Sensitive Drug Distribution System and Method (US Patent 7765106)

IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
US007765106B2
&12~
United States Patent

Reardan et al.
SENSITIVE DRUG DISTRIBUTION SYSTEM
AND METHOD
(Io) Patent
(45)
No.: Date of Patent:

A A A A
2/2000
US 7,765,106 B2 *Jul. 27, 2010

Lester et al.
(54)
(75) Inventors:
Dayton T. Reardan, Excelsior, MN (US); Patti A. Engel, Eagan, MN (US); Bob Gagne, St. Paul, MN (US)
(73) Assignee:
JPI Commercial, LLC, Palo

(US)
Alto, CA
* ( ) Notice:
Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 1645 days.
This patent is subject to a terminal claimer.
6,021,392 6,045,501 6,055,507 6,112,182 6,315,720 6,347,329 6,564,121 6,687,676 6,755,784 6,952,681 7,058,584
4/2000 4/2000
8/2000
El sayed et al.
Cunningham
Akers et al. Williams et al.

Evans
Bl Bl Bl Bl
B2 B2 B2
11/2001 2/2002 5/2003 2/2004 6/2004 10/2005 6/2006
Wallace et al.
Denny
Williams et al.
McQuade et al.
Kosinski et al.
dis(Continued)
(21) Appl. No.: 10/979,665

(22)
Filed:
Nov. 2, 2004
OTHER PUBLICATIONS
NASCSA National Conference, iNov. 20001,8 pages.
(65)
Prior Publication Data

US 2005/0090425 Al
Apr. 28, 2005
(Continued)
Primary Examiner Assistant Examiner

filed on Dec.
Related U.S. Application Data
(62)
Division
of application No. 10/322,348,
(74) Attorney, Woessner, P.A.
Gerald J. O'onnor Lena Najarian Schwegman, Agent, or Firm
Lundberg
&
17, 2002, now Pat. No. 7,668,730.
(57)
A drug distribution
ABSTRACT
(51) Int. Cl. (2006.01) G060 10/00 705/2; 705/3 (52) U.S. Cl................................................ 705/2, (58) Field of ClassiTication Search .....................
705/3
See application file for complete search history.
(56)
References Cited
U.S. PATENT DOCUMENTS

3,556,342 4,847,764 4,976,351 5,737,539 5,845,255 5,924,074
A A A A A A
1/1971 7/1989 12/1990 4/1998 12/1998 7/1999
Guarr Halvorson Mangini et al. Edelson et al. Mayaud Evans
system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification 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.
.......... .............
705/3 705/3
202
Hll
S Claims, 16 Drawing Sheets

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204
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US 7,765,106 B2
Page 2

7,668,730 2001/0001144 2001/0042050 2001/0047281 2002/0010661 2002/0032581 2002/0032582 2002/0042725 2002/0042762 2002/0052762 2002/0161607 2002/0177232 2003/0033168 2003/0046110 2003/0050802 2003/0093295 2003/0110060 2003/0127508 2003/0144876 2003/0160698 2003/0197366 2003/0229519 2003/0233256 2004/0008123 2004/0019567 2004/0019794 2004/0078237 2004/0107117 2004/0117126 2004/0122712 2004/0122713 2004/0162740 2004/0176985 2005/0216309 2005/0222874
B2 AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI AI
2/2010 5/2001 11/2001 11/2001 I/2002 3/2002 3/2002 4/2002 4/2002 5/2002 10/2002 11/2002 2/2003 3/2003 3/2003 5/2003 6/2003 7/2003 7/2003
g/2003 10/2003 12/2003 12/2003 I/2004 I/2004 I/2004 4/2004 6/2004 6/2004 6/2004 6/2004 g/2004 9/2004 9/2005 10/2005
Reardon et al. Kapp Fletcher et al. Keresman, HI et al. Waddington et al. Reitberg Feeney, Jr, et al. Mayaud McQuade et al. Kobylevsky et al. Subich Melker et al. Califano et al. Gogolak Jay et al. Lilly et al. Clementi Jones Kosinski et al. Andreasson et al. Kusterbeck Eidex et al. Cardenas et al. Carrender et al. Herceg et al. Moradi et al. Kaafarani et al. Denny Fetterman et al. Hill, Sr, et al. Hill, Sr, et al. Ericsson et al. Lilly et al. Reardan et al. Reardan et al.
"An Interview with Orphan Medical about Xyrem", http: //www. talkaboutsleep.corn/sleepdisorders/archives/ Narcolepsy xyrem interview.htm, (Feb. 12, 2001), 3 pgs. Ukens, C., "Specialty Pharmacy", Drug Topics, 144, (Jun. 5, 2000),
40-47.
"U.S.Appl. No. 10/322,348,

