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PreambleOver the past several years, the Advisory Committee on Population Health and Health Security (ACPHHS) has supported development of a national approach to addressing immunization issues in Canada. During this period, numerous meetings and consultations with federal, provincial, and territorial (F/P/T) public health representatives and other relevant stakeholders were undertaken to identify and develop collaborative approaches to strengthening immunization in Canada. The value of this collaborative work was reflected in the February 2003 First Ministers' Accord on Health Care Renewal, which included direction to Health Ministers to continue their pursuit of a national immunization strategy. The 2003 Federal Budget provided $45 million over five years to assist in the continued pursuit of a national immunization strategy, as directed by First Ministers. Specifically, Health Canada is to receive $5 million in 2003-04 and $10 million in 2004-05 and ongoing. This funding will enable strengthened collaboration with the provinces, territories and key stakeholders to improve the effectiveness and efficiency of immunization programs in Canada, but will not be used for vaccine procurement. The "Final Report: National Immunization Strategy," describes the key components and supporting activities associated with a national immunization strategy in Canada. In June 2003, the Conference of F/P/T Deputy Ministers of Health accepted this document as advice in moving forward with immunization issues in Canada. It was recognized, however, that not all jurisdictions would have the necessary funding available to implement the approach outlined in this document, particularly as it relates to the collaborative purchase of new vaccines. To continue working towards a national immunization strategy, Health Canada will facilitate ongoing discussions with the provinces, territories and key stakeholders. As part of this process, immunization programming activities at Health Canada will be expanded or developed, such as enhancing surveillance of vaccine-associated adverse events and vaccine-preventable diseases, coordinating common approaches to immunization registries, enhancing F/P/T vaccine procurement processes, strengthening immunization research activities, developing approaches to special populations, and public and professional education. Continued discussion with federal, provincial and territorial public health representatives to address current and future immunization issues will contribute to pursuing a national immunization strategy. Provinces and territories will continue to be responsible for planning, funding, and delivering immunization programs to their respective populations and to contribute to the shared activities that support a national immunization strategy. Executive SummaryThe development of a national immunization strategy (NIS) was first endorsed by the F/P/T Deputy Ministers of Health (CDMH) in June 1999. In June 2001, the CDMH approved the development of an NIS, with the following five components:
The purpose of this paper is to present a final report on a comprehensive strategy to address immunization issues in Canada. The development of this strategy has been conducted through the Federal Provincial/Territorial (F/P/T) Advisory Committee on Population Health and Health Security (ACPHHS). In developing the strategy, input was received from various officials, experts, and stakeholders across Canada, including provincial and territorial jurisdictions, Health Canada, the Council of Chief Medical Officers of Health (CCMOH), the Canadian Institutes of Health Research (CIHR), the Canadian Paediatric Society (CPS), the Canadian Immunization Awareness Program (CIAP), vaccine manufacturers, and others. The strategy has been designed to address a number of challenges to immunization, which are currently being faced by all jurisdictions in Canada. For instance, expensive new vaccines will be coming onto the Canadian market in both the immediate and long-term horizon, and decisions will be required regarding their use in publicly-funded vaccine programs. In addition, provincial/territorial (P/T) vaccine expenditures have been increasing substantially in recent years (due to both the introduction of new vaccines and escalating prices of existing vaccines) and concerns have been raised regarding security of supply, particularly given the supply shortages recently experienced in the United States. Public attitudes about immunization, which can include complacency, concerns regarding vaccine safety, and fear of outbreaks, are also important considerations. These issues and challenges reinforce the need for national collaboration. A national strategy is a means for F/P/T jurisdictions to work in partnership to improve the effectiveness and efficiency of immunization programs in Canada. The benefits of strengthening collaboration are anticipated to include the following:
