Volume: 28S6 • December 2002

Functional Standards and Minimum (Core)
Data Sets for a
National Immunization Registry Network
and
Vaccine Associated Adverse Events
Surveillance System

Health Canada
Centre for Infectious Disease Prevention and Control
Bureau of Infectious Diseases*

* Now the Health Care Acquired Infections Division, Blood-borne Pathogens Section.

Functional Standards and Minimum (Core) Data Sets for a National Immunization Registry Network and Vaccine Associated Adverse Events Surveillance System
38 Pages - 103 KB in PDF Format

Table of Contents |Background|

Background

In 1996, at the Canadian Immunization Conference, it was recommended that

An immunization tracking system is urgently needed in Canada to identify children due or overdue for immunization, to notify parents, to make appointments, to provide a database for health care providers to monitor the immunization of patients at each encounter regardless of where the vaccine was administered, to assist in planning and identifying populations at risk for delayed immunization, to target interventions appropriately, and to evaluate the success of the program. In provinces where physicians deliver the bulk of immunization, tracking systems adapted for practice, as well as for public health needs, must be developed. The positive exchange of ideas between conference participants suggests that the time has arrived for a national program to be administered provincially, thus ensuring compatibility between provinces so that this health care information can be accessed when needed.

As a follow-up to these recommendations, Health Canada convened the Canadian Consensus Conference on a National Immunization Records System, held in March 1998. It was at this conference that the goal for a National Immunization Records Network* was developed:

Immunization registries will facilitate the control and elimination of vaccine preventable diseases in Canada by ensuring the provision of information and knowledge necessary to achieve the best possible immunization coverage for Canadians¹.

In 1998, Health Canada created the National Working Group for an Immunization Records Network (NWGIRN) and charged the group with the responsibility of overseeing the implementation of the recommendations from the 1998 Consensus Conference. The working group has representation from key stakeholders, including governments, health care providers, and nongovernmental organizations with an interest in immunization. The terms of reference are as follows:

• To monitor the implementation of immunization registries in Canada;
  
  
• To provide advice to Health Canada, provincial and territorial governments, and providers of health services to other groups to assist them with the establishment and operation of immunization registries;
  
  
• To recommend standards and guidelines, and describe best practices for immunization registries in Canada;
  
  
• To provide a forum for exchange of ideas and information about immunization registries;
  
  
• To create sub-committees as necessary to address issues requiring special expertise; and
  
  
• To provide regular updates to stakeholders regarding progress towards a national immunization registry in Canada.

Sub-committees on Data and Technical Standards

In order to meet the timeframe of development of a National Immunization Registry Network by the year 2003, the NWGIRN created sub-committees to focus on the implementation of the Consensus Conference recommendations. A work plan was developed to ensure that necessary tasks were completed in an orderly and timely fashion. One of the tasks identified in the work plan was the development of national standards, to include the following:

1. A minimum (core) data set for immunization registries;

2. Common data definitions for the elements identified in the minimum data set;

3. System compatibility standards (to ensure that computerized registries in different jurisdictions are capable of sharing data with each other);

4. An individual immunization message (the standard electronic record to be shared between provinces/territories).

Development of data and technical standards was not limited to immunization. As the link to the Vaccine Associated Adverse Events Surveillance System (VAAESS) would benefit both providers of immunization and those in population health who require the information for surveillance, the decision to combine efforts was inevitable.

Vaccine Safety

In 1965, the VAAESS was developed to maintain public confidence in vaccines and immunization programs.

The cornerstone of the VAAESS is a voluntary system in which health care professionals (mainly public health nurses and physicians) report to local, provincial and/or territorial public health authorities events that they feel were temporally associated with administration of a vaccine. These authorities, as well as vaccine manufacturers and occasionally other agencies that receive information, forward all such reports for aggregation at a national level to the Immunization and Respiratory Infections Division of the Centre for Infectious Disease Prevention and Control, Health Canada. About 95% of the reports come from health care professionals and 5% from industry.

The reports are collected in a computerized database. The data collected include epidemiologic and medical information on the reported events. To calculate adverse event rates, the Immunization and Respiratory Infections Division obtains lot-specific data from vaccine manufacturers on the number of doses of their products distributed across the country. These “vaccine distribution” data are used as an approximation of the actual number of doses of vaccine administered. However, because of varying reporting practices, differences in lot-specific adverse event rates require cautious interpretation. Although these denominator data are limited in reliability, they are very useful in risk assessment. Further estimates of denominator data are btained from vaccine coverage studies. The following are the proceedings from NWOGIRN sub-committee meetings held to establish the functional standards and minimum (core) data sets for immunization registries and the VAAESS. These meetings fulfilled the first three recommended tasks of the work plan and established the foundation for a National Immunization Registry Network.

Functional Standards and Minimum (Core) Data Sets for a National Immunization Registry Network and Vaccine Associated Adverse Events Surveillance System
38 Pages - 242 KB in PDF Format