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Off Label Use
The legal use of a drug for an indication other than that for which it was FDA approved
Question: Any suggestions for appealing a Medicare part D (drug) denial based on off label use? Any websites you can suggest for help?
Answer: http://medicareadvocacy.org/archive/partD_07_04.12AppealsIssues.htm
sorry Jerry, the website link will not come up, but google "medicare appeals process" and scroll down to part D
Question: Any suggestions for appealing a Medicare part D (drug plan) denial by Humana based on off label use? Do you know of any websites that are helpful?Thanks.
Answer: Hopefully the doctor who prescribed the medication will work with you on the appeals process. You could try contacting your Local Area Agency on Aging to see if there are any local groups who can help you with the appeals process.
Find your Local Area Agency on Aging at the Eldercare Locator
http://www.eldercare.gov/Eldercare.NET/Public/Home.aspx
If you live in Florida, this group may have someone who can advise you on the appeals process:
SHINE (Florida state health insurance assistance program for elder Floridians)
http://www.floridashine.org/
This group has decent information at their website:
Medicare Interactive
Medicare Rights Center
http://www.medicareinteractive.org/
Here is an article that gives some details on appealing a Medicare Part D denial:
Senior Citizens Have an Appeal Process When Medicare Drug Plan Fails to Cover Needed Drugs
Part D appeals process explained by Medicare Interactive
http://seniorjournal.com/NEWS/Medicare/2009/20090413-SenCitHaveAMedicare.htm
Good luck to you!
Question: Off-label use of Neurontin (Gabapentin) new data? In 2004, Pfizer admitted guilty to promoting Neurontin for use in many different off-label use. Have any recent valid studies supported use of the drug as a off-label treatment for depression and anxiety in conjunction with Zolft (sertraline) or other SSRI's?
Professionals only replies requested with documentation
Answer: After a Medline search of gabapentin combined with sertraline (a rudimentary search at best), this is what I found:
http://www.cma.ca/multimedia/staticContent/HTML/N0/l2/jpn/vol-31/issue-3/pdf/pg168.pdf
Hope you find it interesting.
Question: anyone use risperdal off label for depression anxiety disorders? what were your side effects? little nervous about risperdal as it appears to be approved for serious disorders? my doc is trying it for anxiety and depression. any experiences good or bad ?
Answer: I hope that your doctor is a psychiatrist - as this anti-psychotic is a pretty powerful psychiatric drug, therefore only they should prescribe. The use of anti psychotics to treat anxiety & related illness is increasing. Risperdal isn't really a first choice in depression though, because it is one of the more depressant anti-psychotics, there are better ones out there. Personally I don't think that anti psychotics should be used for any, except the most serious mental illness, they are far too harsh a drug to treat every mental distress. I believe that they're not being prescribed for depression, but for anxiety. You could easily take benzodiazepines such as valium, for this. I refused risperdal for bipolar, with psychosis, after bad experiences with olanzapine & seroquel, once mood stabilisers kicked in the psychosis went. Try breathing techniques, yoga etc for anxiety; try to steer clear of psychotropic meds unless you are psychotic!
Question: Seroquel hearings on off label drug use? I heard Congress may try to pass law making it illegal for Seroquel to be prescibed for social anxiety?
Answer: I took this drug i thought i was going crazy well more than i already am i would not give this to my worst cell mate
Question: What are some drugs with NO recognized off-label uses? I am doing a research project on drug prices and state regulation, and for this purpose it complicates the pricing data if I evaluate drugs that are being used for off-label purposes.
Answer: Maybe zovirax cream?
Question: Off label use: low dose hydrocodone as antidepressent? I have always suffered from mild to moderate depression throughout my life, no matter what is going right or wrong. I am completely healthy, good relationship, good weight, workout, etc. I have tried quite a few antidepressants, but regardless of dosage, they either make me completely spacey and flat, or tweaked out and feel worse than without them. However, due to some minor nerve damage, I have been prescribed hyrdocodone for the past year. I found if I take three 500 mg pills per day, and never more than that EVER, it has almost cured my depression. As I said, I never have to take more than that. I talked to a psychologist about it, and he admitted in my case, he thought it a good solution and he "had to admit" he couldn't see anything wrong with it.
