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1.0
Introduction
1.1
Background
1.2 Populations under
Federal Jurisdiction
1.3 Emergency Management and
Coordination
2.0 Preparedness by Plan
Components
2.1
Surveillance
2.1.1 Current
status
2.1.2 Planning principles
and assumptions
2.2 Vaccine
Programs
2.2.1 Current
status
2.2.2 Planning principles
and assumptions
2.3
Antivirals
2.3.1 Current
status
2.3.2 Planning principles
and assumptions
2.4 Health Services
Emergency Planning
2.4.1 Current
status
2.4.2 Planning principles
and assumptions
(i) Infection prevention
and control, and occupational health
(ii) Clinical management
of influenza
(iii) Resource
management
(iv) Non-traditional
workers: health care workers and volunteers
2.5 Public Health
Measures
2.5.1 Current
status
2.5.2 Planning principles
and assumptions
2.6
Communications
2.6.1 Current
status
(i) Provincial,
territorial and local
(ii) Federal, provincial
and territorial
(iii)
Federal
2.6.2 Planning principles
and assumptions
3.0 Planning Activities and
Preparedness Checklists
The Preparedness Section of the Canadian Pandemic Influenza Plan for the Health Sector (the Plan) addresses prevention and preparedness activities expected to be undertaken predominantly during the Interpandemic Period. It is based on the deliberations of a number of pandemic influenza working groups as well as the input of other stakeholder groups and organizations.
The purpose of the Preparedness Section is to provide information and guidelines that can be used in the development of plans for federal, provincial and territorial (F/P/T) and local management of an influenza pandemic.
Across Canada, various federal departments and agencies provide a varied range of health services to a number of “populations.” These populations (e.g. First Nations reserves, large military bases, federal prisons) could potentially cause an unprecedented increase in demand for health services in local health regions during a pandemic. Advanced planning is required to ensure that all P/Ts and regions in close proximity to these populations, as well appropriate federal authorities, have agreed-upon roles and responsibilities in the event of a pandemic.
The current status, outstanding issues and next steps for coordinated planning for First Nations communities are addressed in Annex B. Annex B also puts forward the proposed roles and responsibilities of different players to ensure proper and equitable management of pandemic influenza in First Nations communities.
Discussions at the federal level have been initiated to ensure that the needs of other populations under federal jurisdiction are also addressed within the context of a coordinated pandemic response. These activities should be discussed at the P/T and local levels where many of the issues may have been already raised.
As a result of recent emergencies, which include the terrorist attacks of September 11, 2001, and severe acute respiratory syndrome (SARS), the Government of Canada has taken a critical look at the way major emergencies are being managed. Following consultation with P/T and regional stakeholders, the federal government has taken and is implementing a number of measures to improve preparedness and response.
One such measure was the consolidation of federal programs related to security and emergency preparedness into a new department, Public Safety and Emergency Preparedness Canada (PSEPC); another was the creation of the Public Health Agency of Canada (PHAC). An identified need for leadership and coordination of activities, while respecting P/T jurisdictions, was fundamental to these changes.
The changes are now resulting in emergency management systems being reviewed, updated or changed. For example, Health Canada (HC) and PHAC are revising their emergency management structure to incorporate the approach of the well-established Incident Management System and to bring it in line with the National Emergency Response System that is also being developed by PSEPC. One common objective of these changes is to ensure that Canada has a complementary framework for dealing with emergencies that transcend provincial or national boundaries, such as a pandemic influenza.
An influenza pandemic is a complex public health emergency and as such the respective Ministries of Health have the primary responsibility for planning. Current activities also include coordination with other sectors to support both the health response and to maintain societal function. For example, as of November 2005, the federal government now has a Deputy Ministers' Committee on Avian and Pandemic Influenza Planning, which will direct and provide oversight for the coordination of all Government of Canada activities related to planning and preparedness for avian and pandemic influenza. In terms of F/P/T activities, Emergency Management Organizations (EMOs) are now represented on the Pandemic Influenza Committee. The “EMO role” is consider to be three fold: 1) managing the normal range of non-health events, 2) coordinating the provision of social/societal support to community residents, and 3) providing support to the health sector as requested and as appropriate, the latter being primarily in the coordination of surge related logistics support. During the pandemic, emergency management organizations at all levels will be engaged in managing the non-health consequences, such as the continuity of operations of essential services impacted by absenteeism.
It is anticipated that the emergency management and coordination of a response to an influenza pandemic will be based on existing plans and structures for health emergencies at all levels of government, including the involvement of the F/P/T Emergency Health Services (EHS) and Emergency Social Services (ESS). The unique aspects of responding to an influenza pandemic need to be addressed as part of preparedness activities; this is so all stakeholders involved in the response are well versed in how a generic health emergency response structure might be modified for pandemic influenza. An Emergency Social Services Generic Infectious Disease Plan is currently under development. This plan will outline pandemic response roles for ESS and the Centre for Emergency Preparedness and Response (CEPR).
See Annex L for more information about the Canadian emergency preparedness and response system.
The components of the 2004 edition of the Plan included surveillance, vaccine programs, antivirals, health services, emergency services, public health measures and communications. In this edition of the Plan, the emergency services component has been removed; it is now addressed as part of the preparedness for overall emergency management and coordination.
Federal, provincial, territorial and local planners are encouraged to consider the psychosocial implications of pandemic influenza when developing their plans for preparedness and response activities. It is anticipated that a component focusing on psychosocial issues will be added to future versions of the Plan.
Each of the Plan components in this section is addressed in terms of current status (including outstanding issues), and planning principles and assumptions. A list of potential planning activities is also included.
Influenza surveillance is required to identify when, where, and which influenza viruses are circulating, the intensity and impact of influenza activity, and high-risk populations. It is also required to detect unusual events (e.g. new strains, unexpected outcomes, changes in distribution or severity). Both virologic and disease surveillance are necessary for identifying influenza virus variants and for determining their ability to spread and cause disease. Surveillance data will drive the pandemic response because it will be used to determine the pandemic phase and to track progression through the phases. FluWatch, Canada's national influenza surveillance program, includes surveillance activities that aim to meet the general objectives stated below.
