MODIFICATION
A -- REQUEST FOR INFORMATION on Active Surveillance Programs in the United States for the Identification of Clinically Serious Adverse Events Associated with Medical Products
- Notice Date
- 4/18/2005
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-RFIHHSF200601
- Response Due
- 6/10/2005
- Archive Date
- 6/25/2005
- Point of Contact
- Elizabeth Osinski, Contracting Officer , Phone 301-827-7043, Fax 301-827-7101, - Karen Gamble, Contract Specialist, Phone 301-827-3366, Fax 301-827-7101,
- E-Mail Address
-
elizabeth.osinski@fda.hhs.gov, karen.gamble@fda.hhs.gov
- Description
- Request for Information (RFI) Number HHSF200601 on Active Surveillance Programs in the United States for the Identification of Clinically Serious Adverse Events Associated with Medical Products The following questions were received on this RFI. They are reprinted below in this modification. The due date is also extended until 6/10/2005: Question #1: The RFI asks for "cost estimate" Is this a budget? Answer: FDA is requesting a price schedule for accessing and/or collaborating on the proposed an active surveillance system. Question #2: Are you looking for "a comprehensive review on surveillance systems"? Answer: No... only descriptions of specific systems. BACKGROUND A vital part of FDA and CDER?s mission is to protect the public health. The Office of Drug Safety (ODS) contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. In 1999, the Task Force on Risk Management?s ?Report to the FDA Commissioner? and the HHS Office of the Inspector General?s ?Report to the FDA Commissioner? both identified the need for greater post marketing pharmacovigilance for prescription drugs. In response to these reports, FDA devoted greater resources to the area of post marketing safety and has expanded the roles and responsibilities of ODS within CDER. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. FDA currently has several tools available to address post marketing safety issues. These tools include a passive surveillance system for adverse events related to drug therapy; several complementary drug utilization databases; and (historically) indirect access to US claims-based health encounter data for pharmacoepidemiology studies. Passive reporting systems provide limited information, though, suffering from underreporting, attribution problems, reporting biases, and a lack of denominator information. To strengthen and complement these resources, FDA seeks information related to ?active surveillance? activities in the US, either ongoing or proposed. DEFINITION OF ACTIVE SURVEILLANCE Active surveillance has been defined by some as regular periodic collection of case reports from health care providers or facilities; in contrast with passive surveillance which refers to case reports provided at the discretion of the health care provider . Due to the complexity of drug safety surveillance, FDA would like to broaden this concept to include data collected from other sources, in addition to traditional case reports used in other types of public health surveillance. Surveillance programs can focus on certain events (or outcomes) or on certain drugs of interest. There are at least three strategies that can be used for the active surveillance of drug-related adverse events. Drug-based surveillance systems look at large numbers of patients exposed to new molecular entities (NMEs) after their launch for all or specified adverse events. This type of system can also examine the utilization of drugs and modes of clinical practice. Setting-based surveillance systems are set up in hospitals or emergency rooms and capture all or specified adverse events that occur in relation to drug use and present for treatment at these facilities. Disease-based systems set up comprehensive disease-specific registries for selected drug-induced diseases. Each methodology is useful, so the ideal program could include more than one methodology. HISTORY OF ACTIVE SURVEILLANCE In the late 1960s, FDA initiated a jointly funded active surveillance program with NIH and a large health maintenance organization to develop a medical record linkage system. This system was the first attempt at linking scanned forms from doctor visits, laboratory test information, electronic pharmacy data, and hospitalization information. The effort failed because computer technology was still in its infancy and it was extremely labor intensive (and hence expensive) to enter the information. In the 1970s, several efforts were made to collect drug exposure information from patients hospitalized for a variety of conditions. Nurse abstractors reviewed charts at hospitals around the country to identify and interview selected patients about their prescription and nonprescription drug exposure history. The early programs did not meet the FDA?s needs for a number of reasons including; lack of funding, underdeveloped computer technology, and low yield of new information. More recently, other surveillance systems include the Drug Abuse Warning Network (DAWN) funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the National Electronic Injury Surveillance System (NEISS) jointly funded by the Consumer Product Safety Commission (CPSC), the Centers for Disease Control and Prevention (CDC) and the FDA. Both of these systems collect adverse drug event information from emergency