Canadian Forum on Implementation of the Antiviral Strategy for Pandemic Influenza: Proceedings Report

October 25-26, 2007 Montreal, Quebec

Table of Contents

• Executive Summary
• October 25, 2007 - Day One
• Day One. Key Findings/ Outstanding Issues and Recommendations
• October 26, 2007 - Day Two
• Day Two. Key Findings/Outstanding Issues and Recommendations
• Conclusion

Executive Summary

On October 25 and 26, 2007 the Public Health Agency of Canada (PHAC) hosted a Canadian Forum on Implementation of the Antiviral Strategy for Pandemic Influenza. The Forum brought together key stakeholders to seek their agreement on the national elements of an antiviral early treatment strategy, and to review challenges, best practices and models to advance the development and coordination of national antivirals stockpile implementation plans. There were over 120 delegates in attendance.

The Forum was planned with a multi-stakeholder Planning Committee chaired by Patricia Huston (representing both the federal perspective and the Pandemic Influenza Committee (PIC) and Corinne Rowswell (representing both the provincial/territorial perspective and the Pandemic Preparedness Health Operations Coordination Working Group (PPHOC). There were also two Task Groups that assisted with development of Day One and Day Two of the Forum.

Delegates included the Chief Medical Officers of Health (or their delegate), Public Health Network Council (PHNC) appointed provincial/territorial (p/t) health planners, members of PIC, members of PPHOC, local public health officials, federal officials, and representatives of various stakeholder groups (College of Family Physicians of Canada, Canadian Nurses Association etc). First Nations Inuit Health Branch (FNIHB) and representatives from First Nations and Inuit communities were well represented at the Forum. International guests attended from Australia, the United Kingdom, the European Union, Japan and the United States.

October 25, 2007 - Day One

Day One of the Forum focused on the “who”, identifying who should receive antivirals and the surveillance, laboratory, regulatory and communications strategies needed to support this.

It began with a historical overview of Canada's evolving preparedness to deploy antiviral drugs in the event of a pandemic. The overview focused on the creation and ongoing enhancement of the national antivirals stockpile, steps leading up to the adoption of an early treatment strategy and the process underway to complete a national policy on antiviral prophylaxis.

The presentation on “who to treat” featured a proposal developed by the Day One Task Group. Critical gaps were identified in areas such as research and professional education, and included strategies for substantive collaborative action to address the gaps in anticipation of a pandemic. While there was little dissent around the proposal itself, participants raised a number of important considerations that should guide next steps, including the need to clarify definitions and other key dimensions of the early treatment strategy, build pandemic capacity and develop tools and resources to support implementation.

Participants received a summary of the status of influenza surveillance in Canada, an overview of the proposal for pandemic surveillance and recommendations and next steps to advance the pandemic surveillance strategy. The need to establish infrastructure, including modeling capacity in anticipation of a pandemic was stressed by participants.

The current laboratory strategy for influenza and the proposed national approach to guide lab testing during a pandemic was presented. There was strong recognition of the indispensability of laboratory capacity and procedures to guide testing and triage, as well as for a “real-time feedback loop” from surveillance and laboratory data to inform decision making at all levels.

There were presentations on a number of other national issues, including potential steps to address antiviral stockpile expiry; the use of medical directives to facilitate access to antiviral drugs in the event of a pandemic; the regulations that govern prescription status, the regulatory process behind switching a drug from prescription to non-prescription status and an explanation and exploration of the potential of the Health Canada Special Access Program's “block release” mechanism. Plans for a passive, stimulated adverse reaction reporting system were presented, and how it might be maintained and enhanced in the event of a pandemic.

Day One concluded with a presentation on the potential of the risk communications model for ensuring stakeholder and citizen buy-in for an early treatment antiviral implementation plan. Participants expressed collective appreciation for the importance of effective communications during a pandemic, and offered suggestions for translating communication challenges into effective action at all levels.

Day One. Key Findings/ Outstanding Issues and Recommendations

Findings/ Outstanding Issues	Recommendations
Who should receive antivirals for treatment during a pandemic? There was general agreement that criteria for treatment should be consistent across the country. Issues Require clarity on whether antivirals should be held back for a second wave. A research program to facilitate real time clinical research during a pandemic to identify high risk groups, utility and futility indicators needs to be established now. Education of health care workers on the antiviral implementation strategy, including best practices when antivirals are denied A public education program is needed and the optimal time to launch it identified.	Consistent with the FPT Ministry of Health policy decision in May 2006: AVs should be given to anyone ≥ 1 year who presents with influenza (diagnosed by clinical algorithm or lab test if available) when “pandemic virus is known to be circulating in the community”. Preferably within 12-24 hours, but at least within 48 hours after onset of symptoms. Assessment and treatment options include telephone triage, clinical algorithms and the use of medical directives. Children under 7, those with complications or risk conditions, would be assessed by a clinician. Clinicians would be allowed some flexibility in treating children <1 and hospitalized patients. In the event of shortages, priority would be given to high risk groups. The high risk groups for seasonal influenza identified by the National Advisory Committee on Immunization (NACI) would provide the baseline and this would be updated as the clinical and epidemiologic data becomes available.
National surveillance strategy to support AV implementation Surveillance and the national laboratory network are critical to the AV implementation strategy as release of the AV stockpile depends on documenting that “pandemic virus is known to be circulating in the community”. Surveillance will build on FluWatch, the seasonal influenza surveillance program, and will include Severe Respiratory Illness (SRI) reporting and PHAC Alerts. Regional areas in FluWatch are currently based on census-tracts. Issue Capacity for antiviral effectiveness monitoring needs to be enhanced as routine surveillance methods would not be sufficient.	Develop data collection methods/tools that could be used in assessment centres, ideally involving the use of electronic health records. Develop real-time mortality and severity indicators for adults. Improve/establish electronic and web-based reporting systems. Define criteria for “virus is circulating” and a “community” for the purpose of determining when to release antivirals for use.
National laboratory strategy to support AV implementation Currently Point of Care (POC) testing is used in many jurisdictions for seasonal influenza but this is not sufficiently accurate to determine the presence of pandemic influenza in a community. Labs expect the greatest demand for testing will occur just before pandemic influenza is identified in a community; subsequently, diagnosis will be largely clinically based, and the laboratory capacity will be reserved for surveillance, monitoring and research purposes.	Increase nucleic acid (molecular) testing capacity. Increase capacity to assess novel diagnostic methods. Improve access to testing in rural, remote communities.