However....I'm afraid to discuss it with my prescribing family doctor. I still have nerve pain, but it's not as horrible as it was. I'd rather be honest, but yes, I'm afraid he'll stop prescribing it. Should I talk to him anyway? Do doctors ever "okay" this sort of off label usage, especially with an addictive drug? Or is he pretty much required legally (or fear of lawsuits) to stop? Just looking for advice.
Answer: Hydrocodone has some anti-depression results for some people.
People have noticed when taking this medication that their depression has sometimes gotten better.
Doctors do prescribe certain medications ' off label use'
However, this medicine is so highly addictive that the doctor most probalby will not do this.
I'm not saying, your doctor WON'T keep prescribing it for your depression - but it's not likely.
BUT - if you could ask your psychologist to get in touch with your doctor and explain the situation - He (your doctor) MIGHT just keep prescribing it for you
It is worth a try -
They have to be very careful with this medication - it is also highly
scrutinized by the FDA - to check on Pharmacies that dispense this medicine.
Good Luck!
Question: What are the FDA off-label use of Geodon.? Its the magic blue time capsule.
Answer: I'm not aware that there are any yet. It's a bizarre drug, helps with bipolar, may have negative cardiac impact (bad for your heart), does weirdo things with your short-term memory, can actually be bad for bi-polars with manic intensities.
What kind of side-effects are you looking for?
Question: Can someone find me some tape or adhesive label I can use to peel off print from cardboard? I? I have a 7 x 10 logo on a cardboard board. I want to cover this logo with a tape or sticker. I also want it so that when someone tries to peel off this sticker/tape cover, it peels the printed logo off with it, leaving the box with a blank section where the logo used to be. Is there a website that sells this kind of tape or sticker in a 7" x 10" format or larger?
Answer: From the scenario you told i think that you require a custom printing for a cling sticker which is large called decals and I know an online printing company for stickers, they provide free graphic designing and shipping all around as well as they are cheap in the market with high quality products.Contact their customer support they will surely help you in this regard.
Question: what r the off label uses for abilify? I was just wondering.
Answer: pretty much nothing. seriously it sucks. it has like NO street value either. its pretty much only good if u have bipolar. it has no recreatoinal use
Question: How do I get a label off a glass bottle without compromising its integrity? My husband bought me a bottle of Crystal Champagne as a gift on our wedding day. We drank it on our first-year anniversery and now I'd like to get the label off the bottle and use the label in a scrapbook. How do I go about doing this?
Answer: I have been saving wine labels for a while, and I have not yet found a foolproof method.
These have worked in the past:
1. Hairdryer, melts some glues and does not damage the label.
2. Steam, works a little better than hairdryer, but can make some labels soggy and fall apart.
3. Hot water, first try filling the bottle, but if that does not work, submerge the bottle - downside= see #2.
4. Razor blade and a lot of patience. Get the kind you use to scrape paint off of windows, start at an edge and carefully peel back the label, working the razor underneath to separate the glue from the bottle. This works very well with some, and very badly with others. If it does work, you get the added advantage of still having glue on the back of the label, so it goes nicely into a scrapbook.
5. There are commercial wine label removers that you can find through Skymall. I have heard they work, but I have never tried them. They go on over the label and when you peel them off, the label comes with.
Good luck.
Question: So my teenage son is going off to college next week. What should I use to label his undergarments? It's been advised that each college student label their belongings. We used sharpies to label all of his clothes but he gets a strange patch of red bumps on his private area if I use certain laundry detergents, so I was thinking I need to label his underwear with something that he won't break out from. Any suggestions?
Answer: Paint your lips, kiss the label, let dry.
Question: Off-label uses of Comtan? Can anyone point me to some studies of off-label use of Comtan (entacapone)? I am interested in its use in the following conditions: ADHD, chronic fatigue syndrome, narcolepsy, and restless leg syndrome.
