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United States Patent Application 20160154947
Kind Code A1
Reardan; Dayton T. ;   et al. June 2, 2016

SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD

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.


Inventors: Reardan; Dayton T.; (Shorewood, MN) ; Engel; Patti A.; (Eagan, MN) ; Gagne; Bob; (St. Paul, MN)
Applicant:
Name City State Country Type

Jazz Pharmaceuticals, Inc.

Palo Alto

CA

US
Family ID: 1000001742969
Appl. No.: 15/014831
Filed: February 3, 2016


Related U.S. Patent Documents

Application NumberFiling DatePatent Number
14196603Mar 4, 2014
15014831
13592202Aug 22, 20128731963
14196603
13013680Jan 25, 2011
13592202
12704097Feb 11, 20107895059
13013680
10322348Dec 17, 20027668730
12704097

Current U.S. Class: 705/2
Current CPC Class: G06F 19/3456 20130101; G06F 19/322 20130101; G06F 19/328 20130101; G06F 19/345 20130101; G06F 19/326 20130101
International Class: G06F 19/00 20060101 G06F019/00

Claims



1. (canceled)

2. A method, using a computer processor and an exclusive computer database, to control the distribution of a prescription drug that has a potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising: receiving into the computer processor and the exclusive computer database of the company that obtained approval for distribution of the prescription drug, for any and all patients being prescribed the company's prescription drug, any and all prescriptions for the company's prescription drug with the potential for abuse, misuse or diversion; entering into the computer processor and the exclusive computer database information sufficient to identify the any and all patients for whom the company's prescription drug is prescribed; entering into the computer processor and the exclusive computer database information sufficient to identify any and all physicians or other prescribers of the company's prescription drug and information to show that the any and all physicians or other prescribers are authorized to prescribe the company's prescription drug; and entering into and maintaining with the computer processor and the exclusive computer database any information that indicates that a patient or a prescriber has abused, misused, or diverted the company's prescription drug; wherein the computer processor checks for abuse with the exclusive computer database by transforming prescription data, patient data, and prescriber data into one or more queries to access data in the exclusive computer database that relates to abuse, misuse, or diversion, the queries indicating whether investigatable abuse, misuse, or diversion has occurred; and wherein the computer processor controls the distribution of the company's prescription drug based upon the transformation of the prescription data, patient data, and prescriber data in response to the checking for abuse, misuse, or diversion, and authorizes filling of a prescription for the company's prescription drug if there is no record of an incident that indicates abuse, misuse, or diversion by the patient and the prescriber, and if there is a record of such incident, the exclusive computer database indicates that such incident has been investigated, and the exclusive computer database indicates that such incident does not involve abuse, misuse or diversion.

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

4. The method of claim 2, wherein a pharmacy enters data into the exclusive computer database.

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

6. The method of claim 2, wherein an abuse pattern is associated with the 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 the patient.

9. A non-transitory computer readable medium comprising instructions to control distribution of a prescription drug that has a potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising: receiving into a computer processor and an exclusive computer database of the company that obtained approval for distribution of the prescription drug, for any and all patients being prescribed the company's prescription drug, any and all prescriptions for the prescription drug with the potential for abuse, misuse or diversion, the prescription drug sold or distributed under a single name in the United States; entering into the computer processor and the exclusive computer database information sufficient to identify the patient for whom said prescription drug was prescribed; entering into the computer processor and the exclusive computer database information sufficient to identify any and all physicians or other prescribers of said prescription drug and information to show that the any and all physicians or other prescribers are authorized to prescribe said prescription drug; entering into and maintaining with the exclusive computer database any information that may suggest that the patient or the prescriber has abused, misused, or diverted said prescription drug; and checking for abuse with the computer processor and the exclusive computer database by processing and tracking prescription data, patient data, and prescriber data to determine whether investigatable abuse, misuse, or diversion has occurred, and controlling the distribution of said prescription drug based upon the processing and tracking of the prescription data, patient data, and prescriber data and in response to the checking for abuse, misuse, or diversion, and authorizing filling of prescriptions for said prescription drug if there is no record of an incident that may suggest abuse, misuse, or diversion by the patient and the prescriber, and if there is a record of such incident, the computer database indicates that such incident has been investigated, and the computer database indicates that such incident does not involve abuse, misuse or diversion.

