Saturday, May 5, 2012
Monday, April 30, 2012
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, theObama 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."
"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.
Rasouli case shows benefit of doctors discussing treatment options with patients before surgery - The Globe and Mail
Bedbound and dependent on machines, Mr. Rasouli, 60, sustained a brain infection after surgery for a brain tumour in October, 2010. Since then, he has required round-the-clock care, with machines breathing, feeding and hydrating him; medications maintain his blood pressure.
Two critical-care physicians, Brian Cuthbertson and Gordon Rubenfeld at Sunnybrook Health Sciences Centre in Toronto, see no medical purpose in keeping Mr. Rasouli on life support. They propose to shift him to palliative care – a recommendation with which the family disagrees. This matter has made its way through the courts.
An unexpected development has come in the form of a changed diagnosis: Mr. Rasouli is now in a minimally conscious, not a persistent vegetative state. And his medical case turns on whether he can communicate; a neuroscientist is conducting tests as part of a research project in order to determine if he is consciously aware but trapped in a paralyzed body.
This new diagnosis will alter the debate. It is difficult to make the case for withdrawal of life support when a patient has some awareness, even if the long-term prognosis is grim. These shifting facts do little to advance the doctors' appeal to the Supreme Court of Canada, which is expected to be heard in mid-May. The Rasouli family's lawyer has brought a motion to quash the appeal.
Across Canada, doctors have been on the front lines of such issues, trying to hold delicate end-of-life discussions with families and conducting research into how much treatment is too much in a patient's last days.
Hospitals also have a strong role to play. They should consider creating a policy that requires health-care providers to discuss treatment options with patients booked to undergo an operation, procedure or intervention – especially one with risks to the brain – should a serious complication arise.
Eliciting values and treatment preferences before a critical illness strikes would help prevent tragedies – in which no one knows what the patient wants.