Immunization Competencies Education Program

Transcription

1 Immunization Competencies Education Program Adapted by: Michael Boivin, B Pharm Susan Bowles, BSc Phm, PharmD, MSc Danielle Grenier, MD, FRCPC Ian Gemmill, MD, CCFP, FCFP, FRCPC Alex Henteleff, BN, Med Expert video commentary by: Upton Allen, MD, FRCPC, MBBS, FAAP Maryanne Crockett, MD, MPH Andrea Derban, BScN Simon Dobson, MD Joanne Embree, MD Ian Gemmill, MD, CCFP, FCFP, FRCPC Carol McConnery, MD Shelly McNeil, MD Caroline Quach, MD, FRCPC, MSc David Scheifele, MD Accreditation: This version of the program is unaccredited and intended for informational purposes only. An accredited version is available online at until July 31, Sponsor: This program is developed in collaboration with the Canadian Paediatric Society, the Public Health Agency of Canada and Health Canada.

2 Contents Learning Objectives... 3 Canadian Immunization System... 3 Diphtheria... 4 Polio... 5 H. Influenza b... 6 National Immunization Strategy National Goals and Objectives Immunization Program Planning Vaccine Safety Vaccine Procurement Immunization Registry Network... 9 National Advisory Committee on Immunization (NACI) The Canadian Immunization Guide The Canadian Immunization Committee (CIC) and Provincial Bodies Provincial and Territorial Immunization Schedules and Resources National Alberta British Columbia Manitoba New Brunswick Newfoundland and Labrador Northwest Territories Nova Scotia Nunavut Ontario Prince Edward Island Quebec Saskatchewan Yukon Key Learning Points Post-Test Discussion Forum References version is available online at until July 31, Page 2

3 Competency: Demonstrates an understanding of the immunization system in Canada and its impact on his or her own practice. Learning Objectives Upon successful completion of this continuing education lesson, you will be better able to: 1. Discuss the structure of the Canadian Immunization System. 2. Describe how the National Immunization Strategy (NIS) is relevant to practice. 3. Distinguish between federal and provincial or territorial responsibilities as related to immunization programs in Canada. 4. List who can administer immunizations in Canada. 5. Describe the current status of immunization registries in the province or territory where practice is based. 6. Describe the process required to introduce a new publicly funded vaccine in a province or territory. 7. Explain the reasons for the variable immunization schedules among the provinces and territories. 8. Locate the current immunization schedule for the province or territory of practice. 9. Identify laws and regulations that may affect immunization delivery programs in provinces and territories. Canadian Immunization System Canada s immunization program has been rated in the top 3 among developed nations, historically and currently. Table 1 lists some of the Canadian immunization milestones. Table 1 Honours List for Canadian Vaccination Smallpox Early control (late 1800 s) and eradication (1962) Diphtheria Control (from 1930 s) Tetanus Control (from 1940 s) Paralytic polio Second country to use IPV (1955) Congenital rubella syndrome Rare since 1980 s H. influenzae b Early complete control (1990 s) Pertussis Early adoption of acellular vaccines (1995) Influenza Outstanding uptake in seniors (1990 s), inclusion of young children (2004) Pneumococcal and meningococcal C Early control (2002) HPV Early adoption, school programs (2007) version is available online at until July 31, Page 3

4 Immunizers should be aware of the benefits of vaccines for the Canadian population. Three diseases will be reviewed to provide an overview of the success of the Canadian immunization system. Diphtheria Diphtheria causes illness, including airway obstruction as a result of infection with toxigenic Corynbacterium diphteriae. In addition, the toxin causes mucosal damage, nerve injury and cardiotoxicity. It has a high fatality rate and the peak number of cases in Canada of 9,000 occurred in Today, cases in Canada are extremely rate. Figure 1 shows the impact of diphtheria on infected children and Figure 2 provides a review of diphtheria control in Canada. The diphtheria toxoid vaccine has been routinely used in Canada since The disease has been well controlled since 1950 (using DPT). The toxin positive strains of the bacteria have disappeared over time. This is a great example of herd immunity, with indirect protection of older adults who often lack antitoxin. The condition has not disappeared, as there were massive outbreaks in Russia in the early 1990 s, the result of lapses in coverage. Figure 1 -Patients Infected with Diphtheria version is available online at until July 31, Page 4