10. The non-transitory computer-readable medium of claim 9, comprising instructions for delivering the prescription drug to the patient in order to treat the patient with the prescription drug.

11. The non-transitory computer-readable medium of claim 9, comprising instructions for an exclusive central pharmacy to enter data into the exclusive computer database.

12. The non-transitory computer-readable medium of claim 9, comprising instructions for selectively blocking shipment of the prescription drug to the patient.

13. The non-transitory computer-readable medium of claim 9, comprising instructions for associating an abuse pattern with the patient, and comprising instruction for blocking shipment of the prescription drug based upon such association.

14. The non-transitory computer-readable medium of claim 9, wherein the prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

15. The non-transitory computer-readable medium of claim 14, wherein said GHB drug product treats cataplexy in said patient.

16. A non-transitory computer-readable medium comprising instructions to control distribution of a prescription drug that has a potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising: receiving into a computer processor and an exclusive computer database of the company that obtained approval for distribution of the prescription drug, any and all prescriptions for the company's prescription drug from any and all patients being prescribed the company's prescription drug, wherein the company's prescription drug has been manufactured at a single manufacturing site, and wherein the company's prescription drug has the potential for abuse, misuse or diversion; entering into the computer processor and the exclusive computer database information sufficient to identify the patient for whom the company's prescription drug was prescribed; entering into the computer processor and the exclusive computer database information sufficient to identify any and all physicians or other prescribers of the company's prescription drug and information to show that the any and all physicians or other prescribers were authorized to prescribe the company's prescription drug; entering into and maintaining with the computer processor and the exclusive computer database any information that may suggest that the patient or a prescriber has abused, misused, or diverted the company's prescription drug; checking for abuse with the computer processor and the exclusive computer database by querying, monitoring, and verifying prescription data, patient data, and prescriber data to access relational data in the exclusive computer database relating to abuse, misuse, or diversion to determine whether investigatable abuse, misuse, or diversion has occurred, and controlling the distribution of said prescription drug based upon the querying, monitoring, and verifying of the prescription data, patient data, and prescriber data and in response to the checking for abuse, misuse, or diversion, and authorizing filling of the prescription for the company's prescription drug if there is no record of an incident that may suggest abuse, misuse, or diversion by the patient and the prescriber, and if there is a record of such incident, the computer database indicates that any such incident has been investigated and found not to involve abuse, misuse or diversion; and providing the company's prescription drug to the patient in order to treat the patient with the company's prescription drug; wherein the company's prescription drug that has the potential for misuse, abuse or diversion is a gamma hydroxybutyrate (GHB) drug product; and wherein said GHB drug product treats cataplexy in said patient.

17. The non-transitory computer-readable medium of claim 16, comprising instructions for an exclusive central pharmacy to enter data into the exclusive computer database.

18. The non-transitory computer-readable medium of claim 16, comprising instructions for selectively blocking shipment of the prescription drug to the patient.

19. The non-transitory computer-readable medium of claim 16, comprising instructions for associating an abuse pattern with the patient, and comprising instructions for blocking shipment of the prescription drug based upon such association.