3 pgs.
Advisory Action mailed Feb. 5, 2007",
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 Committee", Department of Health and Human Service Food and Drug Admi ni strati on. Center for Drug Evaluation and Research, Holiday Inn, Bethesda, Maryland,(Jun. 6, 2001),7 pages. "Peripheral and Central Nervous System Drugs Advisory Committee", 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. PS.) Starter Kit", Celgene Corporation, (2001),103 pgs.
Amendment and Response to Final Office Action mailed Jan. 17, 2007", 17 pgs. "U.S. Appl. No. 10/322,348, Amendment and Response to Final Office Action mailed Feb. 29, 2006", 11 pgs. "U.S. Appl. No. 10/322,348, Final Office Action mailed Oct. 18, 2006", 14 pgs. "U.S. Appl. No. 10/322,348, Final Office Action mailed Dec. 29, 2005", 11 pgs. "U.S.Appl. No. 10/322,348, Non Final Office Action mailed Jun. 17, 2005", 26 pgs. "U.S.Appl. No. 10/322,348, Non Final Office Action mailed Jun. 29, 2005", 12 pgs. "U.S. Appl. No. 10/322,348, Non Final Office Action Response mailed Aug. g, 2006", 10 pgs. "U.S. Appl. No. 10/322,348, Preliminary Amendment mailed Sep. 30, 2004", 11 pgs. "U.S.Appl. No. 10/731,915 Non Final Office Action mailed Oct. 5, 2004", 21 pgs. "U S.Appl. No. 10/731,915, Non Final Office Action mailed Aug. 12, 2005", 22 pgs. "U.S. Appl. No. 10/731,915, Non Final Office Action Response mailed Feb. 2, 2005", 17 pgs. "U.S.Appl. No. 10/322,348, Non Final Office Action mailed Jun. 19, 2006", 18 pgs. "U.S.Appl. No. 11/097,651, Preliminary Amendment mailed Apr. I, 2005", 6 pgs. "U.S. Appl. No. 11/097,651, Non-Final Office Action mailed May 29, 2009", 21 pgs. "U.S. Appl. No. 10/322,348, Appeal Brief filed May 21, 2007", 32 pgs "U.S. Appl. No. 10/322,348, Examiner Interview Summary mailed Oct. 21, 2009", 3 pgs. "U.S. Appl. No. 10/322,348, Notice of Allowance mailed Dec. 31, 2009", 16 pgs. "U.S.Appl. No. 10/322,348, Reply Brief filed Dec. 3, 2007", 4 pgs. "U.S. Appl. No. 10/322,348, Response filed Sep. 29, 2005 to Non Final Office Action mailed Jun. 29, 2005", 19 pgs. "U.S.Appl. No. 11/097,651, Non-Final Office Action mailed Mar. 3, 2010", 19 Pgs. "U.S. Appl. No. 11/097,651, Final Office Action mailed Nov. 12, 2009", 14 pgs. "U.S. Appl. No. 11/097,651, Response filed Feb. 9, 2010 to Final Office Action mailed Nov. 12, 2009", 11 pgs. "U.S. Appl. No. 11/097,651, Response filed Sep. 17, 2009 to Non Final Office Action mailed May 29, 2009", 10 pgs. "U S. Appl. No. 11/097985, Non Final OfficeAction mailed Sep. 14, 2009", 22 pgs. "U.S.Appl. No. 11/097,985, Preliminary Amendment mailed Apr. I, 2005", 7 pgs. "U.S. Appl. No. 11/097,985, Response filed Nov. 3, 2009 to Non Final Office Action mailed Sep. 14, 2009", 15 pgs.
"U.S. Appl. No. 10/322,348,
U.S. Patent
Jul. 27, 2010
Sheet 1 of 16
US 7,765,106 B2
100
110
cpu
120
MEMORY
130
140
STORAGE
150
i/O
COMM
160
U.S. Patent
Jul. 27, 2010
Sheet 2 of 16
202
US 7,765,106 B2
MO
IIAILS/FAXES
IN
IAt/ENROLLMEIO
FORII
204
AN
INTAKE/REIMBURSEMENT
THE Rx/ENROLLMENT
SPECIALIST MAKE A COPY OF

