SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD

• US 20140207481A1
• Filed: 03/19/2014
• Published: 07/24/2014
• Est. Priority Date: 12/17/2002
• Status: Abandoned Application

• Current Assignee: JPI Commercial LLC (Jazz Pharmaceuticals Plc)
• Original Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
• Inventors: Reardan, Dayton T., Engel, Patti A., Gagne, Bob
• Application Number:
  US14/219,941
• Publication Number:
  US 20140207481A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

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.

Claims

1. (canceled)

29. The computer-implemented system of claim 1, wherein current inventory is cycle counted and reconciled with database quantities before shipments for a day or other time period are sent.

2. A computer-implemented system for treatment of a patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising:

one or more computer memories for storing a computer database of a company that obtained approval to distribute the prescription drug that has a potential for misuse, abuse or diversion, the computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields relating to the company'"'"'s prescription drug;

said prescription fields, contained within the database schema, storing prescriptions for the company'"'"'s prescription drug that has a potential for abuse, misuse or diversion, wherein all prescriptions for the company'"'"'s prescription drug are stored only in the computer database of the company that obtained approval to distribute the prescription drug, and wherein the company'"'"'s prescription drug is sold or distributed by the company using only the computer database;

said patient fields, contained within the database schema, storing information sufficient to identify the patient for whom the company'"'"'s prescription drug that has a potential for misuse, abuse or diversion is prescribed, wherein the patient fields comprise all patients being prescribed the company'"'"'s prescription drug;

said prescriber fields, contained within the database schema, storing information sufficient to identify a physician or other prescriber of the company'"'"'s prescription drug that has a potential for misuse, abuse or diversion, and said prescriber fields storing information to show that the physician or other prescriber is authorized to prescribe the company'"'"'s prescription drug, wherein the prescriber fields include all physicians or other prescribers allowed to prescribe the company'"'"'s prescription drug; and

a data processor for processing a database query to identify information in said prescription fields, said patient fields, and said prescriber fields for reconciling inventory of the prescription drug that has a potential for misuse, abuse or diversion before shipments of the prescription drug for a time period are sent.

3. The computer-implemented system of claim 2, wherein the database query operates over all the data related to said prescription fields, said prescriber fields, and said patient fields for the prescription drug that has a potential for misuse, abuse or diversion.

4. The computer-implemented system of claim 2, wherein the data processor facilitates delivering the prescription drug to the patient in order to treat the patient with the prescription drug.

5. The computer-implemented system of claim 2, wherein a pharmacy enters data into the computer database.

6. The computer-implemented system of claim 2, wherein the data processor selectively blocks shipment of the prescription drug to the patient.

7. The computer-implemented system of claim 2, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association.

8. The computer-implemented system of claim 2, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

9. The computer-implemented system of claim 7, wherein said GHB drug product treats cataplexy in the patient.

10. A computer-implemented method for treatment of a patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising:

storing, in one or more computer memories, a computer database of a company that obtained approval to distribute the prescription drug that has a potential for misuse, abuse or diversion, the computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields relating to the company'"'"'s prescription drug;

said prescription fields, contained within the database schema, storing prescriptions for the company'"'"'s prescription drug that has a potential for abuse, misuse or diversion, wherein all prescriptions for the company'"'"'s prescription drug are stored only in the computer database of the company that obtained approval to distribute the prescription drug, and wherein the company'"'"'s prescription drug is sold or distributed by the company using only the computer database;

said patient fields, contained within the database schema, storing information sufficient to identify the patient for whom the company'"'"'s prescription drug that has a potential for misuse, abuse or diversion is prescribed, wherein the patient fields comprise all patients being prescribed the company'"'"'s prescription drug;

said prescriber fields, contained within the database schema, storing information sufficient to identify a physician or other prescriber of the company'"'"'s prescription drug that has a potential for misuse, abuse or diversion, and said prescriber fields storing information to show that the physician or other prescriber is authorized to prescribe the company'"'"'s prescription drug, wherein the prescriber fields include all physicians or other prescribers allowed to prescribe the company'"'"'s prescription drug; and

processing a database query to identify information in said prescription fields, said patient fields, and said prescriber fields for reconciling inventory of the prescription drug that has a potential for misuse, abuse or diversion before shipments of the prescription drug for a time period are sent.

