Flu shot shortfall: Physicians scramble to direct high-risk patients to scarce vaccine

The problems of massive vaccine shortages and the need to move vaccine to those who need it most marked the start of the flu season.

By Susan J. Landers — Posted Oct. 25, 2004

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Physicians are being called upon to help direct a suddenly limited supply of influenza vaccine to patients most in need -- that is, if their practices are lucky enough to have any vaccine to begin with.

This year's best-laid vaccination plans were abandoned Oct. 5 when federal health officials announced that the Chiron Corp. would not provide the 46 million to 48 million influenza vaccine doses expected across the nation. The manufacturer's license was suspended by British health authorities because of contamination problems in its Liverpool plant.

Now, just as the flu season is beginning, physicians and patients are scrambling to make the most of a scarce resource -- only having about half of the total anticipated U.S. vaccine available for fall and winter months. As a result, physicians are facing another frustrating year of flu shot shortages and rations.

They also are confronting the challenges of educating patients about who should be vaccinated in the wake of this changed landscape and are again trying to form ad hoc supply chains to ensure access for their most vulnerable patients.

"Take a deep breath," said Julie Gerberding, MD, MPH, director of the Centers for Disease Control and Prevention, at an Oct. 5 news conference. "We are going to work through this as we have other shortages in the past."

But how to work through not having any vaccine was uppermost in many physicians' minds.

Consider the example of an 11-member practice in Shreveport, La. About 10,000 doses were ordered, but these physicians now find themselves empty-handed. Vanderbilt University Medical Center in Tennessee is also out of luck. Both of these facilities decided to try to purchase some from local supermarkets and pharmacies that had received their shipments.

And while one Minnesota hospital has half of its supply, having hedged its bets and split its order between the two remaining manufacturers of injectable flu vaccine, the Henry Ford Health System in Detroit was lucky enough to receive its full allotment of about 110,000 doses.

Share and share alike

The Henry Ford Health System opted to share its supply with some of the public health departments in the area, said AMA Trustee Ronald M. Davis, MD, who directs the system's center for health promotion and disease prevention.

And early signs were good that there will be more vaccine to share as many workplace immunization clinics were canceled and supermarkets were restricting supplies to those on the CDC's high-priority list of the very young, the elderly, health care workers and those with chronic conditions.

The CDC also joined with the remaining manufacturer, Aventis Pasteur, to ensure that its 22.4 million doses of unshipped vaccine reach those most in need. The first 14 million of those doses are earmarked for pediatricians who have contracts with Aventis, the Vaccines for Children program, hospitals and long-term-care facilities, and public health departments that had contracted with Chiron for vaccine, Dr. Gerberding said.

Of the remaining 8 million doses, 4.5 million are intended for the vaccine stockpile, where they will be available for at-risk people as the need becomes apparent, she said, noting that the plan is a "work in progress."

While preserving the vaccine for those most in need is a job being shared by the public and private medical communities, the task is expected to be most difficult for physicians in private practices who are rarely, if ever, placed in the position of turning patients away from care.

"One way of handling this is to get a lot of press out," said Greg Poland, MD, director of the Mayo Vaccine Research Group and professor of medicine at the Mayo Clinic in Rochester, Minn. Physicians can post notices from the CDC or [Dept. of Health and Human Services] in their waiting rooms or on their Web sites explaining the urgency of the situation and asking that patients not in high-risk groups refrain from asking for the vaccine.

Sending out letters to patients also could work, he said. The letters would urge patients in high-priority categories to get a flu shot while asking others to forgo immunization this year "for the common good."

Dr. Davis began drafting just such a letter to all patients in the Henry Ford Health System soon after the shortfall was revealed. The letter includes the CDC's list of those who should get the shot; a request that those not in the priority categories postpone receiving a flu shot; symptoms of the flu; and information on preventive measures, such as frequent hand washing and the effectiveness of antiviral medication.

In addition, healthy children and adults ages 5 to 49 can take the nasal flu vaccine, although there are only between 1 million and 2 million doses of the live, attenuated influenza vaccine available for this flu season.

Vaccine messages collide

Physicians also might need to address the "communication confusion" from the collision of the earlier public health messages about the importance of getting a flu shot each year with the newer realities of this year's shortage, Dr. Poland said. It must be explained that this is a unique year for flu shots, and when the supply returns to normal, physicians will be asking everyone to be immunized.

There is also some fear of a stampede to get the scarce shots. "Two or three years ago, when word got out that there was going to be a vaccine shortage, it paradoxically moved people who never get the flu vaccine to get it because it wasn't going to be available," Dr. Poland said. "It made the situation worse."

Last year, physicians ran short when the 86 million doses on hand were depleted as news that a harsher than usual flu season was hitting early. This year, by early October, the World Health Organization and the CDC reported limited flu activity.

There remains a recognition that all the advice and reasoning in the world won't prevent some healthy patients from seeking a flu shot.

"If, after all the explanations, a patient still wants the vaccine and is not in one of the priority groups, I think most physicians would give it. They are not in the tradition of turning away patients," said William Schaffner, MD, chair of the Dept. of Preventive Medicine at Vanderbilt University Medical Center in Tennessee.

In addition, the issue of liability has been raised, Dr. Davis said. "Rejecting a patient's request for the flu vaccine could create substantial liability if that patient were to develop influenza and serious complications from it."

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Who should be vaccinated?

Groups considered at highest risk for flu complications have top priority for vaccinations:

  • Children 6 to 23 months old
  • Everyone older than 65
  • Children and adults from 2 to 64 years old who have chronic medical conditions
  • Women who will be pregnant during the flu season
  • Residents of nursing homes and long-term care facilities
  • Children from 6 months to 18 years old who are on long-term aspirin therapy
  • Health care workers with direct patient care
  • People in direct contact with children younger than 6 months

Source: Centers for Disease Control and Prevention, Oct. 5

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Efforts under way to reallocate vaccine, but concerns remain

Counseling patients to make responsible use of the scarce public health resource is fine advice for those who have the influenza vaccine, but physicians who don't are relying on a grassroots reallocation system that is being cobbled together.

Such a system has not worked well in the past, said Greg Poland, MD, director of the Mayo Vaccine Research Group and professor of medicine at the Mayo Clinic in Rochester, Minn. "The redistribution piece is not centralized and not routinely planned for, and is not very operational."

For one thing, questions about the vaccine's safety could be raised unless a donated supply of vaccine is accepted from a trusted source. But state and private efforts were made late last year and now this year to move the vaccine to those without it.

Rhode Island and several other states have begun inventorying available vaccine within their jurisdictions as a first step to reallocation.

Although the Centers for Disease Control and Prevention stepped in to help with the distribution of vaccine that was still rolling off the production lines at Aventis Pasteur, the one remaining manufacturer, there is a consensus among physicians that federal action is needed to prevent such a situation from becoming the norm.

"The health of the nation cannot depend on one or two [vaccine] suppliers," Dr. Poland said.

The scarcity of manufacturers has much to do with the fact that there is very little money to be made in the vaccine business. "We have to get over the idea that vaccines are cheap," said William Schaffner, MD, chair of the Dept. of Preventive Medicine at Vanderbilt University Medical Center in Tennessee. "If we want more vaccines, we are going to have to be willing to pay for them. And they are worth it."

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External links

Patient education materials on the vaccine shortage from the Centers for Disease Control and Prevention (link)

Centers for Disease Control and Prevention on flu (link)

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