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.

Description:
RELATED APPLICATIONS 
     This application is a divisional application of U.S. patent application Ser. No. 10/322,348, filed Dec. 17, 2002, now U.S. Pat. No. 7,668,730 which application is incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to distribution of drugs, and in particular to the distribution of sensitive drugs. 
     BACKGROUND OF THE INVENTION 
     Sensitive drugs are controlled to minimize ensure that they are not abuse and 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. 
     Certain agents, such as gamma hydroxy buterate (GHB) are also abused, yet also are effective for theraputic 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. 
     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 
     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. 
     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&#39;s tracking system is used to confirm delivery in further embodiments. If a shipment is lost, an investigation is launched to find it. 
     In one embodiment, the drug may be shipped by the central pharmacy to another pharmacy for patient pick-up. The second pharmacy&#39;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. 
     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. 
     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 
         FIG. 1  is a block diagram of a computer system for use in implementing the system and method of the present invention. 
         FIGS. 2A ,  2 B and  2 C are a flowchart describing a method for sensitive drug distribution at least partially utilizing a computer system such as that shown in  FIG. 1 . 
         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 . 
         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 . 
         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 . 
         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 . 
         FIG. 7  is a block diagram of database fields. 
         FIG. 8  is a block diagram showing a list of queries against the database fields. 
         FIG. 9  is a copy of one example prescription and enrollment form. 
         FIG. 10  is a copy of one example of a NORD application request form for patient financial assistance. 
         FIG. 11  is a copy of one example voucher request for medication for use with the NORD application request form of  FIG. 10 . 
         FIG. 12  is a copy of certificate of medical need. 
         FIGS. 13A ,  13 B and  13 C are descriptions of sample reports obtained by querying a central database having fields represented in  FIG. 7 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     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. 
     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. 
     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 4 H 7 NaO 3 ) which is useful for treatment of cataplexy in patients with narcolepsy. GHB is marketed under the trademark of Xyrem® (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. 
     In one embodiment, Xyrem® 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. 
     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® 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. 
       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. 
       FIGS. 2A ,  2 B and  2 C 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. 
     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&#39;s appropriate dosage, and number of refills allowed, along with a line for the prescriber&#39;s signature. Patient insurance information is also provided. 
     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®. 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. 
     If the information is complete at  212 , the MD is contacted at  220  to verify receipt and accuracy of the patient&#39;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. 
     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&#39;s prescription. If coverage is approved at  228 , the intake reimbursement specialist also submits the coveral approval form with the enrollment form to the pharmacy team as notification to process the patient&#39;s prescription. Processing of the prescription is described below. 
     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® success packet via mail. In one embodiment, the Xyrem® 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&#39;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 . 
     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 . 
     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. 
     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. 
     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. 
     At  250 , the pharmacist schedules the patient&#39;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&#39;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&#39;s designee who is at least 18 years old, must sign for the package upon delivery. 
     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. 
     As noted at  266 , for the sensitive drug, Xyrem, all inventory is cycle counted an reconciled with the database system quantities before shipments for the day are sent. This provides a very precise control of the inventor. 
     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 . 
     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. 
     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 . 
     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 . 
     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&#39;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 . 
     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&#39;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 . 
     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 . 
     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. 
     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 . 
     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&#39;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 . 
     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. 
     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 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. 
     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. 
       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. 
       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. 
       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. 
       FIGS. 13A ,  13 B and  13 C 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. 
     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.