Case 2:10-Cv-06108-SDW -MCA Document “nil "MINNIE Ilflflllllllllll mm Imam.” “In“
`
`US007765107BZ
`
`: 150
`
`(12)
`
`United States Patent
`Reardan et a].
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,765,107 B2
`*Jul. 27, 2010
`
`(54)
`
`(75)
`
`SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`Inventors: Dayton T. Reardan, Excelsior, MN
`(US); Patti A. Engel, Eagan, MN (US);
`Bob Gagne, St. Paul, MN (US)
`
`(73)
`
`Assignee: JPI Commercial, LLC., Palo Alto, CA
`(US)
`
`(‘)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(1)) by 13-69 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21)
`
`Appl. No.: 11/097,985
`
`(22)
`
`Filed:
`
`Apr. 1, 2005
`
`(65)
`
`(62)
`
`(51)
`
`(52)
`(58)
`
`(56)
`
`Prior Publication Data
`
`US 2005/0216309 A1
`
`Sep. 29, 2005
`
`Related U.S. Application Data
`
`Division of application No. 10/322,348, filed on Dec.
`17, 2002, now Pat. No. 7,668,730.
`
`Int. Cl.
`(2006.01)
`G06Q [0/00
`U.S. Cl.
`............................................... 705/2; 705/3
`Field of Classification Search ..................... 705/2,
`705/3
`
`See application file for complete search history.
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,556,342 A
`4,847,764 A
`4,976,351 A ‘
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`
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`Evans
`Lester et a1.
`
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`2001/0001144 A1
`
`4/2000 Elsayedetal.
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`11/2001 Williamsetal.
`2/2002 Evans
`5/2003 Wallaceetal.
`212004 Denny
`6/2004 Williams etal.
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`5/2001 Kapp
`
`7005231
`
`(Continued)
`OTHER PUBLICATIONS
`
`NASCSA National Confirmce, (Nov. 2000),8 pages.
`
`(Continued)
`
`Primary Examiner—Gerald J. O’Connor
`Assistant Examiner—Lena Najarian
`(74) Attorney, Agent, or Firm—Schwegman, Lundberg &
`Woessner, BA.
`
`(57)
`
`ABSTRACT
`
`A drug distribution system and method utilizes a central
`pharmacy and database to track all prescriptions for a sensi-
`tive 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 monitor-
`ing data in the database for prescription patterns by physi-
`cians and prescriptions obtained by patients. Further verifi-
`cation 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.
`
`6 Claims, 16 Drawing Sheets
`
`Il-IIWIWUIAn
`,
`:r
`rm.
`.:-' 1.-
`
`
`
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`