Answer: Try this:
http://www.fda.gov/cder//consumerinfo/druginfo/COMTAN.HTM
Or this
Question: Adderall/Modafinil: Off-label uses of prescription drugs? I take adderall. It sharpens my brain and its great for me. I need this, it's the only way I can survive. My problem is my dependency. If I don't take it, I basically lose the day in my bed. Also, its an amphetamine. I've seen pictures of methheads years after. I don't know if adderall would contribute to aging like that but DANG. I'm also worried about it speeding my heart up too dramatically.
Now I've been reading about Modafinil. (http://en.wikipedia.org/wiki/Modafinil)
Apparently its main use is for narcolepsy, but it significantly increases (for lack of better words) brain power. The FDA decided not to offer it to people with ADHD even though it helps basically because it may cause a skin rash in some people. I would be interested in taking that risk and trying to see how I like it.
How would my psych react if I suggested something like this? Would a doctor even consider encouraging an FDA decided off-label use? Would I have to fake narcolepsy to even try out a script?
Answer: For one, Doctors are allowed to proscribe any drug, to treat any symptom or disease they want, provided they have a rational for using it. You don't have to have a diagnosis of 'narcolepsy', though some insurance companies would decline to pay for it if you didn't.
Adderall is an amphetamine, but there's a massive difference in potency here. Meth is smoked and taken in huge doses, or injected. Adderall is in small doses and in a pill. You would literally have to take dozens of times a normal dose, if not more, to have comparable damage.
Question: how do you use steam to remove the label off of a cd? like using a steam iron to remove the art work/label off of the actual disc
Answer: Water or steam will damage the disc and a steam iron will melt the disc!
Question: What are the off-label uses of Seroquel? Since i don't have bipolar, psychosis or schizophrenia.
Answer: i have no idea in hell why anyone on earth would want to take seroquel unless forced to in a psychiatric hospital as i was. That shit is horrible. Get ready to be sedated, urinate all over yourself, and gain only bout a million pounds.
Question: do you think it is good or right that doctors are using drugs for off the label uses they weren't designed for? I just heard on the radio that an anti-psychotic drugs was given to people who did not have schizophrenia or bipolar and that the drug is thought to cause diabetes..wtf?
these drugs have serious side effects...did the doctors even inform the people what the drug was supposed to be used for..I bet not.
It says they have had to play the largest off label settlement ever for encouraging doctors to do this.
http://search.yahoo.com/search?ei=UTF-8&fr=ytff1-&p=antipsychotic+drugs+diabetes+off+the+label+use
Do you think doctors should also be charged so they stop doing this. I know a doctor did that to me once and I later found out there was a class action lawsuit of people it harmed. I immediately weaned off it myself and then told her I was not taking i anymore. I have never taken a drug from this doctor since. to be honest, I think she lied to me in telling me why she was prescribing it too, I am glad I quit going to her.
What is your opinion on any of this.
Isn't the millions they make on its approved uses enough...we know they only make drugs for illnesses they can make money on and have enough people with that illness to make it worth their while. I think they need to remove the profit motive on drugs or rather hold it to a set amount, go after them as hard as they do people practicing alternative medicine with its battering rams and machine gun raids as this could be more dangerous than some guy dispensing herbs and nutrition and exercise and hydrotherapy certainly as most herbs are quite safe with few side effects.\
Maybe also not make them spend billions to get their exclusive patents so they don't feel they have to recoup multiple times with things like this with nary a care for the people's health who take them..if they are one of the unfortunates to get some of these rare and very serious side effects, who told the drug makers that they have the right to put people in harm's way for money.
Pretty sure the skeptics all think this is fine (unless it is them that is harmed I guess).
Answer: This is an extremely complex issue the specifics of which vary enormously across the type of drug, disease, and therapeutic class. There are a couple basic stipulations that need to be established first:
It is flat out illegal for a drug manufacturer, either the orignal creator or a generic manufacturer, to in any way shape or form promote the use of a drug for any condition which it has not received explicit approval by the FDA. Astronomical fines, penalties and sanctions have been given out when companies get caught doing this.