20. A method, using a computer processor and an exclusive computer database, to control distribution of a single prescription drug that has a potential for misuse, abuse or diversion, comprising: receiving into the computer processor and the exclusive computer database of a company that obtained approval for distribution of the single prescription drug and storing in a computer memory of the company that obtained approval for distribution of the single prescription drug, any and all prescriptions for the single prescription drug received at a pharmacy and sold or distributed by the company that obtained approval for distribution of the single prescription drug, the single prescription drug having the potential for abuse, misuse or diversion, wherein the pharmacy is permitted to distribute the single prescription drug based on two or more of the following: processing of a prescription enrollment form for the single prescription drug; agreeing to document adverse events relating to the single prescription drug; providing educational materials relating to the single prescription drug; and verifying that the single prescription drug is medically necessary; entering into the computer processor and the computer memory information sufficient to identify the patient for whom the single prescription drug is prescribed; entering into the computer processor and the computer memory information sufficient to identify any and all physicians or other prescribers of the single prescription drug and information to show that the any and all physicians or other prescribers are authorized to prescribe the single prescription drug, including verifying that the any and all prescribers' drug enforcement agency (DEA) number and state license are current and that there are no pending disciplinary actions against the any and all prescribers; verifying two or more of the following with the computer processor prior to providing the single prescription drug to the patient: patient name; patient address; that the patient has received educational material regarding the single prescription drug; a quantity of the single prescription drug; and dosing directions for the single prescription drug; and entering into and maintaining with the computer processor and the computer memory any information that indicates that the patient or a prescriber has abused, misused, or diverted the single prescription drug; wherein the computer processor checks for abuse with the computer memory by processing and tracking prescription data, patient data, and prescriber data in the exclusive computer database relating to abuse, misuse, or diversion to determine whether investigatable abuse, misuse, or diversion has occurred; and wherein the computer processor controls the distribution of the prescription drug based upon the processing and tracking of the prescription data, patient data, and prescriber data and in response to the checking for abuse, misuse, or diversion, and authorizes filling of the prescriptions for the single prescription drug if there is no record of an incident that indicates abuse, misuse, or diversion by the patient and the prescriber, and if there is a record of such incident, the computer memory indicates that such incident has been investigated, and the computer memory indicates that such incident does not involve abuse, misuse or diversion.

21. The method of claim 20, comprising delivering the single prescription drug to the patient in order to treat the patient with the single prescription drug.

22. The method of claim 20, wherein there is an exclusive central pharmacy that enters data into the computer memory.

23. The method of claim 20, comprising selectively blocking shipment of the single prescription drug to the patient.

24. The method of claim 20, wherein an abuse pattern is associated with the patient, and shipment of the single prescription drug is blocked based upon such association.

25. The method of claim 20, wherein the single prescription drug comprises a gamma hydroxy butyrate (GHB) drug product.

26. The method of claim 25, wherein said GHB drug product treats cataplexy in said patient.

27. The method of claim 2, comprising identifying, with the computer processor, information relating to the prescriptions and the information relating to the patient, and using the information for reconciling inventory for the company's prescription drug before shipments for a time period are sent.

28. The method of claim 2, wherein the exclusive computer database is associated with an exclusive central pharmacy, wherein inventory of the prescription drug is owned by the company, and wherein the inventory is consigned to the exclusive central pharmacy and managed by the exclusive central pharmacy.

30. The method of claim 2, comprising generating periodic reports to evaluate potential diversion patterns.

31. The method of claim 2, wherein the exclusive computer database of the company that obtained approval for distribution of the prescription drug is the only database in existence for the company's prescription drug, such that all prescriptions for the company's prescription drug are processed only by the exclusive computer database of the company.

32. The method of claim 2, comprising determining that a patient is unable to pay for the prescription drug, and determining whether third party funds are available to pay for the prescription drug.
Description



RELATED APPLICATIONS

[0001] This application is a Continuation of and claims priority to U.S. application Ser. No. 14/196,603, filed on Mar. 4, 2014, which is a Continuation of and claims priority to U.S. application Ser. No. 13/592,202, filed on Aug. 22, 2012 and issued on May 20, 2014 as U.S. Pat. No. 8,731,963, which is a Continuation of and claims priority to U.S. application Ser. No. 13/013,680, filed on Jan. 25, 2011, which is a Continuation of and claims priority to U.S. application Ser. No. 12/704,097, filed on Feb. 11, 2010 and issued on Feb. 22, 2011 as U.S. Pat. No. 7,895,059, which is a Continuation of and claims priority to U.S. application Ser. No. 10/322,348, filed on Dec. 17, 2002 and issued on Feb. 23, 2010 as U.S. Pat. No. 7,668,730, which applications are herein incorporated by reference in their entirety.

FIELD OF THE INVENTION

[0002] The present invention relates to distribution of drugs, and in particular to the distribution of sensitive drugs.

