FDA considers expanding drug sales
Wed, 03 Oct 2007 21:08:41 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - A change may be brewing for U.S. drugstores: The government is mulling more "behind-the-counter" sales, to let patients buy certain medicines directly from pharmacists without a doctor's prescription.
The Food and Drug Administration announced Wednesday that it was seeking public reaction to such a switch, including whether it would ease access for the uninsured.
"This is an issue that has been raised by pharmacists, by manufacturers, by patients," said Ilisa Bernstein, FDA's director of pharmacy affairs.
Today, most U.S. drugs either require a prescription or are sold in a traditional over-the-counter method — no prescription required, just grab a bottle and head for the cashier.
"Behind-the-counter" sales offer a middle ground. Last year, the FDA allowed the emergency contraceptive Plan B, also called the morning-after pill, to be sold without a doctor's note to women 18 and older — but only by pharmacies that checked women's photo identification before handing over the pills. Minors still require a prescription.
Now the question is whether requiring additional interaction with a trained pharmacist — health advice or even, say, a blood pressure or cholesterol check — might further spur the evolution of nonprescription drugs from quick symptom relief to more complex therapy.
Routine birth control pills are an often-cited candidate. And in 2005, the FDA rejected a bid to sell cholesterol-lowering Mevacor without a prescription — although some of the agency's scientific advisers said such a move might one day be possible if pharmacists could help guide which customers bought the pills.
Indeed, Britain allows the anti-cholesterol drug Zocor to be sold behind the counter.
Variations of behind-the-counter sales also are allowed in Australia, Canada, France, Denmark, Germany, Italy, the Netherlands, New Zealand, Sweden and Switzerland, the FDA said.
On Nov. 14, FDA will hold a meeting in Washington to solicit input from patients, pharmacists, doctors — in short, anyone interested — on whether it's time for such a switch here. FDA also will accept written comments through Nov. 28.
The agency doesn't have any petitions to switch specific drugs, said FDA's Bernstein. Nor would she list potential candidates.
"The purpose is just to gather information and find out more about how behind-the-counter availability of drugs can improve patient access to certain medications that would be helpful," she said.
The National Association of Chain Drug Stores welcomed the FDA discussion, saying it was open to behind-the-counter sales, depending on what would be required of pharmacists.
FDA acknowledged that drugstores would face logistical issues, such as how to stock behind-the-counter drugs. Also, while advising customers about safe drug use already is part of a pharmacist's job, another question is whether behind-the-counter sales would increase that workload enough to raise reimbursement issues.
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On the Net:
FDA — http://www.fda.gov
Uganda confirms new outbreak of virus
Wed, 03 Oct 2007 20:42:51 GMTBy KATY POWNALL, Associated Press Writer
KAMPALA, Uganda - A miner who guided scientists to a mine believed to have been the source of an Ebola-like outbreak has contracted the disease, health officials said Wednesday.
Ministry of Health spokesman Paul Kagwa urged the public to remain calm following the emergence of a new case two months after the outbreak was declared contained, and cautioned miners to avoid re-entering the mine. Guards were posted at entrances to the mine, which has been closed since June, he said.
The Marburg virus, a rare hemorrhagic illness, killed a gold miner in Kitaka, about 100 miles west of the country's capital, Kampala. Another 29-year-old miner died of the illness at the same mine in June.
The latest victim, now being treated in an isolation war near the mine, "was guiding a team of scientists who were taking samples from bats in the gold mine," Kagwa told the Associated Press.
According to the World Health Organization, the patient was wearing complete head-to-toe protective equipment when he helped international scientists investigate the source of the Marburg outbreak in the mine.
"We think that he must have sneaked back into the mine without wearing his protective clothing," Kagwa said.
Gregory Hartl, a WHO spokesman, said the victim's "prognosis is as good as can be expected for Marburg. Hartl said that the patient developed symptoms on September 17, and now appears to have a healthy supply of antibodies.
Since Marburg was first identified in miners at the site in June, only virus hunters swathed in protective gear are supposed to have entered the mine in search of the bats they believe may have been the source of the outbreak.
"The analysis team have completed their ecological studies and we are now awaiting the results from the samples they took," Kagwa said.
Marburg has a death rate that can be higher than 90 percent and no treatment or vaccine. The disease can cause headaches, nausea, diarrhea and vomiting. In severe cases, the central nervous system is attacked, and patients may bleed from the eyes, ears and elsewhere.
