(12) Unlted States Patent
`(10) Patent N0.:
`US 7,668,730 B2
`
`Reardan et a1.
`(45) Date of Patent:
`*Feb. 23, 2010
`
`USOO7668730B2
`
`6,347,329 131
`6,564,121 Bl
`6,755,784 132
`6,952,681 132*
`7,058,584 132*
`2001/0001144 A1
`2001/0042050 A1
`2001/0047281 A1
`2002/0010661 A1*
`
`2/2002 Evans ......................... 709/202
`5/2003 Wallace et a1,
`............ 600/300
`6/2004 Williams et a1,
`.
`.. 705/28
`10/2005 McQuade et a1.
`
`. 705/2
`6/2006 Kosinskietalr
`705/3
`5/2001 Kapp
`11/2001 Fletcheretal.
`......
`.. 705/64
`
`11/2001 Keresman, 111 et a1.
`705/2
`1/2002 Waddington et a1.
`.......... 705/28
`
`2002/0032581 A1
`2002/0032582 A1
`
`3/2002 Reitberg ........................ 705/2
`3/2002 Feeney, Jr. et a1.
`............. 705/2
`
`.
`(Continued)
`OTHER PUBLICATIONS
`
`Ukens, C. “Specialty Pharmacy," Jun. 5,2000, Drug Topics, V. 144, p,
`40*
`
`(Continued)
`Primary ExamineriGerald J. O’Connor
`Assistant ExamineriLena Naj arian
`(74) Attorney, Agent, or Firmischwegman, Lundberg &
`Woessner, RA.
`
`(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
`phys1c1ans allowed to prescribe the sens1tive 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
`'
`
`11 Claims, 16 Drawing Sheets
`
`(54) SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`(75)
`
`Inventorsz Dayton T-ReardansExcelsiorJVH‘T
`(US); PattlEngle: Eagan, MN (US);
`30b Gagne: St-PaulsMNwS)
`.
`.
`(73) ASSlgnee‘ ggéfommerc‘al’ LLC"Pa1°Alt°’ CA
`
`( 5x: ) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 446 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21) App1.N0.: 10/322,348
`
`(22) Filed:
`
`Dec. 17, 2002
`
`(65)
`
`Prior Publication Data
`US 2004/0117205 A1
`Jun. 17, 2004
`
`(51)
`
`Int. Cl.
`(2006.01)
`G06Q 10/00
`(52) US. Cl.
`................................ 705/2; 705/3; 600/300
`(58) Field of Classification Search
`705/2,
`705/3; 600/300
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUlVIENTS
`
`*
`*
`
`1/1971 Guarr ............................ 221/2
`7/1989 Halvorson .................. 700/231
`12/ 1990 Mangini et 31~
`~~~~~~~~~~~~~~~~~ 705/3
`4/1998 Edclson et all
`*
`.. 705/3
`* 12/1998 Mayaud
`.. 705/3
`7/1999 Evans
`
`2/2000 LeSter et al'
`’
`" 705/2
`
`4/2000 Elsayed et al‘ "
`600/300
`4/2000 Cunningham .................. 705/3
`8/2000 Akcrs ct a1.
`.................... 705/2
`11/2001 Williams et a1,
`............ 600/300
`
`1
`
`AAAAA
`
`3,556,342
`4,847,764
`419765351
`5,737,539
`5,845,255
`5,924,074 A
`
`AAAAB
`
`6’021’392
`6’045’501
`6,055,507
`6,112,182
`6,315,720
`
`
`20
`M EXP/«11mm EWHMDM
`Murmur 15 901mm 70 001101 M
`
`mm WEWEW 51m
`
`
`
`
`
`240
`
`mm mm at mi Mum/mm m m
`Mllfllflmm M Mm mm
`was mi Mm in 0001mm 'mum"
`swam ms 01 M mm
`
`00mm was!
`242
`[RUN
`in
`m u
`W
`
`
`286YES
`mm mm M mum: 5mm: 91 M
`minus/um in: mm mmmum
`m'msmmmlrmmm
`mm»: mm EMKNNI) mm m:
`
`m 'mwm' mum stunsm
`
`M m5! mum: in m m m: mm
`.
`V
`mm ”(WWW sumwwnnm
`
`mimw Wm
`01
`256
`ummmgazwnmzmmm
`
`WNWUMW 59021100707
`*WW’KWWSWWW
`nwmmmimlm 1mm
`Mumwrsswwmimaumw
`,
`mumwwmnsmmmm "”‘mW‘WS‘WMW/W"
`lPlWDflAm
`2 ‘
`mm; mm insist: m 71: mm:
`Mmsimsmmm
`mmrmmmmm
`
`
`2 5
`M mmmixw: in mi 01me
`
`mmmmmzmmm
`l
`252
`APKXWUEWMMMWEWBM
` Mxmmummmunum 252
`msmmmwmmmmw2m
`
`wimmmsmwww
`m
`Mmumm
`I‘LWMWWEL‘MWW
`25‘
`
`memmrsmm mmmscmmm
`1m M um 511mm ARE m an
`
`
`h
`
`
`
`
`PAR1001
`
`CBM of US. Patent No. 7,668,730
`Page 1 of 25
`
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`
`Page 1 of 25
`
`

`

`US 7,668,730 B2
`
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`4/2002 Mayaud ......................... 705/2
`2002/0042725 A1
`4/2002 McQuade et al.
