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Koenig_and_Schultz_s_Disaster_Medicine_Ch_16.pdf

Mass Dispensing of Antibiotics

and Vaccines

Susan E. Gorman and Nicki T. Pesik

The findings and conclusions in this chapter are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention (CDC).

OVER V IEW

Following a terrorist event or other large-scale public health emergency, the need to distribute rapidly antibiotic prophylaxis or vaccinations to a large population may be necessary. To accom- plish this task successfully a significant amount of planning and preparation must occur in advance of such an event. The ability to respond in the initial phase of an infectious event at the local, regional, state, national or international levels is a key compo- nent of public health preparedness. This was demonstrated in the U.S. in 2001, when more than 30,000 people were advised to take antibiotics during the anthrax event.1 Although the need to plan for mass dispensing is essential, many areas have not engaged in the process. A survey in one U.S. state showed that less than half of 138 community health centers polled in 2004 had begun to address bioterrorism issues in their planning efforts; only 19% surveyed were included in their county’s mass prophylaxis plan.2

In the same survey, only 46% had sufficient space to create a mass immunization or vaccination area, and 23% had plans to communicate bioterrorism events with the public and media.2

Results such as these emphasize the need for enhanced planning. The inability of a community to dispense needed pharmaceu- ticals efficiently and effectively to its population may result in the loss of lives. Therefore, the development of mass dispensing clinics and mass vaccination clinics should be incorporated into community disaster plans.

HISTORICAL PERSPECTIVES

Information gathered from past experiences can be applied to future preparations for mass vaccinations and prophylaxis. Those

past mass vaccination campaigns that have been considered suc- cessful in halting outbreaks have each demonstrated areas for improvement. In 1947, New York City conducted a mass small- pox vaccination campaign that successfully halted an outbreak of smallpox (Figure 16.1). Vaccine tracking and recordkeeping make it difficult to establish the exact number of individuals vac- cinated in April 1947. It is estimated that more than 2.5 million persons received smallpox vaccine. This vaccination campaign also dealt with vaccine shortages; little public health information such as vaccine side effects was provided to the public.3

In an effort to halt a smallpox outbreak that began with an infected person returning from a pilgrimage to Mecca, the Fed- eral Epidemiologic Commission organized a larger mass vacci- nation campaign in Yugoslavia in 1972. In a period of 3 weeks, they vaccinated 18 million persons out of a population of 20.8 million persons. The epidemic included 175 cases and 35 deaths and was declared under control in 6 weeks. This mass vaccination campaign noted unsuccessful vaccination uptakes and included the use of strict isolation and quarantine as well as declaration of martial law to include the mandatory restriction of population movement in affected areas.4

Considerations for current preparation for mass vaccination or mass prophylaxis can also be gleaned from a historical review of the 1976 Swine Flu vaccination program. In February 1976, serological studies of personnel at Fort Dix, New Jersey suggested that more than 200 persons had been infected with a strain of virus similar to the one that caused the 1918 influenza pandemic. By March of that year, public health authorities decided to launch a mass vaccination program to prevent the effects of a possible pandemic. Information gathered from this campaign applies to current mass dispensing and mass vaccination planning. This includes addressing the following issues: 1) inclusion of spe- cial populations when considering formulation of vaccines or antimicrobials, 2) liability issues related to medical countermea- sures, 3) interagency cooperation at various levels of government, 4) establishment of surveillance systems for adverse events, and 5) appropriate and timely public health messaging.5

213 Koenig and Schultz's Disaster Medicine : Comprehensive Principles and Practices, edited by Kristi L. Koenig, and Carl H. Schultz, Cambridge University Press, 2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/apus/detail.action?docID=564432. Created from apus on 2018-03-08 12:23:30.

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Figure 16.1. 1947 smallpox vaccine line. Used with permission: AP.

CURRENT STATE OF THE AR T

Examples of International Efforts

Given the ease of international travel and the possibility for rapid spread of disease, a public health emergency in one country has the potential to become an international issue. Many countries are preparing for the need to undertake mass vaccination or mass dispensing campaigns. For example, Israel has stockpiled enough smallpox vaccine for its population and visitors. Supervision of mass vaccination occurs under the direction of the Public Health Services of the Ministry of Health. The Ministry of Health anticipates operating vaccination clinics 24 hours a day. District health officers would determine the locations of these clinics.6

Clinic sites might include schools, large existing clinics, or other appropriate community buildings.

The United Kingdom anticipates using response teams (SMART teams), whose members have been vaccinated prior to the event, to assist with the initial management of a smallpox incident. In the event of an outbreak, initial cases and contacts would be vaccinated; however, it is planned that sufficient vac- cine will be available to vaccinate the entire country’s population

should it be deemed necessary. Mass vaccination would be con- sidered in the event of multiple attacks if new cases are identified without epidemiological link to previously identified cases, or in overwhelming public demand in the face of increasing threat. Regional epidemiologists are responsible for identifying, train- ing, and vaccinating individuals for regional response teams. In addition, regional epidemiologists are responsible for identifying vaccination centers and training vaccinators.7 Vaccinia Immune Globulin would be delivered along with vaccine to local author- ities within 48 hours of the decision to begin a mass vaccination campaign.8

The Canadian national antiviral stockpile for pandemic influenza was established in 2004 as the result of a joint fed- eral, provincial, and territorial purchase. The Canadian federal, provincial, and territorial governments have a goal to provide a stockpile of 55 million regimens of antivirals. The national stock- pile is distributed on a per capita basis to each of the provinces and territories. Delivery of antivirals is primarily the responsibility of the respective province and territory and the local governments. Canada plans to address in its preparedness efforts: develop- ment of public health and clinical information regarding the use

Koenig and Schultz's Disaster Medicine : Comprehensive Principles and Practices, edited by Kristi L. Koenig, and Carl H. Schultz, Cambridge University Press, 2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/apus/detail.action?docID=564432. Created from apus on 2018-03-08 12:23:30.

