Mass Dispensing of Medical Countermeasures

Figure 18.1.

SNS 12-Hour Push Package.



Within the United States, the governor of an affected state (or a designee) may contact CDC directly to request SNS assets. A Presidential Disaster Declaration is not required to request SNS support, and activation of the National Response Framework is not necessary; however, procedures for requesting assets may change once there is federal-level involvement. Materiel requested from the SNS will be shipped either by air or ground transport to the nearest safe receipt, store, and stage (RSS) location designated by the state health department. RSS sites are designated warehouses where the 12-Hour Push Package or other assets will be delivered, off-loaded, and organized for further distribution. From the RSS location, the distribution of assets to individual hospitals, clinics, or points of dispensing (PODs) is the responsibility of the state or city. It is therefore recommended that contingency plans be made with shipping companies or other partners to provide local transportation. CDC has program consultants who collaborate on a regular basis with state planners to address how to receive, store, stage, distribute, and dispense assets from the SNS.


Other resources for antibiotics and vaccines should also be explored at the local and state level, as activation of federal assets will only occur after regional resources are depleted. Potential sources can include the normal supply chain, wholesale distributors, manufacturers, local or state stockpiles, or other vendors. Memoranda of agreement (MOAs) with neighboring communities and states should be established prior to a public health emergency. Local planners should consider factors such as immediate availability, timeliness, and security when developing these agreements. Additionally, neighboring regions or countries may enter into mutual aid agreements to share products and provide assistance. Disaster planners should be aware of what inventories are available to them domestically and internationally before a disaster occurs. Some medical countermeasures may be in short supply, necessitating difficult allocation decisions as to who will receive them. Three broad ethical issues related to handling public health emergencies include rationing, restrictions, and responsibilities.12 Policymakers may benefit from including ethicists in their discussions regarding allocation of scarce resources.13,14 A triage or tiered process should be developed to determine the order of need for such supplies.15


Once antibiotics, vaccines, or other assets are received by the affected area, they must be dispensed to the patient population in a timely manner. Assets from the SNS are delivered to the local receiving authority, which are then responsible for distributing the medical material to hospitals or PODs. Depending on the type of incident, the timeframe for providing effective prophylaxis or vaccination may vary. The Cities Readiness Initiative (CRI) is a federal program established by the U.S. HHS and Department of Homeland Security (DHS) to assist cities with delivering or dispensing medications during large-scale public health emergencies. CRI is in alignment with Presidential Policy Directive 8 (PPD 8) and the National Preparedness Goal, and is directly related to one of the top four national priorities to strengthen medical surge and mass prophylaxis capabilities. The goal of CRI is to enhance preparedness at federal, state, and local levels of government by using a consistent national approach and response to a catastrophic incident requiring mass antibiotic prophylaxis with assets from the SNS. Federal funding is provided to participating cities that were chosen based on population and location. In 2004, the original program included twenty-one cities; in 2006, the program expanded to encompass seventy-two cities and their metropolitan statistical areas. Approximately 56% of the U.S. population resides in a CRI jurisdiction (personal communication, Stephanie Dulin, Centers for Disease Control and Prevention, March 20, 2007).


The planning scenario for each CRI jurisdiction is to initiate prophylaxis for the entire city population within 48 hours of an anthrax release. To accomplish this, three different mechanisms could be used individually or in combination: 1) methods developed and created by the city or state; 2) delivery of medicines and supplies by the U.S. Postal Service (USPS); or 3) setting up and running PODs. HHS, along with DHS, has negotiated with USPS to provide home delivery of initial doses of antibiotics at any time. This would serve as a stopgap measure while states or cities activate their PODs, and would permit the use of an existing and reliable delivery mechanism while allowing people to shelter-in-place after an incident. Not all U.S. states have chosen to use the USPS delivery option in their planning.




