SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD

• US 20110119085A1
• Filed: 01/25/2011
• Published: 05/19/2011
• Est. Priority Date: 12/17/2002
• Status: Abandoned Application

• Current Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc), Orphan Medical, Inc. (Jazz Pharmaceuticals Plc)
• Original Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc), Orphan Medical, Inc. (Jazz Pharmaceuticals Plc)
• Inventors: Engel, Patti A., Gagne, Bob, Reardan, Dayton T.
• Application Number:
  US13/013,680
• Publication Number:
  US 20110119085A1
• 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. A method of treatment of a narcoleptic patient with a prescription drug that has the potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug is distributed by a company that obtained approval for distribution of the prescription drug;

entering into the single database information identifying the narcoleptic patient and a prescriber, and entering into the single database information relating to the company'"'"'s prescription drug;

entering information into the single database relating to abuse, misuse, or diversion of the company'"'"'s prescription drug;

processing all prescriptions for the company'"'"'s prescription drug using the single computer database to control the distribution of the company'"'"'s prescription drug by tracking prescriptions and identifying patterns of abuse, misuse, or diversion;

providing the company'"'"'s prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the company'"'"'s prescription drug;

and selecting two or more controls from the group consisting of;

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

verifying the prescription;

obtaining patient information;

verifying that a physician or other prescriber is eligible to prescribe the company'"'"'s prescription drug by consulting the National Technical Information Services to determine whether the physician or other prescriber has an active DEA number and to check on whether any actions are pending against the physician or other prescriber;

contacting the narcoleptic patient'"'"'s insurance company;

verifying patient registry information;

providing educational information to the narcoleptic patient concerning the use of or risks associated with the company'"'"'s prescription drug;

verifying that the narcoleptic patient has received or read the educational materials concerning the company'"'"'s prescription drug;

verifying the home address of the narcoleptic patient;

shipping the company'"'"'s prescription drug via US Postal Service or other commercial shipping service;

receiving the name of at least one 18-year-old designee to receive the company'"'"'s prescription drug;

confirming receipt of an initial shipment of the company'"'"'s prescription drug to the narcoleptic patient;

returning the company'"'"'s prescription drug to a pharmacy after two attempts to deliver have failed;

launching an investigation when a shipment is lost;

shipping the company'"'"'s prescription drug to a pharmacy for delivery to or pick-up by the narcoleptic patient;

inquiring about the reason for requested early refills of the company'"'"'s prescription drug;

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

limiting the prescription of the company'"'"'s prescription drug 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;

authorizing the filling, using the single computer database, of a prescription for the company'"'"'s prescription drug that has been subjected to the two or more controls and has been approved for shipment to the narcoleptic patient; and

noting, based on the analysis of potential abuse, misuse, or diversion of the company'"'"'s prescription drug, that there is a potential for abuse, misuse, or diversion by the narcoleptic patient to whom the company'"'"'s prescription drug is prescribed;

wherein the prescription drug that has the potential for misuse, abuse or diversion is a gamma hydroxy butyrate (GHB) drug product;

wherein said GHB drug product treats cataplexy in said narcoleptic patient.

2. A method of treatment of a narcoleptic patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug;

entering into the single computer database information sufficient to identify the narcoleptic patient for whom the company'"'"'s prescription drug is prescribed;

entering into the single computer database information sufficient to identify a physician or other prescriber of the company'"'"'s prescription drug and information to show that the physician or other prescriber is authorized to prescribe the company'"'"'s prescription drug;

entering and maintaining in the single computer database information that indicates that the narcoleptic patient or prescriber has abused, misused, or diverted the company'"'"'s prescription drug; and

using the single computer database to authorize filling of the prescriptions for the company'"'"'s prescription drug only if there is no record of incidents that indicate abuse, misuse, or diversion by the narcoleptic patient or prescriber, or if there is a record of such incidents, the single computer database indicates that such incidents have been investigated, and the single computer database indicates that such incidents do not involve abuse, misuse or diversion.

