Department of Health and Human Services
 

OFFICE OF 

INSPECTOR GENERAL 

LOCAL PANDEMIC INFLUENZA 


PREPAREDNESS:
 

VACCINE AND ANTIVIRAL DRUG 


DISTRIBUTION AND DISPENSING 


Daniel R. Levinson
 

Inspector General 


September 2009
 

OEI-04-08-00260
 
 

 

 

 

 

 

 

Office of Inspector General
 http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components: 

Office of Audit Services 

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits 

examine the performance of HHS programs and/or its grantees and contractors in carrying 

out their respective responsibilities and are intended to provide independent assessments of 

HHS programs and operations. These assessments help reduce waste, abuse, and 

mismanagement and promote economy and efficiency throughout HHS. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on significant 

issues. These evaluations focus on preventing fraud, waste, or abuse and promoting 

economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI 

reports also present practical recommendations for improving program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 

of fraud and misconduct related to HHS programs, operations, and beneficiaries. With 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

by actively coordinating with the Department of Justice and other Federal, State, and local 

law enforcement authorities. The investigative efforts of OI often lead to criminal 

convictions, administrative sanctions, and/or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support for OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

also negotiates and monitors corporate integrity agreements. OCIG renders advisory 

opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities. 
 

 

 

 

 

 

 

Δ EXECUTIVE SUMMARY 

OBJECTIVES 

To determine the extent to which 10 selected localities: 

1.	 addressed in their planning documents the vaccine and antiviral 

drug distribution and dispensing components and preparedness 

items that we identified based on Department of Health and Human 

Services (HHS) pandemic influenza guidance, 

2.	 conducted exercises related to vaccine and antiviral drug 

distribution and dispensing and documented these exercises with 

After Action Reports and Improvement Plans, and 

3.	 collaborated with community partners to develop and exercise their 

plans to distribute and dispense vaccines and antiviral drugs during 

an influenza pandemic. 

BACKGROUND 

An influenza pandemic is a global outbreak of a highly infectious 

influenza virus that can cause serious illness in humans. HHS 

estimates that even a mild pandemic could cause between 2 million and 

7.4 million deaths worldwide. In June 2009, the World Health 

Organization raised the pandemic influenza alert level to Phase 6 and 

declared the start of the 2009 H1N1 influenza pandemic. Although 

scientists believe this pandemic will initially be moderate, its severity 

over time may increase. 

In its review of 2008 State pandemic influenza operating plans, the 

Assistant Secretary for Preparedness and Response (ASPR) found “very 

few gaps in State-level readiness for antiviral drug distribution.” 

Additionally, ASPR found that States were “doing well” with respect to 

developing State-level pandemic influenza vaccination plans. However, 

its review did not assess local pandemic influenza vaccine and antiviral 

drug distribution and dispensing preparedness. 

HHS has provided guidance to States and localities to use in planning 

for pandemic influenza vaccine and antiviral drug distribution and 

dispensing. Based on this guidance and input from the Centers for 

Disease Control and Prevention (CDC) and ASPR, we identified eight 

planning areas (i.e., components) and 89 preparedness items within the 

eight components that provided a framework for our evaluation. These 

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EXECUTIVE SUMMARY 
 

components are: Receiving & Staging, Dispensing, Tracking, 

Vulnerable Populations, Priority Groups, Security, Storage, and 

Transportation. 

HHS recommends that States and localities exercise their vaccine and 

antiviral drug distribution and dispensing plans and prepare After 

Action Reports to document exercise objectives and recommendations. 

They can also use Improvement Plans to assign responsibility and 

timeframes for completing plan improvements. Finally, HHS 

recommends that States and localities collaborate with community 

partners to develop and exercise their pandemic influenza vaccine and 

antiviral drug distribution and dispensing plans. 

We examined plans for distributing and dispensing vaccines and 

antiviral drugs during an influenza pandemic in 10 selected localities 

and their five respective States. We also collected data about the 

selected localities’ exercises and collaboration with community partners. 

FINDINGS 

Selected localities had not addressed in their planning documents 

most of the vaccine and antiviral drug distribution and dispensing 

components and preparedness items identified in HHS pandemic 

influenza guidance. None of the 10 selected localities had started 

planning in all eight distribution and dispensing components. Across 

components, localities’ plans generally were not actionable. For 

example, localities did not generally have valid and detailed formal 

agreements, such as a Memorandum of Agreement, with partnering 

agencies. Additionally, localities had generally not identified sufficient 

sources of staff or factored absenteeism into their staffing estimates. 

Localities varied in the extent to which they addressed the distribution 

and dispensing components in their planning documents. Localities 

addressed the highest percentage of preparedness items in the 

components of Receiving & Staging and Dispensing. They addressed a 

lower percentage of preparedness items in Tracking, Vulnerable 

Populations, and Priority Groups. Finally, localities addressed the 

lowest percentage of preparedness items in Security, Storage, and 

Transportation. 

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E X E CUTIVE S U MMAR Y 

All selected localities conducted exercises related to vaccine and 

antiviral drug distribution and dispensing; however, most did not 

create After Action Reports and Improvement Plans for these 

exercises. Between September 2006 and July 2008, the 10 selected 

localities conducted a total of 63 exercises related to distributing and 

dispensing vaccines and antiviral drugs, ranging from 2 to 12 exercises 

within a locality. Most of the exercises tested more than one component 

of vaccine and antiviral drug distribution and dispensing. All selected 

localities conducted at least one exercise to test their ability to receive 

and stage, provide security for, and transport medications. In addition, 

seven localities conducted exercises to test their ability to dispense 

these medications to priority groups or store them during the 

distribution and dispensing process. Further, localities did not create 

both After Action Reports and Improvement Plans for 80 percent of all 

exercises they conducted. 

All selected localities collaborated with community partners to 

develop and exercise their plans to distribute and dispense 

vaccines and antiviral drugs during an influenza pandemic. 

The 10 selected localities worked with different types of community 

partners to develop and test their plans for distributing and dispensing 

vaccines and antiviral drugs during an influenza pandemic. To develop 

these plans, all localities collaborated with partners such as educational 

institutions, emergency management agencies, and hospitals. To test 

these plans, most localities collaborated with educational institutions, 

law enforcement agencies, and the medical community. 

RECOMMENDATIONS 

While the majority of selected localities had begun planning to 

distribute and dispense vaccines and antiviral drugs, more needs to be 

done to improve local preparedness. Therefore, we recommend that 

CDC work with States to: 

Improve local pandemic influenza vaccine and antiviral drug 

distribution and dispensing preparedness. CDC, in coordination with 

States, could improve pandemic influenza vaccine and antiviral drug 

distribution and dispensing preparedness at the local level by taking the 

following actions: 

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EXECUTIVE SUMMARY 

•	 Determine why localities appear to be in the early stages of planning 

for pandemic influneza vaccine and antiviral drug distribution and 

dispensing, and provide assistance to improve their preparedness. 

•	 Prioritize the planning areas where States should focus any 

carryover or future pandemic influenza funding to quickly improve 

local preparedness to distribute and dispense vaccines and antiviral 

drugs. 

•	 Place special emphasis on ensuring localities develop actionable 

vaccine and antiviral drug distribution and dispensing plans. 

Specifically, plans should identify the organizations or individuals 

responsible for carrying out specific actions and the sources that 

would be necessary to staff distribution and dispensing positions 

and should be supported by valid, detailed formal agreements with 

partnering agencies. 

Ensure that localities consistently create both After Action Reports 

and Improvement Plans to enhance their preparedness to 

distribute and dispense vaccines and antiviral drugs during an 

influenza pandemic. 

Facilitate the sharing of pandemic influenza planning and response 

information and emerging promising practices. 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CDC agreed with two of our three recommendations. Specifically, CDC 

agreed to work with States to encourage localities to develop After Action 

Reports and Improvement Plans that comply with the Homeland Security 

Exercise and Evaluation Program. CDC also agreed that States and 

localities should use the Lessons Learned Information Sharing Web site to 

facilitate the sharing of planning resources. 

CDC did not indicate whether it agreed with the first recommendation, but 

noted that it plans to use some of the Office of Inspector General’s (OIG) 

suggested actions to address this recommendation. For example, CDC 

acknowledged the need for States to prioritize some of the planning areas 

OIG identified, which include receiving and storing vaccines and antiviral 

drugs and identifying dispensing sites and staffing requirements. Finally, 

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EXECUTIVE SUMMARY 

CDC agreed that localities need to develop actionable vaccine and antiviral 

drug distribution and dispensing plans. 

We addressed CDC’s comments in the Background and Methodology 

sections of the report. We ask that in its final management decision, CDC 

more clearly indicate whether it concurs with our first recommendation. 

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Δ TABLE OF CONTENTS 

EXECUTIVE SUMMARY .....................................i 
 

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 
 

FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 
 

Selected localities had not addressed in their planning documents 

most of the vaccine and antiviral drug distribution and dispensing 

components and preparedness items identified in HHS pandemic 

influenza guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 
 

All selected localities conducted exercises related to vaccine and 

antiviral drug distribution and dispensing; however, most did not 

create After Action Reports and Improvement Plans for these 

exercises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 
 

All selected localities collaborated with community partners 

to develop and exercise their plans to distribute and dispense 

vaccines and antiviral drugs during an influenza pandemic. . . . . 28 
 

 

RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 
 

Agency Comments and Office of Inspector General Response . . . 32 

APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 
 

A: Selected States and Localities. . . . . . . . . . . . . . . . . . . . . . . . . . 34 
 

B: Number of Selected Localities With Planning and Supporting 

Documents for the Eight Vaccine and Antiviral Drug Distribution 

and Dispensing Components, by Preparedness Item . . . . . . . 35 
 

C: Number of Selected Localities Collaborating With Each Type of 

Community Partner During Pandemic Influenza Vaccine and 

Antiviral Drug Distribution and Dispensing Planning and 

Exercising . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 
 

D: Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 
 

 

ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 
 

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Δ INTRODUCTION 

OBJECTIVES 

To determine the extent to which 10 selected localities: 

1.	 addressed in their planning documents the vaccine and antiviral 

drug distribution and dispensing components and preparedness 

items that we identified based on Department of Health and Human 

Services (HHS) pandemic influenza guidance, 

2.	 conducted exercises related to vaccine and antiviral drug 

distribution and dispensing and documented these exercises with 

After Action Reports and Improvement Plans, and 

3.	 collaborated with community partners to develop and exercise their 

plans to distribute and dispense vaccines and antiviral drugs during 

an influenza pandemic. 

BACKGROUND 

An influenza pandemic is a global outbreak of a highly infectious 

influenza virus that can cause serious illness in humans.1 HHS 

estimates that even a mild pandemic could cause between 2 million and 

7.4 million deaths worldwide.2 In June 2009, the World Health 

Organization raised the pandemic influenza alert level to Phase 6 and 

declared the start of the 2009 H1N1 influenza pandemic. Although 

scientists believe this pandemic will initially be moderate, its severity 

over time may increase. 