Laboratory surveillance involves the isolation of influenza viruses for analysis of antigenic and genetic properties. This activity is essential for monitoring the antigenic drift and shift of influenza viruses circulating among humans. Because the signs and symptoms of influenza are similar to those caused by other respiratory pathogens, laboratory testing must be conducted to definitively diagnose influenza. Rapid identification of a novel influenza virus and timely tracking of virus activity throughout the duration of the pandemic is critical to the success of a pandemic response. Prompt identification of a novel strain increases the lead-time for the development of a vaccine and the implementation of prevention and control measures.
The collection of epidemiologic data on influenza-like illness (ILI) and influenza-related hospitalizations and deaths is essential for determining the extent and severity of influenza epidemics. Access to real-time data is particularly important during outbreaks or epidemics associated with a newly recognized influenza variant. Determination of epidemiological parameters and indicators (e.g. indicators of human-to-human transmission, incubation period, period of communicability) is critical to informing the public health response. During the pandemic, epidemiologic data will be used to inform those developing prevention and control strategies, for example those strategies that require the identification of high-risk groups.
Jurisdictions need to be prepared to rapidly implement or modify enhanced surveillance activities. For the purpose of informing public health risk assessment and response activities, a coordinated and rapid epidemiological investigation that includes the collection, collation and analysis of detailed epidemiological, laboratory and clinical data is required. Further, rapid sharing of data and efficient communication at all levels of government are critical for facilitating a coordinated response.
The objectives of influenza surveillance are to:
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The national FluWatch surveillance system incorporates data on a weekly basis, year-round. Data sources include ILI surveillance from a sentinel primary-care network, virologic data from the national network of laboratories, influenza activity levels reported from P/T jurisdictions, and real-time paediatric morbidity and mortality data from the Immunization Monitoring Program, ACTive (IMPACT) surveillance network. Data akin to that provided by IMPACT for the paediatric population are not currently available for the adult population, however pilot projects are underway.
At the federal level, regular environmental scanning for the detection of potentially significant ILI is conducted using official information sources for influenza surveillance (e.g. World Health Organization [WHO] and government influenza surveillance programs from other countries) and unconfirmed reports from early warning systems (e.g. ProMed and other media scanning software, such as the Global Public Health Intelligence Network).
On an ongoing basis, the newly created national expert Working Group for Vaccine Preventable and Respiratory Infections Surveillance (VPRIS-N) will be assessing surveillance systems and making recommendations for enhancements and improvements for the Interpandemic, Pandemic Alert and Pandemic Periods. Recommendations from this group are being refined on an ongoing basis; current recommendations are included in Annex N, Pandemic Influenza Surveillance Guidelines.
The need for timely surveillance for severe respiratory illness in travellers and the development of special study protocols that can be activated at the time of a pandemic has been recognized by the Pandemic Influenza Committee (PIC) and currently remains an outstanding issue.
The Canadian Public Health Laboratory Network has updated the laboratory guidelines for pandemic planning and preparedness (Annex C, Pandemic Influenza Laboratory Preparedness Plan). There is a need to enhance laboratory-based surveillance including laboratory-testing capacity and the standardization of testing protocols. Progress has been made with respect to the increasing the capacity to detect novel influenza viruses in Canada. The National Microbiology Laboratory now has the ability to detect all novel influenza subtypes and the capacity to do antiviral resistance testing, and provincial laboratories are developing the capacity to perform polymerase chain reaction testing for novel subtypes.
Progress has also been made with respect to linkages and collaboration with animal health experts involved in influenza surveillance and control.
During each phase of a pandemic, epidemiologic and virologic data needs will change. Surveillance objectives during each phase will aim to meet the evolving information needs that will occur during the pandemic. Accordingly, surveillance roles and responsibilities for all levels of government are outlined by phase in Annex N, Pandemic Influenza Surveillance Guidelines.
Because surveillance data will drive the pandemic response, it is important that physicians and other health care workers are educated and updated on an ongoing basis about the importance of ILI surveillance as well as their roles in the system. Surveillance systems must be established in advance of a pandemic because there will be little time to augment capacity at the time of a pandemic. At the time of a pandemic, surveillance and laboratory-testing capacity will be reduced (e.g. due to staff absenteeism and potential supply shortages) compared with pre-pandemic periods; only streamlined, resource-efficient systems will continue to function. Special study protocols if required (e.g. to determine epidemiology or to investigate reported adverse events following immunization) at the time of a pandemic must be developed and pretested during the pre-pandemic period, recognizing that refinements may be necessary at the time of a pandemic.
The intensity and methods of virologic surveillance will differ depending on the phase of the pandemic. Initially, efforts should be directed at detecting the arrival of the novel virus into previously unaffected areas and collecting epidemiologic data on infected persons. This data will be used to characterize virus activity and to better target prevention and control measures. In addition, the arrival of the novel virus in a particular area will guide the mobilization of resources that are needed to implement control measures. After the virus has spread throughout the country, a basic level of virologic surveillance should continue in order to detect any changes in the virus, including the development of resistance to antiviral drugs in different populations. Targeted studies may include serologic studies of immunity to the virus in different populations.
Studies of the etiologic agents that are responsible for secondary complications of influenza and their susceptibility to antimicrobial drugs will also be important, especially in times of short supply. In addition, surveillance data and targeted studies will be useful in assessing the impacts of the pandemic on the health care system as well as its social and economic impacts.
Vaccination of susceptible individuals is the primary means to prevent disease and death from influenza during an epidemic or pandemic. The National Advisory Committee on Immunization (NACI) produces annual recommendations on the use of influenza vaccine in persons who are most at risk for influenza or those who could spread influenza to persons at greatest risk. These interpandemic recommendations are published annually in the Canada Communicable Disease Report. In the event of a pandemic, PIC, which includes representation from NACI, will provide recommendations to F/P/T immunization programs on the development, production and use of the pandemic vaccine, and priority groups for immunization. Efforts should be made to encourage all jurisdictions to adopt the national recommendations on priority groups at the time of a pandemic in order to facilitate equitable access and consistent messaging.