3. The method of claim 2, comprising delivering the prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug.

4. The method of claim 2, wherein an exclusive central pharmacy controls the single computer database.

5. The method of claim 2, comprising selectively blocking shipment of the prescription drug to a narcoleptic patient.

6. The method of claim 2, wherein an abuse pattern is associated with a narcoleptic patient, and shipment of the prescription drug is blocked based upon such association.

7. The method of claim 2, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

8. The method of claim 7, wherein said GHB drug product treats cataplexy in said narcoleptic patient.

9. A method of treatment of a narcoleptic patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for the prescription drug that has the potential for abuse, misuse or diversion;

entering into the single computer database information sufficient to identify the narcoleptic patient for whom the prescription drug is prescribed;

entering into the single computer database information sufficient to identify a physician or other prescriber of the prescription drug and information to show that the physician or other prescriber is authorized to prescribe the prescription drug;

entering and maintaining in the single computer database information that indicates that the narcoleptic patient or prescriber has abused, misused, or diverted the prescription drug;

using the single computer database to authorize filling of the prescriptions for the prescription drug only if there is no record of incidents that indicate abuse, misuse, or diversion by the narcoleptic patient or prescriber, or if there is a record of such incidents, the single computer database indicates that such incidents have been investigated, and the single computer database indicates that such incidents do not involve abuse, misuse or diversion; and

distributing the prescription drug by a company that obtained approval for distribution of the prescription drug.

10. The method of claim 9, comprising delivering the prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug.

11. The method of claim 9, wherein an exclusive central pharmacy controls the single computer database.

12. The method of claim 9, comprising selectively blocking shipment of the prescription drug to the narcoleptic patient.

13. The method of claim 9, wherein an abuse pattern is associated with the patient, and shipment of the prescription drug is blocked based upon such association.

14. The method of claim 9, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

15. The method of claim 14, wherein said GHB drug product treats cataplexy in said narcoleptic patient.

16. A method of treatment of a narcoleptic patient with a gamma hydroxy butyrate (GHB) drug product while controlling potential misuse, abuse or diversion of said GHB drug product, comprising:

controlling with a computer processor the distribution of the GHB drug product, the GHB drug product sold or distributed by a company that obtained approval for distribution of the GHB drug product, the distribution implemented via an exclusive central pharmacy that maintains an exclusive central database that tracks all prescriptions of the company'"'"'s GHB drug product and that analyzes for potential abuse situations;

receiving in the computer processor all prescription requests, for any and all narcoleptic patients being prescribed the company'"'"'s GHB drug product, only at the exclusive central pharmacy, from any and all medical doctors allowed to prescribe the company'"'"'s GHB drug product;

processing in the computer processor all prescriptions for the company'"'"'s GHB drug product only by the exclusive central pharmacy using only the exclusive central database;

determining with the computer processor current and anticipated patterns of potential prescription abuse of the company'"'"'s GHB drug product from periodic reports generated only by the exclusive central database, based on prescription request data from a particular medical doctor and based on filling of prescriptions by a particular narcoleptic patient, wherein the request data contain information identifying the narcoleptic patient, GHB as the drug prescribed, and credentials of the medical doctor; and

selecting with the computer processor multiple controls for distribution by the exclusive central pharmacy, the controls selected from the group consisting of communicating prescriptions from the medical doctor to the exclusive central pharmacy;

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

verifying the prescription;

obtaining patient information;

verifying the medical doctor is eligible to prescribe the company'"'"'s GHB drug product by consulting the National Technical Information Services to determine whether the medical doctor has an active DEA number and to check on whether any actions are pending against the medical doctor;

providing comprehensive printed materials to the medical doctor;

contacting the narcoleptic patient'"'"'s insurance company;

verifying patient registry information;

providing comprehensive educational information to the narcoleptic patient;

verifying the narcoleptic patient has reviewed the educational materials;

verifying the home address of the narcoleptic patient;

shipping the GHB drug product via US postal service or a commercial shipping service;

receiving the name of an at least 18 year old designee to receive the GHB drug product;

confirming receipt of an initial shipment of the GHB drug product to the narcoleptic patient;

returning the GHB drug product 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 exclusive 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.

