ARCHIVED - Lessons Learned Review: Public Health Agency of Canada and Health Canada Response to the 2009 H1N1 Pandemic
3.7 Emergency stockpile
National Emergency Stockpile System
The National Emergency Stockpile System is a federally owned stockpile of emergency pharmaceuticals, medical supplies and equipment managed by the Public Health Agency of Canada. Medical supplies and equipment range from beds and blankets to advanced pediatric ventilators. Pharmaceuticals include antibiotics and antivirals. Antivirals are drugs used for the prevention and early treatment of influenza. If taken shortly after getting sick, they can reduce influenza symptoms, shorten the length of illness and potentially reduce the serious complications of influenza. Antivirals work by reducing the ability of the virus to reproduce but do not provide immunity against the virus. The H1N1 influenza virus can be treated with two different antivirals, Oseltamivir (Tamiflu®) and Zanamivir (Relenza®).
The National Emergency Stockpile System inventory is stored in 10 federal warehouses and approximately 1,300 additional pre-positioned supply centres across Canada. These pre-positioned sites, which operate under the combined management of the provincial/territorial and federal governments, are intended to respond within 24 hours to a provincial/territorial request. The National Emergency Stockpile System includes a federal stockpile of 24.2 million doses of antiviral drugs owned and managed by the Public Health Agency of Canada to provide surge capacity to provinces and territories during a pandemic.
The National Emergency Stockpile System increased its holdings of antiviral drugs, personal protective equipment and ventilators during the H1N1 pandemic. The provinces and territories accessed the System for the following items:
- 135 adult ventilators
- 198,800 masks
- 24,320 capsules of pediatric antivirals.
National Antiviral Stockpile
In collaboration with provincial and territorial governments, the federal government created the National Antiviral Stockpile in the fall of 2004. The National Antiviral Stockpile is a federal/provincial/territorial government-controlled supply of antiviral drugs: enough to treat 17.5 percent of the Canadian population. The National Antiviral Stockpile is held in provincial/territorial warehouses; the provinces and territories are responsible for the implementation of the national antiviral strategy and distribution of antiviral drugs from the National Antiviral Stockpile in their jurisdictions. Antivirals in this stockpile are used for early treatment in an emergency, targeting those who are deemed to be most at risk of serious morbidity and mortality. It was agreed that antivirals would be distributed on a per capita basis to the provinces and territories, each of which would have responsibility for care and control under the terms of a national agreement for use. As of May 2009, the stockpile consisted of 48.7 million doses of adult Oseltamivir capsules, two million pediatric Oseltamivir capsules and five million doses of Zanamivir.Footnote 57 Some provinces and territories chose to purchase additional quantities. The release of antivirals from the National Antiviral Stockpile is determined by provinces and territories on an individual basis. During the H1N1 pandemic, provinces and territories released 4.4 million doses of antiviral drugs from the National Antiviral Stockpile.
Canada’s antiviral stockpiles are regularly reassessed by federal and provincial/territorial governments for:
- composition (type of antiviral) and relative proportion of the stockpile in line with new science
- technologies and formulations
- changing resistance rates
- disease epidemiology
- changing populations.
In addition, all drugs have a shelf life or an amount of time specified by the manufacturer during which the drug is documented to be stable and potent. This necessitates the development of a stockpile management approach that allows for the regular replacement of inventory.Footnote 58
Health Canada regulates and authorizes the sale of health products, including antivirals, sanitizers/disinfectants, ventilators and masks, contained in the stockpiles. During the H1N1 pandemic, for example, Health Canada provided regulatory authorization of antivirals (e.g. Tamiflu® for children under one year of age) and the Special Access Program authorizations for unlicensed health products (i.e. intravenous Relenza®, Peramivir). It also developed guidance, along with the Public Health Agency of Canada, on the use of disinfectants such as bleach and hand sanitizers with health claims, and provided guidance and regulated health claims supporting various masks and ventilators.
What worked well?
Advance planning ensured antivirals and emergency medical supplies were readily available
Several interviewees agreed, “It was more of ‘When do we decide when we want to draw on that, if we need to?’ I think those were sort of the pluses from the standpoint of the wave one response.”
During the H1N1 pandemic, the Public Health Agency of Canada was the federal lead for stockpiling and distributing supplies from the National Emergency Stockpile System to the provinces and territories, as well as for facilitating the procurement of additional emergency supplies to complement provincial/territorial stockpiles, and, to the extent possible, for coordinating federal and provincial/territorial planning and response activities.
Advance planning in anticipation of a pandemic influenza led to decisions to procure additional antivirals and other health supplies, including sanitizers/disinfectants, ventilators and masks for the National Emergency Stockpile System/National Antiviral Stockpile. One interviewee indicated, “We stockpiled gloves and masks, as well as medications, antivirals, antibiotics. We made the decision to purchase ventilators very fast at the beginning – a good decision because we didn‘t know the severity in what was to come in the winter.“
Federal Budget 2006 allocated $600 million for general pandemic planning and preparedness activities. Among the range of health sector activities supported by these funds was the purchase of antivirals.