Since Marburg was first identified in 1967, large outbreaks have been reported in Congo, Angola and elsewhere.
Scientists are not sure how it is transmitted to humans, but believe people may become infected by being bitten by bats or by insects or other animals that have been infected by bats. Another possibility is that people catch it by breathing in air carrying virus particles from bat feces.
Panel urges more benefits for veterans
Wed, 03 Oct 2007 16:08:05 GMTBy HOPE YEN, Associated Press Writer
WASHINGTON - Veterans disability payments should be increased immediately by up to 25 percent as part of a sweeping overhaul designed to compensate for a wounded warrior's lost "quality of life," a special commission recommended Wednesday.
The 2 1/2-year study being released by the Veterans' Disability Benefits Commission offers the most comprehensive look yet at the ailing government benefits system that provides millions of injured veterans with about $30 billion a year in payments.
Tracking the findings of recent reports that detailed flaws in veterans care, the 13-member congressional commission concluded in its 544-page report that both the Pentagon and Veterans Affairs Department fall woefully short in providing adequate mental health care as well as timely and fair disability payments.
But going a step further, the commission also recommended the immediate extra payments to injured veterans, many of whom feel they lose out on benefits because of an overly narrow government focus on earnings losses or other reasons.
That could offer veterans some stopgap relief as the Bush administration and Congress consider proposals from an array of task forces and commissions aimed at fixing an outdated system that critics have long said was broken. Such changes could take into account new medical therapies, prosthetics and other effects of war injuries on the daily functioning of wounded warriors.
"Congress should increase the compensation rates up to 25 percent as an interim and baseline future benefit for loss of quality of life, pending development and implementation of quality of life measures," the report states. "In particular, the measure should take into account the quality of life and other non-work related effects of severe disabilities on veterans and family members."
In an interview with The Associated Press, retired Lt. Gen. James Terry Scott, the commission's chairman, said the disability system needed to be revamped, expressing his belief that the Army might be seeking to lowball veterans' disability ratings to avoid paying more benefits.
A key recommendation of the commission seeks to bring more fairness to the government system by shifting more responsibility to assigning benefits from the Pentagon to the VA, which tends to rate disabilities higher, even if it ran the risk of putting additional strains on an already backlogged VA.
Scott cited a Pentagon policy put in place in the mid-1980s at a time of budget restraint that calls for consideration of only one disability when determining benefits, not multiple ones as the VA does. That policy is still in place today, creating a climate in which Army officials might consider at least subconsciously cost-saving factors when awarding benefits, he said.
"We have come up with 113 recommendations — some of them are cheap. Some are easy. Some are extremely hard and complex. Some of them, there is a significant bill attached to it," Scott said. "But what we're hoping is that the Congress carefully looks at all 113."
Among the findings:
_Veterans with post-traumatic stress disorder are in danger of slipping through the cracks because there is little coordination among agencies to ensure they get the full range of services from needed medical treatment to proper compensation and vocational rehabilitation so they can return to work.
_After initial screenings, the VA often does not follow up soon enough with re-examinations of veterans with suspected PTSD. The report blamed in part the VA's struggles to reduce its backlog of disability claims, which it said was diverting the agency's attention and resources away from needed PTSD care. The commission called for mandatory re-examinations for PTSD to gauge treatment and other issues every two to three years.
_Benefits should be awarded to veterans for any service-related injury, regardless of whether it was incurred during combat.
_The VA must make better use of technology as a way to reduce its overwhelming delay of 177 days, on average, in handing out disability payments.
The commission report comes after the Government Accountability Office last week found that the Bush administration has yet to find clear answers to some of the worst problems afflicting wounded warriors, such as personalized medical care and reducing backlogs in disability pay.
Former VA Secretary Jim Nicholson, who stepped down this week, has said his successor will have to be creative in solving intractable delays in payments and improving coordination in care between the Pentagon and VA. Gordon Mansfield, the VA's deputy secretary, is serving as acting secretary pending a nomination of a successor by President Bush.
"VA appreciates the efforts of the recent commissions created to find ways to improve the disability benefits process for eligible veterans," VA spokesman Matt Smith said in response to the report. "Our goal is to help our disabled veterans become whole and continue their lives by providing them with health care, rehabilitation, as well as disability, education, and home loan benefits."
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On the Net:
Veterans' Disability Benefits Commission: http://www.vetscommission.org/
