(12) Ulllted States Patent
`Reardan et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,765,106 B2
`*Jul. 27, 2010
`
`US007765l06B2
`
`(54) SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`(75)
`
`Inventors: Dayton T. Reardan Excelsior MN
`.
`’
`’
`(US); PamA' Engel’ Eagan’ MN (US);
`Bob Gagne, St. Paul, MN (US)
`(73) Assignee: JPI Commercial, LLC, Palo Alto, CA
`(US)
`.
`.
`.
`.
`S“tbJet°F‘° aIt1Y‘(111S(°11a1me(§a‘h:3:1‘3rmd°f‘1;1§
`paenisexene orajuse uner
`U.S.C. 154(1)) by 1645 days.
`
`.
`NOUCB3
`
`(*)
`
`This patent is subject to a terminal dis-
`C1aimer'
`(21) App1.N0.: 10/979,665
`
`6,021,392 A
`6,045,501 A
`6,055,507 A
`6,112,182 A
`6 315 720 B1
`’
`’
`6,347,329 B1
`6,564,121 B1
`6,687,676 B1
`6,755,784 B2
`6,952,681 B2
`7,058,584 B2
`
`2/2000 Lester et al.
`4/2000 Elsayed et al.
`4/2000 Cunningham
`8/2000 Ak
`tal.
`1
`11/2001 w'iir'S e
`1
`/
`1 ‘ms 6 a '
`22002 Evans
`5/2003 Wallace Gt 31
`2/2004 Denny
`6/2004 Williams et al.
`10/2005 McQuade et al.
`.
`.
`6/2006 Kosinski et al.
`
`(Continued)
`OTHER PUBLICATIONS
`
`(22)
`
`Filed:
`
`NOV. 2, 2004
`
`NASCSA National Conference, (Nov. 2000),8 pages.
`
`(65)
`
`Prior Publication Data
`
`US 2005/0090425 A1
`
`Apr. 28, 2005
`
`(51)
`
`Related U-S-Application Data
`(62) Division of application No. 10/322,348, filed on Dec.
`17, 2002, now Pat. No. 7,668,730.
`Int. Cl.
`(2006.01)
`G06Q 10/00
`(52) U.s. Cl.
`............................................. .. 705/2, 705/3
`.
`.
`.
`(58) Field of Classification Search ................... .. 705/2,
`705/3
`See application file for complete search history
`
`'
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`3,556,342 A
`4,847,764 A
`4,976,351 A
`5,737,539 A
`5,845,255 A
`5,924,074 A
`
`1/1971 Guarr
`7/1989 Halvorson
`12/1990 Manginietal.
`4/1998 Edelson et al.
`12/1998 Mayaud ....................... .. 705/3
`7/1999 Evans .......................... .. 705/3
`
`(COI1tiI111ed)
`
`Primary Examz'ner—Gerald J . O’Connor
`Assistant Examiner—Lena Naj arian
`(74) Attorney, Agent, or Firm—Schwegman, Lundberg &
`Woessner’ PA‘
`(57)
`
`ABSTRACT
`
`.
`.
`.
`.
`.
`A dmg d1S‘“b““°“ System and me‘h°d. “‘.1hZeS a °em”.‘1
`pharmacy and database to track all prescriptions for a sensi-
`five drug Information is kept in the database regarding an
`.
`.
`’
`.
`.
`.
`physlclans allgwed to prescnbe the S€.mSm.Ve drug’
`an
`patients receiving the drug. Abuses are identified by momtor-
`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.
`
`8 Claims, 16 Drawing Sheets
`
`202
`111 was/mi: :1 111/M11111011 ram201
`»1 u1u<i/ia11ma1i1i1 91121151 111111 1 W1 111
`mi 11./11111111111111 mm 1111 ou>11ss11u1=i1i
`“1x:1>r'1 11111 mi ms11111i11 5 m1 iammi
`in mi 1>111111m 12111
`21113
`111 111115/M3111 R11/11111111111011 M1
`210
`1
`mi uiuii/11i11nxs:11:u1 s1>inw1s1 aims mi
`1-11115111140 PNVSIMM ID 111111 11115
`212
`
`m
`15111 I111
`m1ni1i1
`220
`YES
`111 11111111/11311311591911 SPICMLEI mums 111:
`111 vim miwi 1 u:v:111u1'.v at M mmi111's 111
`smismmisnimimiuuuas
`1
`222
`111 11flM1E/Rl11Iil‘EEMDll SPIMEV suns mm
`11m11111)1c1r1i111i11momi1>111i1i1
`1
`221
`mi 1111111<i/11u111n1m1:111 s1=i0a1s1 ms 1
`31111111111 or 11101 1111351110 mi
`10 111 mniii
`1
`226
`mi 111111:/11i111m1si11i1« 91111151 111111215
`mi m11i11rs :1-mu mm 0 101111
`E11‘/[W41 I IINDTIS
`.1 11.