BACKGROUND OF THE INVENTION

[0003] Sensitive drugs are controlled to minimize risk and ensure that they are not abused, or cause adverse reactions. Such sensitive drugs are approved for specific uses by the Food and Drug Administration, and must be prescribed by a licensed physician in order to be purchased by consumers. Some drugs, such as cocaine and other common street drugs are the object of abuse and illegal schemes to distribute for profit. Some schemes include Dr. shopping, diversion, and pharmacy thefts. A locked cabinet or safe is a requirement for distribution of some drugs.

[0004] Certain agents, such as gamma hydroxy buterate (GHB) are also abused, yet also are effective for therapeutic purposes such as treatment of daytime cataplexy in patients with narcolepsy. Some patients however, will obtain prescriptions from multiple doctors, and have them filled at different pharmacies. Still further, an unscrupulous physician may actually write multiple prescriptions for a patient, or multiple patients, who use cash to pay for the drugs. These patients will then sell the drug to dealers or others for profit.

[0005] There is a need for a distribution system and method that directly addresses these abuses. There is a further need for such a system and method that provides education and limits the potential for such abuse.

SUMMARY OF THE INVENTION

[0006] A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in a central 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 for a valid DEA license, and optionally state medical boards to determine whether any corrective or approved disciplinary actions relating to controlled substances have been brought against the physician. Multiple controls beyond those for traditional drugs are imposed on the distribution depending on the sensitivity of the drug.

[0007] Education is provided to both physician and patient. Prior to shipping the drug for the first time, the patient is contacted to ensure that product and abuse related educational materials have been received and/or read. The patient may provide the name of a designee to the central pharmacy who is authorized to accept shipment of the drug. Receipt of the initial drug shipment is confirmed by contacting the patient. Either a phone call or other communication to the patient within a set time after delivery may be made to ensure receipt. Further, a courier service's tracking system is used to confirm delivery in further embodiments. If a shipment is lost, an investigation is launched to find it.

[0008] In one embodiment, the drug may be shipped by the central pharmacy to another pharmacy for patient pick-up. The second pharmacy's ability to protect against diversion before shipping the drug must be confirmed. This ability may be checked through NTIS and State Boards of Pharmacy.

[0009] Prescription refills are permitted in the number specified in the original prescription. In addition, if a prescription refill is requested by the patient prior to the anticipated due date, such refills will be questioned. A lost, stolen, destroyed or spilled prescription/supply is documented and replaced to the extent necessary to honor the prescription, and will also cause a review or full investigation.

[0010] The exclusive central database contains all relevant data related to distribution of the drug and process of distributing it, including patient, physician and prescription information. Several queries and reports are run against the database to provide information which might reveal potential abuse of the sensitive drug, such as early refills.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a block diagram of a computer system for use in implementing the system and method of the present invention.

[0012] FIGS. 2A, 2B and 2C are a flowchart describing a method for sensitive drug distribution at least partially utilizing a computer system such as that shown in FIG. 1.

[0013] FIG. 3 is a flowchart of a physician success program at least partially implemented on a computer system such as that shown in FIG. 1.

[0014] FIGS. 4A and 4B are a flowchart describing a method for handling refill requests at least partially utilizing a computer system such as that shown in FIG. 1.

[0015] FIG. 5 is a flowchart of a process for requesting special reimbursement when a patient is uninsured or underinsured at least partially utilizing a computer system as that shown in FIG. 1.

[0016] FIG. 6 is a flowchart of a process for inventory control at least partially utilizing a computer system such as that shown in FIG. 1.

[0017] FIG. 7 is a block diagram of database fields.

[0018] FIG. 8 is a block diagram showing a list of queries against the database fields.

[0019] FIG. 9 is a copy of one example prescription and enrollment form.

[0020] FIG. 10 is a copy of one example of a NORD application request form for patient financial assistance.

[0021] FIG. 11 is a copy of one example voucher request for medication for use with the NORD application request form of FIG. 10.

[0022] FIG. 12 is a copy of certificate of medical need.

