Department of Health and Human Services
 
OFFICE OF 

   
INSPECTOR GENERAL 

 
 
 
 
 
 
 
L P I
OCAL  ANDEMIC  NFLUENZA 

 
 
P :
   
REPAREDNESS   
 
V   A D
ACCINE AND  NTIVIRAL  RUG 

 
D D
ISTRIB  UTION AND  ISPENSING 

 
 
 
 
 
Daniel R. Levinson 
  
Inspector General 

 
September 2009 
 
 
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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 OIGs  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.  
   
     
   
   
  E X E C U T I V E   S U M M A R Y  
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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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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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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 	  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 Generals (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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CDC agreed that localities need to develop actionable vaccine and antiviral 
drug distribution and dispensing plans. 
We addressed CDCs 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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  T A B L E   O F   C O N T E N T S 
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
  
 
 
I N T RO DUC T IO N  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1 
  
 
 
F I N D IN G S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  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 a n influenza pandemic. . . . .  28 
  
   
R E C O MMEN D A T ION S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  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 P  reparedness 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 
  
   
 
A C K NO WL E D G M E N T S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  49 
  
 
   
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  I N T R O D U C T I O N 
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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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 Vermonts Pandemic Influenza Expenditures for the Period August 31, 
2005, Through June 30, 2008, A-01-08-01500, June 25, 2009.  OIG, Review of Washington 
States 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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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, CDCs  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 All-
Hazards 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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  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 
programs 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, 2008August 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, 2007August 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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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 CDCs 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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systems, such as those developed to  receive and distribute medications 
from CDCs 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, 2007August 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, 2007August 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 Nations 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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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 
 
  Number of Preparedness  
  Component  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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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 localitys and States 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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  F I N D I N G S  
 
  Selected localities had not addressed in their  As of late summer 2008, the         
planning documents most of the vaccine and  10 selected localities had not 
antiviral drug distribution and dispensing  addressed most of the eight vaccine 
and antiviral drug distribution and 
components and preparedness items identified 
dispensing components and          
in HHS pandemic influenza guidance  
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   
                   
  Receiving &      Vulnerable  Priority          
Locality   Staging  Dispensing  Tracking  Populations  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 
Average  Average 
Number of   Number of   Percentage of  
Items in  Items  Items  Range of Items 
Component   Component  Addressed  Addressed  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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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 localitys 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 localitys 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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F I N D I N G S  
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 sheriffs 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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All selected localities conducted exercises  All 10 selected localities conducted 
related to vaccine and antiviral drug distribution  exercises related to vaccine and 
antiviral drug distribution and 
and dispensing; however, most did not create 
dispensing, but 9 localities did not 
After Action Reports and Improvement Plans for 
create both After Action Reports 
these exercises 
and Improvement Plans for all of 
their exercises.   
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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Table 4:  Selected Localities That Conducted At Least One Exercise To Test the 
Vaccine and Antiviral Drug Distribution and Dispensing Components* **   
                   
                   
  Receiving &      Vulnerable  Priority          
  Staging  Dispensing  Tracking  Populations  Groups  Security   Storage  Transportation   
  (n=32  (n=39  (n=30  (n=27  (n=27  (n=42  (n=25  (n=29   
Locality   Exercises)  Exercises)  Exercises)  Exercises)  Exercises)  Exercises)  Exercises)  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 discussion-
based 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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Table 5:  Number and Percentage of Exercises Related to 
V  accine 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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F I N D I N G S  

 
Figure 1: 
Number and 
After Action 
 
Percentage* 
Report and 

of Localities 
Corrective Action  

Distribution  
Plan 
  No  
and Dispensing  
(13 Exercises;  Documentation 
Exercises 
21%)  (20 Exercises; 
With No  
32%) 
Documentation,  
After Action  
Reports Only,  
and Both  
After Action  
Reports and 
Improvement 
Plans 
  After Action  
Report Only  
(30 Exercises; 
48%) 
  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  12 
Distribution and 
Dispensing   10 
Exercises  s 
Each Selected    cise 8  ACfotrerre Acctitvieo nA cRteiopno rPt laannd  
Locality  er
x
Conducted   E After Action Report Only 
by the Number    r of  6 
of Exercises   be No Documentation 
m 4 
With No    u
N
Documentation,  
2 
After Action  
Reports Only,  
and Both   0 
After Action   A  B  C  D  E  F  G  H  I  J 
Reports and   Selected Localities 
Improvement 
Plans 
 
 
  Source:  OIG analysis of data from selected States and localities, 2009.  
 
 
All selected localities collaborated with  All 10 selected localities worked 
community partners to develop and exercise  with different types of community 
partners (e.g., hospitals, educational 
their plans to distribute and dispense vaccines 
institutions) to develop and exercise 
and antiviral drugs during an influenza 
their plans to distribute and 
pandemic 
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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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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R E  CR OE MC MO EMNMD EA NT DI OA NT SI  O N S  
 
The World Health Organizations 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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 	  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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R E C O M M E N D A T I O N S  

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 OIGs 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 OIGs 
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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R E C O M M E N D A T I O N S  
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  
CDCs comments, see  Appendix D. 
 
   
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  A P P E N D I X ~ 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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A P  PA EP NP DE INX D~ IBX  ~ B
 
Table B-1:  Number of Selected Localities With Planning and Supporting Documents for the 
Receiving & Staging Component, by Preparedness Item 
 
 
Number of Localities With 
Receiving & Staging Item (n=15)   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  7 
dispensing locations) to the distributor.  
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) 
 
 
Number of Localities With 
Dispensing Item (n=23)  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,  0 
State, county, and ZIP Code of recipient.  
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                4 
6 months). 
 