17. The method of claim 16, comprising consulting a separate database to verify that the medical doctor is eligible to prescribe the GHB drug product.

18. The method of claim 16, comprising delivering the GHB drug product to the narcoleptic patient in order to treat the narcoleptic patient with the GHB drug product.

19. The method of claim 16, wherein the exclusive central pharmacy controls the exclusive computer database.

20. The method of claim 16, comprising selectively blocking shipment of the GHB drug product to the narcoleptic patient.

21. The method of claim 16, wherein an abuse pattern is associated with the narcoleptic patient, and shipment of the GHB drug product is blocked based upon such association.

22. A method of treatment of a narcoleptic patient with a prescription drug while controlling potential misuse, abuse or diversion of said prescription drug, comprising:

receiving in a computer processor all prescription requests, for any and all narcoleptic patients being prescribed the prescription drug, wherein the prescription drug is distributed by a company that obtained approval for distribution of the prescription drug, only at the exclusive central pharmacy from any and all medical doctors allowed to prescribe the company'"'"'s prescription drug, the prescription requests containing information identifying narcoleptic patients, the prescription drug, and various credentials of the any and all medical doctors;

requiring entering of the information into an exclusive computer database associated with the exclusive central pharmacy for analysis of potential abuse situations, wherein the exclusive central pharmacy and the exclusive central database are unique in that they are the only pharmacy and database in existence for the company'"'"'s prescription drug, and such that all prescriptions for the company'"'"'s prescription drug are processed only by the exclusive central pharmacy using only the exclusive computer database;

checking with the computer processor the credentials of the any and all doctors to determine the eligibility of the doctors to prescribe the company'"'"'s prescription drug;

confirming with a narcoleptic patient that educational material has been read prior to shipping the company'"'"'s prescription drug;

checking the exclusive computer database for potential abuse of the company'"'"'s prescription drug, wherein the uniqueness of the exclusive central pharmacy and the exclusive central database facilitates a determination of the potential abuse of the company'"'"'s prescription drug;

providing the company'"'"'s prescription drug to the narcoleptic patient only if no potential abuse is found by the narcoleptic patient to whom the company'"'"'s prescription drug is prescribed and the doctor prescribing the company'"'"'s prescription drug;

confirming receipt by the narcoleptic patient of the company'"'"'s prescription drug; and

generating with the computer processor periodic reports via the exclusive computer database to evaluate potential diversion patterns.

23. The method of claim 22, wherein one or more of the exclusive central pharmacy and the exclusive central database are distributed over multiple computers, and wherein a query operates over all data in all the distributed databases relating to the prescriptions, the doctors, and the narcoleptic patients.

24. The method of claim 22, wherein the providing the company'"'"'s prescription drug to the narcoleptic patient comprises the exclusive central pharmacy authorizing the company'"'"'s prescription drug to be dispensed to the narcoleptic patient by another pharmacy.

25. The method of claim 22, comprising delivering the company'"'"'s prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the company'"'"'s prescription drug.

26. The method of claim 22, wherein the exclusive central pharmacy controls the exclusive computer database.

27. The method of claim 22, comprising selectively blocking shipment of the company'"'"'s prescription drug to the narcoleptic patient.

28. The method of claim 22, wherein an abuse pattern is associated with the narcoleptic patient, and shipment of the company'"'"'s prescription drug is blocked based upon such association.

