FDA has created an FDA Federal-State Partnership for Food Protection Coordinating Committee, comprising Federal partners (FDA, CDC, USDA, and DHS) and a wide range of state, territorial, tribal, and local representatives. Natural disaster risk is typically defined as a combination of the likelihood of an event occurring and the consequences should the event happen. Another important goal of the crisis communications plan is to move from reacting to the incident, to managing a strategy, to overcome the incident. Regulators may need to be notified and local government officials will want to know what is going on in their community. RiskBenefit Information Provides Context and Is Adapted to Audience Needs. For example, with respect to medical products, without the expectation of benefit, people are unlikely to accept even a small amount of risk. Management does not want to learn about a problem from the news media. Along with obtaining the scientific knowledge needed to prepare effective risk communications and evaluate impact, FDA must be able to apply that knowledge. % FDAs Internet Web site is a primary vehicle for communicating with the publicboth directly and through the press. In addition, FDA recognizes the need to explore the variety of electronic tools that fall under the broad scope of the Internet. LockA locked padlock Information and communication geared towards harnessing the capabilities of the civilian population, integrating the public into public health activities, and generally treating the public as a capable ally in the response to an incident may help to shape an appropriate public response (Henderson, Inglesby, & OToole, 2002). The second category relates to how the agency oversees what regulated industry says about its products. Such an approach will also be needed when overseeing communications from regulated industry. Over the course of a recall, as both FDA and the industry gather more information, advice for consumers can change significantly. For example, FDA relies on a voluntary and passive adverse event reporting system. Electronic lists can also be hosted on a secure server for remote access with a web browser. ), Pens, pencils, paper, clipboards and other stationery supplies. 1 Disaster Communications Plan - Zombie Apocalypse Introduction Disaster Communications Plan is a critical component in all communications during a disaster. Warnings and Risk Communication. The Project Management Office (PMO) of the Office of Civil Defense (OCD) is calling for proposal for the Development and Implementation of the Strategic Communication Plan under the Risk Analysis Project. 1 Hamburg, M.A., & Sharfstein, J.M. Be honest, frank, and open. Comprehension of Prescription Drug Information: Overview of a Research Program, Proceedings of the American Association for Artificial Intelligence, Argumentation for Consumer Healthcare. With your family or household members, discuss how to prepare and respond to the types of emergencies that are most likely to happen where you live, learn, work and play. Attempts should also be made to ensure that information disseminated from different sources is consistent, and most importantly truthful, even if it is bad news (Fullerton, Ursano, & Norwood, 2004). The strategy is intended to guide program development and research planning in a dynamic environment where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their health and well-being. Stakeholders or audiences will ask questions and request information. But that decision is made within a specific legal context, which is that the product meets the legal standard of safe and effective for its labeled or intended useto read either word as an absolute would be misleading. Develop detailed action plans at agency and Center levels for implementing the strategies and achieving the proposed action steps, including timelines, responsibilities, and resource needs. The key challenges of risk communication are changing risks or future risks due to temporal and spatial changes in hazard, exposure, and vulnerability, and climate change impacts; a lack of good governance, limited efforts to redefine disaster risk communication beyond warning generation; inadequate emphasis on disaster risk communication at . Messages can be pre-scripted as templates with blanks to be filled in when needed. 19 The phrase emerging risks of medical products refers to information about potential product risks that is still uncertainthat is, neither a full analysis nor a clear confirmation that a specific identified risk is associated with the product in question yet exists. The FDA as a Public Health Agency. To avoid this, FDA must clarify, both internally and externally, when and how it will communicate about emerging risks of FDA-regulated products and how to standardize communication formats. Other regulations require that FDA enforce identical information disclosure requirements within each promotional material category (ads and labeling), regardless of whether the target audience is healthcare professionals or consumers. The information must be marketed internally and presented in a way that will best meet the requirements of relevant staffers to help produce communication materials that reflect this new data on stakeholders needs. 5 The Risk Communication Advisory Committee (RCAC) met three times in 2008 and is scheduled to meet four times in 2009. OSHI and the MedWatch staff are working with several organizations to explore mechanisms for targeting MedWatch safety alerts to a subscriber subset who wish to receive selected notices. May help you identify those groups of individuals who require differing messages from the general . How do healthcare professionals, consumers, and patients integrate new information into their existing belief models about the risks and benefits of medical products? Three strategies under the policy goal target internal policies governing FDA-generated risk communications. Laughery. Within FDA, a need exists for greater clarity about who in the communications review chain is responsible for determining that an information piece has been sufficiently refined for a particular target audience. FDAs Approach to Risk Communication Is Results-Oriented. There may be many different scenarios but the need for communications will relate more to the impacts or potential impacts of an incident: Messages should be scripted to address the