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 3.2–Health System/Logistical Considerations

Submitted by:
Allison Stuart
Director Emergency Management Unit
Ontario Ministry of Health and Long-Term Care

Intended for: Task Group on Antivirals for Prophylaxis

SUMMARY

The decision has been made to use antivirals for treatment and plans are in development across jurisdictions regarding how best to address the logistical challenges. Should the decision be made to institute an antivirals for prophylaxis program within selected critical infrastructure sectors there are several significant issues to be resolved.

One assumes the decision as to who receives antivirals for prophylaxis is being decided as a result of consideration of all the consultation papers informing the Task Group on Antivirals for Prophylaxis. The WHO significantly impacts logistics issues. Resolution of issues relating to prescribing, compliance, delivery and security will also benefit resolution of those issues for treatment purposes—and vice versa.

• Is the strategy based on a pre-exposure or post-exposure model or a combination of the two?
• How does one ensure that health care professionals are fulfilling their obligations to the end user in terms of appropriateness of drug for the individual, informed consent and related health teaching?
• How does one ensure that the prophylaxis regime is initiated at the right time and who is responsible for making that decision?
• How does one address supply chain issues related to multiplicity of delivery sites and security of product?
• How does one ascertain how many individuals fall within the selected critical infrastructure sectors.

Issues for Resolution:

• How can one ensure that those responsible for prescribing will be willing to prescribe for large groups without scientific backing?
• How does one ensure that the prophylaxis regime is initiated at the right time and who is responsible for making that decision?
• How does one ascertain how many individuals fall within the selected critical infrastructure sectors?
• How does one address supply chain issues related to multiplicity of delivery sites and security of product?

METHODOLOGY AND CONSULTATION

The use of antivirals for treatment has been well established and, in concert with this, plans are being developed across jurisdictions to address the logistical challenges to ensure the antivirals are appropriately positioned to ensure access in a timely fashion.

The first level of consideration was to assess whether the existing plans for stockpiling, distributing and delivering antivirals would suffice for antivirals to be used for prophylaxis. The assessment was that the same method of distribution could not work for the following reasons:

• Distribution complexities due to the volume of drug required by each end user and the breadth of sites required to serve each end provider
• Significant security issues related to the stockpiling of such large amounts of antiviral
• Storage issues regardless of distribution model espoused

The second level of consideration was to identify themes relevant to the operational activities required to get antivirals for prophylaxis to the end user. The themes included:

• Who would be eligible
• Prescription-related activities
• Compliance with prophylaxis program principles
• Delivery of antivirals from a centralized stockpile to the end user
• Security of antivirals in centralized stockpile through to the end user
• Related issues

The themes and potential issues related to each were circulated to operational leads for pandemic planning at the provincial/territorial level, members of the Council of Health Emergency Management Directors, as well as a small group of materiel management experts. There was overlap among the groups and some participated to a much greater extent than others. No attempt was made to follow up with non-responders, although the penultimate draft paper was circulated to those consulted.

A third level of review has taken place by the Task Group on Antivirals for Prophylaxis and their comments have been incorporated into the current document which has, again, been distributed as above for comment. Very limited feedback was received, but has been included as appropriate. The final review by the TGAP has resulted in some additional changes that are included in this version so as to reflect the breadth of logistics issues raised as the work of TGAP evolved.

THEMES

1.Who Would Be Eligible?

There are two groups of individuals who must be considered for eligibility, depending on decisions made by other groups and overall recommendations by the Task Group: those to receive prophylaxis before known exposure to the virus (pre-exposure prophylaxis) and those to receive prophylaxis post-exposure (post-exposure prophylaxis).

a)Pre-Exposure Prophylaxis

A decision must be made as to which selected workers within which selected sectors would be eligible to receive prophylaxis should such a program be initiated. That decision is not the topic of this paper; however, there are related issues. Most, if not all, jurisdictions could agree on an approximation of the following groups as being critical infrastructure: food; water;

energy and utilities; health; transportation; manufacturing; public safety and security; government; telecommunications and information technology; and banking and finance

Health Workers

Direct Contact

Identification of health workers who would be selected is theoretically easier to determine: those with direct exposure to individuals with confirmed cases of influenza in a pandemic. In practical terms this would be modified to include not only those who have direct exposure to confirmed cases of influenza but also to those with direct contact with individuals with clinical cases of influenza. From an operational perspective in the health setting it may be difficult to differentiate among the groups

Indirect Contact

Others who may not have direct contact with individuals with influenza may be considered as critical to receive the antiviral pre-exposure due to their related systems work, e.g., some staff within the public health field. The same operational and practical issues as described above would come into play as those involved in surveillance and epidemiology may come quickly to mind, but circumstance may require others to step into different roles.