(THE COPY IS STAMPED
FAX IS THEN
TEAM
FORM
'OPY')
AND
THE ORIGINAL
FORWARDED
TO THE PHARMACY
I
t
MO
206
FORM
MAILS/FAXES
IN
Rx/ENROLLMENT
I
THE INTAKE/REIMBURSEMENT
210
SPECIALIST ENTERS THE
INFO INTO CHiPS
PATIENT AND
PHYSICIAN
212
THE INFO
AN
214
INTAKE
REPRESENTATIVE
WILL
NKE
1 ATTEMPT
TO
COMPLETE?
REACH
THE MD TO OBTAIN
THE MISSING
INFORMATION
YES
TO VERIFY RECEIPT
220
THE MISSING
INFORMATION
MD
WITHIN
216
HAS NOT BEEN OBTAINED
SPECIALIST CONTACTS
24
HOURS,
THE Ih/ENROLLMENT
FORM IS FAXED
LETTER
&
ACCURACY
OF THE PATIENT'S
IN
Rx
BACK TO THE MD WITH A REJECTION
EXPlNATION
& THIS
CONTACT
IS RECORDED
CHiPS
I
222
A NOTE
218
IS ENTERED
IN
CHiPS THAT THE
SPECIALIST SENDS CONSENT

LETTER TO THE PATIENT
APPLICATION
WAS REJECTED
FORM AND A COVER
I
224
232
SPECIALIST FAXES A
STATEMENT
OF MEDICAL NECESSITY TO THE

MD TO COMPLETE
I
226
SPECIALIST CONTACTS
PROVIDER TO VERIFY
SEE NORD PROCESS FOR PATIENTS
WHO ARE UNINSURED
OR UNDERINSUREDJ
i
234
NQ
230
IS THE
PATIENT
THE PATIENTS
INSURANCE
WILLING/ABL
COVERAGE
& BENEFITS
TO PAY?
228
IS
OVERAGE
YES
THE PATIENT
FOR XYRE
IS INFORMED OF THE COST OF THE

PAYMENT
PROVED?
PRODUCT AND IS GIVEN
OPTIONS
236
YES
APPROVAL
238
ONCE PAYMENT
IS RECEIVED, INTAKE/REIMBURSEMENT
FORM
SUBMITS A COVERAGE
SUBMITS A COVERAGE APPROVAL

THE
(STAPLED TO
FORM) TO THE
FORM
(STAPLED TO THE
COPY" OF THE Rx
TEAM
"COPY" OF
PHARMACY
THE Rx/ENROLLMENT
ENROLLMENT
NOTIFICATION
FORM) TO THE PHARMACY
AS
TEAM AS NOTIFICATION
TO PROCESS
TO PROCESS THE PATIENTS
Rx
THE PATIENT'S
Rx
FIG. 2A
U.S. Patent
Jul. 27, 2010
Sheet 3 of 16
US 7,765,106 B2
208
PHARNCY
WORK
FLOW
268
THE PATIENT
A XYREM
IS SHIPPED
IF ANY DISCIPLINARY ACTIONS ARE