In February 2008, the Assistant Secretary for Preparedness and 

Response (ASPR) within HHS asked the Office of Inspector General 

(OIG) to evaluate State and local preparedness for an influenza 

pandemic, particularly with regard to distributing and dispensing 

vaccines and antiviral drugs and medical surge at the local level. ASPR 

annually reviews State-level pandemic influenza operating plans and 

1 HHS, “Flu Terms Defined.” Available online at http://www.pandemicflu.gov. Accessed 

on February 17, 2009. 

2 HHS, “Why are pandemics such dreaded events?” Available online at 

http://www.pandemicflu.gov/faq/pandemicinfluenza/1108.html. Accessed on February 17, 

2009. 

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INTRODUCTION

identifies planning strengths and deficiencies. 3 In its review of the 

2008 plans, ASPR found “very few gaps in State-level readiness for 

antiviral drug distribution” and that States were “doing well” with 

respect to developing State-level pandemic influenza vaccination plans.4 

However, its review did not assess local pandemic influenza vaccine and 

antiviral drug distribution and dispensing preparedness. 

This evaluation focuses on the extent to which selected localities have 

prepared to distribute and dispense vaccines and antiviral drugs during 

an influenza pandemic. A second OIG evaluation focuses on the extent 

to which selected States and localities have prepared for medical surge 

during an influenza pandemic.5 In addition, OIG has audited 

two States and is auditing one other to determine whether expenditures 

used to prepare for an influenza pandemic complied with Federal 

requirements.6 

HHS Support of State and Local Preparedness Efforts 

Since 2002, HHS has provided more than $8 billion to awardees 

(hereinafter referred to as “States”) for programs to enhance their 

3 While ASPR coordinates the review of States’ pandemic influenza operating plans, the 

Centers for Disease Control and Prevention (CDC) reviews the sections related to vaccine 

and antiviral drug distribution and dispensing. 

4 Assessment of States’ Operating Plans to Combat Pandemic Influenza: Report to 

Homeland Security Council, January 2009. Available online at 

http://www.pandemicflu.gov/plan/states/state_assessment.pdf. Accessed on April 23, 2009. 

5 OIG, “State and Local Pandemic Influenza Preparedness: Medical Surge,” 

OEI-02-08-00210. 

6 OIG, “Review of Vermont’s Pandemic Influenza Expenditures for the Period August 31, 

2005, Through June 30, 2008,” A-01-08-01500, June 25, 2009. OIG, “Review of Washington 

State’s Pandemic Influenza Expenditures for the Period August 31, 2005, Through June 30, 

2008,” A-09-08-01006, August 21, 2009. OIG is also auditing pandemic influenza 

expenditures in Georgia. 

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INTROD U C T I O N 
 

emergency preparedness for large-scale public health emergencies.7 8 

HHS has distributed these funds primarily through cooperative 

agreements under programs such as the PHEP, which is administered 

by the CDC. 

Beginning in 2005, Congress appropriated supplemental funding 

specifically for pandemic influenza preparedness. Through the existing 

PHEP cooperative agreements, CDC awarded $500 million in pandemic 

influenza funding in three phases:9 10 

• In Phase I (August 31, 2005, through August 30, 2006), States were to 

identify unmet needs and develop and exercise a pandemic influenza 

preparedness plan and an antiviral drug distribution plan. 

• In Phase II (August 31, 2006, through August 30, 2007), States were 

to complete and submit to CDC a work plan and progress reports and 

develop a pandemic influenza exercise schedule. 

7 In a 2007 press release, HHS described providing more than $7 billion in funding since 

2002 through various HHS agencies. HHS, “HHS Announces $896.7 Million in Funding to 

States for Public Health Preparedness and Emergency Response.” Available online at 

http://www.hhs.gov/news/press/2007pres/07/pr20070717c.html. Accessed on July 20, 2009. 

Then, in 2008, HHS provided an additional $1 billion in Public Health Emergency 

Preparedness Program (PHEP) and Hospital Preparedness Program funds. See HHS, 

“HHS Provides More Than $1 Billion to Improve All Hazards Public Health.” Available 

online at http://www.hhs.gov/news/press/2008pres/06/20080603a.html. Accessed on May 12, 

2009. 

8 Awardees include all 50 States; Washington, DC; five territories (Puerto Rico, the 

Virgin Islands, American Samoa, the Commonwealth of the Northern Mariana Islands, and 

Guam); the Pacific Freely Associated States (Republic of the Marshall Islands, the Republic 

of Palau, and the Federated States of Micronesia); and the localities of Chicago, Los Angeles 

County, and New York City. 

9 CDC has cited various authorities for the bioterrorism program and the pandemic 

influenza supplement. Initially, CDC’s grant announcements for the bioterrorism program 

indicated that funding was authorized under sections 301(a), 317(k)(1)(2), and 319 of the 

Public Health Service (PHS) Act (42 U.S.C. §§ 241(a), 247b(k)(1)(2), and 247(d)). Beginning 

in August 2005, CDC indicated that funding was authorized under section 319C of the PHS 

Act (42 U.S.C. § 247d-3), which was subsequently repealed by the Pandemic and AllHazards Preparedness Act, P.L. No. 109-417 (Dec. 19, 2006). The pandemic influenza grant 

announcements and guidance do not consistently describe the statutory authorizations, but 

the CDC grant award documents list sections 301(a), 317(k)(1)(2), and 319 of the PHS Act 

for Phases I and II and sections 319(a) and 317(k) of the PHS Act for Phase III. CDC is 

currently relying on section 319C-1 of the PHS Act (42 U.S.C. § 247d-3a) for all of these 

grant awards. 

10 In September 2008, CDC also awarded $24 million to fund 55 projects in 29 State and 

local public health departments to develop innovative approaches for pandemic influenza 

preparedness. 

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INTRODUCTION 
 

• In Phase III (August 31, 2007, through August 9, 2008), States were to 

fill gaps identified in Phases I and II. 

For the most recent cooperative agreement budget year (August 10, 

2008, through August 9, 2009), Congress did not appropriate additional 

funding specifically for pandemic influenza preparedness. However, 

CDC encourages States to request permission to use any unobligated 

funds from the previous two funding periods to continue pandemic 

influenza preparedness projects.11 As the PHEP has evolved, the 

program’s guidance has become less prescriptive by allowing States to 

select the projects that they intend to complete to improve their 

preparedness. 

In addition to issuing the PHEP cooperative agreement guidance, HHS 

has distributed supplemental pandemic influenza preparedness 

guidance.12 For example, the Phase II Pandemic Influenza Guidance 

Supplement included planning and exercising recommendations for 

distributing and dispensing vaccines and antiviral drugs. It also 

referred to other HHS guidance documents that States and localities 

could use in their pandemic influenza distribution and dispensing 

planning, including the State and Local Pandemic Influenza Planning 

Checklist.13 14 

PHEP funding is provided to States, but localities will carry out many of 

the activities needed to respond to an influenza pandemic. Although not 

specified in PHEP cooperative agreement guidance, HHS has indicated 

that it provides guidance to States that are in turn “expected to provide 

11 Program Announcement AA154 (August 10, 2008–August 9, 2009). Available online at 

http://emergency.cdc.gov/cotper/coopagreement/08/pdf/fy08announcement.pdf. Accessed on 

May 12, 2009. 

12 CDC, Pandemic Influenza Guidance Supplement to the 2006 Public Health Emergency 

Preparedness Cooperative Agreement Phase II, 2006, Budget Period August 31, 2006– 

August 30, 2007, and Phase III, 2007, Budget Period August 31, 2007–August 9, 2008. 

13 HHS, State and Local Pandemic Influenza Checklist. Available online at 

http://www.pandemicflu.gov/plan/pdf/checklist.pdf. Accessed on February 17, 2009. 

14 The State and Local Pandemic Influenza Checklist identifies a number of supplements 

to the HHS Pandemic Influenza Plan. Two of these supplements include recommendations 

for State and local health departments regarding vaccine distribution and use and antiviral 

drug distribution and use. Available online at 

http://www.hhs.gov/pandemicflu/plan/sup6.html and 

http://www.hhs.gov/pandemicflu/plan/sup7.html. Accessed on May 18, 2009. 

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INTROD U C T U C T I O N I O N 

guidance to their respective localities to ensure cohesion between State 

and local preparedness plans.”15 

Local Health Department Structure 

Local health departments vary considerably in structure and size of 

populations they serve. In 2005, the National Association of County and 

City Health Officials identified a total of 2,864 local health departments 

in the United States.16 These health departments can be a part of the 

State health agency, part of the local government, or some combination 

of these structures. Additionally, they serve both small and large 

populations, ranging from less than 1,000 to nearly 10 million people. 

These variations contribute to the complexity of providing guidance and 

technical assistance to prepare for an event such as an influenza 

pandemic.17 

Vaccine and Antiviral Drug Distribution and Dispensing Components 

Based on HHS pandemic influenza guidance documents and input from 

CDC and ASPR, we identified eight broad components of vaccine and 

antiviral drug distribution and dispensing planning. These components 

provided a framework for our evaluation. We also developed 89 

preparedness items to determine the extent of preparedness within each 

of the components; these items are discussed at length in the 

“Methodology” section. The following provides a general description of 

the eight components and the activities that fall within each: 

1. Receiving & Staging. Receiving and staging involves identifying 

locations where vaccines and antiviral drugs will be received and staged 

and developing procedures necessary to deliver them to dispensing sites. 

These receiving and staging systems may differ for vaccines and 

antiviral drugs. Vaccines will be delivered by the manufacturer to a 

central State-controlled location or to multiple “ship-to” locations 

throughout the State. Antiviral drugs are available in State caches (i.e., 

State or local stockpiles) and will be delivered through CDC’s Strategic 

15 ASPR, CDC, Final Report Technical Comments, issued to OIG on June 11, 2009. 

16 National Association of County and City Health Officials, 2005 National Profile of 

Local Health Departments. Available online at 

http://www.naccho.org/topics/infrastructure/profile/upload/NACCHO_report_final_000.pdf. 

Accessed on June 24, 2009. 

17 ASPR/CDC, Final Report Technical Comments, issued to OIG on June 11, 2009. 

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National Stockpile (SNS) program to a State-designated location.18 

Localities may further distribute the vaccines and antiviral drugs to 

other local receiving and staging locations or dispensing sites, as 

needed. 

2. Dispensing. Dispensing involves administering medications, such as 

vaccines and antiviral drugs. It includes identifying facilities at which 

dispensing will occur and developing procedures to operate and staff 

these sites. For example, localities can identify facilities, such as local 

schools, to serve as dispensing sites. They can also identify the 

individuals who would be authorized to receive medications as well as 

ensure that they have sufficient personnel to staff other necessary 

positions. 

3. Tracking. Tracking involves managing vaccine and antiviral drug 

inventories by implementing inventory management systems at State or 

local stockpiles, receiving and staging locations, and dispensing sites 

and during transport between these facilities. 

4. Vulnerable Populations. Vulnerable populations refer to groups, such 

as the homeless, prison inmates, and nursing home residents, which 

may not have access to traditional dispensing sites. Localities have 

flexibility in defining these groups according to local circumstances. 

They can also estimate the size of each vulnerable population and 

develop specific dispensing plans for them. 