Planning for Points of Dispensing


Dispensing medication or administering vaccines to a large population in a public health emergency will most likely occur at PODs. These have also been called dispensing/vaccination clinics by some authors.16 PODs and points of distribution may or may not mean the same thing. A point of distribution can be a holding area from which assets are further distributed before being dispensed. The goals for a mass dispensing program are two-fold: 1) reducing the overall risk of the population becoming ill; and 2) providing public health information to the general public and healthcare providers.17


Mass vaccination is usually performed to rapidly increase population immunity in the setting of an outbreak.18 During a smallpox or other contagious infectious disease outbreak, surveillance and containment may be implemented. If multiple cities experience simultaneous cases of a contagious disease or multiple near-simultaneous releases of a biologic agent, it is possible that voluntary mass vaccination may be implemented.19 In the United States, dispensing or distributing medications or vaccinating patients is mainly a local-level public health responsibility. Since dispensing laws, policies, procedures, and expectations may differ between states, it is important for state disaster planners to provide assistance and guidance for local planners to ensure a consistent approach throughout their jurisdiction.


Planning for PODs should take into account such logistical issues as design, operation, staffing, and activation and deactivation.20 The number of persons needing prophylaxis or vaccination and the time necessary to implement effective prophylaxis or vaccination strategies will help determine how many PODs are required for any particular incident. Using a full 48-hour window of time for providing prophylaxis to the entire population will allow planning for worst-case scenarios. Plans can then be adjusted to fit the size and scope of the emergency. This flexibility is important since it is impossible to have a set of throughput measurements for every possible scenario.21


POD throughput may be defined as the number of persons receiving prophylaxis per unit of time. The number of PODs required can then be determined using the formula:



where TP is the total population needing prophylaxis, HPP is the number of hours to provide prophylaxis to the population (i.e., 48 hours), S is the amount of time needed to establish the POD once the decision is made to do so, and PPH is the number of persons per hour who are provided prophylaxis (i.e., throughput). This equation has limitations in that it makes several assumptions that may not be correct, including: a 24-hour-a-day operation; an equal distribution of population among the PODs; equivalent types of PODs within a jurisdiction; POD performance at 100% capacity; adequate staffing; and a constant flow of people into and out of the POD.16,20


To ensure adequate facilities are available, it is prudent to identify such resources in advance of any emergency and establish written agreements (i.e., MOAs). Such agreements should address immediate use of the facility during an incident, periodic access for building inspections, 24-hour contact information, security, compensation or liability/indemnification agreements (if applicable), and authority to use the facility for exercises or drills. The MOA should also clearly identify the entity having responsibility and authority for managing response operations.



Points of Dispensing Site Selection


Facility site selection is critical to a successful response effort. Publicly owned facilities such as schools, universities, community recreation centers, firehouses, polling places, and armories are usually well known to the community, easy to find, have adequate parking, and are accessible by public transportation or private vehicle. The problem with use of these locations includes possible disruption of their regular functions and potentially enduring stigmatization of the site due to a gathering of exposed people. Alternate locations may include aircraft hangers and shuttered public areas such as hospitals no longer in use. Although military installations may have available space, heightened security during a terrorist incident or other public health emergency may result in restricted access to these sites.


Hospitals, commercial pharmacies, or other healthcare institutions may be overwhelmed with additional patient loads created by the incident and may not be the best choice to locate PODs. Although a recent survey indicated the willingness of private industry to partner with public health entities for administration of medications or vaccines, concerns regarding liability remain.22 In the United States, liability protection is provided to covered persons who administer a covered countermeasure as defined through the Public Readiness and Emergency Preparedness Act.23 This takes effect after the U.S. Secretary of HHS declares a public health emergency that requires administration of such countermeasures as identified by the secretary.23 Section 224(p) of the Public Health Service Act also specifically addresses the liability concerns associated with administration of smallpox countermeasures.24 Fewer liability protections exist for institutions responding to emergencies compared with available protection for individuals.25


Commercial facilities such as grocery stores, wholesale clubs, or retail stores may be useful vaccine administration settings because many of these organizations host annual influenza vaccination clinics. Use of such nontraditional settings for influenza vaccination campaigns is becoming a more common practice.26 Nontraditional settings have positive cost/utility ratios, and their convenience and desirable locations increase their value as potential vaccination sites. Ninety-five percent of the U.S. population resides within 5 miles of a retail pharmacy.27