The objectives of the pandemic vaccine program are to:
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The annual influenza vaccine available in Canada is a trivalent vaccine, which is composed of two influenza A subtypes and one influenza B subtype. The vaccine contains 15 micrograms of hemagglutinin antigen for each constituent strain. For adults and older children previously exposed to viruses similar to those present in the vaccine, a single dose is normally recommended. In children (under the age of 9 years) lacking such previous exposure, two doses are recommended.
Currently, Canada uses approximately 10 million doses of trivalent influenza vaccine a year (equivalent to 30 million monovalent doses of 15 micrograms), which are delivered mainly by publicly funded programs with established vaccine delivery infrastructures. Provinces and territories vary in their target populations for annual influenza programs; the majority provides vaccine to NACI-recommended high-risk groups. Some P/Ts have expanded their programs to include populations not currently identified as high-risk groups (e.g. the Ontario “universal” program) and have experience in conducting large influenza vaccination campaigns.
Influenza vaccine is usually available in October of each year and is currently provided by three suppliers. Annual influenza immunizations are administered in a variety of settings across Canada, including physician offices, public health clinics at schools or other community settings, workplace clinics and other settings (e.g. pharmacies).
The Canadian approach to vaccine procurement and supply contingency planning includes the development of the domestic infrastructure, a standby supply of fertilized hens eggs and other essential vaccine production supplies, the phasing-in of new technologies and further security of supply through multiple suppliers. In 2005, the federal government committed CAN$34 million to the development of prototype (“mock”) vaccines to facilitate testing and streamlining of the pandemic vaccine strategy.
Health Canada is the regulatory authority in Canada that is responsible for ensuring the safety, efficacy and quality of all drugs, including vaccines, marketed in Canada for human use. Vaccine regulation in Canada is subject to the provisions of the Food and Drugs Act and Regulations. New vaccines are authorized for marketing in Canada following the review of data that is submitted by the manufacturer to support the safety, efficacy (immunogenicity) and quality of the vaccine. The regulatory challenge for a pandemic influenza vaccine will be to have mechanisms in place that can be used to review and authorize a safe and efficacious vaccine for use in Canada, within the shortest time frame possible, and to verify, once that vaccine is in use, that it is effective. Health Canada has prepared a regulatory preparedness strategy, outlining how this authorization will be accomplished in the circumstances of a pandemic. This documentation is available on the internet at: http://web.hc-sc.gc.ca/ dhp-mps/brgtherap/reg-init/vac/pandemicvaccine_nov2005-eng.html http://web.hc-sc.gc.ca/dhp-mps/brgtherap/reg-init/vac/pandemicvaccine_nov2005_f.html
Although enough vaccine will be made to immunize all Canadians, it is anticipated that the new pandemic vaccine will become available in batches, necessitating prioritization within the population as the initial doses become available. The Vaccine Working Group has made recommendations with regard to the priority groups for immunization in the event of a pandemic (see Annex D, Recommendations for the Prioritized Use of Pandemic Vaccine). In addition, P/T and local jurisdictions have developed guidelines for planning a mass immunization campaign (e.g. Mass Immunization Campaigns: A ‘How To' Guide, Capital Health Region of Alberta, April 2000, and Guideline to Planning a Mass Immunization Campaign, Waterloo Region Community Health Department, Ontario, January 2001), Guidepour la réalisation d'une vaccination de masse – À l'usage des directions de santé publique, Ministère de la Santé et des Services sociaux, Février 2006); these can be adapted for use during a pandemic. (Access these documents through the respective organizations). The Vaccine Working Group will also develop guidelines for monitoring of vaccine use during a pandemic and identify issues related to adverse events following immunization (AEFI) tracking and liability. In addition, this group with other experts will provide input into clinical trial protocols.
The Immunization and Respiratory Infections Division of the Centre for Infectious Disease Prevention and Control (CIDPC) maintains an AEFI surveillance system. Reports of adverse events associated with influenza vaccination are monitored through reports from P/T Ministries of Health (approximately 95%), with some being reported by health care professionals and manufacturers directly to Health Canada (approximately 5%). The reporting is based mainly on voluntary notifications by clinicians and public health nurses, although there is a legal reporting requirement in some P/Ts such as Saskatchewan, Ontario, Quebec and Nova Scotia. The network of children's hospitals that participate in IMPACT provide data on hospitalizations of children with possible AEFIs.
Outstanding issues with respect to vaccine programs include the dose in micrograms required to achieve a protective response to a novel strain in a naive host, if one or two doses of vaccine will be required, and the timing of vaccine availability in conjunction with onset of pandemic activity in Canada. This information is unlikely to be available until the pandemic has begun. Continued international vaccine research efforts are a priority, including clinical studies to evaluate influenza vaccines that contain novel subtypes (e.g. H5N1 vaccines) in immunologically naive populations. Priorities also include the development and evaluation of new vaccine technologies (e.g. non-egg based production technologies, recombinant vaccines, adjuvant vaccines) to increase the capacity to produce an effective pandemic vaccine, reduce the lead time for vaccine production and increase the capacity to vaccinate larger populations.
Another outstanding issue is the equitable distribution of vaccine to P/Ts and the development ofimplementation plans. The implementation plans will need to take into account the vaccination of federal populations (i.e., First Nations, Royal Canadian Mounted Police, Canadian Forces and federal penitentiary inmates).
The vaccines currently available in Canada are inactivated vaccines that are manufactured in fertilized hens' eggs. This production depends on egg availability, and it is characterized by stringent time requirements for the identification of vaccine candidate strains, the preparation of seed lots, testing and licensing, and manufacturing and distribution. Manufacturers typically require a minimum of 48 days from the availability of the seed strain to the production of the first lot of vaccine for testing.1 Delays in the production of pandemic vaccine seed strains may occur as highlighted by the difficulties encountered in trying to produce a vaccine against the H5N1 virus that was involved during the 1997 Hong Kong outbreak. Consequently, vaccine may not be available when the first wave of the pandemic strikes Canada.
1 The figure of a minimum of 48 days for availability of first lot (through to availablility of internal quality control tests) assumes delivery of seed virus on day 0 and receipt of the ncessary reagent on later than 13 days after the seed strain has been provided.
