Public Health Emergency Preparedness
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From Principles to Practice: Examples of Antibiotic Dispensing and Vaccination Clinic Plans
Since the 2001 U.S. anthrax attacks, a number of scientific studies have underscored the importance of rapid mass prophylaxis of civilian populations to prevent casualties in real-life and hypothetical disease outbreak scenarios.37,43,92-94 This Section suggests ways to use some of the design principles introduced in Section 2 to develop efficient patient flow plans for mass prophylaxis clinics. Following the BERM model, it includes examples of both antibiotic dispensing clinics (e.g., for prophylaxis against inhalational anthrax) and vaccination clinics (e.g., for pre- or post-event vaccination against smallpox).
6. Example of an Antibiotic Dispensing Clinic Plan
Mass antibiotic prophylaxis would be needed for outbreaks of disease due to any of the 3 bacterial pathogens on the CDC list of "Category A" agents posing the maximum risk to public health and welfare: anthrax, plague, or tularemia.6 Anthrax, for example, is a spore-forming bacterium that can infect humans via inhalation, direct contact, or ingestion, and is highly lethal if untreated.17 The 2001 experience with inhalational anthrax suggests that approximately half of those presenting with fulminant inhalational anthrax may die despite advanced medical care. However, there is considerable evidence that use of prophylactic antibiotics may prevent the development of fatal anthrax even in patients who have inhaled an infectious dose of anthrax spores and who have early symptoms of the disease, such as fever, cough, severe headache, nausea, and chest discomfort.32,37
While scientific uncertainty remains about the average duration of the asymptomatic incubation period in patients exposed to anthrax, the 2001 U.S. experience suggests that in a number of cases there was ample time and opportunity for initiation of prophylactic antibiotics after exposure.1 Over the past five years, the Federal Government has overseen the purchase and stockpiling of a number of antibiotics that may be effective in prophylaxis against inhalational anthrax as well as against plague and tularemia. These medications, which are managed and delivered by Strategic National Stockpile (SNS), were used in the Florida, New York/New Jersey, and National Capital Region anthrax response.40-43,56,71
B. Design Considerations
An antibiotic dispensing clinic suited to anthrax post-exposure prophylaxis (or pill-based prophylaxis for other biological pathogens) would need to accomplish a limited number of goals, the most important of which is getting the correct antibiotic to the correct patient in the shortest amount of time. Since patient compliance with prescribed medication regimens and side effects from those medications proved to be an unexpectedly important factor in the 2001 U.S. anthrax response, an additional goal would be to provide educational material and the opportunity for patients to ask questions of emergency health care providers.31-33 To assist in epidemiological investigations, patient followup, and resource management for the mass prophylaxis response, a further goal of the clinic design would be to allow for the documentation of patient-related information either through written forms or through question and answer sessions with clinic staff.40 Clinic planners may want to include a separate area for on-site crisis counseling to help manage individuals who are incapacitated by stress or anxiety.78 Finally, each clinic should have a designated area for triage and management of acutely ill individuals who require emergency transfer out of the dispensing clinic to a health care facility.
For bacterial agents that pose the risk of patient-to-patient spread (e.g., pneumonic plague), an additional goal would be to separate any symptomatic individuals from the asymptomatic populace as soon as they reach the clinic. In this setting, application of appropriate respiratory precautions (e.g., by giving symptomatic individuals OSHA-rated N-95 masks or the equivalent immediately upon identification) may minimize the risk of intra-clinic spread of disease. While it is always preferable to prevent infection when possible, it should be noted that even if a patient were to become infected with a contagious disease inside the dispensing clinic, the chance of that infection progressing to actual symptomatic illness should be greatly diminished by the use of prophylactic medications.
C. Model Patient Flow Plan
These design considerations led to the antibiotic dispensing clinic flow plan (select for Figure 3), which was highly influenced by the published reports of Montello and Haffer regarding the design and operation of the dispensing clinics used for the 2001 National Capital Region anthrax response.56,71 Patients are greeted immediately inside the clinic by a staff member whose sole purpose is to identify anyone who is acutely ill in order to send them immediately for medical evaluation. In the case of a contagious disease, the staff member would also supply the affected individual with a mask at this time. The remaining patients would be given forms to fill out; it is preferable to give out forms prior to any briefing, since the individuals performing the briefing may want to refer to information or questions on the forms.
The next step is the first triage station. Triage may be accomplished by reading the patient's form (e.g., by visually scanning checkboxes for questions about symptoms) or may be accomplished through a limited series of questions. This general triage step seeks to identify patients who have symptoms that warrant either medical or psychological evaluation and/or management. Patients who screen positive at this stage are sent either to the medical evaluation or to crisis counseling stations. All others proceed to the briefing area, where they may be joined by individuals returning from those 2 stations (i.e., individuals whose symptoms or concerns were evaluated and addressed by health care professionals and whose condition was deemed stable enough to warrant return to the main clinic).