Retail stores and other non-clinical community establishments in the United States administer upwards of 30 million influenza vaccinations annually, along with third-party logistics providers and health service providers.22 Because of increased use of such facilities, guidelines have been established to define quality standards for immunizations in nontraditional settings.28 Although there have been some concerns regarding safety, one study assessed over half a million persons vaccinated in nontraditional settings and found that adverse events were extremely rare, totaling only 112 occurrences, most of which resolved within minutes.26


Physical characteristics of the POD location should include the ability to accommodate hundreds or even thousands of people at one time, while keeping them protected from adverse weather conditions. Communities have used a varying range of POD sizes, ranging from 1,670 to 5,500 square meters. Desirable features include heating and air conditioning, adequate bathrooms, water and electricity, handicap access with a minimum of stairs, a public address system, an unloading area for receipt of supplies, parking, a helicopter landing site, and a break room/canteen. Good security, including the ability to control access, is a requirement. These physical characteristics will provide the security team sufficient space to coordinate traffic, manage parking, maintain crowd control, and protect staff and assets.29



Equipment for Points of Dispensing


Adequate equipment and supplies will be useful at the POD. Table 18.1 describes equipment and supplies that should be considered. This is not a comprehensive list and each city or state may identify additional items that are useful. Some areas have developed a go-kit of items that can be easily transported to POD locations, have multiple uses during different types of disasters, are easily stored at room temperature, and are packaged pre-event according to different POD functions.30



Table 18.1.

POD Equipment and Supplies















































































Name badges Batteries Large trash bags
Badge strap clips Calculators Waste cans
Badge neck straps Clipboards Regular trash bags
Vests Dry-erase boards White copy paper
Whistles Dry-erase markers Scotch tape
Bullhorns Adult scales Paper towels
Red barrier tape Bike flags Kleenex
Traffic cones Red ink pens Duct tape
Portable copy machines Black ink pens Accordion folders
Emergency alert radios Walkie-talkies Colored paper
Extension cords Blankets Biohazard bags
Power strips Hand sanitizer Sharp containers
Flashlights Surgical masks or N95 respirators Disposable cups
Sign easels Label makers Labels
Thermometers Candy (simulated medicine) Staplers
Paper clips Permanent markers Highlighters
Post-it notes Lanterns Gloves
Trash cans with wheels Toilet paper Pencils


Points of Dispensing Operations


All PODs within an affected area should be uniform in their medication delivery system, patient flow process, staff roles, operating procedures, projected throughput, hours of operation, information products, and policies. Uniformity of PODs will make it easier to share personnel between PODs if needed, and will avoid the public perception of better service at one location versus another.17,31 Distributing the population evenly among the PODs will be a challenge. To optimize the chances for success, a robust public information campaign is necessary. This can include distribution of the population by first letter of last name, postal code, census tract, school district, or neighborhood. POD sites should nevertheless be prepared for greater than anticipated numbers of people because the population may be unable or unwilling to follow instructions despite an aggressive public information campaign.


Each POD must designate an on-site director (incident commander) capable of managing large numbers of people under difficult circumstances and who is familiar with the specific needs of the community. Although POD management is a local responsibility, POD locations, sizes, operations, and leaders are often chosen after collaboration between local, state, and regional health agencies. The Incident Command System (ICS) and National Incident Management System (NIMS) are both well recognized command and control systems in the United States that may be used in POD management.16,31,32 Using these command and control systems facilitates establishing clear leadership roles and chains of command, as well as the delegation of duties. Such processes are necessary to support effective reporting systems and recordkeeping.


PODs may be organized in one of two primary ways using a segmented or non-segmented structure. This organizational plan will have a direct impact on transportation and traffic management surrounding the POD. In a segmented POD, greeting/information, triage, or registration is performed in a central location with medication and/or vaccine dispensing conducted at another location. Segmented PODs allow the public to gather at staging sites accessible by public transportation and that also provide adequate parking. Examples include stadiums and sporting arenas, convention centers, and shopping malls. At the initial site, the exposed population is screened, triaged, and given information before being transported to the actual dispensing location. Symptomatic patients can be transported or directed to treatment facilities. Advantages to a segmented POD include a reduction in traffic congestion and parking at the actual POD location; improved security; a potential decrease in the number of people presenting to the POD who do not need prophylaxis; a regulated flow of people; and the ability to triage symptomatic patients away from the POD. Disadvantages include the need for large parking facilities at the staging site, the necessity of utilizing transportation assets to shuttle people to the POD, a potential lack of understanding by the public of where to go, more difficult just-in-time (JIT) training for staff in two locations, a greater security burden, and an increase in staffing requirements. Figures 18.2 and 18.3 depict segmented POD operations.