[0023] FIGS. 13A, 13B and 13C are descriptions of sample reports obtained by querying a central database having fields represented in FIG. 7.

DETAILED DESCRIPTION OF THE INVENTION

[0024] In the following description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the scope of the present invention. The following description is, therefore, not to be taken in a limited sense, and the scope of the present invention is defined by the appended claims.

[0025] The functions or algorithms described herein are implemented in software or a combination of software and human implemented procedures in one embodiment. The software comprises computer executable instructions stored on computer readable media such as memory or other type of storage devices. The term "computer readable media" is also used to represent carrier waves on which the software is transmitted. Further, such functions correspond to modules, which are software, hardware, firmware of any combination thereof. Multiple functions are performed in one or more modules as desired, and the embodiments described are merely examples. The software is executed on a digital signal processor, ASIC, microprocessor, or other type of processor operating on a computer system, such as a personal computer, server or other computer system.

[0026] A sensitive drug is one which can be abused, or has addiction properties or other properties that render the drug sensitive. One example of such a drug is sodium oxybate, also known as gamma hydroxy butyrate (GHB C.sub.4H.sub.7NaO.sub.3) which is useful for treatment of cataplexy in patients with narcolepsy. GHB is marketed under the trademark of Xyrem.RTM. (sodium oxybate oral solution), which trademark can be used interchangeably with GHB herein. Sensitive drugs also include narcotics or other drugs which require controls on their distribution and use to monitor behaviors to prevent abuse and adverse side effects.

[0027] In one embodiment, Xyrem.RTM. is subject to a restricted distribution program. One aspect of the program is to educate physicians and patients about the risks and benefits of Xyrem, including support via ongoing contact with patients and a toll free helpline. Initial prescriptions are filled only after a prescriber and patient have received and read the educational materials. Further, patient and prescribing physician registries are maintained and monitored to ensure proper distribution.

[0028] In a further embodiment, bulk sodium oxybate is manufactured at a single site, as is the finished drug product. Following manufacture of the drug product, it is stored at a facility compliant with FDA Schedule III regulations, where a consignment inventory is maintained. The inventory is owned by a company, and is managed by a central pharmacy, which maintains the consignment inventory. Xyrem.RTM. is distributed and dispensed through a primary and exclusive central pharmacy, and is not stocked in retail pharmacy outlets. It is distributed by overnight carriers, or by US mail in one embodiment to potentially invoke mail fraud laws if attempts of abuse occur.

[0029] FIG. 1 is a simplified block diagram of a computer system 100, such as a personal computer for implementing at least a portion of the methods described herein. A central processing unit (CPU) 110 executes computer programs stored on a memory 120. Memory 120 in one embodiment comprises one or more levels of cache as desired to speed execution of the program and access to data on which the programs operate. The CPU is directly coupled to memory 120 in one embodiment. Both CPU 110 and memory 120 are coupled to a bus 130. A storage 140, I/O 150 and communications 160 are also coupled to the bus 130. Storage 140 is usually a long term storage device, such as a disk drive, tape drive, DVD, CD or other type of storage device. In one embodiment, storage 140 is used to house a database for use with the present invention. I/O 150 comprises keyboards, sound devices, displays and other mechanisms by which a user interacts with the computer system 100. Communications 160 comprises a network, phone connection, local area network, wide area network or other mechanism for communicating with external devices. Such external devices comprise servers, other peer computers and other devices. In one embodiment, such external device comprises a database server that is used in place of the database on storage 140. Other computer system architectures capable of executing software and interacting with a database and users may also be used. Appropriate security measures such as encryption are used to ensure confidentiality. Further, data integrity and backup measures are also used to prevent data loss.

[0030] FIGS. 2A, 2B and 2C represent an initial prescription order entry process for a sensitive drug, such as Xyrem. At 202, a medical doctor (MD) sends a Rx/enrollment form via mail, fax, email or other means to an intake/reimbursement specialist at 204, who makes a copy of the RX/enrollment form that is stamped "copy". The original fax is forwarded to a pharmacy team. The enrollment form contains prescriber information, prescription information, checkboxes for the prescriber indicating they have read materials, educated the patient, understand the use in treatment, and understand certain safety information, and also contains patient information.