`Case 2:10-cv-06108-SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 54 of 75 PagelD: 151
`
`US 7,765,107 B2
`Page 2
`
`US. PATENT DOCUMENTS
`
`2001/0042050 A1
`2001/0047281 A1
`2002/0010661 A1
`2002/0032581 A1
`2002/0032582 A1
`2002/0042725 A1
`2002/0042762 A1
`2002/0052762 A1
`2002/0161607 A1
`2002/0177232 A1
`2003/0033168 A1
`2003/0046110 A1
`2003/0050802 A1
`2003/0093295 A1
`2003/0110060 A1
`2003/0127508 A1
`2003/0144876 A1
`2003/0160698 A1
`2003/0197366 A1
`2003/0229519 A1
`2003/0233256 A1
`2004/0008123 A1
`2004/0019567 A1
`2004/0019794 A1
`2004/0078237 A1
`2004/0107117 A1
`2004/0117126 A1
`2004/0122712 A1
`2004/0122713 A1
`2004/0162740 A1
`2004/0176985 A1
`
`11/2001 Fletcheret a1.
`11/2001 Keresman, III etal.
`1/2002 Waddington etal.
`3/2002 Reitberg
`3/2002 Feeney, Jr. eta].
`4/2002 Mayaud
`4/2002 McQuade et al.
`5/2002 Kobylevskyetal.
`10/2002 Subich
`11/2002 Melkeretal.
`2/2003 Califanoetal.
`3/2003 Gogolak
`3/2003 layetal.
`5/2003 Lilly etal.
`6/2003 Clementi
`7/2003 Jones
`7/2003 Kosinskietal.
`8/2003 Andreasson etal.
`10/2003 Kusterbeck
`12/2003 Eidexetal.
`12/2003 Cardenasetal.
`[/2004 Carrenderet al.
`1/2004 Herceg et al.
`1/2004 Moradi et al.
`4/2004 Kaafaranietal.
`6/2004 Denny
`6/2004 Fetterman etal.
`6/2004 Hill, Sr. et al.
`6/2004 Hill, Sr. et al.
`8/2004 Ericsson et al.
`9/2004 Lilly et a1.
`
`OTHER PUBLICATIONS
`
`“Diversion Prevention Through Responsible Distribution”, NADDI
`Regional Training, (May 2001),12 pages.
`“Diversion Prevention Through Responsible Distribution", NADDI
`Regional Training Tennessee, (Jun. 2001), 14 Pages.
`“Diversion Prevention Through Responsible Distribution“, NADDI
`National Conference, (Nov. 2001),15 pages.
`
`“Peripheral and Central Nervous System Drugs Advisory Commit-
`tee", Department ofHealth and Human Services Food and Drug
`Administration Carterfor Drug Evaluation and Research, Holiday
`Inn, Bethesda. Maryland,(.lun. 6, 2001),7 pages.
`“Preliminary Amendment Pursuant to 37 CFR Sec. 1.115", U.S.
`Appl. No. 11/104,013, filed Apr. 12, 2005, (Jun. 17, 2005), 3 pgs.
`“System for Thalidomide Education and Prescribing Safety (STE.
`RS.) Starter Kit”, Celgene Corporation, (2001), 103 pgs.
`“An Interview with Orphan Medical about Xyrem", httpzl/www.
`talkaboutsleep.com/sleepdisorders/archives/
`Narcolepsy xyrem_interview.htm,('Feb. 12, 2001), 3 pgs.
`Ukens, C., “Specialty Pharmacy", Drug Topics, 144, (Jun. 5, 2000),
`40—47.
`“U.S. Appl. No. 10/322,348, Advisory Action mailed Feb. 5, 2007",
`3 pgs.
`“U.S. Appl. No. 10/322,348, Amendment and Response to Final
`Oflice Action mailed Jan. 17, 2007”, 17 pgs.
`“U.S. Appl. No. 10/322,348, Amendment and Response to Final
`Ofiice Action mailed Mar. 29, 2006”, ll pgs.
`“US. Appl. No. 10/322,348, Final Oflice Action mailed Oct. 18,
`2006", 14 pgs.
`“U.S. Appl. No. 10/322,348, Final Oflice Action mailed Dec. 29,
`2005”, ll pgs.
`“U.S.Appl.No. 10/322,348, Non Final Oflice Action mailedlun. 17,
`2005”, 26 pgs.
`“U.S.Appl.No. 10/322,348, Non Final Office Action mailed Jun. 29,
`2005”, 12 pgs.
`“US. Appl. No. 10/322,348, Non Final Ofiice Action Response
`mailed Aug. 8, 2006", 10 pgs.
`“U.S. Appl. No. 10/322,348, Preliminary Amendment mailed Sep.
`30, 2004”, ll pgs.
`“U.S. Appl. No. 10/73 1,915 Non Final Office Action mailed Oct. 5,
`2004”, 21 pgs.
`“U.S. Appl. No. 10/731,915, Non Final OfficeAction mailedAug. 12,
`2005", 22 pgs.
`“U.S. Appl. No. 10/73l,915, Non Final omce Action Response
`mailed Feb. 2, 2005", 17 pgs.
`“U.S.Appl.No. 10/73 1,915, Non Final Ofi‘ice Action mailedlun. 19,
`2006”, 18 pgs.
`“U.S. Appl. No. 11/097,651 , Non-Final Oflice Action mailed Mar. 3,
`2010”, 19 Pgs.
`* cited by examiner
`
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`