29. The computerized method of claim 22, wherein the company'"'"'s prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

30. A method of treatment of a narcoleptic patient with a prescription drug that has the potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for a prescription drug with the potential for abuse, misuse or diversion sold or distributed under a single trademark;

entering into the single database, information identifying the narcoleptic patient, the prescriber; and

the trademarked prescription drug;

entering information into the single database relating to or indicating abuse, misuse, or diversion of said prescription drug;

processing all prescriptions for said prescription drug using the single computer database to control the distribution of said prescription drug by tracking prescriptions and identifying patterns of abuse, misuse, or diversion;

providing said prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug;

and selecting two or more controls from the group comprising;

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

verifying the prescription;

obtaining patient information;

verifying that the physician or other prescriber is eligible to prescribe said prescription drug by consulting the National Technical Information Services to determine whether the physician or other prescriber has an active DEA number and to check on whether any actions are pending against the physician or other prescriber;

contacting the narcoleptic patient'"'"'s insurance company if any;

verifying patient registry information;

providing education information to the narcoleptic patient concerning the use of or risks associated with said prescription drug;

verifying that the narcoleptic patient has received or read the educational materials concerning said prescription drug;

verifying the home address of the narcoleptic patient;

shipping said prescription drug via US Postal Service or other commercial shipping service;

receiving the name of at least one 18-year-old designee to receive said prescription drug;

confirming receipt of an initial shipment of said prescription drug to the narcoleptic patient;

returning said prescription drug to a pharmacy after two attempts to deliver have failed;

launching an investigation when a shipment is lost;

shipping said prescription drug to a pharmacy for delivery to or pick-up by the narcoleptic patient;

requiring manufacture of said prescription drug at a single location;

inquiring about the reason for requested early refills of said prescription drug;

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

limiting the prescription of said prescription drug to a one-month supply;

requiring rewriting of the prescription periodically;

making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data;

authorizing the filling, using the single computer database, of a prescription for said prescription drug that has been subjected to two or more controls and has been approved for shipment to the narcoleptic patient;

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

wherein the prescription drug that has the potential for misuse, abuse or diversion is a gamma hydroxy butyrate (GHB) drug product;

wherein said GHB drug product treats cataplexy in said narcoleptic patient.

31. A method of treatment of a narcoleptic patient with a prescription drug that has the potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for a prescription drug that has the potential for abuse, misuse or diversion which has been manufactured at a single manufacturing site;

entering into the single database, information identifying the narcoleptic patient, the prescriber; and

the trademarked prescription drug;

entering information into the single database relating to or indicating abuse, misuse, or diversion of said prescription drug;

processing all prescriptions for said prescription drug using the single computer database to control the distribution of said prescription drug by tracking prescriptions and identifying patterns of abuse, misuse, or diversion;

providing said prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug;

and selecting two or more controls from the group comprising;

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

verifying the prescription;

obtaining patient information;

verifying that the physician or other prescriber is eligible to prescribe said prescription drug by consulting the National Technical Information Services to determine whether the physician or other prescriber has an active DEA number and to check on whether any actions are pending against the physician or other prescriber;

contacting the narcoleptic patient'"'"'s insurance company if any;

verifying patient registry information;

providing education information to the narcoleptic patient concerning the use of or risks associated with said prescription drug;

verifying that the narcoleptic patient has received or read the educational materials concerning said prescription drug;

verifying the home address of the narcoleptic patient;

shipping said prescription drug via US Postal Service or other commercial shipping service;

receiving the name of at least one 18-year-old designee to receive said prescription drug;

confirming receipt of an initial shipment of said prescription drug to the narcoleptic patient;

returning said prescription drug to a pharmacy after two attempts to deliver have failed;

launching an investigation when a shipment is lost;

shipping said prescription drug to a pharmacy for delivery to or pick-up by the narcoleptic patient;

requiring manufacture of said prescription drug at a single location;

inquiring about the reason for requested early refills of said prescription drug;

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

limiting the prescription of said prescription drug to a one-month supply;

requiring rewriting of the prescription periodically;

making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data;

authorizing the filling, using the single computer database, of a prescription for said prescription drug that has been subjected to two or more controls and has been approved for shipment to the narcoleptic patient;

