(12) Ulllted States Patent
`Reardan et a].
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 7,668,730 B2
`*Feb. 23, 2010
`
`US007668730B2
`
`(54) SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`(75) Inventors: Dayton T-Rear?lan,Excelsiors MN
`(Us); PattlEngle, Eagan, MN (Us);
`Bob Gagne, St PauL MN(US)
`
`.
`_
`(73) Asslgnee' ‘(Igéfommerclal’ LLC"Pa1°Ah°’ CA
`
`(,1) Notice.
`
`subjectto any disclaimer’theterm ofthis
`patent is extended Or adjusted under 35
`U.S.C. 154(b) by 446 days.
`
`This patent is subject to a terminal dis-
`Claimem
`
`(21) Appl.No.: 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 61 ClaSSi?CatiOIl $661611 ................... .. 705/2,
`705/3; 600/300
`See application ?le for complete search history.
`
`(56)
`
`References Cited
`U_S_ PATENT DOCUMENTS
`
`2/2002 Evans ....................... .. 709/202
`6,347,329 B1
`5/2003 w611666 6161.
`6,564,121 B1
`6/2004 w1111611166161. .......... .. 600/300
`6,755,784 B2
`6,952,681 B2* 10/2005 M6Q116d6 6161. ........... .. 705/28
`7,058,584 B2* 6/2006 K6611161<16161 .............. .. 705/2
`2001/0001144 A1
`5/2001 K6pp .......................... .. 705/3
`
`2001/0042050 A1 11/2001 11161611616161. ............. .. 705/64
`2001/0047281 A1 11/2001 KeIeSIIlaIl, 1116161. ...... .. 705/2
`2002/0010661 A1* 1/2002 w6dd111g16116161. ........ .. 705/28
`
`2002/0032581 A1
`2002/0032582 A1
`
`3/2002 R611b61g ...................... .. 705/2
`3/2002 Feeney, Jr. et al. ........... .. 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, PA.
`
`(57)
`
`ABSTRACT
`
`A drug distribution system and method utiliZes a central
`pharmacy and database to track all prescriptions for a sensi
`tive
`Information is kept in the database regarding all
`phys1c1ans alloWed to prescr1be the sensitive drug, and all
`patients receiving the
`Abuses are identi?ed
`monitor
`jng data in the database for prescription patterns by physi
`cians and prescriptions obtained by patients. Further Veri?
`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
`.
`.
`.
`.
`.
`.
`.
`d1str1but1on depending on the sens1t1v1ty of the drug.
`
`11 Claims, 16 Drawing Sheets
`
`A
`l/l97l Guarr .......................... .. 221/2
`*
`3,556,342
`A
`7/ 1989 Halvoirsion ................ .. 700/231
`*
`4,847,764
`A
`12/1990 Manglnl et a1~
`4,976,351
`A
`4/1998 Edelson et al. ............... .. 705/3
`*
`5,737,539
`5,845,255 A * 12/1998 Mayaud
`705/3
`5,924,074 A
`7/1999 Evans .... ..
`. 705/3
`A
`6,021,392
`2/2000 Lester et al. ................. .. 705/2
`A
`A
`A
`B
`1
`
`4/2000 Elsayed et al. ............ .. 600/300
`400% Cunningham "
`~~~~ " 705/3
`
`8/2000 Akers et al. .................. .. 705/2
`11/2001 Williams et al. .......... .. 600/300
`
`6,045,501
`6,055,507
`
`6,112,182
`6,315,720
`
`01m 10m 01 WE MM mm m mm
`mm M PWIKJ 1mm
`mm: 1111 PAHLNT 10 11mm M ‘710040111’
`swam SW5 m M mm
`001111.111 mm!
`
`M 10m 0 M Imus a 00mm 110
`011mm 1m 15 111mm 70 010491 N
`MW WE 011 mm 5 5m
`
`261
`511110111 111mm 1m
`
`1N1 um 111114125 wanna/111mm
`MPATDITSIWIMYC 51111010111001:
`2 1
`
`1
`
`, n 0011 me 1115 War 1111 1mm
`
`1110115 1130111 uusv 5111 m1 IKE WWE
`mm mm
`
`:11 m 100111111001 1101111 110
`Rim VIM ME ME SYSTEM MIME
`1m 111 1116 61111018 1116141 0n
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 1 of 25
`
`

`
`US 7,668,730 B2
`Page 2
`
`US. PATENT DOCUMENTS
`
`2002/0042725 A1
`4/2002 Mayaud ....................... .. 705/2
`2002/0042762 A1
`4/2002 McQuade et al. .
