3 m
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`I10131.1.8.PTO\
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`11/09708‘
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`9831.IA
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`SOL0170
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`ST‘I
`§e Patent Application of: Dayton T. Reardan et al.
`TitlefiENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`Attorney Docket No.:
`101.031US4
`Customer No.: 21186
`
`PATENT APPLICATION TRANSMITTAL
`
`Commissioner for Patents
`PO. Box 1450
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`Alexandria, VA 22313-1450
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`We are transmitting herewith the following attached items and information (as indicated with an "X"):
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`|><|><|><|><
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`X X |
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`><|><|><|><|><|><|><|><
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`Return postcard.
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`10/322 348)
`(under 37 CFR l.53(b)) comprising:
`CONTINUATION of prior Patent Application No.(
`Specification (fipgs, including claims numbered _1_ through 25 and a _1_ page Abstract).
`Formal Drawing(s) (E sheets).
`Copy of signed Combined Declaration and Power of Attorney (4 pgs) from prior application.
`Incorporation by Reference: The entire disclosure ofthe prior application, from which a copy ofthe oath or declaration is
`supplied herewith, is considered as being part ofthe disclosure ofthe accompanying application and is hereby
`incorporated by reference therein.
`Prior application is assigned of record to Orphan Medical, Inc..
`Pre-Examination Statement for Petition to Make Special Under 37 CFR 1.102(d) (6 pgs.)
`Petition to Make Special Under 37 CFR 1.102(d) (1 pg.)
`Appendix I (1 pg.).
`Preliminary Amendment (7pgs.).
`Information Disclosure Statement (2 pgs); PTO 1449 (2 pgs.).
`Authorization to Charge Deposit Account No. 19-0743 in the amount of $500.00 for the filing fee.
`Authorization to Charge Deposit Account No. 19-0743 in the amount of $ 130.00 for the petition fee.
`The filin_ fee OT ENCLOSED) will be calculated as follows:
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`TOTAL CLAIMS
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`-—
`INDEPENDENTCLAIMS -— x 100.00 =
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`x 25.00 =
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`[]MULTlPLE DEPENDENT CLAIMS PRESENTED
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`$0.00
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`$0.00
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`$0.00
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`$500.00
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`THE FILING FEE WILL BE PAID UPON RECEIPT OF THE NOTICE TO FILE MISSING PARTS.
`
`
` SCHWEGMAN LUNDBERG WOESSNER&KLUTH P.A.
`
`TOTAL
`
`Customer Number: 21186
`
`
`
`By: 4 21¢ fl/fi
`
`Atty: Bradley
`Reg. No. 30,837
`
`.Forrest
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`"Express Mail" mailing label number: EV 553 984 061 US
`Date of Deposit: April 1, 2005
`This paper or fee is being deposited on the date indicated above with the United States Postal Service pursuant to 37 CFR 1.10, and is addressed to The Commissioner
`for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
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`10
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`Sensitive Drug Distribution System and Method
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`Field of the Invention
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`The present invention relates to distribution of drugs, and in particular to the
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`distribution of sensitive drugs.
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`Background of the Invention
`Sensitive drugs are controlled to minimize risk and ensure that they are not
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`abused, or cause adverse reactions. Such sensitive drugs are approved for specific uses
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`by the Food and Drug Administration, and must be prescribed by a licensed physician in
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`order to be purchased by consumers. Some drugs, such as cocaine and other common
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`street drugs are the object of abuse and illegal schemes to distribute for profit. Some
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`schemes include Dr. shopping, diversion, and pharmacy thefts. A locked cabinet or safe
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`15
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`is a requirement for distribution of some drugs.
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`Certain agents, such as gamma hydroxy buterate (GHB) are also abused, yet also
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`are effective for therapeutic purposes such as treatment of daytime cataplexy in patients
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`with narcolepsy. Some patients however, will obtain prescriptions fiom multiple doctors,
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`and have them filled at different pharmacies. Still further, an unscrupulous physician
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`may actually write multiple prescriptions for a patient, or multiple patients, who use cash
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`to pay for the drugs. These patients will then sell the drug to dealers or others for profit.