`705/29
`2
`2/0042762 A1
`
`.. 705/2
`5/2002 Kobylevsky et a1.
`2002/0052762 A1
`10/2002 Subich .......................... 705/3
`2
`2/0161607 A1
`
`.....
`.. 436/151
`2002/0177232 A1* 11/2002 Melker et a1.
`2/2003 Califano et a1.
`.. 705/3
`2
`3/0033168 A1*
`
`3/2003 Gogolak ........................ 705/2
`2003/0046110 A1
`
`.................... 705/3
`2
`3/0050802 A1
`3/2003 Jay et a1.
`.. 705/2
`2
`3/0110060 A1
`6/2003 Clementi
`
`7/2003 Jones ......................... 235/375
`2
`3/0127508 A1
`7/2003 Kosinski et al.
`................ 705/2
`2
`3/0144876 A1
`2
`3/0160698 A1*
`8/2003 Andreasson et al.
`340/573.1
`
`3/0197366 A1 * 10/2003 Kusterbeck .................. 283/69
`2
`2
`3/0229519 A1
`12/2003 Eidex et a1. ............ 705/2
`2
`3/0233256 A1
`12/2003 Cardenas et a1.
`..... 705/3
`
`...... 340/825.49
`2
`4/0008123 A1 *
`1/2004 Carrender et a1.
`2
`4/0019567 A1
`1/2004 Herceg et a1.
`705/64
`..
`2
`4/0019794 A1*
`1/2004 Moradi et a].
`713/185
`
`2
`4/0078237 A1
`4/2004 Kaafarani et a1.
`.
`..... 705/2
`2
`4/0107117 A1
`6/2004 Denny ........................... 705/2
`2004/0117126 A1
`6/2004 Felterman et al
`. 702/19
`
`.
`. 705/2
`2
`4/0122712 A1
`6/2004 Hill, Sr. et a1.
`
`. 705/2
`2004/0122713 A1
`6/2004 Hill, Sr. et a1.
`.
`.. 705/3
`8/2004 Ericsson et a1.
`2
`4/0162740 A1
`
`. 705/2
`2004/0176985 A1 *
`9/2004 Lilly et a1.
`..
`OTHER PUBLICATIONS
`
`
`
`
`
`“An Interview with Orphan Medical about Xyrem,” http://www.
`mlkaboutsleep.com/sleep-disorders/archives/
`Narcolepsyixyremiinterviewhtm, Feb. 12, 2001.*
`
`NASCSA National Conference, (Nov. 2000), 8 pages.
`“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 of Health and Human Services Food and Drug
`Administration Centerfor Drug Evaluation and Research, Holiday
`Inn, Bethesda, Maryland, (Jun. 6, 2001), 7 pages.
`Preliminary Amendment Pursuant to 37 CFR 1.115 filed with United
`States Patent and Trademark Office on Jun. 17, 2005 in US. Appl.
`No. 11/104,013 (3 pages).
`“System for Thalidomide Education and Prescribing Safety (STE.
`PS.) Starter Kit", Celgene Corporation, (2001),103 pgs.
`“U.S.App1.No. 11/097,985, Preliminary Amendment mailedApr. l,
`2005”, 7 pgs.
`“U.S.App1.No. 11/097,985 Non Final OfficeAction Mailed Sep. 14,
`2009”, 22.
`“US. Appl. No. 10/731,915, Non Final Office Action Response
`mailed Feb. 2, 2005”, 17 pgs.
`“U.S,App1.No. 10/979,665, PreliminaryAmendment mailedNov. 2,
`2004”, 3 pgs.
`“U.S.App1.No. 11/097,651, Preliminary Amendment mailedApr. l,
`2005”, 6 pgs.
`“US. Appl. No. 11/097,651, Non-Final Office Action mailed May
`29, 2009”, 21 pgs.
`“U.S. Appl. No. 11/097,651, Response filed Sep. 17, 2009 to Non
`Final Office Action mailed May 29, 2009”, 10 pgs.
`
`* cited by examiner
`
`PAR1001
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`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 1 of 16
`
`Us 7,668,730 B2
`
`MEMORY
`
`STORAGE
`
`O14
`
`FIG.