[0031] The prescriber information contains standard contact information as well as license number, DEA number and physician specialty. Patient and prescription information includes name, social security number, date of birth, gender, contact information, drug identification, patient's appropriate dosage, and number of refills allowed, along with a line for the prescriber's signature. Patient insurance information is also provided.

[0032] There are two workflows involved at the pharmacy team, intake reimbursement 206 and pharmacy workflow 208, which may proceed in parallel or serially. The intake work flow 206 starts with an intake reimbursement specialist entering the patient and physician information into an application/database referred to as CHIPS, which is used to maintain a record of a client home infusion program (CHIP) for Xyrem.RTM.. A check is made to ensure the information is complete at 212. If not, at 214, an intake representative attempts to reach the MD or prescriber to obtain the missing information. If the missing information has not been obtained within a predetermined period of time, such as 24 hours at 216, the Rx/Enrollment form is sent back to the MD with a rejection explanation. A note is entered in CHIPS that the application was rejected.

[0033] If the information is complete at 212, the MD is contacted at 220 to verify receipt and accuracy of the patient's Rx. This contact is recorded in CHIPS. The intake and reimbursement specialist then sends a consent form and a cover letter to the patient at 224. The insurance provider is contacted at 226 to verify coverage and benefits. At 228, a determination is made regarding coverage for the drug. If it is not available, it is determined at 230 whether the patient is willing and able to pay. If not, a process is performed for handling patients who are uninsured or underinsured. In one embodiment, the process is referred to as a NORD process.

[0034] If the patient is willing and able to pay at 230, the patient is informed of the cost of the product and is given payment options at 234. At 236, once payment is received, the intake reimbursement specialist submits a coverage approval form with the enrollment form to the pharmacy team as notification to process the patient's prescription. If coverage is approved at 228, the intake reimbursement specialist also submits the coverage approval form with the enrollment form to the pharmacy team as notification to process the patient's prescription. Processing of the prescription is described below.

[0035] Upon receipt and initial processing of the prescription enrollment form and sending an original to the pharmacy work flow block 208, the patient is shipped a Xyrem.RTM. success packet via mail. In one embodiment, the Xyrem.RTM. success packet contains educational material for a patient that advises of the proper use, care and handling of the drug and consequences of diversion at 268. The medical doctor's credentials are checked to determine if the physician has a current DEA license to prescribe controlled substances and if he or she has had any actions related to misuse/misprescribing of controlled drugs against him or her, within a predetermined time, such as three months at 270. If they have, a pharmacist holds the prescription until receiving a coverage approval form from the intake reimbursement specialist at 272.

[0036] If the credentials have not been recently checked, the pharmacist verifies the credentials and enters all findings in the database at 274. If the credentials are approved at 276, the physician is indicated as approved in a physician screen populated by information from the database at 280. The prescription is then held pending coverage approval at 282.

[0037] If any disciplinary actions are identified, as referenced at block 278, management of the pharmacy is notified and either approves processing of the prescription with continued monitoring of the physician, or processing of the prescription is not performed, and the physician is noted in the database as unapproved at 284. The enrollment form is then mailed back to the physician with a cover letter reiterating that the prescription cannot be processed at 288. The patient is also sent a letter at 290 indicating that the prescription cannot be processed and the patient is instructed to contact their physician.

[0038] Actual filling of the approved prescription begins with receipt of the coverage approval form as indicated at 240. The patient is contacted by the pharmacy, such as by a technician to complete a technician section of a patient counseling checklist. If a pharmacist verifies that the program materials were not read at 242, the receipt of the material is confirmed at 244 and another call is scheduled to counsel the patient before the drug is shipped.

[0039] If the program materials, were read at 242, the checklist is completed at 246 and the technician transfers the patient to the pharmacist who reviews the entire checklist and completes remaining pharmacist specified sections. At 248, the pharmacists indicates in the database that the patient counseling and checklist was successfully completed, indicating the date completed.

