HHS draft: Hospitals must purchase antivirals for pandemic influenza

Draft recs would place new prophylaxis burden on hospitals

Hospitals need to make a huge new investment in antiviral medications to protect their workers from pandemic influenza, according to new draft recommendations from the U.S. Department of Health and Human Services. Prophylaxis could cost an individual hospital more than $125,000.

In a proposed major shift in strategy, federal public health authorities are recommending the use of antiviral medications for prophylaxis of workers "in the health care sector who have significant patient exposure and therefore increased risk of becoming ill and increased risk of transmitting illness to patients or, in long-term care settings, to residents," says Ben Schwartz, MD, senior science adviser in the National Vaccine Program Office.

"If [hospitals] prophylax for the entire duration that pandemic influenza is in your community, it may take up to eight regimens, which would be 12 weeks," he explains. A regimen is 10 doses.

Providing prophylaxis to the workers at highest risk — those in the ED and cohorted flu treatment units — may be essential to maintaining the work force, says Eric Toner, MD, senior associate with the Center for Biosecurity of the University of Pittsburgh Medical Center." It's likely you're not going to get people to work in those units if you don't provide them with prophylaxis," he says.

Yet the logistics are daunting. Tamiflu has a shelf life of five years. "It's a lot of money to invest if nothing happens," concedes Toner. "Hospitals that have little money to spend are going to take a lot of convincing to spend it on this."

Toner has estimated that it will cost a 164-bed hospital about $1 million to prepare for a severe (1918-like) pandemic by drafting a pandemic plan, educating staff, and purchasing basic supplies and personal protective equipment.1

The additional cost of providing prophylaxis to frontline workers for eight weeks would be about $125,000 to $250,000 "depending on the severity of the outbreak, the cost of the Tamiflu and the percentage of health care workers involved in the care of flu patients," Toner estimates.

Currently, the federal government is stockpiling 50 million doses of antiviral medications and has asked states to stockpile another 31 million to treat patients during a pandemic. States have made variable progress in stockpiling their portion, says Schwartz.

Yet hospitals will be largely responsible for the antivirals needed for prophylaxis. Nationally, providing prophylaxis for health care workers at risk of exposure would require a vaccine purchase as large as the target national stockpile — or another 81 million doses. HHS also is recommending post-exposure prophylaxis of household contacts of those who become ill — a tripling of the demand for antivirals, which would require yet another 80 million doses.

Based on federally negotiated prices for the antiviral medications of $18.81 per treatment course for Tamiflu (oseltamivir), which may be lower than prices available to hospitals, the doses would cost the nation's hospitals about $1.5 billion.

Can hospitals afford that tab? "When you look at the cost of the antiviral drugs as a fraction of a hospital's total pharmacy budget, it would be very small," says Schwartz.

The proposed emphasis on antivirals for prophylaxis already has gained some traction. The Healthcare Infection Control Practices Advisory Committee, an expert panel that advises the Centers for Disease Control and Prevention in Atlanta, endorsed the recommendation in a November vote.

Four 'partially effective' strategies

This new strategy places a greater emphasis on the use of antivirals to prevent the spread of pandemic influenza. Protecting health care workers will require the use of four "partially effective" measures, says Schwartz.

"The concept of our pandemic response is layered protection," he says. "It may include pre-pandemic vaccine, which we are stockpiling. Pre-pandemic vaccine is likely not to perfectly match the pandemic virus, and therefore will provide [only] partial protection."

Personal protective equipment, including respirators, gowns, and gloves that would be stockpiled by hospitals, provides another layer of protection "but is not perfect," Schwartz says. The experience of severe acute respiratory syndrome (SARS) in Toronto showed inconsistencies in the use of personal protective equipment, he notes. And some health care workers became ill despite the use of PPE.

Hospitals also may alter work practices to limit the number of workers who are exposed to infected patients.

Prophylaxis with antiviral drugs would be the fourth strategy. "I think antiviral drugs are particularly important because they have been shown to be 70%-90% effective [in prophylaxis] with seasonal influenza and they've been shown to be effective with H5N1 [the avian influenza strain that has infected several hundred people worldwide].

"In our planning, I think it's important that we plan to provide as many of these layers of protection as we can," Schwartz says.

Some hospitals have stockpiled antiviral medications as part of pandemic influenza preparedness. In fact, the HHS Hospital Preparedness Checklist for pandemic influenza advises hospitals to set priorities for vaccine and prophylactic antiviral medications.

Reference

1. Toner E, Waldhorn R, Maldin B, et al. Hospital preparedness for pandemic influenza. Biosecur Bioterror 2006; 4:207-217.