`
`1
`
`PAR1001
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`Page 3 of 25
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`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 2 of 16
`
`Us 7,668,730 B2
`
`202
`
`MO MAILS/FAXES IN Rx/BIIROILMENT FORM AN INTAKE/REIMBURSEMENT SPECIAUST MAKE A COPY OF
`
`THE FIX/ENROLLMENT FORM (THE COPY IS STAMPEO
`uCOPY") AND THE ORIGINAL FAX IS THEN FORWARDED
`TO THE PHARMACY TEAM
`
`
`205
`
`
`MO MAILS/FAXES IN Rx/ENROLLMENT FORM
`
`21 0
`
`THE INTAKE/REIMBURSEMENT SPECIALIST ENTERS THE
`PATIENT AND PHYSICIAN INFO INTO CHIPS
`
`212
`
`2T4
`
`IS
`
`AN INTAKE REPRESENTATIVE WILL MAKE I ATTEMPT TO
`N0
`THE INFO
`
`
`REACH THE MD TO OBTAIN THE MISSING INFORMATION
`COMPLETE?
`
`216
`
`YES
`
`THE MISSING INFORMATION HAS NOT BEEN OBTAINED
`
`WITHIN 24 HOURS, THE Rx/ENROLLMENT FORM IS FAXEO
`
`
`BACK TO THE MD WITH A REJECTION EXPLANATION LETTER
`
`
`220
`
`THE INTAKE/REIMBURSEMENT SPECIALIST CONTACTS MD
`TO VERIFY RECEIPT & ACCURACY OF THE PATIENTS Rx
`& THIS CONTACT IS RECORDED IN CHiPS
`
`222
`
`THE INTAKE/REIMBURSEMENT SPECIALIST SENDS CONSENT
`FORM AND A COVER LETTER TO THE PATIENT
`224
`
`
`
`APPLICATION WAS REJECTEO
`A NOTE IS ENTERED IN CHIPS THAT THE
`
`218
`
`THE INTAKE/REIMBURSEMENT SPECIALIST FAXES A
`STATEMENT OF MEDICAL NECESSTTY TO THE
`MO TO COMPLETE
`
`226
`
`THE INTAKE/REIMBURSEMENT SPECIALIST CONTACTS
`THE PATIENTS INSURANCE PROVIDER TO VERIFY
`
`COVBIACE 8: BENEFITS
`
`238
`
`
`INTAKE/REIMBURSEMENT
`ONCE PAYMENT IS RECEIVED,
`
`INTAKE/REIMBURSEMENT SUBMITS A COVERAGE
`SUBMITS A COVERAGE APPROVAL FORM (STAPLED TO
`
`
`
`
`APPROVAL FORM (STAPLED TO THE "COPY" OF THE Rx
`THE "COPY" OF THE Rx/ENROLIMENT FORM) TO THE
`
`
`PHARMACY TEAM AS NOTIFICATION T0 PROCESS
`ENROLLMENT FORM) TO THE PHARMACY TEAM AS
`
`
`
`NOTIFICATION TO PROCESS THE PATTENT'S Rx
`THE PATIENT'S Rx
`
`
`
`
`
`PAR1001
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`Page 4 of 25
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`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 3 of 16
`
`US 7,668,730 B2
`
`3
`
`208
`
`PHARMACY WORK FLOW
`
`268
`
`THE PATIENT IS SHIPPE)
`A XYREM SUCCESS
`PACKET VIA 2-DAY USPS
`
`
`
`
`
` THE PHARMACIST HOLDS THE
`
`PATIENT'S Rx UNTIL RECEIVING
`A COVERAGE APPROVAL FORM
`
`
`
`
`274
`
`0
`
`THE PHARMACIST VERIFIES
`THE MD.'S CREDENTIALS AND
`ENTERS AIJ. FINDINGS IN CHIPS
`
`276
`
`MO.'SAE)RET)ETVTIALS
`
`
`
`
`APPROVED?
`
`YES
`280
`
`N0
`
`THE PHYSICIAN IS INDICATED
`AS APPROVED IN THE
`PHYSICIAN SCREEN IN CHIPS
`282
`
`
`THE PHARMACIST HOLDS THE
`PATIENTS Rx UNTIL RECEIVING
`
`A COVERAGE APPROVAL FORM
`
`FROM INTAKE REIMBURSEMENT
`
`
`
`
`
`
`
`
`IF ANY DISCIPLINARY ACTIONS ARE
`
`IS
`IDENTIFIED, THE DIR. OF PHARM.
