Countermeasure Inventory Tracking
| Countermeasure Inventory Tracking Overview | Library |
Countermeasure Inventory Tracking Overview
The CRA Countermeasure Inventory Tracking (CIT) system, currently in prototype, will provide the quantities and location of selected critical pharmaceuticals and medical materials within the commercial market. 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. Initial priorities for tracking within CIT include antiviral medications for pandemic influenza and selected pharmaceuticals for Category A conditions (Anthrax, Botulism, Plague, Smallpox, Tularemia and viral hemorrhagic fevers).{return to top}
CIT Background
Partnering for Preparedness
Recent national events, such as Hurricanes Katrina and Rita, the anthrax attacks on America, and the tragic events of September 11th, have pushed emergency preparedness to the top of our list of national priorities. Without the generosity and partnership of the pharmaceutical and medical supply industries, federal response efforts to these and other emergencies would have been far less effective.Today’s threats—including the potential for a devastating influenza pandemic, the danger of bioterrorism, and the plausibility of a new natural disaster—challenge us at the Centers for Disease Control and Prevention (CDC) to expand and strengthen these partnerships. We share the unified vision of a safer and healthier future for ourselves and for our children. As partners, CDC and private industry can combine strengths and resources now, for the best and most effective responses to the challenges that threaten the future health and safety of all Americans.
Tracking Critical Medical Countermeasures
The CDC must be prepared at all times to respond to public health emergencies, and to mitigate their impact. To effectively meet this challenge, CDC is expanding the Countermeasure and Response Administration (CRA) Program to track the availability of critical medical countermeasures within the private-sector supply chain. By receiving timely data on inventory and distribution of key pharmaceuticals and medical supplies, CDC will be better prepared to ensure that critical countermeasures reach vulnerable populations during an emergency.Voluntary participation of the pharmaceutical and medical supply industries is the key to successful planning for events that may impact our national future.
Objectives of Countermeasure Inventory Tracking
Countermeasure Inventory Tracking is designed to give public health emergency managers critical information needed to partner effectively with the private sector to protect and treat the American public. Using the Countermeasure Inventory Tracking program, public health emergency managers will be able to identify the location and quantities of critical pharmaceuticals and medical materials in the private sector. This information will be combined with corresponding data from federal stockpiles and vaccine supplies as well as potentially available state and local stockpiles to provide a complete picture of countermeasure supplies, thus enabling CDC to make more effective emergency decisions.Program Focus
Items to be tracked by the CRA Inventory Tracking Program are known pharmaceutical countermeasures, or medical interventions, for pandemic influenza and potential bioterrorism agents considered “Category A Public Health Threats”—smallpox, anthrax, plague, tularemia, botulism, and viral hemorrhagic fevers, such as the Lassa and Ebola viruses. These threats are of particular concern because they are easily disseminated or transmitted from person to person and result in high mortality rates. They are high priorities to the public health system due to the national security risks they impose. The pharmaceuticals and medical materials targeted by CRA Inventory Tracking may be critical to the care and treatment, or prophylaxis, of victims of these lethal threats.The medications below are of particular interest. Critical medical supplies include ventilators, masks, additional personal protective equipment, and other medical materials.
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Data Types
CDC is seeking specific data related to inventory on hand and recent distribution. These include basic product information such as NDC numbers; units of measure/packaging; lot number and expiration date; inventory data such as quantities on hand, in process/on order, and commitments; and distribution data, to include the receiving location and purchaser type. All are standard pharmaceutical supply chain data types. No financial or pricing information is needed or desired.
How to Participate
Pharmaceutical and medical supply manufacturers and distributors are asked to voluntarily contribute existing data to CDC regarding current inventory and distribution of selected products.To make this as easy as possible, the Countermeasure Inventory Tracking program uses EDI transaction standards common to the pharmaceutical industry. Additionally, CDC has dedicated a team of IT implementation specialists to collaborate with participating organizations to mitigate the level of IT effort required.
Data are transmitted to CDC via secure electronic data interchange (EDI) transactions following guidelines established by the Healthcare Distribution and Management Association (HDMA). Use of data is strictly governed by the terms of binding legal data share agreements (DSA), and the Trade Secrets Act.
Benefits of Participation
CDC greatly appreciates the voluntary participation of manufacturers and distributors of pharmaceuticals and medical supplies in this critical emergency preparedness and response program. Program participants will be better prepared to coordinate their own emergency response efforts with public health officials during future emergency events. Ultimately, this means faster and more effective response for the community. Participants are welcome to publicize this important partnership with CDC and their contribution to American readiness.{return to top}
CIT FAQ
Background
What is the Countermeasure and Response Administration program?Countermeasure and Response Administration (CRA) is a program of the Centers for Disease Control and Prevention (CDC) that supports public health preparedness and emergency response by tracking the availability and dispensing of medical countermeasures. The program is made up of two complementary systems: (1) CRA Countermeasure Inventory Tracking assists public health officials to locate critical countermeasures within the commercial supply chain; (2) CRA Countermeasure Administration Tracking is used at emergency dispensing sites to manage mass prophylaxis activities. The CRA program is a component of the Public Health Information Network (PHIN), a national initiative to implement a standards-based business and technical architecture for public health information systems that interoperates with the National Health Information Network (NHIN).