Figure 18.2.

Segmented POD.



Figure 18.3.

Segmented POD with one staging area feeding multiple PODs.


In contrast, non-segmented PODs conduct all operations in a single location. Advantages to this type of operation include reduced requirements for staffing and security. Disadvantages include the need for increased parking, the risk of having symptomatic patients in proximity to those who were exposed but are not yet symptomatic, and the potential for secondary disease transmission (for example, pneumonic plague) as a result of crowded conditions. Figure 18.4 depicts a non-segmented POD operation.



Figure 18.4.

Non-Segmented POD.



Points of Dispensing Functional Areas


There are four basic functional areas to a POD: intake, screening, dispensing, and exit. Intake includes the processes, procedures, stations, and personnel involved in introducing people into the POD. Paperwork such as medical history can be completed at this stage, with patients being appropriately directed to receive the correct medication. Patient information collected at this time can be used for monitoring medication compliance and adverse events, as well as tracking dispensed medication in case of a drug recall. The amount of information collected is a decision made by state and local planners but should be concise and useful. In certain circumstances, there may be federal requirements as well. Such data can be collected and transmitted on paper forms, computer databases, telephones, or faxes.33 Throughput of the POD will decrease as the amount of paperwork or data increases; therefore, forms should be short, simple, and specific. Many U.S. states have developed templates for information collection, both for individuals and for heads of household.3437


Public health information and education must be conveyed at the POD. This may be accomplished during intake with written materials; however, other methods such as television, newspaper, Internet, video, or recordings may be used, and would lessen the burden of replicating printed materials at the time of an incident. If written patient information is used, a small inventory of previously printed sheets or electronic master templates can be distributed initially, followed by additional information sheets that may be generated through contingency contracts with local printing or photocopy businesses. Other functions that may be necessary at this step include traffic management, security, greeting, registration, and triage.


Screening encompasses sorting and classifying individuals to optimize resources and maximize patient survival. This step may involve a variety of functions including greeting, sorting, roaming (helping with any task), first aid delivery, medical transport, providing social services, and mental health counseling.


Dispensing involves the processes and procedures for preparing and distributing medications to the public. Various methods of dispensing may be used. Certain populations may be unable to access PODs and will, therefore, require different dispensing methods. These groups include prison inmates, nursing home or other institutionalized long-term care patients, workers at large industries operating 24-hour-a-day schedules, hospitalized or homebound patients, homeless persons, and undocumented immigrants. Dispensing methods for these populations may include deliveries to large corporations or universities that have occupational health clinics or medical staff on site. These sites may serve as closed PODs that take care of employees and their families to further relieve the burden on regular PODs. Other alternatives may include: mobile dispensing clinics, drive-through clinics, or the USPS delivery system previously described.17 Drive-through clinics have been tested in some states and offer advantages such as alleviation of crowding and a decrease in risk for disease transmission. Noted pitfalls of this dispensing method included confusing traffic flow and congestion, long processing times, and limited access to parking or restrooms.38 Distributing or pushing medical countermeasures out to these special populations could be faster and may cover a larger area, but does not allow for the medical evaluation of patients for adjustment of medication dosing or addressing drug contraindications. Also, the push method is not feasible for mass vaccinations.16 Transporting or pulling people into PODs for prophylaxis or vaccination more efficiently uses healthcare workers and resources and facilitates medical evaluation and centralized data collection. Logistical delays and establishing multiple PODs are the disadvantages of pulling people into POD locations. A combination of both pushing and pulling methods may be most useful.