`705/29
`5/2002 Kobylevsky et al. .
`.. . 705/2
`2002/0052762 A1
`2002/0161607 A1 10/2002 Subich ........... ..
`705/3
`2002/0177232 A1* 11/2002 Melker et al. ..
`. 436/151
`2003/0033168 A1* 2/2003 Califano et al.
`.. . 705/3
`2003/0046110 A1
`3/2003 Gogolak ...... ..
`705/2
`2003/0050802 A1
`3/2003 Jay et al.
`.. . 705/3
`2003/0110060 A1
`6/2003 Clementi
`705/2
`2003/0127508 A1
`7/2003 Jones .......... ..
`. 235/375
`2003/0144876 A1
`7/2003 Kosinski et al.
`705/2
`2003/0160698 A1* 8/2003 Andreasson et al. .
`. 340/573.1
`
`. . . .. 283/69
`2003/0197366 A1* 10/2003 Kusterbeck . . . . . . .
`705/2
`2003/0229519 A1 12/2003 EideX et al. ..... ..
`2003/0233256 A1 12/2003 Cardenas et a1. ............. .. 705/3
`2004/0008123 A1 *
`1/2004 Carrender et a1. .... .. 340/825.49
`
`2004/0019567 A1
`
`1/2004 Herceg et al. . . . . .
`
`. . . . . . . .. 705/64
`
`713/185
`2004/0019794 A1* 1/2004 Moradi et a1.
`705/2
`2004/0078237 A1
`4/2004 Kaafaraniet a1. .
`705/2
`2004/0107117 A1
`6/2004 Denny ......... ..
`702/19
`2004/0117126 A1
`6/2004 Fetterman et a1. .
`705/2
`2004/0122712 A1
`6/2004 Hill, Sr. et al.
`705/2
`2004/0122713 A1
`6/2004 Hill, Sr. et al.
`705/3
`2004/0162740 A1
`8/2004 Ericsson et al.
`2004/0176985 A1* 9/2004 Lilly et al. ................... .. 705/2
`
`OTHER PUBLICATIONS
`
`“An Interview With Orphan Medical about Xyrem,” http://WWW.
`talkaboutsleep.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 Center for Drug Evaluation and Research, Holiday
`Inn, Bethesda, Maryland, (Jun. 6, 2001), 7 pages.
`Preliminary Amendment Pursuant to 37 CFR 1. 1 15 ?led With United
`States Patent and Trademark Of?ce on Jun. 17, 2005 in US. Appl.
`No. 11/104,013 (3 pages).
`“System for Thalidomide Education and Prescribing Safety (S.T.E.
`P.S.) Starter Kit”, Celgene Corporation, (2001),103 pgs.
`“U.S. Appl. No. 11/ 097,985, Preliminary Amendment mailed Apr. 1,
`2005”, 7 pgs.
`“U.S. Appl. No. 11/097,985 Non Final Of?ce Action Mailed Sep. 14,
`2009”, 22.
`“US. Appl. No. 10/731,915, Non Final Of?ce Action Response
`mailed Feb. 2, 2005”, 17 pgs.
`“U.S. Appl. No. 10/979,665, PreliminaryAmendment mailed Nov. 2,
`2004”, 3 pgs.
`“U.S. Appl. No. 11/097,651, Preliminary Amendment mailed Apr. 1,
`2005”, 6 pgs.
`“U.S. Appl. No. 11/097,651, Non-Final Of?ce Action mailed May
`29, 2009”, 21 pgs.
`“U.S. Appl. No. 11/097,651, Response ?led Sep. 17, 2009 to Non
`Final Of?ce Action mailed May 29, 2009”, 10 pgs.
`
`* cited by examiner
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 2 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 1 6f 16
`
`US 7,668,730 B2
`
`100
`r.)
`
`120
`H
`
`MEMORY
`
`1 10
`r/
`
`CPU
`
`130
`I.)