[0040] At 250, the pharmacist schedules the patient's shipment for the next business day or the next business day that the patient or designee is able to sign for the package. Further, as indicated at 252, the shipment must be sent to the patient's home address unless the patient is traveling or has moved. In that event, the pharmacist may determine that an exception may be made. The patient or the patient's designee who is at least 18 years old, must sign for the package upon delivery.

[0041] At 254, the pharmacist enters the prescription order in the database, creating an order number. The pharmacist then verifies at 256 the prescription and attaches a verification label to the hard copy prescription. At 258, a pick ticket is generated for the order and the order is forwarded to the pharmacy for fulfillment. The shipment is confirmed in the database at 260, and the order is shipped by USPS Express Mail. Use of the US mail invokes certain criminal penalties for unauthorized diversion. Optionally, other mail services may be used. Potential changes in the law may also bring criminal penalties into play. Following shipment, the patient is called by the central pharmacy to confirm that the prescription was received.

[0042] As noted at 266, for the sensitive drug, Xyrem, all inventory is cycle counted and reconciled with the database system quantities before shipments for the day are sent. This provides a very precise control of the inventory.

[0043] A physician success program materials request process begins at 310 in FIG. 3. At 320, the MD calls to the central pharmacy to request program materials. A special phone number is provided. MD demographics, DEA number, and data or request are entered into the database at 330. At 340, a request is made to ship the materials to the MD via a fulfillment website, or other mechanism. The request process ends at 350.

[0044] A refill request process begins at 302 in FIGS. 4A and 4B. There are two different paths for refills. A first path beginning at 404 involves generating a report from the central database of patients with a predetermined number of days or product remaining. A second path beginning at 406 is followed when a patient calls to request an early refill.

[0045] In the first path, a copy of the report is provided to an intake reimbursement specialist at 408. No sooner than 8 days before the medication depletion, a pharmacy technician contacts the patient at 410 to complete the pre-delivery checklist. At 412, if the patient is not reached, a message is left mentioning the depletion, and a return number at 414. A note is also entered into the database indicating the date the message was left at 416.

[0046] If the patient is reached at 412, the next shipment is scheduled at 418, the prescription is entered into the database creating an order at 420, the pharmacist verifies the prescription and attaches a verification label at 422 and the shipment is confirmed in the database at 424. Note at 426 that the inventory is cycle counted and reconciled with the database quantities before the shipments for a day or other time period are sent. A pick ticket is generated for the order and the order is forwarded for fulfillment at 428, with the first path ending at 430.

[0047] The second path, beginning at 406 results in a note code being entered into the database on a patient screen indicating an early refill request at 432. The pharmacist evaluates the patient's compliance with therapy or possible product diversion, misuse or over-use at 436. In one embodiment, cash payers are also identified. The pharmacist then contacts the prescribing physician to alert them of the situation and confirm if the physician approves of the early refill at 438. If the physician does not approve as indicated at 440, the patient must wait until the next scheduled refill date to receive additional product as indicated at 442, and the process ends at 444.

[0048] If the physician approves at 440, the pharmacist enters a note in the database on a patient screen that the physician approves the request at 446. The pharmacist notifies an intake reimbursement specialist to contact the patient's insurance provider to verify coverage for the early refill at 448. If the insurance provider will pay as determined at 450, the specialist submits the coverage approval form as notification that the refill may be processed at 452. At 454, the pharmacy technician contacts the patient to schedule shipment of the product for the next business day, and the process of filling the order is continued at 456 by following the process beginning at 240.

[0049] If the insurance provider will not pay at 450, it is determined whether the patient is willing and/or able to pay at 458. If not, the patient must wait until the next scheduled refill date to receive additional product at 460. If it was determined at 458 that the patient was willing and able to pay, the patient is informed of the cost of the product and is given payment options at 462. Once payment is received as indicated at 464, the specialist submits a coverage approval form to the pharmacy team as notification that the refill request can be processed at 466. At 468, the pharmacy technician contacts the patient to schedule shipment. The process of filling the order is continued at 470 by following the process beginning at 240.