`NOTIFIED AND TAKES ONE OF THE
`FOLLOWING ACTIONS:
`- Rx IS PROCESSED AND THE,
`PHARMACIST MONITORS THE MDS
`PROGRAM ACTMTY
`* Rx IS NOT PROCESSED AND
`THE MD IS NOTED AS UNAPPROVED
`
`2 8 4 278
`THE PHYSICIAN IS INDICATED
`AS UNAPPROVEO IN CHIZPS36
`
`
`
`
`
`
`THE MD IS CONTACTED BY A
`PHARMACIST & INFORMED THAT
`THE PATTENT'S Rx CANNOT
`BE PROCESSED
`
`288
`
`
`
`
`
`
`
`
`
`THE Rx AND ENROLLMENT FOR
`IS MAILEO BACK TO THE MD
`ALONG WITH A COVER LETTER
`REITERATTNG THAT THE Rx
`CANNOT BE PROCESSED
`
`290
`
`
`
`
`
`
`
`A IEI'IER IS SENT TO THE
`PATIENT INDICATING THAT THE
`
`
`Rx CANNOT BE PROCESSED II:
`
`
`THE PATIENT IS INSTRUCTED TO
`
`
`CONTACT HIS/HER PHYSICIAN
`
`
`
`FIG. 28
`
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`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 4 of 16
`
`Us 7,668,730 B2
`
`
`
`240
`
`
`
`UPON RECEIPT OF THE COVERAGE APPROVAL FORM FROM
`INTAKE/REIMBURSEMENT THE PHARMACY TECHNICIAN
`
`
`CONTACTS THE PATIENT T0 COMPLETE THE "TECHNICIAN"
`SPECIFIED SECTIONS OF THE PATIENT
`
`
`COUNSELING CHECKLIST
`
`
`
`
`THE RECEIPT OF THE MATERIALS IS CONHRMED AND
`ANOTHER CALL IS SCHEDULED TO COUNSEL THE
`
`PATIENT BEFORE THE XYREM IS SHIPPED
` 246
`
`_L_
`AFTER COMPLETING THE SPECIFIED SECTIONS OF THE
`CHECKLIST WITH THE PATIENT THE PHARMACY TECHNICIAN
`TRANSFERS THE CALLER TO THE PHARMACIST WHO
`REVIEWS THE ENTIRE CHECKLIST AND OOMPLEIES THE
`REMAINING "PHARMACIST" SPECIFIED SECTIONS
`248
`
`244
`
`THE PHARMACIST INDICATES IN CHIPS THAT THE PATIENT
`COUNSELING CHECKUST WAS SUCCESSFULLY COMPLETED
`INCLUDING THE DATE COMPIETED
`
`250
`
`.
`THE PHARMACIST SCHEDULE THE PATIENTS SHIPMENT F0
`THE NEXT BUSINESS DAY OR THE NEXT BUSINESS DAY
`THE PATIENT IS AVAILABLE TO SIGN FOR THE PACKAGE
`254
`
`THE PHARMACIST ENTERS THE RX ORDER
`
`IN CHIPS, CREATTND AN ORDER NUMBER
`
`256
`
`THE PHARMACIST VERIFIES THE RX AND ATTACHES THE
`VERIFICATION LABEL TO THE HARD COPY Rx
`
`258
`
`A PICK TICKET IS GENERATED FOR THE ORDER & THE
`IRDER IS FORWARDED TO THE PHARMACY FOR FULFILLME
`260
`
`THE SHIPMENT IS CONFIRMED IN CHIPS
`
`262
`
`THE ORIGINAL Rx IS HLED WAR THE PHARMACY
`Rx’S IN NUMERICAL ORDER
`
`264
`THE ORDER IS SHIPPED BY USPS EXPRESS MAIL
`
`252
`
`THE SIIIPMENT MUST BE SENT TO THE PATIENTS HOME
`ADDRESS UNLESS THE PATIENT IS TRAVELING OR HAS
`MOVED- "I W” CASE "IE PHARMACIST W DHERM'NE
`IF AN EXCEPTION WILL BE MADE. THE PATIENT OR THE
`PATIENTS DESIGNEE MUST SIGN FOR THE PACKAGE
`
`UPON DELIVERY
`
`255
`ALL XYREM INVENTORY IS CYCLE COUNTED AND
`RECONCIUED WITH THE CHIPS SYSTEM QUANTITIES
`BEFORE THE DAYS SHIPMENTS ARE SENT OUT
`
`END
`
`FIG . 2C
`
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`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 5 of 16
`
`US 7,668,730 B2
`
`310
`
`
`
`
`PHYSICIAN SUCCESS
`PROGRAM MATERIALS
`
`
`REQUEST
`
`320
`
`MD CALLS XYREM SUCCESS
`
`PROGRAM AT I—Bfifi-XYREMBO
`
`
`
`
`
`
`
`
`TO REQUEST PROGRAM
`MATERIALS
`
`
`
`
`
`330
`
`
`
`
`MD DEMOGRAPHICS. DEAII
`AND DATE OF REQUEST ARE
`
`
`ENTERED INTO CHiPS
`
`
`340
`
`SOS REQUESTS MATERIALS TO
`BE SHIPPED TO THE MD VIA
`THE OMI FULFILLMENT WEBSITE
`
`
`
`
`AT WWWPRAEULFILLMENTCOM
`
`
`
`
`
`
`
`
`
`PAR1001
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`Page 7 of 25
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`Page 7 of 25
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`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 6 of 16
`
`Us 7,668,730 B2
`
`402
`
`2 POSSIBLE REFILL
`REQUEST PROCESSES
`
`404
`
`Q
`
`A MESSAGE IS LEFT ONLY MEMTIONTNG
`SOS R A RETURN NUMBER
`
`4T4
`
`416
`
`A NOTE IS ENTERED IN THE CHIPS INDICATING THE
`DATE THE MESSAGE WAS LEFT FOR THE PATIENT
`
`EACH WEEK A REFILL REPORT IS GENERATED OF
`PATIENTS WITH ID DAYS OF PRODUCT REMAINING
`408
`
`A COPY OF THE REFILL REPORT IS PROVIDED
`TO INTAKE/REIMBURSEMENT
`
`410
`
`NO SOONER THAN 8 DAYS BEFORE MEDICATION
`DEPLETION, A PHARMACY TECHNICIAN CONTACTS THE
`PATIENT TO COMPLETE THE PRE—DEUVERY CHECKLIST
`
`4T2
`IS
`
`THE pAnEm
`N0
`
`REACHED?
