# Presentation: 231594

## Countermeasure Allocation, Distribution, and Administration

- Tom Savel, MD
- National Center for Public Health Informatics
- June 15, 2007
- AHIC** **Population Health and
- Clinical Care Connections Workgroup

**Notes:**
Good morning, my name is Tom Savel, and I am with the Centers for Disease Control and Prevention.

Thank you for the opportunity to provide testimony on Countermeasure Allocation and Distribution.  I’ll be focusing on the area of countermeasure administration and inventory tracking and how these capabilities assist local, state, and federal public health response work.

I would like to begin by providing a brief overview of needs related to Countermeasure Allocation, Distribution, and Administration tracking, focusing on events in the recent past that have brought us to the requirements and emerging health threats we need to address in the present. I will also briefly discuss the progress CDC has made in this area and conclude by identifying challenges that we face and recommendations for working together. 

Events including the threat of pandemic influenza, SARS outbreaks, smallpox preparedness and the anthrax attacks have all demonstrated that information systems are critical to managing the response and tracking the countermeasures administered for containing and preventing further outbreaks.  Within this broad categorization, I will be focusing on two primary needs: the need for pharmaceutical and medical materials inventory and the need for information about who receives countermeasures.

## Countermeasure Allocation and Distribution Tracking

- Coordination and management of pharmaceutical and/or non-pharmaceutical responses; At any given moment, know the location and quantities of critical pharmaceuticals and medical supplies within the private sector
- Managing allocation, based on priority risk groups, of products that have limited supply; Be able to purchase and redirect quickly during an event

**Notes:**

The need to locate and provide critical pharmaceuticals and medical material to responders and the public quickly, has increased significantly in recent years. CDC and the public health community must be ready at all times to respond to and manage public health emergencies and reduce their impact in terms of public health threats and loss of lives, property, time and money. 

Being able to provide the quantities and location of selected critical pharmaceuticals and medical materials within the commercial market, at any given moment, is critical.   During an emergency, this information will be combined with corresponding data from federal stockpiles and vaccine supplies and if available state, and local stockpiles to provide a full picture of countermeasure supplies. The impact of this capability lies in managing allocations by being able to purchase or redirect these supplies to the most vulnerable at risk portions of the population.  

Ideally, a functionality like this would support situational awareness and provide analysis, visualization, and reporting capabilities to see the national picture of countermeasure availability

These capabilities are necessary for single events and multiple simultaneous events where containing an outbreak or allocating a limited supply pharmaceuticals is critical.  

## Countermeasure Administration Tracking

- Tracking the administration of treatments, prophylaxes, vaccinations and isolation/quarantine  in pre-event, early event and post event situations
- Monitoring adverse events and tracking follow-ups such as “take” responses
- Exchanging information across systems involved in the identification, confirmation, and management of an event

**Notes:**
The need to track the administration of countermeasures in the population is the second focused topic I would like to address.

When a public health emergency occurs there is a need to manage information about the event, not only what countermeasures are available but also who has received them .  In addition, once countermeasures are received, there is a need to monitor their effectiveness and identify any resulting adverse events.  If isolation and quarantine measures are put into place, it is important to be able to track these measures in the community.  Being able to exchange this type of information across systems for identification, confirmation and management have proved challenging. 

Capabilities should include aggregate counts and detail (person level) tracking for any size event and be able to track any type of countermeasure. For pre-event or early event vaccination or prophylaxis efforts such as another instance similar to the National Smallpox Vaccination Program or preventive use of an influenza vaccination due to pandemic outbreak conditions, aggregate counts and person level information will be needed.  Person level information can be used for individual follow up and aggregate data can help track the progress of the program.   Administration tracking capabilities should be able to integrate with inventory systems, surveillance systems, and adverse event reporting systems. 

Countermeasure administration tracking also plays a role in post-event prophylaxis tracking.  In a situation such as an aerosolized anthrax attack, tracking mass prophylaxis could be critical.  Treatment for anthrax can be long and onerous on affected persons.  Having tracking information for a large population of affected individuals would be critical for follow up care and monitoring adherence to treatment regimes.

I would like to provide two examples which illustrate the need for pharmaceutical inventory tracking and countermeasure administration tracking.

