Rx Response Program Structure

1. What is Rx Response?
   Rx Response was built to help ensure the continuing flow of medicine to patients during a severe natural disaster, large-scale terrorist attack or an influenza pandemic. Rx Response is a single point of contact for the entire biopharmaceutical supply system and coordinates a robust network of partners providing information designed to help federal and state emergency management officials and public health officials to communicate with Rx Response regarding biopharmaceutical needs and other issues which may impact the supply system. The communications are actively monitored by all partners in the biopharmaceutical supply system to ensure speedy resolution.
   
   The Rx Response program is:
   • A multi-party, private-sector driven, closed-system (non-public) coalition to share information and, as appropriate, address biopharmaceutical supply system risks in a disaster
   • A means to support individual sectors/parties' first-line emergency response
   • A conduit for sharing appropriate biopharmaceutical supply chain best practices and making the biopharmaceutical supply system more resilient
   • A collective medium to work with government agencies to address barriers to critical product delivery
   • A source of information for DHS critical-infrastructure industries or groups
   • A purveyor of organized intelligence
   • Applicable to medicines only
   
   The Rx Response program is not:
• A source of medical advice, healthcare or prescriptions (only medical providers that are licensed and authorized to write prescriptions can provide this service)
• A pharmacy, distributor or dispenser of medicines
• A decision-making body for individual industry partners
• A one-stop shop for pandemic information
• A source of information on inventory of medicines
• A public call center
  
  
2. Who are the primary Rx Response members?
   Created initially by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Rx Response coalition expanded to include a broad cross-section of private and public sector parties:

   Manufacturers

   • Pharmaceutical Research and Manufacturers of America (PhRMA)
   • Generic Pharmaceutical Association (GPhA)
   • Biotechnology Industry Organization (BIO)

   Distributors

   • Healthcare Distribution Management Association (HDMA)

   Dispensers

   • National Association of Chain Drug Stores (NACDS)
   • National Community Pharmacists Association (NCPA)
   • American Hospital Association (AHA)

   Disaster / Relief Organizations

   • American Red Cross (ARC)

These partners constitute the Rx Response Coordinating Body, which convenes in the event of a severe public health emergency (or threat) to exchange appropriate information about supply system challenges and how to address those challenges.


3. What other agencies or groups are partners of the Rx Response program?
   Federal, state and local government parties that respond to disasters are an essential component of Rx Response's information-sharing network, though they are not part of the Coordinating Body. In addition, Rx Response works with a broad variety of organizations to address complex or large-scope issues, including developing national pharmacy guidance, among other biopharmaceutical supply system issues.



4. Who are ancillary members and why do they choose to participate as part of this effort?
   Ancillary members are state and federal government agencies responsible for responding to major disasters. These agencies typically participate in the Rx Response effort because they are involved in helping to coordinate emergency response to public emergencies, and they understand what an integral and important part the biopharmaceutical supply chain plays in delivering medicines to patients and protecting public health. Connecting with Rx Response enables these agencies to have a single-point of contact for the entire biopharmaceutical supply system.



5. What interactions does Rx Response have with government agencies?
   Rx Response works in active partnership with numerous federal agencies and state emergency management agencies. Since its creation, Rx Response has engaged with dozens of state emergency management leaders and public health officials so that a relationship exists between Rx Response and state officials prior to an emergency. This relationship building activity has been instrumental in allowing effective coordination between Rx Response and states impacted by disaster. This enables swift Rx Response action to address numerous disasters, including the California wildfires in the summer of 2008, the Kentucky ice storm of 2009 and Hurricanes Gustav and Ike in 2008.
   
   At the federal level, Rx Response leadership has a role in the Healthcare Sector Coordinating Council (HSCC), a public-private partnership created by the Departments of Homeland Security and Health and Human Services to increase coordination between the government and the private sector in addressing protection of healthcare and public health as part of the critical infrastructure of the United States.

1. Who initiated the Rx Response program?
   The Rx Response project was initiated by the Pharmaceutical Research and Manufacturers of America, or PhRMA, in the aftermath of Hurricane Katrina and based on fears of a new pandemic outbreak in 2005. PhRMA is the trade association representing the country’s leading biopharmaceutical research and manufacturing companies.



2. What were the specific lessons from Hurricane Katrina that inspired the creation of Rx Response?
   Following Hurricane Katrina, there was no single point of contact for emergency managers and relief agencies to contact the biopharmaceutical supply system. As a result, efforts to deliver donated supplies and other material were disjointed and in many cases, pharmaceutical companies received multiple requests for the same products or materials.
   
   Another example of insufficient coordination in the aftermath of Katrina was the inability of supply trucks bringing donated materials to get through security check points. In these cases, there was no system to contact security personnel to alert them that relief supplies would be passing through check points. Rx Response now provides a means to potentially resolve issues related to transportation and credentialing, which arise during a response to a public health incident.



3. What is the real benefit of Rx Response's planning efforts?
   First and foremost, Rx Response helps ease communication between first responders and those involved in the biopharmaceutical supply system to support the continued delivery of prescription medicines to patients during a severe public health emergency or disaster. For example, instead of a public or private emergency response organization having to contact dozens of biopharmaceutical companies or multiple distributors, pharmacies, and hospitals, there is now a streamlined process that centrally processes communications through Rx Response.
   
   In addition, Rx Response helps encourage greater resilience among the individual companies that comprise the Rx Response coalition and promotes a greater understanding of the biopharmaceutical supply system and where its points of weakness exist. Among Rx Response's greatest contribution to emergency preparedness is the comprehensive but concise situational awareness reports that it provides to federal and state officials on the status of the biopharmaceutical supply system during public health emergencies.



