# US 2014/0207480 A1 · Sensitive drug distribution system and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0207480 A1 - Document ID: US20140207480A1 - Status: Published application - Kind: A1 - Application number: 14/219,904 - Filed: 2014-03-19 - Published: 2014-07-24 - Earliest claimed: 2002-12-17 - Assignees: Jazz Pharmaceuticals, Inc. - Applicants: Jazz Pharmaceuticals, Inc. - Inventors: Dayton T. Reardan; Patti A. Engel; Bob Gagne - Web page: https://patentgrep.com/patent/US20140207480A1 ## CPC - G16H 40/20: for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms - G16H 10/60: for patient-specific data, e.g. for electronic patient records - G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - G16H 70/40: relating to drugs, e.g. their side effects or intended usage - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## 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 ### Claim 1 (canceled) ### Claim 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 single 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 prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug; said patient fields, contained within the database schema, storing information sufficient to identify the patient for whom the company's prescription drug is prescribed; said prescriber fields, contained within the database schema, storing 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; a data processor to: process a database query that operates over all data related to the prescription fields, prescriber fields, and patient fields for the prescription drug; and reconcile inventory of the prescription drug before the shipments for a time period are sent by using said database query to identify information in the prescription fields and patient fields. ### Claim 3 (depends on 2) The computer-implemented system of claim 2, wherein the data processor arranges for delivery of the prescription drug to the patient in order to treat the patient with the prescription drug. ### Claim 4 (depends on 2) The computer-implemented system of claim 2, wherein a pharmacy enters data into the single computer database. ### Claim 5 (depends on 2) The computer-implemented system of claim 2, wherein the data processor selectively blocks shipment of the prescription drug to the patient. ### Claim 6 (depends on 2) 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. ### Claim 7 (depends on 2) The computer-implemented system of claim 2, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product. ### Claim 8 (depends on 7) The computer-implemented system of claim 7, wherein said GHB drug product treats cataplexy in the patient. ### Claim 9 A computer-implemented method for treatment of a patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising: storing, using a computer processor, in a single computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields, the single computer database comprising one or more computer memories; said prescription fields, contained within the database schema, storing prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug; said patient fields, contained within the database schema, storing information sufficient to identify the patient for whom the company's prescription drug is prescribed; said prescriber fields, contained within the database schema, storing 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; processing, using the computer processor, a database query that operates over all data related to the prescription fields, prescriber fields, and patient fields for the prescription drug; and reconciling inventory of the prescription drug before a shipment for a time period is sent by using said database query to identify information in the prescription fields and patient fields. ### Claim 10 (depends on 9) The method of claim 9, comprising delivering the prescription drug to the patient in order to treat the patient with the prescription drug. ### Claim 11 (depends on 9) The method of claim 9, wherein a pharmacy enters data into the single computer database. ### Claim 12 (depends on 9) The method of claim 9, comprising selectively blocking shipment of the prescription drug to the patient. ### Claim 13 (depends on 9) The method of claim 9, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association. ### Claim 14 (depends on 9) The method of claim 9, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product. ### Claim 15 (depends on 14) The method of claim 14, wherein said GHB drug product treats cataplexy in said patient. ### Claim 16 A computer-implemented method for treatment of a patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising: storing, using a computer processor, in a single computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields, the single computer database comprising one or more computer memories; said prescription fields, contained within the database schema, storing prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, and wherein the company's prescription drug has been manufactured at a single manufacturing site; said patient fields, contained within the database schema, storing information sufficient to identify the patient for whom the company's prescription drug is prescribed; said prescriber fields, contained within the database schema, storing 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; processing, using the computer processor, a database query that operates over all data related to the prescription fields, prescriber fields, and patient fields for the prescription drug; and reconciling inventory of the prescription drug before the shipments for a time period are sent by using said database query to identify information in the prescription fields and patient fields. ### Claim 17 (depends on 16) The method of claim 16, wherein a pharmacy enters data into the single computer database. ### Claim 18 (depends on 16) The method of claim 16, comprising selectively blocking shipment of the prescription drug to the patient. ### Claim 19 (depends on 16) The method of claim 16, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association. ### Claim 20 A computer-implemented method for treatment of a patient with a single prescription drug that has a potential for misuse, abuse or diversion, comprising: storing, using a computer processor, in a single computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields, the single computer database comprising one or more computer memories; said prescription fields, contained within the database schema, storing prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the single prescription drug is sold or distributed by a company that obtained approval for distribution of the single prescription drug, and wherein the distribution of the single prescription drug is 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; said patient fields, contained within the database schema, storing information sufficient to identify the patient for whom the company's single prescription drug is prescribed; said prescriber fields, contained within the database schema, storing information sufficient to identify a physician or other prescriber of the company's single prescription drug and information to show that the physician or other prescriber is authorized to prescribe the company's single prescription drug; processing, using the computer processor, a database query that operates over all data related to the prescription fields, prescriber fields, and patient fields for the single prescription drug; and reconciling inventory of the single prescription drug before a shipment for a time period is sent by using said database query to identify information in the prescription fields and patient fields. ### Claim 21 (depends on 20) The method of claim 20, comprising delivering the single prescription drug to the patient in order to treat the patient with the single prescription drug. ### Claim 22 (depends on 21) The method of claim 21, comprising verifying two or more of the following using the computer processor prior to providing the single prescription drug to the 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. ### Claim 23 (depends on 20) The method of claim 20, wherein a pharmacy enters data into the one or more computer memories. ### Claim 24 (depends on 20) The method of claim 20, comprising selectively blocking shipment of the single prescription drug to the patient. ### Claim 25 (depends on 20) The method of claim 20, wherein an abuse pattern is associated with the patient, and shipment of the single prescription drug is blocked based upon such association. ### Claim 26 (depends on 20) The method of claim 20, wherein the single prescription drug comprises a gamma hydroxy butyrate (GHB) drug product. ### Claim 27 (depends on 26) The method of claim 26, wherein said GHB drug product treats cataplexy in said patient. ### Claim 28 (depends on 2) The system of claim 2, wherein current inventory is cycle counted and reconciled with database quantities before shipments for a day or other time period are sent.