5 Figure 2 - Diphteria - Reported Cases, Canada, Polio Immunization strategies throughout the developed world have led to the elimination of polio from the majority of the world. Most of the people alive today have been protected from this condition through immunization. Images of patients in Figure 3 are a distant memory in Canada. Figure 4 reviews the history of paralytic polio in Canada. Although polio has been essentially eliminated from Canada for over half a century, it still occurs in a few countries of the world. In spring 2010, there was an outbreak of polio in Tajikistan. Tajikistan had been polio free since 2002, but this outbreak is believed to have occurred through the spread of polio from India. Even with polio vaccine uptake of 87% in 2008 in Tajikistan, there were 500 paralytic cases that appeared in 5 weeks. Canadian childhood immunization rates against polio range between 70-80%, and the threat of polio reappearance in Canada is possible. Figure 3 - Children Affected with Paralytic Polio version is available online at until July 31, Page 5

6 Figure 4 - Poliomyelitis, Paralytic - Reported Cases, Canada, H. Influenza b Hib was the leading cause of purulent meningitis in children until the mid-1980 s. It was an important cause of epiglottitis, sepsis, pneumonia and arthritis. Cumulative risk of Hib was approximately 1 in 250 children by the age of 6 years. A portion of the children with Hib meningitis have the long-term complications of deafness (15%) or permanent brain damage (15%). In the 1980 s, there were reported cases per year. Since 1992 all provinces have used the conjugated Hib vaccine. There was a baseline case total in 1985 of 485 cases. By 1994, the total were only 24 cases (95% ). Since 2000, there have been a reported 2-9 cases per year in Canada. Vaccination has led to a 99% reduction in cases. The cases of Hib in Canada is reviewed in Figure 5. Figure 5 - Haemophilus Influenzae Type B (Hib) Disease, Reported Cases, Canada, version is available online at until July 31, Page 6

7 National Immunization Strategy The National Immunization Strategy (NIS) was developed in Canada to address many of the unaddressed issues related to immunizations. 2 The federal government of Canada, in collaboration with provincial and territorial (F/P/T) governments launched the NIS in It is a comprehensive strategy to meet the current and future needs of all Canadians for immunization. 2 The NIS is a means for F/P/T jurisdictions to work in partnership to improve the effectiveness and efficiency of immunization programs in Canada. 2 The benefits of strengthening collaboration are anticipated to include: 2 Reduction in vaccine-preventable diseases Improved access to timely immunization programs Improved efficiencies of immunization programs Better vaccine safety monitoring and response Enhanced affordability of vaccines Improved security of vaccine supply Public confidence in vaccines/response to growing anti-immunization concerns Enhanced research on vaccines and immunization programs Better surveillance of vaccine-preventable diseases Enhanced education for health professionals and for the public to support immunizations programs A national immunization registry The NIS planned to achieve these goals through the use of five different strategies. These include: 2 1. National goals and objectives 2. Immunization program planning 3. Vaccine safety 4. Vaccine procurement 5. Immunization registry network 1. National Goals and Objectives The purpose of having national goals and objectives for immunization programs would be to support: Reductions in vaccine-preventable diseases Improved vaccine coverage rates Objective measurement of progress/ program evaluation In the current model, national goals are determined by consensus conferences developed by Health Canada. 2 Although these conferences have a broad level of stakeholder participants, the national goals are not necessarily endorsed by all F/P/T governments. 2 Endorsement of national goals is crucial to allow their full integration into immunization program planning and delivery efforts. These national goals are also crucial for ensuring maximal vaccine coverage and disease rate reduction. 2 Proposed NIS approach: The 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. version is available online at until July 31, Page 7

8 2. Immunization Program Planning Immunization program planning is a key component of the proposed National Immunization Strategy. The goal of this NIS component is to use common criteria to support collaborative, national assessment and prioritization of new vaccines. 2 Currently the National Advisory Committee on Immunization (NACI) makes recommendations on the use of specific vaccines for all Canadians. Each province or territory then adapts NACI recommendations based on their regional situation. This leads to the development of 13 independent decisions on immunization. 2 Based on the NIS recommendations, the Canadian Immunization Committee (CIC) was created to evaluate the integration of vaccines into the publicly funded immunization program. The CIC is the F/P/T body that provides leadership in immunization by giving advice and recommendations on implementation of a NIS and issues affecting immunization. 3 The objectives of a national process for immunization program planning are to minimize duplication of effort and to move towards harmonization of immunization schedules across the country. 3 Watch Dr. Ian Gemmill s presentation 3. Vaccine Safety Vaccine safety is an integral component of a national immunization strategy. Objectives of this component are to optimize the vaccine safety system, to maintain professional and public confidence in the safety of vaccines, and to address growing anti-immunization factions by improving the vaccine safety monitoring system and the public health response. 2 The very success of immunization programs has proven to be their "weakness", 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 the protection of immunization. The result today is a low risk tolerance for vaccines, and 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 misinformation and misguided opinions also highlights the need to address safety concerns in a more co-ordinated and effective manner. 2 Proposed NIS approach: The NIS proposed three methods to increase vaccine safety: 2 1. Establish a network of dedicated F/P/T vaccine safety contacts in all jurisdictions to: a. Improve signal generation of potential AEFI and surge capacity for response. b. Identify and address potential vaccine safety issues. c. Conduct surveillance of adverse events following immunization (AEFI) reports. 2. Improve the current system of public health response. Establish a clinical assessment/referral system to clinically assess and follow up individuals with suspected AEFIs. If physicians and other health care 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. version is available online at until July 31, Page 8