departments in a representative sample of U.S. hospitals and can be used to make national estimates. DAWN and NEISS are examples of setting-based surveillance systems. In addition, FDA has co-sponsored pilot development of a drug-based surveillance system which explores the feasibility of using data mining techniques to identify safety signals in automated claims databases. FDA remains interested in learning about other systems of all three types that might complement these programs. DESCRIPTION This is a Request for Information (RFI) only. It is not a request for proposal/bid/quotation and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned. In general, FDA is interested in, 1) Systems that can provide any of the following information: a) Rapid identification of drug/adverse event associations; b) Systems to actively identify cases of selected adverse events of interest, possibly in relation to specific drugs of interest; these may or may not be automated. These systems would not necessarily require health care practitioners to make causal attribution of the event to a drug. Access to medical records by local system personnel (i.e., not FDA), while not mandatory, is highly desirable. c) Systems that are able to measure and/or estimate incidence rates based on signals of possible drug safety problems originating from adverse reaction reports received by FDA 2) Systems that are nationally representative; or at least include a multi center or multi state population or network. Specific systems might include, 1) A focus on the three strategies listed above, for example, a) Setting-based systems that would allow FDA to monitor selected health care settings such as acute care hospitals (or specific departments within a hospital, e.g., emergency departments, operating rooms, transplant centers, outpatient clinics, or dialysis services), long-term care facilities (e.g., nursing homes, psychiatric hospitals, or rehabilitation centers), urgent care centers, outpatient surgical centers, freestanding outpatient specialty clinics (e.g., those that treat HIV patients, family planning services), physicians? offices, etc., for the occurrence of adverse events of interest. b) Drug-based systems that would allow identification of all adverse events associated with selected prescription or nonprescription drugs. Information about patients prescribed these drugs would be used to identify signals of previously unknown adverse events. c) Outcome-based systems that would allow identification of specific acute outcomes for which drug therapy is frequently considered as a potential cause, e.g., acute liver failure, rhabdomyolysis, serious blood dyscrasias, serious skin reactions, anaphylaxis, QT prolongation, GI bleeding. Other outcomes of interest may be more difficult to ascertain because they occur a long time after the start of drug therapy and may make attribution more difficult. Examples of these outcomes include congenital anomalies and certain cancers. 2) A focus on particular safety areas that traditionally have been difficult to study, such as, a) Abuse or misuse of prescription drugs that have serious public health consequences b) Drug-related medication errors c) Drug-related death surveillance d) Pediatric and geriatric populations Interested organizations are invited to submit a description of their perspective on existing or potential active surveillance program components and information describing their ability to operationalize those components. In addition, these submissions should contain cost estimates for FDA to access or develop these systems for day to day use in drug safety surveillance. Submitted information could include a discussion addressing some or all of the following criteria, described in a comprehensive review on surveillance systems : Simplicity Flexibility Data Quality Acceptability Sensitivity Positive Predictive Value Representativeness Timeliness Stability Footnotes: i Lilienfeld DE, Stolley PD. Foundations of Epidemiology 3rd Edition. New York, 1994 Oxford University Press ii Beard K et al. Intensive Hospital-based Cohort Studies. In: Strom BL., ed., Pharmacoepidemiology, 3rd edn. Chichester: John Wiley & Sons, Ltd., 2000; 194- 207. iii Shapiro S. Case-Control Surveillance. In: Strom BL., ed., Pharmacoepidemiology, 3rd edn. Chichester: John Wiley & Sons, Ltd., 2000; 209-230. iv Centers for Disease Control and Prevention. Updated Guidelines for Evaluating Public Health Surveillance Systems: Recommendations from the Guidelines Working Group. Morbidity and Mortality Weekly Report 2001; 50:(No. RR-13). All information submitted to FDA will be kept confidential as allowed by relevant federal law. All information submitted will be reviewed; however, FDA will not acknowledge or respond to any submissions. Information should reference RFI No. HHSF200601 must be submitted by May 26, 2005. Responses are preferred in electronic format (Word or PDF) and can be e-mailed to the attention of the Contracting Officer listed below. Point of Contact: Elizabeth Osinski, Contracting Officer - Phone: 301-827-7043 and FAX: 301-827-7101; Email: Elizabeth.Osinski@fda.hhs.gov or Karen Gamble, Contracting Officer, 301-827-7162; FAX: 301-827-7101 Email: Karen.Gamble@fda.hhs.gov.
- Record
- SN00790119-W 20050420/050418211603 (fbodaily.com)
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