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Smallpox vaccination policy: Part II--preparedness begins. (Health Policy Update).

To begin preparing the nation for a smallpox bioterrorist attack, President George W. Bush announced his plan to begin revaccinating the American people. Vaccination for the civilian population is voluntary while it is mandatory for selected members of the military. Bush also received the vaccine as Commander in Chief.

The civilian component of the plan as proposed has three phases.

1. Phase one consists of two categories of emergency teams: public health response and hospital response.

2. Phase two will include all health care and other emergency response workers.

3. Phase three will cover all Americans.

The president proposed that phase one, which started in January, is to be followed shortly by phase two. He did not recommend the initiation of phase three at this time although there is a provision to allow access to vaccine for citizens who demand receiving the vaccine under certain conditions. The military component of the phase one plan began immediately.

Pre-event vaccination

Phase one will include as many as 500,000 people and will use a fully licensed vaccine. The public health response teams are to be trained and prepared to respond 24/7 and would be available to go to the site where a suspected case of smallpox is located and make a definitive diagnosis.

The team would also be able to begin the disease containment process (vaccination and isolation) as well as the epidemiological investigation. These teams will include physicians, nurses, epidemiologists, laboratory personnel and support staff to include public safety and legal staff.

Hospital response teams would include up to 200 people and be composed of those whom the hospital felt it needed to provide initial diagnostic, clinical and health service support (e.g. dietary and laundry) pending prophylactic vaccination of the exposed and expanded staff.

This first phase also includes another 500,000 military members scheduled for deployment to the Persian Gulf.

While the administration is. not recommending vaccine be made available to the general public, they will allow individuals without clinical contraindications to receive the vaccine if they insist. The plans on how best to do this are unclear but one way for individuals to accomplish this is by participating in any of the vaccine research protocols currently underway.

The second phase includes up to 10 million health care workers and emergency responders. The purpose of vaccinating these workers is based on the prior experience that when secondary spread occurred, it was to other health care workers usually in hospitals. (1)

Phase three will include all Americans and is not recommended as a pre-attack strategy at this time. Decisions on whether to vaccinate all Americans as a pre-attack strategy requires: adequate stores of licensed vaccine (available in 2004), demonstrated acceptance of the risks of the vaccine by the public after phases one and two and/or a clear risk assessment that the return of smallpox is imminent.

National public health officials stress that there is enough vaccine available today should we need to vaccinate all Americans as an emergency measure.

Post-event vaccination

Should a case of smallpox occur, the plan is to utilize ring vaccination and other containment techniques as initial strategy followed by broader vaccination as necessary. This was effective during the smallpox eradication program and is generally viewed as an effective way to contain an outbreak.

Whether there will be a general demand for vaccination after an outbreak is unclear although state and local public health professionals are planning for mass vaccination clinics in order to be prepared to meet the demand.

Controversial issues

A recent poll funded by the Robert Wood Johnson Foundation showed that 65 percent of the public was willing to be vaccinated against smallpox despite the risks. In addition, 58 percent were somewhat worried or worried that terrorist would attack the United States using smallpox. (2)

Despite this apparent strong degree of support, the proposal leaves several unanswered questions that may alter public participation. Ensuring that the individuals that give the vaccine have adequate protection against potential legal action is an important requirement because of the incidence of complications associated with vaccinia vaccine. It is believed that as many as 15 out of every million individuals who receive the vaccine may have a serious complication and 1-2 of them may die.

In an attempt to address this concern, Congress added Section 304 to the recently passed legislation creating the new department of homeland security. This legislation allows a "covered person" to be considered an employee of the public health service if they administer a smallpox countermeasure.

A declaration from the secretary of the U.S. Department of Health and Human Services defines the period of protection and the covered countermeasure. This declaration triggers this liability protection for both manufactures and vaccinators. There are some concerns that this provision does not cover all potential situations and efforts are underway to find a legislative solution to these perceived loopholes.

About 41 million Americans have no health insurance and many more are underinsured. Many advocacy organizations are voicing concern over how both of these groups will receive care should the nation go to universal vaccination. This is probably a minor issue during phase one but will become an increasing concern during phase two and three.