5. Priority Groups. Priority groups are typically defined by occupation or 

health status, such as health care and law enforcement personnel and 

pregnant women. HHS has developed preliminary guidance regarding 

priority group definitions, but localities and States are responsible for 

determining how to best implement this guidance according to local and 

State circumstances.19 They can also estimate the size of each priority 

group, create specific dispensing plans for them, and identify which 

groups will be the first to receive the limited supplies of vaccines and 

antiviral drugs. 

18 SNS is an HHS program that stores and delivers medicines and medical supplies from 

Federal storage facilities to State receiving and staging locations. Available online at 

http://www.bt.cdc.gov/stockpile/. Accessed on February 17, 2009. 

19 HHS, Guidance on Allocating and Targeting Pandemic Influenza Vaccine. Available 

online at http://www.pandemicflu.gov/vaccine/allocationguidance.pdf. Accessed on July 7, 

2009. HHS, HHS Pandemic Influenza Plan. Available online at 

http://www.hhs.gov/pandemicflu/plan/appendixd.html. Accessed on July 7, 2009. 

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6. Security. Providing security for the vaccines and antiviral drugs 

involves protecting these medications at State or local stockpiles and 

receiving and staging locations through the point of dispensing. 

Security may be an important component of a distribution and 

dispensing plan because the vaccines and antiviral drugs will be limited 

in quantity, yet high in demand, during an influenza pandemic. 

Localities and States can develop detailed security plans for their own 

stockpiles, receiving and staging locations, and dispensing sites and 

during transport between these facilities. 

7. Storage. Storing the vaccines and antiviral drugs involves ensuring 

that the proper environmental conditions are maintained at State or 

local stockpiles and receiving and staging locations until they are 

dispensed. Vaccines and antiviral drugs may become less effective if 

they are not stored in the environmental conditions specified by their 

labeling. Vaccines typically require refrigeration, while antiviral drugs 

should be stored at controlled room temperature. Localities and States 

can develop detailed storage plans to ensure these conditions are 

maintained at their own stockpiles, receiving and staging locations, and 

dispensing sites and during transport between these facilities. 

8. Transportation. Transporting the vaccines and antiviral drugs 

involves moving them from State or local stockpiles and receiving and 

staging locations to dispensing sites. Generally, States are responsible 

for transportation to the localities. However, localities with distribution 

responsibilities also need to provide local transportation. Localities and 

States can develop detailed transportation plans, such as those that 

specify routes and frequency of delivery. 

Developing Plans for Vaccine and Antiviral Drug Distribution and 

Dispensing 

Localities and States may develop their plans for distributing and 

dispensing vaccines and antiviral drugs during an influenza pandemic 

by building on existing systems. For example, they may develop these 

plans by building on existing local and State emergency preparedness 

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INTROD UCTION 

systems, such as those developed to receive and distribute medications 

from CDC’s SNS program.20 

In addition, the entity (i.e., locality or State) responsible for 

implementing plans to distribute and dispense vaccines and antiviral 

drugs during an influenza pandemic can differ by State. Localities 

within the same State can also be responsible for implementing 

different aspects of the plan. For example, one locality may have 

transportation responsibilities while another locality within the same 

State may rely on the State to transport medication to its dispensing 

sites. Localities and States can also share the responsibility for 

implementing a certain aspect of the plan (e.g., they both may share 

responsibility for transporting vaccines and antiviral drugs to local 

dispensing sites). 

Ensuring That Plans for Vaccine and Antiviral Drug Distribution and 

Dispensing Are Actionable 

HHS, in conjunction with the Department of Homeland Security, 

encourages States to develop emergency operating plans, in general, 

and pandemic influenza operating plans, in particular, that are 

actionable.21 22 That is, plans should specify the organization and/or 

individuals responsible for carrying out specific actions; identify 

personnel, equipment, facilities, and supplies available for use in a 

disaster; and outline how all actions will be coordinated. 

HHS recommends that States and localities identify sources of 

personnel to staff positions in their plans for distributing and 

dispensing vaccines and antiviral drugs during a pandemic.23 24 

20 CDC, “Public Health Preparedness: Mobilizing State by State: A CDC Report on the 

Public Health Emergency Preparedness Cooperative Agreement,” February 2008. Available 

online at http://emergency.cdc.gov/publications/feb08phprep/pdf/feb08phprep.pdf. Accessed 

on February 17, 2009. 

21 HHS and Department of Homeland Security, “Assessment of States’ Operating Plans 

to Combat Pandemic Influenza: Report to Homeland Security Council,” January 2009, pp. 

6-7. 

22 Federal Emergency Management Agency, State and Local Guide (SLG) 101: Guide for 

All-Hazard Emergency Operations Planning, p. 1-1, September 1996. Available online at 

http://www.fema.gov/pdf/plan/slg101.pdf. Accessed on May 12, 2009. 

23 HHS, HHS Pandemic Influenza Plan, Supplement 6 Vaccine Distribution and Use, B. 

Preparedness planning for vaccination against a pandemic influenza virus, 2. Vaccine 

production, procurement, and distribution. Available online at 

http://www.hhs.gov/pandemicflu/plan/sup6.html. Accessed on May 18, 2009. 

24 Sources of personnel could include volunteers from community emergency response 

teams, the Medical Reserve Corps, and the National Disaster Management System. 

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Additionally, in their staffing estimates, localities can consider factoring 

in an absenteeism rate that could reach 40 percent during an influenza 

pandemic.25 Localities and States can also train personnel prior to 

performing their assigned duties. 

Establishing formal agreements with partnering agencies is another 

mechanism to ensure that plans are actionable and that the responsible 

partnering agencies understand their roles and responsibilities. For 

example, HHS uses the presence of written specific strategies and a 

Memorandum of Agreement (MOA) or other type of formal agreement 

with private and/or public agencies as a criterion when it evaluates 

State-level pandemic influenza operating plans.26 Similarly, when CDC 

reviews local SNS planning, it expects localities to provide written 

documentation of local partnering agencies, acknowledging their roles 

and responsibilities.27 

Exercises To Address Vaccine and Antiviral Drug Distribution and 

Dispensing 

Exercises can test and improve localities’ and States’ preparedness to 

distribute and dispense vaccines and antiviral drugs.28 Starting in 

fiscal year 2007, CDC required that States’ exercise strategies build 

on previous work and reflect Homeland Security Exercise and 

Evaluation Program principles.29 30 

25 HHS estimates that absenteeism because of illness, fear of infection, school closures, 

and/or quarantining infected individuals’ contacts could reach 40 percent in a severe 

pandemic. Available online at http://www.pandemicflu.gov/plan/pandplan.html. Accessed 

on April 22, 2009. 

26 HHS, “Evaluation Criteria for Key Supporting Activities Linked to PHEP Funding.” 

Available online at http://emergency.cdc.gov/cotper/coopagreement/08/pdf/evaluation.pdf. 

Accessed on June 30, 2009. 

27 CDC conducts annual Technical Assistance Reviews of each State to determine its 

level of preparedness to receive and distribute SNS assets. SNS program preparedness 

requires States to distribute stockpile items, including antiviral drugs, during certain types 

of emergencies. CDC, “Public Health Preparedness: Mobilizing State by State: A CDC 

Report on the Public Health Emergency Preparedness Cooperative Agreement,” February 

2008. 

28 CDC, Pandemic Influenza Guidance Supplement to the 2006 Public Health Emergency 

Preparedness Cooperative Agreement Phase II, 2006, Budget Period August 31, 2006– 

August 30, 2007, op. cit., p. 6. 

29 Program Announcement AA154 (August 31, 2007–August 9, 2008). Available online at 

http://www.bt.cdc.gov/cotper/coopagreement/pdf/fy07announcement.pdf. Accessed on June 

29, 2009. 

30 Homeland Security Exercise and Evaluation Program. Available online at 

https://hseep.dhs.gov/pages/1001_HSEEP7.aspx. Accessed on March 6, 2009. 

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Initial preparedness exercises are generally discussion based to 

enable participants to become familiar with the plan or role-play. 

Discussion-based exercises include seminars, workshops, games, and 

tabletop exercises. More advanced exercises are generally operations 

based and enable participants to execute and validate plans and 

clarify roles. Operations-based exercises include drills, full-scale 

exercises, and functional exercises.31 Exercises can also test the 

functionality of one or several components of the plan (e.g., security, 

transportation). 

Once a preparedness exercise is completed, participants should create 

an After Action Report to document the exercise.32 These reports 

typically include the exercise objectives, participant observations, and 

general recommendations to improve future performance. To 

incorporate the lessons learned during the exercise, participants 

should also develop an Improvement Plan that identifies specific 

corrective actions necessary to improve the plan, assigns the actions 

to responsible parties, and establishes target completion dates.33 

Finally, participants should test the corrective actions in subsequent 

exercises and update their planning documents accordingly.34 

Collaborating With Community Partners To Plan for and Conduct Exercises 

Related to Vaccine and Antiviral Drug Distribution and Dispensing 

HHS recommends that States and localities collaborate with 

community partners to develop and exercise their pandemic influenza 

plans.35 A successful response to an influenza pandemic depends on 

established partnerships and collaborative planning by public health 

officials, law enforcement officials, hospital administrators, tribal 

31 Ibid. 

32 CDC, Pandemic Influenza Guidance Supplement to the 2006 Public Health Emergency 

Preparedness Cooperative Agreement Phase II, loc. cit. 

33 Ibid. 

34 Ibid. 

35 CDC, Pandemic Influenza Guidance Supplement to the 2006 Public Health Emergency 

Preparedness Cooperative Agreement Phase II, op. cit., p. 34. 

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nations, and other community leaders (hereinafter referred to as 

“community partners”).36 37 

CDC requires all State and local public health exercises to be entered 

into the Lessons Learned Information Sharing Web site or into the 

National Exercise Schedule, which is maintained by the Department 

of Homeland Security.38 This Web site also enables State and local 

planners to share planning documents, lessons learned, and 

innovative practices, as well as comments, experiences and 

observations.39 

Related Work 

In February 2009, the Government Accountability Office (GAO) 

identified major gaps in domestic pandemic influenza planning and 

exercising, such as insufficient capacity to acquire and distribute 

medical supplies and inadequate vaccine production, distribution, and 

dispensing capacities.40 

In December 2002, OIG reported that State and local public health 

infrastructure was underprepared to detect and respond to 

bioterrorism.41 Specifically, OIG found that some States and localities 

did not have complete SNS receipt and deployment plans and had not 

tested some of their existing response protocols. 

METHODOLOGY 

Scope 

We assessed 10 selected localities’ preparedness to distribute and 

dispense vaccines and antiviral drugs during an influenza pandemic 

as of late summer 2008. Through conducting onsite interviews and 

36 Ibid, p. 3. 

37 The Pandemic Influenza Guidance Supplement does not list the community partners 

that States and localities should collaborate with when developing and exercising their 

plans. 

38 CDC, Program Announcement AA154 (August 31, 2007–August 9, 2008), p. 17. 

Available online at http://www.bt.cdc.gov/cotper/coopagreement/pdf/fy07announcement.pdf. 