From the briefing, patients proceed to drug triage, where patients needing special assistance with drug prescribing (e.g., alternative drug regimens, dosage adjustment) are identified and sent to a designated dispensing area where pharmacists or other trained health professionals can tailor the dispensed regimen to a patient's individual medical requirements (e.g., due to other medical conditions or age, height, or weight considerations). All other patients proceed to an "express" dispensing area where no further decisions regarding type or quantity of medication are necessary. Splitting dispensing this way increased efficiency in the 2001 anthrax response.56,71 After receiving their antibiotics, patients may deposit their forms and exit.
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7. Example of a Vaccination Clinic Plan
Both smallpox and the viral hemorrhagic fever (VHF) viruses are classified by the CDC as "Category A" biological agents posing the maximum risk to public health and welfare.6 At the time of this writing, a well-tested, highly effective, and widely available vaccine exists only for smallpox, although considerable scientific effort is being devoted to developing countermeasures for VHFs. Smallpox infection carries a 30 percent mortality rate in unvaccinated individuals; in previously vaccinated individuals who develop the disease (e.g., in whom immunity has waned years after vaccination), the mortality rate drops to 3 percent.95,96 U.S. residents under the age of 30 have virtually no immunity to the disease, and older adults likely have little remaining immunity since immunizations and booster shots for the general public were halted in 1971.97
Despite its high mortality and morbidity, smallpox has 2 features that should give a measure of optimism to public health officials planning a mass vaccination response. First, the virus is not among the most contagious from person to person (compared to measles, for example), requiring exposure to respiratory droplets that usually occurs only among household or health care contacts.98 Second, successful vaccination within 4 days of exposure to the virus can halt infection.99 Over the past 3 years, the Federal Government has overseen the purchase and testing of large quantities of smallpox vaccine, so that, as of this writing, there is sufficient vaccine to inoculate every U.S. resident.100 The challenge for public health planners is to devise feasible strategies to accomplish that task in a reasonable time frame.
B. Design Considerations
A smallpox mass vaccination campaign most likely would be carried out at designated smallpox clinics. Any smallpox clinic design must accommodate 2 unique features of smallpox vaccination. First, vaccination involves creating a localized infection with a live virus (vaccinia, or cowpox) so special instructions must be given for post-inoculation wound care to prevent inadvertent spread of the virus in the recipient (e.g., auto-inoculation of the eye) or in others.101 Second, since the Food and Drug Administration (FDA) has only approved DryVax® for general public use, all recipients of other vaccines must give witnessed informed consent under an Investigational New Drug (IND) protocol prior to the inoculation.102 Additional design considerations include:
- Pre- and post-event dual-use capability. Clinic plans should address the needs of campaigns that occur in the absence of any known smallpox outbreak ("pre-event") or in the setting of a known or suspected release of the virus ("post-event").
- Clinic contact precautions. Plans should address the need for rapid presumptive identification and respiratory isolation of suspected cases or contacts in a post-event setting.
- Crisis Counseling. Plans should be able to accommodate mental health crisis counseling stations in both pre- and post-event scenarios.
- Testing. Plans may need to accommodate stations for pregnancy testing and/or rapid HIV testing or stations at which information for off-site testing may be provided. Although there are no absolute contraindications to vaccination for a suspected case or contact in a post-event scenario, individuals may still decline the vaccine based on personal evaluation of risks and benefits. These individuals may then be recommended for isolation, as noted below.
- Isolation considerations. Plans need to address isolation counseling in a post-event setting for those suspected cases or contacts who decline vaccination. This station would be linked to transport to designated isolation facilities.
C. Model Patient Flow Plan
These design considerations led researchers at the Department of Public Health at Weill Medical College of Cornell University to develop a sample smallpox clinic patient flow plan (select for Figure 4). Stations, spoken text, and annotations in grey (located on the right in the diagram) would be used in a post-event scenario only. All other stations would be used in both pre- and post-event settings.
The general clinic layout exemplifies the notion of "express lines" described in the previous section, in that the clinic divides into uncomplicated (left-hand side) versus complex (right-hand side) service lines. In the post-event (grey) version of the clinic, anyone thought to be a potential case or contact would be immediately separated from the general flow of patients for physically separate processing in a designated "Post-Event Precaution Area."
The following sub-sections describe in detail how this model clinic would function in both pre- and post-event settings.
1. Pre-Event Patient Flow
In a pre-event mass vaccination campaign, only the stations in the left-hand and center portion of this flow diagram would be used (i.e., only the un-shaded portions). All persons entering the vaccination center would be met by a greeter/screener and asked if they felt acutely ill (any positive response in this pre-event setting would indicate a non-smallpox intercurrent illness like acute asthma, myocardial infarction, acute panic, etc.). These symptomatic patients would be taken immediately to the medical evaluation area where health care professionals could assess the severity of symptoms and the likelihood of a serious underlying medical condition requiring further medical care.