`11111111111
`5
`mm
`»»-1 m
`235
`113
`1111u1i/11i111a11su1:111 311111113 11 110111211:
`112110111 11111151117101 m mi
`us 11¢ 111
`11I1r11.11i1111a1i1i1 in mi mm 11111 15
`1n111m1m1 in mam 111 W111‘: 111
`
`214
`u11111111i11msc1111i11i mi 11111: 1111111 10
`W0! M1010 WWN W1 EEK; 111F\X|WD11
`1
`216
`IE IIISME WWII]!!! W8 W1 BEEN WYMNED
`111111112: 11111;, mi R:/E|lHX|Mfll1 1111111151115:
`KlI)INEIlDl11|<A1l.1EE1ll1lUWM1lMLE1'1LR
`]
`218
`A 1111i 15 iuiinm 111 111115 111A1l1(
`imuiim ws mum
`232
`sii min miss mi PAl1Dl1S
`11111 M! 1I1IIE11fiED 111? WIK|1l1S11RE|)
`
`E” 230
`211
`ii:
`1111 MINT 5 11111111111 a1 mi msi 1111111
`Pmimci m111s1:1i11 11111111 111111115
`1
`in
`max 911111111 5 11191111, WK!/HEIIBISCIIEVIV
`51151115 A mama mum rm (swim 10
`mi "mvr 1111111 111/511111111111 1111111) In mi
`P11111041 1:111 11 imlumi 111 miss
`i1( PAIIEMTS [1
`
`ip
`
`Wocl<hz11‘dt 1001
`
`Wockhardt 1001
`
`

`
`US 7,765,106 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`7,668,730 B2
`2001/0001144 A1
`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
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`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
`2005/0216309 A1
`2005/0222874 A1
`
`2/2010 Reardon et al.
`5/2001 Kapp
`11/2001 Fletcher et al.
`11/2001 Keresman, III et al.
`1/2002 Waddington et al.
`3/2002 Reitberg
`3/2002 Feeney, Jr. et al.
`4/2002 Mayaud
`4/2002 McQuade et al.
`5/2002 Kobylevsky et al.
`10/2002 Subich
`11/2002 Melker et al.
`2/2003 Califano et al.
`3/2003 Gogolak
`3/2003 Jay et al.
`5/2003 Lilly et al.
`6/2003 Clementi
`7/2003 Jones
`7/2003 Kosinski et al.
`8/2003 Andreasson et al.
`10/2003 Kusterbeck
`12/2003 Eidex et al.
`12/2003 Cardenas et al.
`1/2004 Carrender et al.
`1/2004 Herceg et al.
`1/2004 Moradi et al.
`4/2004 Kaafarani et al.
`6/2004 Denny
`6/2004 Fetterman et al.
`6/2004 Hill, Sr. et al.
`6/2004 Hill, Sr. et al.
`8/2004 Ericsson et al.
`9/2004 Lilly et al.
`9/2005 Reardan et al.
`10/2005 Reardan et al.
`
`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 of Health and Human Service Food and Drug
`Administration.
`Center for Drug Evaluation and Research, Holiday Inn, Bethesda,
`Maryland,(Jun. 6, 2001),7 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 1.115 filed Jun. 17,
`2005 in U.S. Appl. No. 11/104,013”.
`“System for Thalidomide Education and Prescribing Safety (S.T.E.
`P.S.) Starter Kit”, Celgene Corporation, (2001),103 pgs.
`
`“An Interview with Orphan Medical about Xyrem”, http://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.
`“L .S. Appl. No. 10/322,348, Advisory Action mailed Feb. 5, 2007”,
`3 pgs.
`“L.S. Appl. No. 10/322,348, Amendment and Response to Final
`Office Action mailed Jan. 17, 2007”, 17 pgs.
`“L.S. Appl. No. 10/322,348, Amendment and Response to Final
`Office Action mailed Feb. 29, 2006”, 11 pgs.
`“L.S. Appl. No. 10/322,348, Final Office Action mailed Oct. 18,
`2006”, 14 pgs.
`“L.S. Appl. No. 10/322,348, Final Office Action mailed Dec. 29,
`2005”, 11 pgs.
`“L .S. Appl. No. 10/322,348, Non Final Office Action mailed Jun. 17,
`2005”, 26 pgs.
`“L .S. Appl. No. 10/322,348, Non Final Office Action mailed Jun. 29,
`2005”, 12 pgs.
`“L.S. Appl. No. 10/322,348, Non Final Office Action Response
`mailed Aug. 8, 2006”, 10 pgs.
`“L .S. Appl. No. 10/322,348, Preliminary Amendment mailed Sep.
`30, 2004”, 11 pgs.
`“L .S. Appl. No. 10/731,915 Non Final Office Action mailed Oct. 5,
`2004”, 21 pgs.
