Pandemic fears raise stakes for hospital administrators

Supplies to protect HCWs may become scarce

For hospitals that want to create their own stockpile of Tamiflu as a part of pandemic influenza preparedness, infectious disease expert Michael Osterholm, PhD, MPH, has one comment: "Good luck."

Worldwide demand for Tamiflu, or oseltamivir, has swamped supply, which presents just a hint of the challenges that may lie ahead for hospitals when they actually need to treat patients and health care workers during a pandemic influenza outbreak. Similar supply issues will arise when a vaccine is developed to protect against H5N1, the avian influenza strain that is spreading throughout Asia.

Amid those concerns, hospitals are being urged to develop contingency plans and to work with state and local health departments on pandemic planning.

"In the next three to four months, we're going to see runs on Tamiflu and [N95 respirator] masks in that they will completely exhaust supply," predicts Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis. "We've seen this coming for months. It's really unfortunate."

A Roche pharmaceutical division spokesman told Hospital Employee Health that Tamiflu orders are being filled on schedule.

The prospects of a pandemic from H5N1 continue to rise with reports from Russia that avian influenza has been detected as far west as Siberia. Between mid-December 2004 and mid-August, 68 people contracted H5N1 influenza and 25 died, most of them in Vietnam, according to the World Health Organization (WHO).

A vaccine against H5N1 has shown promising results in a study of healthy adults. It may become an important tool to protect health care workers and to prepare for a pandemic, influenza experts say.

"Clearly, there needs to be aggressive efforts to maximize the availability of these critical interventions," says Frederick Hayden, MD, professor of internal medicine at the University of Virginia Health Sciences Center in Charlottesville. He also has consulted with the WHO.

The Department of Health and Human Services was completing work on a detailed pandemic influenza preparedness plan as Hospital Employee Health went to press. Hospitals and state and local health departments already were well under way with their own plans.

"I'm hoping that people take this seriously," says Marion Kainer, MD, MPH, infectious disease physician and medical epidemiologist with the Tennessee Department of Health in Nashville.

"It's my opinion this is the one thing we definitely need to prepare for; it's a question not of if, it's a question of when this is going to happen. The consequences are enormous in terms of mortality, morbidity, and economic costs," she notes.

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires hospitals to conduct a "hazard vulnerability analysis" to determine what stresses the hospital might face in an infectious disease outbreak. For example, BJC Healthcare in St. Louis conducted a mass vaccination drill as part of a bioterrorism exercise.

JCAHO began debriefing hospitals after disasters even before the Sept. 11 tragedy to find out what issues they faced and what lessons could be learned, says Robert Wise, MD, vice president of JCAHO's Division of Standards and Survey Methods.

One conclusion: Disaster drills are not as effective as they should be, he adds. The Joint Commission will be revising its standard and raising expectations on how drills should be conducted, Wise continues.

The Joint Commission's infection control standard requires hospitals to have a process for responding to a large influx of patients. Hospitals need to assume that ambulatory care providers will be overwhelmed during a pandemic and may simply send people to the hospital, he explains.

"If the doctors are no longer there, all these people start coming to the hospital," Wise says. "At a time when sick people are coming to the hospital because they have flu, you have other people who are needing help with diabetes, high blood pressure, and on and on.

"It's a cascading of the pressures on the hospital," he adds. "Pandemic flu will bring out stresses on the system that it's very difficult to model ahead of time."

Pandemic influenza is especially difficult because other communities throughout the world will be facing the same crises and competing for scarce resources, Wise says.

"The issue of preparedness for a pandemic is probably the most complex of all the emergencies this country is going to have to face," he notes.

You can count on staffing to be an issue during a pandemic. During the severe acute respiratory syndrome (SARS) outbreak in Toronto, some health care workers were afraid to come to work.

"It's not clear at all whether you're going to get 70% of your staff or 30% of your staff," Wise explains.

Hospitals should think about how they will obtain additional staff, perhaps by calling retired or semiretired health care workers into duty, Kainer says.

"They have to ensure they can get sufficient staff and not rely on the same staff everybody else is relying on," she says.

When health care workers report for work during a pandemic, they're going to expect protective gear, and hospitals will find there is little surge capacity for those products, Osterholm warns.

"I think health care workers are going to be a very difficult area to address without some type of primary protection, either a vaccine, neuraminidase inhibitor, or a [N95] mask," he says. "And we're going to be short of all three. We'll very quickly exhaust the ability to find masks.

"There are many health care workers who, in the absence of the vaccine or potential drug treatment, are going to demand a very high level of protection to — day in and day out — be on the front lines," Osterholm continues.

Although a recent study of oseltamivir showed promising results, the study involved prophylactic use, he notes. The mice in the study received an initial dose of the antiviral medication before being inoculated with H5N1. Oseltamivir then was given in varying doses, with higher doses providing improved survival rates.1

Hospitals should draft plans to prioritize the use of available antiviral medications and/or vaccines during a pandemic, based on the Centers for Disease Control and Prevention (CDC) recommendations, Kainer says. CDC advisory panels have designated that health care workers involved in direct patient care will be the top priority for vaccination in a pandemic and the second-highest priority for antiviral treatment.

Hospitals also will need a greater supply of gowns, gloves, surgical masks, and if a vaccine is available, syringes, Kainer notes.

Building a stockpile

Some hospitals already have begun to slowly increase their storage of Tamiflu. Hayden, at the University of Virginia, began advocating stockpiling of Tamiflu a year ago.

At least five European countries are developing stockpiles of antiviral medications to treat 20% to 40% of their population. The federal stockpile currently is 2 million courses of treatment. Mike Leavitt, Health and Human Services secretary, said that will rise to 20 million doses within about four to six months, the Associated Press reported. Even that would cover less than 10% of the U.S. population.

"In the short term, I do think that because of the pace of federal decision making and the timing of getting access to drug, it makes sense for institutions to evaluate their own approach to pandemic preparation and seriously consider having an institutional stockpile they can call upon," Hayden says.

Hospitals need a plan for maintaining and using a stockpile, notes Roche spokesman Terry Hurley.

"Proper storage would be important for maintaining a hospital stockpile, as would plans for utilization and distribution," he says. "[The] best experience for hospitals would be interpandemic use — in other words, use during the flu season to become familiar with the product. We expect to have adequate supply of Tamiflu for the upcoming flu season."

Roche, which markets and manufactures Tamiflu, also is responding to the surge in demand, Hurley explains.

"To achieve levels of production needed for stockpiling, Roche has doubled production capacity at our European facility from 2003 to 2004, and we are doing so again during 2005. We plan additional expansion of production capacity for Tamiflu in 2006," he says.

Hospitals also can play a role in enhancing the potential for vaccine use during a pandemic by raising the annual rates of health care workers' immunization, says Tammy Lundstrom, MD, JD, senior vice president and chief quality and safety officer at Detroit Medical Center.

Having an influenza vaccine should become a habit for health care workers, she says.

Organizing a mass vaccination clinic "gives you a way to test out a plan [that could be used] in an avian influenza outbreak," Lundstrom adds.

Reference

1. Yen H, Monto AS, Webster RG, et al. Virulence may determine the necessary duration and dosage of oseltamivir treatment for highly pathogenic A/Vietnam/1203/04 influenza virus in mice. J Infect Dis 2005; 192:665-672.