`
`140
`r/
`
`150
`r1
`
`160
`/
`
`STORAGE
`
`|/0
`
`COMM
`
`FIG. 1
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 3 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 2 6f 16
`
`US 7,668,730 B2
`
`202
`E MO MAILS/FAXES IN Rx/ENROLLMENT FORTI
`w
`204
`AN INTAKE/REIMBURSEMENT SPECIALIST MAKE A COPY OF
`THE Rx/ENROLLMENT FORM (THE COPY IS STAMPEO
`“COPY") AND THE ORIGINAL FAX IS THEN FORWARDED
`TO THE PHARMACY TEAM
`I
`
`I
`
`206
`v
`L MO MAIIS/FAIIEs IN Rx/ENROLLMENT FORM
`2 I 0
`I
`THE INTAKE/REIMBURSEMENT SPECIAIJST ENTERS THE
`PATIENT AND PHYSICIAN INFO INTO CHIPS
`
`'
`THE WINE/REIMBURSEMENT SPECWJST CONTACT? MD
`TO VERIFY RECEIPT & ACCURACY OF THE PATIENTS RX
`0 THIS CONTACT IS RECORDED IN CHIPS
`
`222
`H
`THE INTAKE/ REIMBURSEMENT SPECIALIST SENDS CONSENT
`FORM ANO A COVER LETTER TO THE PATIENT
`I
`224
`~
`THE INTAKE/REIMBURSEMENT SPECIALIST FAXES
`STATEMENT OF MEDICAL NECESSIIY TO THE
`MI) TI) COMPLETE
`H226
`,
`THE INTAKE/REIMBURSEMENT SPECIALIST CONTACTS
`THE PATIENTS INSURANCE PROMIBER TO VERIFY
`COVERAGE A BENEFITS
`
`,J
`INTAKE/REIMBURSEMENT SUBMITS A COVERAGE
`APPROVAL FORM (STAPLED TO THE "COPY" OF THE Rx
`ENROLLMENT FORM} TO THE PHARMACY TEAM AS
`NOTIFICATION TO PROCESS THE PATIENT'S Rx
`
`2 I A
`[J
`AN INTAKE REPREsENTATIIIE WILL MAKE I ATTEMPT TO
`REACH THE MD TO OBTAIN THE MISSINO INFORMATION
`2 I 6
`
`THE MISSING INFORMATION HAS NOT BEEN OBTAINEO
`wITHIN 24 HOURS, THE Rx/ENROLLMENT FORM IS FAxEB
`BACK TO THE MD wHH A REIEcTION EXPLANATION IETTER
`‘
`218
`
`A NOTE IS ENTEREO IN CH'PS THAT THE
`APPUCAHON WAS REUECTED
`
`252
`L
`SEE NORD PROCESS FOR PATIENTS
`WHO ARE UNINSURED 0R UNDERINSURED
`
`234
`THE PATIENT IS INFORMED OF THE COST OF THE
`PRODUCT AND IS GIVEN PAYMENT OPTIONS
`‘
`r1236
`ONCE PAYMENT IS RECEIVED, INTAKE/REIMBURSEMENT
`SUBMITS A COVERAGE APPROVAL FORM (STAPLED TO
`THE "COPY" OF THE Rx/ENROLIMENT FORM) TO THE
`PHARMACY TEAM AS NOTIFICATION TO PROCESS
`THE PATIENT'S Rx
`
`Cb FIG. 2A dB
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 4 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 3 0f 16
`
`US 7,668,730 B2
`
`PHARMACY WORK FLOW
`A
`268
`THE PATIENT IS SHIPPED
`A XYREM SUCCESS
`PACKET VIA 2~DAY USPS
`
`4-’
`THE PHARMACIST HOLDS THE
`PATIENT’S Rx UNTIL RECEIVING
`A COVERAGE APPROVAL FORM
`FROM INTAKE/REIMBURSEMENT
`
`CE)
`
`IF ANY DISCIPLINARY ACTIONS ARE
`IDENTIFIED, THE DIR. OF PHARM. IS
`NOTIFIED AND TAKES ONE OF THE
`FOLLOWING ACTIONS:
`- Rx IS PROCESSED AND THE
`PHARMACIST MONITORS THE MD'S
`PROGRAM ACTIVITY
`— Rx IS NOT PROCESSED AND
`[THE MD IS NOTED AS UNAPPROVED|
`8
`
`’
`
`A
`
`THE PHYSICIAN IS INDICATED
`A5 UNAPPROVED IN CHIPS
`‘
`286
`L1
`THE MD IS CONTACTED BY A
`PHARMACIST & INFORMED THAT
`THE PAIIENT'S Rx CANNOT
`BE PROCESSED
`
`288
`I
`4/
`THE Rx AND ENROLLMENT FORM
`IS MAILED BACK To THE MD
`ALONG WITH A com LETTER
`REITERAIING THAT THE RX
`CANNOT BE PROCESSED
`290
`II
`L1
`A LETTER IS SENT TO THE
`PATIENT INDICATING THAT THE
`Rx CANNOT BE PROCESSED &
`THE PATIENT IS INSTRUCTED TO
`CONTACT HIS/ HER PHYSICIAN
`
`END
`
`274
`(J
`THE PHARMACIST VERIFIES
`THE MD.'S CREDENTIALS AND
`ENTERS AIJ. HNDINGS IN CHIPS
`
`276
`
`ARE THE
`MD.'S CREDENTIALS
`APPROVED?