At the time of a pandemic, it is assumed that monovalent vaccines containing only the pandemic strain will be used. The dosage and schedule of the pandemic vaccine needed to induce immunity in different populations must be determined through clinical testing. Where possible, clinical testing with vaccines for novel virus subtypes should be performed during the Interpandemic Period and confirmatory trial for the specific pandemic vaccine should be carried out at the time of a pandemic.
It is assumed all persons who lack previous exposure to the pandemic virus subtype will likely require two doses of vaccine, but the dosage is unknown (e.g. two 15-microgram doses or higher). It may be possible to give in advance an initial immunization with a generic vaccine of the correct H type and then give a second dose with the specific antigen. If that is possible, domestic vaccine production and immunization could begin before Canada has the required specific strain. Strategies to enhance the immunogenicity of influenza vaccines and reduce the amount of antigen required (e.g. use of adjuvants, whole-cell vaccines, intradermal route of injection) require further research.
Most countries will probably view a pandemic as a national health emergency or a threat to national security, therefore embargos on vaccines must be anticipated by countries with capacity for influenza vaccine production. Canada has invested in a domestic supplier to offset this possibility.
When vaccines become available, initial supplies may not be sufficient to immunize the whole population and prioritization of vaccine administration will be necessary. The F/P/T governments will control the allocation and distribution of influenza vaccine during a pandemic and will implement specific recommendations with regard to priority groups for immunization. Priority groups, based on the overall pandemic preparedness goal of minimizing serious illness, overall deaths and societal disruption, have been proposed in Annex D, Recommendations for the Prioritized Use of Pandemic Vaccine. However these priority groups may change when more is known about the epidemiology of the pandemic. It is assumed that for a two-dose program, completion of the second dose should be carried out as soon as possible to effect immunity; administration of the second dose should not wait until after every priority group has received a first dose. This strategy will require extensive planning that involves tracking and recall mechanisms.
The aim during a pandemic is to vaccinate the whole Canadian population on a continuous prioritized basis as quickly as possible. The current domestic pandemic vaccine production capacity is 8 million 15 microgram (ug) doses per month as specified in the current contract with this supplier. The possibility of increasing this capacity is currently being explored. Knowledge regarding anticipated schedules (i.e., antigen per dose, number of doses, and interval between doses) to optimize immunity may be derived from prototype vaccine clinical trails before a pandemic. Further clinical trails may be needed at the time of the pandemic. Vaccine recommendations may not be finalized until pandemic activity has commenced. These recommendations will be distributed as national guidelines as soon as possible, to facilitate a consistent and equitable approach.
For vaccine program planning purposes, it is important to be prepared to immunize 100% of the population; however, the actual proportion of the population that will voluntarily seek vaccination will depend on public perception of the risk and the severity of the disease. Therefore, the demand, which will manifest as clinic attendance, will likely vary among jurisdictions and within each jurisdiction as the pandemic evolves. Previous experience with outbreak-related immunization clinics indicates that it would be prudent to prepare for an initial demand of 75% of the target population. It is recommended that planning activities also focus on delivering a two-dose program to ensure that the public health response is ready to deal with this possibility.
A plan needs to be in place to monitor vaccine safety and to ensure the timely communication of any potential adverse event following immunization (AEFI) during the pandemic. Information on potential AEFIs must still be communicated in a timely manner from local to P/T public health authorities and on to the Immunization and Respiratory Infections Division, CIDPC, PHAC. The CIDPC will provide information to the Biologics and Therapeutic Products Directorate, HC and other stakeholders. Specific targeted studies and epidemiological investigations may be required in addition to passive surveillance.
Clinical trial protocols should be developed in advance of a pandemic and updated as needed, based on available knowledge about influenza vaccines and changing technologies. Phase three clinical trials for vaccine efficacy may not be performed prior to the implementation of vaccine programs at the time of a pandemic. Estimation of vaccine effectiveness may need to be carried out by studying predetermined target populations during the pandemic. The PHAC will coordinate studies on vaccine effectiveness with P/Ts, researchers and the vaccine manufacturer.
During the Interpandemic Period, consideration should also be given to improving pneumococcal vaccination coverage levels in NACI-recommended “high-risk” groups and to optimizing vaccine coverage in children with the 7 valent conjugate vaccine. Streptococcus pneumoniae is a common cause of secondary bacterial pneumonia. The incidence and severity of secondary bacterial pneumonia during the pandemic may be reduced if there is a high level of immunity to the most common serotypes of Streptococcus pneumoniae in the high-risk groups.
Vaccines, when available, will be the primary public health intervention during a pandemic. However at the start of the pandemic, vaccines may not be available as soon as required and two doses of vaccine may be necessary to achieve an adequate immune response. Antivirals (anti-influenza drugs) are effective for both treatment and prophylaxis of annual influenza. These drugs were not available during past pandemics, but are expected to be effective against pandemic strains of the influenza virus. Antivirals will likely be the only virus-specific intervention during the initial pandemic response. Protection afforded by antivirals is virtually immediate and does not interfere with the response to inactivated influenza vaccines.
Two classes of antiviral drugs are currently available in Canada for the prevention and treatment of annual influenza infection: M2 ion channel inhibitors (cyclic amines) and neuraminidase inhibitors. M2 ion channel inhibitors interfere with the replication cycle of influenza A, but they are not effective against influenza B. Amantadine and rimantadine are examples of M2 ion channel inhibitors. Zanamivir and oseltamivir are examples of neuraminidase inhibitors. These drugs interfere with replication of both influenza A and B viruses and are well tolerated; they have been used effectively for the prophylaxis and treatment of influenza A and B infections. The latest data regarding these drugs and recommendations for their strategic use are provided in Annex E, Planning Recommendations for the use of Anti-influenza (Antiviral) Drugs in Canada during a Pandemic.
The objectives of the antivirals initiative are to:
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The neuraminidase inhibitor oseltamivir, previously approved in Canada for treatment purposes only, was approved for post-exposure prophylaxis in December 2003. Prior to December 2003, only amantadine was approved for use in Canada for both prophylaxis and treatment of influenza A infections. Rimantadine is not currently approved for use in Canada, and zanamivir is approved for treatment purposes only. At this time neuraminidase inhibitors are much more expensive than amantadine which is made by several generic drug manufacturers.