`Case 2:10-cv-06108—SDW —MCA Document 1—4
`
`Filed 11/22/10 Page 55 of 75 PageID: 152
`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 1 of 16
`
`US 7,765,107 B2
`
`100
`
`STORAGE
`
`01 4
`
`FIG.
`
`1
`
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`Case 2:10—cv-06108-SDW —MCA Document 1-4
`
`Filed 11/22/10 Page 56 of 75 PageID: 153
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 2 of 16
`
`US 7,765,107 B2
`
`MO MATES/TAXES IN Rx/ENROLUIENT FORM
`
`202
`
`204
`
`AN INTAKE/REIMBURSEMENT SPECWJST MAKE A COPY OF
`THE TEX/ENROLLMENT FORM (THE COPY IS STAMPEO
`"COPY") AND THE ORIGINAL FAX IS THEN FORWARDEO
`
`TO THE PHARMACY TEAM
`
`MO MAIlS/FAXES IN Rx/ENROLIJIENT FORM
`
`206
`
`21 0
`
`THE INTAKE/REIMBURSEMENT SPECIAUST ENTERS THE
`PATENT AND PHYSICIAN INFO INTO CHIPS
`
`212
`
`NO
`
`MEMO
`COMPLETE?
`
`YES
`
`220
`
`THE INTAKE/RHMBURSEMENI SPECIALIST CONTACTS MD
`Io VERIFY RECEIPT & ACCURACY or RE PAREIIrs Rx
`&HIISCONTACTISRECOIH)ED IN CHIPS
`
`222
`THE INTAKE/REIMBURSEMENT SPECIALIST SENDS CONSENT
`EORII AND A COVER lETTER IO IIIE PATIENT
`224
`THE IIIIAKE/RERIRORSEIIEIR SPECIAUST FAXES A
`STATEMENT or MEDICAL NECESSITY 10 THE
`m) T0 coupmg
`
`226
`
`THE INTAKE/REIMBURSBIENT SPECIAIISI CONTACTS
`RE PATIENTS INSURANCE PROVIDER Io VERIFY
`COVERAGE & BENEFITS
`
`
`
`238
`IRIARE/ROIIRORSEIIENI 500mg A COVERAGE
`
`APPROVAL FORM (SIAPIOI Io THE COPY or RE Rx
`ENROLLMENT roan] 10 THE PHARMACY TEAM As
`
`NOTIFICATION TO PROCESS THE PATIENTS Rx
`
`9
`
`214
`AN INTAKE REPRESENTATNE WILL MAKE 1 ATTEMPT TO
`REACH THE NO TO OBTAIN THE MING INFORMATION
`216
`
`THE III-RC INFORMATION HAS NOT BEEN ORIAIIIEO
`VIIIIIIN 24 HOURS. THE RIC/ENROLLMENT FORM IS FAXED
`I: A Io THE MD VIIIII A REJECTION EXPlANATION
`:-
`218
`
`IN CIIPs THAT THE
`A ROIE Is EIIIEREII
`mum" ms “hm,
`
`232
`
`SEE NORD PROCIS FOR PATIENTS
`WHO ARE UNINSURED 0R UNDERINSUREO
`
`230
`
`"0
`5 m
`mm mm, :.
`TO MY?
`
`YES
`
`234
`
`THE PAIEIII IS INEORIIEO or IHE COST OE THE
`PRODUCT AND IS CIIEII PAYMENT OPIIOIIs
`
`235
`INIAKE/RERIRURSEIIEIII
`ONCE PAYMENT IS RECEIVED,
`5000115 A COVERAGE APPROVAL FORM (STAPLED IO
`THE "COPY" OE THE Rx/ENROUMENT FORM) TO IIIE
`PHARMACY TEAM A5 NOTIFICATION IO PROCESS
`THE PATIENTS Rx
`
`
`
`
`
`
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`

`Case 2:10-cv—06108-SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 57 of 75 PagelD: 154
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 3 of 16
`
`US 7,765,107 B2
`
`208
`
`PHARMACY m now
`
`268
`
`IR mu m [S smpp
`EAXYREM succgssm
`PACKET VIA 2-0m usps
`
`270
`
`
`CREDENTIALS BEEN VERIFIED
`& APPROVED IN THE WT
`
`YES
`272
`
`
`
`
`IF ANY DISCIPUNARV ACTIONS ARE
`IOENRFIEO.
`IRE OIR OF PRARII Is
`NOIIEIEO AND TAKES ONE OF THE
`FOLLONING ACTIONS:
`- Rx IS PROCESSED AND THE
`PHARMACIST NONIIORs IRE HD.'S
`PROGRAM AEIMIV
`- Rx IS NOT PROCESSED AND
`THE MD IS NOTED AS UNAPPROVED
`
`274
`
`IRE PIRRNAOISI VERIFIES
`
`ENTERS AU. FINDINGS IN CHIPS
`
` THE ND.'S CREDENTIALS AND
`
`
`
`IRE PHARMACIST HOLDS IRE
`PAIIENrs Rx UNTIL RECEMNG
`A COVERAGE APPROVAL EORII
`FROM INTAKE/REIMBURSEMENT
`
`
`
`
`
`
`284 278
`IRE PHYSICIAN Is INDICATED
`m UNAPPROVEO IN CIfiPS
`286
`IRE IID IS CONTACTED III A
`PRARIIACISI & INIOIIIIEO IIIAI
`IRE PAIIENI's Rx CANNOT
`BE PROEEsII
`
`288
`
`THE Rx AND ENROUJIENT FOR
`IS NAILED BACK TO THE ID
`ALONG WITH A COVER LETTER
`REITERATING THAT THE Rx
`CANNOT BE PROCESSED
`29"
`
`A LETTER IS SENT TO THE
`PATIENT INDICATING THAT TIE
`Rx CANNOT BE PROCESSED &
`THE PATIENT IS INSTRUCTED TO
`
`N0
`
`276
`
`
`
`WSAEEEEEEMM
`
`
`”PW
`
`'
`280
`IRE PHYSICIAN IS INDICATED
`As APPROVED IN IRE
`PHYSICIAN SCREEN IN CIfiPS
`282
`
`THE PHARMACIST HOLDS THE
`
`
`PATIENT'S Rx UNTIL RECEMNG
`
`
`A COVERAGE APPROVAL FORM
`FROM INTAKE/REIMBURSEMENT
`
`
`
` - YES
`
`
`CONTACT HIS/HER PHYSICIAN
`
`FIG. 28
`
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`