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

32. A method of treatment of a narcoleptic patient with a prescription drug that has the potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for a prescription drug with the potential for abuse, misuse or diversion sold or distributed under a single trademark;

entering into the single database information sufficient to identify the narcoleptic patient for whom said prescription drug was prescribed;

entering into the single database information sufficient to identify the physician or other prescriber of said prescription drug and information to show that the physician or other prescriber was authorized to prescribe said prescription drug;

entering and maintaining in the single database information which may suggest that the narcoleptic patient or prescriber has abused, misused, or diverted said prescription drug;

using the single computer database to authorize filling of the prescriptions for said prescription drug only if there is no record of incidents that may suggest abuse, misuse, or diversion by the narcoleptic patient or prescriber or if any such incidents have been investigated and found not to involve abuse, misuse or diversion.

33. A method of treatment of a narcoleptic patient with a prescription drug that has the potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for a prescription drug that has been manufactured at a single manufacturing site with the potential for abuse, misuse or diversion;

entering into the single database information sufficient to identify the narcoleptic patient for whom said prescription drug was prescribed, entering into the single database information sufficient to identify the physician or other prescriber of said prescription drug and information to show that the physician or other prescriber was authorized to prescribe said prescription drug;

entering and maintaining in the single database information which may suggest that the narcoleptic patient or prescriber has abused, misused, or diverted said prescription drug;

using the single computer database to authorize filling of the prescription for said prescription drug only if there is no record of incidents that may suggest abuse, misuse, or diversion by the narcoleptic patient or prescriber or if any such incidents have been investigated and found not to involve abuse, misuse or diversion;

providing said prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug;

wherein the prescription drug that has the potential for misuse, abuse or diversion is a gamma hydroxybutyrate (GHB) drug product;

wherein said GHB drug product treats cataplexy in said narcoleptic patient.

36. The method of claim 33, comprising delivering the prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the prescription drug.

34. A method of treatment of a narcoleptic patient with a prescription drug that has the potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug inventory is owned by a company and is managed thorough said single computer database;

entering into the single database information identifying the narcoleptic patient and a prescriber, and entering into the single database information relating to the company'"'"'s prescription drug;

entering information into the single database relating to abuse, misuse, or diversion of the company'"'"'s prescription drug;

processing all prescriptions for the company'"'"'s prescription drug using the single computer database to control the distribution of the company'"'"'s prescription drug by tracking prescriptions and identifying patterns of abuse, misuse, or diversion;

providing the company'"'"'s prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the company'"'"'s prescription drug;

and selecting two or more controls from the group consisting of;

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

verifying the prescription;

obtaining patient information;

verifying that a physician or other prescriber is eligible to prescribe the company'"'"'s prescription drug by consulting the National Technical Information Services to determine whether the physician or other prescriber has an active DEA number and to check on whether any actions are pending against the physician or other prescriber;

contacting the narcoleptic patient'"'"'s insurance company;

verifying patient registry information;

providing educational information to the narcoleptic patient concerning the use of or risks associated with the company'"'"'s prescription drug;

verifying that the narcoleptic patient has received or read the educational materials concerning the company'"'"'s prescription drug;

verifying the home address of the narcoleptic patient;

shipping the company'"'"'s prescription drug via US Postal Service or other commercial shipping service;

receiving the name of at least one 18-year-old designee to receive the company'"'"'s prescription drug;

confirming receipt of an initial shipment of the company'"'"'s prescription drug to the narcoleptic patient;

returning the company'"'"'s prescription drug to a pharmacy after two attempts to deliver have failed;

launching an investigation when a shipment is lost;

shipping the company'"'"'s prescription drug to a pharmacy for delivery to or pick-up by the narcoleptic patient;

inquiring about the reason for requested early refills of the company'"'"'s prescription drug;