Antivirals are usually prescribed during the annual influenza season by individual physicians on a first-come, first-served basis. Early in the 2005-2006 influenza season higher than expected demand, possibly due to heightened public concern regarding the outbreak of avian influenza in Asia, resulted in the manufacturer of oseltamivir limiting public access to this drug. This move was intended to ensure that sufficient quantities of this previously relatively low usage drug would be available for the management of influenza outbreaks in institutions for the duration of the annual influenza season. While the supply of oseltamivir is expected to increase, this occurrence highlights the potential surges in demand that may occur both in the public and private sector as recognition and use of this drug increases.
The WHO has encouraged countries, where it is economically feasible, to start stockpiling antiviral drugs because not only national but global supplies of antivirals could be consumed rapidly at the start of a pandemic. Many developed countries now have antiviral stockpiles, at least 10 of which intend to stockpile enough neuraminidase inhibitors to treat 20-40% of their population.
In Canada, a National Antiviral Stockpile composed of 1.6 million treatment courses of oseltamivir was established in the fall of 2004 to ensure that all P/Ts would have access to antiviral drugs. The antivirals from this stockpile were distributed on a per capita basis to the P/Ts. Further work in this area yielded recommendations from the national Antivirals Working Group and the PIC to increase the size and diversify the composition of the national stockpile.
At a joint meeting of the Council of Chief Medical Officers of Health (CCMOH) and the Public Health Network in February 2006, recommendations for the size, composition and use of the National Antiviral Stockpile were formalized. In alignment with the overall goals and principles of the Canadian Pandemic Influenza Plan, it was recommended that the size of the National Antiviral Stockpile be increased to 55 million doses (5.5 M treatment courses) of neuraminidase inhibitors2 in order to provide for early treatment of those with illness. It was
2 This recommendation was endorsed by the F/P/T Ministers of Health in May 2006 when the Ministers agreed to seek authority as necessary to increase the joint National Antiviral Stockpile from 16 million to 55 million doses.
agreed that the national stockpile should be used for early treatment with targeting those with ILI who are deemed to be most at risk of serious morbidity and mortality. Furthermore, there was agreement that a national process should be developed, including broad consultation, to facilitate more informed decision making regarding the inclusion of antivirals for prophylaxis in the national stockpile.
It was also recommended at this meeting that the national stockpile be composed of approximately 10% zanamivir and sufficient oseltamivir solution (approximately 2 million doses) to treat young children and people who cannot swallow capsules. In addition, as part of a comprehensive containment strategy, it was agreed that a specified quantity of antiviral drugs should be designated for containment of spread of a novel virus during the Pandemic Alert Period in the event that this becomes necessary in Canada. The use of antivirals as part of the containment measures during the Pandemic Alert Period is briefly addressed in Annex M, Public Health Measures. Development of a comprehensive containment strategy requires further planning and discussion at the national level.
In addition to the National Antiviral Stockpile, the National Emergency Stockpiling System (NESS) also contains oseltamivir which could be used during domestic avian influenza outbreaks or for P/T support during the Pandemic Alert or Pandemic Period.
Mechanisms for the delivery, administration and monitoring of the use of antivirals still needs to be addressed with most of the implementation details requiring P/T and local level planning. Other outstanding issues include the development of protocols for monitoring drug resistance during the pandemic and for determining the appropriate treatment dose and duration for the novel virus.
Health Canada currently receives adverse drug reaction reports from health care providers. Although further discussions are required on the unique needs of monitoring the extensive use of antivirals during a pandemic, it is expected that the current reporting system will be used.
An effective intervention with antivirals will require:
The Antivirals Working Group is currently addressing many of these issues.
During a pandemic, antiviral strategies should use all the types of effective anti-influenza drugs that are available to Canadians, and should be adaptable to changing disease epidemiology and vaccine availability. If the novel virus is found to be susceptible to amantadine, which is not currently part of the National Antiviral Stockpile, it is recommended that amantadine be used for prophylaxis (not treatment) only. Oseltamivir could be used for both treatment of cases and prophylaxis. The efficacy of oseltamivir and amantadine are approximately equal for the treatment of cases infected with sensitive strains; however, amantadine is recommended exclusively for prophylaxis to minimize the development of amantadine resistance (which would render the drug ineffective) during the pandemic. The timing of the use of antivirals during a pandemic should be guided by local surveillance data.
Planning by the health sector should focus on implementation of an early treatment strategy using neuraminidase inhibitors (mostly oseltamivir), as this has been agreed upon as the use for the drugs in the current National Antiviral Stockpile. In determining this approach consideration was given to the effectiveness, efficiency and ethical implications of the strategy and the role of the antiviral strategy as one part of the comprehensive response.
The role and impact of antivirals in preventing transmission and slowing down the spread of a novel influenza virus during the Pandemic Alert Period is unknown. Although this potential role is now under discussion as part of the containment measures for the Pandemic Alert Period, it is currently not recommended for the Pandemic Period.
Depending on the epidemiology of the pandemic, the recommended treatment course (e.g., if changes need to be made to duration or dosage), and the antiviral supplies available at the time, it may be necessary to focus on treating those at highest risk for complications. This decision will be made based on the information available at the time. For planning purposes, those implementing the strategy need to determine in advance:
During the pandemic there will be a marked increase in demand for people (health care providers and others) to care for the sick and for appropriate locations and equipment to facilitate the provision of health care. Communities and health care organizations will need to have plans in place that will address what will be done when the health care system is overwhelmed and care must be provided by persons, both health care workers and volunteers, doing work that is not normally part of their daily activities and possibly in settings not usually used for health care.
The objectives of health services emergency planning are to:
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Outbreaks of influenza occur annually in Canada. The morbidity and mortality during any given influenza season depends mainly on the circulating strain(s) of influenza virus and the susceptibility of the population. Those normally at high risk of influenza complications are the elderly, persons with chronic cardiac or respiratory conditions, and the immunocompromised.
