Data processing: database and file management or data structures – Database design – Data structure types
Reexamination Certificate
2001-03-12
2003-06-24
Mizrahi, Diane D. (Department: 2175)
Data processing: database and file management or data structures
Database design
Data structure types
C705S003000, C600S300000
Reexamination Certificate
active
06584472
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 new adverse event data associated with medical and non-medical products, including drugs, medicaments, biologicals, food additives, chemicals and the like, or devices, as well as computer databases for generating, storing, analyzing and processing information related thereto.
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, safety information relating to the drug has already been generated and shared. Thus, a manufacturer of a generic drug enjoys the benefits of the information without incurring the cost of the original safety studies, and there is no legal or economic motivation to conduct additional studies after a drug goes off patent.
Manufacturers also have little incentive to identify adverse events related to their products. As the number and/or types of identified adverse event 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.
The safety studies necessary for medical and/or related products, such as drugs, biologicals, medical devices and cosmetics, to receive marketing approval generally involve relatively small populations of individuals (typically a few hundred to a few thousand, or less), who are observed for relatively short periods of time in prospective randomized studies. The studies generally involve strict inclusion criteria, thus persons in the study often differ in many respects from those individuals who actually use the drug post-marketing. The differences between the safety studies participants and the 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 that may occur in populations of general and specific post-marketing consumers.
Post-marketing safety studies normally involve the voluntary reporting of potential adverse events. However, there is often no way to be certain that all occurrences are reported or, in fact, whether each reported event was 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. Thus, it is difficult for a clinician to link an adverse event to a medical product if the event occurs months or years after it was first prescribed, or even after use of the product was discontinued.
Additionally, when a potential adverse event is something that also frequently occurs in people who have not used the medical product, it is difficult to determine if the medical product may have increased 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. Thus, under normal safety testing conditions, 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. Consequently, since the rate or intensity of an adverse event associated with the use of a product cannot be accurately determined, a reliable assessment cannot be made of whether the risk of using a product exceeds its benefit.
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 of the studies are performed by contract research organizations, funded by pharmaceutical companies as part of the FDA-required evaluation. A few government-funded studies may also be performed. However, in general, neither of these sorts of studies detect the frequency of adverse events in specific subgroups, such as those defined by typical demographic factors, e.g., age, race, sex, etc.
Moreover, the data from each manufacturer's study into the potential adverse events resulting from the use of a product is made free to the public, including to competing product manufacturers, and to the FDA. However, because the data is limited, it has in some instances been misused, and sectors of the pharmaceutical industry remain underdeveloped. In other words, some products continue to be prescribed, when they should not be, while other products are not prescribed, when they should be. The result in either case, may be the occurrence of unnecessary adverse events and patient suffering. Accordingly, consumer costs for improperly prescribed medical products is needlessly high, since a manufacturer's cost to produce a medical product, which is passed on to the consumer, includes not only actual manufacturing costs, but also any costs arising from the occurrence of adverse events. For example, some vaccine manufacturers are responsible for compensating individuals who develop unforeseen adverse responses to the vaccine.
Most manufacturers or distributors of products or devices are required by law to warn consumers about potential adverse events, even though this information is generally inadequate as described above. With prescription pharmaceuticals, this information is called “labeling,” and is generally included in a “package insert.” With industrial chemicals, there is often a “material safety data sheet,” also called a “product safety data sheet.” Consumer products including foods with chemical additives, over the counter medicines, electronic instruments, machinery or chemicals the information may be inserted in a piece of paper or written on a outer container, such as a cardboard box, or on an inner container, such as a plastic, paper or foil container which holds the drug or medicament. However, the location of the safety information may vary with the product and or industry.
One skilled in the art will know where and how the safety information, is or can be provided by the company manufacturing or selling the product or device. This information can also be termed a “safety data sheet,” as a generic term describing safety information included with any type of product or device.
By comparison, proper product labeling discourages those at high risk for an adverse response 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 adverse drug combinations. If consumers are placed on notice through proper labeling, which describes the potential for the occurrence of an adverse event associated with dosage, drug interactions, preexisting conditions and other high risk factors, the number of adverse events is significantly reduced. This decreases the manufacturer's product liability exposure, which ultimately reduces product cost to the consumer. To date, however, there has been no realization of the potential for comprehensive, subscriber-accessible proprietary product safety information, such as a database, 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 acc
Classen Immunotherapies, Inc.
Dilworth Paxson LLP
McConathy Evelyn H.
Mizrahi Diane D.
Spiegel Michael
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