will subject to using heroine when they are unable to obtain pills which will lead to a whole other BIGGER issue....less overdoses from painkillers, but the number of heroine overdoses will increase. What a dumb idea....*shaking my head...*
As a chronic pain sufferer I took Oxycontin for several years and NSAIDS for over two decades. I gradually stopped taking the Oxycontin on my own as the NSAIDS with other medications began to sufficiently control the pain. Having had to stop working and losing both my job and my only occupation (medical) helped since it was occupationally related. I didn't take the opioids if I didn't need it. There is a difference between dependence and addiction and abuse. In my case when NSAIDS started to affect the kidneys I had to stop taking those. After 20 years of also taking Neurontin(I always wondered if it was a 'sugar pill') to help me sleep I was one of the rare persons who developed an allergic reaction to it of terrible itching and a rash such that I could not sleep -it was like bed bugs crawling and biting. As a result you finally come to the point where you cannot use other medications that had previously worked. At that point opioids were the only option I really had left. Break through pain is frequent as the extended release opioids never last more than 7 hours. Fortunately my doctor prescribed some Narco as neither of us wanted to up the dose of the opioids. I fail to understand why anyone would want to take opiods due to the side effects. Never have they made me high, they are downers; constipation is always an uncomfortable side affect as is one's reaction time and alertness. I don't like driving. But I have to drive to pick up the medication and go to doctor appointments. The pharmacy often is a hassle so I have to call ahead to make sure they will have it in stock. Ordering it is a hassle for them, and trying to ration your pain medication can be horrible. Yes I know what it is like when you'd like to phone Dr. Kavorkian. I understand why people reach that point and without medication that controls pain I could be there. Making it even more difficult to obtain pain medication when you need it to even want to live is very scary. I am sure there are many in the same situation and know just what that feeling is like.
posted by Marsha Fulkerson on 9 Feb 2013 at 1:03 pm
Well, I agree with Karen, how about alcohol! How many deaths a year for that. Car wrecks, related diseases, over dosing!!! Yes you can drink too much alcohol! I am laying in bed as I write, with pain meds, which help, but does not completely stop the pain.
First our guns, then our meds, what else folks? Anything they want, looks like!! This will just make the drug dealers more money! And I probably should not say it, but kind of hope these people suffer some, then "maybe they will understand!!!
Interesting to see the big panic about the deaths from painkiller "abuse" and yet alcohol is pushed on people as if it was virtually harmless. People in pain don't have a lobby like the alcohol industry does; additionally, where is the logic of punishing those with legitimate prescriptions for theft done against them? Last, it wwould be interesting to know how many deaths from painkiller abuse are really last acts of desperation to get away from inadequate pain control, which proposed legal restrictions will merely increase. What a world,where you can go to jail for not treating a pet in pain and yet a human in pain can't get his or her pain controlled because x, y or z might happen.
I'm a long term osteoarthritis sufferer. Due to the stupidity and deliberate blindness of the FDA and DEA, I'm presently being subject to the insanity of taking NSAIDS with a proven case of chronic gastritis. I get Prilosec to help with the gastric pain, but it's not entirely adequate. All this because I am getting four doses of 1 1/2 Norco pills four times a day, while my doctor refuses to raise my dose to 2 pills, which would relieve the pain. Somehow, 40mg of hydrocodone magically turns me into a druggie, although 30 is fine. Nuts, and dangerous to me. The stomach pain scares me more than the Norco ever did. If this advisory is followed, a whole new class of drug seekers will be out searching for pain relief. Hydrocodone becoming a Schedule II drug will not stop abuse, but will actually create more. If the government wants to stop illegitimate use of pain pills, go after the folks who divert the medication wholesale from the factory. That's where the money and the real abuse is. Anyway, I don't feel responsible in any way for deliberate drug abusers. That's a choice they made, which is more than I can say for the arthritis that limits my life.
I am 43 years old and have been on 180 Vicodins a month and 60 morphines. Sound like alot. Lets see if the people who want to take these away can deal with what I have to deal with. Fifteen years ago I was 25 feet in the air above a ceiling. I slipped off the latter feel threw the ceiling hit a telephone on the way down and had the ceiling lans on me.
It tore my back mucles off my spine and the tore them in half. I partly recovered with out help because my boss at the time would not pay for it and I was young and dumb. I then had a 500 pond beam dropped on me hurting me again. I go to pain management which is highly overbooked and sometimes have to sit for hours.