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`There is a need for a distribution system and method that directly addresses these
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`abuses. There is a further need for such a system and method that provides education and
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`limits the potential for such abuse.
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`Summary of the Invention
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`A drug distribution system and method utilizes a central pharmacy and database
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`to track all prescriptions for a sensitive drug. Information is kept in a central database
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`regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving
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`the drug. Abuses are identified by monitoring data in the database for prescription
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`patterns by physicians and prescriptions obtained by patients. Further verification is
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`Docket
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`made that the physician is eligible to prescribe the drug by consulting a separate database
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`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
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`brought against the physician. Multiple controls beyond those for traditional drugs are
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`imposed on the distribution depending on the sensitivity of the drug.
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`Education is provided to both physician and patient. Prior to shipping the drug
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`for the first time, the patient is contacted to ensure that product and abuse related
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`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
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`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
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`delivery in fiirther embodiments. If a shipment is lost, an investigation is launched to
`find it.
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`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.
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`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
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`prescription, and will also cause a review or full investigation.
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`The exclusive central database contains all relevant data related to distribution of
`the drug and process ofdistributing 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.
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`FIG. 1
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`Brief Description of the Drawings
`is a block diagram of a computer system for use in implementing the
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`system and method of the present invention.
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`FIGS 2A, 2B and 2C are a flowchart describing a method for sensitive drug distribution
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`at least partially utilizing a computer system such as that shown in FIG. 1.
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`FIG. 3
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`is a flowchart of a physician success program at least partially
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`implemented on a computer system such as that shown in FIG. 1.
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`FIGS 4A and 4B are a flowchart describing a method for handling refill requests at least
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`partially utilizing a computer system such as that shown in FIG. 1.
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`FIG. 5
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`is a flowchart of a process for requesting special reimbursement when a
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`patient is uninsured or underinsured at least partially utilizing a computer
`system as that shown in FIG. 1.
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`10
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`FIG. 6
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`is a flowchart of a process for inventory control at least partially utilizing a
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`FIG. 7
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`FIG. 8
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`FIG. 9
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`computer system such as that shown in FIG. 1.
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`is a block diagram of database fields.
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`is a block diagram showing a list of queries against the database fields.
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`is a copy of one example prescription and enrollment form.
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`FIG. 10
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`is a copy of one example of a NORD application request form for patient
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`financial assistance.
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`FIG. 11
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`is a copy of one example voucher request for medication for use with the
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`NORD application request form of FIG. 10.
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`FIG. 12
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`is a copy of certificate of medical need.
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`FIG.s 13A, 13B and 13C are descriptions of sample reports obtained by querying a
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`central database having fields represented in FIG. 7.
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`Detailed Description of the Invention
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`In the following description, reference is made to the accompanying drawings that
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`form a part hereof, and in which is shown by way of illustration specific embodiments in
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`which the invention may be practiced. These embodiments are described in sufficient
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`detail to enable those skilled in the art to practice the invention, and it is to be understood
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`that other embodiments may be utilized and that structural, logical and electrical changes
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`may be made without departing from the scope of the present invention. The following
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`description is, therefore, not to be taken in a limited sense, and the scope of the present
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`invention is defined by the appended claims.
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`The functions or algorithms described herein are implemented in software or a
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`combination of software and human implemented procedures in one embodiment. The
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`software comprises computer executable instructions stored on computer readable media
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`such as memory or other type of storage devices. The term “computer readable media” is
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`also used to represent carrier waves on which the software is transmitted. Further, such
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`functions correspond to modules, which are software, hardware, firmware of any
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`combination thereof. Multiple functions are performed in one or more modules as
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`desired, and the embodiments described are merely examples. The software is executed
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`on a digital signal processor, ASIC, microprocessor, or other type of processor operating
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`on a computer system, such as a personal computer, server or other computer system.
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`A sensitive drug is one which can be abused, or has addiction properties or other
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`properties that render the drug sensitive. One example of such a drug is sodium oxybate,
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`also known as gamma hydroxy butyrate (GHB C4H7Na03) which is useful for treatment
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`of cataplexy in patients with narcolepsy. GHB is marketed under the trademark of
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`Xyrem® (sodium oxybate oral solution), which trademark can be used interchangeably
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`with GHB herein. Sensitive drugs also include narcotics or other drugs which require
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`controls on their distribution and use to monitor behaviors to prevent abuse and adverse
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`side effects.
