Monday, November 23, 2009

Shifting Vaccine for Flu to Elderly

Federal health officials are trying to shift supplies of the seasonal flu vaccine away from chain pharmacies and supermarkets to nursing homes, hoping to counter a shortage that threatens to cause a wave of deaths this winter among the nation’s most vulnerable population.

The extent of the shortage is still unclear, but Janice Zalen, director of special programs for the American Health Care Association, which represents 11,000 nursing homes and assisted-living facilities, called it “a very big problem.”

Ms. Zalen said that of 1,000 nursing home managers who responded to a survey of the association’s 11,000 members, 800 reported they could not get enough vaccine.

Dr. Carol Friedman, head of adult immunization at the Centers for Disease Control and Prevention, said she did not have a figure for the size of the shortage, but added, “It’s a problem, and it’s all over the country.”

Mary Hahn, who manages six Ohio nursing homes with 800 beds, said she could not get vaccine for any of her patients.

“It’s just so disheartening, because we’re having to leave people unprotected,” she said. “You see people get flus and get sent to the hospital because they really can’t fight it off.”

A nationwide shortage of the seasonal flu vaccine has been reported for several weeks, but nursing homes and their suppliers have grown more alarmed in recent days. Of the 36,000 Americans who die of seasonal flu in the average year, more than 90 percent are 65 or older, and nursing home outbreaks are particularly deadly. By contrast, the swine flu epidemic has been most deadly among younger people.

The nursing homes’ predicament has been caused by a confluence of factors. Because of the swine flu pandemic, far more people than usual are seeking vaccination, Dr. Friedman said — even though the seasonal vaccine does not protect against swine flu.

The five companies licensed to make flu shots for the United States originally planned to make only slightly more than the 118 million they made in 2008. Then, production problems caused GlaxoSmithKline to cut its run by half; Novartis’s shrank by 10 percent. Then all five companies had to switch over early to making swine flu vaccine.

So the total supply of vaccine is about 114 million doses, of which about 95 million have been shipped.

At the same time, reports of price gouging have grown more frequent. That also happened in 2004, when sterility problems at a British plant cut the American flu vaccine supply in half; prices shot up as high as $90 a dose, from the normal level of $8 to $9.

Gouging is illegal in about half the states, but each state varies in how big a price increase constitutes gouging and as to whether an emergency must have been declared for the law to kick in.

“To pursue a case, we need to show it’s not just a couple of dollars but is very significant,” said Attorney General Richard Blumenthal of Connecticut, who has opened an investigation.

Criminal charges are less likely than a civil suit, Mr. Blumenthal said. But he added that if distributors were “masquerading or fraudulently claiming to have vaccine,” that could end in a criminal charge. While he had suspicions, he said, “we don’t have hard evidence yet.”

Dr. Friedman said that once the agency became aware of the shortage at nursing homes, “we began working with the manufacturers to see if they could redirect some of their vaccine.”

“Several big-box retailers and pharmacies volunteered to go into the long-term-care facilities and set up flu clinics,” she said.

Dr. Friedman said she knew of one major supplier to nursing homes that received 100,000 fewer doses from the vaccine makers than it had ordered. Her agency began acting as a broker among the homes, vaccine distributors and other customers. Since then, she said, that supplier has found about 50,000 more doses.

“That’s definitely not going to close the gap,” she said, “but it will help.”

Also, both she and Ms. Zalen said, pharmacy and supermarket chains like Walgreen’s and Safeway that bought millions of doses to sell for $25 to $30 have offered to give shots in nursing homes. They do not charge but get Medicare reimbursements, which vary by state but run up to $25.

By contrast, Bob McKay, chief of sales for PharMerica, one of the two largest wholesale pharmacies supplying nursing homes, said he had received 95 percent of the 300,000 doses he ordered and “the voids are getting filled in” at the nursing homes he supplies.

“We’re not hearing rage and craziness out there,” Mr. McKay said. “If a lot of homes were still short, they’d be beating our doors down.”

But he said he had asked some not to buy shots for their staffs. Flu experts say that in nursing homes, vaccination of staff members is just as important as patient vaccination.

Prices offered to PharMerica for the extra doses they needed were “in the $15-$16 range,” Mr. McKay said. “That’s more than we’d normally pay, but not price-gouging.”

Jim Mathews, an executive at Hometown Pharmacy, a smaller wholesale pharmaceutical company supplying Michigan nursing homes, said that late last month he found himself 3,000 doses short; his usual supplier, which charges $6.75 per dose, was out of stock. He called the C.D.C. for advice, was directed to a Web page listing other suppliers and contacted all 10. Only one had vaccine, and it sent him a fax in broken English asking for $57 to $59 per dose.

Mr. Mathews said he reported that to local law enforcement officials, but he is more worried about the patients who will not get shots.

“When I first recognized the potential death toll from this shortage, there was time to prioritize the remaining supply for the most vulnerable elderly,” he said. “Now I’m afraid it’s too late. From what I see, the seasonal flu vaccine shortage is going to cost more lives than the H1N1 shortage is.”

Dr. Friedman, of the C.D.C., said she had heard of “about 15” price-gouging complaints.

Dr. Lillian Overman, an internist in East Hartford, Conn., was one of the first to alert Mr. Blumenthal, the state’s attorney general, about gouging accusations. On Oct. 26, her office manager began looking for vaccine, for which she normally pays $8.50 a dose. A saleswoman at ABO Pharmaceuticals in San Diego wanted $60 per dose, she said.

“That’s just prohibitive,” a frustrated Dr. Overman said. “If I’d known there would be a shortage, I would have called in my most vulnerable patients first.”

Mark Nemeth, an ABO sales manager, denied that anyone there had asked for $60.

“I can guarantee you without a shadow of a doubt, we would never have offered it at that price,” he said; the company is asking “in the ballpark of $12 to $14” for its remaining supplies.

Courtesy: Newyorktimes