Very hard to walk, lay down, stand, or sit for very long. And now you want to change what helps me get up and raise my two kids and operate. Lets see if you could make it one day in my life with the pain. Punish the people that are not suppose to have them not the ones that need them.
Methadone should be used and prescribed by very experienced pain clinicians. MANY deaths occur from narcotic overdose every year, but rx per capita, methadone is by far one of the most dangerous. Look, there is no easy answer to this. I have been a pharmacist for more than 30 years, and this situation with pain relief, pain management specialists, ER docs and pain relief in general has all evolved into a regulatory nightmare.... especially for pharmacists. Medical professionals want to take care and treat patients with legitimate medical needs properly. Given the current social and regulatory environment, this mission is more daunting than ever. No easy answers.
I do not see where adding this pain medication to a stricter regime will keep it out of the hands of the people who are determined to abuse it, it has never stopped this type of behavior before and will not now. It will only make things more difficult for the people who truly need pain medications as well as add expense to Medicare for all the extra doctor visits. There has got to be a better way to manage this.
I am a 59yr old male , an I have been on some sort of pain killer since 1976. I have had 2 operations on my neck for blown out disk an also 2 0n my back for the same thing.
People like me that don't draw enough from SS to hardly make it each month anyway'. (I Guess) should just go ahead and find us a Doctor Death an end our pain forever. I am sure all the Rich people in the world will still get their painkillers anyway, but what about people like me that live on a very limited income.
Do this , and I will guarantee that there will be someway that myself , and thousands of others who have been on these painkillers for a long period of time , will find a way to Sue whomever we have to, to take care of us for the rest of our lives.......
make people that are in pain wait longer,go to the doctor more often and cost more to get the meds they need.
posted by doris on 30 Jan 2013 at 10:54 pm
the gov. has made it harder to get common cold meds to stop the meth epadimic" that worked real well !!" all it did is make people with allergies jump through hoops to get meds they need! if people want to get and sell drugs illegaly they will!! it does not matter what the government does, they give criminals more rights than law abiding citizens already !! this is just another slam on the constitional rights of the natural citizens of this country !! it will only cause more people to turn to illegal drugs if this happens !! if they keep pushing people like this im afraid the people are going to start pushing back in a bad way !!
My wife and myself are both disabled from accidents at work that deeply affected a disease that we already had, degenerative disk disease starting at the lower three 3 disks and working upward. We both drive over 100 miles each month to get our pain meds that we could not even live without. We both use a long term pain med that is supposed to last 12 hrs which it never does, therefore, we have to take oxycodone in between just to be able to survive each day.
Please let the politicians that want to change the laws try to live in our shoes just for one week. I guarantee you they would go about it another way and leaves us that really need them alone. Make it mandantory for all high schoolers and college kids and anyone who works for a living take a drug test. The gov. could make the tests affordable and stop the abuse before it starts. Leave us alone to suffer until we die:::::::
the few hurting the many - How does making a prescription drug harder to get help anyone?
posted by Bruce on 30 Jan 2013 at 1:33 pm
With all the negative consequences how do they justify what they are doing? Cocaine and crytal meth are absolutely illegal and I am sure there has been a significant rise in deaths also. How does making a prescription drug harder to get help anyone? It cost EVERYBODY more money and the alternatives are just as bad if not worse. The feds won't legalize marijuana which has very little side affects but will contribute to the increase in pain and possible, probable increase in suicides by people who are truly in pain and have no hope of relief. Tell these senators and governors, who are not doctors, to stay out of the medical field. Arrest the illegal users and sellers and let the doctors diagnose patients.
dont understand - what about patients who depend on painkillers
posted by john on 30 Jan 2013 at 1:16 pm
I am sure there are people that abuse the drug, I am sure it is sold illegaly on the street, but what about ys that depend on it.. I have chronic back pain and have week kidneys. This is about all I can take to get any relief.. Quit causing the people that need it more pain..
I agree that trying to restrict legal use of pain med by doctors is rediculous. Like the proposed Federal immigration laws, it will never work. People who get these drugs wheter it's hydrocodone or what ever, they will get them anyway so putting a burden on the doctor and fear of prescribing pain medications is an interferance of doctor patient relations and should be left alone.
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Leg pain refers to any kind of pain that occurs between the heels and the pelvis. There are many reasons for leg pain, and not all of them are caused by a problem that originates in the leg.