Accessed on May 21, 2009. 

39 Federal Emergency Management Agency. Lessons Learned Information Sharing. 

Available online at https://www.llis.dhs.gov/index.do. Accessed on May 21, 2009. 

40 “Influenza Pandemic: Sustaining Focus on the Nation’s Planning and Preparedness 

Efforts,” GAO-09-334. 

41 OIG, “State and Local Bioterrorism Preparedness,” OEI-02-01-00550. 

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reviewing planning documents, we determined the extent to which 

these 10 localities had prepared to distribute and dispense vaccines 

and antiviral drugs by addressing the eight components and 

89 preparedness items that we identified based on HHS guidance. We 

also determined the extent to which localities conducted and 

documented exercises to test their plans to distribute and dispense 

vaccines and antiviral drugs. Finally, we identified the community 

partners with which the localities collaborated to develop and/or 

exercise these plans. 

Selection of Localities 

We first selected a purposive sample of five States based on variability 

in the following factors: health department structure, population 

density, geographic distribution, tribal representation, number of 

incoming travelers from Asia, information gathered from preinspection 

site visits, SNS Technical Assistance Review scores, and CDC 

recommendations.42 We eliminated States included in recent GAO 

pandemic influenza preparedness work related to this evaluation, and 

we selected one State included in companion OIG studies. 

We then selected two localities within each State based on variability in 

population density, geographic distribution within the State, and receipt 

of Cities Readiness Initiative funding.43 See Appendix A for a list of 

selected States and localities. 

Selection of Vaccine and Antiviral Drug Distribution and Dispensing 

Components and Preparedness Items 

We identified eight broad components of vaccine and antiviral drug 

distribution and dispensing planning and identified a total of 

89 preparedness items within these components to include in our 

evaluation. We identified the components and preparedness items based 

on our review of HHS pandemic influenza guidance and input from CDC 

and ASPR. Table 1 lists the number of preparedness items we developed 

42 According to a June 2007 GAO report, U.S. agency officials consider Egypt, Nigeria, 

and some Southeast Asian countries such as Indonesia to pose high levels of pandemic risk. 

“Influenza Pandemic Efforts to Forestall Onset Are Under Way: Identifying Countries at 

Highest Risk Entails Challenges,” GAO-07-604. Available online at 

http://www.gao.gov/new.items/d07604.pdf. Accessed on February 17, 2009. 

43 CDC provides funding to major United States cities through the Cities Readiness 

Initiative. The Cities Readiness Initiative helps cities prepare to quickly dispense 

medicines and medical supplies during a public health emergency. Available online at 

http://www.bt.cdc.gov/cri/facts.asp. Accessed on February 17, 2009. 

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INTROD U C T U C T I O N I O N 

to determine the level of preparedness within each of the eight 

components. 

Table 1: Number of Preparedness Items We 

Developed for Each Vaccine and Antiviral Drug 

Distribution and Dispensing Component 

Component 

Number of Preparedness 

Items We Developed 

Receiving & Staging 15 

Dispensing 23 

Tracking 6 

Vulnerable Populations 3 

Priority Groups 5 

Security 15 

Storage 13 

Transportation 9 

Total 89 

Source: OIG review of HHS pandemic influenza guidance documents and input from CDC 

and ASPR, 2008. 

Data Collection 

We developed an interview guide based on the eight components and 

89 preparedness items. The interview guide included questions about 

the types of exercises localities and States conducted, the components 

tested during the exercises, and whether the exercises were documented 

with After Action Reports and/or Improvement Plans. In addition, we 

included a checklist of community partners to determine which partners 

each of the selected localities collaborated with to plan for and/or 

conduct exercises related to distributing and dispensing vaccines and 

antiviral drugs in response to an influenza pandemic.44 

Structured interviews. Between July and September 2008, we conducted 

structured interviews with local and State health department officials 

and other officials involved with pandemic influenza preparedness and 

response (e.g., representatives from the State departments of homeland 

security, law enforcement agencies, and emergency management 

agencies). During the interviews, we asked local and State officials to 

identify which entity (e.g., the local or State health department) was 

responsible for implementing each of the components and/or 

44 We developed the checklist based primarily on the collaboration checklist in the SNS 

Technical Assistance Review. 

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INTRODUCTION 

preparedness items in our review. We used this information to identify 

the relevant components and preparedness items for each entity. 

For each preparedness item, we generally requested two types of 

documentation: planning documentation (e.g., Pandemic Influenza and 

SNS plans and any other planning documents that addressed the eight 

components) and supporting documentation (e.g., formal agreements, 

such as MOAs, interagency agreements, and contracts). We expected 

the formal agreement to be both valid (i.e., current and signed by both 

parties) and detailed (i.e., specifying the terms, such as the resource or 

service, that the partnering agency would provide). 

For example, for the preparedness item regarding whether the locality 

had a plan to ensure security at the dispensing site, we asked for: 

• a general description of the security plan in a planning document (e.g., 

identification of the partnering agency responsible for ensuring 

security during the event specified in the planning document); 

• a detailed plan, such as a security site assessment; and 

• a valid and detailed formal agreement, where applicable. 

We also asked local and State officials to identify all exercises related to 

distributing and dispensing vaccines and antiviral drugs that they 

conducted between September 2006 and July 2008. Then we asked 

them to identify the exercise type and component(s) tested. They 

provided After Action Reports and Improvement Plans for these 

exercises, when available. In addition, we asked local officials to 

identify on the collaboration checklist we provided which partners they 

collaborated with to develop and/or exercise their plans to distribute 

and dispense vaccines and antiviral drugs during an influenza 

pandemic. 

We followed up with localities and States to clarify interview responses 

and to request additional planning and supporting documentation, as 

needed. 

Data Analysis 

We reviewed each locality’s and State’s documentation and determined 

whether the plans were actionable for each preparedness item. That is, 

we looked to see whether plans identified the organizations or 

individuals responsible for carrying out specific actions; the sources of 

personnel that would be necessary to staff distribution and dispensing 

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positions; and whether they included valid, detailed formal agreements 

with partnering agencies. 

The results we report reflect the extent to which the locality and its 

respective State addressed the components and preparedness items. 

Specifically, for preparedness items where the State was the only 

responsible entity, we considered the locality to have addressed those 

items if the State provided an actionable plan. 

For preparedness items where the locality and the State were jointly 

responsible for aspects of the plan, both the locality and the State 

needed to provide actionable plans. For example, we considered 

localities that shared distribution responsibilities with the State to have 

planned for identifying receiving and staging locations if both the 

locality and State had all the necessary documentation. That is, (1) the 

locality had to refer to local receiving and staging locations in its 

planning documents and provide valid and detailed formal agreements 

with the facilities and (2) the State had to refer to State-level receiving 

and staging locations in its planning documents and provide valid and 

detailed formal agreements with those facilities. 

For preparedness items that applied to both vaccines and antiviral 

drugs, localities and States needed to provide actionable plans for both 

vaccines and antivirals drugs. For example, for a locality to receive 

credit for defining dispensing priority groups in its plan, it needed to 

include both a general description and detailed lists of these groups for 

both vaccines and antiviral drugs. 

During the interviews, we asked about plans for distributing or 

dispensing vaccines and antiviral drugs separately. Even though 

localities and States typically had different distribution and dispensing 

plans for vaccines and antiviral drugs, there were not many differences 

in whether these plans were actionable. For example, if a locality had 

an actionable plan for vaccines, it generally also had an actionable plan 

for antiviral drugs. Therefore, for ease of presentation, we combined the 

vaccine and antiviral responses and provided a cumulative response in 

favor of presenting the vaccine and antiviral drug results separately. In 

other words, the number of localities that we report in Appendix B as 

having planning and supporting documentation for each preparedness 

item reflects the number of localities that provided actionable plans for 

both vaccines and antiviral drugs, where applicable. 

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Once we reviewed the planning and supporting documentation, we 

analyzed it by component, preparedness item, and locality. We 

determined the number of components for which each locality addressed 

at least one preparedness item. Similarly, we determined the number of 

localities that addressed at least one preparedness item in each of the 

eight components. 

Next, we determined the range, average, and average percentage of 

items addressed in each component across localities. We did this by 

summing the total number of items that localities addressed in a 

component and dividing by the total number of items in that component 

across localities. For reporting purposes, we presented the eight 

components in three groups based on the average percentage of items 

addressed in the components and the functional similarity of the 

components. 

Next, we determined the total number of exercises localities conducted 

or actual emergencies localities responded to that were related to 

vaccine or antiviral drug distribution and/or dispensing (pandemic 

influenza or otherwise) and addressed any of the eight components. 

Similarly, we included any State-level exercises or actual emergencies 

that met the above criteria in which the localities participated either 

directly or indirectly. We also determined the number of components 

for which each locality conducted exercises and the number of localities 

that conducted at least one exercise to test any of the eight components. 

Additionally, we determined the number of exercises that were 

documented with After Action Reports and Improvement Plans. 

Finally, we determined the number of types of community partners each 

locality collaborated with during planning or conducting exercises for 

pandemic influenza vaccine and/or antiviral drug distribution and 

dispensing. 

Limitations 

This study is based on a purposive sample of five States and two 

localities within each State. The findings cannot be projected to other 

States and localities. 

We identified the eight components of vaccine and antiviral drug 

distribution and dispensing planning and the 89 preparedness items to 

serve as indicators of local preparedness from a number of HHS 

guidance documents and with input from CDC and ASPR. However, 

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there are other vaccine and antiviral drug distribution and dispensing 

preparedness items that we did not review. For example, we did not 

include items regarding legal preparedness that HHS recommends 

States and localities resolve prior to an influenza pandemic. 

We assessed localities’ preparedness to distribute and dispense vaccines 

and antiviral drugs in response to an influenza pandemic based on their 

formalized planning documents and agreements with partnering 

agencies. We did not give localities credit for preparedness items that 

were not documented at the time of our review. In addition, some State 

and local emergency managers may have the authority to dictate 

support for their pandemic influenza response efforts from partnering 

agencies without having formal agreements with them in advance. 

Most of the exercise and collaboration data were self-reported. We did 

not determine the extent to which localities collaborated with the 

community partners they identified. 

Standards 

This evaluation was conducted in accordance with the “Quality 

Standards for Inspections” approved by the Council of the Inspectors 

General on Integrity and Efficiency. 

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Δ FINDINGS 

Selected localities had not addressed in their 

planning documents most of the vaccine and 

antiviral drug distribution and dispensing 

components and preparedness items identified 

in HHS pandemic influenza guidance 

As of late summer 2008, the 

10 selected localities had not 

addressed most of the eight vaccine 

and antiviral drug distribution and 

dispensing components and 

89 preparedness items that we 

identified based on our review of HHS pandemic influenza guidance and 

input from CDC and ASPR. That is, none of the selected localities had 

started planning in all eight components. Further, on average, the 

selected localities had not addressed more than half of the preparedness 

items in any of the components. 