The specific objectives and activities to be addressed by each component of the strategy are listed below: National goals and objectives - to reduce vaccine preventable diseases and improve vaccine coverage rates by developing national goals and objectives for immunization programs, leading to recommendations for endorsement by all F/P/T governments, where appropriate. Immunization program planning - to reduce duplication of effort, improve access to vaccines, and facilitate policy analysis of new vaccines, through national collaboration on the assessment and prioritization of new vaccines using common criteria. Vaccine safety - to improve vaccine safety monitoring and public health response, by setting up a network of F/P/T vaccine safety contacts in all jurisdictions, establishing a clinical assessment/ referral system, and addressing potential vaccine safety issues (e.g., through improved data analysis, feedback/ risk communication, and development of national guidelines). Vaccine procurement - to achieve best value for vaccines, long-term security of supply, quality of supply, and improved accountability, by making enhancements to the existing F/P/T procurement process, such as use of multi-year contracts, inclusion of value-added products/services as part of procurement process, collaboration with the vaccine regulator to ensure timely communication, and improvements in the administrative processes. Immunization registry network - to improve national surveillance and the transfer of (and access to) individual immunization records, by establishing and maintaining a comprehensive, compatible national immunization registry network, with a core data set and minimum standards. In addition, there are a number of activities which cut across, and support, the five components of the strategy. These are: immunization research, public and professional education, approaches to special populations and vaccine preventable disease surveillance. A. IntroductionImmunization programs have had a major impact on the health status of the population, as many diseases are prevented through immunization. Since the introduction of mass immunization efforts, infectious diseases which used to be common, are now rare. For instance, smallpox was globally eradicated in 1977 and paralytic poliomyelitis was eliminated from the western hemisphere in 1994, as a result of immunization1. Such immunization programs resulted in substantial savings to the health system and improvements in length and quality of life. Newer immunization programs, where cost savings can be more difficult to demonstrate, still remain among the most cost effective (cost per life saved and/or serious disability prevented) interventions available2, and the net benefit to society in terms of wellness and disease prevention is substantial. In Canada, immunization is a shared responsibility between federal, provincial and territorial governments. Nevertheless, national collaboration on immunization issues could be improved in the current system. The large majority of costs are borne by the provinces and territories, as each province and territory plans, funds, and delivers their respective immunization programs to their populations. In planning their immunization programs, provinces and territories adjust their recommended schedules and selection of vaccines based on the National Advisory Committee on Immunization (NACI) or other expert advisory committee recommendations, as well as on local epidemiological, program, and financial considerations3. Unlike Canada, other countries (United States4, Australia5 and the United Kingdom6) have structures with central mechanisms for immunization planning and funding which contribute significantly to the quality of the overall immunization program, including the procurement process. Canada would benefit from a national mechanism to move from discussion and recommendations to national collaboration and coordinated provincial/ territorial policy decisions within a comprehensive national plan. Such a mechanism would support the following:
The proposed goals of a national immunization strategy (NIS) are to
This strategy has been designed so that all five components and related support activities are interconnected and work together to achieve these goals. B. Description of Each Strategy ComponentA summary of each component of the NIS is provided below. For each NIS component, objectives of that component will be outlined, followed by a description of the existing system as it relates to that component, a summary of the gaps and limitations of the existing system, and an overview of the proposed approach. B.1 National Goals and Objectivesa) ObjectivesThe purpose of having national goals and objectives for immunization programs would be to support the following:
b) Existing SystemIn the current system, national goals and objectives for immunization have been developed by Health Canada-sponsored "consensus conferences", with broad stakeholder participation, including representation from each province and territory. National goals and objectives have been developed for many vaccine preventable diseases, including poliomyelitis, measles, mumps, rubella and congenital rubella syndrome, tetanus, diphtheria, pertussis, invasive Haemophilus influenzae type b (Hib) infections, and hepatitis B. These goals involve either achieving or maintaining the elimination of disease (e.g., polio), or reducing morbidity and mortality (e.g., pertussis), as well as identifying proper handling of vaccines and good delivery programs7. At this time, the national goal to eliminate measles by the year 2005 is the only national goal which has been endorsed by the Conference of F/P/T Deputy Ministers of Health. c) Gaps/Limitations of Existing SystemWithout the official F/P/T endorsement of national goals and objectives, their full integration into immunization program planning and delivery efforts, and associated effects on vaccine coverage and disease rates, may not be maximized. Furthermore, Canada's ability to commit and contribute to international health initiatives could be improved if we had a mechanism to effectively endorse recommended national goals and objectives. As an example, in 1990, Canada, along with 70 other countries, participated in the World Summit for Children at the United Nations, and was a signatory to a declaration establishing a number of child health goals with respect to disease reduction or elimination and immunization coverage. One such goal was to reduce measles cases by 90% (compared to pre-immunization levels) by 1995, as a major step towards the global