The spectrum of illness seen with influenza is extremely broad and ranges from asymptomatic infection to death, which is frequently due to secondary bacterial pneumonia or exacerbation of an underlying chronic condition. Many institutions in Canada are presently running at maximal or near maximal bed capacity. Even currently, during peak annual influenza activity, it is difficult for many facilities to manage the increased demand for beds and emergency room care. A report by the Manitoba Centre for Health Policy and Evaluation showed that the total number of hospital admissions and ambulatory visits provided by the Winnipeg health care system increased only slightly (5% to 7%) during severe influenza seasons; however, the number of patients presenting with ILI increased substantially (approximately 70% for ILI related admissions and 35% to 40% for ILI related physician visits). (This report is available at: http://www.umanitoba.ca/centres/mchp/reports/reports_97-00/seasonal.htm). The report suggests that there is an overall maximum level of service that can be provided; it increases somewhat in response to need, but the patient mix that requires care also affects it.
The scarcity of health resources will be exacerbated during a pandemic and could exceed the capacity of the current health care setting to cope; therefore, it is imperative that planning occur at the individual facility level in addition to regional and P/T levels. “FluSurge” is a spreadsheet-based model that provides the user with estimates of the surge in demand for hospital-based services during an influenza pandemic. The program estimates the number of hospitalizations and deaths attributable to an influenza pandemic (the length and virulence of the pandemic are determined by the user) and compares the number of persons hospitalized, the number of persons requiring care in intensive care units, and the number of persons requiring ventilator support during a pandemic, with existing hospital capacity. This program is a useful tool for local and regional level planners, and it is available free of charge on the United States Centers for Disease Control and Prevention Web site at: http://www.cdc.gov/ flu/flusurge.htm. This program might also be of assistance when examining the potential increased demand for health care related supplies and equipment. Given that many facilities operate on a “just in time” delivery system for medical supplies, strategies for dealing with a sudden increase in demand should be developed in advance of the pandemic.
Various PIC working groups have developed health services guidelines to assist acute-and chronic-care institutions, health care planners, clinicians and other stakeholders with planning for and coping with large numbers of influenza cases, some of whom may have severe disease or life-threatening complications. These guidelines are presented as annexes for ease of use. They can be broadly classified into the following categories, which correspond to the main responsibilities of each of the working groups: clinical care, infection control (including physical management) and occupational health for traditional and non-traditional settings, resource management and non-traditional workers. The annexes provide options, worksheets and guidelines to facilitate planning for a consistent and comprehensive response within the health sector.
The working groups will also be looking at training and education modules for health care workers, volunteers and the public, and aftercare and recovery planning issues.
Because of the broad scope of planning activities, this section has been subdivided according the subgroups that have worked on them. Documents or tools in the annexes will be referred to where relevant.
The incubation period for influenza usually ranges from 1 to 3 days. Person-to-person transmission of influenza virus occurs through droplets from the respiratory tract that are spread by direct contact, through coughing or sneezing, or by hands (or other surfaces) contaminated with respiratory secretions. The importance of the airborne route in transmission is unknown. Influenza is highly contagious; it can spread quickly in settings where large groups of people (e.g. institutionalized populations) are gathered together.
The period of communicability for influenza is during the 24 hours before the onset of symptoms and during the most symptomatic period, usually 3 to 5 days from clinical onset in adults and up to 7 days in young children. Although viral shedding occurs in the 24 hours prior to symptom onset, transmission of the virus to another person is much more efficient once symptoms are present. In adults, the amount of viral particles shed (e.g. while sneezing or coughing) is related to the severity of illness and temperature elevation. For those receiving antiviral therapy, the duration of viral shedding is likely to be shorter.
Survival of the influenza virus outside the body varies with temperature and humidity. It generally survives 24 to 48 hours on hard, non-porous surfaces; 8 to 12 hours on cloth, paper and tissue; and 5 minutes on hands. Survival of the virus is enhanced under conditions of low humidity and in cold temperatures.
During the pandemic, it will be imperative to keep health care workers as healthy as possible. Occupational health issues that need to be considered include vaccination of health care workers, use of personal protective equipment, criteria for work exclusion and/or fitness to work, and work reassignments (see Annex F, Infection Control and Occupational Health Guidelines During Pandemic Influenza in Traditional and Non-Traditional Health Care Settings).
See Annex F for institutional infection control guidelines for traditional health care settings, including acute and long-term care institutions, ambulatory and community settings. The topics addressed include immunization, hand hygiene, use of personal protective equipment (e.g. masks, gloves, gowns), patient isolation and accommodation, restriction of visitors, staff cohorting, environmental cleaning and education for staff, patients and visitors. The same topics are addressed for non-traditional settings (e.g. self-care, triage, pandemic hospitals) as well. Also see Annex J, Guidelines for Non-Traditional Sites and Workers.
The community section of Annex F contains infection control and occupational health guidance for the general public, health care workers providing services in the community, as well as for office-based medical and non-medical health care providers (e.g. public health clinics, physician offices, dental offices, physiotherapy clinics, alternative health care providers). The topics addressed include hand hygiene, the use of personal protective equipment (e.g. masks, gloves) and cohorting of persons with ILI.
Infection control recommendations for the prevention of human infections during avian influenza outbreaks are available on the PHAC website.
The last two influenza pandemics occurred during 1957–1958 and during1968–1969. Therefore, the majority of currently practicing clinicians would have little or no experience with pandemic influenza disease and may not be aware of its potential variant presentations. The clinical guidelines in Annex G provide recommendations on the triage of pediatric and adult patients and recommendations on the management of patients in long-term care facilities. The Clinical Management of Influenza forms in Annex G are designed to help health care staff with case management. One form has sections on investigations that should be considered, treatment recommendations, as well as information about the selection of patients (children and adults) for hospital admission and for admission to intensive care. Standardized admission and primary care forms, with a triage component, will help to ensure consistency and minimize paper work.
During a pandemic, it will be essential to inform both the public and health professionals about the symptoms and treatment of influenza, as well as when to seek advice (see Annex G, Clinical Care Guidelines and Tools, and Annex M, Public Health Measures). The fact sheets on the clinical features of influenza and secondary complications are designed to assist health care providers with diagnosis and the general public with self-treatment (see Annex G). These fact sheets include information pertaining to children, adults and the elderly. Any educational materials will require advance preparation in addition to a plan for efficient and timely distribution.