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of antivirals, guidelines for the delivery of antivirals including tracking delivery of antivirals, and monitoring antiviral resis- tance.9

The World Health Organization (WHO) recognizes the need for developing countries to have access to certain medical coun- termeasures that may be part of a mass dispensing or mass vac- cination campaign. In 2005, Roche donated 3 million treatment courses of antiviral medication for use in containment strate- gies against human cases of avian influenza, to be used to pre- empt a possible influenza pandemic. Logistical considerations for the WHO stockpile include the ability to deliver a portion of this stockpile within 24 hours to countries where assistance will most likely be needed.10 Through the Global Outbreak Alert and Response Network, WHO can also provide rapid technical assistance in managing an outbreak including clinical guidelines for the use of antiviral prophylaxis or disease treatment. As part of the containment strategy, WHO estimates that the amount of antivirals needed includes approximately enough treatment courses for 25% of the population and prophylaxis courses for the remaining 75% of the population.11 WHO is developing procedures for the distribution of antivirals within the outbreak area.

At the time of this writing, WHO is also in the process of developing a smallpox vaccine stockpile. WHO will build its strategic stockpile of smallpox vaccine in Geneva. Countries are invited to donate and maintain additional stocks pledged to WHO that would be dispatched to where they are most needed in the event of an emergency. Progress on this reserve has already begun, with 2.5 million doses in Geneva, and an additional 31 million doses donated by various countries, including 20 mil- lion doses from the United States, 5 million from France, and 4 million from the United Kingdom.

EXAMPLES OF FEDERAL ASSISTANCE FROM THE UNITED STATES MODEL: STRATEGIC NATIONAL STOCKPILE AND CITIES READINESS INITIATIVE PROGRAMS

Federal assistance in the event of a large-scale public health emer- gency requiring mass antibiotic prophylaxis or vaccination may include obtaining necessary medications from several sources. In the United States, the Strategic National Stockpile (SNS) is a federally managed supply of antibiotics, vaccines, antitoxins, antivirals, medical supplies, and equipment that is available to affected areas once local, state, or regional supplies are depleted or systems are overwhelmed. The U.S. CDC, a part of the U.S. Department of Health and Human Services (HHS), manages this program. The SNS maintains its inventory in 12-Hour Push Packages and in Managed Inventory. The 12-Hour Push Packages are dispatched when the threat is unknown or speed is critical. Each 12-Hour Push Package weighs approximately 50 tons and is made up of more than 100 different line items. One 12-Hour Push Package is designed to be moved without repackaging either on eight semitractor trailers or on one wide-body cargo jet. The 12-Hour Push Packages are packaged in specialized cargo con- tainers prior to the event and are strategically placed across the United States with the goal to reach any state within 12 hours of the federal decision to deploy assets. Managed Inventory in the SNS consists of large amounts of palletized material and is generally used as follow-on to the 12-Hour Push Package. Man- aged Inventory can also be used as an initial response when the

type of threat is known. Managed inventory may be tailored for a specific known event. The delivery timeframe for Managed Inventory may vary but for most events is estimated to be 24–36 hours after the federal decision to deploy assets. SNS personnel determine the method of transportation for both the 12-Hour Push Package and Managed Inventory based on weather, safety, security, and other incident-specific factors at the time of the event. Included in the SNS are antibiotics in 10-day unit of use bottles that can be dispensed directly to patients, thereby sav- ing time by eliminating the need to break down bulk bottles of antibiotics into individual regimens. Vaccines for smallpox and anthrax are also included in the SNS, but would be shipped only when clinically indicated, such as in the event of a smallpox case or a large exposure to aerosolized anthrax. Federal plan- ning and response efforts continue to evolve as more scientific data are collected, and inventory levels in the SNS continue to expand.

Within the United States, SNS assets may be requested by the governor, or a designee, of an affected state by contacting the CDC. A Presidential Disaster Declaration is not required to request assets, and the activation of the National Response Plan is not necessary; however, procedures for requesting assets may change when they are in effect. Assets requested from the SNS will be shipped either by air or ground to the nearest safe Receipt, Storing, and Staging (RSS) location designated by the State Health Department. RSS sites are designated warehouses where the 12-Hour Push Package or other assets will be deliv- ered, off-loaded, and organized for further distribution. From the RSS location, the distribution of assets to individual hospi- tals, 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. The SNS has program consultants who collaborate on a regular basis with state planners to address issues regarding how they will 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 federal assets will only be activated once other resources are depleted. Potential suppli- ers can include the normal supply chain, wholesale distributors, manufacturers, local or state stockpiles, or other vendors. Memo- randums of agreement with neighboring communities and states should also be established prior to the event. Local planners such consider factors such as immediate availability, timeliness and security when developing these agreements. Additionally, neigh- boring regions or countries may enter into agreements to share products and provide assistance. Disaster planners should be aware of what inventories are available to them domestically and internationally before an emergency occurs. Some medical countermeasures may be in short supply and will require dif- ficult allocation decisions as to who will receive them. Three broad ethical issues related to handling public health emergen- cies include rationing, restrictions, and responsibilities.12 Policy- makers may benefit from including ethicists in their discussions regarding allocation of scarce resources. A triage or tiered pro- cess should be developed to determine the order of need for such supplies.13

Once antibiotics, vaccines, or other assets are received by the affected area, they must be dispensed to the patient popu- lation in a timely manner. Assets from the SNS are signed over to the receiving authority and it becomes the responsibility of the affected area to distribute the medical materiel to hospitals

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or PODs. Depending on the type of event, the time frame to provide effective prophylaxis or vaccination may vary. The Cities Readiness Initiative (CRI) is a federal program established by the U.S. HHS and the Department of Homeland Security (DHS) to assist cities with their ability to deliver or dispense medica- tions during a large-scale public health emergency. The CRI is in alignment with the U.S. Homeland Security Presidential Direc- tive 8, 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 the CRI is to enhance preparedness at federal, state, and local levels of govern- ment by using a consistent national approach and response to a catastrophic event requiring mass antibiotic prophylaxis with assets from the SNS. Federal funding is provided to participat- ing cities, which were chosen based on population and location. In 2004, the original program included 21 cities and in 2006 expanded to encompass 72 cities and their metropolitan statisti- cal areas. Approximately 56% of the U.S. population resides in a CRI jurisdiction (Stephanie Dulin, CDC, personal communica- tion, March 20, 2007).