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`In one embodiment, Xyrem® is subject to a restricted distribution program. One
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`aspect of the program is to educate physicians and patients about the risks and benefits of
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`Xyrem, including support via ongoing contact with patients and a toll free helpline.
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`Initial prescriptions are filled only afier a prescriber and patient have received and read
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`the educational materials. Further, patient and prescribing physician registries are
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`maintained and monitored to ensure proper distribution.
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`In a further embodiment, bulk sodium oxybate is manufactured at a single site, as
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`is the finished drug product. Following manufacture of the drug product, it is stored at a
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`facility compliant with FDA Schedule III regulations, where a consignment inventory is
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`maintained. The inventory is owned by a company, and is managed by a central
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`pharmacy, which maintains the consignment inventory. Xyrem® is distributed and
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`dispensed through a primary and exclusive central pharmacy, and is not stocked in retail
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`pharmacy outlets. It is distributed by overnight carriers, or by US mail in one
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`embodiment to potentially invoke mail fraud laws if attempts of abuse occur.
`FlG. 1 is a simplified block diagram of a computer system 100, such as a personal
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`computer for implementing at least a portion of the methods described herein. A central
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`processing unit (CPU) 110 executes computer programs stored on a memory 120.
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`Memory 120 in one embodiment comprises one or more levels of cache as desired to
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`speed execution of the program and access to data on which the programs operate. The
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`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, 1/0 150 and communications 160 are also
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`coupled to the bus 130. Storage 140 is usually a long term storage device, such as a disk
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`drive, tape drive, DVD, CD or other type of storage device. In one embodiment, storage
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`140 is used to house a database for use with the present invention. 1/0 150 comprises
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`keyboards, sound devices, displays and other mechanisms by which a user interacts with
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`the computer system 100. Communications 160 comprises a network, phone connection,
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`local area network, wide area network or other mechanism for communicating with
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`external devices. Such external devices comprise servers, other peer computers and other
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`devices. In one embodiment, such external device comprises a database server that is
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`used in place of the database on storage 140. Other computer system architectures
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`capable of executing software and interacting with a database and users may also be used.
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`Appropriate security measures such as encryption are used to ensure confidentiality.
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`Further, data integrity and backup measures are also used to prevent data loss.
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`FIG.s 2A, 2B and 2C represent an initial prescription order entry process for a
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`sensitive drug, such as Xyrem. At 202, a medical doctor (MD) sends a Rx/enrollment
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`form via mail, fax, email or other means to an intake/reimbursement specialist at 204,
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`who makes a copy of the RX/enrollrnent form that is stamped “copy”. The original fax is
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`forwarded to a pharmacy team. The enrollment form contains prescriber information,
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`prescription information, checkboxes for the prescriber indicating they have read
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`materials, educated the patient, understand the use in treatment, and understand certain
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`safety information, and also contains patient information.
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`The prescriber information contains standard contact information as well as
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`license number, DEA number and physician specialty. Patient and prescription
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`information includes name, social security number, date of birth, gender, contact
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`information, drug identification, patient’s appropriate dosage, and number of refills
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`allowed, along with a line for the prescriber’s signature. Patient insurance information is
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`also provided.
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`There are two workflows involved at the pharmacy team, intake reimbursement
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`206 and pharmacy workflow 208, which may proceed in parallel or serially. The intake
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`work flow 206 starts with an intake reimbursement specialist entering the patient and
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`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
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`made to ensure the information is complete at 212. If not, at 214, an intake representative
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`attempts to reach the MD or prescriber to obtain the missing information. If the missing
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`information has not been obtained within a predetermined period of time, such as 24
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`hours at 216, the Rx/Enrollment form is sent back to the MD with a rejection explanation.
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`A note is entered in CHIPS that the application was rejected.
