Sensitive drug distribution system and method

• US 20050216309A1
• Filed: 04/01/2005
• Published: 09/29/2005
• Est. Priority Date: 12/17/2002
• Status: Active Grant

• Current Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
• Original Assignee: Orphan Medical, Inc. (Jazz Pharmaceuticals Plc)
• Inventors: Engel, Patti A., Gagne, Bob, Reardan, Dayton T.
• Granted Patent: US 7,765,107 B2
• 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

1-25. -25. (canceled)

26. A method to control abuse of a sensitive drug by controlling the distribution thereof via an exclusive central pharmacy that maintains a central database that tracks all prescriptions of said sensitive drug and analyzes for potential abuse situations, the method comprising:

determining current and anticipated patterns of potential prescription abuse of said sensitive drug from periodic reports generated by the central database based on prescription request data from a medical doctor, wherein said request data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and

selecting multiple controls for distribution by said exclusive central pharmacy, 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 to check on whether any actions are pending against the physician;

providing 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; and

making the database available to the DEA for checking for abuse patterns in the data, for cash payments, and for inappropriate questions.

27. The method of claim 26 wherein initially selected controls comprise

communicating prescriptions from a physician to the central pharmacy;

identifying the physicians name, license, and DEA 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 to check on whether any actions are pending against the physician;

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;

confirming receipt of an initial shipment of the drug to the patient;

releasing inventory in a controlled manner to the central pharmacy;

flagging repeat instances of lost, stolen, destroyed, or spilled prescriptions; and

making the database available to the DEA for checking for abuse patterns in the data.

28. The method of claim 26 which further comprises consulting a separate database to verify that the medical doctor is eligible to prescribe the drug.

29. A method to control abuse of gamma hydroxy butyrate (GHB) by controlling the distribution of GHB via an exclusive central pharmacy that maintains a central database that tracks all prescriptions of GHB and analyzes for potential abuse situations, the method comprising:

determining current and anticipated patterns of potential prescription abuse of GHB from periodic reports generated by the central database based on prescription request data from a medical doctor, wherein said request data contain information identifying the patient, GHB as the drug prescribed, and credentials of the doctor; and

selecting multiple controls for distribution by said exclusive central pharmacy, 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 to check on whether any actions are pending against the physician;

providing 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; and

making the database available to the DEA for checking for abuse patterns in the data, for cash payments, and for inappropriate questions.

30. The method of claim 29 wherein initially selected controls comprise

communicating prescriptions from a physician to the central pharmacy;

identifying the physicians name, license, and DEA 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 to check on whether any actions are pending against the physician;

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;

confirming receipt of an initial shipment of the drug to the patient;

releasing inventory in a controlled manner to the central pharmacy;

flagging repeat instances of lost, stolen, destroyed, or spilled prescriptions; and

making the database available to the DEA for checking for abuse patterns in the data.

31. The method of claim 29 which further comprises consulting a separate database to verify that the medical doctor is eligible to prescribe the drug.