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

POINTS OF DISPENSING PLANNING

A POD operation is one of the most likely mechanisms avail- able for dispensing medication or administering vaccines to a large population after a catastrophic event. These have also been called dispensing/vaccination clinics by some authors.14 PODs and points of distribution may or may not mean the same thing. A point of distribution may be a holding area from which assets are further distributed before they are dispensed. The goals for a mass dispensing program include reducing risk of the popu- lation becoming ill, and providing public health information to the general public and healthcare providers.15 Mass vaccination is usually performed to rapidly increase population immunity in the setting of an outbreak.16 During a smallpox outbreak or that of another contagious infectious disease, surveillance and containment may be implemented. If multiple cities experience widespread simultaneous cases of a contagious disease or multi- ple near-simultaneous releases of a biological agent, it is possible that voluntary mass vaccination may be implemented.17 In the United States, dispensing or distributing medications or vacci- nating patients is mainly a responsibility at the local level. It will be important for state disaster planners to provide assistance and guidance for local planners regarding state dispensing laws and other applicable policies and procedures or expectations to maintain consistency throughout the state.

Planning for PODs should take into account design-related and operational issues, staffing and volunteers, and activation

and deactivation.18 The time necessary to implement effective prophylaxis or vaccination strategies and the number of per- sons needing prophylaxis or vaccination will help determine how many PODs are required for the event. Using the 48-hour window of time for providing prophylaxis to the entire popu- lation will allow for the worst-case scenario. Plans can then be adjusted to fit the size and scope of the emergency. This flexibility is important because it is impossible to have a set of through- put measurements for every possible scenario.19 Throughput is defined as the number of persons receiving prophylaxis per unit of time.

The number of PODs required can be determined with the formula:

TP ÷ (HPP − S) ÷ PPH = PODs

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 set up 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 in and out of the POD.14,18

To ensure adequate facilities are available, it would be pru- dent to identify the facilities ahead of the emergency and establish written agreements (i.e., memoranda of agreement). Such agreements should address immediate use of the facility during an event, periodic access for building inspections, 24- hour contact information, security, and compensation or lia- bility/indemnification agreements (if applicable) and authority to use the facility for exercises or drills. The memorandum of agreement may also clarify which entity has the responsibility and authority for running the operation.

POINTS OF DISPENSING SITE SELECTION

Facility site selection will be critical. Publicly owned facilities such as schools, universities, community recreation centers, fire- houses, polling places, and armories are usually well known to the community, easy to find, have adequate parking, and are accessi- ble by public transportation or private vehicle. The downside to use of these locations is that it may disrupt their regular functions and associate (potentially enduring) stigmatization due to the gathering of “exposed” people. Alternate locations may include aircraft hangers and shuttered public areas such as hospitals that are no longer in use. Although military installations may have available space, heightened security during a terrorist event or other public health emergency may result in restricted access to these sites. Facilities such as hospitals, commercial pharma- cies, or other healthcare institutions may be overwhelmed with additional patient loads created by the event and may not be the best choice to locate PODs. Although a recent survey indi- cated the willingness of private industries to partner with public health entities for administration of medications or vaccines,20

there were concerns regarding liability. In the United States, lia- bility protection is provided to covered persons who adminis- ter a covered countermeasure through the Public Readiness and

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Emergency Preparedness Act, part of the Department of Defense Appropriations Act of 2006.21 This takes effect after the U.S. Sec- retary of Health and Human Services declares a public health emergency that requires administration of such countermea- sures as identified by the Secretary.21 Section 224(p) of the Public Health Service Act also specifically addresses the liability concerns associated with administration of smallpox counter- measures.22 Fewer liability protections exist for institutions responding to emergencies compared with available protection for individuals.23

Although there could be concerns on the part of the owners for negative effects on their future business after being used as a site, commercial facilities such as grocery stores, wholesale clubs, or retail stores may be more useful vaccine administration set- tings because many of these organizations host annual influenza vaccination clinics. Such nontraditional settings for influenza vaccination campaigns have been increasingly utilized.24 Non- traditional settings have positive cost/utility ratios and their con- venience and locations may make them an important choice of vaccination site. Ninety-five percent of the population is within 5 miles of a retail pharmacy in the United States.25 Retail stores and other nonclinical community settings along with third-party logistics or health service providers in the United States have administered approximately 30 million influenza vaccinations annually.20 Because of the increased use of these settings, guide- lines have been established to define quality standards for immu- nizations in nontraditional settings.26 Although there have been some concerns about safety, one study assessed 542,445 persons vaccinated in nontraditional settings and found that adverse events were extremely low, with a total of 112 events, most of which resolved within minutes.24

Physical characteristics of the POD location should include the ability to handle hundreds or thousands of people at one time, while keeping them protected from adverse weather con- ditions. Communities have used a varying range of POD sizes, ranging from 1,670 to 5,500 m2. Desirable features include heat and air conditioning, adequate bathrooms, water and electricity, handicap access with minimum stairs, public address or speaker system, unloading area for receipt of supplies, parking, helicopter landing, a break room/canteen, and good security, including the ability to control access. These physical characteristics will provide the security team sufficient space to coordinate traffic, manage parking, maintain crowd control, and protect staff and assets.