 
 
 
   
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 A P P E N D I X ~ B   
 
Table B-2:  Number of Selected Localities With Planning and Supporting Documents for the 
Dispensing Component, by Preparedness Item (continued)  
Number of Localities With 
 
Planning and Supporting 
Dispensing Item (n=23)  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 staffs 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  1 
needed. 
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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Table B-3:  Number of Selected Localities With Planning and Supporting Documents for the 
Tracking Component, by Preparedness Item 
Number of Localities With 
 
Planning and Supporting 
Tracking Item (n=6)  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  5 
location. 
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  0 
and priority group of recipient.  
     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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A P P E N D I X ~ B  
Table B-4:  Number of Selected Localities With Planning and Supporting Documents for the 
Vulnerable Populations Component, by Preparedness Item 
Number of Localities With 
Vulnerable Populations Item (n=3) 
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 
Number of Localities With 
 
Planning and Supporting 
Priority Groups Item (n=5)  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  0 
next priority group. 
     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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A P P E N D I X ~ B  
Table B-6:  Number of Selected Localities With Planning and Supporting Documents for the 
Security Component, by Preparedness Item 
Number of Localities With 
 
Planning and Supporting 
Security Item (n=15)  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   0 
and staging location. 
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    0 
or local stockpile. 
9.  Estimated number of personnel/volunteers needed to ensure security for the antiviral drugs during  4 
transport from State or local stockpile. 
10.  Estimated number of personnel/volunteers needed to ensure security for the vaccines and antiviral  3 
drugs at receiving and staging location. 
11.  Estimated number of personnel/volunteers needed to ensure security for the vaccines and antiviral  2 
drugs during transport from receiving and staging location. 
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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A P P E N D I X ~ B  
Table B-7:  Number of Selected Localities With Planning and Supporting Documents for the 
Storage Component, by Preparedness Item 
Number of Localities With 
 
Planning and Supporting 
Storage Item (n=13)  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  0 
local stockpile. 
3.  Has plan to ensure proper storage conditions for the vaccines and antiviral drugs at the receiving and  0 
staging location. 
4.  Has plan to ensure proper storage conditions for the vaccines and antiviral drugs during transport    0 
from the receiving and staging location. 
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  0 
local stockpile. 
9.  Designated responsibility for ensuring proper storage conditions for the antiviral drugs during    0 
transport from the State or local stockpile. 
10.  Designated responsibility for ensuring proper storage conditions for the vaccines and antiviral drugs    0 
at the receiving and staging location. 
11.  Designated responsibility for ensuring proper storage conditions for the vaccines and antiviral drugs  0 
during transport from the receiving and staging location. 
12.  Designated responsibility for ensuring proper storage conditions for the vaccines at the dispensing  2 
sites. 
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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Table B-8:  Number of Selected Localities With Planning and Supporting Documents for the 
Transportation Component, by Preparedness Item 
Number of Localities With 
 
Planning and Supporting 
Transportation Item (n=9)  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   0 
local stockpile. 
6.  Estimated number of personnel/volunteers needed to transport the antiviral drugs from the receiving  0 
and staging location. 
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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  A P P E N D I X ~ 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**  
Number of Localities 
Number of Localities Collaborating 
Community Partner**  Collaborating With Partner 
With Partner During Exercising*  
During Planning  
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  
co llaborated with tribal governments to exercise their plans; the fourth locality did not provide information about whether it  collaborated with the tribal 
go vernments to exercise the  pl an.    
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A P PEN D x
D
COMMENTS
AGE N C Y
DEPARTMENT OF HEALTH &. HUMAN SERVICES Public Health Service
Centers fOf Disease Control
and Prevention (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
Gene.rl's Draft Report: "Local Pandemic InfluenzaPreparcdness:
SUBJECT: Office of Inspector 
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
Health and Human
components and preparedness items OlG identified based on Department of 
and
Services' (HHS) pandemic influenza guidance; 2) conducted exercises related to vaccine. 
exercises with after-action
antiviral drug distribution and dispensing and documented these 
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,
these issues and should help to prioritize
which should yield valuable infonnatin about some of 
local eO'orts.
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44 A P PEN D
x D
Local I'lannIne 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 pandemIe preparedness can and should
the states,
be improved. WhiJc development ofloca,l plans and capabilities is the responsibilty of 
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
the Public Health Emergency Response (FIlER) grantto upgrade
provided $508 million through 
state and local pandemic influenza preparedness and responsc capacity, including vaccination
and antiviral drug distribution and dispensing.
state health departments, CDC guidance
While the majority ohM PHER funds are disttibuted to 
in the PJ-lER funding Oppoiiunily announcement states that CDC expccts a significant portion of
antiviral
the Pl-lER funds to be distributed to and utilized at thc locallevcl for activities related to 
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, and 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.
vaccine and antiviral
Place special emphasis on ensuring localities develop actionable 
drug distribution and dispensing plans. Specifcally, plans should identify the
2
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A P P E N D I X ~ D  

 
   
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Other Comments
receiving and staging locations references
The oro report findings regarding the identification of 
the lack of site.specific 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
plans and documentation bee(iuse their
information, and in many states they are not included in 
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 report to ensure readers fully understand them.
the findings section of 
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 distribnte 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 factor 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
functions could confnse readers
is concemed that aggregating disparate state and local roles and 
about whether the activity 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.
the comments contained in tbis memo as you develop the
We appreciate your consideration of 
final report. We are happy to discuss any of these comments with 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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  A C K N O W L E D G M E N T S
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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