Rationing, price gouging plague hospital influenza vaccine plans

CDC tries to redistribute doses to priority groups

Hospitals began rationing the flu vaccine as the sudden shortage threw their annual fall campaigns into chaos. The complete loss of half the nation’s flu vaccine supply highlighted the fragility of a core public health function: vaccinating the population against a potentially deadly disease. By luck, hospitals that ordered from the "right" manufacturer received their complete vaccine stock, while others had none.

By late October, the Centers for Disease Control and Prevention (CDC) in Atlanta sought to reassure health care providers that more vaccine would become available and would be released through January 2005.

State and local health departments will help redistribute vaccine to those who need it most, including hospitals and long-term care facilities, the CDC announced. Agency officials said they gained unprecedented access to shipment information from Aventis Pasteur of Swiftwater, PA, to learn who received the 33 million doses shipped before the vaccine supply shortage occurred and who was scheduled to receive the remaining 22.4 million doses. Hospitals and long-term care facilities are on a priority list and may receive up to 100% of their orders — although the doses are to be used only with health care workers in direct patient care and high-risk patients, CDC officials said.

"If you don’t have enough vaccine, let your distributor know and let the health department know," advises Lance Rodewald, MD, director of CDC’s Immunization Services Division.

Meanwhile, federal authorities were investigating the contamination and quality problems that led British regulators to shut down the Liverpool facility of Chiron Corp. of Emeryville, CA. Chiron had been expected to provide 46 million to 48 million doses, about half the American supply, but all shipments were halted as of Oct. 5.

In October, the mathematics of vaccine supply changed constantly. Aventis was able to increase its vaccine yield by 8 million doses, and MedImmune, which produces FluMist, the vaccine that uses the live attenuated virus, increased its supply by 2 million doses.

By December or January, the Food and Drug Administration (FDA) may arrange for the importation of "a very limited number of doses," or about a million, from foreign manufacturers under guidelines for investigational drugs, said Norman Baylor, PhD, acting deputy director and associate director for regulatory policy in the FDA’s Office of Vaccines Research Review in Rockville, MD. He spoke at a recent meeting of the Advisory Committee on Immunization Practices, a CDC expert panel.

The CDC maintains a stockpile of 4.5 million vaccine doses, which it will distribute to high-risk populations. the CDC also has a stockpile of Tamiflu and Rimantadine, antivirals that can be used as prophylaxis or to treat the flu.

Meanwhile, the CDC set priorities for the doses, including the Department of Defense, the Vaccines for Children program, the Department of Veterans Affairs medical centers, and long-term and acute-care facilities. All state health departments will receive at least half of the doses they had ordered from Chiron, said CDC director Julie L. Gerberding, MD, MPH.

"We’re doing our very best to get the product to the people who need it the most," she said.

For some hospitals, those words were hardly reassuring. Those who had ordered from Chiron engaged in a mad scramble to find available vaccine. For example, Baystate Health System in Springfield, MA, placed 90% of its order for 17,000 doses with Chiron, which meant it had 1,700 doses for patients, employees, and physician offices.

When the Chiron news broke, the three-hospital health system’s pharmacy director immediately began searching for supply. She found a distributor who offered vaccine at $26 a dose — far higher than the usual $8 to $10 per-dose cost. She checked with her vice president and got the go-ahead. But by the time she called back, the price had risen to $60 a dose.

"It raises tremendous questions about our public health system in this country and how well prepared we are to deal with something like this," says James Garb, MD, Baystate director of occupational health and safety.

The hospital locked up its available vaccine and began debating how to allocate the doses. Employees stopped Garb in the hallway, asking if they would be eligible to receive the vaccine. For example, one told Garb he was on a list for a lung transplant.

"If they’re not direct patient care providers, I apologize and tell them we’re not going to be able to provide it," he says.

In administering the vaccine, the hospital will have to balance between vulnerable patients and the health care workers who care for them. "The ethical dilemma is very tricky of how much you allocate to patients and how much you allocate to health care providers," he says. "I don’t believe there’s a right or wrong answer, and reasonable people can disagree on this issue."

Raymond Strikas, MD, a medical officer in the Immunization Services Division of CDC, emphasized in an Internet-based conference that protecting health care workers is an important part of protecting high-risk patients.

"In this shortage situation, vaccination of health care workers becomes even more critical," he said.

Paradoxically, many hospitals had geared up this fall to make a major push to promote flu vaccination among health care workers. Only about 38% of health care workers are vaccinated each year, according to the 2002 National Health Interview Survey. Strikas called that "a very sad statistic."

Greenville (SC) Memorial Hospital had planned to promote influenza vaccination heavily among its health care workers, as the hospital sought 100% vaccination. It could have proceeded; all its supply came from Aventis. However, the hospital plans to share some of its doses with area hospitals that ended up with none.

"We are limiting who gets it based on the CDC guidelines," says Connie Steed, RN, CIC, director of infection control. "We will be sharing some of it with other facilities and physician practices who were unfortunate enough to order from the company that has the problem. We feel very strongly that it’s the right thing to do for the community."

Only employees in direct patient care or who have risk factors will receive the vaccine, Steed says. That includes employees who transport patients, but not housekeeping, engineering, or dietary personnel.

"I am the director of infection control, and I will not be receiving flu vaccine because I do not have direct patient contact," she says. "Am I concerned about that? I am very willing to give up my vaccine to give it to someone who needs it more than I do."

The hospital also will emphasize other measures, such as hand hygiene and cough etiquette, and will urge employees not to come to work sick, she says.

Some states have developed health rules or orders to enforce the prioritization of vaccine. The commissioner of the Massachusetts Department of Public Health declared a public health emergency and mandated that health care providers limit flu vaccine to those in high-risk categories. Failure to do so could lead to fines from $50 to $200 and/or imprisonment of up to six months. Michigan, New Mexico, Oregon, Wisconsin, and Washington, DC, also have placed restrictions on administration of the available flu vaccine.

Wisconsin provided a definition of health care workers involved in direct patient care.

Unfortunately, the rationing effort is the opposite message public health authorities had hoped to present this fall. The National Foundation for Infectious Diseases set a goal of improving immunization among health care workers, as did the Association for Professionals in Infection Control and Epidemiology, based in Washington, DC.

"Hospitals are being asked to distinguish between health care workers who have direct patient contact and others," says William Schaffner, MD, who is on the board of the foundation. Schaffner also is chair of the department of preventive medicine at Vanderbilt University in Nashville, TN. "That’s a big step back for us because we were trying to get all health care workers to be vaccinated each autumn."

In fact, Schaffner’s facility found itself without flu vaccine because it had ordered from Chiron. A task force developed a strategic plan to give available vaccine to employees in the units with the greatest need, such as intensive care and the emergency department.

"It’s very difficult [to ration] in a large medical center, where we do have high-risk patients who could show up at any point in the system," says Melanie Swift, MD, medical director of Vanderbilt Occupational Health Clinic.

"We have to make a very thoughtful and deliberate decision about the highest risk areas and the essential services," she adds.

Few employee health professionals are thinking about next year’s flu season. But there were hints that the shortage might last longer than one year. "We will take all necessary actions to ensure an adequate supply for the 2005-2006 flu season and to resolve those issues with the regulatory authorities," Chiron president and CEO Howard Pien said at a press conference. But he acknowledged that a theoretical risk exists that the problem would not be fixed by late February or early March, when new strains are announced and flu vaccine production begins.

Editor’s note: More information about the flu vaccine shortage, priorities, and administration is available in a recorded Internet conference from the CDC at www.cdc.gov/nip/ed/ciinc/default.htm.)