`Case 2:10-cv-06108-SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 58 of 75 PageID: 155
`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 4 of 16
`
`US 7,765,107 B2
`
`240
`
`UPON RECEIPT OF THE COVERAGE APPRIWAL FORM FROM
`
`
`INTAKE/RHMBURSEMENT THE PHARMACY TECHNICIAN
`
`
`CONTACTS THE PATIENT TO COMPLETE THE uTECHNICIANn
`SPECIFIED SECTIONS OF THE PATIENT
`
`COUNSELING CHECKLIST
`
` 246
`
`
`AFTER COMPLETING THE SPECIFIED SECTIONS OF THE
`CHECKLIST NIIH THE PATIENT THE PHARMACY TECHNICIAN
`TRANSFERS THE CALLER TO THE PHARMACIST I'IHO
`REVIEWS THE WIRE CHECKIJST AND COMPLETES THE
`REMAINING "PHARMACIST" SPECIFIED SECTIONS
`248
`
`THE PHARMACIST INDICATES III CHIPS THAT THE PATIENT
`COUNSELING CHECKLIST WAS SJCCESSFULLY COMPLETED
`INCLUDING THE DATE COMPLETED
`
`250
`
`E PHARMACIST SCHEDULE IRE PAIIENI'S SHIPMENT Em
`IRE NEXT BUSINESS DAY 0R THE NEXT BUSINESS DAY
`
`"IE mm '5 ”W m 5'6" m“ M mm
`25"
`
`IRE PHARMACIST ENIERS THE Rx oRDER
`IN CHIPS. CREAIINC AN ORDER NUMBER
`
`256
`
`THE PHARMACIST VERIFIES THE Rx AND ATTACHES THE
`VERIFICATION LABEL TO THE HARD COPY Rx
`
`258
`
`A PICK TICKET IS CENERATED FOR THE ORDER & THE
`'RDER IS FORWARDED TO THE PHARMACY FOR FULFILLMI
`260
`
`IRE SHIPMENT Is CDIIIRIIED IN CIIPs
`
`262
`
`THE DRICINAL Rx IS RLED IIIIR IRE PRARIIACY
`Rx'S IN NUMERICAL ORDER
`
`254
`IRE ORDER [5 SHIPPED RY USPS EXPRESS MAIL
`
`244
`
`THE RECEIPT OF THE MATERIALS IS CONFIRMED AND
`ANOTHER ml IS SCHEDULED TO COUNSEL THE
`PATIENT BEFORE THE XYREM IS SHIPPED
`
`252
`THE SHIPMENT MUST BE SENT TO THE PATIENTS HOME
`ADDRESS UNLESS THE PATIENT IS TRAVEIJNC OR HE
`MOVED,
`IN WHICH CASE THE PHARMACIST HILL DETERMINE
`IF AN EXCITTION WILL BE MADE. IRE PAIIENI 0R IRE
`PARENI‘S DESICNEE MUST SIGN FOR IRE PACKAGE
`UPDN DEUVERY
`
`
`
`255
`ALL XYREM IINENIoRY Is CYCLE CDUNIED AND
`REDDNCILED IAIN IRE CHPS SYSIEN QUANTITIES
`BEFORE IRE DAYS SHIPMENTS ARE SENI DUI
`
`m FIG. 2c
`
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`

`Case 2:10-cv-06108-SDW -MCA Document 1—4
`
`Filed 11/22/10 Page 59 of 75 PageID: 156
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 5 of 16
`
`US 7,765,107 132
`
`310
`
`
`
`PHYSICIAN SUCCESS
`PROGRAM MATERIAIS
`
`
`
`REQUEST
`
`
`
`
`
`320
`
`
`
`
`
`
`MO CALLS XYREM SUCCESS
`
`
`PROGRAM AT I-866-XYREM88
`
`
`
`
`TO REQUEST PROGRAM
`
`330
`
`
`MATERIALS
`
`
`
`MD DEMOGRAPHICS, DEA}
`AND DATE or REQUEST ARE
`
`
`
`
`ENTERED mm CHIPS
`
`
`
`
`
`
`340
`
`$03 REQUESTS MATERIALS TO
`
`BE SHIPPED TO THE MD VIA
`
`
`
`
`AT WWWPRAEULFILLMENLCQM
`
`
`THE OMI FULFILLMENT WEBSITE
`
`
`
`
`
`
`
`
`350
`
`FIG. 3
`
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`