specific needs of each audience, which may include: Customer - When will I receive my order? What will you give me to compensate for the delay?, Employee - When should I report to work? Will I have a job? Will I get paid during the shutdown or can I collect unemployment? What happened to my co-worker? What are you going to do to address my safety? Is it safe to go back to work?, Government Regulator - When did it happen? What happened (details about the incident)? What are the impacts (injuries, deaths, environmental contamination, safety of consumers, etc. Poor or delayed communication of statements that appear contradictory can serve to amplify these effects (Tinker & Vaughan, 2004). Communicate the policy to all employees explaining that it is best to speak with one informed voice. The crisis communications team, consisting of members of the management team, should operate in an office environment to support the contact and information centers. optimizing its policies on communicating product risks and benefits. There may be numerous requests for information from local, regional or national media. 6 National Research Council. The plan presents FDAs strategies for risk communication and proposes ways to improve FDAs science base, its capacity for action, and its policy processes. FDA is confident that the strategy outlined in this report will help ensure that FDA-regulated products are used appropriately. Due to the novel nature of COVID-19, to gaps and delays in information-sharing between and within countries, and to the rapidly-changing response landscape, risk communication has been playing catch-up. The public will have legitimate concerns and many specific questions such as: The primary role of communication to the public should be to address these questions and to fill the information vacuum before rumours, myths and misinformation promulgate (Durodie & Wessely, 2002). 8 Examples of Risk Communication. The issue of effective communication between the authorities and the public emerges as a central issue affecting most aspects of public response to disaster, including warning responses, evacuation and health issues (Section 3.9 and is recognised by the literature as a crucial element in determining psychological and behavioural responses to a CBRN incident (Alexander & Klein, 2003; Holloway, Norwood, Fullerton, Engel, & Ursano, 1997; Mileti & Peek, 2000). FDA is also striving to ensure that it and regulated industries, as appropriate, evaluate the communications and communication-related activities conducted in response to regulatory mandates. APPENDIX A | SAMPLE CRISIS COMMUNICATIONS PLAN 3 3 CRISIS COMMAND CENTER If the situation warrants, the CCC Manager will direct that communication functions be centralized in the . It should be clear to staff what situations require immediate notification of management regardless of the time of day. %PDF-1.4 This would be an unintended bad outcome of a recall notice. FDA is committed to streamlining the required processes for moving research projects from conception to implementation so as to make these processes as efficient as possible. Following any disaster, but particularly a CBRN incident, the public will be primarily concerned about safety. FDA has the capacity to empower the public by providing healthcare professionals, patients, and consumers with the information they need about FDA-regulated products, in the form they need it, when they need it. LockA locked padlock The crisis communication or business continuity plan should include documented procedures for notification of suppliers. Risk communication-related activities take place at many levels within FDA, including within the product-focused centers, the Office of Regulatory Affairs, and the Office of the Commissioner. A shorter, more focused message may not address an issues every nuance, but it ensures that a less literate audience will be able to understand critical messages and recommendations. A lock ( Employees and their families will be concerned and want information. This flow of information should be managed through a communications hub. FDA has identified seven strategies it believes will expand its capacity both to generate effective risk communication and to oversee effectively the risk communication-related activities of regulated industries. Mainstreaming disaster risk management into development planning can help lower the impact of disasters on property and lives. The spectra of risk then typically becomes a range of relative risk - Very High, High, Moderate, Low, and Very Low. 1999. Cambridge University Press: Cambridge, U.K., 2002; Wogalter, M.S., D.M. The following table summarizes the goals, strategies, and actions in FDAs Strategic Plan for Risk Communication. By helping the public better understand how it approves and recalls products, FDA can complement its rigorous premarket review and postmarket actions. Download Template Having formal processes in place to disseminate research results and lessons learned within the organization will prevent the same mistakes from recurring. For example, in reviewing certain medical product marketing applications, FDA determines that a product is safe and effective. FDA also believes that it can improve the internal review process by raising reviewers awareness about factors that must be explicitly balanced for the best communications results. With this in mind, a key action item under this strategy to strengthen FDAs risk communication science is to create a prioritized risk communication research agenda. We acknowledge that, to the extent possible, this same science-based approach should guide communications activities. To further enrich your knowledge about disaster plans, download our free disaster plan . The Facts: As part of a healthful diet, American families are urged to eat fruits and vegetables. http://www.fda.gov/cder/news/CMI/default.htm. Pakistan is vulnerable to disaster risks from a range of hazards including avalanches, cyclones/storms, droughts, earthquakes, epidemics, floods, glacial lake outbursts, landslides, pest attacks . Following the Three Mile Island incident, 83% of evacuees cited the receipt of conflicting and confusing information as a reason for evacuating (Mileti & Peek, 2000). Developed SOP for communication with international counterparts about recalled items marketed in other countries. 