Specifically, across components, selected localities’ plans to distribute 

and dispense vaccines and antiviral drugs generally were not 

actionable. For example, the selected localities typically had not 

estimated staffing needs, and when they did, they had not factored 

absenteeism rates into their estimates. Further, across components, 

localities did not have valid and detailed formal agreements with the 

partnering agencies that would be responsible for carrying out various 

distribution and dispensing responsibilities. 

Selected localities varied in the extent to which they addressed the vaccine 

and antiviral drug distribution and dispensing components in their planning 

documents 

The 10 selected localities varied in the extent to which they addressed 

the eight vaccine and antiviral drug distribution and dispensing 

components. That is, these localities varied in the number of 

components in which they addressed at least one preparedness item. 

Table 2 presents the localities that addressed at least one preparedness 

item in each of the eight components. 

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Table 2: Selected Localities That Addressed in Their Planning Documents At 

Least One Preparedness Item in the Eight Vaccine and Antiviral Drug Distribution 

and Dispensing Components 

Locality 

Receiving & 

Staging Dispensing Tracking 

Vulnerable 

Populations 

Priority 

Groups Security Storage Transportation TOTAL 

A X X X X X X X 7 

B X X X X X X 6 

C X X X X X X 6 

D X X X X X X 6 

E X X X X X 5 

F X X X X X 5 

G X X X X X 5 

H X X X X 4 

I X X X X 4 

J X X 2 

TOTAL 10 8 8 4 4 6 7 3 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

All localities addressed at least one preparedness item in two or more of 

the vaccine and antiviral drug distribution and dispensing components. 

However, no locality addressed at least one preparedness item in all 

eight components. 

All 10 localities addressed at least one preparedness item within the 

component of Receiving & Staging. Most localities addressed at least 

one preparedness item in the components of Dispensing and Tracking. 

Conversely, fewer than half of localities addressed at least one 

preparedness item in the components of Vulnerable Populations, 

Priority Groups, and Transportation. 

Selected localities addressed the highest percentage of preparedness items 

in the Receiving & Staging and Dispensing Components 

The 10 selected localities’ planning documents addressed the highest 

percentage of preparedness items in the Receiving & Staging and 

Dispensing components. Table 3 presents the number of preparedness 

items we reviewed in each component and the average number, average 

percentage, and the range of items addressed. See Appendix B for the 

number of localities that addressed each preparedness item, by 

component. 

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Table 3: Average Number, Average Percentage, and Range of 

Preparedness Items Addressed by Selected Locality Planning 

Documents in the Eight Components 

Component 

Number of 

Items in

 Component 

Average 

Number of 

Items 

Addressed 

Average 

Percentage of 

Items 

Addressed 

Range of Items 

Addressed 

Receiving & Staging 15 6.2 41% 1-10 

Dispensing 23 6.8 30% 0-13 

Tracking 6 1.4 23% 0-5 

Vulnerable Populations 3 0.5 17% 0-2 

Priority Groups 5 0.6 12% 0-2 

Security 15 1.7 11% 0-6 

Storage 13 1.1 8% 0-3 

Transportation 9 0.3 3% 0-1 

 Total 89 18.2 20% 2-31 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

Localities addressed a higher percentage of preparedness items in 

Receiving & Staging than in Dispensing. Again, Receiving & Staging 

refers to receiving, organizing, and preparing vaccines and antiviral 

drugs for delivery to dispensing sites, while dispensing refers to 

administering these medications. All five States we reviewed were 

responsible for initial receipt of antiviral drugs from the SNS. Four of 

the five States we reviewed were responsible for initial receipt of 

vaccines from the manufacturer. The following sections present data 

related to identifying receiving and staging locations and dispensing 

sites, developing procedures, and staffing positions at receiving and 

staging locations and dispensing sites. 

Identifying receiving and staging locations and dispensing sites. Five 

localities identified health department facilities as vaccine and antiviral 

drug receiving and staging locations or had valid and detailed formal 

agreements with private distributors. However, only three localities 

identified vaccine dispensing sites and had valid formal agreements 

with these facilities, which typically were schools and community 

centers. 

Generally, localities planned to dispense antiviral drugs only to sick 

individuals seeking treatment at hospitals rather than provide them as 

part of a mass dispensing scenario to prevent illness. Therefore, we did 

not include antiviral drug dispensing in our review of documentation for 

the Dispensing component. 

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FINDING 
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Receiving, staging, and dispensing procedures. Approximately half of the 

localities addressed three items we reviewed regarding receiving and 

staging procedures. These items included identifying the procedures 

for: receiving vaccines and antiviral drugs at the receiving and staging 

location, requesting additional supplies of antiviral drugs if local 

supplies are depleted, and transfer of authority for the vaccines and 

antiviral drugs from officials at the receiving and staging location to 

officials at local dispensing sites. However, only three localities 

identified the officials who would be authorized to receive vaccines at 

local dispensing sites. 

Staffing positions at receiving and staging locations and dispensing sites. 

Localities primarily relied on a combination of health department 

officials and personnel from the receiving and staging location to staff 

receiving and staging positions. Five localities identified these sources 

of personnel and had valid and detailed formal agreements with the 

partnering agencies. However, only two localities’ planning documents 

identified the number of personnel each source would provide. 

Additionally, no locality took absenteeism into account, which could be 

as high as 40 percent, when estimating the number of personnel needed 

at the receiving and staging location. 

To staff positions at local dispensing sites, localities generally planned 

to use individuals from the local health department, local or county 

school districts, the Medical Reserve Corps, the American Red Cross, 

and spontaneous volunteers. Three localities had valid and detailed 

formal agreements with each partnering agency they identified to 

provide dispensing site personnel. However, even though most localities 

estimated the number of individuals they would need to staff one 

dispensing site, no locality’s planning documents identified the number 

of personnel each source of staff would provide. Finally, no locality took 

absenteeism into account when estimating the number of personnel 

needed at dispensing sites. 

Selected localities addressed a lower percentage of preparedness items in 

the Tracking, Vulnerable Populations, and Priority Groups Components 

The 10 selected localities’ pandemic influenza plans addressed a lower 

percentage of preparedness items in the components of Tracking, 

Vulnerable Populations, and Priority Groups than in Receiving & 

Staging and Dispensing. 

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Tracking. Localities differed in the extent to which they documented 

inventory management systems for various segments of their vaccine 

and antiviral drug distribution and dispensing plans. A few localities 

provided documentation of tracking systems at the receiving and 

staging locations, during transit from these locations, and at dispensing 

sites. These tracking systems included the SNS Resource Inventory 

Tracking System, systems used by private distributors, and various 

electronic systems that would be used to track patients after they 

received a vaccine at dispensing sites. However, only 1 of the 

10 localities provided documentation of a tracking system at the State 

or local stockpile and during transit from that location. 

Vulnerable Populations. Four localities included specific definitions of 

vulnerable populations in their planning documents. In addition, one 

locality included a detailed plan describing how it would reach these 

groups and dispense vaccines and antiviral drugs to them. However, no 

locality estimated the size of each vulnerable population it identified. 

Priority Groups. Three localities developed plans to dispense vaccines to 

priority group members. These plans included vaccinating priority 

group members at hospitals, police stations, and/or fire departments. 

However, only one locality’s plan defined priority groups for both 

vaccine and antiviral drug dispensing. Finally, none of the localities 

estimated the size of these groups, so they would not know when to 

move from one priority group to the next. 

Selected localities addressed the lowest percentage of preparedness items 

in the Security, Storage, and Transportation Components 

The 10 selected localities addressed the lowest percentage of 

preparedness items in the components of Security, Storage, and 

Transportation. Specifically, they did not address any of the 

preparedness items regarding security, storage, or transportation plans 

at the State or local stockpiles, receiving and staging locations, or 

dispensing sites or during transport between these facilities. 

Additionally, very few localities addressed the staffing items we 

reviewed for these components, including taking absenteeism into 

account when estimating the number of personnel needed to implement 

security, storage, and transportation plans. 

Security. Although no locality provided an actionable security plan, 

most localities had some documentation. Those localities having partial 

documentation generally listed the partnering agencies they would rely 

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FINDINGS 

on to provide security and outlined areas of responsibility for these 

agencies. The agencies generally included local law enforcement 

groups, such as the police or sheriff’s department. However, most 

localities did not have valid and detailed formal agreements with these 

agencies. Additionally, most localities lacked detailed site and route 

assessments for the State or local stockpiles, receiving and staging 

locations, and dispensing sites and during transit between these sites. 

Finally, while a few localities estimated the number of security staff 

they would need for a portion of their plan, none identified the number 

of personnel the partnering agency would provide. 

Storage. Although no locality provided an actionable storage plan, 

several localities had some documentation. Those localities having 

partial documentation generally noted in their planning documents the 

need to ensure appropriate environmental conditions for the vaccines 

and antiviral drugs. These documents typically included statements 

about providing refrigeration for vaccines and storing antiviral drugs in 

temperature-controlled environments. However, the majority of 

localities did not identify how the appropriate environmental conditions 

would be maintained throughout the distribution and dispensing 

process. For example, their planning documents lacked standard 

storage protocols and site assessments to indicate whether a facility had 

controlled room temperature or refrigeration capabilities. 

Transportation. Although no locality provided an actionable 

transportation plan, several localities had some documentation. Those 

localities having partial documentation generally addressed 

transportation in their planning documents by identifying the 

partnering agencies responsible for transportation. These agencies 

typically included private carriers and school districts. However, the 

majority of localities did not have detailed transportation plans (i.e., 

plans that specify routes and frequency) or valid and detailed formal 

agreements with the partnering agencies responsible for transportation. 

Finally, no locality estimated the number of drivers it would need to 

transport the vaccines and antiviral drugs. 

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FINDINGS 

All selected localities conducted exercises 

related to vaccine and antiviral drug distribution 

and dispensing; however, most did not create 

After Action Reports and Improvement Plans for 

these exercises 

their exercises. 

All 10 selected localities conducted 

exercises related to vaccine and 

antiviral drug distribution and 

dispensing, but 9 localities did not 

create both After Action Reports 

and Improvement Plans for all of 

Between September 2006 and July 2008, the 10 selected localities 

conducted a total of 63 exercises to test their distribution and 

dispensing plans, ranging from 2 to 12 exercises within a locality. 

Selected localities varied in the extent to which they exercised the vaccine 

and antiviral drug distribution and dispensing components 

The 10 selected localities varied in the extent to which they addressed 

the eight vaccine and antiviral drug distribution and dispensing 

components in their exercises. That is, localities varied in the number 

of components tested during these exercises, ranging from four 

components in one locality to all eight components in five localities. 

Overall, localities conducted the most exercises to test the components 

of Security (42 exercises) and Dispensing (39 exercises). Table 4 

presents the total number of exercises that addressed each component. 

It also identifies the number of localities that conducted at least one 

exercise to address each component. 