POINTS OF DISPENSING EQUIPMENT

Adequate equipment and supplies will be useful at the POD. Table 16.1 describes equipment and supplies that should be con- sidered. This is not a comprehensive list and each city or state may find additional items that are useful. Some areas have developed a “go-kit” of items that can be easily transported to POD loca- tions, have multiple uses during different types of disasters, are easily stored at room temperature, and are pre-event packaged according to different POD functions.27

POINTS OF DISPENSING OPERATIONS

All PODs within an affected area should be uniform in their med- ication delivery system, patient flow process, staff roles, operating

procedures, projected throughput, hours of operation, informa- tion, 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.15,28 To optimize the success of distributing the pop- ulation evenly among the PODs, a robust public information campaign will be necessary. This can include population dis- tribution by first letter of last name, postal code, census tract, school district, or neighborhood. POD sites should be prepared for greater than anticipated numbers of people because the pop- ulation may be unable or unwilling to follow instructions despite an aggressive public information campaign.

Each POD must designate an on-site director (incident com- mander) who is capable of managing large numbers of people under difficult circumstances and who is familiar with the spe- cific needs of the community. Although POD management is a local responsibility, POD locations, sizes, operations, and lead- ers are often chosen after collaboration between local, state, and regional health agencies. The Incident Command System and the National Incident Management System are both well-recognized command and control systems in the U.S. that may be used in POD management.14,28,29 Using these command and control systems allows for clear leadership roles and chain of command, delegation of duties, reporting systems, and recordkeeping.

PODs may be organized in a variety of ways. The type of POD will have a direct impact on transportation and traffic manage- ment surrounding the POD. For example, greeting/information, triage, or registration could be performed in a central location with dispensing at another location. This is an example of a seg- mented POD. PODs that operate entirely in one location are called nonsegmented PODs. Segmented PODs allow the pub- lic to gather at a staging site that is accessible by public trans- portation and also has adequate parking available. Examples would include stadiums, convention centers or shopping malls. At the initial site, the exposed population could be screened, triaged, and given information before being transported to the actual dispensing location (POD). Symptomatic patients could 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 at the POD; a potential decrease in the number of people presenting to the POD who do not need prophylaxis; a regulated flow of people to the POD and the ability to triage symptomatic patients away from the POD. Disadvantages include the need for large park- ing facilities at the staging site, 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 training for staff in two locations, a greater burden of security, and an increase in staffing requirements. Figures 16.2 and 16.3 depict segmented POD operations.

A nonsegmented POD allows all operations to be conducted at one location. Advantages to this type of operation include a reduction in the amount of staffing and security. Disadvantages may include the need for increased parking requirements, 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 (i.e., pneumonic plague) from the resultant crowded conditions. Figure 16.4 depicts a nonseg- mented POD operation.

There are four basic functional areas to a POD: intake, screen- ing, dispensing, and exit. Intake includes the processes, proce- dures, stations, and personnel involved in introducing people

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Table 16.1: 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 Facial tissues

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 sanitizers Sharps containers

Flashlights Surgical masks or N-95 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

into the POD. Paperwork such as the medical history can be completed at this stage, with patients being routed to the appro- priate station to receive the correct medication. The patient information collected at this time can be used for monitoring medication compliance and adverse events, as well as track- ing dispensed medication in case of a drug recall. The amount of information collected is a decision made by the state and local planners but should be concise and useful. In certain cir- cumstances there may be federal requirements as well. Such data can be collected on paper forms, computer databases, tele- phones, or faxes.30 Throughput of the POD will slow down 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.31–34 It is important to have adequate patient information sheets on hand at the POD. This may be accomplished by holding a small inventory of user-ready sheets

or electronic master templates that can be used initially, fol- lowed 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 patients to optimize resources and maximize survival of patients. This step may include greeters, screeners, roamers, first aid, med- ical transport, and clinical resources or mental health coun- seling.

Dispensing includes the process and procedures for prepar- ing and distributing medications to the public. Various methods of dispensing may be used. There will be certain popula- tions that may not be able to utilize PODs and will there- fore require different dispensing methods. These groups include prison inmates, nursing home patients or other long-term care

POD Staging Site

Screen Triage Provide information

Symptomatic Patients

Treatment Center

Patients

...

Figure 16.2. Segmented POD.

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POD

Staging Site Screen Triage Provide information

Symptomatic Patients

Treatment Center

Patients

Patients POD

POD

...

Figure 16.3. Segmented POD with one staging area feeding multiple PODs.

institution patients, workers at large industries operating 24- hours-a-day, hospitalized or home-bound patients, homeless persons, and undocumented immigrants. Alternate dispensing methods may include: deliveries to large corporations or uni- versities that have occupational health clinics or medical staff on site; mobile dispensing clinics; “drive through clinics;” or the U.S. Postal Service delivery previously described.15 Drive through clinics have been tested in some states and although advantages such as alleviation of crowding and less possibility for disease transmission were noted, there were pitfalls such as confusing traffic flow, long processing times, and limited access to parking or restrooms.35 Pushing drugs 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.14 Pulling people into PODs for prophylaxis or vaccination could more efficiently use healthcare workers and resources and would allow for medical evaluation and centralized data collection. Logistical delays and setting up multiple PODs are the downsides of pulling people into POD locations. A combination of both pushing and pulling methods may be most useful.

Decisions such as whether one person can pick up med- ications for an entire household should be made in advance. Allowing one person to pick up medications for the entire family would decrease the number of people at the POD and increase the throughput. If regimens are for children, indi- viduals collecting the medications must provide their weights. Other information regarding family members, such as aller- gies, current medications, or existing disease states may also be vital. The type of information or evidence required to jus- tify the number of regimens should be decided before an event

and should be made known to the public so they can pro- vide appropriate documentation for other family members at the POD. POD staff should be prepared to answer questions about the risk of disease transmission between humans, and 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. Depart- ment 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 live- stock.36

Exiting includes moving the public out of the POD and pro- viding any necessary follow-up information. Follow-up meth- ods such as providing hotlines through the local or state health department, poison control center or nurse advice line, imple- menting a community phone bank, setting up a website, and giving information to primary care physicians can all be useful avenues for providing additional information to patients regard- ing compliance, adverse effects, or other questions.

Security and patient education are two issues that permeate all four phases of a POD operation and should be addressed throughout. Every step of the POD process may be used to pro- vide patient education. At the intake step, fact sheets, handouts, or videotapes may be used to provide information. Such infor- mation should be prepared in multiple languages as appropriate to the community. During screening or dispensing, drug infor- mation sheets and individual patient-specific information may be shared. 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.