Although the impact of a pandemic is unpredictable, it is advisable for planning purposes to expect a major disruption in critical community services. The response of the health care system to this situation will be crucial. Regional, local and institutional planners will need to assess their health-resource utilization and the capacity of their health systems to cope during severe influenza epidemics, and to compare this information with the estimated capacity that will be needed to respond to a pandemic in their catchment areas. The FluAid software (available at: http://www2.cdc.gov/od/fluaid/default.htm), which is an American model for estimating the health impact of a pandemic, may be considered for resource planning purposes. However, with the American model, health outcome is based on health care-seeking behaviour or the treatment received. It is expected that the treatment for a person in Canada who is similarly ill with flu may be quite different because of the differences in the health care systems, practice patterns and health care-seeking behavior. The model further assumes that health care is available for all persons seeking care, which is consistent with the American demand-driven health economy.
Although in the majority of cases, influenza is an acute, self-limiting upper-respiratory infection, complications do occur. The overall attack rate is relatively high for influenza epidemics and pandemics, and the impact is usually seen over the course of a few weeks in any one location. Consequently, even a low frequency of complications result in marked increases in rates of hospitalizations. It is important to consider that, although the waves of the pandemic tend to last for 6 to 8 weeks in any locality, the demand on the health care system will not be at a constant rate during this period because the number of new cases seeking health services is likely to increase, peak and then decline. The next pandemic wave may closely follow the first wave and therefore leave little time for recovery. Resource needs will need to be reassessed continuously during this potentially overwhelming situation. It will be a challenge for acute care facilities to manage high ward census, high intensive-care unit census and high emergency department volumes in the face of the reduced availability of health care workers and the limited supply of respiratory support equipment (see Annex H, Resource Management Guidelines for Health Care Facilities). Advance consideration should be given to the management of adult and pediatric patients with respiratory distress when oximeters, ventilators and other respiratory-support equipment must be rationed.
Each facility needs to evaluate its human resources. Because health care and hospital workers include a great number of individuals in many different occupations, a list of health care workers has been developed to assist with planning (see Annex H). Emergency reallocation of staff and the maintenance of staffing levels will be essential. Health care worker training and continuing education to encourage workers to maintain their skills, incentives to maintain training, and ongoing communication are all important; these items should be planned during the pre-pandemic period. During the pandemic, needs for child care, emotional support and grief counseling should be addressed to help maintain adequate staffing levels.
Elective medical and surgical admissions will need to be prioritized, and possibly some admissions will be cancelled to meet the increased health care demands of influenza. See Annex H, Resource Management Guidelines for Health Care Facilities, for a checklist of issues that acute-care facilities should consider during this prioritization process. Each institution will also need to evaluate their bed and ventilator capacity. Annex H also contains a worksheet to help facilities determine their potential surge capacity.
Pandemic influenza historically has been associated with excess mortality. It will be essential for jurisdictions to include a corpse management plan as part of their pandemic plan. See Annex I for guidelines on the management of mass fatalities. Items addressed in this annex include morgue capacity, corpse storage, transportation, management, burial, cremation and grief counseling.
All levels of government and health service institutions need to plan and put into place strategies to meet the greatly increased demand for medical supplies and services along with staff shortages that are anticipated (See planning assumptions regarding absenteeism in Background Section).
See Annex H, Resource Management Guidelines for Health Care Facilities, for recommendations on how to manage scarce resources during an influenza pandemic.
Communities and health care organizations need to have strategies in place that will address what will be done when health care facilities are overwhelmed and medical care must be provided in non-traditional settings. Alternate treatment centres and outpatient clinics may need to be set up to provide care. See Annex J for guidelines on the provision of care in non-traditional settings. Items addressed in this annex include administrative options for non-traditional hospitals, potential resources and sites, critical characteristics, support services needed, type of work done at sites and liability protection. Guidelines in Annex J also address potential sources of additional labour during a pandemic, volunteer recruitment and screening, liability and personal insurance of workers, temporary licensing of workers, roles and responsibilities, and training programs.
Certain decisions will have to be made at each level of government as novel virus and pandemic alerts occur. Local public health officials will be asked about measures that can be taken by the public and within a community to prevent, control or mitigate pandemic influenza in their jurisdictions. These decisions will range from population-based recommendations (e.g. canceling public gatherings, closing schools) to individual measures
(e.g. if members of the public should wear masks). For the most part, the effectiveness of these types of measures for the control of disease within a population has not been systematically evaluated. In addition, the potential impact of these measures will vary depending on the level of pandemic activity in the particular community and the availability of other interventions, such as vaccines and antivirals. The purpose and effectiveness of these measures may also be different in isolated communities compared with large urban centres.
The implications of these potential measures, which range from local school closures to quarantine recommendations for ports of entry into Canada, must be recognized by all potential stakeholders and discussed during the Interpandemic Period.
The objectives of public health measures planning are to:
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Prior to the outbreaks of avian H5N1 influenza in Asia starting in 2003, pandemic planners did not pay much attention to the concept of a prolonged “pandemic alert” period. In March 2004, WHO held an international consultation on public health measures that could be implemented during each pandemic phase. At this meeting, the concept of pandemic prevention by containing outbreaks that occur during the Pandemic Alert Period was discussed extensively for the first time. There was agreement that containment of a novel virus, which is not transmitted as efficiently from person to person as a “routine” seasonal influenza, should be attempted using aggressive public health measures. The role of antiviral drugs, contact tracing, quarantine and exit screening were highlighted as the keys to potential containment.
The Public Health Measures Working Group had already considered these interventions. However, following the international consensus that containment should be attempted during the Pandemic Alert Period, the need for clear direction on implementing these types of measures in Canada was recognized. Consequently, the working group developed an annex on public health measures for this edition of the Plan that includes recommendations on public health management of cases and contacts, community-based control strategies, and travel and border issues (see Annex M, Public Health Measures).