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

limiting the prescription of the company'"'"'s prescription drug 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;

authorizing the filling, using the single computer database, of a prescription for the company'"'"'s prescription drug that has been subjected to the two or more controls and has been approved for shipment to the narcoleptic patient; and

noting, based on the analysis of potential abuse, misuse, or diversion of the company'"'"'s prescription drug, that there is a potential for abuse, misuse, or diversion by the narcoleptic patient to whom the company'"'"'s prescription drug is prescribed

wherein the prescription drug that has the potential for misuse, abuse or diversion is a gamma hydroxybutyrate (GHB) drug product;

wherein said GHB drug product treats cataplexy in said narcoleptic patient.

35. A method of treatment of a narcoleptic patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising:

receiving into a single computer database all prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug inventory is owned by a company and is managed thorough said single computer database;

entering into the single computer database information sufficient to identify the narcoleptic patient for whom the company'"'"'s prescription drug is prescribed;

entering into the single computer database information sufficient to identify a physician or other prescriber of the company'"'"'s prescription drug and information to show that the physician or other prescriber is authorized to prescribe the company'"'"'s prescription drug;

entering and maintaining in the single computer database information that indicates that the narcoleptic patient or prescriber has abused, misused, or diverted the company'"'"'s prescription drug; and

using the single computer database to authorize filling of the prescriptions for the company'"'"'s prescription drug only if there is no record of incidents that indicate abuse, misuse, or diversion by the narcoleptic patient or prescriber, or if there is a record of such incidents, the single computer database indicates that such incidents have been investigated, and the single computer database indicates that such incidents do not involve abuse, misuse or diversion.

37. The method of claim 35, wherein an exclusive central pharmacy controls the single computer database.

38. The method of claim 35, comprising selectively blocking shipment of the prescription drug to a narcoleptic patient.

39. The method of claim 35, wherein an abuse pattern is associated with a narcoleptic patient, and shipment of the prescription drug is blocked based upon such association.

40. The method of claim 35, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

41. The method of claim 40, wherein said GHB drug product treats cataplexy in said narcoleptic patient.

42. A method of treatment of a narcoleptic patient with a gamma hydroxy butyrate (GHB) drug product while controlling potential misuse, abuse or diversion of said GHB drug product, comprising:

controlling with a computer processor the distribution of the GHB drug product, wherein the GHB drug product inventory is owned by a company and the distribution is implemented via an exclusive central pharmacy that maintains an exclusive central database that tracks all prescriptions of the company'"'"'s GHB drug product and that analyzes for potential abuse situations;

receiving in the computer processor all prescription requests, for any and all narcoleptic patients being prescribed the company'"'"'s GHB drug product, only at the exclusive central pharmacy, from any and all medical doctors allowed to prescribe the company'"'"'s GHB drug product;

processing in the computer processor all prescriptions for the company'"'"'s GHB drug product only by the exclusive central pharmacy using only the exclusive central database;

determining with the computer processor current and anticipated patterns of potential prescription abuse of the company'"'"'s GHB drug product from periodic reports generated only by the exclusive central database, based on prescription request data from a particular medical doctor and based on filling of prescriptions by a particular narcoleptic patient, wherein the request data contain information identifying the narcoleptic patient, GHB as the drug prescribed, and credentials of the medical doctor; and

selecting with the computer processor multiple controls for distribution by the exclusive central pharmacy, the controls selected from the group consisting of communicating prescriptions from the medical doctor to the exclusive central pharmacy;

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

verifying the prescription;

obtaining patient information;

verifying the medical doctor is eligible to prescribe the company'"'"'s GHB drug product by consulting the National Technical Information Services to determine whether the medical doctor has an active DEA number and to check on whether any actions are pending against the medical doctor;

providing comprehensive printed materials to the medical doctor;

contacting the narcoleptic patient'"'"'s insurance company;

verifying patient registry information;

providing comprehensive educational information to the narcoleptic patient;

verifying the narcoleptic patient has reviewed the educational materials;

verifying the home address of the narcoleptic patient;

shipping the GHB drug product via US postal service or a commercial shipping service;

receiving the name of an at least 18 year old designee to receive the GHB drug product;

confirming receipt of an initial shipment of the GHB drug product to the narcoleptic patient;

returning the GHB drug product 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 exclusive 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.

