Sensitive drug distribution system and method

• US 8,457,988 B1
• Filed: 08/27/2012
• Issued: 06/04/2013
• Est. Priority Date: 12/17/2002
• Status: Expired due to Term

• Current Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
• Original Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
• Inventors: Reardan, Dayton T., Engel, Patti A., Gagne, Bob
• Primary Examiner(s): Najarian, Lena
• Application Number:
  US13/595,757
• Time in Patent Office: 281 Days
• Field of Search: 705/2, 705/3, 600/300
• 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. A method of treatment of a narcoleptic patient with a prescription drug while controlling potential misuse, abuse or diversion of said prescription drug, comprising:

receiving in a computer processor all prescription requests, for any and all narcoleptic patients being prescribed the prescription drug, wherein the prescription drug is distributed by a company that obtained approval for distribution of the prescription drug, only at an exclusive central pharmacy from any and all medical doctors allowed to prescribe the company'"'"'s prescription drug, the prescription requests containing information identifying narcoleptic patients, the prescription drug, and various credentials of the any and all medical doctors;

requiring entering of the information into an exclusive computer database associated with the exclusive central pharmacy for analysis of potential abuse situations, wherein the exclusive central pharmacy and the exclusive central database are the only pharmacy and database in existence for the company'"'"'s prescription drug, and such that all prescriptions for the company'"'"'s prescription drug are processed only by the exclusive central pharmacy using only the exclusive computer database;

checking with the computer processor the credentials of the any and all doctors to determine the eligibility of the doctors to prescribe the company'"'"'s prescription drug;

confirming with a narcoleptic patient that educational material has been read prior to shipping the company'"'"'s prescription drug;

checking the exclusive computer database for potential abuse of the company'"'"'s prescription drug, wherein the exclusive central pharmacy and the exclusive central database facilitate a determination of the potential abuse of the company'"'"'s prescription drug;

providing the company'"'"'s prescription drug to the narcoleptic patient only if no potential abuse is found by the narcoleptic patient to whom the company'"'"'s prescription drug is prescribed and the doctor prescribing the company'"'"'s prescription drug;

confirming receipt by the narcoleptic patient of the company'"'"'s prescription drug; and

generating with the computer processor periodic reports via the exclusive computer database to evaluate potential diversion patterns.

2. The method of claim 1, wherein one or more of the exclusive central pharmacy and the exclusive central database are distributed over multiple computers, and wherein a query operates over all data in all the distributed databases relating to the prescriptions, the doctors, and the narcoleptic patients.

3. The method of claim 1, wherein the providing the company'"'"'s prescription drug to the narcoleptic patient comprises the exclusive central pharmacy authorizing the company'"'"'s prescription drug to be dispensed to the narcoleptic patient by another pharmacy.

4. The method of claim 1, comprising delivering the company'"'"'s prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the company'"'"'s prescription drug.

5. The method of claim 1, wherein the exclusive central pharmacy enters data into the exclusive computer database.

6. The method of claim 1, comprising selectively blocking shipment of the company'"'"'s prescription drug to the narcoleptic patient.

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

8. The computerized method of claim 1, wherein the company'"'"'s prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

9. A method of treatment of a narcoleptic patient with a prescription drug while controlling potential misuse, abuse or diversion of said prescription drug, comprising:

receiving in a computer processor all prescription requests, for any and all narcoleptic patients being prescribed the prescription drug, wherein the prescription drug inventory is owned by a company, only at an exclusive central pharmacy from any and all medical doctors allowed to prescribe the company'"'"'s prescription drug, the prescription requests containing information identifying narcoleptic patients, the prescription drug, and various credentials of the any and all medical doctors;

requiring entering of the information into an exclusive computer database associated with the exclusive central pharmacy for analysis of potential abuse situations, wherein the exclusive central pharmacy and the exclusive central database are the only pharmacy and database in existence for the company'"'"'s prescription drug, and such that all prescriptions for the company'"'"'s prescription drug are processed only by the exclusive central pharmacy using only the exclusive computer database;

checking with the computer processor the credentials of the any and all doctors to determine the eligibility of the doctors to prescribe the company'"'"'s prescription drug;

confirming with a narcoleptic patient that educational material has been read prior to shipping the company'"'"'s prescription drug;

checking the exclusive computer database for potential abuse of the company'"'"'s prescription drug, wherein the exclusive central pharmacy and the exclusive central database facilitate a determination of the potential abuse of the company'"'"'s prescription drug;

providing the company'"'"'s prescription drug to the narcoleptic patient only if no potential abuse is found by the narcoleptic patient to whom the company'"'"'s prescription drug is prescribed and the doctor prescribing the company'"'"'s prescription drug;

confirming receipt by the narcoleptic patient of the company'"'"'s prescription drug; and

generating with the computer processor periodic reports via the exclusive computer database to evaluate potential diversion patterns.

10. The method of claim 9, wherein one or more of the exclusive central pharmacy and the exclusive central database are distributed over multiple computers, and wherein a query operates over all data in all the distributed databases relating to the prescriptions, the doctors, and the narcoleptic patients.

11. The method of claim 9, wherein the providing the company'"'"'s prescription drug to the narcoleptic patient comprises the exclusive central pharmacy authorizing the company'"'"'s prescription drug to be dispensed to the narcoleptic patient by another pharmacy.

12. The method of claim 9, comprising delivering the company'"'"'s prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the company'"'"'s prescription drug.

13. The method of claim 9, wherein the exclusive central pharmacy enters data into the exclusive computer database.

14. The method of claim 9, wherein an abuse pattern is associated with the narcoleptic patient, and shipment of the company'"'"'s prescription drug is blocked based upon such association.

15. The method of claim 9, wherein the company'"'"'s prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.