`
`280
`YES
`4
`THE PHYSICIAN IS INDICATED
`AS APPROVED IN THE
`PHYSICIAN SCREEN IN CHiPS
`L H282
`THE PHARMACIST HOLDS THE
`PATIENT'S Rx UNTIL RECEIVING
`A COVERAGE APPROVAL FORM
`FROM INTAKE/REIMBURSEMENT
`
`CID
`
`FIG. 2B
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 5 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 4 6f 16
`
`US 7,668,730 B2
`
`CC)
`
`240
`UPON RECEIPT OF THE COVERAGE APPROVAL FORM FROM
`INTAKE/REIMBURSEMENT THE PHARMACY TECHNICIAN
`CONTACTS THE PATIENT TO COMPLETE THE "TECHNICIAN"
`SPECIFIED SECTIONS OF THE PATIENT
`COUNSELING CHECKUST
`
`244
`,./
`THE RECEIPT OF THE MATERIALS IS CONFIRMED AND
`ANOTHER CALL IS SCHEDULED TO COUNSEL THE
`PATIENT BEFORE THE XYREM IS SHIPPED
`
`AFTER COMPLETING THE SPECIFIED SECTIONS OF THE
`CHECKLIST WITH THE PATIENT THE PHARMACY TECHNICIAN
`TRANSFERS THE CALLER TO THE PHARMACIST WHO
`REVIEWS THE ENTIRE CHECKUST AND COMPLETES THE
`REMAINING "PHARMACIST" SPECIFIED SECTIONS
`248
`THE PHARMACIST INDICATES IN CHIPS THAT THE PATIENT
`COUNSELING CHECKLIST WAS SUCCESSFULLY COMPLETED
`INCLUDING THE DATE COMPIETED
`A
`
`252
`,
`THE SHIPMENT MUST BE SENT TO THE PATIENTS HOME
`250
`ADDRESS UNLESS THE PATIENT IS TRAVELING OR HAS
`‘1
`MOVED‘ IN WHICH CASE WE PHARMAC'ST WILL DETERMINE
`HIE PHARMACIST SCHEDULE THE PATIENTs SHIPMENT FOR
`THE NExT BUSINESS DAY OR THE NEXT BUSINESS DAY #
`THE PATTHIT IS AVAILABLE T0 SIGN FOR THE PACKAGE
`‘F A“ EXTEPT'ON W'II BE MADE- THE PATIENT OR THE
`254
`PATIENTS DESIGNEE MusT SIGN FOR THE PACI<ACE
`,/
`UPON DELIVERY
`I
`THE PHARMACIST ENTERs 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
`,4
`A PICK TICKET IS GENERATED FOR THE ORDER & THE
`RDER IS FORWARDED TO THE PHARMACY FOR FULFILLMENT
`260
`I
`,1
`J
`L THE SHIPMENT IS CONFIRMED IN CHIPS
`‘
`262
`,J
`THE ORIGINAL Rx IS FILED WITH THE PHARMACY
`Rx’S IN NUMERICAL ORDER
`
`I
`
`266
`'1
`ALL XYREM INVENTORY IS CYCLE COUNTED AND
`THE ORDER IS SHIPPED BY USPS EXPRESS MAIL? RECONCIIED WITH THE CHIPS SYSTEM QUANTITIES
`I
`BEFORE THE DAYS SHIPMENTS ARE SENT OUT
`QM FIG. 2c
`
`264
`,J
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 6 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 5 0f 16
`
`US 7,668,730 B2
`
`510
`PHYSICIAN SUCCESS
`PROGRAM MATERIALS
`REQUEST
`
`rj
`
`320
`'
`MD CALLS XYREM SUCCESS
`PROGRAM AT 1-865-XYREM88
`T0 REQUEST PROGRAM
`MATERIALS
`530
`J
`MD DEMOGRAPHICS. DEA#
`AND DATE OF REQUEST ARE
`ENTERED INTO CHiPS
`i
`340
`508 REQUESTS MATERIALS TO
`BE SHIPPED TO THE MD VIA
`THE UHI FULFILLMENT WEBSITE
