Motivation for Planning
1. What is Rx Response?
The purpose of Rx Response is to provide support for the continued provision of critical medicines to patients whose health may be threatened by a severe public health emergency by a disruption in the supply of essential medicines.
2. Why did organizations feel this effort was necessary?
Each stakeholder has been active in efforts to help patients gain access to needed medicines after recent major natural disasters; we are now applying valuable lessons learned from these experiences to help aid patients in future severe public health emergencies including bioterrorism and pandemic events and to ensure a continuum of communications that will enhance assistance efforts.
3. Why did Rx Response Partners choose to be involved in this effort?
Each group has chosen to participate in this effort because they are either involved in helping to coordinate emergency responses to public emergencies or because they are an integral and important part of the pharmaceutical supply chain.
4. Is this effort in response to the failures of government and private industry experienced during Katrina?
While Hurricane Katrina is a good example of a natural disaster that merits a widespread emergency response, this effort is about more than that particular event. Each emergency experience provides a basis for lessons learned and an opportunity to identify supply chain challenges in the face of extreme circumstances. Together, those participating in Rx Response want to use our collective experience in past public health emergencies to plan for future emergency situations.
The Rx Response Process 5. Is Rx Response trying to replace government emergency systems?
Not at all. Medicines are a key component in an emergency; Rx Response has been organized and is inviting additional partners and stakeholders into the process to be able to communicate most efficiently with the manufacturers, suppliers, distributors, and dispensers of medicines so that in a real emergency, the efforts of federal, state and local governments, and first-responders are enhanced.
6. What is the real benefit of the Rx Response’s planning effort?
While there are both direct and indirect benefits, first and foremost, this effort should result in easing the way that first-responders communicate with those involved in the supply chain to help support the continued delivery of medicines to patients during a severe public health emergency. For example, instead of a public or private emergency response organization having to contact 40 different pharmaceutical companies or multiple distributors, pharmacies and hospitals, there will be a streamlined process that centrally processes communications.
7. Does Rx Response provide individuals with new prescriptions, refills or medical advice? No. The Rx Response program is not:
- An individual patient service for medicines during a time of emergency
- An individual patient source for:
- medical advice
- prescriptions (only medical providers that are licensed and authorized to write prescriptions can provide this service)
- An order entry or coordinating capability among various parties to order medicines or provide for their distribution and dispensing
- A decision making body for individual sectors
8. 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 as possible in times of a severe public health emergency to help support the continued delivery of needed medicines. We will seek to partner with other agencies and industries involved in this process to help minimize barriers hindering the supply of medicines during severe public health emergencies. However, no one connected with Rx Response will be delivering medicines directly to patients unless authorized or licensed to do so in their normal course of business.
9. 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. Rx Response will not attempt to define, limit or specify these medications.
10. Where can people get more information about Rx Response’s efforts?
Rx Response has a public Web site where people can get information about these efforts; find some tools that may be useful to prepare for disasters and emergencies, as well as links to other resources that would be involved in an emergency response. It can be found at rxresponse.cdmail.biz.
11. What is the real benefit of the Rx Response’s planning effort?
While there are both direct and indirect benefits, first and foremost, this effort should result in easing the way that first responders communicate with those involved in the pharmaceutical supply chain to help support the continued delivery of medicines to patients during a severe public health emergency. For example, instead of a public or private emergency response organization having to contact dozens of pharmaceutical companies or multiple distributors, pharmacies and hospitals, there will be a streamlined process that centrally processes communications.
12. 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 need to respond in a time of a severe public health emergency and communicate with pharmaceutical manufacturers, distributors, community 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.
13. How has Rx Response sought input into the formation of this plan from third parties?
We have sought input from numerous parties – both public and private and at federal, state and local levels — all of whom may have a role to play in a national public health emergency. (Refer to current Coordinating Body Members list)
14. How does the Rx Response plan engage third parties, such as government, healthcare/relief organizations or charities?
Rx Response includes a broad list of partners, including third parties and other industry and government entities. (Refer to current Coordinating Body Members List). Rx Response partners continue to meet to identify important points of contact, potential challenges and ways to enhance and streamline communications in response to a variety of emergency scenarios.
15. What is the normal flow of a pharmaceutical product? How might it differ during a time of emergency?
There is no single answer to this question. There are multiple routes and checkpoints as medications move through the supply chain to a patient’s medicine chest. This begins with the sourcing of raw materials to suppliers, and involves many components such as manufacturers, shippers, distributors, community pharmacies, and prescribers. During a severe public health emergency, potential disruptions can occur at any point along this chain.
Emergency Situations 16. What is the scope of the Rx Response planning?
The Rx Response focus has been on domestic planning in the face of a major natural disaster, bioterror event, or pandemic. Our goal is to facilitate communications between first responders and disaster agencies easing the way that first responders communicate with those involved in the pharmaceutical supply chain to help support the continued delivery of medicines to patients during a severe public health emergency.
17. Does Rx Response include plans for the U.S. only or are there international ramifications?At the present time, our planning is focused on the domestic front. 18. What are the criteria by which an emergency is judged?
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 US Governor or the President
- American Red Cross Level V+ Event
- DHS Severe Classification
- WHO Phase IV+ Event
- HHS Stage 2+ Event
- Other situations warranting a response as determined by the respective decision–making bodies within the represented industry groups.
19. How will Rx Response be coordinating with federal, state, and local governments?
Rx Response partners have met with those responsible for federal, state and local planning efforts for emergency responses, and gathering information that would be the most important to help support communications during a time of crisis.
20. Has Rx Response determined how ready each of its partners are to respond to a crisis?
The focus of this effort is not to develop emergency response plans for individual participants in Rx Response. The responsibility of Rx Response is to reach out to one another, to identify key personnel in each organization, and to develop protocols intended to enhance and facilitate communications and the ability to respond during a time of crisis.
21. Where is the greatest potential for challenges to the system of drug delivery during a crisis or emergency?
There are many different types of events that each could pose different challenges to the medicines delivery system. We are working to anticipate various types of severe public health emergencies and their impact on the system of drug delivery. We are also reviewing past efforts to adapt our understanding of these events to incorporate challenges and opportunities that were realized during emergencies of the past. Clearly, however, our primary focus is on any potential challenge to the pharmaceutical supply chain.
22. What are the obligations of individual participants under the Rx Response plan?
Rx Response does not advise individual participants on their obligations. Our aim is to identify responsible people within each organization in our partnership to help facilitate communications during a time of crisis.
23. Will there be a built-in process to modify the plan after assessment?
The Rx Response program will be under on-going assessment to look for ways to improve and to modify it in relation to changing circumstances. Likewise, after any event where the system is utilized, we will assess and modify accordingly.