`Case 2:10—cv-06108-SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 60 of 75 PagelD: 157
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 6 of 16
`
`US 7,765,107 B2
`
`402
`
`2 POSSIBLE REFILL
`REDUESI PROCESSES
`
`404
`
`(3
`
`EACH WEEK A REFILL REPDRI IS CENERAIED or
`PAIIENIs WITH ID DAYS OF PRODUCT REMAINING
`408
`
`A COPY OF THE REFILL REPORT IS PROVIDED
`TO INIAKE/RIJNRURSENEIR
`
`410
`
`NO SOONER THAN 8 DAYS BEFORE MEDICATION
`OEPLETION, A PHARMACY TECHNICIAN CONTACTS THE
`PATIENT TO COMPLETE THE PRE-OELNERY CHECKLIST
`
`412
`
`
` THE PATIENT
`
`REACHED?
`
`"0
`
`YES
`
`418
`
`
`
`
`
`THE PHARMACY TECHNICIAN SCHEDULES THE PATTENT'S
`
`SHIPMENT FOR THE NEXT BUSINESS DAY OR THE NEXT
`BUSINESS BAY THE PATIENT IS AVAILABIE TO
`SIGN FOR THE PACKMSE
`
`420
`
`THE PHARMACIST ENTERS THE Rx ORDER
`IN CIRPS, CREATING AN ORDER NUMER
`
`A NESSACE IS LET ONLY NENIIDNINC
`$05 a A RETURN NUIIRER
`
`414
`
`416
`
`A NOTE IS flITEREO IN THE CHIPS INDICATING THE
`DATE THE MESSAGE WAS LEFT FOR THE PATIENT
`
`VERIFICATION LABEL TO THE HARD COPY Rx
`
`242
`
`424
`
`42
`
`8
`
`426
`ALL XYREN INVENTORY IS CYCLE COUNTED AND
`RECONCILED WITH THE CHIPS SYSTEM QUANTITIES
`BEFORE THE MS SHIPMENTS ARE SENT OUT
`
`IS CEIIERAIED FOR THE ORDER a IRE
`A PICK IICI<EI
`II-‘II R IS EDINIIARDED 10 THE PHARMACY FOR FUIFILUII
`
`430
`
`FIG. 4A
`
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`

`Case 2:10-cv-06108—SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 61 of 75 PageID: 158
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 7 of 16
`
`US 7,765,107 B2
`
`406
`
`IRE PARENI mus TO REOOESI AN EARLY REPILL
`432
`A NOIE CODE IS ENIERED IN CHIPS ON IRE PAIIENI
`SCREEN LNDICAIINC IRE EARLY REELLL REOUESI
`
`CROPS. THE REPORI IS IREN FAXED IO ONI & IRE 435
`
`434
`A YYREN PROBLEM IDENTIFICATION & NANACENENI RISK
`DIVERSION REPORI IS CONPLEIED & DOCONENIED IN
`
`DRICINAL IS EILED IN A NONIRLY BATCH ELLE
`
`THE PHARMACIST EVALUATES THE PATIENI'S
`COMPLIANCE WITH THERAPY AND/OR POSSIBLE PRODUCT
`DIVERSION. MISUSE 0R OVERUSE
`
`"IE mm“ “was “IE PRESCR'BM
`PHYSICIAN ID ALERI OF IRE SRUARON AND CONRRN
`IF IRE PHYSICIAN APPROVES OF IRE EARLY REFILL
`
`IRE PAIIENI MUST NAN DNIIL IRE NEXT SCHEDULED
`REM M m REM mmm mm
`
`440
`DOES
`
`
`THE PHYSICIAN
`
`
`APPROVE?
`
`
`
`W
`
`THE PHARMACIST ENTERS A NOTE IN CHIPS
`IN THE PATIENT SCREEN THAT THE PIWSICIAN
`APPROVES THE REQUEST
`
`448
`THE PHARNACISI NOTIFIES AN INTAKE/REIMBURSEMENT
`SPECNDSI IO CONIACI IRE PAIIENI'S INSURANCE
`PM” 1° m" comm “’R M [W Rm”
`450
`
`m
`IN
`RAN
`P
`R
`
`5”
`CE ROWE
`
`YES
`
`452
`
`m
`
`444
`
`460
`
`REFILL DATE TO RECEIVE ADDITIONAL PRODUCT
`
`458
`
`"0
`IS THE
`PAIIENI NILL IO
`
`PAY?
`452
`YEs
`THE PATIENT IS INEORNED 0F IRE COST OF IRE
`PRODOCI AND IS CNEN PAYNENI OPOONS
`
`ONCE PAYNENI
`
`464
`IS RECEIVED IRE ORDER Is Rflmfl)
`
`466
`
`INTAKE/REIMBURSEMENT SOBNRS A COVERACE APPROVAL
`EORN ID IRE PRARNACY TWA AS NDIIEICAIION IRAI
`IRE PAILENI'S REEILL REOUESI CAN BE PROCESSED
`454
`
`INIANE/RELNLIURSENENI SUBMITS A COVERAGE APPROVAL
`FORM TO THE PRARNACY TEAM As NOIIPICAIION IRAI
`IRE PAIIENI'S REFILL REOOESI CAN BE PROCESSED
`468
`
`THE PHARMACY TECHNICIAN CONTACTS THE PATIENT T0
`
`
`SCHEDUE SHIPMENT OF THE PRODUCT FOR THE NEXT
`
`BUSINESS DAY OR THE NEXT BUSINESS DAY THE PATIENT
`
`IS AVAILABLE TO SIGN FOR THE PACKAGE
`
`
`
`
`
`
`THE PHARMACY TECHNICIAN CONTACTS THE PATIENT T0
`SCHEDUIE SHIPMENT OF THE PRODUCT FOR THE NEXT
`BUSINESS DAY OR THE NEXT BUSINESS DAY THE PATIENT
`IS AVAILABIE TO SIGN FOR THE PACKAGE
`
`456
`
`470
`
`FIG. 4B
`
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`