October 26, 2007 - Day Two

On Day Two, the objectives of the Forum were to review a range of early antiviral treatment models and emerging plans towards addressing issues such as storage and handling, delivery and dispensing of antivirals, monitoring uptake, legal and ethical considerations. Participants were invited to move from national issues to the operational implications of an antiviral early treatment strategy from the provincial-territorial level to the front line.

A comparative analysis of international implementation planning for antiviral use during a pandemic was presented. The analysis focused on developed countries, most of which have antivirals policies and are further developing their implementation plans. It included a range of issues from stockpiling and distribution to patient assessment and dispensing.

Next, participants received a briefing on the results of a 2006 survey which was subsequently updated in the summer of 2007 of provincial and territorial Emergency Health Planners. The focus of the survey was to determine whether there are logistical plans in place for the delivery of antivirals during an influenza pandemic. The results indicate that the majority of provinces and territories have plans and are continuing to develop their respective logistical plans.

Presentations from some of the Forum's international guests offered a variety of considerations and approaches to help inform domestic planning efforts. There was considerable interest in the range of practical approaches that are being adopted in Australia, the United States and England, and their potential applicability in the Canadian context, for example as they pertain to patient triage and special populations.

Participants were also presented planning and preparedness efforts in some key Canadian jurisdictions. They engaged in a frank discussion of challenges to effective planning and implementation at the provincial, regional and local level.

There were presentations and discussions regarding the legal and ethical questions and considerations related to an antiviral early treatment strategy, and general acknowledgment that these considerations must inform planning efforts and underpin decision-making at all levels.

Day Two. Key Findings/Outstanding Issues and Recommendations

Key Findings/Outstanding Issues

Recommendations

Operational strategies to support AV implementation Most PTs are planning assessment centres to facilitate the distribution and tracking of antivirals. PTs are considering the use of medical directives, understanding that there are different PT legislation and practices regarding who writes the medical directive and who carries them out. Regulatory authorities identified that making AVs non-prescription drugs during a pandemic was unlikely and not encouraged as it may result in increased safety risks. New regulations are in place that will facilitate block release of investigational new drugs and could assist in monitoring of off-label use. Safety monitoring will rely largely on stimulated passive surveillance by the Marketed Health Products Directorate at Health Canada and twice weekly reporting is planned. Giving priority to health care workers (HCW) and other critical infrastructure workers was discussed and likened to the immediate care given to HCW following a needle-stick injury. The concept of pre-placement of antivirals at the workplace was identified as one way to facilitate rapid treatment. There was support for an FPT/multistakeholder approach to address the shelf-life issue of current stock and to develop a stockpile management strategy in the long term. Issues It was noted that the AV implementation plan is based on a moderate scenario and consideration to developing a severe pandemic scenario may be indicated. Consideration of active safety surveillance in certain populations (e.g. infants, pregnant women).

PTs will need to complete their own operational plans to ensure that AV implementation addresses their own unique populations and fits with their health care system. PT operational plans need to ensure antivirals are distributed to First Nations and Inuit communities as well as those in correctional services. Need to identify who determines when the criteria for release of the antivirals for use are met (virus is circulating in the community). This is critical as there will be extreme pressure to begin use of antivirals before the virus is circulating in the community, increasing the risk of shortages. Identify how different plans are tied together and to establish a “clearinghouse” to share ideas, best practices Assess the feasibility of implementation plans with key stakeholders, such as front line health care workers and the public to ensure uptake and inform a risk communications approach.

Conclusion

There are a number of areas that need to be further developed to ensure effective implementation of the early treatment strategy. Some issues can be addressed through existing F/P/T mechanisms and for other issues new mechanisms are needed. As delineated in the key findings/outstanding issues and recommendations, some areas will benefit from national coordination; in other instances no “one size fits all” will be possible, and each jurisdiction will need to develop and advance their own plans.

Participants were advised that national issues that would benefit from a coordinated approach would be brought forward to the F/P/T Public Health Network Council for their consideration.