eradication of measles in the long term8. As described in the 1996 Canadian National Report on Immunization3, "in 1995, with only 3.6% of the population in the Americas, Canada accounted for 40% of all reported cases of measles and nearly 80% of all confirmed cases." That same year, the Conference of federal, provincial, and territorial (F/P/T) Deputy Ministers of Health (CDMH) endorsed the national goal of eliminating measles by 2005, which was subsequently endorsed by the F/P/T Ministers of Health. National data show that the number of measles cases decreased from 523 cases in 19949 to 7 cases in 2002 (Dr. P. Varughese, Centre for Infectious Disease Prevention and Control, Ottawa: personal communication, 2003). Despite this success, measles elimination is the only national goal which has been officially endorsed. d) Proposed ApproachThe long-term vision of this component of the NIS is to develop national goals and objectives for immunization, and the recommendation of these national goals and objectives for endorsement by all F/P/T governments, where appropriate. B.2 Immunization Program Planninga) ObjectivesImmunization program planning is a key component of the proposed National Immunization Strategy. The goal of this NIS component is to support collaborative, national assessment and prioritization of new vaccines, using common criteria. b) Existing SystemCurrently, immunization programs are planned and delivered primarily at the provincial/territorial level, so decisions are independently taken by 13 individual jurisdictions. In planning an immunization program, most jurisdictions have advisory bodies that adapt NACI recommendations on the use of specific vaccines to local situations, based on epidemiological, program, and financial considerations10. In planning their immunization programs, provinces and territories may also consider the advice and input from various national groups, such as the Council of Chief Medical Officers of Health, the Canadian Nursing Coalition on immunization, the Canadian Paediatric Society, and the Canadian Public Health Association. c) Gaps/Limitations of Existing SystemWithin the current system, expert recommendations on immunization are made, but there is no coordinated, national mechanism for assessing and prioritizing new vaccines, from a policy perspective. It is therefore difficult to move from discussion and scientific recommendations on immunization program planning, to national collaboration and coordinated provincial/territorial policy decisions within a comprehensive national plan. This can lead to the following issues:
d) Proposed ApproachTo address the gaps and limitations described above, it is proposed that an analytical framework/common criteria be used for the assessment and prioritization of new vaccines by all F/P/T governments. Such a tool would ensure that important, agreed-upon factors and criteria are considered in the decision-making process. A draft analytical framework/tool was developed by Erickson, De Wals and Farand (unpublished document) for information and consideration by F/P/T jurisdictions. The criteria for decision making, adapted from this framework, are classified into the following broad categories:
The draft framework is meant to be practical and to facilitate rather than replace existing decision-making processes, allowing for more efficient long-term planning and information sharing between F/P/T stakeholders in the area of immunization. National participation will be required to develop further and to refine this draft framework and to move from theory to practice; however, it represents a potentially valuable tool to assist with immunization program planning. The long-term vision of this component of the NIS is to develop an approach that would involve all F/P/T jurisdictions in collaborative decision making on all new vaccines, using common criteria. B.3 Vaccine Safetya) ObjectivesVaccine safety is an integral component of a national immunization strategy. Objectives of this component are to optimize the vaccine safety system, maintain professional and public confidence in the safety of vaccines, and address growing anti-immunization concerns by improving the following:
b) Existing SystemThe current vaccine safety system in Canada can be described as follows: (i) Vaccine Safety Monitoring
(ii) Public Health Response
c) Gaps/Limitations of Existing SystemThe very success of immunization programs has proven to be one of their "weaknesses", as generations grow up in the absence of diseases that used to wreak havoc on the population and provided the stimulus for people to seek protection. There is a resulting low risk tolerance for vaccines, which has raised public expectations for vaccine safety, especially considering that vaccines are administered to healthy people. The presence of organized action groups opposed to immunization and capable of broad dissemination of information/opinions also highlights the need to address safety concerns in a more coordinated and effective manner. The following are specific gaps/limitations of the current system, which need to be addressed to optimize the vaccine safety system in Canada: (i) Vaccine Safety Monitoring
(ii) Public Health Response