`“L .S.Appl. No. 10/731,915, Non Final OfficeAction mailedAug. 12,
`2005”, 22 pgs.
`“L.S. Appl. No. 10/731,915, Non Final Office Action Response
`mailed Feb. 2, 2005”, 17 pgs.
`“L .S. Appl. No. 10/322,348, Non Final Office Action mailed Jun. 19,
`2006”, 18 pgs.
`“L.S.Appl. No. 11/097,651, PreliminaryAmendment mailedApr. 1,
`2005”, 6 pgs.
`“L .S. Appl. \Io. 11/097,651, Non-Final Office Action mailed May
`29, 2009”, 21 pgs.
`“L .S. Appl. \Io. 10/322,348, Appeal Brief filed May 21, 2007”, 32
`pgs.
`“L .S. Appl. \Io. 10/322,348, Examiner Interview Summary mailed
`Oct. 21, 2009”, 3 pgs.
`“L .S. Appl. \Io. 10/322,348, Notice of Allowance mailed Dec. 31,
`2009”, 16 pgs.
`“L .S. Appl. No. 10/322,348, Reply Brief filed Dec. 3, 2007”, 4 pgs.
`“L.S. Appl. \Io. 10/322,348, Response filed Sep. 29, 2005 to Non
`Final Office Action mailed Jun. 29, 2005”, 19 pgs.
`“L .S. Appl. No. 11/097,651 ,Non-Final Office Action mailed Mar. 3,
`2010”, 19 Pgs.
`“L.S. Appl. \Io. 11/097,651, Final Office Action mailed Nov. 12,
`2009”, 14 pgs.
`“L.S. Appl. \Io. 11/097,651, Response filed Feb. 9, 2010 to Final
`Office Action mailed Nov. 12, 2009”, 11 pgs.
`“L.S. Appl. \Io. 11/097,651, Response filed Sep. 17, 2009 to Non
`Final Office Action mailed May 29, 2009”, 10 pgs.
`“L .S. Appl. No. 11/097,985, Non Final OfficeAction mailed Sep. 14,
`2009”, 22 pgs.
`“L.S.Appl. No. 11/097,985, PreliminaryAmendment mailedApr. 1,
`2005”, 7 pgs.
`“L.S. Appl. No. 11/097,985, Response filed Nov. 3, 2009 to Non
`Final Office Action mailed Sep. 14, 2009”, 15 pgs.
`
`Wocl<11zu‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 1 of 16
`
`US 7,765,106 B2
`
`100
`
`Wocl<hzu‘dt 1001
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`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 2 of 16
`
`US 7,765,106 B2
`
`MO MAILS/FAXES IN Rx/ENROLLMENT FORM
`
`202
`
`204
`
`AN INTAKE/REIMBURSEMENT SPECIALIST MAKE A COPY OF
`
`
`THE Rx/ENROLLMENT FORM (THE COPY IS STAMPED
`"COPY") AND THE ORIGINAL FAX IS THEN FORWARDED
`
`TO THE PHARMACY TW
`
`MO MAILS/TAXES IN Rx/ENROLLMENT FORM
`
`206
`
`210
`
`THE INTAKE/REIMBURSEMENT SPECIALIST ENTERS THE
`PATIENT AND PHYSICIAN INFO INTo CHIPS
`
`is
`212
`
`YES
`
`II0
`
`220
`
`THE INTAKE/REIMBURSEMENT SPECIALIST CONTACTS MD
`TO VERIFY RECEIPT A 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
`THE INTAKE/REIMBURSEMENT SPECIALIST FAXES A
`STATEMENT or MEDICAL NECESSIIY To THE
`up To COMPLETE
`
`226
`
`@
`
`214
`AN INTAKE REPRESENIAIWE wILL MAKE 1 ATTEMPT To
`REACH THE MD To OBTAIN THE MIssINc INFORMATION
`
`216
`THE MISSING INFORMATION HAS NoT BEEN OBTAINED
`NITHIN 24 HOURS, THE Rx/ENROLLMENT FORM IS FAXED
`BACK To THE MD wITH A REJECTION EXPLANATION LETTER
`218
`
`A NOTE Is ENT R
`
`APPLWEONEDWAS ESEIESCTED
`
`IN H'P
`
`THAT I
`
`HE
`
`232
`
`SEE NORD PROCESS FOR PATIENTS
`WHO ARE UNINSURED OR UNDERINSURED
`
`THE INTAKE/REIMBURSEMENT SPECIALIST CoNTACTs
`THE PATIENT’s INSURANCE PROVIDER TO VERIFY
`
`"0
`
`230
`
`CovERACE & BENEFITS
` 238
`
`YES
`
`234
`
`THE PATIENT IS INFORMED OF THE COST OF THE
`PRODUCT AND IS CNEN PAYMENT OPTIONS
`
`236
`
`
`
`
`
`INTAKE/REIMBURSEMENT
`ONCE PAYMENT IS RECEIVED,
`SUBMITS A COVERAGE APPROVAL FORM (STAPLED TO
`THE "COPY" OF THE Rx/ENROLLMENT FORM) TO THE
`PHARMACY TEAM AS NOTIFICATION TO PROCESS
`THE PATIENTS Rx
`
`
`
`
`
`
`
`INTAKE/REIMBURSEMENT SUBMIIS A COVERAGE