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`
`Filed 11/22/10 Page 62 of 75 PageID: 159
`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 8 of 16
`
`US 7,765,107 B2
`
`510
`
`
`
`
`
`UPON DETERMINING THAT A PATIENT IS UNINSURED 0R
`
`UNDERINSURED, A REIMBURSEMENT SPECIAUST EXPIAINS
`
`THE NORD PROGRAM TO THE PATIENT AND FAXES AN
`APPUGATIDN REQUEST FORM TO NORD FOR THE PATIENT
`
`515
`
`
`
`THE INTAKE/REIMBURSEMENT SPECIALIST DOCUMENTS
`IN CHIPS THAT AN APPUMTIDN HAS BEEN REOUESTED
`THROUGH NORD
`
`520
`
`NORD MAILS A PAP APPUCATION to THE
`PATIENT mm 1 BUSINESS on
`
`525
`
`IS
`no
`THE WENI
`
`APPROVED?
`
`YES
`
`NORD SENDS A DENIAL LETTER to THE PATIENT
`
`530
`
`545
`
`540
`
`SDS DOCUMENTS IN CHIPS THAT
`THE PATIENT WAS DENIED BY NDRD
`
`NORD SENDS AN ACCEPTANCE LETTER TO THE
`PATIENT AND FAXES A VOUCHER TD SDS INDIGATING THE
`PATIENTS APPROVAL FOR THE PROGRAM
`
`550
`
`
`
`AN INTAKE/REIMBURSEMENT SPECIAIJST SUBMTTS A
`
`COVERAGE APPROVAL FORM TO THE PHARMACY TEAM AS
`
`
`NOTIFICATION THAT THE PATIENT HAS BEEN APPROVED
`FOR COVERAGE THROUGH NORD
`
`
`
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`
`Filed 11/22/10 Page 63 of 75 PagelD: 160
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 9 of 16
`
`US 7,765,107 B2
`
`236
`
`1 WEEK. THE DIRECTOR OF PHARMACY TRANSEE'
`INVENTORY FOR THE WEEK'S SHIPMENTS TO A
`SEGREGATED WARBIOUSE LOCATION
`FOR PRODUCTION INVENTORY
`
`A PURCHASE ORDER IS CENERATED FOR THE
`INVENTORY TRANSFERRED TO THE PRODUCTION
`LOCATION & IS FAXED TO THE DUI CONTROLLER
`
`THE PRODUCT MOVED TO PRODUCTION
`
`THE OUI CONTROLLER INVOICES SDS FOR
`
`FIG. 6
`
`700
`
`800
`
`PRESCRIBER FIELDS
`
`PATIENT FIELDS
`
`PRESCRIPTION FIHDS
`
`
`
`
`720
`
` 710
`
`
`730
`
`INSURANCE FIELDS
`
`74o
`
`OUHIY I - PRESCRIPTIONS BY PHYSICIAN
`
`810
`
`OUERY 2 - PRESCRIPITONS BY PATIENT NAME
`
`820
`
`830
`
`OUHIY 3 - PRESCHPTIONS BY FREQUENCY
`
`QUERY N - PRESCRIPTIONS BY DOSE
`
`840
`
`FIG. 7
`
`FIG. 8
`
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`

