Pharmacists unsure of role in smallpox vaccination
Pharmacists unsure of role in smallpox vaccination
CDC concerned about adverse reaction screening
President Bush has announced a plan to vaccinate millions of Americans against the threat of an attack with smallpox virus. Many pharmacists, however, are not sure of their role in the plan, especially concerning how they should handle any adverse effects from the vaccine.
The first phase of the president’s plan includes vaccinating about 500,000 military and civilian personnel in late January who are or may be deployed in high-threat areas, as well as about 500,000 civilian health care and emergency workers. (These numbers may vary because some may choose not to be vaccinated.) In the second phase, up to 10 million "first responders," such as health care workers, police officers, firefighters, and emergency medical technicians, will be offered the vaccine. The government expects about half to end up being vaccinated. The public should be offered the vaccine at a later date on a volunteer basis.
This smallpox vaccination program is going to unfold under and through the authority of state health departments, explains Marguerite Neill, MD, associate professor of medicine at Brown University in Providence, RI, and chair of the bioterrorism work group at the Infectious Diseases Society of America in Alexandria, VA. State health departments must develop a vaccination plan that satisfies the framework of the Centers for Disease Control and Prevention (CDC) in Atlanta. For example, they must assure the CDC that the smallpox vaccine is locked up and secure, that the workers giving the vaccinations are trained, and that the health departments have around-the-clock medical coverage.
Once the CDC approves the states’ plans, it will send the states a shipment of the vaccine through the national pharmaceutical stockpile. "[The CDC] has the expectation that this is not a plan that is on paper; it is a plan that is ready to go." The state health departments also have to tell the CDC that they are ready to start vaccinating within 30 days of receipt of the vaccine, Neill says.
An overall script has been written for this plan, she continues. The states are given leeway to allow for variances such as size, medical population, and relationships among the hospitals. One state, for example, may vaccinate in the state’s clinic; another state may lease the space from an outpatient facility.
A major question about the smallpox vaccination plan is how state health departments will handle adverse events resulting from administration of the vaccine, which is made from a live virus. According to the CDC, historical data show that per million people vaccinated, there might be from 49 to more than 900 serious but not life-threatening events, 14-52 life-threatening adverse events, and one to two deaths.
The CDC promises to monitor the vaccination program closely, to accumulate information about the results, and to make this information available to clinicians and volunteers and then to the public. "We expect that the monitoring of the safety of this vaccine will be exemplary and that we will be taking measures far beyond those which would ordinarily be required for a vaccine program," says Julie Gerberding, MD, MPH, director of the CDC.
The CDC has developed software that states can use to keep track of the people they are vaccinating. "This software can be compiled centrally at the state or at the CDC, so that we can really do an overall job of comprehensively tracking people," Gerberding says.
If a serious adverse event occurs, the request for vaccinia immune globulin (VIG), the primary product available to treat complications of the smallpox vaccinia vaccination, must go through an undetermined triage screening process run by the states. VIG has previously only been available through the CDC under Investigational New Drug protocols. "As long as the patient met the criteria under its usage in the investigational new drug product form, the product would be released," says Inger Damon, MD, PhD, chief of the poxvirus section of the CDC.
Mechanisms are being put into place by which VIG will be available through a particular network so it can get to each of the sites in a timely manner, Neill says. "[The CDC] is probably going to have some regional stockpiles. There will be a control mechanism built into place."
Pharmacists may play a role in requesting VIG, says Mitchel C. Rothholz, RPh, vice president for professional practice for the American Pharmaceutical Association in Washington, DC. "It hasn’t been clearly stated how people will access it. Based on previous history, the pharmacies will probably be able to get it for physicians who need it."
This often has worked in the past, says John A. Becher, RPh, chief of the CDC Drug Service. "Requests for the vaccines and/or immune globulins and drugs have always come through the drug service, initiated by either the health care provider or by the pharmacist."
The president’s plan, however, dictates a large number of vaccinations, and Becher fears that some health care providers may have difficulty deciding which adverse effects are really serious and need VIG. "Normally, there are a lot of reactions with this vaccine. If you have a severe or moderately robust reaction, it looks pretty nasty," he says. If these people have intact immune systems, they should survive without their clinicians having to administer VIG. "We have to make sure practitioners and whoever requests it understands that releasing VIG won’t really be necessary [in those cases]."
Becher expects that his office will need some assistance in this process. "I have informed the Center that our office is limited and will probably be overwhelmed with the requests for immune globulin for just the screening."
As of late December, the screening process had yet to be set up. To find out the details as they become available, Rothholz advises pharmacists to be in contact with whoever is doing the planning for the smallpox administration clinics in their locality. "Talk to them about what the procedure is locally for getting the immune globulin. They may find that the CDC may be earmarking some for the coordinator."
President Bush has announced a plan to vaccinate millions of Americans against the threat of an attack with smallpox virus. Many pharmacists, however, are not sure of their role in the plan, especially concerning how they should handle any adverse effects from the vaccine.
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