9 3. Use a vaccine safety committee to address any limitations of the current vaccine monitoring and public health response systems. 4. Vaccine Procurement The objectives for the vaccine procurement component of the NIS are to ensure the most-effective value for vaccines, the long-term security of supply for vaccines, the quality of supply, and improvements in accountability. 2 At the time the NIS was established, most of the vaccines purchased in Canada were purchased by the individual province or territory from the manufacturer. The remaining vaccines were purchased through the existing F/P/T procurement process, which is co-ordinated by Public Works and Government Services Canada (PWGSC). 2 This mix of buying has resulted in differential vaccine prices across Canada. 2 A bulk procurement process has been established which has strengthened the security of vaccine supply, including management of vaccine during times of shortage. Currently, P/T are all actively involved in negotiations and are benefiting from multi-year contracts with multiple providers. 4 Proposed NIS approach: To address limitations in the current system, the NIS proposed: Increase the capacity to ensure security of supply (e.g., multi-year contracts). Improve the ability to respond to escalating vaccine prices (e.g., proactive planning of longerterm vaccine needs, use of multi-year contracts). Develop a mechanism to include value-added products and services as part of the process and to redistribute these funds as part of the NIS. Collaborate with vaccine regulator to ensure timely communication on newly developed or released vaccines. Improve information-sharing regarding P/T contracts. Improve the administrative process, including development and use of the following: o Standardized forms and communication tools to streamline process o Standards for specifications concerning vaccine products and delivery processes o Clear contract parameters and bid evaluation criteria before the tendering process o Performance evaluation standards for contracts 5. Immunization Registry Network The NIS called for the development of a national registry to: Enhance national surveillance of immunization coverage rates (i.e., percentages of the recommended population who received the vaccine). Facilitate the transfer of and access to individual immunization records. Measure progress towards national immunization goals and objectives. Facilitate linkage of surveillance data of vaccine preventable diseases and vaccine-associated adverse events (or Adverse Events Following Immunization - AEFI). version is available online at until July 31, Page 9

10 The current system is designed by each of the different provinces and territories (P/T). Some P/T have developed electronic immunization registries to collect immunization information on their population, where others still rely on a paper-based system. 2 The current system does not provide data on the national coverage rates of immunization and the lack of the information prevents the creation of an integrated AEFI monitoring system or the transfer of immunization records when a child moves from one district to another. 2 Proposed NIS approach: The NIS recommended the development of a network of provincial and territorial registries. This network will allow for the: 2 Development of a minimum (core) data set to be collected by each province and territory. Development of business, technical, and functional standards for use by each province and territory. Development and provision of tools and software to interested jurisdictions by Health Canada, to assist in achieving the technical capacity to establish an electronic registry. Establishment of a national profile for immunization registries, in respect of laws regarding confidentiality of and access to data. Development of strategies to populate immunization registries, including bar-coding immunization agents. An interim evaluation of the NIS, from 2003 to 2007, was conducted in The purpose of this evaluation was to: Measure progress towards achievement of short-term outcomes. Identify areas of future improvement. Inform future decisions regarding immunization program planning, design and implementation. Ensure accountability. Provide evidence to support decision making on improvements to the NIS. This evaluation concluded that the NIS remains relevant at both federal and P/T levels. The main objectives and goals are consistent with both federal and P/T priorities with respect to immunization issues in Canada. There is no identified need at this time to revise or realign the overall goals and objectives of the NIS. They also found the NIS is making progress towards reaching its objectives and achieving an impact on key areas of Canadian immunization programs. Making some adjustments at this point would be beneficial in terms of keeping the NIS on track to achieving its objectives in key areas. This evaluation identified some key limitations to the implementation of the NIS. These limitations included: Timeliness of CIC decisions Relation between NACI and CIC Interaction between NIS working groups and the reporting relation with CIC Role of non-government organizations (NGOs) on working groups Resources available to working groups Focus on a longer-term vision version is available online at until July 31, Page 10