No uniform respiratory precautions would be needed for these symptomatic patients in a pre-event scenario. Acutely ill patients may be transported to a medical care facility, while those with a negative medical evaluation could either be sent back through the standard processing line or be sent to a duplicate set of stations with smaller staff in a separate area for those symptomatic patients. Although duplication of stations in a pre-event setting may appear redundant, keeping these ill patients out of the general flow of asymptomatic individuals may result in greater overall efficiency of the DVC operation (i.e., avoiding bottlenecks due to increased triage and management processing times for ill individuals).
Next, all potential vaccinees would be given forms and the means to fill them out (i.e., a writing instrument and either a clipboard or a tabletop on which to write). These individuals then would be directed to briefing areas where either videotaped or live briefings would take place with the opportunity for questions. Patients may be stationary (i.e., seated) for these briefings or may have the opportunity to view them while moving in line. After the briefing, persons with no self-identified contraindications to vaccination would be given the opportunity to sign the witnessed informed consent declarations for receipt of the vaccine.
Individuals would then exit the briefing area to the triage area, where persons with no contraindications would have their written information verified by staff and those with potential contraindications further questioned. From the triage station, rapid testing for pregnancy and/or HIV may be offered to those interested or those uncertain about their status. In this pre-event setting, some people may be denied vaccination due to contraindications or may decline vaccination due to personal weighing of its risk/benefit ratio. Others will proceed to vaccination stations where those who have not yet signed their consent form may do so and have it witnessed.
Prior to exiting the vaccination center, individuals would proceed to the form collection and exit counseling station where DVC staff could reiterate key points of vaccination site care and would check completeness of forms for data entry. At any point in proceeding from entry to exit, patients would have the opportunity to go to the mental health/crisis counseling station located on-site. Those persons who opt for counseling may re-enter the vaccination patient flow where they left.
2. Post-Event Patient Flow
In a post-event setting, all symptomatic individuals and those who may have come in contact with a smallpox case would be physically separated from the main patient flow at the earliest possible station. On the accompanying patient flow diagram, the grey-shaded comments and stations would be used during post-event operation. The most important difference is that these new stations will be physically distinct from the main (non-case, non-contact) patient flow. The purpose of separating the processing areas of these non-case, non-contact patients from presumed cases and contacts is to minimize the potential exposure of healthy vaccine recipients to individuals with possible smallpox exposure or infection.
As in pre-event clinic operation, entry screeners would ask all individuals walking through the door whether they feel ill. In the post-event setting, these screeners would also ask whether individuals have been exposed to someone who has smallpox. Anyone feeling ill or reporting direct contact with a smallpox patient would be sent to the Post-Event Precaution Area and would be instructed to put on an N95 ventilator (mask) to reduce the possibility of droplet transmission of the smallpox virus (an N95 ventilator provides 95 percent filter efficiency of particles with a diameter of less than 0.03 micrometers and where oil particles are not present).98 These individuals would then undergo screening at the medical evaluation station, where detailed questioning about symptoms and exposures and, if needed, an abbreviated physical examination could be performed. As shown in the diagram, these patients would be classified into 1 of 4 categories:
- An acute non-smallpox illness such as myocardial infarction that would require immediate transport to a health care facility (labeled "CRITICAL" in the diagram).
- A subacute illness that is not suggestive of smallpox and does not require immediate transport to a health care facility, or no significant illness.
- An illness syndrome that is suggestive of smallpox (e.g., fever and/or severe backache and/or rash).
- A likely exposure to a case of smallpox but no evidence of symptomatic disease.
Once sent to the presumed contact area, individuals in all 4 categories remain wearing a mask as they undergo briefing, vaccination, exit counseling, and/or transportation. This will minimize droplet transmission from truly infectious individuals (through containment under the mask) to uninfected individuals with either suspected or documented contact (whose masks will prevent inhalation of possibly infectious droplets). Upon exit from the clinic, only those individuals with suspected smallpox or contact would be encouraged to maintain use of the mask until they reach a treatment or domiciliary facility as recommended by CDC.102 These facilities may range from designated health care centers to the individual's home.
Since there are no absolute contraindications to vaccination for presumed cases or contacts in a post-event setting, predetermined protocols will be required to manage individuals in these categories who decline vaccination. Since under evolving Federal and State protocols these unvaccinated patients may be required to undergo isolation for a specified period of time, the clinic design includes a station for counseling and administrative processing of these individuals.
D. Sample Floor Plan
Figure 5 shows how the aforementioned model smallpox clinic could fit into the area of a typical high school basketball court (84 ft. x 50 ft.), a possible site for DVC activities in the event of a large-scale prophylaxis campaign. Note that the presumed contact area, including a separate smaller briefing station, is physically distinct from the non-contact areas. This floor plan shows only one large briefing area in the non-contact area located on the court, although more could be set up in adjacent rooms. Vaccine preparation, data entry, and clinic supplies also may require use of adjoining rooms or staging areas.
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