`APPROVAL FORM (STAPLED To THE ‘COPY’ OF THE Rx
`ENROLLMENT FORM) To THE PHARMACY TEAM AS
`
`NOTIFICATION IO PROCESS THE PATIENT's Rx
`
`WOCI(I12I1‘dt 1001
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`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 3 of 16
`
`US 7,765,106 B2
`
`
`
`
`
`
`208
`
`PHARMACY WORK FLOW
`
`268
`
`IS SHlppED
`‘HE PAHENI
`A XYREM SUCCESS
`pACKE1 VIA 2_DAY Uspg
`
`270
`
`274
`
`
`
`
`
`CREDENTIALS BEEN VERIFIED
`& APPROVED IN THE LAST
`
`
`
`YES
`
`272
`
`THE PHARMACIST HOLDS THE
`
`PATIENT'S Rx UNTIL RECEMNG
`A COVERAGE APPROVAL FORM
`
`FROM INTAKE/REIMBURSEMENT
`
`N0
`
`THE PHARMACIST VERIFIES
`THE MD.'S CREDENTIALS AND
`ENTERS ALL FINDINGS IN CHIPS
`
`275
`
`MD-SAEEEBIEEHNS
`
`
`
`
`
`
`N0
`
`YES
`
`280
`
`THE PHYSICIAN IS INDICATED
`
`AS APPROVED IN THE
`PHYSICIAN SCREEN IN CHIPS
`
`282
`
`THE PHARMACIST HOLDS THE
`
`PATIENTS Rx UNTIL RECEMNG
`A COVERAGE APPROVAL FORM
`FROM INTAKE/REIMBURSEMENT
`
`IF ANY DISCIPLINARY ACTIONS ARE
`IDENTIFIED, THE DIR. OE PHARM.
`IS
`NOTIFIED AND TAKES ONE OF THE
`FOLLOWING ACTIONS:
`- Rx IS PROCESSED AND THE
`PHARMACIST MONITORS THE MD.'S
`PROGRAM ACTMTY
`- Rx IS NOT PROCESSED AND
`THE MD IS NOTED AS UNAPPROVED
`
`284 278
`THE PHYSICIAN IS INDICATED
`
`
`
`
`
`
`
`THE MD IS CONTACTED BY A
`
`PHARMACIST & INFORMED THAT
`THE PATIENT'S Rx CANNOT
`
`BE PROCESSED
`
`288
`
`THE Rx AND ENROLLMENT FOR
`
`
`
`
`
`IS MAILED BACK TO THE MD
`ALONG WITH A COVER LETTER
`
`
`
`
`
`REITERATING THAT THE Rx
`CANNOT BE PROCESSED
`
`
`
`290
`
`
`
`A LETTER IS SENT TO THE
`PATIENT INDIGATING THAT THE
`
`Rx CANNOT BE PROCESSED &
`
`
`
`
`
`
`
`THE PATIENT IS INSTRUCTED TO
`CONTACT HIS/HER PHYSICIAN
`
`
`
`
`FIG. 2B
`
`END
`
`Wocl<hzu‘dt 1001
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`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 4 of 16
`
`US 7,765,106 B2
`
`240
`
`
`
`UPON RECEIPT or THE C0vERACE APPROVAL FORM FROM
`INTAKE/REIMBURSEMENT THE PHARMACY TECHNICIAN
`
`
`CONTACTS THE PATIENT To COMPLETE THE "TECHNICIAN"
`SPECIFIED SECTIONS or THE PATIENT
`
`COUNSELING CHECKLIST
`
` 246
`
`244
`
`THE RECEIPT OF THE MATERIALS IS CONFIRMED AND
`ANOTHER CAl.L 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 CHECKLIST AND COMPLETES THE
`REMAINING "PHARMACIST" SPECIFIED SECTIONS
`
`
`248
`
`
`
`
`
`
`
`252
`
`
`
`THE SHIPMENT MUST BE SENT TO THE PATIENTS HOME
`ADDRESS UNLESS THE PATIENT IS TRAVELING OR HAS
`MOVED,
`IN WHICH CASE THE PHARMACIST WILL DETERMINE
`IF AN EXCEPTION WILL BE MADE. THE PATIENT OR THE
`PAT|ENT'S DESIGNEE MUST SIGN FOR THE PACKAGE
`UPON DELIVERY
`
`
`
`
`
`266
`
`ALL XYREM INVENTORY IS CYCLE COUNTED AND
`
`RECONCILED WITH THE CHIPS SYSTEM OUANTITIES
`BEFORE THE DAYS SHIPMENTS ARE SENT OUT
`
`THE PHARMACIST INDICATES IN CHIPS THAT THE PATIENT
`COUNSELING CHECKLIST WAS SUCCESSFULLY COMPLETED
`
`INCLUDING THE DATE COMPLETED
`
`250
`
`THE PHARMACIST SCHEDULE THE PATIENTS SHIPMENT FO
`THE NEXT BUSINESS DAY OR THE NEXT BUSINESS DAY
`THE PATIENT IS AVAILABLE TO SIGN FOR THE PACKAGE
`254
`
`I
`
`THE PHARMACIST ENTERS THE Rx ORDER
`
`IN CHIPS. CREATING 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
`RDER IS FORWARDED TO THE PHARMACY FOR FULFILLMEN
`
`THE SHIPMENT IS CONFIRMED IN CHIPS
`
`260
`
`262
`
`THE ORIGINAL Rx IS FILED WITH THE PHARMACY
`Rx'S IN NUMERICAL ORDER
`
`264
`
`THE ORDER IS SHIPPED BY USPS EXPRESS MAIL
`
`5””
`
`FIG.
