Sensitive drug distribution system and method

• US 20050222874A1
• Filed: 04/01/2005
• Published: 10/06/2005
• 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 7,797,171 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

1-18. -18. (canceled)

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

determining current and anticipated patterns of potential abuse of the sensitive drug;

selecting multiple controls for distribution while maintaining a central database, the controls selected from the group consisting of communicating prescriptions from a physician to a 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 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 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, 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 the data, cash payments, inappropriate questions; and

negotiating with the FDA by adding further controls from the group until approval is obtained.

20. The method of claim 19 wherein initially selected controls comprise communicating prescriptions from a physician to a 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 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 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.

21. The method of claim 19 wherein the sensitive drug is a scheduled drug in Schedule II-V.

36. The method of claim 19 wherein the pharmacy is a central pharmacy.

37. The method of claim 36 wherein the central pharmacy may ship the sensitive drug to a second pharmacy for pickup when the second pharmacy'"'"'s ability to protect against diversion before shipping the drug is confirmed.

22. A method of distributing a sensitive drug, the method comprising:

determining current and anticipated patterns of potential abuse of the sensitive drug;

selecting multiple controls for distribution of the sensitive drug; and

adding additional controls to provide sufficient reassurance to a governmental regulatory body that the sensitive drug distribution can be adequately controlled in order to obtain marketing approval by the governmental regulatory body.

23. The method of claim 22 wherein the system allows marketing of a drug product pursuant to FDA subpart 4 regulation embodied in Title 21, CFR Part 314.

24. The method of claim 22 wherein distribution of the sensitive drug is controlled by a central distribution center sufficient to allow the DEA (Drug Enforcement Agency) to approve the central distribution center.

25. The method of claim 22 wherein the governmental regulatory body comprises a state regulatory agency that approves distribution of the sensitive drug in a state.

32. The method of claim 22 wherein the distribution of the sensitive drug is monitored by use of a central database that tracks all distribution of the sensitive drug.

33. The method of claim 32 wherein each pharmacy distributing the sensitive drug uses the central database to track distribution of the sensitive drug.

34. The method of claim 32 wherein the sensitive drug is exclusively distributed by a central pharmacy that uses the central database to track distribution of the sensitive drug.

35. The method of claim 34 wherein the central pharmacy may ship the sensitive drug to a second pharmacy for pickup when the second pharmacy'"'"'s ability to protect against diversion before shipping the drug is confirmed.

26-31. -31. (canceled)