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`If the information is complete at 212, the MD is contacted at 220 to verify receipt
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`and accuracy of the patient’s Rx. This contact is recorded in CHIPS. The intake and
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`reimbursement specialist then sends a consent form and a cover letter to the patient at
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`224. The insurance provider is contacted at 226 to verify coverage and benefits. At 228,
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`a determination is made regarding coverage for the drug. If it is not available, it is
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`determined at 230 whether the patient is willing and able to pay. If not, a process is
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`performed for handling patients who are uninsured or underinsured. In one embodiment,
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`the process is referred to as a NORD process.
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`If the patient is willing and able to pay at 230, the patient is informed of the cost
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`of the product and is given payment options at 234. At 236, once payment is received,
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`the intake reimbursement specialist submits a coverage approval form with the
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`enrollment form to the pharmacy team as notification to process the patient’s
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`prescription. If coverage is approved at 228, the intake reimbursement specialist also
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`submits the coverage approval form with the enrollment form to the pharmacy team as
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`notification to process the patient’s prescription. Processing of the prescription is
`described below.
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`Upon receipt and initial processing of the prescription enrollment form and
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`sending an original to the pharmacy work flow block 208, the patient is shipped a
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`Xyrem® success packet via mail. In one embodiment, the Xyrem® success packet
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`contains educational material for a patient that advises of the proper use, care and
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`handling of the drug and consequences of diversion at 268. The medical doctor’s
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`credentials are checked to determine if the physician has a current DEA license to
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`prescribe controlled substances and if he or she has had any actions related to
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`misuse/misprescribing of controlled drugs against him or her, within a predetermined
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`time, such as three months at 270. If they have, a pharmacist holds the prescription until
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`receiving a coverage approval form from the intake reimbursement specialist at 272.
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`If the credentials have not been recently checked, the pharmacist verifies the
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`credentials and enters all findings in the database at 274. Ifthe credentials are approved
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`at 276, the physician is indicated as approved in a physician screen populated by
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`information from the database at 280. The prescription is then held pending coverage
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`approval at 282.
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`If any disciplinary actions are identified, as referenced at block 278, management
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`of the pharmacy is notified and either approves processing of the prescription with
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`continued monitoring of the physician, or processing of the prescription is not performed,
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`and the physician is noted in the database as unapproved at 284. The enrollment form is
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`then mailed back to the physician with a cover letter reiterating that the prescription
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`cannot be processed at 288. The patient is also sent a letter at 290 indicating that the
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`prescription carmot be processed and the patient is instructed to contact their physician.
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`Actual filling of the approved prescription begins with receipt of the coverage
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`approval form as indicated at 240. The patient is contacted by the pharmacy, such as by a
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`technician to complete a technician section of a patient counseling checklist. If a
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`pharmacist verifies that the program materials were not read at 242, the receipt of the
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`material is confirmed at 244 and another call is scheduled to counsel the patient before
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`the drug is shipped.
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`If the program materials were read at 242, the checklist is completed at 246 and
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`the technician transfers the patient to the pharmacist who reviews the entire checklist and
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`completes remaining pharmacist specified sections. At 248, the pharmacist indicates in
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`the database that the patient counseling and checklist was successfirlly completed,
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`indicating the date completed.
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`At 250, the pharmacist schedules the patient’s shipment for the next business day
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`or the next business day that the patient or designee is able to sign for the package.
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`Further, as indicated at 252, the shipment must be sent to the patient’s home address
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`unless the patient is traveling or has moved. In that event, the pharmacist may determine
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`that an exception may be made. The patient or the patient’s designee who is at least 18
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`years old, must sign for the package upon delivery.
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`At 254, the pharmacist enters the prescription order in the database, creating an
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`order number. The pharmacist then verifies at 256 the prescription and attaches a
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`verification label to the hard copy prescription. At 258, a pick ticket is generated for the
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`order and the order is forwarded to the pharmacy for fulfillment. The shipment is
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`confirmed in the database at 260, and the order is shipped by USPS Express Mail. Use of
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`the US mail invokes certain criminal penalties for unauthorized diversion. Optionally,
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`other mail services may be used. Potential changes in the law may also bring criminal
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`penalties into play. Following shipment, the patient is called by the central pharmacy to
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`confirm that the prescription was received.