`
`2C
`
`WOCL(L12l1‘dt 1001
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`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 5 of 16
`
`US 7,765,106 B2
`
`31 O
`
`
`PHYSICIAN SUCCESS
`PROGRAM MATERIALS
`
`
`
`REOUEST
`
`
`320
`
`
`
`
`
`MD CALLS XYREM SUCCESS
`
`
`
`PROGRAM AT I-856-XYREM88
`
`T0 REQUEST PROGRAM
`
`
`MATERIALS 330
`
`
`
`MD DEMOGRAPHICS, DEAE
`AND DATE or REQUEST ARE
`
`ENTERED mm CHIPS
`
`
`
`
`
`
`
`340
`
`SDS REOUESTS MATERIALS TO
`
`
`
`
`AT WWW.PRAFULF|LLMENT.COM
`
`
`BE SHIPPED TO THE MD VIA
`
`THE OMI FULFILLMENT WEBSITE
`
`
`
`
`
` 350
`
`FIG. 3
`
`Wocl<hzu‘dt 1001
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`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 6 of 16
`
`US 7,765,106 B2
`
`402
`
`2 POSSIBLE REFILL
`REOUEST PROCESSES
`
`404
`
`@
`
`A MESSAGE IS LEFT ONLY MENTIONING
`
`SDS & A RETURN NUMBER
`
`414
`
`4T6
`
`A NOTE IS ENTERED IN THE CIHPS INDICATING THE
`DATE THE MESSAGE WAS LEFT FOR THE PATIENT
`
`EACH WEEK A REFILL REPORT IS GENERATED OF
`PATIENTS WITH IO DAYS OF PRODUCT REMAINING
`
`408
`
`A COPY or THE REFILL REPORT IS PROVIDED
`TO INTAKE/REIMBURSEMENT
`
`4T0
`
`NO SOONER THAN 8 DAYS BEFORE MEDICATION
`
`DEPLETION, A PHARMACY TECHNICIAN CONTACTS THE
`PATIENT TO COMPLETE THE PRE-DELNERY CHECKLIST
`
`412
`
`IS
`THE PATIENT
`
`REACHED?
`
`YES
`
`2C3
`
`418
`
`
`
`
`THE PHARMACY TECHNICIAN SCHEDULES THE PATIENT'S
`
`SHIPMENT FOR THE NEXT BUSINESS DAY OR THE NEXT
`BUSINESS DAY THE PATIENT IS AVAIIABLE TO
`SIGN FOR THE PACKAGE
`
`420
`
`THE PHARMACIST ENTERS THE Rx ORDER
`
`IN CHIPS, 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
`
`42 4
`
`428
`
`42 6
`ALL XYREM INVENTORY IS CYCLE COUNTED AND
`RECONCILED WITH THE CHIPS SYSTEM OUANTITIES
`BEFORE THE DAYS SHIPMENTS ARE SENT OUT
`
`A PICK TICKET IS GENERATED FOR THE ORDER & THE
`RDER IS FORWARDED TO THE PHARMACY FOR FULFILLMEN
`
`END
`
`-I>- (44O
`
`FIG. 4A
`
`Wocl<hzu‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 7 of 16
`
`US 7,765,106 B2
`
`6
`
`406
`
`THE PATIENT CALLS TO REOUEST AN EARLY REFILL
`
`432
`
`A NOTE CODE IS ENTERED IN CHIPS ON THE PATIENT
`SCREEN INDICATING THE EARLY REFILL REOUEST
`436
`
`THE PHARMACIST EVALUATES THE PATIENT'S
`COMPLIANCE WITH THERAPY AND/OR POSSIBLE PRODUCT
`DIVERSION, MISUSE OR OVERUSE
`
`438
`
`THE PHARMACIST CONTACTS THE PRESCRIBING
`PHYSICIAN TO ALERT OF THE SITUATION AND CONFIRM
`IF THE PHYSICIAN APPROVES OF THE EARLY REFILL
`
`4 4 O
`
`
`DOES
`
`THE PHYSICIAN
`APPROVE?