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FINDINGS 

Table 4: Selected Localities That Conducted At Least One Exercise To Test the 

Vaccine and Antiviral Drug Distribution and Dispensing Components* ** 

Locality 

Receiving & 

Staging 

(n=32 

Exercises) 

Dispensing 

(n=39 

Exercises) 

Tracking 

(n=30 

Exercises) 

Vulnerable 

Populations 

(n=27 

Exercises) 

Priority 

Groups 

(n=27 

Exercises) 

Security 

(n=42 

Exercises) 

Storage 

(n=25 

Exercises) 

Transportation 

(n=29 

Exercises) TOTAL 

A X X X X X X X X 8 

B X X X X 4 

C X X X X X X X X 8 

D X X X X X X X X 8 

E X X X X X X X 7 

F X X X X X X X 7 

G X X X X X X 6 

H X X X X X X 6 

I X X X X X X X X 8 

J X X X X X X X X 8 

 TOTAL 10 9 8 9 7 10 7 10 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

*One locality did not indicate the components that it tested in two exercises. 

** Most of the 63 exercises tested more than one component. 

All 10 localities conducted at least one exercise to test their ability to 

receive and stage, provide security for, and transport vaccines and 

antiviral drugs. In addition, seven localities conducted exercises to test 

their ability to dispense these medications to priority groups or store 

them during the distribution and dispensing process. 

Selected localities conducted a similar number of discussion-based and 

operations-based distribution and dispensing exercises 

The 10 selected localities conducted a similar number of discussionbased and operations-based distribution and dispensing exercises 

between September 2006 and July 2008. These localities also responded 

to two actual emergencies that tested some aspect of their plans to 

distribute and dispense medications. Table 5 presents the number and 

percentage of these exercises that selected localities conducted, by 

exercise type. 

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FINDINGS 

Table 5: Number and Percentage of Exercises Related to 

Vaccine and Antiviral Drug Distribution and Dispensing That 

Selected Localities Conducted Between September 2006 and 

July 2008, by Type of Exercise 

Type of Exercise Number of Exercises Percentage of Exercises 

Discussion-based 31 49% 

Operations-based 30 48% 

Actual Emergency 2 3% 

 Total 63 100% 

Source: OIG analysis of data from selected States and localities, 2009. 

Discussion-based exercises are generally used to familiarize 

participants with the overall preparedness plan. Most (22 of 31) of the 

discussion-based exercises were tabletop exercises. Localities also 

conducted five workshops and four seminars. 

Operations-based exercises are generally used to validate the 

preparedness plan and clarify participant roles. Most (20 of 30) of the 

operations-based exercises that localities conducted were full-scale 

exercises. Localities also conducted five functional exercises and five 

drills. 

Selected localities did not create both After Action Reports and
 

Improvement Plans for 80 percent of all distribution and dispensing 

exercises they conducted 

The 10 selected localities did not always create both After Action 

Reports and Improvement Plans for the distribution and dispensing 

exercises they conducted. Localities were more likely to document these 

exercises with just After Action Reports. In addition, only one locality 

tested a proposed solution identified in an Improvement Plan. 

Figure 1 provides the number and percentage of distribution and
 

dispensing exercises for which selected localities provided no 

documentation, After Action Reports only, and both After Action
 

Reports and Improvement Plans. 

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No 

(13 Exercises; Documentation 

21%) (20 Exercises; 

32%) 

After Action
 

Report and 

Corrective Action
 

Plan
 

After Action 

Report Only 

(30 Exercises; 

48%) 

FINDINGS 

Figure 1: 

Number and 

Percentage* 

of Localities’ 

Distribution 

and Dispensing 

Exercises 

With No 

Documentation, 

After Action 

Reports Only, 

and Both 

After Action 

Reports and 

Improvement 

Plans 

Source: OIG analysis of data from selected States and localities, 2009. 

*Percentages in figure do not sum to 100 percent because of rounding. 

Localities varied in the extent to which they documented their 

distribution and dispensing exercises with After Action Reports and 

Improvement Plans. Seven localities developed both After Action 

Reports and Improvement Plans for at least one of their exercises. 

However, an equal number of localities did not provide any 

documentation for at least one exercise. 

Figure 2 presents the total number of distribution and dispensing 

exercises each locality conducted and the number of exercises for which 

selected localities provided no documentation, After Action Reports only, 

and both After Action Reports and Improvement Plans. 

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Figure 2: 

Number of 

Distribution and 

Dispensing 

Exercises 

Each Selected 

Locality 

Conducted 

by the Number 

of Exercises 

With No 

Documentation, 

After Action 

Reports Only, 

and Both 

After Action 

Reports and 

Improvement 

Plans 

0 

2 

4 

6 

8 

10 

12 

A B C D E F G H I J 

Selected Localities 

Number of Exercises 

After Action Report and 

Corrective Action Plan 

After Action Report Only 

No Documentation 

FINDINGS 

Source: OIG analysis of data from selected States and localities, 2009. 

All selected localities collaborated with 

community partners to develop and exercise 

their plans to distribute and dispense vaccines 

and antiviral drugs during an influenza 

pandemic 

All 10 selected localities worked 

with different types of community 

partners (e.g., hospitals, educational 

institutions) to develop and exercise 

their plans to distribute and 

dispense vaccines and antiviral 

drugs during an influenza 

pandemic. See Appendix C for a list of community partners and the 

number of selected localities that collaborated with each partner during 

planning and exercising. 

Collaboration in planning. On average, localities collaborated with 

16 types of partners (ranging from 12 to 22) to develop their plans to 

distribute and dispense vaccines and antiviral drugs during an 

influenza pandemic. All selected localities collaborated with 

educational institutions, the State or local emergency management 

agencies, and hospitals. Localities did not generally collaborate in 

planning with the National Disaster Medical System, community 

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F I NDING S 

emergency response teams, the regional HHS Liaison, the Department 

of Transportation, or the Department of Homeland Security. 

Collaboration in exercises. Localities collaborated with an average of 

13 types of partners (ranging from 5 to 19) to exercise their plans to 

distribute and dispense vaccines and antiviral drugs during an 

influenza pandemic. These partners generally included educational 

institutions, law enforcement agencies, and the medical community. 

Localities generally did not collaborate with the Department of 

Homeland Security, the regional HHS Liaison, the National Disaster 

Medical System, home health or visiting nurses agencies, and 

community emergency response teams to exercise their plans. 

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ΔR ECOMMENDATIONS  

 

 

 

RECOMMENDATIONS 

The World Health Organization’s recent declaration of the start of the 

2009 H1N1 influenza pandemic highlights the need for the Nation to be 

prepared to distribute and dispense vaccines and antiviral drugs. In its 

review of 2008 State pandemic influenza operating plans, ASPR found 

“very few gaps in State-level readiness for antiviral drug distribution.” 

Additionally, ASPR found that States were “doing well” with respect to 

developing State-level pandemic influenza vaccination plans. However, 

their review did not assess local preparedness to distribute and dispense 

vaccines and antiviral drugs in response to an influenza pandemic. 

We found that while the majority of selected localities had begun 

planning to distribute and dispense vaccines and antiviral drugs, their 

plans were generally not actionable. Specifically, we found that 

localities had not addressed in their planning and supporting 

documentation most of the vaccine and antiviral drug distribution and 

dispensing components and preparedness items we identified in HHS 

pandemic influenza guidance. Localities addressed the highest 

percentage of preparedness items within the Receiving & Staging and 

Dispensing components and the lowest percentage of items within 

Security, Storage, and Transportation. In addition, all localities had 

conducted exercises related to distributing and dispensing vaccines and 

antiviral drugs. However, localities did not consistently create After 

Action Reports and Improvement Plans for these exercises or test 

solutions identified in the Improvement Plans. Finally, all localities 

collaborated with community partners to develop and test their plans to 

distribute and dispense vaccines and antiviral drugs during an 

influenza pandemic. 

While the majority of selected localities had begun planning to 

distribute and dispense vaccines and antiviral drugs, more needs to be 

done to improve local preparedness. Therefore, we recommend that 

CDC work with States to: 

Improve local pandemic influenza vaccine and antiviral drug distribution 

and dispensing preparedness 

CDC, in coordination with States, could improve pandemic influenza 

vaccine and antiviral drug preparedness at the local level by taking the 

following actions: 

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R E C O MMENDA T I O N S 

•	 Determine why localities appear to be in the early stages of planning 

for pandemic influneza vaccine and antiviral drug distribution and 

dispensing, and provide assistance to improve their preparedness. 

•	 Prioritize the planning areas where States should focus any 

carryover or future pandemic influenza funding to quickly improve 

local preparedness to distribute and dispense vaccines and antiviral 

drugs. 

•	 Place special emphasis on ensuring localities develop actionable 

vaccine and antiviral drug distribution and dispensing plans. 

Specifically, plans should identify the organizations or individuals 

responsible for carrying out specific actions and the sources that 

would be necessary to staff distribution and dispensing positions 

and should be supported by valid, detailed formal agreements with 

partnering agencies. 

Ensure that localities consistently create both After Action Reports and 

Improvement Plans to enhance their preparedness to distribute and 

dispense vaccines and antiviral drugs during an influenza pandemic 

Exercises are an important aspect of stregthening preparedness. 

Therefore, localities should consistently document their distribution and 

dispensing exercises with After Action Reports, develop Improvement 

Plans, and test the proposed solutions to improve their pandemic 

influenza plans. CDC could also consider providing additional guidance 

or technical assistance to States and localities to ensure that they meet 

Homeland Security Exercise and Evaluation Program requirements. 

Facilitate the sharing of pandemic influenza planning and response 

information and emerging promising practices 

CDC should continue to develop strategies to facilitate collaboration and 

information sharing about existing pandemic influenza planning 

practices and encourage the use of existing resources. For example, 

CDC should encourage States and localities to use the Lessons Learned 

Information Sharing Web site to share not only After Action Reports but 

also planning documents and promising practices. These strategies 

could also assist States and localities in collaborating with community 

partners in pandemic influenza planning and exercising. 

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RECOMMENDATIONS 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CDC agreed with two of our three recommendations. Specifically, in 

response to the second recommendation, CDC agreed to work with States 

to encourage localities to develop After Action Reports and Improvement 

Plans that comply with the Homeland Security Exercise and Evaluation 

Program. In response to the third recommendation, CDC agreed that 

States and localities should use the Lessons Learned Information Sharing 

Web site to facilitate the sharing of planning resources. CDC is using this 

Web site to create a national public health exercise calendar and 

encourage the dissemination of national trends and promising practices. 

CDC did not indicate whether it agreed with the first recommendation, but 

noted that it plans to use some of OIG’s suggested actions to address this 

recommendation. For example, CDC agreed that local vaccine and 

antiviral drug distribution and dispensing preparedness can and should be 

improved. Additionally, CDC acknowledged the need for States to 

prioritize some of the planning areas OIG identified, which include 

receiving and storing vaccines and antiviral drugs and identifying 

dispensing sites and staffing requirements. Finally, CDC agreed that 

localities need to develop actionable vaccine and antiviral drug 

distribution and dispensing plans. 

CDC also identified other ways in which it continues to work with States 

and localities to improve their preparedness. Specifically, CDC released a 

gap analysis tool to States in mid-August 2009, which it will use to provide 

targeted technical assistance to States as they prepare to respond to the 

H1N1 pandemic. Additionally, CDC acknowledged that the funding 

provided through the June 2009 Supplemental Appropriations Act to help 

States and localities prepare for and respond to the H1N1 pandemic will 

enable them to improve preparedness and address OIG’s 

recommendations. 