`
`YES
`
`418
`
`
`
`
`
`THE PHARMACY TECHNICIAN SCHEDULES THE PATIENT'S
`
`SHIPMENT FOR THE NEXT BUSINESS DAY OR THE NEXT
`BUSINESS DAY THE PATIENT IS AVAILABLE TO
`SIGN FOR THE PACKAGE
`
`420
`
`THE PHARMACIST ENTERS THE Rx ORDER
`IN CHiFS, CREATING AN ORDER NUMBER
`
`422
`
`THE PHARMACIST VERIFIES THE Rx AND ATTACHES THE
`VERIFICATION LABEL TO THE HARD COPY Rx
`
`THE SHIPMENT IS CONFIRMED IN CHiPS
`
`424
`
`428
`
`425
`ALL XYREM INVENTORY TS CYCLE COUNTED AND
`RECONCILED WITH THE CHiPS SYSTEM QUANTITIES
`BEFORE THE DAYS SHIPMENTS ARE SENT OUT
`
`A PICK TICKET IS GENERATED FOR THE ORDER A THE
`IRDER IS FORWARDED To THE PHARMACY FOR FULFILLME
`
`END
`
`430
`
`PAR1001
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`Page 8 of 25
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`Page 8 of 25
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`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 7 of 16
`
`Us 7,668,730 B2
`
`434
`
` THE PATIENT CALLS T0 REQUEST AN EARLY REFILL
`4:-I>uo[\3O7
`
`A XYREM PROBLDT IDENTIFICATION & MANAGEMENT RISK
`
`
`
`
`A NOTE CODE IS ENTERED IN CHIPS ON THE PATIENT
`DIVERSION REPORT IS COMPLETED & DOCUMENTEO IN
`
`
`
`CHIPS. THE REPORT IS THEN FAXED TO OMI
`III THE
`SCREEN INDICATING THE EARLY REFILL REQUEST
`
`
`ORIGINAL IS FILED IN A MONTHLY BATCH FILE
`
`
`
`THE PHARMACIST EVALUATES THE PATIENT'S
`COMPLIANCE WTTH THERAPY AND/OR POSSIBLE PRODUCT
`
`DIVERSION, MISUSE OR OVERUSE
`
`
`
`438
`
`.1"
`
`THE PHARMACIST CONTACTS THE PRESCRIBING
`PHYSICMN TO ALERT OF THE SITUATION AND CONFIRM
`IF THE PHYSICIAN APPROVES OF THE EARLY REFILL
`
`THE PATENT MUST WA” UNTIL mE ND" SCHEDULED
`REFILL DATE To RECENE ADDmONAL PRODUCT
`
`440
`NO
`DOES
`
`
`THE PHYSICIAN
`
`
`APPROVE?
