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Title: FDA May Let Patients Buy Drugs Without Prescriptions; Move Would Increase Patients’ Out-Of-Pocket Costs
Source:
Washington Times
URL Source: http://www.washingtontimes.com/news ... rescriptio/?page=all#pagebreak
Published: Apr 30, 2012
Author: Paige Winfield Cunningham
Post Date: 2012-04-30 12:27:03 by Brian S
Keywords: None
Views: 4561
Comments: 12
In a move that could help the government trim its burgeoning health care costs, the Food and Drug Administration may soon permit Americans to obtain some drugs used to treat conditions such as high blood pressure and diabetes without obtaining a prescription. The FDA says over-the-counter distribution would let patients get drugs for many common conditions without the time and expense of visiting a doctor, but medical providers call the change medically unsound and note that it also may mean that insurance no longer will pay for the drugs. “The problem is medicine is just not that simple,” said Dr. Matthew Mintz, an internist at George Washington University Hospital. “You can’t just follow rules and weigh all the pros and cons. It needs to be individualized.” Under the changes that the agency is considering, patients could diagnose their ailments by answering questions online or at a pharmacy kiosk in order to buy current prescription-only drugs for conditions such as high cholesterol, certain infections, migraine headaches, asthma or allergies. By removing the prescription requirement from popular drugs, the Obama administration could ease financial pressures on the overburdened Medicare system by paying for fewer doctor visits and possibly opening the door to make seniors pay a larger share of the cost of their medications. The change could have mixed results for non-Medicare patients. Although they may not have to visit a doctor as often, they could have to dish out more money for medications because most insurance companies don’t cover over-the-counter drugs. “We would expect that out-of-pocket costs for insured individuals, including those covered by Medicare, would be increased for drugs that are switched from prescription to OTC status,” said Dr. Sandra Adamson Fryhofer, who testified last month on behalf of the American Medical Association in an FDA-held public hearing. Pharmacists and doctors have lined up on opposite sides of the issue. Often trying to combat a public perception that downplays their medical training, pharmacists embrace the notion that they should be able to dole out medication for patients’ chronic conditions without making them go through a doctor. “We think it’s a great development for everybody — for pharmacists, for patients and the whole health care system,” said Brian Gallagher, a lobbyist for the American Pharmacists Association. “The way we look at it is there are a lot of people out there with chronic conditions that are undertreated and this would enable the pharmacists to redirect these undertreated people back into the health care system.” Medical providers urged caution, saying the government should not try to cut health care costs by cutting out doctors. “What the government via the FDA has decided to do is just bypass the expensive doctor and to satisfy some safety concerns of letting people just pick out their medications is make sure they have to get counsel by the pharmacists,” Dr. Mintz said. “I believe there is value to using pharmacists, but not at the expense of primary care.” Although the FDA says more patients will be likely to obtain the drugs they need under the proposed model, Dr. Fryhofer questioned whether the agency has sufficiently proved that. “The FDA has not offered any evidence establishing that it is safe, or patient outcomes are improved, when patients with hypertension, [high cholesterol], asthma or migraine headaches self-diagnose and manage these (or other) serious chronic medical conditions on their own,” she said. Comments on the proposal are due by May 7. FDA spokeswoman Erica Jefferson said the agency will issue a decision sometime after that but didn’t offer a more specific time frame. “The agency is still reviewing the public comments and will make a determination on the best path forward once this has been completed,” she said.
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#1. To: Brian S (#0)
Self-diagnoses and subsequent Rx administration is a much quicker way to the ER or even death depending on the condition. There is a big difference between a sinus infection and a brain tumor but the symptoms are quite similar. But what the hell, the pharmacist gets to sell more anti-biotics and if the guy has a brain tumor Walgreens doesn't get in on that end of the market. Absurd.
It is the over the counter antibiotic provision that concerns me the most.
Never swear "allegiance" to anything other than the 'right to change your mind'! I've given up trying to understand who the hell is running the F&DA anymore. Social scientists should stick to fucking up the Indian Health Service. I can imagine the questions about cholesterol... When you bleed is there a lot of fat there?
Oh please, how often does one get a brain scan when they have the symptons of a sinus infection? There are many medicines available over the counter in Canada and Europe that are not available over the counter in the U.S. Do people in Canada and Europe die at significantly higher rates than in the U.S. from taking over the counter medicines? No they don't. But they do die at significantly higher rates from catastrophic illnesses like cancer and heart disease because of the government's monopoly on medical finance in Canada and medical treatments in the U.K. The nanny state has also been trying to make vitamins a prescription medication for years. Fortunately, we've been able to fend this off. Perhaps escalating costs are finally turning the tide on this. That would be a good thing.
PhRma and agribusiness run the FDA similarly to how JPM, GS & similar run the SEC. A good general rule is that a regulator is typically owned by the most powerful "regulees".
You are missing the point. If a citizen has a 'sinus headache' by his own definition and continues to take various OTC remedies without remission then he needs an M.D. to check it out. Not a R.Ph. Self-diagnoses is dangerous.
Yes, of course; and having worked both sides of that coin I don't know where all the honest or ethical or moral practitioners have gone. There used to be some honor.
I completely agree. That doesn't he needs to pay to visit a doctor when he first gets the infection just to get a prescription.
Just so long as you realize that he doesn't know whether it is an infection or something more serious. Somebody walking around with a head ache two days after getting his head slammed into the windshield damn well better stop with the extra strength ibuprofen and get to the ER...or he's going to die.
Neither does the doctor on the first visit.
Ah, but the doc is trained in the art and has a better chance to get it right.
Long overdue.
Comments on the proposal are due by May 7.
#2. To: harrowup (#1)
#3. To: Brian S (#2)
It is the over the counter antibiotic provision that concerns me the most.
#4. To: harrowup (#1)
(Edited)
There is a big difference between a sinus infection and a brain tumor but the symptoms are quite similar.
Iran’s main drive for acquiring atomic weapons is not for use against Israel but as a deterrent against U.S. intervention -- Major General Zeevi Farkash, head of the Israeli Military Intelligence Directorate
#5. To: harrowup (#3)
(Edited)
I've given up trying to understand who the hell is running the F&DA anymore.
#6. To: jwpegler (#4)
Oh please, how often does one get a brain scan when they have the symptons of a sinus infection?
#7. To: thoughtomator (#5)
A good general rule is that a regulator is typically owned by the most powerful "regulees".
#8. To: harrowup (#6)
If a citizen has a 'sinus headache' by his own definition and continues to take various OTC remedies without remission then he needs an M.D. to check it out.
Iran’s main drive for acquiring atomic weapons is not for use against Israel but as a deterrent against U.S. intervention -- Major General Zeevi Farkash, head of the Israeli Military Intelligence Directorate
#9. To: jwpegler (#8)
That doesn't [mean] he needs to pay to visit a doctor when he first gets the infection just to get a prescription.
#10. To: harrowup (#9)
Just so long as you realize that he doesn't know whether it is an infection or something more serious.
Iran’s main drive for acquiring atomic weapons is not for use against Israel but as a deterrent against U.S. intervention -- Major General Zeevi Farkash, head of the Israeli Military Intelligence Directorate
#11. To: jwpegler (#10)
Neither does the doctor on the first visit
#12. To: Brian S (#0)
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