IDENTIFIEO,
THE DIR. OF PHARM.
SUCCESS
IS
PACKET VIA 2-OAY USPS
NOTIFIED AND
TAKES ONE OF THE

ACTIONS:
ANO
FOLLOWING
270
HAVE
274
THE MD.'S CREDENTIALS
AND
Rx IS PROCESSED
PHARMACIST
THE
MONITORS
THE MD.
THE MD.
PROGRAM
ACTMTY
AND
I
CREDENTIALS
BEEN VERIFIED
IN
&
APPROVED
THE
KT
Rx IS
I
NOT
PRXESSED
ENTERS ALL FINDINGS
IN
CHj
THE MD IS NOTED AS UNAPPROVED
MONTHS?
YES
THE PHARMACIST
272
276
ARE THE
MD.
284
S
THE PHYSICIAN
HOLDS THE
CREDENTIALS
IS INDICATEO
IN
PATIENT'S
Rx UNTIL RECEMNG
APPROVAL
FORM
APPROVED?
AS UNAPPROVED
CHiPS
A COVERAGE
286
YES
THE PHYSICIAN
FROM
280
THE
THE MD IS CONTACTED
PHARMACIST
BY A
THAT
IS INDICATED
IN
&
INFORMED
AS APPROVED
PHYSICIAN
THE PATIENTS
Rx CANNOT
SCREEN IN CHiPS
BE PROCESSED
282
THE PHARMACIST
288
THE Rx AND
ENROLLMENT
FORN
MD
HOLDS THE
PATIENT'S
Rx UNTIL RECEMNG
APPROVAL
IS NILED BACK TO THE

ALONG
WITH A COVER
THAT
A COVERAGE
FORM
LETTER
FROM INTAKE/REIMBURSEMENT
REITEMNG
CANNOT
THE Rx
BE PROCESSED
290
A LETTER IS SENT TO THE
PATIENT
INDICATING
THAT
THE
Rx CANNOT
THE PATIENT
CONTACT
BE PROCESSED &
IS INSTRUCTED TO
PHYSICIAN
HIS/HER
U.S. Patent
Jul. 27, 2010
Sheet 4 of 16
US 7,765,106 B2
(
UPON
)
240
FORM FROM
TECHNICIAN TECHNICIAN
t
RECEIPT OF THE COVERAGE APPROVAL
THE PHARMACY
CONTACTS
THE PATIENT
TO COMPLETE THE
SPECIFIED SECTIONS OF THE PATIENT

COUNSELING
CHECKLIST
242
ERE TH
PROGRAM
MATERIALS
NO
244
THE RECEIPT OF THE MATERIALS
ANOTHER
CALL IS SCHEDULED
IS CONFIRMED AND
TO COUNSEL
THE
READ?
PATIENT
BEFORE THE XYREM IS SHIPPED
YES
AFTER COMPLETING
246
TECHNICIAN
WHO
THE SPECIFIED SECTIONS OF THE
CHECKLIST WITH THE PATIENT THE PHARMACY
TRANSFERS THE CALLER TO THE PHARMACIST

REVIEWS THE ENTIRE CHECKLIST AND
REMAINING
COMPLETES THE
PHARMACIST
SPECIFIED SECTIONS
248
THE PHARMACIST
INDICATES
IN
CHiPS THAT THE PATIENT
COUNSELING
CHECKLIST WAS SUCCESSFULLY COMPLETED

INCLUDING
THE DATE COMPLETED
252
THE SHIPMENT
260
THE PHARMACIST THE NEXT
MUST BE SENT TO THE PATIENTS
HOME
SCHEDULE THE PATIENTS SHIPMENT

