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Claims for Patent: 8,589,182

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Claims for Patent: 8,589,182

Title:Sensitive drug distribution system and method
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.
Inventor(s): Reardan; Dayton T. (Shorewood, MN), Engel; Patti A. (Eagan, MN), Gagne; Bob (St. Paul, MN)
Assignee: Jazz Pharmaceuticals, Inc. (Palo Alto, CA)
Application Number:13/595,676
Patent Claims: 1. A method of treatment of a narcoleptic patient with a prescription drug that has a potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising: receiving, using a computer processor, into a single computer database of the company that obtained approval for distribution of the prescription drug, from any and all patients being prescribed the company's prescription drug, all prescriptions for the company's prescription drug with the potential for abuse, misuse or diversion; entering, using the computer processor, into the single computer database information sufficient to identify the narcoleptic patient for whom the company's prescription drug is prescribed; entering, using the computer processor, into the single computer database information sufficient to identify any and all physicians or other prescribers of the company's prescription drug and information to show that the physicians or other prescribers are authorized to prescribe the company's prescription drug; entering and maintaining, using the computer processor, in the single computer database information that indicates that the narcoleptic patient or prescriber has abused, misused, or diverted the company's prescription drug; and checking for abuse, using the computer processor and the single computer database, and authorizing filling of the prescriptions for the company's prescription drug only if there is no record of incidents that indicate abuse, misuse, or diversion by the narcoleptic patient and prescriber, and if there is a record of such incidents, the single computer database indicates that such incidents have been investigated, and the single computer database indicates that such incidents do not involve abuse, misuse or diversion.

2. The method of claim 1, comprising delivering the prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug.

3. The method of claim 1, wherein a pharmacy enters data into the single computer database.

4. The method of claim 1, comprising selectively blocking shipment of the prescription drug to the narcoleptic patient.

5. The method of claim 1, wherein an abuse pattern is associated with the narcoleptic patient, and shipment of the prescription drug is blocked based upon such association.

6. The method of claim 1, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

7. The method of claim 6, wherein said GHB drug product treats cataplexy in said narcoleptic patient.

8. A method of treatment of a narcoleptic patient with a prescription drug that has the potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising: receiving, using a computer processor, into a single computer database of the company that obtained approval for distribution of the prescription drug, from any and all patients being prescribed the company's prescription drug, all prescriptions for a prescription drug with the potential for abuse, misuse or diversion sold or distributed under a single trademark; entering, using the computer processor, into the single computer database information sufficient to identify the narcoleptic patient for whom said prescription drug was prescribed; entering, using the computer processor, into the single computer database information sufficient to identify any and all physicians or other prescribers of said prescription drug and information to show that the any and all physicians or other prescribers were authorized to prescribe said prescription drug; entering and maintaining, using the computer processor, in the single database information which may suggest that the narcoleptic patient or prescriber has abused, misused, or diverted said prescription drug; checking for abuse, using the computer processor and the single computer database, and authorizing filling of the prescriptions for said prescription drug only if there is no record of incidents that may suggest abuse, misuse, or diversion by the narcoleptic patient and prescriber, and if there is a record of such incidents, the single computer database indicates that such incidents have been investigated, and the single computer database indicates that such incidents do not involve abuse, misuse or diversion.