`
`YES
`
`434
`
`
`
`
`
`
`A XYREM PROBLEM IDENTIFICATION & MANAGEMENT RISK
`DIVERSION REPORT IS COMPLETED & DOCUMENTED IN
`CHIPS. THE REPORT IS THEN FAXED TO OMI & THE
`ORIGINAL IS FILED IN A MONTHLY BATCH FILE
`
`
`
`
`
`
`THE PATIENT MUST WAIT UNTIL THE NEXT SCHEDULED
`REFILL DATE TO RECEIVE ADDITIONAL PRODUCT
`
`442
`
`[ND
`
`444
`
`460
`
`446
`
`THE PATIENT MUST wm UNTIL THE NEXT SCHEDULED
`REFILL DATE Io RECEIVE ADDITIONAL PRODUCT
`
`46
`
`2
`
`N0
`
`IS THE
`
`
`PATIENT WILL TO
`PAY?
`
`YES
`
`
`
`458
`
`THE PATIENT IS INFORMED OF THE COST OF THE
`PRODUCT AND IS GIVEN PAYMENT OPTIONS
`
`4 4
`6
`
`ONCE PAYMENT IS RECEIVED THE ORDER IS RELEASED
`
`THE PHARMACIST ENTERS A NOTE IN CHIPS
`IN THE PATIENT SCREEN THAT THE PHYSICIAN
`APPROVES THE REOUEST
`
`448
`
`THE PHARMACIST NOTIFIES AN INTAKE/REIMBURSEMENT
`SPECIALIST TO CONTACT THE PATIENTS INSURANCE
`PROVIDER TO VERIFY COVERAGE FOR THE EARLY REFILL
`
`450
`
`
`INSURANCE PROVIDER
`
`YES
`
`452
`
`466
`
`INTAKE/REIMBURSEMENT SUBMITS A COVERAGE APPROVAL
`FORM TO THE PHARMACY TMM AS NOTIFICATION THAT
`THE PATIENTS REFILL REOUEST CAN BE PROCESSED
`454
`
`INTAKE/REIMBURSEMENT SUBMITS A COVERAGE APPROVAL
`FORM TO THE PHARMACY TQM AS NOTIFICATION THAT
`THE PATIENT'S REFILL REOUEST 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 AVAILABLE 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
`
`WOCL(L12I1‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 8 of 16
`
`US 7,765,106 B2
`
`UPON DETERMINING THAT A PATIENT IS UNINSURED OR
`
`510
`
`
`
`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 APPLICATION HAS BEEN REQUESTED
`THROUGH NORD
`
`520
`
`NORD MAILS A PAP APPLICATION TO THE
`
`PATIENT wumm 1 BUSINESS DAY
`
`'5
`525
`
`THE PATTENT
`
`APPROVED?
`
`YES
`
`NO
`
`530
`NORD SENDS A DENIAL LETTER TO THE PATIENT
`
`545
`
`540
`
`NORD SENDS AN ACCEPTANCE LETTER TO THE
`
`SOS DOCUMENTS IN CHIPS THAT
`
`PATIENT AND FAXES A VOUCHER TO SOS INDICATING THE
`PATIENTS APPROVAL FOR THE PROGRAM
`
`550
`
`THE PATIENT WAS DENIED BY NORD
`
`
`
`
`
`
`AN INTAKE/REIMBURSEMENT SPECIALIST SUBMITS A
`COVERAGE APPROVAL FORM TO THE PHARMACY TEAM AS
`
`NOTIFICATION THAT THE PATIENT HAS BEEN APPROVED
`
`FOR COVERAGE THROUGH NORD
`
`
`
`
`
`
`WocL<hzu‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 9 of 16
`
`US 7,765,106 B2
`
`236
`
`CH WEEK, THE DIRECTOR OF PHARMACY TRANSFERS
`INVENTORY FOR THE WEEK'S SHIPMENTS TO A
`
`SECRECATEO WAREHOUSE LOCATION
`
`FOR PRODUCTION INVENTORY
`
`A PURCHASE ORDER IS CENERATED FOR THE
`
`INVENTORY TRANSFERRED TO THE PRODUCTION
`
`LOCATION & IS FAXED TO THE OMI CONTROLLER
`
`THE OMI CONTROLLER INVOICES SOS FOR
`
`THE PRODUCT MOVED TO PRODUCTION
`
`PRESCRIBER FIELDS
`
`PRESCRIPTION FIELDS
`
`PATIENT FIELDS
`
`INSURANCE FIELDS
`
`710
`
`720
`
`730
`
`740
`
`800
`
`OUERY I - PRESCRIPTIONS BY PHYSICIAN
`
`OUERY 2 — PRESCRIPTIONS BY PATIENT NAME
`
`OUERY 5 - PRESCRIPTIONS BY FREOUENCY
`
` 81 O
`
`820
`
`830
`
`
`
`
`
`OUERY N - PRESCRIPTIONS BY DOSE
`
`
`
`840
`
`FIG. 7
`
`FIG. 8
`
`Wocl<hzu‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 10 of 16
`
`US 7,765,106 B2
`
`PRESCRIPTION AND ENROLLMENT FORM /
`