`
`
`THE PHARMACIST ENTERS A NOTE IN CHiPS
`IN THE PATIENT SCREEN THAT THE PHYSICIAN
`APPROVES THE REQUEST
`
`448
`
`THE PHARMACIST NOTIFIES AN INTAKE/REIMBURSEMENT
`SPECIALIST TO CONTACT THE PATIENTS INSURANCE
`WONDER To VER'FY COVERAGE FOR THE EARLY Rm”
`
`
`
`452
`
`444
`
`END
`
`REFILL DATE TO RECENE ADDITIONAL PRODUCT
`
` IS THE0
`
`PATIENT WILL TO
`
`
`
`
`PAY?YES
`
`THE PATIENT IS INFORMED OF THE COST OF THE
`PRODUCT AND IS CIVEN PAYMENT OPTIONS4
`
`ONCE PAYMENT IS RECEIVED THE ORDER Is RELEASED
`
`466
`
`INTAKE/REIMBURSEMENT SUBMITS A COVERAGE APPROVAL
`FORM TO THE PHARMACY TEAM AS NOTIFICATION THAT
`THE PATIENTS REFILL REQUEST CAN BE PROCESSED
`454
`
`INTAKE/REIMBURSEMENT SUBMITS A COVERAGE APPROVAL
`FORM TO THE PHARMACY TEAM AS NOITFICATION THAT
`THE PATIENTS REFILL REQUEST CAN BE PROCESSED
`468
`
`
`THE PHARMACY TECHNICIAN CONTACTS THE PATIENT TO
`SCHEDULE SHIPMENT OF THE PRODUCT FOR THE NEXT
`
`
`BUSINESS DAY OR THE NEXT BUSINESS DAY THE PATIENT
`
`IS AVAIIABLE TO SIGN FOR THE PACKAGE
`
`
`
`THE PHARMACY TECHNICIAN CONTACTS THE PATIENT TO
`
`
`SCHEDULE SHIPMENT OF THE PRODUCT FOR THE NEXT
`
`BUSINESS DAY OR THE NEXT BUSINESS DAY THE PATIENT
`
`IS AVAILABLE TO SIGN FOR THE PACKAGE
`
`
`
`
`CONTINUE
`
`456
`
`CONTINUE
`
`470
`
`FIG. 4B
`
`PAR1001
`
`CBM of U.S. Patent No. 7,668,730
`Page 9 of 25
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`
`Page 9 of 25
`
`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 8 of 16
`
`Us 7,668,730 B2
`
`5T0
`
`
`
`UPON DETERMINING THAT A PATIENT IS UNINSURED 0R
`UNDERINSURED, A REIMBURSEMENT SPECIALIST EXPLAINS
`
`
`THE NORD PROGRAM TO THE PATIENT AND FAXES AN
`
`
`APPLICATION REQUEST FORM TO NORD FOR THE PATIENT
`
`
`515
`
`THE INTAKE/REIMBURSEMENT SPECIALIST DOCUMENTS
`IN CHIPS THAT AN APPUCATION HAS BEEN REQUESTED
`THROUGH NORD
`
`520
`
`NORD MAILS A PAP APPUCATION To THE
`PATENT WITHIN 1 BUSINESS DAY
`
`525
`
`IS
`THE PATIENT
`
`APPROVED?
`
`YES
`
`NO
`
`NORD SENDS A DENIAL LETTER To THE PANENT
`
`530
`
`545
`
`540
`
`NORD SENDS AN ACCEPTANCE LETTER TO THE
`PATIENT AND FAXES A VOUCHER TO SOS INDICATTNG THE
`
`803 DOCUMENTS IN CHTPS THAT
`THE PATIENT WAS DENIED BY NORD
`
`PATIENT'S APPROVAL FOR THE PROGRAM
`
`550
`
`
`
`AN INTAKE/REIMBURSEMENT SPECIALIST SUBMTTS A
`
`
`COVERAGE APPROVAL FORM TO THE PHARMACY TEAM AS
`
`
`NOTIFICATION THAT THE PATIENT HAS BEEN APPROVED
`FOR COVERAGE THROUGH NORD
`
`
`
`PAR1001
`
`CBM of U.S. Patent No. 7,668,730
`Page 10 of 25
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`
`
`Page 10 of 25
`
`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 9 of 16
`
`US 7,668,730 B2
`
`236
`
`CH WEEK, THE DIRECTOR OF PHARMACY TRANSFERS
`INVENTORY FOR THE WEEK'S SHIPMENTS TO A
`SECREGATED WAREHOUSE LOCATION
`FOR PRODUCTION INVENTORY
`
`
`A PURCHASE ORDER IS GENERATED FOR THE
`INVENTORY TRANSFERRED TO THE PRODUCTION
`LOCATION & IS FAXED TO THE OMI CONTROLLER
`
`
`
`
`
`
`
`
`THE ONE CONTROLLER INVOICES SOS FOR
`THE PRODUCT MOVED TO PRODUCTION
`
`700
`
`
`
`PRESCRIBER FIELDS
`PATIENT FIELDS
`
`
`
`PRESCRIPTION FIEIDS
`
`
`
`7I0
`
`720
`
`730
`
`INSURANCE FIELDS
`
`740
`
` QUERY I — PRESCRIPTIONS BY PHYSICIAN
`
`
`QUERY 2 — PRESCRIPTIONS BY PATIENT NAME
`
`
`QUERY 3 ~ PRESCRIPTIONS BY FREQUENCY
`
`
`840 QUERY N - PRESCRIPTIONS BY DOSE
`
`FIG. 7
`
`FIG. 8
`
`PAR1001
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`CBM of U.S. Patent No. 7,668,730
`Page 11 of 25
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`
`
`Page 11 of 25
`
`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 10 of 16
`
`Us 7,668,730 B2
`
`900
`
`
`
`PRESCRIBER INFORMATION
`
`PRESCRIPTION AND ENROLLMENT FORM /
`
`PRESCRIBER'S WWW— OFFICE CONTACT:
`
`STREET ADDRESS:
`
`
`
`ZIP:
`STATE:
`,
`CITY:
`
`
`
`FAX:
`,L. ,,
`PHONE:
`
`
`
`UCENSE NUMBER‘A LEE __ DEA NUMBER:
`
`
`
`MD SPECIALTY:
`
`
`
`
`
`
`PRESCRIPTION FORM
`
`
`
`PAITENT NAME: ,
`DOB:
`L,
`SS#:
`,
`ADDRESS:
`
`
`
`ZIP:
`STATE:
`CITY:
`
`MONTHS SUPPLY
`Rx: YYREM ORAL SOLUTION (500 mg/mL) 180 MI. BOTTIE QUANTITY:
`SIC: TAKE «HCMS P.0. DILUTED IN 50 mL WATER AT H5. AND THEN AGAIN 2 1/2 T0 4 HOURS LATER
`RETIus (CIRCIE ONE):
`0
`I
`2
`(MAXIMUM 0F 3 MONTH SUPPLY)
`DATE: v/__ ,/“~
`
`PRESCRIBER'S SIGNATURE
`
`
`
`
`
`
`
`
`
`
`:I I HAVE READ THE MATERIALS IN THE XYREM PHYSICIAN SUCCESS PROGRAM
`
`E_: I VERIFY THAT THE PATENT HAS BEEN EDUCATED WITH RESPECT TO XYREM PREPARATION, DOSING AND SCHHIULING.
