METHOD OF MANAGING AND REDUCING SIDE EFFECTS ASSOCIATED WITH EXPOSURE TO A DRUG
First Claim
1. A method for restricted distribution of a drug to a patient while minimizing the occurrence of adverse side effects, by preventing access to the drug to certain patients for whom the drug may be contraindicated, said method comprising:
- providing a database;
registering at least one prescriber in the database;
registering at least one pharmacy in the database;
registering the patient in the database;
creating a patient profile in the database, and associating the patient profile with the patient, the at least one registered prescriber, and the at least one registered pharmacy;
creating a prescription request, initiated by the prescriber, wherein the prescription request is an order for the drug to be dispensed to the patient, wherein the prescription request is associated with the patient profile in the database;
enabling the at least one registered prescriber to access the patient profile in the database;
defining a set of health-related information, wherein said set of health-related information is probative of the risk that an adverse side effect is likely to occur if a patient is exposed to the drug;
defining a set of screening criteria for the health-related information, wherein when the health-related information does not satisfy the screening criteria, the risk that an adverse side effect is likely to occur is unacceptable;
obtaining a baseline set of patient-specific health-related information from the patient, and associating the baseline set of patient-specific health-related information with the patient profile;
based at least in part on the baseline set of patient-specific health-related information in the patient profile and the pre-defined screening criteria, determining whether the risk is unacceptable that the patient will experience an adverse side effect upon exposure to the drug;
upon a determination that the risk is not unacceptable, permitting the at least one registered pharmacy to dispense the drug to the patient as ordered by the prescription request;
upon a determination that the risk is unacceptable, prohibiting the at least one registered pharmacy from dispensing the drug to the patient as ordered by the prescription request.
1 Assignment
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Accused Products
Abstract
A method for restricted distribution of a drug to a patient while minimizing the occurrence of adverse side effects. The method restricts access to the drug by preventing distribution to certain patients for whom the drug may be contraindicated. The method permits a prescription to be filled by a pharmacy only after the pharmacy has received an approval for release of the prescription. Generation of the prescription approval depends on registration of a prescriber, pharmacy and patient in a central database, and the determination that the risk is acceptable that the patient will experience an adverse side effect. The database contains a patient profile that may include additional patient-specific health-related information that is probative of the risk that an adverse side effect is likely to occur if the patient is exposed to the drug. Based in part on the information in the patient profile, the registered prescriber makes a determination as to the patient'"'"'s risk of adverse side effects. If the registered prescriber determines that the risk is acceptable, a prescription request is generated. At the time that the prescription is to be dispensed to the patient, the pharmacy also makes a determination as to the patient'"'"'s risk of adverse side effects. If the pharmacy determines that the risk is acceptable, the drug is dispensed to the patient. Additional steps may be taken to ensure compliance with the drug delivery method, such as education, oversight by a drug safety analyst, and/or regular contact with a representative.
34 Citations
28 Claims
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1. A method for restricted distribution of a drug to a patient while minimizing the occurrence of adverse side effects, by preventing access to the drug to certain patients for whom the drug may be contraindicated, said method comprising:
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providing a database;
registering at least one prescriber in the database;
registering at least one pharmacy in the database;
registering the patient in the database;
creating a patient profile in the database, and associating the patient profile with the patient, the at least one registered prescriber, and the at least one registered pharmacy;
creating a prescription request, initiated by the prescriber, wherein the prescription request is an order for the drug to be dispensed to the patient, wherein the prescription request is associated with the patient profile in the database;
enabling the at least one registered prescriber to access the patient profile in the database;
defining a set of health-related information, wherein said set of health-related information is probative of the risk that an adverse side effect is likely to occur if a patient is exposed to the drug;
defining a set of screening criteria for the health-related information, wherein when the health-related information does not satisfy the screening criteria, the risk that an adverse side effect is likely to occur is unacceptable;
obtaining a baseline set of patient-specific health-related information from the patient, and associating the baseline set of patient-specific health-related information with the patient profile;
based at least in part on the baseline set of patient-specific health-related information in the patient profile and the pre-defined screening criteria, determining whether the risk is unacceptable that the patient will experience an adverse side effect upon exposure to the drug;
upon a determination that the risk is not unacceptable, permitting the at least one registered pharmacy to dispense the drug to the patient as ordered by the prescription request;
upon a determination that the risk is unacceptable, prohibiting the at least one registered pharmacy from dispensing the drug to the patient as ordered by the prescription request. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method for restricted distribution of a drug to a patient while minimizing the occurrence of adverse side effects, by preventing access to the drug to certain patients for whom the drug may be contraindicated, said method comprising:
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providing a database;
registering one or more patients in the database;
associating each of the one or more registered patients with respective patient profiles in the database;
defining a baseline set of health-related information to be obtained from each of the one or more patients before the patient receives the drug, wherein said set of health-related information is probative of the risk that an adverse side effect is likely to occur if the patient is exposed to the drug;
obtaining a baseline set of patient-specific health-related information from each of the one or more patients, and associating each of the baseline sets of patient-specific health-related information with the respective patient profiles;
after obtaining baseline sets of patient-specific health-related information from each of the one or more patients, dispensing the drug to each of the one or more patients;
defining a second set of health-related information to be obtained from each of the one or more patients after the drug has been dispensed to the patient, wherein said second set of health-related information is probative of the risk that an adverse side effect is likely to occur if the patient continues to be exposed to the drug;
obtaining at least one second set of patient-specific health-related information from each of the one or more patients at a predetermined interval after the drug has been dispensed to the one or more patients, and associating each of the second sets of patient-specific health-related information with the respective patient profiles; and
evaluating the baseline and second sets of patient-specific health-related information in the collective patient profiles to determine the overall risk of side effects of the drug.
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Specification