POD Screen Triage Provide information Provide medication

Symptomatic Patients

Treatment Center

Patients

...

Figure 16.4. Nonsegmented POD.

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Plans for security should be addressed in preparation for an event, because local law enforcement will likely be performing other duties related to the event. This is especially important as the POD could be a high-risk site if resources are limited. Also, PODs could be sites of secondary terrorist attacks. All POD work- ers 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 con- cept 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 pop- ulation healthcare. Ensuring continual movement of patients through the system to eliminate bottlenecks or “balancing the line” will allow for a more effective mass-dispensing POD model. If necessary, a high throughput rate (increased persons per hour) may be achievable by shortening or foregoing orientation, simpli- fying medical forms, and eliminating secondary medical screen- ing and a final quality assurance check. Also, patients who require specialized attention for any reason could be moved to remote stations outside of the POD. This could include patients with specific medical, safety, mobility, psychiatric, or communication needs including children, unaccompanied minors, travelers, the medically fragile, physically disabled, migratory, homeless, those with language, culture or literacy barriers, or disruptive per- sons.37 These groups may require additional attention for them to understand public information messages. Messages and fact sheets can be translated; translators may be useful as could color coding or pictograms. Identifying bottlenecks and adding addi- tional resources to relieve these areas may also be helpful.38 Bot- tlenecks at PODs may occur when too many patients are allowed into the POD at one time, too many patients arrive at one par- ticular station, too few staff are operating a station, or staff have too many things to do for each patient. This can be alleviated by having “express lanes” for those with no complications, estimat- ing the number of staff and patients at each POD, and having a flexible command and control system in place that allows for modification of staff and type of PODs.14,15 Prophylaxis of POD workers should be addressed before the POD is open to the general public.

POINTS OF DISPENSING STAFFING AND TRAINING

It is the responsibility of each public health jurisdiction to develop and maintain the ability to conduct first response and ongoing, federally assisted, community-wide mass antibiotic dispensing and vaccination campaigns.14 Local mass prophylaxis activities will likely be underway before any federal assets arrive, and fed- eral or state assistance will not likely have sufficient personnel to provide staffing to POD locations, particularly if the event encompasses a wide geographical region such as multiple states or countries. Even after federal assets arrive, POD operations will likely remain under local control, and POD operations may continue well after the departure of state or federal assistance.14

Adequate staffing is of paramount importance in running a successful POD and will require people with the correct skill sets who can be trained for their specific tasks. The trained staff will then be able to quickly set up 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 particu- lar city or state.19,30,39–41 A general rule of thumb would be 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 such as those familiar with the facility or general POD oper- ating tasks. Volunteers or nonclinical staff should be used for any appropriate jobs to free up professional staff and maximize effi- ciency of POD operations. Volunteers may be recruited before an event; however, expect that they will also present unannounced at the time of an event. The enormous task of training volunteers should be conducted to the extent possible before an event occurs. This task is easier if roles and responsibilities are kept consistent throughout the state or region.15 It could also be helpful to main- tain a statewide registry of trained volunteers. Trained volun- teers with special skill sets such as translation and sign language abilities, and those from the Red Cross, can provide invaluable assistance.28 Untrained volunteers may be found in community civic or fraternal organizations, as walk-ins or as spontaneous volunteers.

When planning for staffing, considerations should also include having enough people to staff two or three shifts per day. Some exercises conducted by states and cities have shown a rapid onset of staff burnout, so planning for additional shifts or rotation of staff among duties may be useful.39

Professionals will be in high demand for other jobs or tasks during an emergency; however, some potential sources for access- ing professional services include commercial pharmacies, state licensing agencies, professional associations, nursing, pharmacy, or medical students, the U.S. DHS Emergency Coordinator for the region, the U.S. HHS regional health administrator, and via programs such as the U.S. Medical Reserve Corps.42 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 Dec- laration is in effect.Table 16.2 lists possible roles for healthcare professionals and volunteers.

Training of POD staff will help shape the success of the POD operation. Training should include orientation to their partic- ular tasks or roles, the physical layout and flow of the POD, other team members on the shift, and familiarity with forms and other paperwork. It may be helpful for planners to maintain a database of those who have received training. Ideally, train- ing would be conducted before an event; however, due to staff turnover, skill degradation, and updates or changes in proce- dures, this would require periodic refresher training and even- tually may be too costly or time consuming. Another option would be to provide Just-In-Time training, where staff would not be trained until they were needed. New people could be trained in the POD at their own workstations with a straightfor- ward job action sheet. This method has been used successfully in a number of exercises.34,39,43 A third option would be to train enough staff ahead of time (along with refresher training) to

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Table 16.2: Suggested Roles for Healthcare Professionals and Volunteers

Assignment Staffing Task

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 using a script

Check completion of forms

Briefing Trained volunteer Translate dispensing-site procedures and policies to persons who do not understand local language, are hearing impaired, or illiterate

Volunteer with task-specific training Hand out medical record forms and provide instructions 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 transport vehicle

Drug Triage Professional Screen for contraindications for drugs or medical conditions

Answer questions or prescribe alternate drugs

Dispensing

Express Drug Dispensing Pharmacist supervisor Oversee dispensing process

Volunteer Weigh children younger than 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 – version 10. U.S. Centers for Disease Control and Prevention, Division of Strategic National Stockpile.

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Table 16.3: Software and Programming for POD Modeling

BERM, the Weill-Cornell Bioterrorism and Epidemic Response Model

http://www.ahrq.gov/research/biomodel.html

Clinic Planning Model Generator http://www.isr.umd.edu/Labs/CIM/projects/clinic/

Maxi-Vac software program http://www.bt.cdc.gov/agent/smallpox/vaccination/maxi-vac/index.asp

MEDS/POD [44]

RealOpt c© [48]

comprise the first shift of a POD and provide Just-In-Time train- ing for subsequent shifts. Just-In-Time training should include the person’s role, forms or paperwork that will be used, physi- cal layout and flow of the POD, shift hours, information about related POD functions and where the trainee fits into the pro- cess, to whom to report any problems, and emergency evacu- ation procedures. A POD manager can address issues such as staff shortages, medication shortages, or other problems that arise.