`AT WWWPRAEULHLLMENECOM
`
`FIG. 3
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 7 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 6 6f 16
`
`US 7,668,730 B2
`
`402
`2 POSSIBLE REHLL
`REQUEST PROCESSES
`
`,
`404
`L
`EACH WEEK A REFILL REPORT IS GENERATED OF
`PATIENTS WITH I0 DAYS OF PRODUCT REMAINING
`A
`408 L
`A COPY OF THE REFILL REPORT IS PROVIDED
`TO INTAKE/REIMBURSEMENT
`410
`I
`i
`NO SOONER THAN 8 DAYS BEFORE MEDICATION
`DEPLETION, A PHARMACY TECHNICIAN CONTACTS THE
`PATIENT TO COMPLETE THE PRE—DELIVERY CHECKLIST
`
`g3)
`
`412
`
`IS
`THE PATENT
`REACHED?
`
`4I4
`r/
`A MESSAGE IS LEFT ONLY MENTIONINC
`SOS III A RETURN NUMBER
`
`H418
`
`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
`(i420
`V
`THE PHARMACIST ENTERS THE RX ORDER
`IN CHIPS, CREATING AN ORDER NUMBER
`I
`J22
`THE PHARMACIST VERIFIES THE RX AND AITACHES THE
`VERIFICATION LABEL TO THE HARD COPY Rx
`424
`i
`THE SHIPMENT IS CONFIRMED IN CHiPS
`*
`
`428
`i
`A PICK TICKET IS CENERATED FOR THE ORDER & THE
`RDER IS FORWARDED TO THE PHARMACY FOR FULFILLME
`I
`END
`
`450
`
`A
`
`r/4I6
`
`A NOTE IS ENTERED IN THE CHIPS INOICATING THE
`DATE THE MESSAGE WAS LEFT FOR THE PATIENT
`
`H426
`ALL XYREM INVENTORY IS CYCLE COUNTEO AND
`RECONCILED WITH THE CHiPS SYSTEM QUANTITIES
`BEFORE THE DAYS SHIPMENTS ARE SENT OUT
`
`FIG. 4A
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 8 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 7 0f 16
`
`US 7,668,730 B2
`
`434
`,J
`A XYREM PROBLEM IDENTIFICATION & MANAGEMENT RISK
`DIVERSION REPORT IS COMPLETED & DOCUMENTED IN
`CHIPS. THE REPORT IS THEN FAXED TO OMI 8c THE
`ORIGINAL IS FILED IN A MONTHLY BATCH FILE
`
`442
`I
`THE PATIENT MUST WAIT UNTIL THE NEXT SCHEDULED
`REFILL DATE TO RECEIVE ADDITIONAL PRODUCT
`
`END
`
`444
`
`460
`,./
`THE PATIENT MUST WAIT UNTIL THE NEXT SCHEDULED
`REFILL DATE TO RECEIVE ADDITIONAL PRODUCT
`
`458
`
`N0
`IS THE
`PATIENT w|LL T0
`PAY?
`462
`YES
`41-’
`THE PATIENT IS INFORMED OF THE COST OF THE
`PRODUCT AND IS GIVEN PAYMENT OPTIONS
`464
`
`ONCE PAYMENT IS RECEIVED THE ORDER IS RELEASED
`
`THE PATIENT CALLS TO REQUEST AN EARLY REFILL
`
`432
`,
`(J
`A NOTE CODE IS ENTERED IN CHIPS ON THE PATIENT
`SCREEN INDICATING THE EARLY REHLL REQUEST
`436
`r/
`THE PHARMACIST EVALUATES THE PATIENT’S
`COMPLIANCE WITH THERAPY AND/OR POSSIBLE PRODUCT
`DIVERSION, MISUSE OR OVERUSE
`
`458
`THE PHARMACIST CONTACTS THE PRESCRIBING
`PHYSICIAN TO ALERT OF THE SITUATION AND CONFIRM
`IF THE PHYSICIAN APPROVES OF THE EARLY REFILL
`
`440
`
`DOES
`THE PHYSICIAN
`APPROVE?