CDC also provided other general comments on our draft report. 

Specifically, CDC noted that the lack of site-specific information in local 

and State plans reported by OIG may be because States and localities 

considered this to be sensitive information and intentionally excluded it. 

Additionally, CDC noted that there are distinct differences in vaccine and 

antiviral drug storing, distributing and dispensing requirements and in 

the division of State and local responsibilities for these functions. 

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RECOMMENDATIONS 

Therefore, CDC encouraged OIG to present the vaccine and antiviral drug 

results separately and disaggregate the data by State and local functions. 

OIG acknowledges that the delivery systems for vaccines and antiviral 

drugs differ and we clarified these differences in the Background. We 

present combined results for vaccines and antiviral drugs because we did 

not find substantial differences in the availability of documentation 

provided for each delivery system; see the Methodology for a more 

thorough explanation. Additionally, OIG requested and reviewed all 

available site-specific information, including that which may not have 

been incorporated in planning documents for security reasons. Finally, we 

combined State and local results for shared preparedness items because 

both the State and locality must be able to execute these items for the 

distribution and dispensing system to operate as intended. 

We ask that in its final management decision, CDC more clearly indicate 

whether it agrees with our first recommendation. For the full text of 

CDC’s comments, see Appendix D. 

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Δ APPENDIX~A 

Selected States and Localities 

State Locality 

Hawaii Hilo 

Honolulu 

Massachusetts Boston 

Springfield 

Nevada Las Vegas 

Reno 

Tennessee Knoxville 

Memphis 

Washington Seattle 

Spokane 

Source: Office of Inspector General selection of states and localities for the evaluation of local 

pandemic influenza preparedness: vaccine and antiviral drug distribution and dispensing, 2008. 

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APPENDIX~B 

 

Δ APPENDIX~B 

Table B-1: Number of Selected Localities With Planning and Supporting Documents for the 

Receiving & Staging Component, by Preparedness Item 

Receiving & Staging Item (n=15) 

Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines and/or Antiviral 

Drugs 

1. Estimated the quantities of vaccines and antiviral drugs that State/locality would need. 2 

2. Determined the quantities of antiviral drugs currently available in the State/locality. 10 

Identifying Receiving and Staging Locations 

3. Identified a receiving and staging location for assets coming from Federal agencies. 5 

4. Identified an initial State/local stockpile. 2 

5. Identified alternate receiving and staging locations. 2 

Receiving and Staging Procedures 

6. Developed procedures for receiving vaccines and antiviral drugs at receiving and staging location. 5 

7. Developed procedures for requesting additional supplies of antiviral drugs. 4 

8. Developed transfer-of-authority procedures for distributing vaccines and antiviral drugs. 5 

9. Is prepared to give the names and locations of all end-point recipients (i.e., vaccine clinics and other 

dispensing locations) to the distributor. 

7 

10. Updates end-point recipient contact information at least annually. 1 

Staffing Positions at Receiving and Staging Locations 

11. Identified where receiving and staging staff will come from (i.e., agency, affiliation). 5 

12. Estimated the number of personnel/volunteers needed for receiving and staging. 4 

13. Factored absenteeism into estimated number of receiving and staging staff. 0 

14. Identified number of personnel each source of staff would provide. 2 

Training Receiving and Staging Staff 

15. Developed training materials for receiving and staging staff. 8 

 Total Number and Percentage of Items Addressed (out of 150 items) 62 (41%) 

Source: Office of Inspector General (OIG) analysis of 2008 data from selected States and localities, 2009. 

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Table B-2: Number of Selected Localities With Planning and Supporting Documents for the 

Dispensing Component, by Preparedness Item (continued on next page) 

Dispensing Item (n=23) 

Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines* 

Identifying Dispensing Sites 

1. Identified vaccine-dispensing sites. 3 

2. Identified alternate vaccine-dispensing sites. 2 

Dispensing Procedures 

3. Identified the officials who are authorized to receive vaccines at dispensing sites. 3 

4. Planned to provide identification (i.e., badges) to dispensing staff upon entrance at dispensing sites. 5 

5. Planned to keep symptomatic and nonsymptomatic people separated at dispensing sites. 7 

6. Estimated patient throughput** at dispensing sites. 1 

7. Determined time to vaccinate entire population based on throughput estimate. 1 

8. Planned to collect data regarding number of doses received; date of dispensing; age, priority group, 

State, county, and ZIP Code of recipient. 

0 

9. Documented a data entry system for dispensing sites. 0 

10. Ensures that data entry keeps pace with throughput. 0 

11. Developed a process to dispense vaccines to individuals that have trouble communicating. 5 

Staffing Positions at Dispensing Sites 

12. Identified where dispensing staff will come from (i.e., agency, affiliation). 3 

13. Estimated the number of personnel/volunteers needed for dispensing. 7 

14. Factored absenteeism into estimated number of dispensing staff. 0 

15. Identified number of personnel each source of staff would provide. 0 

16. Has contingency plans for volunteer absenteeism. 0 

17. Has a system to maintain contact information for dispensing staff. 6 

18. Ensures that contact information for dispensing staff is up-to-date (i.e., updated at least every 

6 months). 

4 

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APPENDIX~B 

Table B-2: Number of Selected Localities With Planning and Supporting Documents for the 

Dispensing Component, by Preparedness Item (continued) 

Dispensing Item (n=23) 

Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines* 

Staffing Dispensing Sites 

19. Has a system to ensure that dispensing staff is qualified to administer vaccines. 4 

20. Ensures that dispensing staff’s qualifications are up-to-date (i.e., updated at least every 6 months). 4 

21. Has a process to allow nonlicensed personnel/volunteers to dispense vaccines, when and if needed. 4 

22. Has a process to allow health care workers from other jurisdictions to dispense vaccines, when and if 

needed. 

1 

Training Dispensing Staff 

23. Has training materials for dispensing staff. 8 

 Total Number and Percentage of Items Addressed (out of 230 items) 68 (30%) 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

*Generally, localities planned to dispense antiviral drugs only to sick individuals seeking treatment at hospitals rather than provide them as part of a mass 

dispensing scenario to prevent illness. Therefore, we did not include antiviral drug dispensing in our review of documentation for the Dispensing component. 

**Throughput generally refers to the number of people that can be vaccinated in a given amount of time. 

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APPENDIX~B 

Table B-3: Number of Selected Localities With Planning and Supporting Documents for the 

Tracking Component, by Preparedness Item 

Tracking Item (n=6) 

Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines and Antiviral 

Drugs 

1. Has system to track antiviral drugs at the State or local stockpile. 1 

2. Has system to track antiviral drugs during transport from the State or local stockpile. 1 

3. Has system to track vaccines and antiviral drugs at the receiving and staging location. 3 

4. Has system to track vaccines and antiviral drugs during transport from the receiving and staging 

location. 

5 

5. Has system to track vaccines and patients at the dispensing sites. 4 

6. Has tracking system that includes variables for doses dispensed; lot number; date of dispensing; age 

and priority group of recipient. 

0 

 Total Number and Percentage of Items Addressed (out of 60 items) 14 (23%) 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

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APPENDIX~B 

Table B-4: Number of Selected Localities With Planning and Supporting Documents for the 

Vulnerable Populations Component, by Preparedness Item 

Vulnerable Populations Item (n=3) Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines and Antiviral 

Drugs 

1. Defined vulnerable populations. 4 

2. Estimated the size of each vulnerable population. 0 

3. Developed plan to dispense to vulnerable populations. 1 

 Total Number and Percentage of Items Addressed (out of 30 items) 5 (17%) 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

Table B-5: Number of Selected Localities With Planning and Supporting Documents for the 

Priority Groups Component, by Preparedness Item 

Priority Groups Item (n=5) 

Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines and Antiviral 

Drugs 

1. Defined priority groups. 1 

2. Estimated the size of each priority group. 0 

3. Developed plan to dispense to priority groups. 3 

4. Developed protocols to screen and identify persons in priority groups at dispensing sites. 2 

5. Developed method to determine when it is appropriate to provide vaccines and antiviral drugs to the 

next priority group. 

0 

 Total Number and Percentage of Items Addressed (out of 50 items) 6 (12%) 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

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APPENDIX~B 

Table B-6: Number of Selected Localities With Planning and Supporting Documents for the 

Security Component, by Preparedness Item 

Security Item (n=15) 

Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines and Antiviral 

Drugs 

Security Procedures 

1. Has plan to ensure security for the antiviral drugs at State or local stockpile. 0 

2. Has plan to ensure security for the antiviral drugs during transport from State or local stockpile. 0 

3. Has plan to ensure security for the vaccines and antiviral drugs at the receiving and staging location. 0 

4. Has plan to ensure security for the vaccines and antiviral drugs during transport from the receiving 

and staging location. 

0 

5. Has plan to ensure security for the vaccines at the dispensing sites. 0 

6. Has a contingency plan to provide security for the vaccines and antiviral drugs. 0 

Staffing Security Positions 

7. Identified where security staff will come from (i.e., agency, affiliation). 0 

8. Estimated number of personnel/volunteers needed to ensure security for the antiviral drugs at State 

or local stockpile. 

0 

9. Estimated number of personnel/volunteers needed to ensure security for the antiviral drugs during 

transport from State or local stockpile. 

4 

10. Estimated number of personnel/volunteers needed to ensure security for the vaccines and antiviral 

drugs at receiving and staging location. 

3 

11. Estimated number of personnel/volunteers needed to ensure security for the vaccines and antiviral 

drugs during transport from receiving and staging location. 

2 

12. Estimated number of personnel needed to ensure security for vaccines at dispensing sites. 4 

13. Factored absenteeism into estimated number of security staff. 0 

14. Identified number of personnel each source of staff would provide. 0 

Training Security Staff 

15. Has training materials for security staff. 3 

 Total Number and Percentage of Items Addressed (out of 150 items) 16 (11%) 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

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APPENDIX~B 

Table B-7: Number of Selected Localities With Planning and Supporting Documents for the 

Storage Component, by Preparedness Item 

Storage Item (n=13) 

Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines and Antiviral 

Drugs 

Storage Procedures 

1. Has plan to ensure proper storage conditions for the antiviral drugs at the State or local stockpile. 0 

2. Has plan to ensure proper storage conditions for the antiviral drugs during transport from the State or 

local stockpile. 

0 

3. Has plan to ensure proper storage conditions for the vaccines and antiviral drugs at the receiving and 

staging location. 

0 

4. Has plan to ensure proper storage conditions for the vaccines and antiviral drugs during transport 

from the receiving and staging location. 

0 

5. Has plan to ensure proper storage conditions for the vaccines at the dispensing sites. 0 

6. Has contingency plans for the vaccines and antiviral drugs in adverse storage conditions. 0 

7. Ensures that antiviral drugs in State/local stockpiles have not expired. 7 

Staffing Storage Positions 

8. Designated responsibility for ensuring proper storage conditions for the antiviral drugs at the State or 

local stockpile. 

0 

9. Designated responsibility for ensuring proper storage conditions for the antiviral drugs during 

transport from the State or local stockpile. 

