The Sentinel Network would integrate existing and planned efforts to collect, analyze, and disseminate medical product (human drug, biologic, or medical device) safety information to healthcare practitioners and patients at the point-of-care. The public meeting, which will be held on March 7-8, 2007 in Rockville, MD, will address the current needs in medical product adverse event data collection and analysis, efficient use of information technology, and opportunities for public and private collaborations. Additional information is provided in the Federal Register Notice, http://www.fda.gov/OHRMS/DOCKETS/98fr/07-141.pdf . Written or electronic comments will be accepted until April 5, 2007. Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1388&SUBTYP=CONTINUE&CID=&AGENCY=FDA Excerpts from the Federal Register (for Ann Fonfa's comments on behalf of the Annie Appleseed Project, see below) Each year many Americans experience an adverse event due to the use of misuse of a medical product. Medical products, for purposes of this meeting, include human drugs, biological products and medical devices. Sometimes it is an adverse event known to be associated with the product and sometimes it is not. Patients may experience an adverse event because of errors in the prescribing, selection, use of a medical product, or because of the inherent properties of a medical product or a problem with the product’s manufacturer. When medical products are not used optimally, the public health can be affected in many ways. First there can be direct injuries to patients. Second, the public’s trust in the health care system and in governmental oversight of medical products can be eroded. Finally, patients and health care professionals can become overly cautious in their use of treatments, thus diminishing the usefulness of effective therapies. To make informed decisions about how to use the products safely and effectively, health care professionals need up-to-date and accurate information, about the medical products they may be prescribing. Without this information, treatments, preventatives, and diagnostics may not be utilized optimally. Efforts now underway to develop and harmonize health information standards, such as for electronic health records, and to make use of available health information technologies, are giving the public and private sectors a new array of tools to help improve the safe and effective use of medical products. Premarket clinical trials cannot identify all potential risks from a medical product. FDA and other Federal agencies conduct a variety of postmarket surveillance efforts to monitor the safety of medical products once they have been approved for marketing in the United States. These include adverse event reporting systems used to assess known risks and to identify potential previously unknown risks, and the use of population-based data sets to help assess whether such risks are related to specific medical products. However the effectiveness of these postmarket safety activities has been constrained due to limitations in the quality, quantity, and timeliness of the available data as well as limitations in the existing capacity to rapidly conduct postmarket safety studies when needed. The development of new information technology tools and the growing interest of the private sector in creating the necessary capacity to conduct postmarket safety assessments provide an opportunity to address these limitations through better integration of the nation’s postmarket medical product safety activities. Therefore FDA is exploring opportunities to link existing and planned private and public sector postmarket safety efforts to create a virtual, integrated, and electronic network – a “Sentinel Network”. The Netowrk would foster the seamless, timely electronic flow of medical product safety information from electronic databases and surveillance reporting systems through risk identification analysis processes, to health care practitioners and patients at the point-of-care while protecting patient privacy. The Network would use national and international standards adopted by the Department of Health and Human Services, but would not involve health information technology standards development. The Network would include three principal types of activities: (1) Data collection (2) risk identification and analysis, and (3) risk communication. Objectives: Evaluate current needs in postmarket medical product adverse event data collection and risk identification and analysis; Identify the obstacles to facilitators, and incentives for developing the data collection and risk identification and analysis components of the Sentinel Network; and Identify opportunities for public-private collaborations for building the data collection and risk identification and analysis components of the Network. FDA would like to discuss the following questions: 1. What are the obstacles to facilitators, and incentives for developing the Sentinel Network? 2. How can postmarket medical product safety data collection be integrated into the workflow of clinical practice at the point-of-care while avoiding the imposition of undue burdens on health care practitioners, patients and health care institutions? 3. How can electronic health records serve as an effective data collection tool for medical product safety data without imposing undue burden on health care practitioners and patients at the point-of-care? What would be needed to facilitate this effort? 4. What steps should be taken to ensure the privacy of patient information used by the Network? Current Needs 5. What are the current gaps in postmarket medical product safety data collection and risk identification an analysis? 6. What are the existing data collection systems and methodologies that could be used to fill these gaps in postmarket medical product safety data collection and risk identification and analysis? Please present a comprehensive description of the systems, including the types of questions that they have and have not been able to address and that they have the potential to address. 7. How readily can existing systems be used or be modified to serve as dynamic surveillance loops (e.g. constant integration of data collection from, analysis, and feedback of information to health care practitioners and patients at the point-of-care)? Future Opportunities 8. What are the opportunities for public-private collaborations for building the data collection and risk identification and analysis components of the Sentinel Network? 9. Given that building the Network will be a complex undertaking, are there worthwhile small-scale projects that could be readily achievable? If appropriate, please address what your organization can contribute to these programs. 10. What types of opportunities are there for conducting prospective testing of existing systems (e.g. in real time) to determine their validity for medical product safety risk identification? What benchmarks both inside and outside the health care environment, are optimal for comparison? Ann Fonfa's comments on Sentinel Network Submitted via email, February 8, 2007 Maryann Napoli's comments on FDA Issues Posted from an email, February 8, 2007 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.