Flu vaccine experience leaves physicians watchful, worried

The hard-luck experiences of recent influenza seasons have led physicians to view the upcoming months of coughs, colds and flu shots with both glass-half-full and glass-half-empty attitudes. But vaccine experts are paying close attention to how these feelings translate into ordering and vaccination trends, because they believe it could foreshadow future public health challenges.

According to unpublished data from a survey of 1,200 physicians carried out by University of Colorado Health Sciences Center and funded by the Centers for Disease Control and Prevention, 98% of physicians plan to administer the flu vaccine this season, with an estimated 38% to 51% ordering more doses than last year. A complete analysis of the University of Colorado data is expected to be published later this year.

AMNews, however, conducted a small, unscientific poll of its own to gain insight into what has become a complicated picture. Forty-five family physicians and internists from 27 states responded. All are active in the American Medical Association, the American College of Physicians or the American Academy of Family Physicians, and their work situations range from solo practice to large multispecialty groups.

Overall, most said they had significant problems last year because of Chiron Corp.'s abrupt exit from the market when plant contamination problems triggered a loss of nearly half of the expected U.S. supply. This episode, which came on the tail of other difficult seasons, appears to have changed how some feel about their role in administering the vaccine.

All still consider it important for patients, but many doctors are angry about a distribution system they perceive as putting physicians last. Price increases, too, make it less economically viable for them to administer -- especially when unused vaccine often can't be returned and there seem to be no guarantees that all of it will be used.

"The system has failed," said Arthur Gale, MD, an internist in St. Louis who has ordered 2,000 doses for the past three seasons but did not get any last year. Such perceptions have led some doctors to reduce their orders or get out of the business entirely, which means patients might not be able to get the vaccine from their physicians -- a source public health officials say is critical to achieving vaccination coverage targets.

"Physicians do a great job of reaching the risk groups," said Jeanne Santoli, MD, MPH, deputy director of the Immunization Services Division at the CDC's National Immunization Program. "We have been very concerned about how [recent problems] will impact physicians."

Counting shots

Of the 45 physicians who participated in the AMNews poll, 36 had problems last year getting the vaccine they ordered in a timely manner. Most who didn't have any problems now plan to order more vaccine for the approaching season; a handful of this group are ordering the same.

"[We] increased our order ... to meet patient demand," said Mary Carpenter, MD, a family physician in Winner, S.D., who upped her order from 1,400 to 1,520 doses. She received all of her order last season, though some was redistributed to doctors who weren't so lucky. "I was very impressed with how our state health department and the providers worked together to get the most high-risk patients vaccinated immediately."

For those who did face difficulties during the 2004-05 season, the story is slightly more intricate. Only 10 out of these 36 physicians so far have decided to order more vaccine this time. A handful of them are doing so because they don't expect to get all they ordered, but most also are anticipating more patient interest.

"The shortage increased patients' awareness of flu shots, and their demand for the immunization increased," said Mary Newman, MD, a Baltimore internist who has increased her order from 3,850 to 3,960 doses. She received less than a third of what she ordered last time around.

Fifteen of these 36 doctors said they were ordering the same amount, although this is in part due to the fact that Sanofi Pasteur, the only company confirmed as an approved vaccine provider in 2005-06, placed limits on pre-booked orders.

"We would have ordered more," said Harold Ishler, MD, a family physician at a large multispecialty clinic in Baton Rouge, La. His facility had significant difficulties last year getting all of the 70,000 doses that were ordered. "We are hoping that most of our patients will be able to get the vaccine either from us or other places despite not being able to order what we wanted."

According to Sanofi spokesman Len Lavenda, this mechanism was used to increase the number of physicians and other vaccine providers who could place pre-bookings. The company also wants to ensure that the vaccine is available to long-term-care providers.

Most alarming to public health officials are the doctors who are reducing their orders or giving up completely. Of those who had problems last year, eight out of 36 are cutting their order, and three are getting out of the business altogether. Three more of these physicians are seriously considering dropping out in the future.

"I have ordered 750 doses of influenza vaccine this year because I believe my patients should be immunized. Paying for this order will mean that I probably will not be able to take home any salary in October," said Lawrence M. Markman, MD, a family physician in Wilmington, Del. "This may be the last year that I am willing to play this game."

But in addition to the flu vaccine fatigue and frustration, there also is significant doubt that this year will be better. A quarter of those who had problems last year are bracing for a repeat in which they don't receive all of what they ordered or it arrives too tardy to be useful.

"We need 1,000 doses, but we're not really expecting it all," said Charles Cutler, MD, an internist in Norristown, Pa., who increased his order from 900 doses to 1,000. "Last year we couldn't get vaccine at all for three-quarters of the season, and then we were flooded at the end of November and mid-December. We could get as much as we wanted. I hope we get it earlier this year."

The uncertainty is echoed by public health and medical society officials, because the situation is more in play than ever.

Sanofi is expected to provide at least 50 million doses of the injectable vaccine, and Medimmune plans to produce 3 million doses of the nasal version. GlaxoSmithKline may provide 10 million injectable doses. At press time, though, their contribution was still dependent on regulatory approval.

Chiron is also a wild card. Company statements said it expects to provide 18 million to 26 million doses.

"I can understand physicians' frustration with the instability of the flu vaccine supply," said AMA Trustee Ronald M. Davis, MD. The AMA long has worked on flu vaccine supply issues and co-sponsors an annual summit on the issue with the CDC. "I am as hopeful as anyone would be that the orders will be fulfilled."