4. What is the scope of the Rx Response planning?
   Rx Response's focus has been on domestic United States planning in the face of a major natural disaster, bioterrorism event, or pandemic. At the present time, our planning is focused only on the domestic front.



5. What assumptions has Rx Response made in its planning effort?
   Emergency planning is a process and not an event. We recognize that there are many agencies, both public and private, that must respond during a severe public health emergency and communicate with biopharmaceutical manufacturers, distributors, community or chain pharmacies, prescribers, healthcare providers and relief organizations to help ensure continued delivery of medicines to people who need them. We also recognize that, given different emergency scenarios including natural disasters, bioterrorism or a pandemic, a wide variety of communications alternatives may need to be employed in order to minimize disruptions.
   

1. What is the normal flow of a biopharmaceutical product? How might it differ in an emergency?
   There is no single answer to this question. Given the innumerable routes and checkpoints that medications move through the supply chain to a patient's medicine cabinet (from the sourcing of raw materials to the packaging of manufactured drugs), potential disruptions can occur at any point along this chain. For more information, visit the "Normal Biopharmaceutical Supply System" main page.



2. Where can I find specific information about a current emergency?
   To find specific information about a current emergency, visit www.rxresponse.org and navigate to the EM (Emergency Management) Community page. Here, you will find information about any events to which Rx Response is either monitoring or actively responding.



3. What type of emergency constitutes a potential Rx Response activation?
   While Rx Response is always monitoring potential threats, Rx Response actively responds when a severe natural disaster, large-scale terrorist attack, or a pandemic occurs that threatens to disrupt the normal supply of prescription medicines. Information regarding a significant crisis or disaster situation will flow from a number of sources. Based on information received, the Rx Response Coordinating Body will perform an initial assessment of the situation on a case-by-case basis.
   
   The following existing mechanisms will be used to help guide decision–making:
• Disaster declaration by a Governor or the President; and/or
• DHS Threat Advisory Red/Severe Classification; and/or
• Health and well being of a significant number of persons is materially threatened or affected; and/or
• Local, regional, national or global healthcare infrastructure is significantly compromised; and/or
• The ability to provide ample biopharmaceuticals in sufficient quantities or in a timely fashion is challenged; and/or
• The underlying disaster dynamics are not quickly or simply resolved (e.g. within several days or through normal business practices by individual companies); and/or
• Greater-than-normal requests by the media or government partners for information regarding the biopharmaceutical supply system; and/or
• Other situations warranting a response as determined by the respective decision-making bodies within the represented industry groups.



4. Is Rx Response trying to replace government emergency systems?
   Not at all. Medicines are a key component in an emergency; Rx Response organizes the private-sector biopharmaceutical supply system in order to communicate and conduct its response efforts most efficiently in coordination with federal, state, and local governments. As such, government and first-responder efforts are enhanced and carry the benefit of partnership with an organized, united, and integral sector of the United States' critical infrastructure.



5. Will the Rx Response program actually be delivering drugs to needy patients?
   No. Our primary focus is to ensure that the pathways of communication remain as clear and open as possible in times of a severe public health emergency to support the continued delivery of needed prescription medicines. We will seek to partner with other agencies and industries involved in the process to help minimize barriers hindering the supply of medicines. However, Rx Response does not deliver medicines directly to patients.
   
   
6. Are all medications included in the Rx Response effort or is it only emergency medications? What are the essential medicines that Rx Response will be focusing on during an emergency?
   The term "medication" encompasses a broad range of products, including prescription medicines needed in a severe public health emergency, as well as other critical prescription medications needed for personal use. Rx Response officials realize that a major public health emergency not only has the potential to increase demand for medicines to treat those injured by the emergency but it may also disrupt the flow of critical medicines needed to sustain treatment of chronic diseases like diabetes, cancer, kidney disease, and other ailments. Rx Response will not attempt to define, limit or specify these medications, but will attempt to respond to the requests of all its partners equally during an emergency.

1. How do Rx Response members communicate during an actual event?
   The Coordinating Body and Support Team operates from a central operations center located in Washington, D.C., unless the event affects this location, in which case a new location will be determined. In addition to the operations center, Rx Response participants also communicate virtually through conference calls, automated notification tools and an online communication forum.



2. What does the Rx Response online communication forum consist of?
   The online communication forum has both a public website, as well as a private members-only website for Rx Response. The public site is the Rx Response website, www.rxresponse.org, which provides general information about Rx Response and its resources. The private, password protected site, referred to as InfoCenter and available at http://infocenter.rxresponse.org, provides many more detailed and interactive communication tools for relevant partners.



3. How does someone request access to InfoCenter?
   If a person has not been granted access to the InfoCenter site, they can go to http://infocenter.rxresponse.org and select the link titled "Request Access to RxResponse.org InfoCenter." Once they input the appropriate information and click the "Request Access" button to submit their request, it will be reviewed by an Administrator and the individual will be emailed within 36 hours to notify them if their request was granted or denied.
   
   Rx Response typically grants access to InfoCenter to the following:
   • Rx Response member organization representatives
   • Rx Response trade association member company representatives
   • Local / state / federal public health or emergency management officials
   • National association representatives involved in public health response


4. Can I access contact information for other members of Rx Response?
   One feature of InfoCenter is the contact list, accessed by clicking on the “Contacts” link. This repository stores contact information for all Rx Response participants and other organizations that may participate in a response effort. This information is collected as participants sign up to use InfoCenter. Please make sure to keep your contact information as up to date as possible so that it is available to participants in the contact list. If you are averse to posting contact information publicly, please note that you can hide specific fields of information from public view.

For additional questions or clarifications, please contact the Rx Response Program Director at contactus@rxresponse.org.