The recommendations of the Public Health Measures Working Group are aimed at facilitating a consistent and optimal response to public health communicable disease control issues during a pandemic. Because there is a lack of scientific data on the effectiveness of these types of disease control measures, especially in conjunction with other influenza control measures, it is unlikely that the benefits of these measures will be quantifiable. Therefore, in the absence of any conclusive data, the expert opinions expressed in Annex M, Public Health Measures will assist jurisdictions with the consistent implementation of timely measures that are in line with the objectives of each pandemic period, i.e. preparedness during the Interpandemic Period, containment during the Pandemic Alert Period and mitigation during the Pandemic Period.
The P/T and local planners are encouraged to explore the feasibility and implications of these types of control measures in their jurisdictions and to educate stakeholders (e.g. school boards, the business community, etc.) should it become advisable to implement these types of restrictive measures.
The overarching objectives of communications preparedness are to prepare Canadians to take appropriate action during a pandemic, and to build and maintain the confidence of Canadians in our organizations (e.g. various levels of government, stakeholders). Pandemic influenza communications planning is based on a strategic risk communications approach. This approach focuses on developing communications that are based on a solid understanding of what people know about pandemic influenza, what they do not know, and what they want and need to know. Establishing a dialogue with citizens is the core of this approach. Citizens need to be engaged in a dialogue about pandemic influenza preparedness activities for several reasons:
As the pandemic evolves, the number of organizations that become involved with the media on this issue will be enormous; there will be financial issues, human resource issues and social issues—issues that affect every facet of society. Because of the broad scope of these issues, working towards the development of consistent, coordinated messages that various levels of government and stakeholders agree to in advance of a pandemic is critical to ensure that Canadians are prepared to take action to protect themselves and their loved ones.
The information demands during a pandemic will be sustained over a long period, resulting in tremendous information demands. Sustaining public confidence over many months will be a huge challenge that will require consistent and coherent messages.
All key stakeholders (external, internal, international) must receive consistent and relevant information in a timely manner during any type of emergency. Planning activities are to ensure consistent and coherent messaging across Canada as well as predefining roles and responsibilities as much as possible.
The objectives of communication planning are to:
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Most communication activities related to influenza take place immediately preceding and during the typical influenza season from October to May each year. The P/Ts produce materials to promote immunization each fall; these are specific to the programs they offer in their jurisdictions. Most communication materials and strategies, which target the general public, media, health care workers and other community organizations (considered as “external” key stakeholders), are geared to promoting immunization and reducing unnecessary hospital visits. These materials are developed at the P/T and local levels with minimal federal input. To date, there has not been a centrally coordinated education campaign with regard to pandemic influenza that targets the external key stakeholders. Although campaigns have not been centrally coordinated, substantial work is going into ensuring a greater coordination of key messages. Within the pandemic communications planning process, F/P/T and non-governmental organizations are working on the development of messages that can be adapted to the specific stakeholders in each jurisdiction.
Communication with “internal” key stakeholders, mainly government decision makers and policy advisors, occurs at all levels of government. In addition, communications have established several communications networks for F/P/T interaction. A Health Emergency Communications Network (HECN) has been created. It was mobilized in response to the SARS outbreak and continues to be a key component in communication planning for pandemic influenza and other health emergencies. The HECN will be a key component of the pandemic influenza communications response. As well, a communications subcommittee has been created as part of the PIC and is responsible for pandemic influenza communications planning.
Federal communications on influenza currently focus on the dissemination of surveillance data by FluWatch bulletins. These bulletins are directed to public health professionals, but they are available to the public through the PHAC Web site. They are produced on a weekly basis throughout the influenza season. Information about international influenza activity is disseminated by CIDPC, mainly through the Canadian Integrated Outbreak Surveillance Centre e-mail alert system or Web site postings, to key stakeholders as necessary. As well, fact sheets on influenza, including influenza vaccines, are posted on the HC Web site. The PHAC also communicates with “international” key stakeholders, including WHO and the Pan American Health Organization, about influenza activity within and outside of Canada.
For emergency situations, PHAC has a public information line that can be set up for “around-the-clock” coverage. Other communication issues are also being addressed as part of the “all-hazards approach” to crisis communications.
The guiding principles for pandemic influenza communications planning are as follows:
1) Pandemic influenza communications planning is based on a strategic risk communications approach that:
2) Our approach is a collaborative one that reflects the agreement reached among the PIC communications subcommittee members.
3) Stakeholders are a focal point of our approach.
4) Strategic risk communications is itself a process requiring continuous evaluation and improvement. This must be built into our ongoing work plan for pandemic influenza communications.
5) The PIC communications subcommittee will work collaboratively with the technical experts on the PIC and its other subcommittees to ensure that communications planning reflects the best evidence and information available from the natural and social sciences.
The PHAC Communications, through PIC and with stakeholders at the F/T and local levels, will coordinate and facilitate Canada's public health communications response to pandemic influenza. Stakeholders have varying roles and responsibilities; therefore, coordination is crucial to ensure that messages are accurate and consistent and that jurisdictional boundaries are respected.
The development of a strategic risk communications plan is underway and would become a key part of communications planning for pandemic influenza. The PHAC is working with P/T Ministries of Health to develop key messages and mechanisms to communicate these messages to target stakeholders.
Planning and response activities can be broadly divided into four categories: prevention, preparedness, response and implementation, and post-event recovery and after care. During the Interpandemic Period, activities will focus on prevention and preparedness. Implementation of the response activities will occur in concordance with each change in Canadian Pandemic Phase. Recovery and evaluation activities will occur in the Post-Pandemic Period. Front-end investment of resources in prevention and preparedness activities will facilitate effective management of the pandemic and mitigation of negative outcomes.
To manage an emergency effectively, it is essential to have comprehensive response plans in place. With respect to pandemic planning, the existence of these plans needs to be communicated to all potential stakeholders. Copies should be distributed to organizations and individuals that will be involved in the pandemic response and, if possible, advance testing of these plans should be coordinated with a mechanism to provide feedback for improvement and updating.
In Annex A, Planning Checklists, planning activities are listed and grouped according to Plan components (i.e. surveillance, vaccine programs, antivirals, health services emergency planning and response, public health measures, communications). The checklists are designed to facilitate planning at the P/T and local levels, and they essentially reflect planning activities that should be undertaken during the Interpandemic Period.
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