There is no other public health preparedness objective that has received the effort, emphasis, or funding of mass prophylaxis. When one considers the impact it may have, it is easy to see why. Among the fifteen DHS (Department of Homeland Security) planning scenarios – spelled out more than two years ago in accordance with Homeland Security Presidential Directive 8 – are several related to biological outbreaks or attacks that offer the greatest window of opportunity for lifesaving interventions. The possibility of biological attacks using Yersinia Pestis or Bacillus anthracis – the causative agents of plague and anthrax, respectively, both of which have a delayed impact on health – is of particular significance. If the appropriate antimicrobial medication is received early enough, those exposed can avoid illness. If there are delays, deaths occur.
The Cities Readiness Initiative is the primary U.S. effort to enhance the speed and effectiveness of mass prophylaxis. The goal of the program is to get antibiotics into the hands of an entire metropolitan area population within 48 hours. This initiative has focused primarily on the use of “Points of Dispensing,” or PODs. Using this approach, stockpiles of antibiotics called “push packages” maintained in the Strategic National Stockpile (SNS) are sent to PODs where local public health authorities and volunteers can dispense the medications to individuals at risk.
Through regular exercises at major cities across the nation, it has been clearly demonstrated that reliance on PODs alone is not sufficient. After a local surveillance system, such as environmental monitoring (BioWatch), or the epidemiological monitoring of human illness, detects a threat, the stockpiled drugs are deployed to the area of concern. The push packages are then broken down and sent to the PODs. However, the PODs still must be set up and the public notified where to go for prophylaxis. Finally, the dispensing begins. Each of these steps takes time. However, even though state and local public health professionals have made vast improvements in streamlining the process in recent years, it is still not possible to successfully treat most people living within a major metropolitan area in 48 hours or less.
The USPS Approach – Escorted by PPE Problems
Recognizing that the POD approach alone is not the answer, senior officials have ordered that other distribution approaches be considered. Perhaps the most promising of those alternate approaches has been the use of the U.S. Postal Service (USPS). There is no other system in place that touches every home in every U.S. community almost every day. Basically, the USPS approach would place prophylactic medications, and accompanying instructions, in the mailboxes of every home within an affected region in order to buy time for a more thorough follow-up using the PODs.
However, USPS officials have now defined what they need to carry out this task. Prominent among those needs are armed escorts as well as personal protective equipment (PPE) for USPS employees themselves. While these seem like reasonable requests, the “needs list” triggers all sorts of unwieldy requirements. Providing PPE for all (or almost all) USPS employees would mean, for instance, that they would have to be fit-tested and maintained on a Respiratory Protection Program. In addition, it seems likely that, if USPS workers themselves are wearing PPE gear, their armed escorts would want similar protection – which probably would translate into placing all local law-enforcement officers on a Respiratory Protection Program. (Here it should be noted that some communities have already determined that they do not have enough law-enforcement personnel available to assign one to each USPS carrier.)
Another insightful approach being taken by some metropolitan areas is to recruit large employers to set up PODs for their own employees. This would be an immense help. Much of the mass-prophylaxis planning to date has not included employer stakeholders. It stands to reason that employers have a vested interest in assuring the health and safety of their employees and their families during a public health emergency. Their involvement is long overdue.
The problem is, though, that this approach has not been well planned and/or exercised in most areas of the country. Moreover, no one knows exactly how willing the major employers in some regions may be to assume this responsibility. Of course, in the aftermath of a disastrous incident or event, many undoubtedly would step forward and be willing to assist, not only as good citizens but also for the sake of business continuity. Nonetheless, the willingness of such employers to preplan and engage in the process prior to an event is still limited in most regions.
Is Pre-Placement the Final Answer?
Which leaves what may well be the final option: stockpile pre-placement – which has in fact already been successfully carried out, albeit on a small scale, by some first-responder organizations. There are numerous fire, police, EMS, healthcare, and public health agencies and organizations across the nation that already have established local stockpiles for critical staff and their families. However, although the pre-placement concept seems sound enough in itself, there has been very little data developed to support the policy decisions needed to allow the pre-positioning of medications for homeland-security purposes.
Probably the last bastion for the pre-placement of prophylactic medications would be the homes of individual citizens. This option would in all likelihood be the most controversial and challenging approach to mass prophylaxis. There are, in fact, many healthcare professionals who feel strongly that the pre-placement of antimicrobial drugs in homes would be a potentially catastrophic mistake. The medications might be used inappropriately, and/or be improperly stored, and therefore might pose more risks than benefits to the households maintaining them.
In light of recent trends toward antimicrobial-resistant organisms, this is a noteworthy concern. If the diseases the nation has managed for decades, mostly by using antimicrobial drugs, continue to build resistance to those therapies, it may well be that previously treatable illnesses become untreatable.
The improper use of home “Medkits” could contribute to the problem. The dilemma here is that there are no data either to support, or to refute, the assumption that these drugs, if kept in a home for homeland-security purposes, would contribute to and/or exacerbate the mounting public health challenge posed by antimicrobial resistance. Moreover, it has never been done before – not, at least, in the United States, which has never packaged medications for household preparedness or even carried out a major test program to determine how responsible the general public may be in handling them.
However, an initial study on the potential household placement of antimicrobials was carried out in 2006 and 2007 in an area in and around St. Louis, Missouri. A convenience sample of homes was selected for the study, and a prototype Medkit was created for the test. The kit contained a five-day supply of either doxycycline or ciprofloxacin, sealed in a blister pack. The blister packs for each household were sealed in transparent protective outer bags. A bold warning was placed on each package stating that the medications inside were intended for homeland-security purposes, and should be opened only if and when instructed by authorities.
The Medkits were distributed to local residents belonging to three sociologically cohesive cohorts: first responders; the employees of certain corporations; and the clients of federally qualified health centers. Members of the participating households were given the Medkits and instructed on how to store them. The study households were then randomly assigned follow-up visits at two months, four months, and eight months – those periods were used to help determine if attitudes and/or behaviors changed over a carefully measured period of time.
During the follow-up visits, the participants were asked to retrieve their Medkits. When they had done so, they were given general preparedness kits – each of which contained, among other things, a battery-powered radio and other non-pharmaceutical preparedness supplies to replace the original Medkit. The results were encouraging: 97 percent of the participants returned the Medkits at the end of the study; 99 percent of the returned Medkits had no pills missing; and 94 percent of the participants said they would like to have Medkits in their homes.
This may represent an entirely new approach to public health preparedness. If the public displays responsible behavior with such kits, it could reduce the reliance on PODs and other mass-prophylaxis approaches. It also raises a number of interesting questions, though, including the following: (a) Could anything other than antimicrobials be stored in such kits? (b) Could antivirals be provided in homes for pandemic influenza preparedness? (c) Or could radiological drugs be provided to those living near nuclear power facilities?
It is still too early, of course, to determine what the long-term policy implications of the St. Louis MedKit study might be. It seems safe to say, though, that the data provided by such studies may open new approaches to mass prophylaxis. This is especially true for those in the nation’s critical-infrastructure and special-needs populations, both of which may be difficult to reach during future times of crisis.
Bruce Clements is the Public Health Preparedness Director for the Texas Department of State Health Services in Austin, Texas, and in that post is responsible for health and medical preparedness and response programs ranging from pandemic influenza to the health impact of hurricanes. A well-known speaker and writer, he also serves as adjunct faculty at the Saint Louis University Institute for BioSecurity. His most recent book, Disasters and Public Health: Planning and Response, was released in 2009.