SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD

• US 20100138237A1
• Filed: 02/11/2010
• Published: 06/03/2010
• 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 7,895,059 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. A computerized method of distributing a prescription drug under exclusive control of an exclusive central pharmacy, the method comprising:

receiving in a computer processor all prescription requests, for any and all patients being prescribed the prescription drug, only at the exclusive central pharmacy from any and all medical doctors allowed to prescribe the prescription drug, the prescription requests containing information identifying 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, such that all prescriptions for the 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 prescription drug;

confirming with a patient that educational material has been received and/or read prior to shipping the prescription drug;

checking the exclusive computer database for potential abuse of the prescription drug;

mailing or sending by courier the prescription drug to the patient only if no potential abuse is found by the patient to whom the prescription drug is prescribed and the doctor prescribing the prescription drug;

confirming receipt by the patient of the prescription drug; and

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

2. The method of claim 1, wherein the exclusive central pharmacy controls the exclusive computer database.

3. The method of claim 1, comprising selectively blocking shipment of the prescription drug to a patient.

4. The method of claim 1, wherein an abuse pattern is associated with a patient, and shipment is blocked upon such association.

5. The method of claim 1, wherein the prescription drug comprises gamma hydroxy butyrate (GHB).

6. A computerized method of distributing a prescription drug under control of an exclusive central pharmacy, the method comprising:

receiving in a computer processor prescription requests, for any and all patients being prescribed the prescription drug, only at the central pharmacy from any and all authorized prescribers allowed to prescribed the prescription drug, the prescription requests containing information identifying patients, the prescription drug, and various credentials of the any and all authorized prescribers;

entering the information into an exclusive computer database under exclusive control of the central pharmacy for analysis of potential abuse situations, wherein the use of the exclusive computer database is required for distribution of the prescription drug, such that all prescriptions for the 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 authorized prescribers to determine the eligibility of the prescribers to prescribe the prescription drug;

confirming with a patient that educational material has been received and/or read prior to providing the prescription drug to the patient;

requiring checking of the exclusive computer database for potential abuse associated with the patient and the authorized prescriber;

providing the prescription drug to the patient only provided information in the exclusive computer database is not indicative of potential abuse by the patient to whom the prescription drug is prescribed and the authorized prescriber of the prescription drug;

confirming receipt by the patient of the prescription drug; and

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

7. The computerized method of claim 6, wherein providing the prescription drug to the patient comprises the central pharmacy authorizing the prescription drug to be dispensed to the patient by another pharmacy.

8. The computerized method of claim 7, wherein the another pharmacy places controls on the distribution of the prescription drug, the controls selected from the group consisting of confirming with the patient that the educational material has been received and/or read by the patient, confirming receipt of the prescription drug by the patient, contacting the patient'"'"'s insurance company, questioning early refill requests by the patient, flagging repeat instances of lost, stolen, destroyed or spilled prescriptions, flagging that the patient paid cash for the prescription drug, flagging early requests to refill the prescription drug, and limiting the prescription to a supply of limited duration.

9. A computerized method of distributing gamma hydroxy butyrate (GHB) under control of an exclusive central pharmacy, the method comprising:

receiving in a computer processor prescription requests for GHB, for any and all patients being prescribed GHB, only at the central pharmacy from any and all authorized prescribers allowed to prescribe GHB, the prescription requests for GHB containing information identifying patients and various credentials of the any and all authorized prescribers;

entering the information into an exclusive computer database under exclusive control of the central pharmacy for analysis of potential abuse situations, wherein the use of the exclusive computer database is required for distribution of GHB, such that all prescriptions for GHB 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 authorized prescribers to determine the eligibility of the prescribers to prescribe GHB;

confirming with the patient that GHB educational material has been received and/or read prior to providing GHB to the patient a first time;

requiring checking of the exclusive computer database for potential GHB abuse associated with the patient;

providing GHB to the patient only provided information in the exclusive computer database is not indicative of potential abuse by the patient to whom GHB is prescribed and the authorized prescriber of the GHB;

confirming receipt by the patient of the GHB; and

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

10. The computerized method of claim 9, wherein providing GHB to the patient comprises the central pharmacy authorizing the prescription drug to be dispensed to the patient by another pharmacy.

