SAN FRANCISCO – If you're not providing parents a copy of a Vaccine Information Statement every time they accept or reject a child's immunization, you're not meeting your obligations under the National Vaccine Injury Compensation Program and could even be increasing your legal liability, Dr. Kristina Bryant advised.
The no-fault civil litigation system known as the National Vaccine Injury Compensation Program (NVICP) has benefited U.S. physicians since 1988 by reducing injury claims against vaccine manufacturers– and, the American Academy of Pediatrics (AAP) believes, against health care providers in addition, said Dr. Bryant, an assistant professor of pediatrics at the University of Louisville (Ky.).
If an injury that's listed in the program's Vaccine Injury Table occurs within a specified time after immunization, claimants must file for compensation through the NVICP to cover costs for medical care, pain, and suffering before pursuing a civil lawsuit.
The program streamlines reimbursement for claimants, and those claimants who receive awards cannot file a suit.
“We get some benefit from this, and we have responsibilities” for communication and documentation that are spelled out by the AAP and the Centers for Disease Control and Prevention, Dr. Bryant emphasized in speaking at the annual meeting of the AAP.
Discuss the benefits and risks of the vaccine being administered. “We want to make sure we have an open dialogue with our patients” about this, she said.
Note in the chart that you discussed these, she advised.
Give parents the current version of the Vaccine Information Statement each time you administer a covered vaccine. Handing it to them once and then making copies available in exam or waiting rooms during subsequent immunization visits is not enough.
The most current versions can be found at www.immunize.orgwww.cdc.gov/nip/publications/VIS/default.htm
Document in the patient's chart the date of vaccine administration, the vaccine manufacturer, the vaccine lot number, your name and business address, the date of the Vaccine Information Statement version, and the date you gave parents the statement.
An informal poll of the audience at Dr. Bryant's AAPmeeting presentation suggests that perhaps 25% of physicians do not document the version of the statement given to parents, and the date it is given to them.
If a parent refuses a child vaccination, discuss the risk that the child will pose to others and the risk of disease and potential death for the child, and document in the chart that you addressed these topics, Dr. Bryant said.
Requirements for obtaining informed consent vary by state, so be familiar with your state's regulations, she added.
Review the risks and benefits of vaccination at each encounter and provide a Vaccine Information Statement. At every refusal, ask the parent to sign the NVICP Refusal to Vaccinate form, which you can find at www.cispimmunize.org
On the second page of the form, parents attest that they have read the Vaccine Information Statement, have had the opportunity to discuss this with the child's doctor or nurse, and recognize that the child could contract the illness that the vaccine is meant to prevent, and could moreover face consequences such as pneumonia, need for hospitalization, brain damage, meningitis, or death.
Some antivaccine Web sites advise parents to cross out portions of the Refusal to Vaccinate form, or to write comments in the margins about points of disagreement. Some parents even refuse to sign the form.
With the latter, document that you've shown them the form and discussed risks and benefits, and that they refused to sign, Dr. Bryant said.
A physician in the audience said that many pediatricians in his area have gone along with insurance carrier demands that patients who don't want to be vaccinated be asked to leave a physician's practice.
The AAP, however, urges physicians to avoid discharging vaccine refusers if possible, Dr. Bryant noted, while acknowledging that a lack of trust between parent and physician in some situations will lead to discharges.
Dr. Bryant is associated with several companies that make vaccines. She is on the speakers bureaus of Sanofi Pasteur and Abbott Laboratories, and she has received research funds from Merck & Co., MedImmune, Wyeth Pharmaceuticals, and GlaxoSmithKline.