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`As noted at 266, for the sensitive drug, Xyrem, all inventory is cycle counted and
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`reconciled with the database system quantities before shipments for the day are sent.
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`This provides a very precise control of the inventor.
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`A physician success program materials request process begins at 310 in FIG. 3.
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`At 320, the MD calls to the central pharmacy to request program materials. A special
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`phone number is provided. MD demographics, DEA number, and data or request are
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`entered into the database at 330. At 340, a request is made to ship the materials to the
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`MD via a fulfillment website, or other mechanism. The request process ends at 350.
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`A refill request process begins at 302 in FIGs 4A and 4B. There are two different
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`paths for refills. A first path beginning at 404 involves generating a report from the
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`central database of patients with a predetermined number of days or product remaining.
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`A second path beginning at 406 is followed when a patient calls to request an early refill.
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`In the first path, a copy of the report is provided to an intake reimbursement
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`specialist at 408. No sooner than 8 days before the medication depletion, a pharmacy
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`technician contacts the patient at 410 to complete the pre-delivery checklist. At 412, if
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`the patient is not reached, a message is left mentioning the depletion, and a retum number
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`at 414. A note is also entered into the database indicating the date the message was left at
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`416.
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`If the patient is reached at 412, the next shipment is scheduled at 418, the
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`prescription is entered into the database creating an order at 420, the pharmacist verifies
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`the prescription and attaches a verification label at 422 and the shipment is confirmed in
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`the database at 424. Note at 426 that the inventory is cycle counted and reconciled with
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`the database quantities before the shipments for a day or other time period are sent. A
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`pick ticket is generated for the order and the order is forwarded for fulfillment at 428,
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`with the first path ending at 430.
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`The second path, beginning at 406 results in a note code being entered into the
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`database on a patient screen indicating an early refill request at 432. The pharmacist
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`evaluates the patient’s compliance with therapy or possible product diversion, misuse or
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`over-use at 436. In one embodiment, cash payers are also identified. The pharmacist
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`then contacts the prescribing physician to alert them of the situation and confirm if the
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`physician approves of the early refill at 438. If the physician does not approve as
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`indicated at 440, the patient must wait until the next scheduled refill date to receive
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`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
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`patient screen that the physician approves the request at 446. The pharmacist notifies an
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`intake reimbursement specialist to contact the patient’s insurance provider to verify
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`coverage for the early refill at 448. If the insurance provider will pay as determined at
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`450, the specialist submits the coverage approval form as notification that the refill may
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`be processed at 452. At 454, the pharmacy technician contacts the patient to schedule
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`shipment of the product for the next business day, and the process of filling the order is
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`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
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`is willing and/or able to pay at 458. If not, the patient must wait until the next scheduled
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`refill date to receive additional product at 460. If it was determined at 458 that the patient
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`was willing and able to pay, the patient is informed of the cost of the product and is given
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`payment options at 462. Once payment is received as indicated at 464, the specialist
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`submits a coverage approval form to the pharmacy team as notification that the refill
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`request can be processed at 466. At 468, the pharmacy technician contacts the patient to
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`schedule shipment. The process of filling the order is continued at 470 by following the
`process beginning at 240.
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`A process, referred to as a NORD process in one embodiment is used to
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`determine whether donated, third party funds are available for paying for prescriptions
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`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
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`explains the NORD program to the patient and faxes an application request form to
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`NORD for the patient. At 515, the intake reimbursement specialist documents in the
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`database that an application has been received through NORD. At 520, NORD mails an
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`application to the patient within one business day.
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`A determination is made at 525 by NORD whether the patient is approved. If not,
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`at 530, NORD sends a denial letter to the patient, and it is documented in the database at
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`540 that the patient was denied by NORD. Ifthe patient is approved, NORD sends an
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`acceptance letter to the patient and faxes a voucher to the central pharmacy (SDS in one
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`embodiment) to indicate the approval at 545. At 550, an intake reimbursement specialist
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`submits a coverage approval form to the pharmacy team as notification that the patient
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`has been approved for coverage. The process of filling the order is continued at 555 by
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`following the process beginning at 240.