Drills and exercises will be the most beneficial way to deter- mine whether the POD will be successful. A number of dispens- ing campaign and POD-specific tasks, objectives, and perfor- mance metrics can be evaluated including unlocking and open- ing the facilities; location of lights, circuit breakers and alarms; how to set up the facilities with chairs, tables, rope lanes, and portable toilets; how food and water will be provided; and how the facility will be set up and staffed. After drills or exercises have taken place, after-action reports or briefings can help identify areas of improvement for future focus. Although more research is needed to develop models that will ensure high throughput to meet the 48-hour goal for dispensing, several computer- generated modeling programs have been established to help with POD planning efforts for both antibiotic distribution and vacci- nations.14,18,44–48 The U.S. CDC has also published guidance for setting up large-scale smallpox vaccination clinics.49 In addition, a number of Webcasts are available to assist planners with POD operations.15,37,38,50

Using these tools will allow for the formulation of realistic plans. POD staffing levels for entry screening, triage, medical evaluation, and drug dispensing stations may be determined using various bioterrorism response scenarios.45 The number of staff needed to provide prophylaxis for the entire population within 48 hours can also be determined.15 Other approaches allow for simulation and decision support for planning large- scale emergency dispensing clinics by offering clinic design and staffing models, including scenarios for smallpox or influenza vaccination and antibiotic dispensing.45–48 Most of the software or programming is free to planners and access links can be found in Table 16.3.

Many states and cities have conducted exercises and drills to test their preparedness plans and their dispensing or vaccina- tion capabilities.19,29,34,39–41,43,51–56 Vaccination clinics were also tested beginning in 2002, when President George W. Bush insti- tuted a smallpox vaccination program for military and civilian medical first responders.57 Bush’s two-pronged program called for HHS to immunize a cohort of healthcare workers and first responders, and for the Department of Defense to vaccinate the military population.58 Military administration of anthrax vac- cine has also followed the vaccination clinic model.59 Annual

influenza vaccination clinics are another good source of testing mass vaccination protocols.28,60 Additionally, testing mass vac- cination programs with influenza vaccine provides the opportu- nity to enhance pandemic preparedness while achieving annual prevention goals.28 These exercises have produced similar infor- mation; some of the most important guidelines are highlighted in Table 16.4.

To be effective, POD operations must address the needs of different patient groups, including otherwise healthy people with no complications who require prophylaxis, people with existing medical conditions who require prophylaxis, or those already suffering from illness as a result of the exposure.15 The goal for those with symptoms is to get them to a healthcare facility quickly, for those exposed with no complications to get them appropri- ate prophylaxis medications quickly, and for those exposed with complicated medical histories to determine any contraindica- tions or dosage adjustments and provide rapid prophylaxis. Some patients may be directed to an alternate care site, particularly if they are less ill than others. In some scenarios, healthcare facilities could not handle all patients with symptoms. Secondary goals may include crisis or mental health counseling, recordkeeping, or patient tracking. PODs should have direct communications channels with hospitals and other facilities where symptomatic patients or those who experience adverse reactions can be evalu- ated. Successful operation of PODs may decrease the number of patients who initially present to a healthcare facility; successful

Table 16.4: Important Guidelines for Effective POD Management

■ Limit medical histories

■ Clear signage

■ Collaboration with law enforcement

■ Hotline/phone bank

■ Good communication

■ Redistribution of resources

■ Transportation arrangements

■ Streamlined triage

■ Multiple language/translators

■ Patient education

■ Directions for leftover medication

■ Defined responsibilities

■ Clarity of mission

■ Defined lines of authority

■ Partnerships

■ Liability

■ Just-In-Time training

■ Chain of custody

■ Regulate entrance/exit to limit flow

■ Limit distractions

■ How to obtain refills

■ Procedures for special cases

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Table 16.5: Four Phases of POD Activation

Phase 1 Notify and recall all staff necessary to initiate dispensing campaign

Phase 2 Provide prophylaxis or vaccination to critical infrastructure personnel and their families

Phase 3 Set up POD network – obtain staff, set up the PODs, print forms, unpack inventory

Phase 4 Public notification and opening of PODs

vaccination or mass antibiotic dispensing may reduce the num- ber of patients who become ill and require subsequent treatment.

Once POD sites are selected, staffing is determined, training is provided, and exercises are conducted, the PODs should be ready for use in the event of an emergency. In the activation of a dispensing campaign, implementation of the PODs could occur in four phases as listed in Table 16.5.15,18 Providing prophylaxis or vaccination to critical infrastructure personnel and their families may result in responders being more willing to come to work because they and their families have been protected. Critical infrastructure personnel may include healthcare workers, first responders, law enforcement personnel, government leaders, and others who are necessary to support the essential infrastructure of the affected area. Local supplies may be available to accomplish this while SNS or other assets are being delivered.

POINTS OF DISPENSING PUBLIC INFORMATION

Public information is one of the most critical elements of a suc- cessful dispensing campaign. One key factor is to address the information needs of the public, healthcare workers, and other stakeholders in an effective manner concerning the risks they face and actions they can take to protect themselves and others.37

Messages should be designed to instill trust as well as provide the motivation and reassurance to do what is recommended. Once the PODs are ready to open, the public should be informed. If feasible, planners should wait until all PODs within a region are ready for opening before notifying the public so as to not over- whelm one site. If information regarding PODs is released too far in advance, people may form long lines well before PODs are open or functional. The media may be used as a first level of triage in addition to public address systems outside of the POD, with announcements telling those who have recently become ill to go to the nearest hospital or other designated healthcare site.38