d) Proposed ApproachThe following changes could be made in order to address any limitations of the current system related to vaccine safety monitoring and public health response: First, it is proposed that a network of dedicated F/P/T vaccine safety contacts be established in all jurisdictions. Such a network could improve signal generation and surge capacity. These individuals would be expected to identify and address potential vaccine safety issues, and would have a multi-purpose role of conducting surveillance, VAAE reporting, communication, signal generation, and environmental scanning. They could also be drawn upon in urgent situations requiring coordinated national action. The second aspect of the proposed approach is to improve the current system of public health response. It is proposed that a clinical assessment/referral system be established to clinically assess and follow up individuals with suspected VAAEs. If physicians and other medical professionals require assistance in making the clinical assessment or determining the appropriate follow-up, they could contact the appropriate referral centre with expertise in this area for advice. One option under consideration is to expand the current role of IMPACT (i.e., which conducts active surveillance for serious VAAEs presenting at paediatric hospitals) to include an assessment and referral capacity. The third aspect of the proposed approach is to have a vaccine safety committee to address any limitations of the current vaccine monitoring and public health response systems. The specific activities required by such a mechanism would be the following:
Other important aspects of the Vaccine Safety component of the proposed NIS are research and communication. Research on vaccine safety issues is necessary to support evidence-based practice on VAAEs. Communication of safety data and monitoring activities are essential to maintaining professional and public confidence in vaccine safety, as well as to responding to potential VAAE threats. However, since research and communication are activities that cut across other components of the NIS, they will be discussed separately in section C of this paper. B.4 Vaccine Procurementa) ObjectivesThe objectives for the vaccine procurement component of the NIS are to ensure the best value for vaccines, the long-term security of supply for vaccines, the quality of supply, and improvements in accountability. b) Existing SystemMost vaccines in Canada (i.e., over 75% of the total dollar value of vaccines in 2001/02) are purchased through direct contract with vaccine suppliers by individual provinces/territories. The remaining 25% of vaccines are purchased through the existing F/P/T procurement process, which is coordinated by Public Works and Government Services Canada (PWGSC). The F/P/T Committee on Group Purchasing of Drugs and Vaccines, led by PWGSC, has representation from P/T ministries of health, Health Canada, and National Defense, but does not report to the CDMH. This F/P/T procurement process is low cost ($100K annually, shared equally among the participating jurisdictions) and vaccines are generally purchased at a price equal to or lower than the lowest prices in Canada. Vaccine contracts issued through this process are generally issued on a one-year basis, to the lowest bidder. c) Gaps/Limitations of Existing SystemThe current mix of F/P/T bulk purchasing of vaccines, combined with purchase through direct contract by individual jurisdictions, has resulted in differential vaccine prices across Canada. Without full support and participation in the F/P/T bulk purchase process, the ability to address concerns regarding rising prices or supply issues (described below), using a coordinated national approach, is reduced.
The existing F/P/T bulk purchase process could be improved to address the following:
d) Proposed ApproachTo address any limitations of the existing system, the following enhancements to the existing F/P/T procurement process could be made:
B.5 Immunization Registry Networka) ObjectivesThe key objectives of this component of the proposed NIS are to:
b) Existing SystemEach province and territory maintains their own system for tracking immunization coverage. In most provinces and territories, immunization information is collected primarily on children, and there is variability between jurisdictions with respect to the type of data being collected. The collection of childhood immunization data often begins at the time of enrollment in licensed daycare facilities or schools. Some jurisdictions have electronic databases to track this information, whereas others use paper-based systems. Most provinces and territories are currently establishing electronic immunization registries, which would be consistent and compatible with standards established in a national network. As part of an existing F/P/T initiative, work is being conducted to develop a long-term strategy for the surveillance of communicable diseases, which includes developing data standards and data definitions for immunization, communicable diseases, and vaccine associated adverse events17. c) Gaps/Limitations of Existing SystemProgram planning, evaluation, and research, at a national level, could be improved with a national network of immunization information. For instance, a registry network could provide better access to vaccine coverage data, thereby reducing the need for coverage surveys, which have limitations in terms of timeliness, quality, and cost. It could also provide data to support program planning, such as the identification of populations who are under-immunized and could benefit from targeted efforts. Furthermore, an immunization registry network could provide better access to denominator data on the number of persons immunized, which would support assessments of vaccine safety. Improvements in the standardization of data across jurisdictions would facilitate the transfer of immunization records when a child moves from one jurisdiction to another, and would help to ensure that immunizations continue on schedule. d) Proposed ApproachHealth Canada is currently funding a project to establish a network of provincial/territorial registries. It is proposed that this work continue as a component of the NIS, as follows:
C. Description of Supporting ActivitiesThere are certain activities that cut across, and support, the five components of the NIS. There is potential to incorporate these activities into the overall NIS; however, further work is required to determine how these activities could best be integrated. These supporting activities are as follows: C.1 Immunization ResearchThe objectives of this supporting NIS activity would be to:
The current immunization research community in Canada is better established for the development and pre-licensure testing of new products, with funding predominantly coming from government grants or private industry. Research on effective program implementation and monitoring once vaccines are licensed (e.g., models to predict the effect of the new program, determining the most effective uptake measures, assessing cost-effectiveness, evaluation of education needs of professionals/the public) could be enhanced. Furthermore, the immunization research community in Canada is small, consisting mainly of senior specialists with multiple commitments, clustered in "pockets" across Canada. There is a need to identify, document, and prioritize immunization research needs in Canada, as well as to pro-actively identify gaps in research funding envelopes and discuss strategies for prioritizing future needs. In doing this, strong partnerships must be established with research groups, industry, and funding agencies, such as the Canadian Institutes of Health Research (CIHR), the Canadian Association for Immunization Research and Evaluation (CAIRE), Canadian Population Health Institute (CPHI), and the Canadian Network for Vaccines and Immunotherapeutics (CANVAC). A preliminary list of immunization research priorities was developed using information from a meeting of key stakeholders held in February 2002, and could serve as a basis for further work on this topic. C.2 Public and Professional EducationNational organizations, such as the Canadian Immunization Awareness Program (CIAP), are currently the main sources of national information on immunization and vaccine safety issues and educational materials. There are also local, P/T, federal and professional organizations that provide information on these issues through existing websites. Messages are not always coordinated or consistent. International sources of information may not be relevant as licensed vaccines differ from those in Canada. A national communication strategy for immunization (including vaccine safety issues) to develop national communication and educational tools/materials, and to disseminate immunization information in a coordinated, consistent way would be valuable. Strong partnerships with existing national organizations, such as CIAP, would be important. Consideration could also be given to establishing a communications network of key stakeholders, including F/P/T governments, which would be capable of disseminating pertinent information on immunization and immunization safety issues in a timely manner. C.3 Approaches to Special PopulationsThe Aboriginal peoples require partnership in the NIS. It is proposed that Aboriginal organizations be linked into the NIS and that linkages be developed with the First Nations and Inuit Health Branch. Other special populations, such as immigrants, refugees, travelers, certain religious groups, populations with low socio-economic status, and the elderly, will also require specific program attention as part of the NIS. C.4 Vaccine-Preventable Disease SurveillanceCurrently, Health Canada administers the Notifiable Diseases Reporting System (NDRS), in which reports of "notifiable diseases" are submitted by the provinces and territories across Canada based on a general agreement and recognition of the importance of a centralized data source. Health Canada uses these data to monitor national vaccine-preventable disease trends and provides summary reports through the Health Canada website. Health Canada also facilitates the development and implementation of national standards, such as case definitions and data models, and provides some support for P/T surveillance through material resources (e.g., computer tools), financial resources (e.g., CIPHS collaborative), and human resources (e.g., gap analysis, field epidemiologist support). Other surveillance initiatives include the Canadian Paediatric Surveillance Program (CPSP), sentinel and targeted surveillance for viral hepatitis and influenza, and international circumpolar surveillance for specific vaccine-preventable diseases. There are a number of important limitations to the current vaccine-preventable disease surveillance system, which fall generally into the following categories:
A national mechanism for working with stakeholders to improve the current vaccine-preventable diseases surveillance system would be beneficial. D. Concluding RemarksThis final report represents a vision for moving forward with a national strategy on immunization. It represents a new way of doing business in Canada with regard to one of our most important and proven public health program areas. The five components of the strategy, outlined in the body of this report, are as follows: national goals and objectives; immunization program planning; vaccine safety; vaccine procurement; and immunization registry network. The supporting activities, which cut across and support the five strategy components, include immunization research; public and professional education; approaches to special populations; and vaccine-preventable disease surveillance. If fully implemented, it is anticipated that the strategy will improve our ability to face the new challenges ahead and will be associated with the following important benefits:
References
© Her Majesty the Queen in right of Canada, represented by the Minister
of Health (2004) Cat. No. H39-4/15-2003 ISBN 0-662-68164-9
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