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`An inventory control process is illustrated in FIG. 6 beginning at 610. Each
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`week, a responsible person at the central pharmacy, such as the director of the pharmacy
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`transfers inventory for the week’s shipments to a segregated warehouse location for
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`production inventory. At 620, a purchase order is generated for the inventory transferred
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`to the production location and is sent, such as by fax, to a controller, such as the
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`controller of the company that obtained approval for distribution and use of the sensitive
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`drug. At 630, the controller invoices the central pharmacy for the product moved to
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`production. The process ends at 640.
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`The central database described above is a relational database running on the
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`system of FIG. 1, or a server based system having a similar architecture coupled to
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`workstations via a network, as represented by communications 160. The database is
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`likely stored in storage 140, and contains multiple fields of information as indicated at
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`700 in FIG. 7. The organization and groupings of the fields are shown in one format for
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`convenience. It is recognized that many different organizations or schemas may be
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`utilized. In one embodiment, the groups of fields comprise prescriber fields 710, patient
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`fields 720, prescription fields 730 and insurance fields 740. For purposes of illustration,
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`all the entries described with respect to the above processes are included in the fields.
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`In
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`further embodiments, no such groupings are made, and the data is organized in a different
`manner.
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`Several queries are illustrated at 800 in FIG. 8. There may be many other queries
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`as required by individual state reporting requirements. A first query at 810 is used to
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`identify prescriptions written by physician. The queries may be written in structured
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`query language, natural query languages or in any other manner compatible with the
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`database. A second query 820 is used to pull information from the database related to
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`prescriptions by patient name. A third query 830 is used to determine prescriptions by
`frequency, and a nth query finds prescriptions by dose at 840. Using query languages
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`combined with the depth of data in the central database allows many other methods of
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`investigating for potential abuse of the drugs. The central database ensures that all
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`prescriptions, prescribers and patients are tracked and subject to such investigations.
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`.In
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`further embodiments, the central database may be distributed among multiple computers
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`provided a query operates over all data relating to such prescriptions, prescribers and
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`patients for the drug.
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`An example of one prescription and enrollment form is shown at 900 in FIG. 9.
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`As previously indicated, several fields are included for prescriber information,
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`prescription information and patient information.
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`FIG. 10 is a copy of one example NORD application request form 1000 used to
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`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
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`requested by form 1000. The form requires both patient and physician information.
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`Social security number information is also requested. The form provides information for
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`approving the financial assistance and for tracking assistance provided.
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`FIG. 12 is a copy of one example voucher request for medication for use with the
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`NORD application request form of FIG. 10. In addition to patient and physician
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`information, prescription information and diagnosis information is also provided.
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`FIG.s 13A, 13B and 13C are descriptions of sample reports obtained by querying
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`a central database having fields represented in FIG. 7. The activities grouped by sales,
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`regulatory, quality assurance, call center, pharmacy, inventory, reimbursement, patient
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`care and drug information. Each report has an associated frequency or frequencies. The
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`reports are obtained by running queries against the database, with the queries written in
`one of many query languages.
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`While the invention has been described with respect to a Schedule IH drug, it is
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`useful for other sensitive drugs that are DEA or Federally scheduled drugs in Schedule H-
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`V, as well as still other sensitive drugs where multiple controls are desired for
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`distribution and use.
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`Claims
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`1.
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`A method of distributing a sensitive drug, the method comprising:
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`receiving prescription requests from a medical doctor, containing information
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`identifying the patient, the sensitive drug, and various credentials of the doctor;
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`entering the information into a central database for analysis of potential abuse
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`situations;
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`checking the credentials of the doctor;
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`confirming with the patient that educational material has been read prior‘to
`shipping the sensitive drug;
`‘
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`confirming receipt of the sensitive drug; and
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`generating periodic reports via the central database to evaluate potential abuse
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`patterns.
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`2.
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`The method of claim 1 wherein receipt of the sensitive drug is confirmed by
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`telephone call from the central pharmacy to the patient.
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`3.
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`The method of claim 1 and further comprising launching an investigation of lost
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`shipments.
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`4.
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`The method of claim 1 and further comprising recording the confirmation with the
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`patien