`PRESCRIBER INFORMATION
`
`900
`
`PRESCRIBER'S NAME:__J,_.mj OFFICE CONTACT:
`STREET ADDRESS:
`
`CITY:
`PHONE:
`
`STATE:
`FAX:
`
`ZIP:
`
`
`
`
`
`
`
`
`
`
`
`LICENSE NUMBER:
`
`
`MD SPECIALTY:
`
`
`DEA NUMBER:
`
`_
`
`
`
`PATIENT NAME:
`
`ADDRESS:
`
`
`
`PRESCRIPTION FORM
`
`DOB:
`SSfl:
`
`CITY: _ STATE: ___j: ZIP:
`Rx: XYREM ORAL SOLUTION (500 mg/mL) 180 Ml. BOTTLE OUANTITY:
`MONTHS SUPPLY
`SIG: TAKE __GMS P.O. DILUTED IN 60 mL WATER AT H.S. AND THEN AGAIN 2 I /2 TO 4 HOURS LATER
`REFILLS (CIRCLE ONE):
`0
`I
`2
`(MAXIMUM OF 3 MONTH SUPPLY)
`DATE: __./L. /§
`
`
`
`
`
`
`
`
`
`
`
`
`
`I: I VERIFY THAT THE PATIENT HAS BEEN EDUCATED WITH RESPECT TO XYREM PREPARATION. DOSING AND SCHEDULING.
`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.
`
`{:2 I UNDERSTAND THAT THE SAFETY OF DOSES GREATER THAN 9gm/DAY HAS NOT BEEN ESTABLISHED
`
`
`PRESCRIBER'S SIGNATURE
`
`PHYSICIAN DECLARATION-PLEASE CHECK EACH BOX
`
`
`
`
`
`II I HAVE READ THE MATERIALS IN THE XYREM PHYSICIAN SUCCESS PROGRAM
`
`TO BE COMPLETED AT INITIAL PRESCRIPTION ONLY
`
`BEST TIME TO CONTACT PATIENT: m DAY :3 NIGHT
`
`PATIENT INFORMATION
`
`EVENING ):
`DAY );
`INSURANCE COMPANY NAME:T PHONE T:
`INSURED'S NAME: __L%_____ RELATIONSHIP I0 PATIENT:
`IDENTIFICATION NUMBER: _________ POLICY/GROUP NUMBER:
`PRESCRIPTION CARD: I:I NO :IYEs IF YES, CARRIER: ____PoLIcY 11;
`
`
`
`
`
`
`
`
`
`
`
`
`
`GROUP:
`
`
`
`PLMSE ATTACH COPIES OF PATIENTS INSURANCE CARDS
`
`FAX COMPLETED FORM TO XYREM SUCCESS PROGRAM (TOLL—FREE) I-866-470-1744
`FOR INFORMATION, CALL THE XYREM TEAM (TOLL FREE) AT I-866-XYREM88 (I-866-997-3688)
`
`FIG. 9
`
`WOCl(I12l1‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 11 of 16
`
`US 7,765,106 B2
`
`PATIENT ASSISTANCE APPLICATION REQUEST FORM
`
`I000
`
`/
`
`DATE:
`
`TO:
`
`PATIENT ASSISTANCE ORGANIZATION
`
`FROM:
`
`SDS
`
`FAX 5:
`
`203-798-2291
`
`PLEASE SEND A XYREM PATIENT ASSISTANCE PROGRAM APPLICATION TO:
`
`PATIENT NAME
`
`ADDRESS
`
`TELEPHONE:
`
`(
`
`)
`
`PATIENT DOSAGE:
`
`(GRAMS) TWICE mcnm FOR A TOTAL DOSAGE 0F_.___(GRAMS)
`
`BOTTLES (THREE MONTHS SUPPLY)
`
`BACKGROUND INFORMATION:
`
`FIG. 10
`
`Wocl<hzu‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 12 of 16
`
`US 7,765,106 B2
`
`SENSITIVE DRUG PATIENT ASSISTANCE PROGRAM ,1/'00
`
`VOUCHER REQUEST FOR MEDICATION
`
`PATIENT INFORMATION
`
`<FIRST NAME><IAST NAME>
`
`<ADDRESS I>
`
`<ADDRESS 2>
`
`<CITY, STATE ZIP COOE>
`
`PHONE: <I23-456-7890
`Im O1 /01 /I 900
`Ssl I23—45—6789
`DRUG ALLOTMENT:
`IOOZ
`
`ID 03/OI/2001
`
`CASE CODE: ‘"""‘
`
`DRUG
`XYREEM I80mI btl
`
`OUANTITY
`I
`
`PHYSICIAN INFORMATION
`
`<PHYSIcIAN NAME>
`
`<ADDRESS I>
`
`<ADDRESS 2>
`
`(CITY, STATE ZIP CODE>
`
`PHONE: 023-456-7890
`
`FIRST SHIPMENT THIS YEAR
`
`VALIDATION DATE:
`EXPIRATION DATE:
`ISSUE DATE:
`
`APPROVED
`
`03/01/2001
`05/31/2001
`03/15/2001
`
`
`
`“PHARMACY USP"
`
`NDRD COPY
`****III*****************III***llI***III************************
`
`(DETACH HERE)
`
`PATIENT INFORMATION
`
`<FIRST NAME><LAST NAME>
`
`<ADDRESS I>
`
`<ADDRESS 2>
`
`<CITY, STATE ZIP CODE>
`
`PHONE: 023-456-7890
`Em OI /01 /1 900
`Si 12345-6789
`DRUG ALLOTMENT:
`I007.
`
`& O3/OI/2001
`
`CASE CODE: '"""'
