Sensitive drug distribution system and method

• US 7,797,171 B2
• Filed: 04/01/2005
• Issued: 09/14/2010
• Est. Priority Date: 12/17/2002
• Status: Active Grant

• 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): Morgan; Robert W
• Assistant Examiner(s): Fuelling; Michael
• Application Number:
  US11/097,651
• Publication Number:
  US 20050222874A1
• Time in Patent Office: 1,992 Days
• Field of Search: 705/2
• 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 obtaining FDA (Food and Drug Administration) approval for a prescription drug, the method comprising:

maintaining with a computer processor an exclusive central computer database;

determining with the computer processor current and anticipated patterns of potential abuse of the prescription drug, wherein the anticipated patterns of potential abuse are determined in part by requiring entry of information into the exclusive central computer database such that any and all prescriptions for the prescription drug, for any and all patients being prescribed the prescription drug, and from any and all doctors allowed to prescribe the prescription drug, are processed only via the exclusive central computer database;

selecting with the computer processor multiple controls for distribution while maintaining the exclusive central computer database, the controls comprising controls beyond the controls for traditional prescription drugs based on the sensitivity of the prescription drug, the controls selected from the group consisting of communicating prescriptions from a physician to a pharmacy, 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 check on whether any actions are pending against the physician, provide 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 or 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 prescription drug, confirming receipt of an initial shipment of the prescription drug to the patient, returning the prescription drug 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, 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, making the database available to the DEA for checking for abuse patterns in data in the database, analyzing cash payments stored in the database, analyzing inappropriate questions stored in the database;

displaying the selected controls to an output device; and

receiving negotiation input from the FDA and adding with the computer processor further controls from the group until approval is obtained;

wherein the prescription drug is a scheduled drug in Schedule II-V of FDA subpart 4 regulation embodied in Title 21, CFR Part 314, existing on Apr. 1, 2005.

2. The method of claim 1 wherein initially selected controls comprise communicating prescriptions from a physician to a pharmacy, identifying the physician'"'"'s name, license and DEA 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 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 received or reviewed the educational materials, verifying the home address of the patient, shipping via US postal service, confirming receipt of an initial shipment of the prescription drug to the patient, releasing inventory in a controlled manner, 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.

3. A method of obtaining FDA (Food and Drug Administration) approval for a sensitive drug, the method comprising:

maintaining with a computer processor an exclusive central computer database;

determining with the computer processor current and anticipated patterns of potential abuse of the sensitive drug, wherein the anticipated patterns of potential abuse are determined in part by requiring entry of information into the exclusive central computer database such that any and all prescriptions for the sensitive drug, for any and all patients being prescribed the sensitive drug, and from any and all doctors allowed to prescribe the sensitive drug, are processed only via the exclusive central computer database;

selecting with the computer processor multiple controls for distribution while maintaining the exclusive central computer database, the controls comprising controls beyond the controls for traditional prescription drugs based on the sensitivity of the sensitive drug, the controls selected from the group consisting of communicating prescriptions from a physician to a pharmacy, 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 check on whether any actions are pending against the physician, provide 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 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 sensitive drug, confirming receipt of an initial shipment of the sensitive drug to the patient, returning the sensitive drug 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, 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, making the database available to the DEA for checking for abuse patterns in data in the database, analyzing cash payments stored in the database, analyzing inappropriate questions stored in the database;

displaying the selected controls to an output device; and

receiving negotiation input from the FDA and adding with the computer processor further controls from the group until approval is obtained;

wherein the sensitive drug is a scheduled drug in Schedules II-IV of FDA subpart 4 regulation embodied in Title 21, CFR Part 314, wherein the Schedules II-IV are as of Apr. 1, 2005.

4. The method of claim 3, wherein initially selected controls comprise communicating prescriptions from a physician to a pharmacy, identifying the physician'"'"'s 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 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 received or reviewed the educational materials, verifying the home address of the patient, shipping via US postal service, confirming receipt of an initial shipment of the sensitive drug to the patient, releasing inventory in a controlled manner, 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.