Permitting a single individual to accept medications for an entire household is a decision that should be made in advance by the local jurisdiction. This practice has the potential advantage of decreasing the number of people at the POD and increasing throughput. If dispensed medications are for children, individuals collecting the drugs must provide an accurate body weight, to ensure accurate pediatric dosing. Providing other medical information on family members, such as allergies, current medications, or existing disease states may also be necessary. The type of information or evidence required to justify the number of regimens for a family should be decided before an incident and should be made known to the public so they can provide appropriate documentation for family members. POD staff should be prepared to answer questions about the risk of disease, transmission between humans, the risk to pets, and whether prophylaxis would be provided for pets. It is unlikely that prophylaxis would be provided to pets with the exception of service animals. The U.S. Department of Agriculture maintains a National Veterinary Stockpile that may have applicability to certain animal diseases in the event of an impending economic disaster involving cattle or livestock.39


Exiting includes moving the public out of the POD and providing any necessary follow-up information. Useful avenues for providing additional information to patients regarding compliance, adverse effects, or other questions include: 1) hotlines established through the local or state health department; 2) poison control centers or nurse advice lines; 3) implementing a community phone bank; 4) creating a website; and 5) providing information to primary care physicians.


Security and patient education permeate all four phases of a POD operation and should be addressed throughout. Every step of the POD process may be used to provide patient education. At the intake step, fact sheets, handouts, or videotapes may be used to provide information. Such information should be prepared in multiple languages as appropriate to the community. During screening or dispensing, drug and individual patient-specific information may be shared through a variety of means. At the exit, follow-up information can be provided. Security should be present at each step of the POD as well as outside of the POD. Security should address crowd and traffic control inside and outside of the POD, and protection of staff and assets. All staff should wear badges identifying them as such. Plans for security should be addressed in preparation for an incident, because local law enforcement will likely be performing other duties as a consequence of the incident and not be available. This is especially important as unprotected PODs are at increased risk for theft of supplies in situations where resources are limited. In addition, PODs could become sites of secondary terrorist attacks. All POD workers should be made aware of security concerns and know how to report suspicious individuals or activities. POD locations with controllable entry and exit points will assist security with traffic flow. An evacuation route for patients and personnel should be part of the disaster plan of the POD itself.


In streamlining POD operations, a simple assembly line concept may help improve efficiency and increase throughput. If standing in lines is culturally feasible, using multiple parallel lines rather than a single line is likely to increase throughput. In a mass-casualty situation requiring mass dispensing, a thorough individual-based medical practice approach will not be practical. The focus shifts from individual patient medical care to population healthcare. Ensuring continual movement of patients through the system to eliminate bottlenecks will allow for a more effective mass dispensing POD model.


If necessary, a high throughput rate (increasing the numbers of persons per hour moving through the POD) may be achievable by shortening or foregoing orientation, simplifying medical forms, and eliminating secondary medical screening and a final quality assurance check. Patients requiring specialized attention for any reason may be moved to remote stations outside of the POD. This could include individuals with specific medical, safety, mobility, psychiatric, or communication needs. Typical groups consist of: children; the medically fragile; those with physical disabilities; migratory and homeless persons; those with language, culture or literacy barriers; and disruptive persons.40 These groups may require additional attention in order to understand public information messages. Options include translating messages and fact sheets, using on-site translators, and implementation of color coding and pictograms.


Identifying bottlenecks and adding additional resources to relieve these congested locations may also be helpful.41 Bottlenecks at PODs may occur when: 1) too many people are allowed into the POD at a time; 2) too many people arrive at one particular station; 3) too few staff are operating a station; or 4) staff have too many activities to perform for each person presenting. These obstructions can be alleviated by having express lanes for those with no complications, by properly estimating the number of staff and individuals at each POD, and by having a flexible command and control system in place that allows for modification of staff and type of PODs.16,17 Prophylaxis of POD workers should be addressed before the POD is open to the general public.