`
`DRUG
`XYREM I80mI bII
`
`QUANTITY
`I
`
`PHYSICIAN INFORMATION
`
`<PHYSICIAN NAME>
`
`<ADDRESS I>
`
`<ADDRESS 2>
`
`<CITY, STATE ZIP CODE)
`
`PHONE: < I23-456-7890
`
`FIRST SHIPMENT THIS YEAR
`
`VALIDATION DATE:
`EXPIRATION DATE:
`ISSUE DATE:
`
`03/01/2001
`05/31/2001
`03/15/2001
`
`APPROVED
`
`“PHARMACY USE'"
`
`FIG.
`
`1 1
`
`WOCI(I12l1‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 13 of 16
`
`US 7,765,106 B2
`
`1200
`
`/
`
`SENSITIVE DRUG PHYSIC|AN'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
`
`PHYSICIANS NAME (PLEASE PRINT):
`
`PHYSICIANS SIGNATURE:
`
`DATE:
`
`PLEASE FAX BACK TO SENSITIVE DRUG SUCCESS PROGRAM: (I-800-TOLL FREE NUMBER)
`
`FIG. 12
`
`Wocl<hzu‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`61f0MW
`
`US 7,765,106 B2
`
`
`
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`Wocl<hzu‘dt 1001
`
`Wockhardt 1001
`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 15 of 16
`
`US 7,765,106 B2
`
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`Wockhardt 1001
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`
`

`
`U.S. Patent
`
`Jul. 27, 2010
`
`Sheet 16 of 16
`
`US 7,765,106 B2
`
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`
`Wockhardt 1001
`
`
`
`

`
`US 7,765,106 B2
`
`1
`SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`RELATED APPLICATIONS
`
`This application is a divisional application of U.S. patent
`application Ser. No. 10/322,348, filed Dec. 17, 2002, now
`U.S. Pat. No. 7,668,730 which application is incorporated
`herein by reference.
`
`FIELD OF THE INVENTION
`
`The present invention relates to distribution of drugs, and
`in particular to the distribution of sensitive drugs.
`
`BACKGROUND OF THE INVENTION
`
`Sensitive drugs are controlled to minimize ensure that they
`are not abuse and adverse reactions. Such sensitive drugs are
`approved for specific uses by the Food and Drug Administra-
`tion, and must be prescribed by a licensed physician in order
`to be purchased by consumers. Some drugs, such as cocaine
`and other common street drugs are the object of abuse and
`illegal schemes to distribute for profit. Some schemes include
`Dr. shopping, diversion, and pharmacy thefts. A locked cabi-
`net or safe is a requirement for distribution of some drugs.
`Certain agents, such as gamma hydroxy buterate (GHB)
`are also abused, yet also are effective for theraputic purposes
`such as treatment of daytime cataplexy in patients with 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
`
`2
`
`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 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.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`FIG. 7 is a block diagram of database fields.
`FIG. 8 is a block diagram showing a list of queries against
`the database fields.
`
`50
`
`55
`
`60
`
`65
`
`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
`Wockhzlrdt 1001
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`Wockhardt 1001
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`US 7,765,106 B2
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`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 performe