11 The evaluation team not only identified these limitations but have developed a set of recommendations to ensure that the goals of NIS are met and the limitations are addressed. Watch Dr. Ian Gemmill s presentation National Advisory Committee on Immunization (NACI) A vaccine is approved by the biologics and genetic therapies directorate (BGTD) of Health Canada. BGTD is the Canadian federal authority that regulates biological drugs (products derived from living sources) and radiopharmaceuticals for human use. 5 The BGTD is discussed in more detail in Module 3, but it is responsible for the approval of the vaccine in Canada and their product monograph with suggested number, timing and spacing of doses. The organizations involved in the approval and implementation of a vaccine are shown in Figure 6. For more detail on each of the groups in the table please refer to Module 3, where they are discussed in greater detail. Figure 6 The Organizations Involved in the Approval and Implementation of a Vaccine. Manufacturer researshes the vaccine and conducts preclinical trials and safety testing. The Biologics and Genetic Therapies Directorate (BGTD) receives the clinical information from the manufacturer and reviews the information, inspects the manufacturing facilities and, if satisfactory, approves the vaccine and its monograph. National Advisory Committee on Immunization (NACI) is a group of clinical experts that advises the Public Health Agency of Canada on the appropriate use of the vaccine based on their extensive literature search and analysis. The Canadian Immunization Committee (CIC) is a national body that provides leadership and gives advice and recommendations on the implementation of the national immunization strategy and vaccine programs. Provinicial Immunization Committees are responsible for determining how a vaccine should be used in a province or territory and if the vaccine will be publicly funded. version is available online at until July 31, Page 11

12 Once a vaccine is approved in Canada, the next step is to determine who should receive the immunization based on the burden of the disease, the efficacy and safety of the vaccine as well as other factors such as the economic analysis of the cost of immunization. This role is managed by the National Advisory Committee on Immunization (NACI). NACI s mandate is to provide the Public Health Agency of Canada (PHAC) with ongoing and timely medical, scientific, and public health advice relating to vaccines and certain prophylaxis agents. 6 More specifically, advice may relate to the use of vaccines in humans, vaccine evaluation, and the monitoring of vaccine-associated adverse events. 6 NACI is comprised of twelve voting members who are knowledgeable in the field of immunization practices, have multidisciplinary expertise in public health, and have expertise in the use of vaccines and prophylaxis agents for the prevention of vaccine preventable disease. 6 This committee includes specialists in paediatrics, infectious disease & medical microbiology, public health, immunology and internal medicine. The process through which NACI develops their recommendations include: 1. Review of product monograph. 2. Thorough review of the scientific literature on: a. The burden of disease (morbidity, mortality) in the population in general and in specific risk groups b. Vaccine characteristics (e.g. safety, efficacy, effectiveness) c. Additional various factors outlined in An Analytic Framework for Immunization Programs in Canada. Consideration will be given to the relevance, quality and quantity of published and unpublished data. 3. Review of the recommendations of other groups: i.e. Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), Canadian Paediatrics Society (CPS). 4. Grading and reporting the level of evidence associated with its recommendations. In the absence of data or when it is inadequate, the expert opinions of members and other experts (consultation of experts from outside the committee) will be used to make recommendations. NACI s recommendations are reported to both the Chief Public Health Officer of Canada (CPHO) and the Public Health Agency of Canada (PHAC). 6 Watch Dr. Ian Gemmill s presentation The Canadian Immunization Guide NACI s recommendations on vaccine use are published online in the Canadian Immunization-Evergreen Edition. This guide provides clinicians a national reference on the appropriate use of vaccines, as well as an extensive amount of information that is required knowledge for every clinician involved in immunizing the Canadian population. Updates are published as needed in the Canada Communicable Disease Report (CCDR). version is available online at until July 31, Page 12

13 All professionals who can administer immunizations (physicians, nurses and certified pharmacists) should be very familiar with this guide. The Canadian Immunization Committee (CIC) and Provincial Bodies NACI provides recommendations based on extensive research and literature review. The Canadian Immunization Committee (CIC) is the F/P/T body that provides leadership in immunization by giving advice and recommendations on implementation of a national immunization strategy and issues affecting immunization and immunization programs. 3 The objectives of a national process for immunization program planning are to minimize duplication of effort and to move towards harmonization of immunization schedules across the country. 3 Canada has slightly different immunization in most of its provinces or territories. The reason is that health is considered a provincial responsibility and therefore each province and territory decides on its own publicly funded vaccine programs. In most jurisdictions it is provincial or territorial advisory committees on immunization that make recommendations to their provincial government. The provincial government then decides the coverage and schedule of the vaccine to its residents. Watch Dr. Ian Gemmill s presentation Provincial and Territorial Immunization Schedules and Resources National The Canadian Immunization Guide Overview of all publically funded Immunization programs in Canada Alberta Alberta Immunization Strategy Routine Immunization Schedule British Columbia Immunization Manual Manitoba Manitoba Immunization Schedules, Reference Guide for Health Professionals New Brunswick Routine Immunization Schedule Newfoundland and Labrador Immunization Manual version is available online at until July 31, Page 13