[0050] A process, referred to as a NORD process in one embodiment is used to determine whether donated, third party funds are available for paying for prescriptions where neither insurance will, nor the patient can pay. The process begins at 510 upon determining that a patient is uninsured or underinsured. A reimbursement specialist explains the NORD program to the patient and faxes an application request form to NORD for the patient. At 515, the intake reimbursement specialist documents in the database that an application has been received through NORD. At 520, NORD mails an application to the patient within one business day.

[0051] A determination is made at 525 by NORD whether the patient is approved. If not, at 530, NORD sends a denial letter to the patient, and it is documented in the database at 540 that the patient was denied by NORD. If the patient is approved, NORD sends an acceptance letter to the patient and faxes a voucher to the central pharmacy (SDS in one embodiment) to indicate the approval at 545. At 550, an intake reimbursement specialist submits a coverage approval form to the pharmacy team as notification that the patient has been approved for coverage. The process of filling the order is continued at 555 by following the process beginning at 240.

[0052] An inventory control process is illustrated in FIG. 6 beginning at 610. Each week, a responsible person at the central pharmacy, such as the director of the pharmacy transfers inventory for the week's shipments to a segregated warehouse location for production inventory. At 620, a purchase order is generated for the inventory transferred to the production location and is sent, such as by fax, to a controller, such as the controller of the company that obtained approval for distribution and use of the sensitive drug. At 630, the controller invoices the central pharmacy for the product moved to production. The process ends at 640.

[0053] The central database described above is a relational database running on the system of FIG. 1, or a server based system having a similar architecture coupled to workstations via a network, as represented by communications 160. The database is likely stored in storage 140, and contains multiple fields of information as indicated at 700 in FIG. 7. The organization and groupings of the fields are shown in one format for convenience. It is recognized that many different organizations or schemas may be utilized. In one embodiment, the groups of fields comprise prescriber fields 710, patient fields 720, prescription fields 730 and insurance fields 740. For purposes of illustration, all the entries described with respect to the above processes are included in the fields. In further embodiments, no such groupings are made, and the data is organized in a different manner.

[0054] Several queries are illustrated at 800 in FIG. 8. There may be many other queries as required by individual state reporting requirements. A first query at 810 is used to identify prescriptions written by physician. The queries may be written in structured query language, natural query languages or in any other manner compatible with the database. A second query 820 is used to pull information from the database related to prescriptions by patient name. A third query 830 is used to determine prescriptions by frequency, and a n.sup.th query finds prescriptions by dose at 840. Using query languages combined with the depth of data in the central database allows many other methods of investigating for potential abuse of the drugs. The central database ensures that all prescriptions, prescribers and patients are tracked and subject to such investigations. In further embodiments, the central database may be distributed among multiple computers provided a query operates over all data relating to such prescriptions, prescribers and patients for the drug.

[0055] An example of one prescription and enrollment form is shown at 900 in FIG. 9. As previously indicated, several fields are included for prescriber information, prescription information and patient information.

[0056] FIG. 10 is a copy of one example NORD application request form 1000 used to request that an application be sent to a patient for financial assistance.

[0057] FIG. 11 is a copy of one example application 1100 for financial assistance as requested by form 1000. The form requires both patient and physician information. Social security number information is also requested. The form provides information for approving the financial assistance and for tracking assistance provided.

[0058] FIG. 12 is a copy of one example voucher request for medication for use with the NORD application request form of FIG. 10. In addition to patient and physician information, prescription information and diagnosis information is also provided.

[0059] FIGS. 13A, 13B and 13C are descriptions of sample reports obtained by querying a central database having fields represented in FIG. 7. The activities grouped by sales, regulatory, quality assurance, call center, pharmacy, inventory, reimbursement, patient care and drug information. Each report has an associated frequency or frequencies. The reports are obtained by running queries against the database, with the queries written in one of many query languages.

[0060] While the invention has been described with respect to a Schedule III drug, it is useful for other sensitive drugs that are DEA or Federally scheduled drugs in Schedule II-V, as well as still other sensitive drugs where multiple controls are desired for distribution and use.

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