Other Critical Infrastructure Workers

Efforts to identify which positions within those sectors are truly critical have been challenging. Definitions of what is critical to a sector are difficult to achieve particularly in the absence of an overall arbiter who knows all sectors and can ensure that the application of “critical” is consistent. A further layer of complexity is introduced with the anticipated length of a pandemic. An informal survey of jurisdictions did not result in a model which could be applied across all jurisdictions or even satisfy requirements within the sponsoring jurisdiction.

The absence of good measures to ascertain numbers within the sectors is a significant challenge to a prophylaxis program in terms of planning, costing and delivery. However, difficulty in measuring and a lack of familiarity with critical sectors beyond health should not preclude the consideration of other critical infrastructure sectors from the discussion.

Post-Exposure Prophylaxis

At least two countries have made a decision to go with post-exposure prophylaxis, i.e., provision of antivirals for a ten day period (subject to change based on further information regarding the virus) for primary and secondary contacts of confirmed and/or clinical cases of influenza. The obvious advantage in the early stages is more judicious use of the antiviral and the absence of a need to determine who receives it and who does not as eligibility of recipients is pre-determined. However, it may be necessary for those developing a post-exposure model to identify eligibility, particularly as the number of post-exposure cases mount as the pandemic takes hold.

Disadvantages to this approach include: limited ability to monitor who is the final recipient of the antiviral (see below); the need to transition out of this approach when the number of exposures increase to an as-yet undefined level or to recognize that post exposure prophylaxis will quickly encompass most direct health care providers and eventually most of the population; and the unknown as to whether critical infrastructure workers, including health workers, will turn up for work in the absence of pre-exposure prophylaxis.

2. Prescription-Related Activities

Antivirals may only be accessed through prescription and are usually dispensed by a pharmacist. However some jurisdictions are considering other methods of prescribing/dispensing the medication to address the unique needs in a pandemic.

a) Pre-Exposure Prophylaxis

Prescribers and dispensers of medication are both required by their professional/licensing bodies to take steps to ensure the drug is safe for the specific patient (end user) and provide appropriate health teaching for that individual so as to ensure informed consent. While fact sheets could be provided to address the basic health teaching that is required, it is more difficult to develop strategies to ensure the safety of the drug for the individual normally achieved through history-taking, health assessment, etc. It will also be important to ensure that prescribers and dispensers are using the same protocols and applying them in a consistent fashion.

Workplaces that are geographically defined, a hospital, a water treatment plant, a bank, are easier places to manage the health assessments, the distribution of the medication and the direction to initiate treatment. Those critical infrastructures that have staff that are more dispersed, like home care providers or transport workers, would be more difficult environments within which to manage a pre-exposure prophylaxis program.

Questions for resolution:

• One assumes the drug would be dispensed in advance of when the end user should start taking the antiviral for prophylaxis.
• How does the individual know when to start taking the drug?
• Who is responsible for making that decision, i.e., when to instruct end users to initiate prophylaxis?
  • If the direction comes from someone other than the individual’s clinician, is that other person acquiring liability for any misadventure associated with the end user initiating prophylaxis?
  • Will there be enough qualified prescribers/dispensers?

Post-Exposure Prophylaxis

This model would lend itself to appropriate health assessments, health teaching and time sensitive delivery of the antiviral to the target groups in the initial stages.

3.Compliance with Prophylaxis Program Principles

a) Pre-Exposure Prophylaxis

One assumption is that antiviral drugs, in the quantity required for prophylaxis (a pill a day for as long as protection is sought), would become a valuable commodity. Its use could be diverted for both value-driven and profit-driven reasons by the end user and, in fact, by others along the supply chain. Health workers, and presumably this is true to a lesser or greater extent in other critical infrastructure sectors, work in multiple settings. There would be a need for a generally accepted protocol to ensure that individuals did not inadvertently get access to multiple delivery systems.

Questions for resolution:

• How would the authorities ensure that the antiviral was taken by the identified recipient and not diverted to family members, or personal profit through a “black market”?
• Reference is made to directly observed treatment (DOT) as a response to these issues. Who would be accountable for DOT? How would it be managed on days away from the workplace? What about those situations where the individual is working from home and is considered a critical worker or is not based at one site?

b) Post-Exposure Prophylaxis

Initially this would represent a smaller number of people and thus be easier to superficially monitor for compliance, however, as the pandemic proceeds this will become more difficult. Given the diversity of exposure sites, i.e., home and/or workplace of primary and secondary contacts, the ability to use DOT is limited

4.Delivery of Antivirals from a Centralized Stockpile to the End User

There are still many issues to be resolved regarding delivery and management of antivirals from warehouse (centralized or decentralized) to end-user.

a) Pre-Exposure Prophylaxis

Although exact numbers are not available for the potential number of end users of the antivirals, nor the number of sites that those end users operate from, one can assume that the numbers are large. The complexity of the distribution system would add significantly to both the time required to appropriately plan and, presumably, to the cost of delivery. If one uses a procurement rule of thumb of 10% for stockpile management and distribution, the cost of each dose would increase from $2.33 to $2.56. It could be argued that the costs would be higher than the 10% identified here.