14 Northwest Territories Immunization Schedule Northwest Territories Immunization Competency Study and Completion Guide Nova Scotia Routine Childhood Immunization Schedule Nunavut Routine Immunization Schedule 2007 Ontario Publicly funded immunization schedule for Ontario August 2011 Prince Edward Island Immunization Schedule Quebec Guide des normes et pratiques de gestion des vaccins à l intention des vaccinateurs Protocole d'immunisation du Québec (PIQ) Saskatchewan Immunization Manual Yukon Immunization Manual Key Learning Points 1. Canada s immunization program is a top-rated program both historically and currently. 2. The National immunization Strategy (NIS) was designed to: Improve immunization coverage Coordinate immunization activities between the provinces Improve vaccine safety and monitoring Improve vaccine procurement Promote the development of a national registry 3. The National Advisory Committee on Immunization (NACI) makes recommendations on the use of different vaccines by reviewing the burden of the disease, vaccine characteristics and using the Analytic Framework for Immunization Programs in Canada factors. 4. The Canadian Immunization guide is published by PHAC, based on NACI s recommendations. 5. The Canadian Immunization Committee (CIC) was developed to provide recommendations from a national level on the inclusion of vaccines into the publicly funded immunization program. 6. Each province and territory has slightly different immunization schedules and they are available for download online. version is available online at until July 31, Page 14

15 Post-Test 1. To improve vaccine procurement, which of the following strategies was NOT recommended by the National Immunization Strategy? a. Use short-term (1 year) contracts to improve competitiveness amongst manufacturers b. Co-ordinate the buying activities nationally c. Collaborate with vaccine regulator to ensure timely communication on newly developed or released vaccines d. Develop a mechanism to include value-added products and services as part of the process and to redistribute these funds as part of the NIS 2. Based on the National Immunization Strategy which of the following is a benefit of the development of a vaccine registry? a. Enhance national surveillance of immunization coverage rates b. Facilitate the transfer of and access to individual immunization records c. Facilitate linkage of surveillance data of vaccine-preventable diseases and vaccineassociated adverse events d. All of the above 3. Which of the following activities is a responsibility of the National Advisory Committee on Immunization (NACI)? a. Approve the vaccine for use in Canada b. Make recommendations on the use of the vaccine c. Approve the product monograph of the vaccine d. Monitor all the adverse events reported to the Public Health Agency of Canada 4. How often does the NACI publish the Canadian Immunization guide? a. Online, as updates are available b. Every 6 months c. Every year d. Every 4 years 5. Which group approves the coverage of a vaccine in the publicly funded immunization program? a. The National Immunization Strategy (NIS) b. Biologics and Genetic Therapies Directorate (BGTD) c. National Advisory Committee on Immunization (NACI) d. Canadian Immunization Committee (CIC) e. Provincial or territorial ministries of health Discussion Forum 1. Looking at each of the objectives from the National Immunization Strategy (NIS), which do you feel is the most important and why? 2. The difference in the immunization schedules between the province and territories can cause confusion for both patients and health care professionals. What procedures do you follow when a patient has moved to your region from another province or territory? version is available online at until July 31, Page 15

16 References 1. National Advisory Committee on Immunization. Canadian Immunization Guide. Seventh edition. Ottawa, Ontario: Public Health Agency of Canada; Government of Canada PHA of C. National Immunization Strategy: Final Report Public Health Agency of Canada. Available at: Accessed July 10, Government of Canada PHA of C. Recommendations on a Human Papillomavirus Immunization Program - Canadian Immunization Committee. Available at: Accessed July 10, Anon. Interim Evaluation of the National Immunization Strategy - Public Health Agency Canada. Available at: Accessed June 10, Government of Canada HC. Biologics and Genetic Therapies Directorate - Health Products and Food Branch - Health Canada. Available at: Accessed July 10, Government of Canada PHA of C. Terms of Reference - National Advisory Committee on Immunization (NACI) - Public Health Agency of Canada. Available at: Accessed July 10, version is available online at until July 31, Page 16