## Lessons Learned

- National Smallpox Preparedness Program
- Need to track countermeasure administration is critical (Pre-Event Vaccination System (PVS))
- Flexibility for any event is necessary
- Influenza vaccine shortage in 2004/2005
- Need to track supply from manufacturing through points of distribution
- Ability to redirect for at risk populations
- Systems Integration and Data Exchange
- Integration with other preparedness systems is necessary

**Notes:**
In early 2004, the Pre-Event Vaccination System (PVS) was implemented nationwide to track and monitor the administration of smallpox vaccines as part of the National Smallpox Preparedness Program. The purpose of the program was to track public health and healthcare providers who were given smallpox vaccinations as a national preparedness effort. The system was able to track demographic information, vaccine information, follow up care requirements and adverse events.  CDC and others quickly saw the utility of a system like PVS, but envisioned something that could be flexible enough for any kind of event or countermeasure tracking, not just a system designed for one purpose.   
The Influenza vaccine shortage which occurred during the 2004/2005 Flu season, illustrated the need to establish partnerships with the pharmaceutical industry in order to know details about vaccine manufacturing supplies, surpluses, and distribution across the county.  Being able to track selected, priority pharmaceuticals and medical materials in the commercial sector, and combining that information with existing vaccine ordering and distribution systems and stockpiles within the government, could be a tremendous value to public health at every level during an emergency.  Being able to purchase or redirect supplies to the most at risk portions of the populations is vital for managing public health emergency responses.  

Both of these capabilities could be critical during a Pandemic Influenza situation where vaccine or countermeasure supplies are in short supply and the need to track vaccine doses administered would be vital. 

IT Infrastructure lessons where also learned during these two public health situations.
System Integration and Data Exchange is necessary to integrate with other preparedness systems which:
Exchange countermeasures that have been requested 
Exchange countermeasures that have been administered 

Data exchange must be bi-directional and secure, using industry standards for messaging and destination and source authentication.

## Data Requirements Inventory Tracking

- Focus on Pandemic Influenza and countermeasures  for Category A public health threats
- Medical materials such as ventilators, masks, other personal protective equipment
- Data such as manufacturer, supplier, and distributor ids and names; lot numbers and expiration dates; quantity and units of measure; shipping location

**Notes:**
To address one of the questions posed in the invitation: What types of data would be needed? 

Critical items needed to support the public health response to high-priority national threats should be the first functionality of a system for commercial inventory tracking. These include pharmaceutical countermeasures or medical interventions for pandemic influenza and potential bioterrorism agents considered “Category A Public Health Threats”—including smallpox, anthrax, plague, tularemia, botulism, and viral hemorrhagic fevers such as Lassa and Ebola viruses. These threats are of particular concern because they are easily transmitted from person to person and result in high mortality rates.  
Critical medical materials include ventilators, masks, additional personal protective equipment and other medical materials are also important.

Important data requirements would includes items such as manufacturer, supplier, and distributor ids and names; lot numbers and expiration dates; quantity and units of measure and shipping location information. 

## Data RequirementsAdministration Tracking

**Organization information:** name, address, phone and fax, owning jurisdiction
**Staff information**: identifier or name, responsibility within an organization, owning jurisdiction
**Product (drug) information**: drug type, brand name, lot number, manufacturer, NDC code, expiration date, deactivation date and reason
**Patient information**: name, address (state of residence required), contact points (phone numbers, email address), SSN, gender, date or year of birth, occupation, race/ethnicity, owning jurisdiction
**Administration information:** location (organization), date of administration, drug administered, manufacturer & lot, administering staff, administration site, comments
**Isolation/Quarantine information:** where a person is located (home, other residence, or healthcare facility).

**Notes:**
These are the data requirements that could be beneficial for Countermeasure Administration Tracking capabilities.  Categories include organizational information, staff information, product data, patient demographics, actual administration information, and isolation and quarantine data.

CDC has collaborated across the agency to choose the fields.  Initially, they reflected the information needed for the National Smallpox Preparedness Program that started in 2003.  The list has grown to include information recommended by NCIRD as the core data set for immunization information systems.  Other events, including the Monkeypox outbreak of 2004, anthrax outbreak planning, and pandemic influenza planning have contributed to and enhanced the fields selected.  Isolation and quarantine fields were selected by studying Smallpox post-event plans and working with a number of stakeholders including states/project areas and partners such as NACCHO.

Another questions from the Committee was: What areas of response management does this program address?  CDC has begun working on many of the issues I’ve been describing in close collaboration with state and local public health.  

One effort is the Countermeasure and Response Administration program.  Building from the success of the Pre-Event Vaccination System, CDC, with many state and local public health contributions, expanded on the capacities of PVS for national state and local use.  