The Public Health Agency of Canada, with the provinces and territories, developed guidelines for the distribution of antivirals from the National Emergency Stockpile System in the event of a depleted National Antiviral Stockpile. The guidelines were approved September 11, 2009, by the Special Advisory Committee. The Public Health Agency of Canada also developed guidelines for the distribution of ventilators, which was approved by federal, provincial and territorial Deputy Ministers on October 29, 2009. Under a loan agreement, two provinces requested that their allocation be pre-positioned early in the second wave.
This planning paid off. Canada was able to mobilize quickly in response to the H1N1 threat. Having a stockpile of antiviral and medical supplies available ahead of time enabled the provinces and territories to distribute the antivirals and supplies more quickly.
Areas for action
Review the National Emergency Stockpile System and the National Antiviral Stockpile in light of the H1N1 experience
Following the H1N1 response, three primary areas for further discussion and decision emerged:
Inventory replacement strategy for both stockpiles
As a result of usage during the H1N1 pandemic, stocks (including antivirals and other supplies) were reduced. A replacement strategy is currently under development.
Expiring stockpiles and renewal of both stockpiles
Antiviral stockpiles are nearing the end of their shelf life (antivirals have a shelf-life of five to seven years). A staggered purchasing and maintenance plan could be explored for antivirals in both the National Emergency Stockpile System and the National Antiviral Stockpile, which will ensure that a scalable and ‘evergreen’ stockpile of antivirals is available, level out commitments from year to year, and maximize the ability to adjust stock as new developments arise.
Equitable regional distribution (by population or by need)
In collaboration with the provinces and territories, the Public Health Agency of Canada is in the process of determining an equitable allocation strategy for antiviral distribution of the National Emergency Stockpile System as their respective National Antiviral Stockpile stocks are depleted.
The Public Health Agency of Canada also identified the stockpile content, function, lifecycle and distribution processes as areas for action in a 2006 review of the National Emergency Stockpile System.
Consider options for prescribing and dispensing antivirals in remote and isolated communities during a pandemic
A discussion emerged during the H1N1 emergency about allowing community health workers, paramedics or other officials within remote and isolated communities to dispense antivirals to influenza-stricken residents during an outbreak, specifically in cases where no doctor or registered nurse is available.
It has been suggested that “every single day they [an infected person] don‘t get Oseltamivir places their health at greater risk.”Footnote 59 Opposing views to this approach suggest:
- there is a risk of people mistakenly receiving antivirals when they have not been properly diagnosed and should actually be treated for another condition
- it is outside prescribing authority
- it implies people in remote and isolated communities are being provided a different standard of care.
Consideration should be given to national and international best practices for prescribing and dispensing antivirals. For example, during the H1N1 pandemic, one Canadian jurisdiction, with support from its provincial medical association, instituted a temporary fee item to allow physicians to consult patients with suspected H1N1 symptoms over the phone and to prescribe antivirals by phone. Other countries, for example the United Kingdom, have a program that allows people to contact call centres, describe their symptoms and get a prescription, which a family member or friend can pick up.
A potential solution would be to have antivirals pre-positioned within remote and isolated communities and have them distributed by a responsible local official who is in telephone contact with physicians. A contributor to the Canadian Medical Association Journal suggested, “You hand it out if people meet the symptoms and in the interim, you can start to transport them out for assessment. God knows, I don’t think you should be waiting a week to get treatment.”Footnote 60
Health Canada is considering several options with provinces and territories, such as flying doctors into outbreak sites or adjusting prescribing practices to allow for prescribing of antivirals in remote and isolated communities where access to licensed prescribers may be of concern.
Seek authority to donate stockpile supplies to other countries
Currently, since the mandate of the National Emergency Stockpile System does not allow the Public Health Agency of Canada to use stockpile supplies for the purpose of international assistance, it cannot donate or loan products for this purpose unless they are declared surplus. There is sufficient statutory authority to make international donations of federally owned vaccine that is surplus to Canada’s needs, as long as the donations comply with statutory and contractual requirements. Consequently, if the Public Health Agency of Canada wants to provide international assistance, prior to the stockpile being declared surplus, it could consider seeking financial and program authorities to expand the current mandate of the National Emergency Stockpile System. If the Public Health Agency of Canada were to secure such authorities, it should follow the practice of the World Health Organization and enter into agreements with recipients setting out the terms and conditions governing the donation, whether the recipient is an international organization or another country. Further, the Public Health Agency procurement policies would need to ensure that there are no impediments to the international donation.
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