43. The method of claim 42, comprising consulting a separate database to verify that the medical doctor is eligible to prescribe the GHB drug product.

44. The method of claim 42, comprising delivering the GHB drug product to the narcoleptic patient in order to treat cataplexy in the narcoleptic patient with the GHB drug product.

45. The method of claim 42, wherein the exclusive central pharmacy controls the exclusive computer database.

46. The method of claim 42, comprising selectively blocking shipment of the GHB drug product to the narcoleptic patient.

47. The method of claim 42, wherein an abuse pattern is associated with the narcoleptic patient, and shipment of the GHB drug product is blocked based upon such association.

53. The method of claim 46, comprising selectively blocking shipment of the company'"'"'s prescription drug to the narcoleptic patient.

56. The method of claim 53, wherein said GHB drug product treats cataplexy in said narcoleptic patient.

48. A method of treatment of a narcoleptic patient with a prescription drug while controlling potential misuse, abuse or diversion of said prescription drug, comprising:

receiving in a computer processor all prescription requests, for any and all narcoleptic patients being prescribed the prescription drug, wherein the prescription drug inventory is owned by a company, only at the exclusive central pharmacy from any and all medical doctors allowed to prescribe the company'"'"'s prescription drug, the prescription requests containing information identifying narcoleptic patients, the prescription drug, and various credentials of the any and all medical doctors;

requiring entering of the information into an exclusive computer database associated with the exclusive central pharmacy for analysis of potential abuse situations, wherein the exclusive central pharmacy and the exclusive central database are unique in that they are the only pharmacy and database in existence for the company'"'"'s prescription drug, and such that all prescriptions for the company'"'"'s prescription drug are processed only by the exclusive central pharmacy using only the exclusive computer database;

checking with the computer processor the credentials of the any and all doctors to determine the eligibility of the doctors to prescribe the company'"'"'s prescription drug;

confirming with a narcoleptic patient that educational material has been read prior to shipping the company'"'"'s prescription drug;

checking the exclusive computer database for potential abuse of the company'"'"'s prescription drug, wherein the uniqueness of the exclusive central pharmacy and the exclusive central database facilitates a determination of the potential abuse of the company'"'"'s prescription drug;

providing the company'"'"'s prescription drug to the narcoleptic patient only if no potential abuse is found by the narcoleptic patient to whom the company'"'"'s prescription drug is prescribed and the doctor prescribing the company'"'"'s prescription drug;

confirming receipt by the narcoleptic patient of the company'"'"'s prescription drug; and

generating with the computer processor periodic reports via the exclusive computer database to evaluate potential diversion patterns.

49. The method of claim 48, wherein one or more of the exclusive central pharmacy and the exclusive central database are distributed over multiple computers, and wherein a query operates over all data in all the distributed databases relating to the prescriptions, the doctors, and the narcoleptic patients.

50. The method of claim 48, wherein the providing the company'"'"'s prescription drug to the narcoleptic patient comprises the exclusive central pharmacy authorizing the company'"'"'s prescription drug to be dispensed to the narcoleptic patient by another pharmacy.

51. The method of claim 48, comprising delivering the company'"'"'s prescription drug to the narcoleptic patient in order to treat the narcoleptic patient with the company'"'"'s prescription drug.

52. The method of claim 48, wherein the exclusive central pharmacy controls the exclusive computer database.

54. The method of claim 48, wherein an abuse pattern is associated with the narcoleptic patient, and shipment of the company'"'"'s prescription drug is blocked based upon such association.

55. The method of claim 48, wherein the company'"'"'s prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.