Workman's compensation insurance will cover some workers who suffer injury from the vaccine and may mitigate the health insurance concern to some degree, but there are concerns that some insurers will not honor the coverage since the vaccination' program is voluntary. Public heath planners initiating such programs will need to get a firm decision on this aspect of worker protections as they implement this program.

Who pays the costs?

A larger concern is how to pay for the program beyond phase one. Vaccination costs for other vaccine programs costs about $10-$12 dollars per shot to actually deliver the vaccine. Total societal costs to include lost workdays, complications and other health care developments add additional costs to the proposal.

State and local governments received $1 billion dollars for public health preparedness. These dollars are appropriated to improve the public health infrastructure to ensure the capacity to respond to bioterrorist events for all hazards. Some of these dollars are being diverted to fund the smallpox vaccination program, but many feel this will make the nation vulnerable to attack with other agents. (3)

Other costs are both functional and financial. The national nursing and other staff shortages will require significant juggling of work schedules and other measures to avoid the exposure of high-risk patients.

The blood supply will also be affected as people who are vaccinated are prohibited from donating until the scab falls off which is between three and four weeks after vaccination. Health planners will have to address issues such as these as the program expands.

Ensuring quality

The U.S. Center for Disease Control and Prevention (CDC) has set up mechanisms to track adverse reactions and is working with state and local public health agencies to ensure the availability of expert consultation to help patients and providers sort through the various types of vaccine reactions.

The Institute of Medicine has also been asked by the CDC to review and make recommendations concerning outstanding clinical issues relating to the plans. These issues include: (4)

* Current guidelines and tools used to identify people at high risk of vaccine adverse events and complications

* Measures to ensure appropriate diagnosis and treatment of people with adverse events

* The adequacy of data collection plans

* The adequacy of the informed consent process

* Training and educational materials for professional

* Public and professional communication plans

* State smallpox implementation plans

* Achievement of the overall program goals

This process should provide an additional level of expert advice since many individuals believe the national experience will be quite different from the 1940s.

References

(1.) Benjamin, G., "Smallpox Vaccine Policy: The National Debate." The Physician Executive, American college of Physician Executives. Vol. 28, No 5, 2002.

(2.) Lake Snell Perry & Associates, Inc., Americans Speak Out On Bioterrorism and US. Preparedness to Address Risk. Robert Wood Johnson, 2002.

(3.) Hardy, G., Testimony by Association of State and Territorial Health officials to the Institute of Medicine committee on Smallpox Vaccination Program Implementation December 19, 2002.

(4.) Institute of Medicine, National Academy of Sciences, Statement of Tasks committee on Smallpox Vaccination Program Implementation December 2002.

RELATED ARTICLE: Benjamin Takes Reins At APHA

ACPE congratulates College member and longtime columnist Georges Benjamin on his new role as executive director of the 130-year-old American Public Health Association based in Washington, D.C.

Benjamin was chosen by the APHA board to be executive director for a three-year term following a nationwide search. He replaced Mohammad N. Akhter, MD, MPH, who stepped down after six years at the helm.

"APHA has found itself an outstanding new leader," Akhter said. "He has both the vision and experience to help the association succeed in its mission to promote and protect the health of the public."

Benjamin, a nationally known leader in public health, left his post as secretary of the Maryland Department of Health and Mental Hygiene at the end of 2002. In that job, he helped lead the public health preparedness efforts of the state while managing the core public health responsibilities of one of the state's largest agencies.

"In today's world, the public health community must be prepared for all hazards -from disease outbreaks to bioterrorism. Dr. Benjamin played a key role developing Maryland's bioterrorism plan," says said Sen. Barbara Mikulski (D-Md.). Benjamin has worked on issues such as emergency preparedness, West Nile virus and mental health care.

Benjamin is a graduate of the Illinois Institute of Technology and the University of Illinois College of Medicine. He is board-certified in internal medicine and is a fellow of the American College of Physicians.

APHA is the oldest and largest organization of public health professionals and represents more than 50,000 members from over 50 public health occupations.

Georges C. Benjamin, MD, FACP, is executive director of the American Public Health Association in Washington D.C. He can be reached by phone at (202) 777-2430 or by email to georges.benjamin@abha.org
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Author:Benjamin, Georges C.
Publication:Physician Executive
Geographic Code:1USA
Date:Mar 1, 2003
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