It is explicitly the privilege and prerogative of a doctor to prescribe any medication for any condition they professionally see fit, however, if they prescribe in a way that is indefensible and irresponsible, it can be considered malpractice and possibly health fraud - the penalties for that are insane, and can reach up to a full sanction by the HHS - which is career ending, or even prison.
Health insurance, as a universal will not pay for drugs that are used off-label, or in a way that is unsupported by scientific literature.
The primary scenario when you see off-label use is when a drug has been approved for condition X, but there has been research done to support its use in other areas. This is technically off-label use, however, there is published scientific literature of a high quality that says Drug Z is useful to treat Condition Y. There may not be an FDA approval for this, and may never be, but this is accepted on a general level. This sort of off-label use is considered universally acceptable. These uses are generally documented in medical compendia, such as Thomson Reuters' Micromedex, or the American Hospital Formulary Service Drug Information(AHFS-DI). Those two publications are considered of such high quality, that if a use is supported by one of them, it is carte-blanche accepted as a substitute for FDA approval for a condition, by the medical profession, and by health insurance.
As an example, let's use Metformin. Metformin has FDA approval for one thing - treating type II diabetes. This drug is decades old, has an impressive safety profile, and enormous amounts of research done on it. It is a very well understood drug. Micromedex documents an off-label use for it, treating polycystic ovarian syndrome. In this case, PCOS has pathology that is extremely similar in mechanism and effect to Type II Diabetes. There is also a simply staggering body of published trials showing that this is safe, and that this is effective to treat this condition. Because this drug is so old, and costs, quite literally, the sort of money you can find in your couch cushions for a week's supply, it will never be sent to the FDA for regulatory approval, even though it would be an almost instant approval.
The primary issue with off-label use is when the use is -not- well supported and accepted. Say a doctor were to prescribe Provigil (an atypical stimulant/wakefulness agent) to treat a yeast infection. That's complete idiocy by any standard. Totally irresponsible and incredibly stupid (and an actual case that a former student in mine working in health insurance got). Something where there's no clinical studies, science, or even theoretical justification to do.
A slight exception would be when you're dealing with a very rare condition, one that's life threatening. For example, say you had a lung transplant patient who was going into rejection - to treat this, you need a strong immunosuppressant drug to stop their immune system from killing the lungs. But say the only immunsuppressants available haven't been approved for treating this, and because there's so few lung transplant patient's there's very little published data. In that case a doctor might be justified in prescribing off-label with poor support. But note the difference between this example and the yeast infection above.
It's -extremely- important that off-label use be evaluated for a specific use and case. Pigeonholing off-label as bad is unjustified, but there definitely are cases where it is unforgivable and exceptionally bad by any standard.
Question: is strattera used off label in the UK? im researching medications that help with lack of energy, motivation and concentration caused by depression or side effects from other medications like anti depressants.
does anyone know if Strattera is used off label in the UK? (its listed as a ADHD med on the NHS website)
Answer: They tend to use Reboxetine instead, it is a NRI like Strattera but is cheaper to buy, it is often used with a SSRI.
Question: What are the off-label uses of Wellbutrin?
Answer: Off-Label Uses: Weight Loss, Bipolar Depression, ADD/ADHD, Fibromyalgia, Arthritis, Chronic Fatigue, Multiple Sclerosis, Lupus, Headaches, Irritable Bowel Syndrome (IBS)
Question: What can I use to label large wet plastic totes filled with ice and fish? I've tried blank sticky labels but they tend to fall off and using a Sharpie permanent marker smears when wet....there has to be an answer...can anyone help?
Answer: There is a new brand of paint made to paint on plastic - and stay on. I've seen it most recently in an add to spray paint your old outdoor plastic chairs and/or tables to make them look new.
I believe it's by Rustoleom, you can find it at Home Depot or Loews. To use in writing - spray into a shallow disposable bowl, then use a fine paint brush to dip in and paint onto the totes.
Paint may come in a "paint pen" format or available in small container, but I'm not sure - check the manufacturer.
If you can't find the above mentioned paint, try regular paint pens found in the art supply section of Michael's craft store. They may or may not work, depending on the plastic surface.
Off Label Use Related Products and News
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