11. The computerized method of claim 10, wherein the another pharmacy places controls on the distribution of GHB, the controls selected from the group consisting of confirming with the patient that the educational material has been received and/or read by the patient, confirming receipt of GHB by the patient, contacting the patient'"'"'s insurance company, questioning early refill requests by the patient, flagging repeat instances of lost, stolen, destroyed or spilled prescriptions, flagging that the patient paid cash for GHB, flagging early requests to refill the GHB, and limiting the prescription to a supply of limited duration.

12. A computerized method of distributing gamma hydroxy butyrate (GHB) under control of an exclusive central pharmacy, the method comprising:

receiving in a computer processor prescription requests for GHB, for any and all patients being prescribed GHB, only at the central pharmacy from any and all authorized prescribers allowed to prescribe GHB, the prescription requests containing information identifying patients and various credentials of the any and all authorized prescribers;

entering the information into an exclusive computer database under exclusive control of the central pharmacy for analysis of potential abuse situations, wherein the use of the exclusive computer database is required for distribution of GHB, such that all prescriptions for GHB 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 authorized prescribers to determine the eligibility of the prescribers to prescribe GHB;

confirming with the patient that GHB educational material has been received and/or read prior to providing GHB to the patient a first time;

requiring checking of the exclusive computer database for potential GHB abuse associated with the patient;

mailing or sending by courier GHB to the patient only provided information in the exclusive computer database is not indicative of potential abuse by the patient to whom GHB is prescribed and the authorized prescriber of the GHB;

confirming receipt by the patient of the GHB; and

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

13. A computerized method of distributing gamma hydroxy butyrate (GHB) under control of an exclusive central pharmacy, the method comprising:

manufacturing GHB;

providing manufactured GHB only to the exclusive central pharmacy;

receiving in a computer processor all prescription requests for GHB, for any and all patients being prescribed GHB, only at the central pharmacy from any and all authorized prescribers allowed to prescribe GHB, the prescription requests containing information identifying patients and various credentials of the any and all authorized prescribers;

entering the information into an exclusive computer database under exclusive control of the central pharmacy for analysis of potential abuse situations, wherein the use of the exclusive computer database is required for distribution of GHB, such that all prescriptions for GHB 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 authorized prescribers to determine the eligibility of the prescribers to prescribe GHB;

confirming with the patient that GHB educational material has been received and/or read prior to providing GHB to the patient a first time;

requiring checking of the exclusive computer database for potential GHB abuse associated with the patient;

mailing or sending by courier GHB to the patient only provided information in the exclusive computer database is not indicative of potential abuse by the patient to whom GHB is prescribed and the doctor prescribing the GHB;

confirming receipt by the patient of the GHB; and

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

14. A computerized method of distributing a prescription drug under control of an exclusive central pharmacy, the method comprising:

receiving in a computer processor all prescription requests, for any and all patients being prescribed the prescription drug, only at the central pharmacy from any and all authorized prescribers allowed to prescribed the prescription drug, the prescription requests containing information identifying patients, the prescription drug, and various credentials of the any and all authorized prescribers;

entering the information into an exclusive computer database under exclusive control of the central pharmacy for analysis of potential abuse situations, wherein the use of the exclusive computer database is required for distribution of the prescription drug, such that all prescriptions for the 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 authorized prescribers to determine the eligibility of the prescribers to prescribe the prescription drug;

confirming with the patient that educational material has been received and/or read prior to providing the prescription drug to the patient;

requiring checking of the exclusive computer database for potential abuse by the patient to whom the prescription drug is prescribed and the authorized prescriber allowed to prescribe the prescription drug;

providing the prescription drug to the patient only provided information in the exclusive computer database is not indicative of potential abuse by the patient to whom the prescription drug is prescribed and the authorized prescriber allowed to prescribe the prescription drug; and

confirming receipt by the patient of the prescription drug.

15. The computerized method of claim 14, wherein providing the prescription drug to the patient comprises the central pharmacy authorizing the prescription drug to be dispensed to the patient by another pharmacy.

16. The computerized method of claim 15, wherein the another pharmacy places controls on the distribution of the prescription drug, the controls selected from the group consisting of confirming with the patient that the educational material has been received and/or read by the patient, confirming receipt of the prescription drug by the patient, contacting the patient'"'"'s insurance company, questioning early refill requests by the patient, flagging repeat instances of lost, stolen, destroyed or spilled prescriptions, flagging that the patient paid cash for the prescription drug, flagging early requests to refill the prescription drug, and limiting the prescription to a supply of limited duration.