Why does CDC need to track pharmaceuticals and medical materials?
The need to quickly locate and provide critical pharmaceuticals and medical supplies to responders and the public has increased significantly. CDC must be ready at all times to respond to, manage, and reduce the impact of public health emergencies.
During a public health emergency, Government response officials need to have a comprehensive picture of the assets available to make critical purchasing and distribution decisions. By receiving near real-time data on inventory and distribution of key pharmaceuticals and medical supplies, CDC will be better prepared to ensure that critical countermeasures reach vulnerable populations during an emergency.
How is this different from the Strategic National Stockpile?
The Strategic National Stockpile contains limited quantities of critical pharmaceuticals and supplies specific to dealing with the top national planning scenarios, including category A agents and pandemic influenza.
How will CRA Countermeasure Inventory Tracking data be used?
CRA Countermeasure Inventory Tracking data provide critical information for health situational awareness and emergency response to a natural disaster, pandemic flu, or bioterrorism attack. Public health decision makers will use the private sector information, in concert with information available from the Strategic National Stockpile and state and local public health sources, to plan appropriate and timely public health interventions. During a public health emergency, decision-makers will be able to monitor the available inventory and location of medical countermeasures within the supply chain, and current distribution to affected areas, to ensure that appropriate countermeasures reach vulnerable populations.
Why does CDC need to track these countermeasures daily? Can’t we just send these data during an emergency event?
Public health personnel monitor world health conditions 24 hours a day, 365 days a year, and take action when necessary to contain health threats or avert health crises around the globe. Many situations neither become declared emergencies nor garner media attention. Public health emergency response teams need continuous access to timely data so that they can familiarize themselves with available pharmaceutical countermeasures to meet these threats and to test emergency response plans.
Data
How will these data be transmitted to CDC?The data are sent to CDC through standard pharmaceutical Electronic Data Interchange (EDI) transactions over secure connections. CRA Countermeasure Inventory Tracking transactions use Healthcare Distribution Management Association (HDMA) EDI guidelines to minimize the level of effort required to participate in the program. It is anticipated that the 846, 856, 852, and 867 EDI transactions that are currently used in pharmaceutical commerce will also be used by this program.
Who will have access to the CRA Countermeasure Inventory Tracking data?
The data are viewed by CDC personnel and CDC’s public health partners. All uses of the data and potential disclosures will be covered in a Data Sharing Agreement that CDC signs with each data source. Data are used for public health preparedness and emergency response purposes only. Competitors will never have access to data provided to CDC.
Privacy/Legal
What legal protections and security controls are available to protect the confidentiality of the data and to prevent unauthorized users?CDC is sensitive to business concerns over issues of privacy and confidentiality and has taken precautions to ensure all data are transmitted securely. As a critical information system, Countermeasure Inventory Tracking leverages security services and protections for key CDC information systems. The services and protections provided by security mechanisms such as the Secure Data Network (SDN) include user identity management and authentication and authorization controls to ensure appropriate access to CRA Countermeasure Inventory Tracking data. Additionally, the privacy and security measures used by CRA Countermeasure Inventory Tracking facilitate compliance with various federal laws and regulations, including the Privacy Act of 1974, Federal Information Security Management Act of 2002 (FISMA), E-Government Act of 2002, and Homeland Security Presidential Directive 12 (HSPD-12).
What is being done to ensure the security of the data transmissions?
CDC routinely manages sensitive data, and CRA Countermeasure Inventory Tracking data will be treated with the proper security measures. The security package used by CDC conforms to the National Institute of Standards and Technology (NIST) federal guidelines for the level of sensitivity of the kinds of data being transmitted.
The data connections between the individual data sources and CDC are over Secure Sockets Layer (SSL) connections, which are very common on the Internet and considered secure. Typically, such connections are identified by the prefix “https.” In addition, the collected data, or what is known as the message payload, is encrypted separately using RSA 128-bit encryption algorithms. These algorithms use public private key pairs via VeriSign digital certificates. RSA algorithms are commonly used for encryption of data sent over the Internet. The message payload is also digitally signed using the same VeriSign certificates. Only bearers of the Countermeasure Inventory Tracking private key are able to decrypt the data.
Each connection to CDC is authenticated using SSL client authentication via digital certificates. After each send, the connection is dropped and must be re-authenticated before the next send. These methods ensure nonrepudiation, which means that the data source cannot deny having sent the message payload, and CDC cannot deny receiving the message payload.
These security measures ensure confidentiality, authenticity, integrity, and nonrepudiation of data being sent to CRA Countermeasure Inventory Tracking.
Responsibilities of Data Providers
What are CDC’s expectations of data providers during the pre-event phase (or routine operations)?Data providers are asked to provide a point of contact familiar with their data to respond to any questions from CDC staff. Data providers should also include CDC on routine correspondence about changes in NDC numbers, new products in the categories of interest, etc.
What are CDC’s expectations of data providers during a health emergency?
Data providers are requested to provide a point of contact within their internal emergency response organizations to serve as a liaison to the CDC Director’s Emergency Operations Center (DEOC).
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