`
`
`: I UNDERSTAND THAT XYREM IS APPROVED FOR THE TREATMENT OF CATAPLEXY IN PATIENTS WITH NARCOLEPSY,
`
`AND THAT SAFETY 0R EFFICACY HAS NOT BEEN ESTABUSHED FOR ANY OTHER INDICATION.
`I:] I UNDERSTAND THAT THE SAFETY OF DOSES GREATER THAN ng/DAY HAS NOT BEEN ESTABLISHED
`
`
`
`PHYSICIAN DECLARATION~PLEASE CHECK EACH BOX
`
`TO BE COMPLETED AT INTITAL PRESCRIPTION ONLY
`
`
`
`
`
`
`
`
`
`PATIENT INFORMATION
`
`
`
`
`
`
`
`
`
`
`BEST TIME TO CONTACT PATIENT: I: OAY L: NIGHT
`EVENING T:
`DAY I:
`
`INSURANCE COMPANY NAME:m PHONE II:
`INSURED'S NAME:
`REIAIIONSHIP TO PATIENT:
`IDENTIFICATION NUMBER:w POUCY/GROUP NUMBER:
`
`
`PRESCRIPTION CARD: :I ND C YES
`IF YES, CARRIER:
`,POIICY A:
`GROUP:
`
`PLEASE ATTACH COPIES OF PATIENTS INSURANCE CARDS
`FAX COMPLETED FORM TO XYREM SUCCESS PROGRAM (TOLL-FREE) 1—866—470-1744
`FOR INFORMATION, CALL THE XYREM TEAM (TOLL FREE) AT I—866—XYREM88 (I—BOB—QBT—BOSB)
`
`FIG. 9
`
`PAR1001
`
`CBM of U.S. Patent No. 7,668,730
`Page 12 of 25
`
`
`
`Page 12 of 25
`
`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 11 of 16
`
`Us 7,668,730 B2
`
`PATIENT ASSISTANCE APPLICATION REQUEST FORM
`
`1000
`
`/
`
`DATE:
`
`TO:
`
`PATIENT ASSISTANCE ORGANIZATION
`
`FROM:
`
`SDS
`
`FAX If:
`
`203-798—2291
`
`PLEASE SEND A XYREM PATIENT ASSISTANCE PROGRAM APPLICATION TO:
`
`PATIENT NAME
`
`ADDRESS
`
`
`
`
`
`
`
`
`
`
`
` TELEPHONE: ( )
`
`
`
`
`
`(GRAMS) TWICE NIGHTLY FOR A TOTAL DOSAGE 0F___(GRAMS)
`
`PATIENT DOSAGE:
`
`
`BOTTLES (THREE MONTHS SUPPLY)
`
`BACKGROUND INFORMATION:
`
`
`
`
`
`
`
`
`
`
`
`
`
`FIG. 10
`
`PAR1001
`
`CBM of U.S. Patent No. 7,668,730
`Page 13 of 25
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`Page 13 of 25
`
`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 12 of 16
`
`Us 7,668,730 B2
`
`SENSITIVE DRUG PATIENT ASSISTANCE PROGRAM [900
`
`VOUCHER REQUEST FOR MEDICATION
`
`PATIENT INFORMATION
`(FIRST NAME><LAST NAME)
`(ADDRESS 1>
`<ADDRESS 2>
`
`<CIIY, STATE ZIP CODE>
`
`EHO_NE_: «231—456—7890
`[1111: 01/01/1900
`fl 123—455—6789
`DRUG ALLOTMENT: 100%
`
`[E 03/01/2001
`
`DRUG
`XYREEM 180ml MI
`
`CASE CODE: “mm
`
`QUANTITY
`1
`
`PHYSICIAN INFORMATION
`<PHYSICIAN NAME)
`(ADDRESS 1>
`<ADDRESS 2>
`
`<CTTY. STATE ZIP CODE)
`
`PHONE: 023—456—7890
`
`FIRST SHIPMENT THIS YEAR
`
`VAUDATION DATE:
`EXPIRATION DATE:
`ISSUE DATE:
`
`03/01/2001
`05/31/2001
`03/15/2001
`
`APPROVED
`
`***PHARMACY USEm
`
`NORD COPY
`*******************************************************
`
`(DETACH HERE)
`
`PATIENT INFORMATION
`(FIRST NAME><1AST NAME>
`(ADDRESS 1>
`<ADDRESS 2>
`
`(CITY, STATE ZIP CODE)
`
`1% (123—456-7890
`D_O_B_: 01/01/1900
`$1; 123-45—0739
`DRUG'ALLOTMENT: 1007..