A variety of media outlets may be used to disburse messages to the community, including newspaper, radio, television, Inter- net, telephone hotlines such as poison control centers or nurse advice lines, and press conferences. The Public Broadcast System or other emergency broadcast systems may also be implemented. Local media outlets should be alerted regarding the potential for opening PODs to ensure consistent messages across all levels of government. The media can be helpful during an event and they should have a designated area at the POD location. A media kit prepared before an event occurs will be a useful tool and should discuss background information on threat agents, signs and symptoms, information about the medical products that may be used, as well as information about the communications plan that would be utilized during a disaster along with con-

tact information. Monitoring of media reports will be essential to make sure that critical information is being relayed accu- rately and to determine if changes, corrections, or updates are necessary.15

POINTS OF DISPENSING DEACTIVATION

Once the emergency is entering the recovery phase, implement- ing a plan for deactivation of PODs will be important. PODs may be deactivated individually or in groups, but should not be simultaneously deactivated. This allows the community to retain some capability while people continue to receive medications, in case renewed activity is warranted. Sites most needed for the community, such as businesses or schools should be deactivated first. Information and data from the PODs, including through- put figures, staffing hours, expenses, and comments from staff for improvements as well as what went well, should be gathered. Some people may have difficulty adjusting after this event so counseling should be provided for staff as well as the public.

SPECIAL CONSIDERATIONS

Drug Formulations for Patients at Extremes of Age

Small children or elderly persons may have difficulty swallowing tablets or capsules as part of a postexposure prophylaxis cam- paign. The U.S. National Advisory Committee on Children and Terrorism recommends that suspension formulations be avail- able for children aged 9 and younger.61 The SNS contains a limited quantity of pediatric suspensions. The quantity of sus- pensions under recommendation that may be required to fulfill a 60-day prophylactic antibiotic course (i.e., for anthrax) greatly exceeds the manufacturing capacity and storage capabilities of most countries. Additionally, suspension formulations have a rel- atively short shelf life, may be costly, and may have a small annual usage. For these reasons, alternative methods for creating suit- able formulations for children have been explored. One potential avenue is to pharmaceutically compound the needed suspension from pills that are triturated, wetted, and suspended with fla- voring agents added, as could be accomplished in a pharmacy setting. This method is very time consuming, and when per- formed on a large scale, pharmacies may be subject to regulatory implications imposed by the U.S. Food and Drug Administra- tion (FDA) such as those applying to a manufacturer. Another option is the potential to crush tablets in the home setting and add the crushed medications to a food or liquid which would then be administered to the child. Informal testing of the initial guidelines provided by the FDA revealed that they were too dif- ficult for some parents to follow. In addition, some of the oral dosage forms have an extremely bitter taste that is difficult to conceal. At the time of this writing, the FDA has updated the guidelines for crushing doxycycline tablets to make them easier to understand and execute. The doxycycline guidelines are avail- able on the FDA website at http://www.fda.gov; others are under consideration and will be made available upon completion.

DISPENSING LAWS – THE U.S. SYSTEM

The label of a drug must have certain information accord- ing to U.S. federal law (Food Drug and Cosmetic Act (FDCA)

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Section 502 (21 U.S.C. § 352) and the Code of Federal Regula- tions (CFR) (21 C.F.R. Part 201). These laws state that the label of a drug should include (but is not limited to): established name of drug; name and address of manufacturer, packer, or distribu- tor; quantity of contents (weight, measure, or numerical count); lot number; expiration date; and adequate directions for use. Additionally, under federal law (FDCA Section 503(b)(2) and (21 U.S.C. § 353(b)(2)), the label of a dispensed prescription drug must include: name and address of the dispenser, serial number, date of prescription or of its filling, name of prescriber, name of patient if stated on prescription, directions for use, and cautionary statements if contained in the prescription. State laws may also impose further requirements on the label of a dispensed drug.

The labeling regulations were originally developed to support the day-to-day needs of medication dispensing. Planners may want to explore options for attaining regulatory relief (from state and federal regulations) on the labeling requirements for phar- maceutical medications dispensed during an emergency event.

There are also dispensing requirements for prescription drugs. Under U.S. federal law (FDCA Section 503(b) (1) and (21 U.S.C. § 353(b) (1)), prescription drugs must be dispensed only upon a written prescription, an oral prescription (which is reduced promptly to writing), or by refilling a prescription. State laws also impose requirements on the dispensing of prescription drugs.

The size and scope of an emergency may dictate that person- nel other than pharmacists or physicians must dispense medica- tion to the public. Disaster planners may need to investigate exist- ing legislative authorities such as the Emergency Powers Act and possibly regulatory relief that would allow individuals other than pharmacists to dispense prescription drugs during an emergency. It is also recommended that disaster planners become familiar with state laws surrounding these issues. Currently, 44 states allow pharmacists to administer vaccines. Although it would require authorization for an expanded scope of practice in some states, trained paramedics may be an untapped source for vac- cine administration and may provide the benefit of having access to underserved populations.62

INVESTIGATIONAL NEW DRUGS

In the instance that a pharmaceutical or biological product is approved by the U.S. FDA but not for a particular indication, or the product itself has not yet been approved by the FDA, its use may require an Investigational New Drug (IND) protocol. Drugs that are used under an IND process can only be admin- istered to patients according to an Institutional Review Board (Ethics Committee) approved protocol, which is maintained by the principal investigator and approved by the FDA. The prin- cipal investigator may have coinvestigators who are also able to administer the protocol. Pharmaceuticals or biological agents used under IND protocols require informed consent from each patient.