`446
`YES
`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 PATIENT'S INSURANCE
`PROVIDER TO VERIFY COVERAGE FOR THE EARLY REFILL
`
`,J
`INTAKE/REIMBURSEMENT SUBMITS A COVERAGE APPROVAL
`FORM T0 THE PHARMACY TEAM AS NOTIFICATION THAT
`THE PATTEMT's REFILL REQUEST CAN BE PROCESSED
`454
`II
`,1
`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
`
`466
`‘
`INTAKE/REIMBURSEMENT SUBMITS A COVERAGE APPROVAL
`FORM TO THE PHARMACY TEAM AS NOTTFICATION THAT
`THE PATIENT'S REFILL REQUEST CAN BE PROCESSED
`A
`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 AVAILABLE TO SIGN FOR THE PACKAGE
`
`ENE)“
`
`I
`
`CONTINUE F456
`
`FIG.
`
`45
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 9 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 8 6f 16
`
`US 7,668,730 B2
`
`UPON DETERMINING THAT A PATIENT IS UNINSURED OR
`UNDERINSURED, A REIMBURSEMENT SPECIALIST EXPLAINS
`THE NORD PROGRAM TO THE PATIENT AND FAXES AN
`APPLICATION REQUEST FORM TO NORD FOR THE PATIENT
`A
`H515
`THE INTAKE/REIMBURSEMENT SPECIALIST DOCUMENTS
`IN CHiPS THAT AN APPUCATION HAS BEEN REQUESTED
`THROUGH NORD
`A
`520
`[1
`NORD MAILS A PAP APPUCATION TO THE
`PATIENT WITHIN I BUSINESS DAY
`
`525
`
`IS
`THE PATIENT
`APPROVED?
`1545
`YES
`NORD SENDS AN AccEPTANcE LETTER To THE
`PATTENT AND FAXES A VOUCHER T0 SOS INDICAIING THE
`PATIENT'S APPROVAL FOR THE PROGRAM
`A
`£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
`
`550
`
`NORD SENDS A DENIAL LETTER TD THE PATIENT
`
`£540
`I
`805 DocDNENTs IN CHIPS THA
`THE PATIENT WAS DENIED BY NORD
`
`FIG. 5
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 10 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 9 6f 16
`
`US 7,668,730 B2
`
`236
`,J
`CH WEEK, THE DIRECTOR OF PHARMACY TRANSFERS
`INVENTORY FOR THE WEEK'S SHIPMENTS TO A
`SEGREGATED WAREHOUSE LOCATION
`FOR PRODUCTION INVENTORY
`
`236
`i
`
`A PURCHASE ORDER IS CENERATED FOR THE
`INVENTORY TRANSFERRED TO THE PRODUCTION
`LOCATION & IS FAXED TO THE OMI CONTROLLER
`
`236
`i
`
`THE OMI CONTROLLER INVOICES SOS FOR
`THE PRODUCT MOVED TO PRODUCTION
`
`350
`
`FIG. 6
`
`700\\
`
`PRESCRIBER FIELDS
`
`PATIENT FIELDS
`
`PRESCRIPTION FIELDS
`
`,/8OO
`
`~ 7T 0
`
`H 720
`
`I» 750
`
`OUERY I — PRESCRIPTTONS BY PHYSICIAN
`
`~ BI O
`
`QUERY 2 - PRESCRIPTTONS BY PATIENT NAME ~82O
`
`QUERY 3 ~ PRESCRIPTTONS BY FREQUENCY ~85O
`
`INSURANCE FIELDS
`
`~74O
`
`QUERY N — PRESCRIPTTONS BY DOSE
`
`6- 840
`
`FIG. 7
`
`FIG. 8
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 11 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 10 6f 16
`
`US 7,668,730 B2
`
`BOO
`PRESCRIPTION AND ENROLLMENT FORM /
`PRESCRIBER INFORMATION
`PRESCRIBER'S NAMEW OFFICE CONTACT: _
`STREET ADDRESS:
`
`CITY: ~_E,
`
`STATE: E_ _ __
`
`_
`
`ZIP:
`
`PHDNE:_
`
`_ EEV
`
`_ __
`
`FAX:
`
`,4
`
`IICENSE NUMBER:
`MD SPECIALTY:
`
`,
`
`DEA NUMBER:
`
`E
`
`PATIENT NAME: E
`
`ADDRESS: _i EEE
`
`PRESCRIPTION FORM
`SS#:
`
`DOB: _E,
`
`SEX M / F
`
`CITY:
`STATE: m ZIP: ‘_____
`RXZ XYREM ORAL SOLUTION (OOO mg/mL) TOO MI. BOTTLE QUANTITY:
`MONTHS SUPPLY
`SIOI TAKE aqGMS P.O. OILUTEO IN 60 mL WATER AT HS. AND THEN AGAIN 2 I /2 TO 4 HOURS LATER
`REFILLS (OIROIE ONE): 0 I
`2 (MAXIMUM 0F 3 MONTH SUPPLY)
`DATE: __/__ /_~
`
`PRESCRIBER'S SIGNATURE
`TO BE COMPLETED AT INTITAL PRESCRIPTION ONLY
`PHYSICIAN DECLARATION~PLEASE CHECK EACH BOX
`S I HAVE READ THE MATERIALS IN THE XYREM PHYSICIAN SUCCESS PROGRAM
`[j I VERIFY THAT THE PATIENT HAS BEEN EDUCATED WITH RESPECT TO XYREM PREPARATION, DOSING AND SCHIDULING.