DAY OR THE
ADDRESS UNLESS THE PATIENT

FOR
IS TRAVELING OR HAS
WILL DETERMINE
BUSINESS
NEXT BUSINESS
DAY- MOVED,
IF AN
IN
WHICH
CASE THE PHARMACIST
THE PATIENT
IS AVAILABLE TO SIGN FOR THE PACKAGE
EXCEPTION WILL BE MADE. THE PATIENT OR THE
t
THE PHARMACIST
IN
254
AN
PATIENTS
DESIGNEE MUST SIGN FOR THE PACKAGE

UPON
DELIVERY
ENTERS THE Rx ORDER

ORDER NUMBER
CHiPS, CREATING
t
THE PHARMACIST
256
VERIFIES THE Rx AND ATTACHES THE
VERIFICATION
lABEL TO THE HARD COPY Rx
258
A
PICK TICKET IS GENERATED
FOR THE ORDER 8( THE

FOR FULFILLMEN
()RDER IS FORWARDED
TO THE PHARMACY
260
THE SHIPMENT
IS CONFIRMED
IN
CHiPS
t
THE ORIGINAL
262
ORDER
Rx IS FILED WITH THE PHARMACY
Rx
IN
NUMERICAL
266
264
ALL XYREM INVENTORY
MAIL
t
THE ORDER IS SHIPPED
IS CYCLE COUNTED
AND
BY USPS EXPRESS
RECONCILED WITH THE CHiPS SYSTEM QUANTITIES
BEFORE THE DAYS SHIPMENTS ARE SENT OUT
FIG. 2C
U.S. Patent
Jul. 27, 2010
US 7,765,106 B2
310
PHYSICIAN
PROGRAM
SUCCESS
NTERIALS
REQUEST
320
MD
CALLS XYREM SUCCESS

AT
PROGRAM
I-866-XYREM88
TO REQUEST PROGRAM
MATERIALS
330
MD DEMOGRAPHICS,
AND
DFAII
DATE OF REQUEST ARE
ENTERED INTO CHiPS
340
SDS REQUESTS NTERIALS
BE SHIPPED TO THE
TO
MD VIA
THE OMI FULFILLMENT WEBSITE

AT WWW.PRAFULFILLMENT.COM
II
END
+3ro
U.S. Patent
Jul. 27, 2010
Sheet 6 of 16
IJS 7,765,106 B2
402
2 POSSIBLE REFILL
REQUEST PROCESSES
i 2
t
EACH
404
OF
WEEK A REFILL REPORT IS GENERATED
PATIENTS WITH
ID DAYS OF PRODUCT RENINING
I
A COPY OF THE REFILL REPORT
408
IS PROVIDED
TO INTAKE/REIMBURSEMENT
I
NO
410
CONTACTS
SOONER THAN
DAYS BEFORE MEDICATION TECHNICIAN
DEPLETION,
PATIENT
A PHARMACY
THE
TO COMPLETE
THE PRE-DELIVERY CHECKLIST
412
THE PATIENT
A MESSAGE IS LEFT ONLY MENTIONING
414
SDS &
A RETURN
REACHED?
NUMBER
YES
THE PHARMACY
TECHNICIAN
418
A NOTE IS ENTERED
DATE THE
IN
U
THE CHiPS INDICATING
416
THE
SCHEDULES THE PATIENTS
SHIPMENT
FOR THE NEXT BUSINESS DAY OR THE NEXT

DAY THE
MESSAGE WAS LEFT FOR THE PATIENT
BUSINESS
PATIENT
IS AVAILABLE TO
SIGN FOR THE PACKAGE
t
THE PHARMACIST
IN
420
AN
ENTERS THE Rx ORDER

