Sensitive drug distribution system and method

• US 20050090425A1
• Filed: 11/02/2004
• Published: 04/28/2005
• 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: Eneel, Patti A., Gagne, Bob, Reardan, Dayton T.
• Granted Patent: US 7,765,106 B2
• Time in Patent Office: Days
• US Class Current: 514/1
• 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 distributing a sensitive drug, the method comprising:

receiving prescription requests from a medical doctor containing information identifying the patient, the sensitive drug, and various credentials of the doctor;

entering the information into a central database for analysis of potential abuse situations;

checking the credentials of the doctor;

confirming with the patient that educational material has been read prior to shipping the sensitive drug;

confirming receipt of the sensitive drug; and

generating periodic reports via the central database to evaluate potential abuse patterns.

2. The method of claim 1 wherein receipt of the sensitive drug is confirmed by telephone call from the central pharmacy to the patient.

3. The method of claim 1 and further comprising launching an investigation of lost shipments.

4. The method of claim 1 and further comprising recording the confirmation with the patient that the educational material has been read in the central database.

5. The method of claim 1 and further comprising verifying the patient'"'"'s home address.

6. The method of claim 1 and further comprising recording a designee identified by the patient to receive the sensitive drug.

7. The method of claim 1 and further comprising establishing a delivery date.

8. The method of claim 1 wherein prescription refills requested prior to an anticipated date are questioned by the pharmacist.

9. The method of claim 1 and further comprising shipping comprehensive printed materials to the physician if the physician is a first time prescriber of the sensitive drug.

10. The method of claim 1 wherein the credentials of the doctor comprise DEA (Drug Enforcement Agency) and state license numbers.

11. A method of monitoring potential abuse of a sensitive drug by use of an exclusive central database, the method comprising:

generating queries of prescription information from a database containing selected information for all prescriptions of the sensitive drug, wherein the queries comprise prescriptions by physician specialty, prescriptions by patient name, prescriptions by frequency and prescriptions by dose.

12. The method of claim 11 and further comprising running multiple predetermined reports based on data in the exclusive central database.

13. The method of claim 12 wherein such reports are selected from groups of reports consisting of sales, regulatory, quality assurance, pharmacy, inventory, reimbursement, patient care, and drug information.

14. The method of claim 13 wherein sales reports are selected from the group consisting of prescriptions by zip code, prescriptions by physician by zip code and total dollars by zipcode.

15. The method of claim 13 wherein regulatory reports are selected from the group consisting of number of physician registries, number of denied physician registries and reasons, number of completed patient registries, number of problem identification, number of cycle counts performed.

16. The method of claim 13 wherein inventory reports are selected from the group consisting of number of returned products and reasons, number of outdated bottles of product, inventory counts of consignment and production inventory, number of units received, and lots received.

17. The method of claim 13 wherein patient care reports are selected from the group consisting of number of adverse events, number of dosing problems and type, number of noncompliance episodes and reason, number of patients counseled and reason, number of discontinued and reason, number of patients referred to physician and reason, number of active patients, number of new patents, number of restart patients, and number of discontinued patients and reason.

18. The method of claim 13 wherein selected reports are run weekly, monthly or quarterly.

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 by an exclusive central pharmacy maintaining a central database, 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 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 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, 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 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 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

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

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.

26. A method comprising:

controlling the distribution of a sensitive drug via an exclusive central pharmacy that maintains a central database that tracks all prescriptions of said sensitive drug and analyzes for potential adverse reaction situations;

determining current and anticipated patterns of potential adverse reactions to said sensitive drug from periodic patient care reports generated by the central database; and

selecting multiple controls for distribution by said exclusive central pharmacy;

whereby an adverse reaction to the sensitive drug is controlled by the method.

27. The method of claim 26 wherein patient care reports are selected from the group consisting of number and type of adverse events;

number of adverse events sent to the OMI;

number and type of dosing problems;

number of episodes of noncompliance and reasons for noncompliance;

number of patients counseled and reason for counseling;

number of patients discontinued and reason for discontinuance;

number of patients referred to a physician and reason for referral;

number of active patients;

number of new patients; and

number of restart patients.

28. The method of claim 27 wherein reports are run weekly, monthly, or quarterly

29. The method of claim 26 wherein the central database contains patient, physician, and prescription information.

30. The method of claim 26 wherein the controls for distribution are 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;

shipping to another pharmacy for delivery; and

requiring rewriting of the prescription periodically.

31. The method of claim 26 wherein distribution of the sensitive drug is controlled by the central pharmacy in a manner sufficient to allow the DEA (Drug Enforcement Agency) to approve the central pharmacy.

32. The method of claim 26 wherein the sensitive drug is a scheduled drug in Schedule II-V.

33. A therapeutic method for treating a patient in need of treatment with a sensitive drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused comprising:

controlling the distribution of said sensitive drug via an exclusive central pharmacy that maintains a central database that tracks all prescriptions of said sensitive drug and analyzes for potential abuse situations by 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;

filling by the central pharmacy of a prescription for the sensitive drug that has been subjected to said multiple controls and has been approved for shipment to the patient;

shipping the sensitive drug by the central pharmacy to the patient in order to begin treatment therewith; and

treating the patient with the drug.

34. The method of claim 33 wherein the controls for distribution are 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 patient registry information;

providing comprehensive education information to the patient;

verifying the patient has reviewed the educational materials;

or requiring rewriting of the prescription periodically.

35. A therapeutic method for treating a narcoleptic patient in need of treatment with gamma hydroxy butyrate (GHB) for daytime cataplexy comprising:

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 by 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;

filling by the central pharmacy of a prescription for GHB that has been subjected to said multiple controls and has been approved for shipment to the patient;

shipping the GHB by the central pharmacy to the patient in order to begin treatment therewith; and

treating the patient with GHB.

36. The method of claim 35 wherein the controls for distribution are 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 patient registry information;

providing comprehensive education information to the patient;

verifying the patient has reviewed the educational materials;

or requiring rewriting of the prescription periodically.