2. Englewood Cliffs, NJ: Prentice-Hall, 1980; Ajzen, I. Throughout the disaster literature, various recommendations have been put forward for how to effectively communicate risk, warnings and action plans to the public. The goal of the crisis communications team is to gather information about the incident. This side event will discuss partner experiences on disaster risk communication before and during disasters, drawing from recent lessons and experiences from COVID-19 and other disasters including key challenges and opportunities in the digital and social media era which could ultimately enhance the capacity of disaster risk management. The government is committed to the interactive development of policy. For example, FDA is analyzing data from interviews with consumers focused on their awareness of the possibility that food could be a vehicle for a terrorism event. We define three key areasscience, capacity, and policyin which strategic actions can help improve how we communicate about the risks and benefits of regulated products, as well as how we oversee communications produced by regulated entities. If you lose trust and credibility, you will find them almost impossible to regain. Underlying this definition of risk communication is the recognition that even if people are getting direct FDA recommendations, it is ultimately an individuals personal choice to, for example, purchase a prescription drug and take or give it to their pet, pick the right food choice for their health, use a medical device appropriately for a particular patient, or avoid unnecessary exposure to radiation. However, the lengthy process needed to gain approval for conducting research and testing can make it difficult to test communications with more than nine14 members of the public in the time needed for rapid communication, especially about emerging risks of regulated products. Additionally, some Committee members have noted the need to ensure that the public understands fully the context of approvals and recalls. Capacity Strategy 3: Streamline processes for conducting communication research and testing, including evaluation. For this, the media should have access to frequent updates to pass on to the public, even if nothing new is happening (Expanding local healthcare structure in mass casulty terrorism incident, 2002). Risk Communications Plan. FDA recognizes the importance of communicating effectively about FDA-regulated products to achieve its mission of protecting and promoting the public health. Customers may become aware of a problem as soon as their phone calls are not answered or their electronic orders are not processed. The use of jargon can lead to misunderstandings, as well as defining an us and them situation, and should be minimised. Risk communication is the process of communicating potential losses and how they might be prevented. 1. As already mentioned, some of the actions address more than one strategy within the particular goal and may overlap across goal areas. FDA also may need to address how to improve public understanding of the limits of FDAs authority, at least to the extent it is relevant to informed decision-making about regulated products (see also the discussion in Science Strategy 1). Disaster recovery templates are good references in the course of building your own disaster plan. Risk communication is a two-way exchange. must be evaluated to ensure optimal effectiveness. Producing effective communications requires that initial drafts be tested, preferably with target audience members. FDA recognizes the need to consider how to optimize policies on its oversight of the communications of regulated industries. Honest appraisals of the situation and truthful answers about the severity and scope of the incident should be given from the outset. In these cases, seamless coordination among the agencies increases the timeliness and consistency of communications on identical issues. The staff working within the contact center should be provided with scripts and a frequently asked questions (FAQ) document to answer questions consistently and accurately. In pursuit of a shared acknowledgment of how FDA conceptualizes risk communication, a cross-FDA group of staff involved in communications agreed on the working definition of FDA risk communication described in the following section. fcoordination of disaster risk management programs within their territorial jurisdiction to: 1. is integral to carrying out FDAs mission effectively; must be adapted to the various needs of the parties involved; and. CERC Pandemic Influenza Manual (PDF) By Leaders for Leaders (PDF) Event Assessment Wizard. They also need to understand their roles (e.g., prescriber, patient, caregiver) in managing the risks of using FDA-regulated products. 10121 of 2010, which pr ovides the legal basis for policies, plans and programs to . IBM's Disaster Recovery Plan. Conducted pilot customer satisfaction survey among health professionals - presented results to the internal Drug Safety Board, and to the Risk Communication Advisory committee. The Advisory Committee was established to help FDA improve its communication policies and practices, review and evaluate relevant research, and help to implement communication strategies consistent with the most current knowledge.5. Established multiple Twitter feeds for quick communication, Developed questions and answers on FDA's decision-making process for "FDA Basics" educational series, Developed web-based instructional material, Developed and launched Internal Message Testing network, Developed PRA generic clearances for communications-relevant research, Established roles and responsibilities for FDA rollouts, Used targeted feedback mechanisms on web pages, Collected and disseminated ASCI reports on intranet, Established Facebook presence and piloted communication process on Facebook, Established streaming video library on safe food handling practices, Developed new media resources (Twitter feed, RSS feeds widgets, etc) to communicate about the risks of tobacco use, Evaluated advisory committee communication and developed evaluation tools for future use, Established partnership with the Partnership for Food Safety Education to determine the direction of its food safety education programming, Holding regular conference calls with CDC/FDA/FSIS. It also outlines disaster preparedness and prevention mechanisms. Strengthen the science that supports effective risk