## Countermeasure and Response Administration Program: An Overview

- Tracks *Selected *Priority Countermeasures in the Commercial Sector (non-vaccine)
- Complementary to VO*DS & *SNS

- Tracks *All* Countermeasures Identified for an Event
- Complementary to OMS

- Liaison with Partners
- Informatics Support for Users of CRA Application
- Communications Support

**Notes:**
CRA the program includes the people, processes and tools to increase public health capabilities in monitoring and tracking countermeasures pre-event, early event, and post-event.  The program at CDC addresses many of the capabilities I have been describing.  
The Countermeasure Administration tool can tracks All Countermeasures Identified for an Event, with information at the individual or aggregate level.  This program is complementary to the Outbreak Management System or OMS, and in this capacity we work closely with the Immunization Services Division on aggregate reporting for Influenza vaccine doses administered.  With this tool, CRA is increasing the capacity of all levels of public health in tracking and managing countermeasures during an event so that the delivery of interventions can be monitored, their impact assessed, and adverse events by identified and rapidly handled. This capability impacts public health by providing the ability to quickly and intuitively configure and collect countermeasure and response administration data. This will allow for faster data collection and analysis during an event. And, it will provide the capability to produce data that can be used to more efficiently distribute limited countermeasures based on the reported number of persons provided with a countermeasure when compared to the affected population. 
The Countermeasure Inventory tool will be able to track priority countermeasures in the commercial sector.  This capability is complementary to  other CDC Activities including the Vaccine Ordering and Distribution System and the Strategic National Stockpile.  This capability will impact public health by giving Public Health emergency managers critical information needed to identify the location and quantities of critical pharmaceuticals and medical materials in the private sector. 
Partner Liaison & Informatics Support: This is a support function only, not a separate component of CRA.  Activities described on the slide

## Use of SDO Endorsed Standards

- Inventory Tracking
- Healthcare Distribution Management Association (HDMA) Electronic Data Interchange guidelines
- Administration Tracking
- Existing vocabulary or terminology standards, such as HL7, NAICS, SOC, NIMS, CHI, and others, are being repurposed by the CDC for response management as needed.

**Notes:**
One of the questions posed by the Committee referred to Standard Development Organizations endorsed standards which support this type of data exchange. For the work being accomplish around Countermeasure Inventory Tracking, information data exchange should be as simple as possible to entice participation from the commercial sector.  CDC has recommended standard pharmaceutical Electronic Data Interchange (EDI) transactions recommended by Healthcare Distribution Management Association (HDMA).

Particularly the HDMA 846, 856, 852, and 867 EDI transactions that are currently used in pharmaceutical commerce EDI transactions.  Using manufacturer and distributor inventory and shipping data for Countermeasure Inventory Tracking Public Health emergency managers will be able to identify the location and quantities of critical pharmaceuticals and medical materials in the private sector. 

For administration tracking, existing vocabulary or terminology standards, such as HL7, NAICS, SOC, NIMS, CHI, and others, are being repurposed by the CDC for response management as needed.  

Where standards do not exist, standards are being developed by the CDC.  Furthermore, the CDC is actively involved in a number of SDOs in order to ensure that the needs of Public Health, in general, and response and response management, in particular, are considered and, if appropriate, adopted by the SDO.  Where available, these standards are implemented in the systems.

To answer another of the Committee’s questions: With which existing registries do you interface or augment as part of response management?  CRA Administration Tracking interfaces with immunization registries.  Longer-term plans may include augmenting immunization registries and interfaces with other registries such as emergency responders, adverse event systems (such as VAERS), or others. The interfaces at this time are both automated and manual in order to ensure  that the maximum amount of data can be shared across systems.

## Ongoing ChallengesWhere can AHIC play a role?

- Leverage public/private partnerships to facilitate the incorporation of countermeasure management functionality into EHR systems
- Leverage relationship with the PhRMA to garner support in the pharmaceutical industry for inventory tracking
- Support for funding to states for automating administration tracking and interoperability with registries and healthcare organizations

**Notes:**
In addition to the integration activities that need to take place between the many systems involved in countermeasure management (VODS, SNS, VAERS, Countermeasure Inventory, Countermeasure Administration, etc.), in time, this countermeasure functionality needs to be incorporated into the expanding EHR landscape.

We many need the help of the Community to leverage relationships or partnerships with PhRMA for the inventory tracking capability we are building.  We need to understand this industry better and determine if PhRMA can endorse our value proposition for how their industry can support public health and urge their constituents to participate in the inventory tracking program.

In addition, states need funding to support automated administration tracking capabilities and to be interoperable with registries and potentially healthcare organizations.  Particularly for hardware that can be used at points of distribution during an emergency. 

Finally, I would like to conclude by saying that you will hear a tremendous amount of information from all of the presenters here today and understanding what a complicated arena this is, is a large undertaking.  Public health at every level has made considerable progress and moving forward we will all benefit from continued partnerships, the work of the Community, and the evolution of informatics applied to public health.