0 

10. Designated responsibility for ensuring proper storage conditions for the vaccines and antiviral drugs 

at the receiving and staging location. 

0 

11. Designated responsibility for ensuring proper storage conditions for the vaccines and antiviral drugs 

during transport from the receiving and staging location. 

0 

12. Designated responsibility for ensuring proper storage conditions for the vaccines at the dispensing 

sites. 

2 

Training Staff Responsible for Storage 

13. Has training materials for staff responsible for storage. 2 

 Total Number and Percentage of Items Addressed (out of 130 items) 11 (8%) 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

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APPENDIX~B 

Table B-8: Number of Selected Localities With Planning and Supporting Documents for the 

Transportation Component, by Preparedness Item 

Transportation Item (n=9) 

Number of Localities With 

Planning and Supporting 

Documentation for 

Vaccines and Antiviral 

Drugs 

Transportation Procedures 

1. Has plan to transport the antiviral drugs from the State or local stockpile. 0 

2. Has plan to transport the vaccines and antiviral drugs from the receiving and staging location. 0 

3. Has contingency plans to transport the vaccines and antiviral drugs. 0 

Staffing Transportation Positions 

4. Identified where transportation staff will come from (i.e., agency, affiliation). 2 

5. Estimated number of personnel/volunteers needed to transport the antiviral drugs from the State or 

local stockpile. 

0 

6. Estimated number of personnel/volunteers needed to transport the antiviral drugs from the receiving 

and staging location. 

0 

7. Factored absenteeism into estimated number of transportation staff. 0 

8. Identified number of personnel each source of staff would provide. 0 

Training Transportation Staff 

9. Has training materials for transportation staff. 1 

 Total Number and Percentage of Items Addressed (out of 90) 3 (3%) 

Source: OIG analysis of 2008 data from selected States and localities, 2009. 

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Δ APPENDIX~C 

Number of Selected Localities Collaborating With Each Type of Community Partner During 

Pandemic Influenza Vaccine and Antiviral Drug Distribution and Dispensing Planning and 

Exercising** 

Community Partner** 

Number of Localities 

Collaborating With Partner 

During Planning 

Number of Localities Collaborating 

With Partner During Exercising* 

1. Educational institutions 10 9 

2. Emergency management agencies 10 7 

3. Hospitals 10 7 

4. State health departments 9 7 

5. Law enforcement 9 8 

6. Fire departments 9 5 

7. Emergency medical services 9 7 

8. Medical Reserve Corps 9 7 

9. Medical community 9 8 

10. Military installations 8 4 

11. Mental health/crisis professionals 8 6 

12. Private industry 8 6 

13. Volunteer organizations 8 3 

14. Critical infrastructure/public works 7 4 

15. Home health/visiting nurses 7 2 

16. Organizations serving at-risk populations 7 3 

17. Metropolitan Medical Response System 5 6 

18. Departments of Correction 4 3 

19. Professional associations 4 4 

20. Department of Homeland Security 3 0 

21. Department of Transportation 3 3 

22. Regional health and human services liaisons 3 1 

23. Community emergency response teams 3 2 

24. National Disaster Medical System 2 1 

Source: Office of Inspector General analysis of 2008 data from selected States and localities, 2009. 

* One locality did not provide the types of partners it collaborated with during its exercises. 

** In addition, three out of the four localities with tribal populations collaborated with tribal governments during planning. Two of three localities also 

collaborated with tribal governments to exercise their plans; the fourth locality did not provide information about whether it collaborated with the tribal 

governments to exercise the plan. 

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.. A P PEN D x D

AGE N C Y COMMENTS

DEPARTMENT OF HEALTH &. HUMAN SERVICES Public Health Service

Centers fOf Disease Control

and Preventíon (CDC)

Atlanta GA 30333

AUG 2 5 20

TO: Daniel R. Levinson, Inspector General

Department of Health and Human Services

FROM: Thomas R. Frieden, M.D., M.P.H., Director

Centers for Disease Control and Prevention

SUBJECT: Office of Inspector Gene.rl's Draft Report: "Local Pandemic InfluenzaPreparcdness:

Vaccine and Aiitiviral Drug Distribution and Dispensing,"

OEI-04-08-00260

The Centers for Disease Control and Pteventicl)(CDC) appreciates. the opportunity to review and

coiiment on the Office of Inspector General's (OlCf) draf'report, "Local Pandemic Influenza

Prepardness: Vaccine andAntiviral Drug Distribution and Dispensing." Thank you tpr your

review ofthis important and timely issue.

The objectives of the review were to determine the extent to which the selected localities I)

addressed in their planning documeits the vaccine atid antiviml drng distribution and dispensing

components and preparedness items OlG identifíed based on Department of Health and Human

Services' (HHS) pandemic influenza guidance; 2) conducted exercises related to vaccine. and

antiviral drug distribution and dispensing and documented these exercises with after-action

reports and improvement plans; and 3) collaborated with community pi:nersto develop and

exercisc their plans to distribute and dispense vaccines and antiviral drugs during an influenza

pandemic. The OlG completed their data collection in September 2008.

As stated in the draft report, this evaluation focuses on the extent to which i 0 selected localities

in Hawaii, Massachusetts, Nevada, Tennessee, and Washington have prepared to distribute and

dispense vaccines and antiviral drugs during an influenza pandemic.

The report's findings provide important information regarding the readiness of these selected

localitics to respond to an influenza pandemic. CDC is conducting a gap analysis of state

pandemic preparedness and response related to the ClUTcnt novel HINI influenza outbreak,

which should yield valuable infonnatin about some of these issues and should help to prioritize

local eO'orts.

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A P PEN D x D

Local I'lannÌne Important to Pandemic Inflnenza Response

Thank you for drawing attention to these gaps. CDC is working hard to address local gaps in

pandemic planning. CDC agrees that while staes, overall, are doing well with antiviral dnig

distrbution and development of vaccination plans, local pandemÌe preparedness can and should

be improved. WhiJc development ofloca,l plans and capabilities is the responsibìlty of the states,

CDC pl'vides resources and giiidance to the states to enhance their ability to improve

preparedness at the local leveL.

Recognizing the critical importance of state and local pandemicHINl response, Congress

appropriated fmiding in June 2009 through the 2009 Supplemeiial Appropriations Act to prepare

for and reSpond to thc novel IlINl influenza, outbreak in the United States. To date, CDC has

provided $508 million through the Public Health Emergency Response (FIlER) grantto upgrade

state and local pandemic influenza preparedness and responsc capacity, including vaccination

and antiviral drug distribution and dispensing.

While the majority ohM PHER funds are disttibuted to state health departments, CDC guidance

in the PJ-lER funding Oppoiiunily announcement states that CDC expccts a significant portion of

the Pl-lER funds to be distributed to and utilized at thc locallevcl for activities related to antiviral

distribution/dispensing, community mitigation, and mass vaccination. The gUidance also strongly

encoura,ges states to work closely with local and tribal entities and governments to assure access

to the funding necessary to achieve preparedness at all lcvels ofgovernment.

In addition, recipients ofPHER funding must conduct a pandemic preparedness gap assessmcnt

to identify gaps that are most critical or of highest priority for their jurisdictions, develop work

plans and program goals that address the prioritized gaps, and build detailed budgets that reflect

how funding will be directcd to address gaps and achieve the program goals. CDC expccts states

to direct appropriate funds to their localities to address local pandemic preparedness gaps that

thcy identify in these gap assessments. Furthermore, PHER awardees are required to have

comprehensive, up-to-date plans in place no later than September i 5,2009, for a potential mass

vaccination campaign. These plans should incorporate local activities.

Specific Recommendations fInd CDC's Response

DIG Recommendation: Improve local pandemic influenza vaccine and antiviral drug

distribution and dispensing preparedness. CDC, in coordination with states, could improve

pandemic influenza vaccinc and antiviral drug distribution.and dispensing preparedness at the

local level by taking the following actions:

Determine whyloealitiesappcar to be in the early stages of planning for pandemic

influneza vaccine and antiviral drug distribution and dispensiiig, ånd provide assistance to

improve their preparedness.

. Prioritize the planing areas where states sllOuld focus any carryover or future pandemic

in1hienza funding to quickly improve local preparedness to distribute and dispense

vaccines and antiviral drugs.

Place special emphasis on ensuring localities develop actionable vaccine and antiviral

drug distribution and dispensing plans. Specifcally, plans should identify the

2

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APPENDIX~D 

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APPENDIX~D 

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A P PEN 0 x D

Other Comments

The oro report findings regarding the identification of receiving and staging locations references

the lack of site.specífic infomiation for receiving and staging sites in local and state plans. As a

point of clarification, locations and addresses of such facilities are considered sensitive

information, and in many states they are not included in plans and documentation bee(iuse their

plans are subject to state open records laws and public release.

There are distinct differences between the requirements for storing, distributing, and dispensing

antiviral diugs and vaccines, and it is important to not confuse the two by combining them in the

mamier that was undertaken in this report. We encourage oro to make these distinctions clear in

the findings section of the report to ensure readers fully understand them.

Antiviral drugs are available in state caches and come from the federally imiintained

Strategic National Stockpile (SNS). SNS.stored antiviral drugs are distributed to one

location designated by the state. The state can further distríbnte al1tivinil drugs in

nonrefTigerated vehicles to their localities for dispensing. Antiviral drugs can be stored

centrally or at the receiving locations at room temperatnre. Antiviral drugs are dispensed

at medical facilities, such as hospitals, clinics, and alternate care facilities, forthc purpose

of treating symptomatic patients.

Vaccine is delivered by the manufacturer to a central state location 01" multiplepmvide1"

sites thronghoiit the state. Cold chainmanagement is a fàctor for distribiition and storage.

Vaccine is targeted to priority populations and to the general public for prevention of

inOuenza. Vaccine can be administered in various locations, such as clinics, schools, or

malls, as designated by the localities.

CDC strongly encourages the oro to break out in the data tables ili the appendix not only the

data in teiins of antiviral drugs and vaccine but also by state and local rnles and fnnctions. CDC

is concemed that aggregating disparate state and local roles and functions could confnse readers

about whether the activìty is a state or a local responsibilty. CDC recommends thisbc done

throughout the report, including a separate oro analysis ofeaeh system to help readers more

easily understand this distinction.

We appreciate your consideration of the comments contained in tbis memo as you develop the

final report. We are happy to discuss any of these comments wìth you. Please direct any

qiiestions regarding these comments to Mr. Shauii Ratliff by telephone at (404) 639-2809 or by

e-mail at iggaoc&cde.gov.

Sincerely,

Thomas R. Frieden, MD., M,P.H.

Director

5

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Δ ACKNOWLEDGMENTS 

This report was prepared under the direction of Dwayne Grant, 

Regional Inspector General for Evaluation and Inspections in the 

Atlanta regional office. 

Jaime Durley and Mina Zadeh served as team leaders for this study. 

Erica Bushong served as the Lead Analyst. Other principal Office of 

Evaluation and Inspections staff from the Atlanta regional office who 

contributed include Leila Samy; central office staff who contributed 

include Talisha Searcy and Kevin Farber. 

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