Background and Rationale

    The National Childhood Vaccine Injury Act of 1986 (U.S. public law 99-660), which established the National Vaccine Injury Compensation Program (VICP), mandates that each health care provider administering vaccines covered by the act -- principally those recommended for children -- must record in the medical record the date, manufacturer, and lot number of the vaccine (Public Health Service Act, Title 42, Chapter 6A, Subchapter XIX, Part 2, subpart c).

    The task of manually transcribing vaccine identity, manufacturer name, and lot number is a burden on busy health-care providers with competing responsibilities and limited time.  It is a challenge to decipher the wide variety of hastily scribbled notations often used to identify vaccines.  Omitted or ambiguous data or erroneous transcriptions inevitably occur.

    One study by Wilson and Pennisi (Pediatrics 1994;94:902-906) evaluated the accuracy of computerized immunizations records transcribed from handwritten records of 2,098 children vaccinated at the UCLA Children's Health Center during a 12 month period. The overall transcription error rate was at least 10.2%. Moreover, it was found that 38.4% of the children who were determined from the records to be "underimmunized" had previously received undocumented immunizations from other providers. 

    Since actual vaccine lot numbers in circulation are proprietary information not available to CDC, "inaccurate" numbers were defined as those received in fewer than 5 reports from among the approximately 10,000 reports received each year.  (This may artifactually increase slightly the number of reports classified with inaccurate numbers for new lots that recently entered the market before the cutoff date of each time period.) 

    The listing in the illustration at the right (click to enlarge) represents the first 13 lot numbers output numerically from the database for a specific DT vaccine.  The lot number recorded most frequently (the mode), 0J21027, was accompanied by many similar ones with much rarer frequency, suggesting these numbers represent reading or transcription errors.  Among all 1585 immunizations with this DT vaccine, there were 13 lot numbers reported for more than 10 vaccinations each (n=1422), while 91 numbers were reported with 10 or fewer vaccinations each (n=163).  The latter 10 percent are presumed erroneous.

    In another analysis not shown here, Wyeth-Lederle furnished lot numbers for all their DTP vaccine in circulation; 19 percent of lot numbers recorded in the VSD database for this vaccine did not exist.

IMMUNIZATION REGISTRIES.    Immunization registries have an important role in improving the efficiency and impact of the immunization system.  Registries are usually located within or affiliated with state and local health departments, with financial and technical assistance from public health agencies and non-governmental organizations.  

    Registries keep track of the specific vaccinations received by individual children, while maintaining appropriate confidentiality.  Their two main purposes are (1) to provide proper follow-up reminders to parents when the next doses are due, and (2) to furnish accurate and timely information to authorized health care workers about the prior vaccinations received by new patients transferring into their care.  Such information can help avoid unnecessary extraimmunization.  Future roles may include furnishing parents with documentation of vaccinations received from scattered providers to satisfy school entry requirements, reporting and monitoring vaccine adverse events, and assessing immunization coverage.  

    Registries rely on the voluntary cooperation of vaccination providers in furnishing the necessary information.  Thus, improving the convenience of recording and transmitting such information may improve the rates of participation of providers in the system.

     VISI is a voluntary, cooperative effort among relevant and interested individuals and organizations which comprise the vaccine and immunization system. 

     VISI has focused on developing application guidelines and prototypes which fall into six major related components:

1. Peel-off stickers containing all essential information in English and barcoding affixed by manufacturers on their vaccine vials and prefilled syringes
2. Redundant full barcoding of essential information on outer cardboard packaging
3. Uniform vaccine administration record form to receive peel-off stickers
4. National Drug Code vaccine database on the web to identify vaccines from their NDC and vice versa
5. Vaccine Facts sidebar on outer cardboard packaging to standardize the format and location of key information needed by immunization providers
6. Standardized abbreviations for vaccine types and vaccine manufacturers and distributors