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PEDIATRICIANS AND THE LAW

Doctor, do you know what a VIS is?

Providing Vaccine Information Statements is good risk management, good medicine

It has been 20 years since Congress enacted the National Childhood Vaccine Injury Act (NCVIA) of 1986 and 18 years since the National Vaccine Injury Compensation Program (VICP) was enacted, yet many pediatricians still fall short when it comes to meeting their obligations under the program.

Dr. Marcus

For some, the stumbling block is a piece of paper — the Vaccine Information Statement (VIS). Following are answers to some frequently asked questions regarding VISs.

What is a VIS?

The Centers for Disease Control and Prevention (CDC) produces VISs to inform patients and their legal representatives of the benefits and risks of vaccines that are going to be administered. Under the amended NCVIA, VISs for vaccines covered by the VICP must be given out each time a vaccine is administered to a child or an adult whether the vaccine is administered by a public or private physician and regardless of the funding source.

Pediatricians need to be sure the VIS used is the current version. The newest version must be used as soon as possible after the published date as it may contain new and valuable information. If the patient or his or her parent or legal representative is unable to read or is limited by a physical disability, the VIS must be supplemented by visual aids or oral presentation.

Which vaccines are covered by the VICP?

As of Sept. 30, 2006, the following vaccines are included in the VICP and all have up-to-date information on the handout sheets: diphtheria, tetanus, pertussis (DTP, DTaP, Tdap, DT, TT or Td), measles, mumps, rubella (MMR or any components), polio (OPV or IPV), hepatitis A (HAV), hepatitis B (HBV), Haemophilus influenzae type b (Hib), varicella (VZV), rotavirus (RV), pneumococcal conjugate (PCV) and trivalent influenza (TIV, LAIV) vaccines.

Where can I obtain copies of the forms?

The current version of each VIS can be downloaded from the CDC Web site, www.cdc.gov/nip, and also should be available from state health departments. Hard copies can be ordered at www.cdc.gov/nip/publications or by calling 800-CDC-INFO (1-800-232-4636). The VISs are available in 30 languages and can be downloaded from the Immunization Action Coalition Web site, www.immunize.org/vis/#index.

Am I required to use VISs for vaccines not covered under the VICP?

VISs are available for the following vaccines: pneumococcal polysaccharide, meningococcal, rabies, yellow fever, typhoid, Japanese encephalitis, anthrax and smallpox. Interim VISs are available for the newly licensed zoster (shingles) and human papillomavirus vaccines.

Since these vaccines are not covered by the VICP, providing a VIS would be mandated only if they were purchased as part of a CDC contract (i.e., Vaccines for Children program, state immunization grants or state purchases through the CDC). Because VISs are excellent risk communication tools, it would be prudent to use them when administering these vaccines.

Does providing a VIS imply informed consent?

VISs were created to comply with the NCVIA mandate to provide information to the patient. There is no federal requirement to have informed consent when administering a vaccine. Yet physicians have an ethical obligation to inform parents of the risks and benefits of immunizations and seek their consent or permission for immunizing their children. Check with your state to see if there are more stringent vaccine consent laws and whether parental signatures are necessary.

The VIS must not be altered nor can you substitute them with your own VIS handouts. The standard form provided by the CDC must be used. Your name and address (as the vaccine provider) can be added, but no other changes should be made.

What must be documented?

Under the VICP, vaccine administrators are required to document the following information in the patient's medical record:

• VIS edition date;
  
• date the vaccine was administered and date the VIS was given;
  
• name, address and title of vaccine administrator; and
  
• vaccine manufacturer and vaccine lot number.
  

The Vaccine Administration Record provides a space for recording parental signatures for immunizations, if required by state law. It is available for purchase from the AAP Bookstore, www.aap.org/bst/showdetl.cfm?&DID=15&Product_ID=1234.

How well do pediatricians comply with the VICP?

According to AAP Periodic Survey of Fellows #48, six out of 10 pediatricians report distributing a VIS with every dose of each vaccine, about one-fourth do so with the first dose only, about 10% sometimes do so and fewer than 6% say they never distribute a VIS.

More than half of pediatricians say they document the provision of a VIS at every dose and about 11% do so at the first dose only. While about 16% sometimes document provision of a VIS, nearly 20% say they never do so. There seems to be room for improvement.

Periodic Survey of Fellows #48 was a self-administered survey mailed to a random sample of 1,622 active AAP members in the United States in 2001. Response rate was 64%.

The VIS is more than a piece of paper or a symbol of government regulation. It is physicians' duty to inform their patients of the risks and benefits of every test or treatment they advise patients to have. Immunizations are the cornerstone of pediatric preventive medicine. The VISs have been developed to help physicians communicate essential facts that patients or their parents are required to have to make appropriate health care decisions.

Risk communication can be difficult and challenging with certain parents. Many pediatricians find the Red Book's discussion of vaccine risk communication helpful. (See Section 1 under "Parental Misconceptions About Immunizations.")

Here is an easy way to remember your responsibilities as a vaccine administrator every time you give a VICP-covered vaccine: Discuss risk communication, distribute the most current version of the VIS, document appropriate aspects of the immunization process and dialogue with vaccine-hesitant parents.

That's not just good risk management, it's good medicine, too.

Dr. Marcus is a member of the AAP Committee on Medical Liability and Risk Management.

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