`II] I UNDERSTAND THAT XYREM IS APPROVED FOR THE TREATMENT OF CATAPLEXY IN PATIENTS WITH NARCOLEPSY,
`AND THAT SAFETY OR EFFICACY HAS NOT BEEN ESTABLISHED FOR ANY OTHER INDICATION.
`1:] I UNDERSTAND THAT THE SAFETY OF DOSES GREATER THAN Qgm/DAY HAS NOT BEEN ESTABLISHED
`
`PATIENT INFORMATION
`BEST TIME TO CONTACT PATIENT: c DAY E1 NIGHT
`DAY I}; W EVENING II;
`INSURANCE COMPANY NAME: m PHONE {11”
`INSURED’S NAME:
`RELATIONSHIP TO PATIENT:
`IDENTIFICATION NUMBER: m POLICY/GROUP NUMBER:
`PRESCRIPITON CARD: ET NO ET YES IF YES, CARRIER:
`., POLICY #: 4______ 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—XYREMB8 (1-866-997-3688)
`FIG. 9
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 12 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 11 6f 16
`
`US 7,668,730 B2
`
`/
`PATIENT ASSISTANCE APPLICATION REQUEST FORM
`
`I 000
`
`DATE:
`
`T0:
`FROM:
`
`PATIENT ASSISTANCE ORGANIZATION
`SDS
`
`FAX If:
`
`203498-2291
`
`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
`IPR of U.S. Patent No. 7,668,730
` Page 13 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 12 0f 16
`
`US 7,668,730 B2
`
`‘IIOO
`SENSITIVE DRUG PATIENT ASSISTANCE PROGRAM /
`VOUCHER REQUEST FOR MEDICATION
`
`PATIENT INFORMATION
`(FIRST NAME><IAST NAME)
`(ADDRESS 1>
`(ADDRESS 2>
`(CITY, STATE ZIP CODE>
`PHONE: 023-450-7000
`015; 01/01/1900
`& 123-423-0739
`0000 ALLOTMENT: 1002;
`131; 03/01/2001
`
`01100
`XYREEM 10011111311
`
`VAIJDATION DATE:
`EXPIRATION DATE:
`ISSUE DATE:
`
`APPROVED
`
`CASE CODE: "mm
`
`QUANTITY
`I
`
`03/01/2001
`05/31/2001
`03/13/2001
`
`PHYSICIAN INFORMATION
`(PHYSICIAN NAME)
`(ADDRESS 1>
`(ADDRESS 2>
`(CITY, STATE ZIP CODE)
`PHONE: (123-456-7890
`
`FIRST SHIPMENT 1111s YEAR
`
`*"PHARMACY USE***
`
`NORD COPY
`******>I<****>I<*******************************************
`
`(DETACH HERE)
`
`PHYSICIAN INFORMATION
`(PHYSICIAN NAME)
`(ADDRESS I)
`(ADDRESS 2)
`(CITY, STATE ZIP CODE)
`PHONE: (123-456-7890
`
`FIRST SHIPMENT THIS YEAR
`
`*"PHARMACY USE*“
`
`PATIENT INFORMATION
`(FIRST NAME><LAST NAME)
`(ADDRESS I)
`(ADDRESS 2)
`(CITY, STATE ZIP CODE)
`1% <123-450-7090
`000 01/01/1900
`& 123-423-0709
`DRUG'ALLOTMENT: 100%
`L130 03/01/2001
`DRUG
`XYREM 180ml btI
`
`VALIDATION DATE:
`EXPIRATION DATE:
`ISSUE DATE:
`
`APPROVED
`
`01131 CODE: ********
`
`QUANTITY
`I
`
`03/01/2001
`05/31/2001
`03/15/2001
`
`FIG. 11
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 14 of 25
`
`

`
`US. Patent
`
`Feb. 23, 2010
`
`Sheet 13 6f 16
`
`US 7,668,730 B2
`
`I 200
`
`/
`SENSITIVE DRUG PHYSICIAN'S CERTIFICATE
`OF MEDICAL NEED
`
`PATIENT INFORMATION
`
`DATE:
`
`NAME:
`LAST
`DATE OF BIRTH:
`
`FIRST
`
`M
`
`DRUG BEING PRESCRIBED: XYREM
`
`DIAGNOSIS/CONDITION FOR WHICH DRUG IS BEING PRESCRIBED:
`
`ICD-9:
`
`PHYSICIAN INFORMATION
`
`PHYSICIAN'S NAME (PLEASE PRINT):
`
`PHYSICIANS SIGNATURE:
`
`DATE:
`
`PLEASE FAX BACK TO SENSITIVE DRUG SUCCESS PROGRAM: (I—800-TOLL FREE NUMBER)
`
`FIG. 12
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 15 of 25
`
`

`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 16 of 25
`
`

`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 17 of 25
`
`

`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 18 of 25
`
`

`
`US 7,668,730 B2
`
`1
`SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`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 speci?c 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 pro?t.
`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 ?lled 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 pro?t.