`Case 2:10-cv-06108-SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 64 of 75 PagelD: 161
`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 10 of 16
`
`US 7,765,107 B2
`
`PRESCRIPTION AND ENROLLMENT FORM /
`
`PRESCRIBER INFORMATION
`
`900
`
`PRESCRIBER'S NAME:________ OFFICE CONTACT:
`STREET ADDRESS:
`CITY:____________ STATE
`PHONE:______________..________.___
`FAX:
`UCENSE NUMBER:_—________ DEA NUMBER:
`MD SPECIALTY:
`
`PRESCRIPTION FORM
`
`PATIENT NAME:__—____ SSE: _____.. DOB:
`ADDRESS:
`
`cm; __—_______ sme—__ ZIP:
`Rx: XYREM ORAL SOLUTION (500 mg/ml) 130 Ml. BOTTLE OUANTITY:
`MONTHS SUPPLY
`SIG: TAKE _GMS P.O. OILUTED IN 60 mL WATER AT HS. AND THEN AGAIN 2 I/2 TO 4 HOURS lATER
`REFILLS (CIRCLE ONE):
`0
`I
`2
`(MAXIMUM OF 3 MONTH SUPPLY)
`___—__— DATE: __/__ /__.
`PRESCRIBER'S SIGNATURE
`
`PHYSICIAN DECLARATION-PLEASE CHECK EACH BOX
`
`TO BE COMPIEIED AT INITIAL PRESCRIPTION ONLY
`
`I: I HAVE READ THE MATERIALS IN THE XYREN PHYSICIAN SUCCESS PROGRAM
`
`[:1 I VERIFY THAT THE PATIENT HAS BEEN EOUCATEO WITH RESPECT TO XYREN PREPARATION. DOSING AND SCHEDUUNG.
`I: I UNDERSTAND THAT XYREM IS APPROVED FOR THE TREATMENT OF CATAPLEXY IN PATIENTS WITH NARCOLEPSY.
`AND THAT SAFETY OR EFFICACY HAS NOT BEEN ESTABUSHED FOR ANY OTHER INOICATION.
`l:] I UNDERSTAND THAT THE SAFETY OF DOSES GREATER THAN gym/DAY HAS NOT flN ESTABIJSHED
`
`
`
`PATIENT INFORMATION
`
`BEST TIME TO CONTACT PATIENT: CI DAY CI NIGHT
`DAY I:—______ EVENING 5:
`INSURANCE COMPANY NAME: _— PHONE A:
`INSUREUS NAME: __—____._ RELATDNSHIP T0 PATIENT:
`IDENTIFICATION NUMBER:___.______ POUCY/GROUP NUMBER:
`PRESCRIPTION CARD: CI N0 CI YES
`IF YES. CARRIER: __________ POLICY 3:
`
`PLEASE ATTACH COPIES OF PATIENTS INSURANCE CARDS
`
`FAX COMPLETED FORM TO XYREM SUCCESS PROGRAM (TOLL-FREE) T-856-470-I744
`FOR INFORMATION. CALL THE XYREN TEAM (TOLL FREE) AT I-856-XYREM88 (1-866-997-3588)
`
`FIG. 9
`
`ROX 1001
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`

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`
`Filed 11/22/10 Page 65 of 75 PageID: 162
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 11 of 16
`
`US 7,765,107 B2
`
`PATIENT ASSISTANCE APPLICATION REQUEST FORM
`
`1000
`
`/
`
`DATE:
`
`T0:
`
`PATIENT ASSISTANCE ORGANIZATION
`
`FROM:
`
`$05
`
`FAX 3:
`
`203-798-2291
`
`PLEASE SEND A XYREM PATIENT ASSISTANCE PROGRAM APPLICATION TO.
`
`PATIENT NAME
`
`ADDRESS
`
`
`(GRATIS) TWICE NIGHTLY FOR A 1011 DOSAGE or- ._..
`
`(GRAMS)
`
`)
`
`TELEPHONE:
`
`(
`
`PATIENT DOSAGE:
`
`
`BOTTLES (THREE uonms SUPPLY)
`
`BACKGROUND INFORMATION:
`
`
`
`
`
`FIG. 10
`
`ROX 1001
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`

`Case 2:10-cv-06108-SDW -MCA Document 1—4
`
`Filed 11/22/10 Page 66 of 75 PageID: 163
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 12 of 16
`
`US 7,765,107 B2
`
`SENSITIVE DRUG PATIENT ASSISTANCE PROGRAM 200
`
`VOUCHER REQUEST FOR MEDICATION
`
`PATIENT INTDRHADDN
`(HRST NATIE><UIST NANE>
`<ADDRESS 1>
`(ADDRESS 2>
`
`(CITY. STATE ZIP CODE)
`
`PHONE: (123-455-7010
`DD_B: 01/01/1900
`Si 123-15—5709
`W 10071
`LRIL 03/01/2001
`
`DRUC
`XYREEM 180111th
`
`
`CASE CODE mm"
`
`DUANTITY
`1
`
`PHYSICIAN INTDRHATIDN
`<PHYSIC1AN NAIIE>
`<ADDRESS 1>
`<ADDRESS 2>
`
`<CITY, STATE ZIP CDDE>
`
`PHONE (123—456—7890
`
`TIRST SHIPMENT THIS YEAR
`
`mPHARIIACY USP”
`
`VALIDAITDN DATE:
`EXPIRATION DAIE:
`ISSUE DATE
`
`APPRDIIED
`
`
`
`03/01/2001
`05/31/2001
`03/15/2001
`
`NORD coPY
`*$*#*******i*3********#***#***********#**i*****i****i**
`
`(DEIACH HIRE)
`
`PATIENT INTDRIAATIDN
`<HRST NANExIAST NAHE>
`<ADDRESS I>
`<ADDRESS 2>
`
`mm. STATE ZIP CDDE>
`
`PHONE: 023-455-7090
`m 01/01/1900
`Sfl 123-45-5739
`01100 ALIDTHENT: 1002
`[Lt 03/01/2001
`
`
`CASE CDDE: "W"
`
`DRUC
`011011801111th
`
`DUANTITY
`1
`
`VALIDATION DATE
`EXPIRATION DATE:
`ISSUE DATE-
`
`APPROVED
`
`03/01/2001
`05/31/2001
`03/15/2001
`
`PHYSICIAN INTDRIIATTDN
`(PHYSICIAN NAHE>
`(ADDRESS 1)
`<ADDRESS 2)
`
`<CITY, STATE ZIP CDDE>
`
`PHONE:
`
`(123—456—7890
`
`FIRST SHIPMENT THIS YEAR
`
`'"PHARMACY USE.”
`
`ROX 1001
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`