`LED 03/01/2001
`
`DRUG
`XYREM 180ml b0
`
`
`CASE CODE: mum
`
`QUANTITY
`1
`
`PHYSICIAN INFORMATION
`<PHYSICIAN NAME)
`(ADDRESS 1>
`(ADDRESS 2>
`
`<CTIY, STATE ZIP CODE)
`
`W (123—456—7890
`
`FIRST SHIPMENT THIS YEAR
`
`VALIDATION DATE:
`EXPIRATION DATE:
`ISSUE DATE:
`
`03/01/2001
`05/31/2001
`03/15/2001
`
`APPROVED
`
`*upHARMACY USE*“
`
`FIG.
`
`1 1
`
`PAR1001
`
`CBM of U.S. Patent No. 7,668,730
`Page 14 of 25
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`
`Page 14 of 25
`
`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 13 of 16
`
`Us 7,668,730 B2
`
`1 200
`
`/
`
`SENSITIVE DRUG PHYSICIAN'S CERTIFICATE
`
`OF MEDICAL NEED
`
`PATIENT INFORMATION
`
`DATE:
`
`NAME
`
`DATE OF BIRTH:
`
`
`' LAST
`FIRST
`M
`
`
`DRUG BEING PRESCRIBED: XYREM
`
`DIAGNOSIS/CONDITION FOR WHICH DRUG IS BEING PRESCRIBED:
`
`
`
`ICD-9:
`
`PHYSICIAN INFORMATION
`
`PHYSICIANS NAME (PLEASE PRINT):
`
`
`
`PHYSICIANS SIGNATURE:
`
`
`DATE:
`
`PLEASE FAX BACK TO SENSITIVE DRUG SUCCESS PROGRAM: (I-800-TOLL FREE NUMBER)
`
`FIG. 12
`
`PAR1001
`
`CBM of U.S. Patent No. 7,668,730
`Page 15 of 25
`
`
`
`Page 15 of 25
`
`

`

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`U.S. Patent
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`Feb. 23, 2010
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`Sheet 14 of 16
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`US 7,668,730 B2
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`CBM of U.S. Patent No. 7,668,730
`Page 16 of 25
`
`
`
`Page 16 of 25
`
`

`

`U.S. Patent
`
`Feb. 23, 2010
`
`Sheet 15 of 16
`
`US 7,668,730 B2
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`PAR1001
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`CBM of U.S. Patent No. 7,668,730
`Page 17 of 25
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`Page 17 of 25
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`

`

`U.S. Patent
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`CBM of U.S. Patent No. 7,668,730
`Page 18 of 25
`
`
`
`Page 18 of 25
`
`
`
`
`
`

`

`US 7,668,730 B2
`
`1
`SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND IVIETHOD
`
`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 different phar-
`macies. 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 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 of a designee to the central pharmacy who is authorized
`to accept shipment of the drug. Receipt of the initial drug
`shipment is confirmed by contacting the patient. Either a
`phone call or other communication to the patient within a set
`time after delivery may be made to ensure receipt. Further, a
`courier service’s tracking system is used to confirm delivery
`in further embodiments. If a shipment is lost, an investigation
`is launched to find it.
`
`In one embodiment, the drug may be shipped by the central
`pharmacy to another pharmacy for patient pick-up. The sec-
`ond pharrnacy‘s ability to protect against diversion before
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`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 suflicient 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 imple-
`mented in software or a combination of software and human
`
`PAR1001
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`Page 19 of 25
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`Page 19 of 25
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`

`US 7,668,730 B2
`
`3
`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 C4H7NaO3) which
`is useful for treatment of cataplexy in patients with narco-
`lep sy. 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 andpatients about the risks andbenefits 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 drug product. Following
`manufacture of the drug product, it is stored at a facility
`compliant with FDA Schedule III regulations, where a con-
`signment 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 phar—
`macy, and is not stocked in retail pharmacy outlets. It is
`distributed by overnight carr