Sensitive drug distribution system and method

• US 7,765,106 B2
• Filed: 11/02/2004
• Issued: 07/27/2010
• Est. Priority Date: 12/17/2002
• Status: Expired due to Fees

• Current Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
• Original Assignee: JPI Commercial LLC (Jazz Pharmaceuticals Plc)
• Inventors: Engel, Patti A., Gagne, Bob, Reardan, Dayton T.
• Primary Examiner(s): O'Connor; Gerald J.
• Assistant Examiner(s): Najarian; Lena
• Application Number:
  US10/979,665
• Publication Number:
  US 20050090425A1
• Time in Patent Office: 2,093 Days
• Field of Search: 705/2, 705/3
• 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 therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused, misused, or diverted, comprising:

receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed the prescription drug and from any and all doctors allowed to prescribe the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical doctor who is prescribing the prescription drug;

requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for authorization only using the exclusive central computer system and the exclusive computer database;

controlling the distribution of said prescription drug using the exclusive central computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the exclusive central computer system and the exclusive computer database based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and

selecting multiple controls for distribution using said exclusive central computer system, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive central computer system;

identifying the physician'"'"'s name, license, and DEA (Drug Enforcement Agency) registration information;

verifying the prescription;

obtaining patient information;

verifying the physician is eligible to prescribe the prescription 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 received and/or reviewed the educational materials;

verifying the home address of the patient;

shipping via US postal service or a commercial 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 a 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;

authorizing release of inventory in a controlled manner;

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, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions;

authorizing the filling, using the exclusive central computer system, of a prescription for the prescription drug that has been subjected to said multiple controls and has been approved for shipment to the patient;

noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and

delivering the prescription drug to the patient in order to treat the patient with the prescription drug.

2. The method of claim 1 , wherein the controls for distribution are communicating prescriptions from a physician to the exclusive central computer system;

identifying the physician'"'"'s name, license, and DEA (Drug Enforcement Agency) registration information;

verifying the prescription;

obtaining patient information;

verifying patient registry information;

providing comprehensive education information to the patient;

verifying the patient has received and/or reviewed the educational materials;

or requiring rewriting of the prescription periodically.

3. A therapeutic method for treating a narcoleptic patient with sodium oxybate for daytime cataplexy comprising:

receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed sodium oxybate and from any and all medical doctors allowed to prescribe sodium oxybate, the prescriptions containing information relating to the patient, sodium oxybate, and various credentials of the medical doctor who is prescribing the sodium oxybate;

requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion, such that all prescriptions for sodium oxybate are processed for authorization only using the exclusive central computer system and the exclusive computer database;

controlling the distribution of sodium oxybate using the exclusive central computer system that tracks all prescriptions of sodium oxybate and analyzes for the potential abuse, misuse, or diversion by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of sodium oxybate from periodic reports generated by the exclusive central computer system based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, sodium oxybate as the drug prescribed, and credentials of the doctor; and

selecting multiple controls for distribution using said exclusive central computer system, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive central computer system;

identifying the physician'"'"'s name, license, and DEA (Drug Enforcement Agency) registration information;

verifying the prescription;

obtaining patient information;

verifying the physician is eligible to prescribe sodium oxybate 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 received and/or reviewed the educational materials;

verifying the home address of the patient;

shipping via US postal service or a commercial 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 a 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;

authorizing release of inventory in a controlled manner;

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, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions;

authorizing the filling, using the exclusive central computer system, of a prescription for sodium oxybate that has been subjected to said multiple controls and has been approved for shipment to the patient;

noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and

delivering the sodium oxybate to the patient in order to treat the patient with the sodium oxybate.

4. The method of claim 3, wherein the controls for distribution are communicating prescriptions from a physician to the exclusive central computer system;

identifying the physician'"'"'s name, license, and DEA (Drug Enforcement Agency) registration information;

verifying the prescription;

obtaining patient information;

verifying patient registry information;

providing comprehensive education information to the patient;

verifying the patient has received and/or reviewed the educational materials;

or requiring rewriting of the prescription periodically.

5. A therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused, misused, or diverted, comprising:

receiving, only into an exclusive computer database in a computer system, from any and all medical doctors allowed to prescribe the prescription drug and any and all patients being prescribed the prescription drug, all prescriptions for the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical doctor who is prescribing the prescription drug;

requiring entering of the information into the exclusive computer database for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for authorization only via the exclusive computer database;

controlling the distribution of said prescription drug with the computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the computer system based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and

selecting multiple controls for distribution of the prescription drug, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive computer database;

identifying the physician'"'"'s name, license, and DEA (Drug Enforcement Agency) registration information;

verifying the prescription;

obtaining patient information;

verifying the physician is eligible to prescribe the prescription 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 received and/or reviewed the educational materials;

verifying the home address of the patient;

shipping via US postal service or a commercial 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 a 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;

authorizing the release of inventory in a controlled manner;

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, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions;

authorizing the filling, using the exclusive computer database, of a prescription for the prescription drug that has been subjected to said multiple controls and has been approved for shipment to the patient;

noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and

delivering the prescription drug to the patient in order to treat the patient with the prescription drug.

6. The method of claim 5, wherein the controls for distribution are communicating prescriptions from a physician to the exclusive computer database;

identifying the physician'"'"'s name, license, and DEA (Drug Enforcement Agency) registration information;

verifying the prescription;

obtaining patient information;

verifying patient registry information;

providing comprehensive education information to the patient;

verifying the patient has received and/or reviewed the educational materials;

or requiring rewriting of the prescription periodically.

7. A therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused, misused, or diverted, comprising:

receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed the prescription drug and any and all medical doctors allowed to prescribed the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical doctor who is writing the prescription;

requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for authorization only using the exclusive central computer system and the exclusive computer database;

controlling the distribution of said prescription drug using the exclusive central computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the exclusive central computer system and the exclusive computer database based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and

selecting multiple controls for distribution using the exclusive central computer system, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive central computer system;

identifying the physician'"'"'s name, license, and DEA (Drug Enforcement Agency) registration information;

verifying the prescription;

obtaining patient information;

verifying the physician is eligible to prescribe the prescription 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 received and/or reviewed the educational materials;

verifying the home address of the patient;

shipping via US postal service or a commercial 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 a 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;

authorizing release of inventory in a controlled manner;

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, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions;

authorizing the filling, using the exclusive central computer system, of a prescription for the prescription drug that has been subjected to said multiple controls and has been approved for shipment to the patient;

noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and

delivering the prescription drug to the patient in order to treat the patient with the prescription drug.

8. The method of claim 7, wherein the controls for distribution are communicating prescriptions from a physician to the exclusive central computer system;

identifying the physician'"'"'s name, license, and DEA (Drug Enforcement Agency) registration information;

verifying the prescription;

obtaining patient information;

verifying patient registry information;

providing comprehensive education information to the patient;

verifying the patient has received and/or reviewed the educational materials;

or requiring rewriting of the prescription periodically.