`Case 2:10-cv-06108-SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 67 of 75 PageID: 164
`
`US. Patent
`
`Jul. 27, 2010
`
`Sheet 13 of 16
`
`US 7,765,107 B2
`
`1200
`
`/
`
`SENSITIVE DRUG PHYSICIAN'S CERTIFICATE
`
`OF MEDICAL NEED
`
`PATIENT INFORMATION
`
`DATE:
`
`NAME
`
`' LAST
`
`IIIIIE or 31le
`
`FIRST
`
`II
`
`DRUG BEING PRESCRIBED: XYREM
`
`DIAGNOSIS/CONDITION FOR WHICH DRUG IS BEING PRESCRIBED:
`
`[CD-9:
`
`PHYSICIAN INFORMATION
`
`PHYSICIANS NAME (PLEASE PRINT):
`
`PHYSICIANS SIGNATURE: _.__________ DATE:
`
`PLEASE EAX BACK TO SENSITIVE DRUG SUCCESS PROGRAM: (I-800—TOLl FREE NUMBER)
`
`FIG. 12
`
`ROX 1001
`CBM of U.S. Patent No. 7,765,107
`15 of 23
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`

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`

`Case 2:10-cv-06108-SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 69 of 75 PagelD: 166
`
`US. Patent
`
`Jul. 27
`
`9
`
`2010
`
`Sheet 15 of 16
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`US7
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`18 of 23
`
`
`

`

`Case 2:10-cv-06108-SDW -MCA Document 1-4
`
`Filed 11/22/10 Page 71 of 75 PageID: 168
`
`US 7,765,107 B2
`
`1
`SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`RELATED APPLICATION
`
`This application is a divisional application of US. patent
`application Ser. No. 10/322,348, filed Dec. 17, 2002, now
`US. 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 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 phar-
`macy 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 therapeutic purposes
`such as treatment of daytime cataplexy in patients with nar-
`colepsy. Some patients however, will obtain prescriptions
`from multiple doctors, and have them filled at difi‘erent phar-
`macies. Still fiuther, 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.
`
`SUIVIMARY OF THE INVENTION
`
`A drug distribution system and method utilizes a central
`pharmacy and database to track all prescriptions for a sensi-
`tive 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 monitor-
`ing data in the database for prescription patterns by physi-
`cians and prescriptions obtained by patients. Further verifi-
`cation 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 relat-
`ing to controlled substances have been brought against the
`physician. Multiple controls beyond those for traditional
`drugs are imposed on the distribution depending on the sen-
`sitivity 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 ofa 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
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`courier service’s tracking system is used to confirm delivery
`in further embodiments. Ifa 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 sec-
`ond 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.
`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 ofthe
`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 inven-
`tion.
`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.
`FIG. 3 is a flowchart ofa 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 enroll-
`ment 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, 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
`
`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
`
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`

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`
`Filed 11/22/10 Page 72 of 75 PagelD: 169
`
`US 7,765,107 B2
`
`3
`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 imple-
`mented in software or a combination of software and human
`implemented procedures in one embodiment. The software
`comprises computer executable instructions stored on com~
`puter 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 pro-
`cessor, 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 addic-
`tion properties or other properties that render the drug sensi-
`tive. One example of such a drug is sodium oxybate, also
`known as gamma hydroxy butyrate (GHB C4H7Na03) which
`is useful for treatment of cataplexy in patients with narco-
`lepsy. 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 ofthe program is to educate
`physicians and patients about the risks and benefits ofXyrem,
`including support via ongoing contact with patients and a toll
`free helpline. Initial prescriptions are filled only after a pre-
`scriber and patient have received and read the educational
`materials. Further, patient and prescribing physician regis-
`tries are maintained and monitored to ensure proper distribu-
`tion.
`In a further embodiment, bulk sodium oxybate is manufac-
`tured at a single site, as is the finished