Pan-canadian public health network council report and policy recommendations on the use of antivirals for prophylaxis during an influenza pandemic

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Annex 3.4–Ethical/Societal Considerations on the Prophylactic Use of Antivirals in an Influenza Pandemic

Submitted by:
Caroline Alfieri
Ethicist
Associate research professor
CHU Ste-Justine/Université de Montréal

Intended for: Task Group on Antivirals for Prophylaxis

Introduction: The context

Prophylactic use of antivirals during an influenza pandemic raises issues of resource allocation at the macro level. Two questions which arise when considering antiviral stockpiles for large-scale prophylaxis are whether benefits exceed burdens and whether the expense incurred represents an appropriate use of public money.

If it is the obligation of government to provide a basic array of health services, as determined by the average health care needs of its constituents, one can argue that F/P/T governments have fulfilled this basic need through provision of an antiviral stockpile intended for early treatment. This meets the equity requirement for medical need-based allocation since anyone sick enough to warrant use would have access.

Pandemic planning, however, is a complex exercise with a two-pronged mission which, as stipulated in the Canadian Pandemic Influenza Plan, is to minimize overall morbidity and mortality, as well as societal disruption among the people of Canada. To properly accomplish this mission it is incumbent on planners and decision-makers to carefully consider all pre-emptive strategies, including amassing antiviral stockpiles for prevention, in an attempt to mitigate the serious toll on human life and societal structure that would be incurred in the wake of an influenza pandemic.

Choice of ethical framework—the criteria system

Consultations: the criteria system was first proposed as an operational framework for scarce resource allocation in a pandemic context within a Masters thesis dissertation submitted by C. Alfieri in 2005 to the Faculty of Graduate Studies of McGill University. There is some precedent in the medical literature to support the use of a criteria-based framework for resource allocation in health care.^62,63 This idea was vetted through discussions with McGill University bioethicists Kathleen Glass and Jonathan Kimmelman, as well as Thérèse Leroux, lawyer and bioethicist at the University of Montreal, all of whom were members of the evaluation committee for C. Alfieri’s thesis. More recently (June 2006), the idea was further vetted when it was submitted as an ethics pilot grant proposal to a competition opened by CIHR’s Ethics Office. The proposal was evaluated by the Health Ethics, Law and Humanities peer review committee and has just been granted approval for funding. Further, a prior version of this paper was sent to Ted Schrecker (associate scientist at the Institute for Population Health, University of Ottawa) for input from a social science perspective.

Rationale for the criteria system: Should the establishment of an antiviral stockpile for prophylaxis be deemed necessary—following scientific, economic, logistical, legal, social and ethical assessment—then the next level of inquiry must consider the size of the stockpile. Roche’s recent announcement that their production capacity exceeds demand means that, if contracts are drawn ahead of a pandemic, the size of the stockpile can theoretically be as large as government coffers will allow. In practice, however, the population is best served if governments perform cost-benefit analysis along with careful evaluation of benefits and burdens for each group considered for prophylaxis. To do this fairly and in respect of the principle of justice, it is necessary to adopt a process that is completely transparent, operational and easy to communicate to stakeholders and the general public. We have proposed the criteria system as one such approach based on its relevance to resource allocation in health care.⁶⁴ Choice of criteria might include contribution (toward pandemic planning goals), medical need, scientific merit and logistics, as defined below.

1. The contribution or social need criterion

Since pandemic preparedness constitutes an issue of public health importance and, like other public health initiatives, is ‘goal-oriented,’⁶⁵ one important selection criterion might be the contribution of the individual or group in terms of accomplishing the goals of minimizing morbidity and mortality as well as societal disruption in Canada. For example, one might argue that offering antiviral prophylaxis to health care workers (nurses, doctors, and hospital support workers) and essential service workers (military, police, firefighters, air traffic controllers, hydroelectric workers, etc) is acceptable based on the contribution criterion. This means that the social role of these individuals (safe-guarding public health, safety and/or security) justifies their access to antivirals for prophylaxis because protection of this group will support the goals of reducing morbidity, mortality and societal disruption.

Further, the impact of higher than usual absenteeism in some key sectors where maintaining near-complete business continuity is essential (e.g., communications or utilities companies, businesses involved in the food chain, etc) also requires careful examination. It is possible that a decision not to provide antivirals for prophylaxis to those critical to the pandemic response in Canada would result in increased societal disruption due to excess absenteeism or labour problems.

One difficulty here is that it may be operationally challenging to identify and enumerate narrowly those truly critical to the pandemic response. Hence, cost estimates for prophylaxis of such groups will be difficult to obtain.

2. The scientific merit criterion

Ethically, best medical practice is founded in sound scientific evidence. Hence there should be solid scientific justification for efficacy, along with a scientific assessment of risks (both for and against use), before one can recommend the drug on a large-scale basis. Without such assessments, the burdens (in terms of risks and costs) may prove to be too high relative to the potential benefits.

3. The medical need criterion

In keeping with the goals of pandemic planning, one might consider prophylaxis of individuals with pre-existing conditions (e.g., immunodeficiency, diabetes, asthma, cardiac problems, etc) along with the elderly and the very young. If infection of these individuals, or any other group defined by the epidemiology of the pandemic strain, results in higher morbidity/mortality compared with the general population, or if it follows a particularly rapid course such that early treatment would not be beneficial, the care of this group alone might quickly overwhelm the health care system. Hence prophylaxis may be considered for such indications to prevent the high morbidity/mortality rate and the burden it will cause to the health care system.

