After big decisions, the devil in the details
Beyond the big questions of who and how many health care workers and first responders are going to be eventually vaccinated for smallpox, there are some nagging smaller questions that may actually be harder to answer. For example, are missed days of work due to vaccine reactions going to be covered under workers’ compensation programs? Who is going to be liable for serious adverse reactions and/or transmission to people contraindicated for the vaccine?
"All of these issues have to be addressed," says Audrey Crouch, RN, BSN, a first responder with the San Jose (CA) Fire Department. "Whatever entity decides that it is going to give [the vaccine], it is going to have to take the responsibility. Because if something happens, you know how people are. They want someone to blame. Even if you sign [consent] papers."
The consent process itself will be laborious, but tools must be developed for screening out those contraindicated for the vaccine, such as people with eczema or HIV.
"I’ve worked on consent forms, and I mean you can spend as long on a consent form as you have years to live," says William Bicknell, MD, PhD, professor of international health at Boston University. "You want to do that in advance and say here is the [pre-exposure] form for hospital workers, here is the form for the man in the street. Post-exposure, were not going to be quite so careful, but this all has to be thought through in advance. Thus far I have no evidence that [public health officials] are doing that."
In that regard, the Association for Professionals in Infection Control and Epidemiology (ACIP) and several other major infectious disease groups signed off on a letter to ACIP emphasizing that many issues will have to be considered, including:
• Indemnity
— Who will pay for complications?
— Should this be federal, state, local, or the responsibility of those accepting the vaccination via their usual health care resources addressed in their consent?
— Companies, governmental agencies, and individuals involved in providing and administering smallpox vaccine must not be subject to lawsuits due to reactions/ complications from vaccination unless recognized standards were not met.
— Would personnel administering smallpox vaccine be individually liable for adverse outcomes relevant to the vaccination? If so, up to what level? Will the Good Samaritan law be applied here? Liability should be worked out in advance and this information should be part of the written informed consent.
• Informed consent
— Acceptance of vaccination must be voluntary. Health care workers who decline vaccination must be required to sign a declination form.
— The document must be carefully worded to include description of the vaccination, care of the injection site, and complications, and define "at your own risk." The document must include identification of who will pay for potential adverse effects. Acknowledge that the form will vary based on the situation: pre-emergency or crisis.
• Screening/vaccine-related issues
— Health care provider’s occupational health function should include documentation of history of smallpox vaccination, history of any contraindications for vaccine, as well as a history of varicella immunization or disease.
— Simple, effective screening tool for high-risk indicators is necessary, if mass-vaccination programs are to occur.
— Will vaccine used be new stock or reserved stock that must be diluted? Who will be responsible for the dilution?
— What personal protective equipment is required for dilution and/or administration of smallpox vaccine?
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