Pre-positioning of the antiviral with the designated worksite or worker would streamline logistics in advance of the emergency. For those critical infrastructure sectors with defined geographic locations (as discussed above) the challenges of delivery to the appropriate end user is much easier than in those sectors where the geographic location is diffuse. It is recognized that while broader distribution provides easier access for the individual and may share the monitoring responsibilities, it also heightens the potential for mis-use.

Questions for resolution:

• Where would the antiviral be stored? If in centralized stockpiles there are related issues of distribution particularly as the decision to implement will be made with short notice and require a very quick action time. If in work settings there are related issues of security, control of use, etc.
• How would the antivirals be accessed?
• Would the government—which level of government—be responsible for distribution to critical workers or their organizations or would the drug be accessed through a pharmacy?

Post-Exposure Prophylaxis

This model would require antivirals to be easily accessed everywhere so as to be able to

be accessed quickly. This in turn would require more antiviral for prophylaxis than might be immediately assumed given the level of dispersement required.

5. Security of Antivirals from Centralized Stockpile through to the End User

The security needs for stockpiled antivirals has been recognized, however, this needs much more detailed discussion as to who provides the security and to what level—just at federal/provincial/territorial levels or at regional/local and even end user levels as well. As discussed above, the potential for diversion from intended purpose is significant and can happen at many points along the supply chain.

If the decision is to use antivirals for prophylaxis, expectations of local critical service employers regarding security must be developed and disseminated at the same time as the announcement regarding prophylactic use.

6.Related issues

a) Public Health

Dependent on the definition of who is eligible for receipt of prophylaxis, most public health workers may not be recipients. This may impact on their availability during a pandemic.

The public health role traditionally would focus on both compliance and efficacy of a strategy. In a pandemic, compliance cannot be truly monitored with the breadth of potential recipients and the other roles that the public health authorities must play. It is important that in the planning stages, consideration is given as to how the efficacy of either strategy will be monitored. The role of public health authorities in the development and distribution of an antiviral prophylaxis program, should one be offered, requires definition and description.

b) Health Care Workers

There is no clear evidence to indicate that health care workers following appropriate infection control precautions will be at higher risk for illness during the pandemic. Equally, the opinion of a health care worker (and the public and their families) caring for those with active diagnoses of influenza will likely be that (s) he is at greater risk. Prophylaxis of these workers may encourage continued work in a high exposure setting and help reduce the risk of health care workers transmitting influenza to other patients and to health care workers’ families. The trust of health care workers may be severely compromised if they are NOT provided with prophylactic antivirals as some existing pandemic plans state or imply that antivirals will be available for prophylaxis.

In a pandemic, the whole priority group structure could be challenged. If prophylaxis is successful, there will be competition for the scarce resource which may be an obstacle to health care workers getting priority over other critical workers that keep the community functioning.

Northern Isolated and Remote Areas

Given the breadth of Canada and the relatively low population, there are logistical issues

related to access to smaller communities. These include:

• Timely access: Depending on the time of year it may be difficult to bring supplies, including antivirals, to a community. This would then assume pre-location of antivirals
• Appropriate storage: Remote communities are less likely to have the quantity and quality of space that would allow for storage of quantities of supplies.
• Security.
• Health workers’ Given the number of health workers who have their primary residence outside the community they serve, there may not be the appropriate individuals in place to address either a pre-exposure or a post-exposure program.
• Cultural issues: It is the tradition within some groups to return home when someone is ill. This could have significant impacts on smaller communities that are artificially extended in an influenza pandemic

Miscellaneous Issues

• A decision regarding the use of antivirals for prophylaxis needs an informed decision regarding the length of administration. (Australia is proposing a second cadre of staff to replace those who have served for 6 weeks.)
• Prophylaxis creep: the mechanic who maintains the ambulance; the transport industry; etc. Where to stop?
• How to deal with prophylaxis issues for families so that staff do not need to care for ill families.

CONCLUSION

The decision to initiate a program for antiviral prophylaxis, pre- or post-exposure, cannot be made based on any one area of focus. It is important that the decision attempt to weave together the breadth of issues under consideration by the Task Group on Antiviral Prophylaxis. Equally, the reader should not assume that any one paper will address all the themes considered by the Task Group.

This paper attempts to identify the current thinking on issues related to logistics and antivirals for prophylaxis and to highlight areas of significant debate or questions that would need to be addressed should a decision be made to pursue a prophylaxis program. It has been informed by those involved in health emergency management, pandemic planning, and logistics, however, any errors rest with the author.

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