9. The method of claim 8, comprising delivering the prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug.

10. The method of claim 8, wherein a pharmacy enters data into the single computer database.

11. The method of claim 8, comprising selectively blocking shipment of the prescription drug to the narcoleptic patient.

12. The method of claim 8, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association.

13. The method of claim 8, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

14. The method of claim 13, wherein said GHB drug product treats cataplexy in said narcoleptic patient.

15. A method of treatment of a narcoleptic patient with a prescription drug that has the potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising: receiving, using a computer processor, into a single computer database of the company that obtained approval for distribution of the prescription drug, all prescriptions for the prescription drug from any and all patients being prescribed the company's prescription drug, wherein the company's prescription drug has been manufactured at a single manufacturing site, and wherein the company's prescription drug has the potential for abuse, misuse or diversion; entering, using the computer processor, into the single database information sufficient to identify the narcoleptic patient for whom the company's prescription drug was prescribed, entering, using the computer processor, into the single database information sufficient to identify the physician or other prescriber of the company's prescription drug and information to show that the physician or other prescriber was authorized to prescribe the company's prescription drug; entering and maintaining, using the computer processor, in the single database information which may suggest that the narcoleptic patient or prescriber has abused, misused, or diverted the company's prescription drug; checking for abuse, using the computer processor and the single computer database, and authorizing filling of the prescription for the company's prescription drug only if there is no record of incidents that may suggest abuse, misuse, or diversion by the narcoleptic patient and prescriber and if there is a record of such incidents, the single computer database indicates that any such incidents have been investigated and found not to involve abuse, misuse or diversion; and providing the company's prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the company's prescription drug; wherein the company's prescription drug that has the potential for misuse, abuse or diversion is a gamma hydroxybutyrate (GHB) drug product; and wherein said GHB drug product treats cataplexy in said narcoleptic patient.

16. The method of claim 15, wherein a pharmacy enters data into the single computer database.

17. The method of claim 15, comprising selectively blocking shipment of the prescription drug to the narcoleptic patient.

18. The method of claim 15, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association.

19. A method of treatment of a narcoleptic patient with a single prescription drug that has a potential for misuse, abuse or diversion, comprising: receiving, using a computer processor, into a single computer database and storing in a computer memory all prescriptions for the single prescription drug received at a pharmacy and sold or distributed by a company that obtained approval for distribution of the prescription drug, the single prescription drug having the potential for abuse, misuse or diversion, wherein the pharmacy is permitted to distribute the single prescription drug based on two or more of the following: processing of a prescription enrollment form for the single prescription drug; agreeing to document adverse events relating to the single prescription drug; providing educational materials relating to the single prescription drug; and verifying that the single prescription drug is medically necessary; entering, using the computer processor, into the single computer database information sufficient to identify the narcoleptic patient for whom the company's prescription drug is prescribed; entering, using the computer processor, into the single computer database information sufficient to identify a physician or other prescriber of the company's prescription drug and information to show that the physician or other prescriber is authorized to prescribe the company's prescription drug, including verifying that the prescriber's drug enforcement agency (DEA) number and state license are current and that there are no pending disciplinary actions against the prescriber; verifying two or more of the following using the computer processor prior to providing the single prescription drug to the narcoleptic patient: patient name; patient address; that the patient has received educational material regarding the single prescription drug; a quantity of the single prescription drug; and dosing directions for the single prescription drug; entering and maintaining, using the computer processor, in the single computer database information that indicates that the narcoleptic patient or prescriber has abused, misused, or diverted the company's single prescription drug; and checking for abuse, using the computer processor and the single computer database, and authorizing filling of the prescriptions for the company's single prescription drug only if there is no record of incidents that indicate abuse, misuse, or diversion by the narcoleptic patient and prescriber, and if there is a record of such incidents, the single computer database indicates that such incidents have been investigated, and the single computer database indicates that such incidents do not involve abuse, misuse or diversion.

20. The method of claim 19, comprising delivering the prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug.

21. The method of claim 19, wherein a pharmacy enters data into the single computer database.

22. The method of claim 19, comprising selectively blocking shipment of the prescription drug to the narcoleptic patient.

23. The method of claim 19, wherein an abuse pattern is associated with the narcoleptic patient, and shipment of the single prescription drug is blocked based upon such association.

24. The method of claim 19, wherein the single prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

25. The method of claim 19, wherein said GHB drug product treats cataplexy in said narcoleptic patient.

26. The method of claim 1, comprising identifying, using the computer processor, information relating to the prescriptions and the information relating to the narcoleptic patient, and using the information for reconciling inventory for the company's prescription drug before shipments for a day or other time period are sent.
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