communication, Science Strategy 1: Identify gaps in key areas of risk communication knowledge and implementation and work toward filling those gapsScience Strategy 2: Evaluate the effectiveness of FDAs risk communication and related activities and monitor those of other stakeholdersScience Strategy 3: Translate and integrate knowledge gained through research/evaluation into practice, Expand FDA capacity to generate, disseminate, and oversee effective risk communication, Capacity Strategy 1: Streamline and more effectively coordinate the development of communication messages and activitiesCapacity Strategy 2: Plan for crisis communicationsCapacity Strategy 3: Streamline processes for conducting communication research and testing, including evaluationCapacity Strategy 4: Clarify roles and responsibilities of staff involved in drafting, reviewing, testing, and clearing messagesCapacity Strategy 5: Increase staff with decision and behavioral science expertise and involve them in communication design and message developmentCapacity Strategy 6: Improve the effectiveness of FDAs Web site and Web tools as primary mechanisms for communicating with different stakeholdersCapacity Strategy 7: Improve two-way communication and dissemination through enhanced partnering with government and nongovernment organizations, Optimize FDA policies on communicating risks and benefits, Policy Strategy 1: Develop principles to guide consistent and easily understood FDA communicationsPolicy Strategy 2: Identify consistent criteria for when and how to communicate emerging risk informationPolicy Strategy 3: Re-evaluate and optimize policies for engaging with partners to facilitate effective communication about regulated productsPolicy Strategy 4: Assess and improve FDA communication policies in areas of high public health impact. Directing rapid deployments of the MERS Detachments by providing strategic level DEC resource augmentation to facilitate effective communications, information exchanges, and whole community support during emergencies. It also identifies and details 14 specific strategies. Consider events that occur on a holiday weekend or in the middle of the night. UNDRR Global Assessment Report, 2015 = X X Disaster risk is widely recognized as the consequence of the interaction between a hazard and the characteristics that make people and places vulnerable and exposed. Providing self-sustaining telecommunications, logistics and operations support through staff, equipment and equipment assets that are immediately deployable to support a large disaster field office and multiple field operating sites within the disaster area. See http://www.fda.gov/Safety/SafetyofSpecificProducts/ucm180325.htm. CERC Templates and Tools. It remains unknown whether the publichealthcare professionals, consumers, patients, patients caregivers, and even the mediafully understands the ramifications of the legal context within which approvals are made. Hence, an emergency plan needs to be a living document that is periodically adapted to changing circumstances and that provides a guide to the protocols, procedures, and division of . Sometimes, people stop taking their drugs when they feel better, even though the condition is just temporarily hidden and could return. Risk communication must be viewed similarly. GiGe\))Ki-/wl5Xp(gU`?f2S?W.sW Understanding potential audiences is key, as each audience wants to know: How does it affect me? Guidance for scripting messages that are specific to the interests of the audience is another element of the plan. If a child brings home a disaster plan template they were given in school and assigned to fill out with a parent as a homework assignment, communicators are fostering an interpersonal interaction. Special Populations Assessment Tool. Presentation Transcript. BC FDA issued guidance (some draft and some final) on how advertisements directed to consumers can provide information in language that is more easily understood by this audience and still meet regulatory requirements. However, having general ground rules is not enough. Risk communication is a critical component of FDA's mission to protect and promote the public health. 1 0 obj A second guiding principle is that for people to make informed decisions, they need access to critical risk and benefit informationadapted for their specific needswhen, where, and in the form they need to best understand and apply this information. Identify outcomes and develop measures for assessing progress toward goals and strategies, Develop detailed action plans at agency and Center levels for determining time frames and resources to achieve proposed action steps, and coordinating budget needs through the annual budget process. 14Requirements of the Paperwork Reduction Act of 1990 include the need to seek public comment and clearance from the Office of Management and Budget when information is collected from more than nine members of the public. Human Resources (HR) is responsible for the day-to-day communications with employees regarding employment issues and benefits administration. In a related move, FDA is increasing its surge capacity for managing a larger-than-normal volume of emergency-related calls during and outside of normal business hours. One of the aims of the crisis communication plan is to ensure consistency of message. This article discusses the crucial issue of communicating information to the public. Understanding the audiences that a business needs to reach during an emergency is one of the first steps in the development of a crisis communications plan. Therefore, risk communication must involve describing both the risks and the benefits of regulated products, including adequate instructions to guide appropriate use. Held inaugural "FDA Health Professional Organizations Annual Conference" in October, 2011. Why is it needed? Developing an Emergency and Risk Communication Plan Guidance Document July 16, 2013. The message should be specific about the steps taken by officials to minimise risk, treat victims and detect or monitor exposure; moreover, even if specificity is not possible for the entire content, the message itself need not be non-specific (Mileti & Peek, 2000). Pre-scripted messages can be developed, approved by the management team and stored on a remotely accessible server for quick editing and release when needed. 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