11. The computer-implemented method of claim 10, comprising delivering the prescription drug to the patient in order to treat the patient with the prescription drug.

12. The computer-implemented method of claim 10, wherein a pharmacy enters data into the computer database.

13. The computer-implemented method of claim 10, comprising selectively blocking shipment of the prescription drug to the patient.

14. The computer-implemented method of claim 10, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association.

15. The computer-implemented method of claim 10, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

16. The computer-implemented method of claim 15, wherein said GHB drug product treats cataplexy in said patient.

17. A computer-implemented system for treatment of a patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising:

one or more computer memories for storing a computer database of a company that obtained approval to distribute the prescription drug that has a potential for misuse, abuse or diversion, the computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields;

said prescription fields, contained within the database schema, storing prescriptions for the company'"'"'s prescription drug that has a potential for abuse, misuse or diversion, wherein the prescription drug is sold or distributed by the company that obtained approval for distribution of the prescription drug, wherein the prescription fields store all prescription requests, for all patients being prescribed the company'"'"'s prescription drug, only in the computer database of the company, from all physicians or other prescribers allowed to prescribe the company'"'"'s prescription drug, such that all prescriptions for the company'"'"'s prescription drug are processed using only the company'"'"'s computer database;

said patient fields, contained within the database schema, storing information sufficient to identify the patient for whom the company'"'"'s prescription drug is prescribed and which has a potential for abuse, misuse or diversion;

said prescriber fields, contained within the database schema, storing information sufficient to identify a physician or other prescriber of the company'"'"'s prescription drug that has a potential for abuse, misuse or diversion, and said prescriber fields storing information to show that the physician or other prescriber is authorized to prescribe the company'"'"'s prescription drug;

a data processor for processing a database query to identify information in said prescription fields, said patient fields, and said prescriber fields for reconciling inventory of the prescription drug that has a potential for abuse, misuse or diversion before shipments of the company'"'"'s prescription drug for a time period are sent.

18. The computer-implemented system of claim 17, wherein the database query operates over all data related to said prescription fields, said prescriber fields, and said patient fields for the prescription drug that has a potential for misuse, abuse or diversion.

19. The computer-implemented system of claim 17, wherein a pharmacy enters data into the computer database.

20. The computer-implemented system of claim 17, wherein the data processor selectively blocks shipment of the prescription drug to the patient.

21. The computer-implemented system of claim 17, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association.

22. A computer-implemented method for treatment of a patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising:

storing, in one or more computer memories, a computer database of a company that obtained approval to distribute the prescription drug that has a potential for misuse, abuse or diversion, the computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields;

said prescription fields, contained within the database schema, storing prescriptions for the company'"'"'s prescription drug that has a potential for abuse, misuse or diversion, wherein the prescription drug is sold or distributed by the company that obtained approval for distribution of the prescription drug, wherein the prescription fields store all prescription requests, for all patients being prescribed the company'"'"'s prescription drug, only in the computer database of the company, from all physicians or other prescribers allowed to prescribe the company'"'"'s prescription drug, such that all prescriptions for the company'"'"'s prescription drug are processed using only the company'"'"'s computer database;

said patient fields, contained within the database schema, storing information sufficient to identify the patient for whom the company'"'"'s prescription drug is prescribed and which has a potential for abuse, misuse or diversion;

said prescriber fields, contained within the database schema, storing information sufficient to identify a physician or other prescriber of the company'"'"'s prescription drug that has a potential for abuse, misuse or diversion, and said prescriber fields storing information to show that the physician or other prescriber is authorized to prescribe the company'"'"'s prescription drug;

a data processor for processing a database query to identify information in said prescription fields, said patient fields, and said prescriber fields for reconciling inventory of the prescription drug that has a potential for abuse, misuse or diversion before shipments of the company'"'"'s prescription drug for a time period are sent.

23. The computer-implemented method of claim 22, comprising delivering the prescription drug to the patient in order to treat the patient with the prescription drug.

24. The computer-implemented method of claim 22, wherein a pharmacy enters data into the one or more computer memories.

25. The computer-implemented method of claim 22, comprising selectively blocking shipment of the prescription drug to the patient.

26. The computer-implemented method of claim 22, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association.

27. The computer-implemented method of claim 22, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

28. The computer-implemented method of claim 27, wherein said GHB drug product treats cataplexy in said patient.