`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
`
`20
`
`25
`
`30
`
`35
`
`40
`
`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 identi?ed by monitor
`ing data in the database for prescription patterns by physi
`cians and prescriptions obtained by patients. Further veri?
`cation is made that the physician is eligible to prescribe the
`45
`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 ?rst 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 con?rmed 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 con?rm delivery
`in further embodiments. If a shipment is lost, an investigation
`is launched to ?nd 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
`
`50
`
`55
`
`60
`
`65
`
`2
`shipping the drug must be con?rmed. This ability may be
`checked through NTIS and State Boards of Pharmacy.
`Prescription re?lls are permitted in the number speci?ed in
`the original prescription. In addition, if a prescription re?ll is
`requested by the patient prior to the anticipated due date, such
`re?lls will be questioned. A lost, stolen, destroyed or spilled
`prescription/ supply is documented and replaced to the extent
`necessary to honor the prescription, and will also cause a
`review or full investigation.
`The exclusive central database contains all relevant data
`related to distribution of the drug and process of distributing
`it, including patient, physician and prescription information.
`Several queries and reports are run against the database to
`provide information which might reveal potential abuse of the
`sensitive drug, such as early re?lls.
`
`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 ?owchart 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 ?owchart of a physician success program at least
`partially implemented on a computer system such as that
`shown in FIG. 1.
`FIGS. 4A and 4B are a ?owchart describing a method for
`handling re?ll requests at least partially utiliZing a computer
`system such as that shown in FIG. 1.
`FIG. 5 is a ?owchart 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 ?owchart 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 ?elds.
`FIG. 8 is a block diagram showing a list of queries against
`the database ?elds.
`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 ?nancial 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 certi?cate of medical need.
`FIGS. 13A, 13B and 13C are descriptions of sample
`reports obtained by querying a central database having ?elds
`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 speci?c embodiments in
`which the invention may be practiced. These embodiments
`are described in su?icient 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 de?ned by the appended claims.
`The functions or algorithms described herein are imple
`mented in software or a combination of software and human
`
` PAR1001
`IPR of U.S. Patent No. 7,668,730
` Page 19 of 25
`
`

`
`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, ?rmware 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
`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 subj ect to a restricted
`distribution program. One aspect of the program is to educate
`physicians and patients about the risks and bene?ts of Xyrem,
`including support via ongoing contact with patients and a toll
`free helpline. Initial prescriptions are ?lled 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 ?nished drug product. Following
`manufacture of the drug product, it is store