A few examples of such products integrated into the SNS include the use of smallpox vaccine diluted in a 1:5 ratio, the use of colony-stimulating factors for the treatment of radiation- induced neutropenia, and the use of anthrax immune globulin to treat symptomatic anthrax patients. Obtaining informed con- sent can be a tedious process especially during a disaster involv- ing mass casualties. To better serve the population in a time

of disaster, the U.S. Project BioShield law was enacted in 2004 to help provide new tools to assist with protecting Americans against terrorist threats involving chemical, biological, radio- logical, or nuclear materials.63 Oversight of the program lies with the U.S. Secretaries of HHS and DHS. One of the key aspects of the legislation is to give the FDA the ability to rapidly offer promising treatments in emergency situations.64 Project BioShield amended section 564 of the Federal Food Drug and Cosmetic Act to permit the FDA Commissioner, upon official declaration of an emergency by either the Secretary of HHS, the Secretary of Defense, or the Secretary of Homeland Security, to authorize the use of medical countermeasures for the diagnosis, treatment, or prevention of serious or life-threatening diseases or conditions for which there are no adequate, approved, or available alternatives. This process is known as an Emergency Use Authorization (EUA). The EUA is an authorization by the FDA to allow the use of medical products during a real or poten- tial emergency. This may include either unapproved products (products that have not yet been approved under sections 505, 510(k) and 515 of the Federal Food Drug and Cosmetic Act or section 351 of the Public Health Service Act), or unapproved uses of approved products (drugs, biological agents, or devices). An EUA is authorized for a specific time frame, not to exceed 1 year.

One example of an unapproved use for an approved product may be administration of an antibiotic for post-exposure pro- phylaxis to a bacterium that is not included on approved labeling for the drug. It may also encompass dispensing of prescription drugs by a unlicensed healthcare provider. The following criteria must be met before the FDA Commissioner may issue an EUA:

■ A serious or life-threatening condition could result from the agent specified in the emergency declaration

■ It is reasonable to believe the product may be effective in diag- nosing, treating, or preventing the serious or life-threatening disease or condition based on the total scientific evidence available

■ The known and potential benefits outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition

■ There is no adequate, approved, available alternative to the product

Informed consent is not required for products used under an EUA; however, recipients must still be informed and provided with general information regarding the risks and benefits. The use of an EUA, granted by the FDA at the time of the emergency, may be a more expeditious way of dispensing investigational countermeasures than an IND approach. Not all investigational or IND products will qualify or be approved for use under an EUA. Additional information on EUA may be found on the FDA website at http://www.fda.gov/oc/bioterrorism/emergency use.html.

ADVERSE EVENTS

Medication-related adverse events may be seen in varying num- bers in a mass dispensing or mass vaccination campaign. Using medical products under an IND or an EUA may require the capturing of medication-related adverse events data. This could be accomplished using existing mechanisms available for passive

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reporting of adverse events such as the Vaccine Adverse Event Reporting System hosted by the U.S. CDC, or MedWatch, which is sponsored by the FDA. Further research, however, is needed to determine the capabilities of these systems to manage events of large magnitude. Additionally, the details of who is respon- sible for adverse event reporting during a mass casualty require further definition. The timing and peak number of clinically sig- nificant medication-related adverse events will likely be related to the duration of the mass prophylaxis campaign, with short cam- paigns having the greatest potential to overwhelm the capacity of emergency departments, clinics, or PODs.65 States may also have their own reporting mechanisms in place such as toll free num- bers that patients may call to report medication-related adverse events.

COLD CHAIN MANAGEMENT

Cold chain management is defined as maintaining the quality of temperature-sensitive pharmaceuticals throughout transporta- tion, product handling, and storage. Dispensing sites must be able to maintain the temperature of the drugs or vaccines they provide to the public, in accordance with the package insert of the products. In some cases, vaccines may be frozen at tempera- tures of −20◦C or may be refrigerated at 2–8◦C. Some vaccines have strict thawing guidelines. Deliveries of assets to the POD locations should not be left outside both for security and proper storage reasons. Each POD location should have the appropri- ate equipment such as forklifts or pallet jacks to move deliveries as well as sufficient equipment to provide cold chain storage as needed.

ANCILLAR Y SUPPLIES

For successful mass vaccination and dispensing, the necessary supplies to administer assets must be available. Ancillary sup- plies (alcohol swabs, bandages, syringes, and needles) should be procured in advance to ensure that vaccines may be admin- istered when necessary. These supplies may not automatically be provided with the vaccines when ordered from vendors or requested from stockpiles. Planners need to consider other addi- tional supplies that may be critical to dispensing, including water for reconstitution of pediatric medications.

RECOMMENDATIONS FOR FURTHER RESEARCH

Although advances in the area of mass dispensing and mass vacci- nation continue to accumulate, progress has been slow.66 Oppor- tunities for future research include the development of standard- ized policies governing the use of businesses (partnerships and agreements) during a public health response; clarifying potential liability issues and solutions that may differ from state to state and may not be well explained in the U.S. December 2005 Public Readiness and Emergency Preparedness Act; providing guidance and funding for inclusion of public and private organizations to partner with public health entities; improving communication to local communities regarding partnerships and plans between public health and private industry; and encouraging state author- ities to establish legal authorization and regulatory guidelines (i.e., to allow pharmacists in all states to vaccinate, and provision

of guidance on who can dispense).66 Additional guidance at the federal level is needed to allow for easier dispensing of products under an IND or EUA and identifying data collection require- ments for products distributed under an EUA. In addition, more research is required to obtain licensed indications for pediatric or other special populations in product labeling. Creation of alternative dosage forms for pediatrics would help relieve the shortage and storage costs associated with antibiotic suspensions and may also increase compliance. Development of alternative vaccination forms such as a transdermal patch would simplify administration and decrease storage needs.67 Additional work is needed on mass dispensing models for vaccinations and medi- cation distribution to help communities streamline their oper- ations and provide prophylaxis to their populations in a timely manner. Standardization of data collection forms for gathering patient information before dispensing or vaccination should be considered. More innovation is required to meet the challenge of providing prophylaxis or vaccination to large populations in a short time while maintaining adherence to appropriate regu- lations. Mass dispensing and vaccination must be tailored to the available local, regional, national, and global resources. Given the rapidity with which a public health emergency could become a national or international event, it is imperative that prepared- ness, training, and exercise implementation continue at every level. There is a need for continued funding to maintain an acceptable level of readiness. Building a more robust basic public health infrastructure would not only benefit the national and international communities on a daily basis, but would also pro- vide the foundation for conducting a response to a large-scale public health emergency.

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