Staffing and Training for Points of Dispensing


It is the responsibility of each public health jurisdiction to conduct both first response and ongoing community-wide mass antibiotic dispensing and vaccination campaigns that can be federally supported.16 Local mass prophylaxis activities will probably be underway before any federal assets arrive. In addition, federal and state assistance will likely not include sufficient personnel to supplement POD staff, particularly if the incident encompasses a wide geographical region such as multiple states or counties. Even after federal assets arrive, POD operations will probably remain under local control, and POD operations may continue well after the departure of state or federal assistance.16


Adequate staffing is paramount in running a successful POD, and will require people with the correct skill sets who can be trained to fulfill specific tasks. Trained staff should be able to quickly establish the POD and ensure its operation at maximal efficiency with the highest possible throughput. Staffing the PODs has been accomplished in many different ways depending on historical successes for a particular city or state.21,33,4244 A general guiding principle is to require various types of staff, such as professionals (physicians, nurses, pharmacists, public health workers, and social workers), volunteers (trained and untrained), and management support staff familiar with the facility or general POD operations. Volunteers or non-clinical staff should be used for any appropriate jobs to unburden professional staff and maximize efficiency of POD operations. Volunteers may be recruited before an event occurs. However, expect that others will present unannounced at the time of the incident. The enormous task of training volunteers should be conducted, to the extent possible, before an incident occurs. This task is easier if roles and responsibilities are kept consistent throughout the state or region.17 Maintaining a statewide registry of trained volunteers may also be helpful. Trained volunteers with special skill sets such as translation and sign language abilities, and those from the Red Cross, can provide invaluable assistance.31 Untrained volunteers may be found in community civic or fraternal organizations, or as spontaneous volunteers.


When planning for staffing, considerations should also include having enough people to support two or three shifts per day. Some exercises conducted by states and cities have shown a rapid onset of staff burn-out, so planning for additional shifts or rotating staff between several different duty stations may be useful.42


During an emergency, professionals will be in high demand to perform other jobs or tasks. However, potential sources for accessing professional services include: 1) commercial pharmacies; 2) state licensing agencies; 3) professional associations; 4) nursing, pharmacy, or medical schools; 5) the DHS Emergency Coordinator for the region; 6) the HHS regional health administrator; and 7) programs such as the U.S. Medical Reserve Corps.45 Federal staff support for dispensing efforts may be obtained through the U.S. Public Health Service, National Pharmacy Response Teams, National Nursing Response Teams, and Disaster Medical Assistance Teams. These federal personnel assets may be available depending on the situation, such as when a Federal Disaster Declaration is in effect. Table 18.2 lists possible roles for healthcare professionals and volunteers.



Table 18.2.

Suggested Roles for Healthcare Professionals and Volunteers
























































































































































Assignment Staffing Tasks
Intake
Greeting/Entry Volunteer with standardized script Greet, direct, answer nonmedical questions
Assist disabled persons
Orient the public
Forms Distribution Volunteer Distribute medical history forms
Explain form completion with a script
Check completion of forms
Briefing Trained volunteer Translate dispensing-site procedures and policies to persons who do not understand English, are hearing impaired or illiterate.
Volunteer with task specific training Hand out medical record forms and provide instruction on completing them
Volunteer with script Educate and orient people standing in line
Health professional or video Provide information about drugs, including pediatric medicines
Volunteer with script Advise about importance of adhering to regimen instructions
Warn about danger of overmedicating
Confirm date to return for additional medication if needed
Screening
Triage Professional Perform initial health screen
Redirect symptomatic people to treatment facility
Volunteer Assist seriously ill persons to transport vehicles
Mental Health Screening and Counseling Health professional and social worker Watch for signs of anxiety, fear, impatience
Provide counseling
Medical Evaluation Professional Perform health examination and assessment
Healthcare Center Transport Volunteer Drive ambulance or other vehicle
Drug Triage Professional Screen for contraindications for drugs or medical conditions
Answer questions or prescribe alternate drug
Dispensing
Express Drug Dispensing Pharmacist supervisor Oversee dispensing process
Volunteer Weigh children under 5
Volunteer Dispense regimens depending on state regulations
Pharmacist or pharmacy technician Dispense regimens
Assisted Drug Dispensing Pediatrician or pediatric nurse practitioner Examine infants and small children
Dispense proper medication
Exit
Collection and Review of Medical Data Volunteer with professional supervision Check for completeness of forms
Distribute patient information sheets
Explain importance of compliance with regimen
Stress danger of overmedicating
Note date to return for additional medications if needed


Adapted from Receiving, Distributing, and Dispensing SNS Assets: A Guide for Preparedness.20

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May 10, 2017 | Posted by in EMERGENCY MEDICINE | Comments Off on Mass Dispensing of Medical Countermeasures

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