Further, in the interest of equity, it may be advisable to consider the differential needs of these vulnerable individuals in terms of the higher risk to their health if they were to contract pandemic influenza (see discussion of egalitarian justice referred to below in section “Adherence to basic ethical principles”). Provision of antivirals for prophylaxis to this group might therefore be warranted based on the criterion of medical need.

4. The logistics criterion

Implementation of a prophylaxis strategy during a pandemic will involve challenges such as the ability to identify and access members of groups recommended for antiviral prophylaxis. Other logistical issues include ability to determine onset of prophylaxis timing, ability to monitor use and compliance, as well as the ability to monitor side effects of drug use. Further, it will be important to communicate to users that any sign of Influenza like Illness (ILI) will demand a switch to the therapeutic protocol (i.e. higher doses of drug). The inability to properly address logistical problems may defy arguments in favour of the establishment of a prophylaxis stockpile.

Adherence to basic ethical principles

While the underlying ethic in resource allocation pertinent to public health medicine is driven by best consequences—doing the greatest medical good for the greatest number^66,67—one cannot ignore basic human rights and the dignity of the person. Hence it is vital that all decisions in terms of distribution of antivirals for prophylaxis be done in respect of ethical principles including transparency, stewardship, accountability, and reciprocity.⁶⁸ In fact, for any program to pass public scrutiny, consideration must be given to the value which Canadian society and its health care system places on equal rights, freedoms and opportunity for all persons.⁶⁹ These concerns are integral to egalitarian justice, whereby “equal opportunity for all” is the guiding principle.⁷⁰

In the Canadian health care system where supply of medical services is largely dependent on public funds, all decisions made at the macro level must consider societal preferences given that society is not only the recipient of health care services but also the ultimate funder of the system through Canadian resources. Hence it follows that public and stakeholder consultation should be a necessary part of the process before public money can be allotted to any major initiative. This issue has been addressed through the seven dialogue sessions with the Canadian public, as well as the two consultation sessions with target groups and stakeholders, respectively. Nonetheless, any decision for or against the stockpile should be accompanied by education campaigns targeting health care providers and the general public in order to build awareness of the issue and the reasons for the decision.

Other concerns

If a goal-oriented and criteria-based approach is adopted as an operational framework for decision-making on the need and use of an antiviral prophylaxis stockpile, then it is incumbent on the part of decision-makers to be consistent with the set goals. Therefore, it stands to reason that appeals to issues unrelated to the Plan’s goals, as for example global relief, would not conform to this framework. Thus, any argument in favour of or against the stockpile should be contextualized within the mission statement of the Canadian Pandemic Influenza Plan.

The suggested use of criteria provides a practical and transparent means to tackle the ethical quandary of whether an antiviral prophylaxis stockpile is warranted and whether a group should (or should not) be considered for antiviral prophylaxis. One note of caution concerns any decision to stratify selection of groups based on employer. Many health care workers in First Nations communities, long term care facilities or who provide home care, are private sector employees. Similarly, many essential service workers are not employed by government (e.g., utility workers). This argues for making decisions based on occupation and role in the response as opposed to employer identity (i.e., government sector employees versus private sector employees).

Summary

Public health medicine is goal-oriented, therefore the underlying ethic of public health missions, including any program to provide prophylactic antivirals for influenza in the context of a pandemic, invokes the duty to respect the goals of the mission. For the issue in question, the goal is clearly stated in Canada’s lead reference document for pandemic preparedness, the Canadian Pandemic Influenza Plan for the Health Sector. Also, because the overall aim of any public health program is to provide the greatest medical good for the greatest number of people, it is important—when distribution issues are at stake—to respect the principle of justice. The appeal to objective criteria is suggested as a means of ensuring that the distribution process is fair and transparent. In order for the process to appeal to stakeholders and the general public, the criteria themselves must be chosen carefully to reflect values that Canadian society cherishes, such as protection of the most vulnerable.

Further, when any medical intervention is proposed, there is a duty to weigh all advantages and disadvantages. For example, in considering the use of prophylactic antivirals for pandemic influenza, it is important to keep in mind that there are risks related to the use as well as the non-use of antivirals. Thus, proper risk-benefit assessments must be performed in order to evaluate efficacy in preventing influenza along with the downfalls of short- and long-term use. Also, planners must consider logistical or implementation issues since the inability to confront such impediments may trump arguments in favour of a prevention stockpile.

Based on the above considerations, the following criteria have been proposed to assist in advancing discussions as to which groups should be considered for prophylactic use of antivirals during an influenza pandemic:

1. contribution towards the goals of reducing morbidity/mortality and societal disruption
2. medical need
3. scientific merit
4. logistics

Finally, decision-makers have the duty of accountability to their constituents. Thus, any decision in favour of, or against, the acquisition of a public stockpile for prophylaxis should be accompanied by carefully designed education and/or public awareness campaigns to inform and educate stakeholders (such as healthcare providers) and the general public on the intricacies of the issue and the reasons for the decision.

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