Millions of Flu Vaccines May Go Unused

Oct. 16, 2008 -- Flu shot regulations in states restricting pharmacies from freely administering flu shots may keep many people from getting immunized and leave millions of vaccines unused, many health care professionals say.

As the CDC looks to expand the scope of immunizations to the largest number of people yet, states that require citizens to get a prescription to receive the flu vaccine by pharmacists are finding it difficult to accommodate the increasing numbers who are recommended for vaccinations.

The policy will turn many people away from getting a flu shot, said Dr. William Schaffner, professor of medicine in the division of infectious diseases at Vanderbilt University.

"Over the past decade, pharmacists have shown that they are very important partners in providing influenza vaccinations to the population," Schaffner said. "Having a physician's prescription is a barrier to more effective delivery of immunizations."

The flu vaccine is the primary method recommended by health officials to prevent the flu, which kills an estimated 36,000 Americans every year. While in past years the demand for flu shots outweighed the number of vaccines available, this season, Schaffner said, there may be too many flu vaccines created and not enough health professionals to administer the shots.

According to the CDC, licensed manufacturers in the United States have created 146 million doses of the vaccine for use during this flu season.

"Two-thirds of the population already falls into the CDC recommendations for the flu vaccine," Schaffner said. "And there is a great fear that we may have to discard as many as 20 million or more vaccines."

Sanofi Pasteur, Inc., a pharmaceutical company that supplies 50 percent of vaccines across the country to health care providers, has increased its workforce in anticipation of the growing market. But, in fact, the company expects losses because of the large amount of vaccines predicted to be disposed, said Len Lavenda, spokesman for Sanofi Pasteur.

"We haven't seen any change in patterns of [providers] ordering [the flu vaccine]," Lavenda said. "Right now, the big drive is to have as many people vaccinated, and we support removing the barriers and the inconvenience that will keep people from doing just that."

Making the Case for Prescriptions

While some states have successfully changed regulations to let pharmacists immunize, others are finding ways to work around policies requiring prescriptions.

New York Gov. David Paterson signed legislation this month to allow pharmacists to administer flu and pneumonia vaccinations, which was not previously permitted in the state. In Arizona and South Carolina, a person needs a prescription from a physician before a pharmacist can administer the vaccine. And in other states, such as Maine, and the District of Columbia, pharmacists have never been allowed to give flu shots.

In September, Georgia became the latest state requiring a prescription for flu shots. Georgia's medical code states pharmacists can only give immunizations to patients with a valid prescription order for each dose. A complaint filed this year with the Georgia Board of Pharmacy prompted a new understanding of the code: Pharmacies can no longer give a flu shot without a prescription.

Vaccines are classified as a dangerous drug in Georgia, due to rare adverse effects reported with some vaccines. Georgia health officials now say they understand the code to mean that a prescription was required all along.

"This is not a law change," Georgia Pharmacy Association director of government affairs Stuart Griffin said, "but rather, a change in how the law is interpreted."

But Schaffner says the Georgia board needs to examine its decision by re-evaluating the dangers of the flu vaccine.

"The number of adverse events [from the flu vaccine] is exceedingly remote," Schaffner said. "We give more influenza vaccine than almost any vaccine annually, and it's among the safest vaccines that we give."

Many Georgia physicians were not consulted before the medical board's decision, said Dr. Jim Wilde, associate professor of Pediatrics and Emergency Medicine at Georgia Medical College, who serves on the governor's panel for Georgia's state planning committee for the pandemic flu. He said physicians would agree that the added step of states requiring a prescription for a flu shot is useless.

"Whether the vaccine is administered in a pharmacy or a doctor's office will not change the slight possibility of an adverse effect," Wilde said.

In a written statement on Sept. 11, Georgia Gov. Sonny Perdue assured that pharmacists would still be allowed to administer a flu shot with or without a prescription.

"We believe it is imperative that pharmacists and others act as they have in the past," he said. "This administration will not call for sanctions against those acting in the best interests of Georgians and in a manner consistent with past practices."

But even with the governor's declared position on prescriptions, Griffin said he believes there is still a public health concern, because the number of vaccines ordered by pharmacies decreased between 50 to 80 percent.

"We've been trying to keep this quiet to avoid confusion by the public," Griffin said. "We think the confusion would cause frustration, and the last thing we need is people to avoid getting the flu shot because of this."

Conflicting information between the medical board and the governor has also further confused pharmacies and physicians, according to Wilde.

"The issue is whether or not the shot is being administered with or without a physician's approval," Wilde said. "My request is that we have one common message sent to the state and not two different messages."

Pharmacies Bypass Prescriptions

Even with the obstacles to flu vaccination apparent, an immediate solution might be difficult to accomplish.

Hrant Jamgochian, director of congressional and state relations with the American Pharmacist Association, said he is working with local offices within each state, including the American Pharmacist Association, the Georgia Pharmacy Board, and other public health organizations within Georgia, to change legislation. However, they will have to wait until the end of this flu season, when lawmakers return to their state offices, to modify the law.

"The growing trend is that the pharmacist is the most accessible health provider out there," Jamgochian said. "There are critical public health needs for immunizations and pharmacists are ready to fill that need with access and quality of care."

Meanwhile, larger pharmacies across the country are finding alternative ways to immunize without the need for prescriptions.

CVS/pharmacy, which has 29 stores in Georgia, will continue to hold its scheduled flu clinics, but is now working with third parties to bring in nurses to immunize in place of its own pharmacists, said Joanne Dwyer, a spokeswoman for CVS/pharmacy. CVS/pharmacy holds a similar third party policy in its stores in 35 other states, although not all require prescriptions for flu shots.

But, Schaffner said, not all pharmacies will be able to have professionals available for the same amount of time as a pharmacist. This will also keep the vaccine from being available to individuals who want it, he said.

"This seems quite counterproductive," Schaffner said. "Influenza vaccine that remains in the refrigerator cannot prevent influenza."