HHS antiviral plan: 100 million regimens in U.S. hospitals
HHS antiviral plan: 100 million regimens in U.S. hospitals
Strategy includes prolonged prophylaxis, PEP
If hospitals nationwide followed draft recommendations to stockpile flu antivirals to protect health care workers against an influenza pandemic more than 100 million antiviral regimens would be required, according to the U.S. Department of Health and Human Services (HHS).1 Key portions of the HHS recommendations are summarized as follows:
- Antiviral drugs should be used as prophylaxis for the duration of community outbreaks for health care workers who have direct high-risk exposures to pandemic influenza patients and for frontline emergency services (e.g., law enforcement, fire, and emergency medical services personnel). Workers in these occupational settings will be exposed to persons with pandemic illness and be at increased risk of acquiring infection. Moreover, burdens on health care and emergency services will be increased in a pandemic and prophylaxis will reduce absenteeism due to illness as well as from fear of becoming infected while at work. Because exposures would be frequent and prophylaxis before exposure is likely to be most effective in reducing illness and absenteeism, outbreak (pre-exposure) prophylaxis is recommended rather than post-exposure prophylaxis (PEP).
- PEP is recommended for exposed persons in the health care and emergency services sectors who do not have regular contact with ill persons and are not receiving outbreak prophylaxis. Many workers in health care and emergency services are important to the delivery of those essential services but are not at high risk for exposure in the occupational setting. Examples might include kitchen and medical records staff at hospitals and 911 dispatchers for emergency response. PEP is recommended for these workers as this strategy requires fewer antiviral drug regimens compared with outbreak prophylaxis and is likely to provide sufficient protection for less exposed groups, the HHS states.
Of the approximate 13 million workers in the health care sector as defined by the Bureau of Labor Statistics, the HHS estimated that two-thirds of health care workers, or about 8.7 million, may have frequent high-risk exposures to pandemic flu. In addition, there are some 2 million people in the emergency services sectors, including medical services, fire service and law enforcement personnel. "The remaining 4.3 million health care sector workers would receive post-exposure prophylaxis when unprotected exposure occurs, estimated as four times during a 12-week community outbreak," the HHS calculated. "Based on these estimates, a total of 102.8 million antiviral regimens would be needed."
Other general recommendations in the guidelines include:
- Use antiviral drugs from the Strategic National Stockpile to support a multifaceted international containment response, if feasible, to slow the introduction of pandemic influenza into the United States, and to respond to the first cases that are introduced, if warranted based on the epidemiological situation.
- Recommended antiviral drug use strategies should be reconsidered at the time of a pandemic based on the epidemiology and impacts of the pandemic. Data collected during the pandemic may be critical for policy decisions. Preparation of protocols before a pandemic to facilitate rapid data collection would be useful. Data needs include:
- Attack rate of pandemic illness, case fatality rates, and identification of groups at high risk for severe morbidity and mortality.
- Susceptibility of the pandemic virus to antiviral drugs and monitoring data on the rate of antiviral resistance.
- Estimates of the effectiveness of treatment in preventing severe morbidity and death.
- Evaluation of increased treatment dose and/or duration, if appropriate, based on estimates of effectiveness of the standard regimen.
- Adverse event surveillance to identify unanticipated adverse events following antiviral treatment and prophylaxis — especially if prophylaxis is continued for longer than FDA-approved indications. Current adverse event surveillance systems such as MedWatch should be supplemented with more active approaches.
- If experience early during an influenza pandemic indicates that a treatment-focused strategy is not optimal because of biological (e.g., lower-than-anticipated antiviral treatment effectiveness), implementation (e.g., inability to deliver treatment early after illness onset), or behavioral (e.g., worker absenteeism due to fear of infection in the workplace) reasons, a mechanism needs to be in place to consider alternative strategies and provide national guidance. Advice from public health organizations, medical societies, and government advisory committees should be influential for decision making.
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