Data processing: database and file management or data structures – Database design – Data structure types
Reexamination Certificate
1999-11-24
2001-04-17
Amsbury, Wayne (Department: 2171)
Data processing: database and file management or data structures
Database design
Data structure types
C707S793000, C705S002000, C705S003000, C600S300000
Reexamination Certificate
active
06219674
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates in general to computer systems and databases for managing product data. More particularly, the invention employs computer systems and proprietary databases for gathering, storing, processing and distributing adverse events data associated with medical and non-medical products.
BACKGROUND OF THE INVENTION
For several reasons, adverse events associated with medical and non-medical products are greatly understated. As a matter of cost, thorough safety studies are typically very expensive to conduct. In the field of generic pharmaceuticals, for example, the cost of doing safety testing is prohibitive because a manufacturer's survival in the business is based on being a low cost producer. By the time a product becomes generic, its safety information has already been generated and shared. Thus, manufacturers that did not fund the original safety studies enjoy the benefits of the information without incurring the costs thereof and have no economic motivation to conduct additional studies.
Manufacturers also have little incentive to identify adverse events related to their products. As the number and/or type of identified adverse events increases with respect to a particular product, the product becomes less attractive to consumers and the manufacturer's exposure to potential product liability litigation increases.
Safety studies to receive marketing approval for medical and related products such as drugs, biologicals, medical devices and cosmetics generally involve relatively small populations of individuals (typically a few thousand or less) observed for short periods of time in prospective randomized studies. The studies generally involve strict inclusion criteria and persons in the study often differ in many respects from persons taking the drug post-marketing. The differences between the safety studies participants and post-marketing consumers may include age, sex, race, preexisting medical conditions, and use of other drugs or devices. Pre-marketing safety studies are therefore a less than desirable means of identifying the full array of potentially adverse product events in the general and specific post-marketing consumers populations.
Post-marketing safety studies normally involve voluntary reporting of potential adverse events. However, there is often no way to be certain that these occurrences are caused by the medical product or not. For instance, adverse events generally are reported if they occur within a short time of initiating treatment with a product. It is difficult for a clinician to link an adverse event to a medical product if it occurs months after starting or even discontinuing use of the product.
Additionally, when a potential adverse event is something that frequently occurs in people who do not use the medical product it is difficult to determine if the medical product increases the frequency and/or magnitude of the event. This scenario is problematic because the incidence of such events in a matched control population is often not known. Under these circumstances, it cannot be readily discerned whether the incidence of adverse events is greater in the group using the medical product versus a corresponding control population. Therefore, since the rate or intensity of adverse events associated with use of a product cannot be accurately determined, a reliable assessment of whether the risk of using a product exceeds the product's benefit cannot be made.
Pre-marketing and post-marketing of medical products is regulated by the Food and Drug Administration (FDA) and manufacturers are required to disclose all adverse events caused by their products. Nevertheless, in the pharmaceutical industry very few truly comprehensive and detailed studies on adverse events are conducted. Most studies are performed by contract research organizations funded by pharmaceutical companies as part of required FDA safety studies. A few government funded studies are also performed. Both of these sorts of studies generally do not detect frequency of adverse events in specific subgroups as defined by typical demographic factors like age, sex, etc. The adverse events data from these studies is made free to the public, including competing product manufacturers, and the FDA. Such limited data has resulted in misused and underdeveloped sectors of the pharmaceutical industry. That is, some products continue to be prescribed when they should not be while other products are not prescribed when they should be. In either case, unnecessary adverse events and patient suffering may occur. Accordingly, the consumer cost of improperly prescribed medical products is needlessly high since a manufacturer's cost to produce a medical product includes manufacturing costs and costs arising from adverse events. For example, some vaccine manufacturers are responsible for compensating individuals who develop unforeseen vaccine adverse events.
Proper product labeling discourages those at high risk from utilizing the product thus decreasing adverse events and, ultimately, the consumer cost of the product. Some factors affecting high risk use include drug dosing and drug combinations. Proper labeling of adverse events associated with these and other high risk factors reduces the number of adverse events, thereby decreasing a manufacturer's product liability exposure and consumer product cost. To date, however, there has been no realization of the potential for comprehensive, subscriber-accessible proprietary product safety information to enhance the quality and reliability of adverse event reporting and product labeling.
U.S. Pat. Nos. 5,737,539, 5,833,599 5,845,255 and 5,908,383 disclose computerized systems for providing patient-specific medical treatment information. The systems enable health care providers such as medical doctors to access databases containing pharmacological or other medical information via a computer and match a patient's medical symptoms and/or prescription history with known data to produce an appropriate prescription or treatment for the patient. These systems do not analyze raw adverse event data or create proprietary adverse event information based on such data that may be used to identify new uses or restrictions for medical products or to develop improved packaging information that can accompany medical products.
As described by Robert T. Chen, M.D., et al. in “Vaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United States” published in Pediatrics, Vol.99, No. 6, June 1997, computers have also been used to verify previously reported adverse events related to vaccines. The so-called VSD project discussed therein promotes utilizing its research in the development and use of safer vaccines. However, it does not disclose the notion of identifying new and proprietary uses for existing vaccines based on the discovery of new adverse events associated with the vaccines. Moreover, the VSD project cannot discern new adverse events from previously reported adverse events.
An advantage exists, therefore, for a system for analyzing adverse event data associated with medical and non-medical products and for creating useful proprietary adverse event information based on the analyzed adverse event data. The adverse event information may be used, for example, to identify new uses or restrictions for medical or non-medical products or to develop improved packaging information that can accompany medical or non-medical products. Particular benefits arising from the use of such a system would be in connection with products already on the market because of the potentially extensive pre-existing data for the products that may be analyzed for adverse events.
SUMMARY OF THE INVENTION
The present invention utilizes a computerized system for gathering, storing and processing adverse event data associated with medical and non-medical products to create proprietary databases containing useful adverse event information. The adverse event information may be used, for example, to identify new
Amsbury Wayne
Classen Immunotherapies, Inc.
Dilworth Paxson LLP
McConathy Evelyn H.
Pardo Thuy
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