Sensitive drug distribution system and method
First Claim
1. A method of distributing a sensitive drug, the method comprising:
- receiving prescription requests from a medical doctor containing information identifying the patient, the sensitive drug, and various credentials of the doctor;
entering the information into a central database for analysis of potential abuse situations;
checking the credentials of the doctor;
confirming with the patient that educational material has been read prior to shipping the sensitive drug;
confirming receipt of the sensitive drug; and
generating periodic reports via the central database to evaluate potential abuse patterns.
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Accused Products
Abstract
A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database, and optionally whether any actions are taken against the physician. Multiple controls beyond those for normal drugs are imposed on the distribution depending on the sensitivity of the drug.
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Citations
25 Claims
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1. A method of distributing a sensitive drug, the method comprising:
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receiving prescription requests from a medical doctor containing information identifying the patient, the sensitive drug, and various credentials of the doctor;
entering the information into a central database for analysis of potential abuse situations;
checking the credentials of the doctor;
confirming with the patient that educational material has been read prior to shipping the sensitive drug;
confirming receipt of the sensitive drug; and
generating periodic reports via the central database to evaluate potential abuse patterns. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of monitoring potential abuse of a sensitive drug by use of an exclusive central database, the method comprising:
generating queries of prescription information from a database containing selected information for all prescriptions of the sensitive drug, wherein the queries comprise prescriptions by physician specialty, prescriptions by patient name, prescriptions by frequency and prescriptions by dose. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18)
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19. A method of obtaining FDA (Food and Drug Administration) approval for a sensitive drug, the method comprising:
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determining current and anticipated patterns of potential abuse of the sensitive drug;
selecting multiple controls for distribution by an exclusive central pharmacy maintaining a central database, the controls selected from the group consisting of communicating prescriptions from a physician to the central pharmacy, identifying the physicians name, license and DEA (Drug Enforcement Agency) registration information, verifying the prescription;
obtaining patient information, verifying the physician is eligible to prescribe the sensitive drug by consulting the National Technical Information Services to determine whether the physician has an active DEA number and check on whether any actions are pending against the physician, provide comprehensive printed materials to the physician, contacting the patient'"'"'s insurance company if any, verifying patient registry information, providing comprehensive education information to the patient, verifying the patient has reviewed the educational materials, verifying the home address of the patient, shipping via US postal service or similar shipping service, receiving the name of an at least 18 year old designee to receive the drug, confirming receipt of an initial shipment of the drug to the patient, returning the drug to the pharmacy after two attempts to deliver, launching an investigation when a shipment is lost, shipping to another pharmacy for delivery, requiring manufacture at a single location, releasing inventory in a controlled manner to the central pharmacy, questioning early refills, flagging repeat instances of lost, stolen, destroyed or spilled prescriptions, limiting the prescription to a one month supply, requiring rewriting of the prescription periodically, making the database available to the DEA for checking for abuse patterns in the data, cash payments, inappropriate questions; and
negotiating with the FDA by adding further controls from the group until approval is obtained. - View Dependent Claims (20, 21)
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22. A method of distributing a sensitive drug, the method comprising:
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determining current and anticipated patterns of potential abuse of the sensitive drug;
selecting multiple controls for distribution of the sensitive drug; and
adding additional controls to provide sufficient reassurance to a governmental regulatory body that the sensitive drug distribution can be adequately controlled in order to obtain marketing approval by the governmental regulatory body. - View Dependent Claims (23, 24, 25)
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Specification