ORDER NUMBER
CHiPS, CREATING
t
THE PHARMACIST
422
COPY Rx
VERIFIES THE Rx AND ATTACHES THE
VERIFICATION
N3EL
TO THE HARD
t
THE SHIPMENT
424
ALL XYREM INVENTORY
IN
426
IS CYCLE COUNTED AND
RECONCILED
WITH
IS CONFIRMED
CHiPS
THE CHiPS SYSTEM QUANTITIES
t
A
428
FOR THE ORDER & THE
BEFORE THE DAYS SHIPMENTS ARE SENT OUT
PICK TICKET IS GENERATED
ORDER IS FORWARDED
TO THE PHARMACY
FOR FULFILLMEN
END
)- 4X
FIG. 4A
U.S. Patent
Jul. 27, 2010
Sheet 7 of 16
US 7,765,106 B2
406
THE PATIENT
CALLS TO REQUEST AN
EARLY REFILL
434
A XYREM PROBLEM
IDENTIFICATION
432
A NOTE
& NNAGEMENT
RISK
IN
CODE IS ENTERED IN CHiPS ON THE PATIENT

THE EARLY REFILL REQUEST
DIVERSION
REPORT IS COMPLETED
&
DOCUMENTED
SCREEN INDICATING
CHiPS. THE REPORT IS THEN FAXED TO OMI & THE

ORIGINAL
436
THE PHARMACIST
IS FILED
IN
A MONTHLY
BATCH
FILE
EVALUATES
THE PATIENTS
COMPLIANCE
WITH
THERAPY AND/OR
POSSIBLE PRODUCT
DIVERSION,
MISUSE OR OVERUSE
438
THE PHARMACIST
442
THE PATIENT
MUST WAIT
UNTIL
CONTACTS
THE PRESCRIBING THE NEXT SCHEDULED

AND
PHYSICIAN
TO ALERT OF THE SITUATION
CONFIRM
REFILL DATE TO RECEIVE ADDITIONAL

IF THE PHYSICIAN
PRODUCT
APPROVES OF THE EARLY REFILL
440
DOES
THE PHYSICIAN
NP
(
446
THE PATIENT
ENO
P 444
460
THE NEXT SCHEDULED
APPROVE?
YES
THE PHARMACIST
IN
MUST WAIT UNTIL
REFILL DATE TO RECEIVE ADDITIONAL
PRODUCT
ENTERS A NOTE IN CHiPS

NO
THE PATIENT
SCREEN THAT THE PHYSICIAN
APPROVES THE REQUEST
448
THE PHARMACIST
IS THE
PATIENT WILL TO
NOTIFIES AN
INSURANCE
PAY?
SPECIALIST TO CONTACT
PROVIDER
THE PATIENTS
YES
THE PATIENT
462
TO VERIFY COVERAGE
FOR THE EARLY REFILL
IS INFORMED
OF THE COST OF THE
450
WILL THE
PRODUCT AND
NO
IS GIVEN PAYMENT OPTIONS
464
ONCE
PAYMENT
INSURANCE
PROVIDER
PAY?
IS RECEIVED THE ORDER IS RELEASED
YES
FORM
THE
TO THE
452
THAT
466
THAT

PHARMACY
FORM TO THE PHARMACY
PATIENT'S
REFILL REQUEST CAN
BE PROCESSED
THE PATIENTS
REFILL REQUEST CAN
BE PROCESSED
454
THE PHARMACY
TECHNICIAN
468
THE PHARMACY
TECHNICIAN
CONTACTS
THE PATIENT TO
CONTACTS
THE PATIENT
TO
SCHEDULE
SHIPMENT
OF THE PRODUCT
FOR THE NEXT
SCHEDULE SHIPMENT
OF THE PRODUCT FOR THE NEXT

DAY THE
BUSINESS DAY OR THE NEXT BUSINESS DAY THE PATIENT
BUSINESS DAY OR THE NEXT BUSINESS
PATIENT
CONTINUE
456
FIG.
4B
CONTINUE
42O
U.S. Patent
Jul. 27, 2010
Sheet 8 of 16
US 7,765,106 B2
510
UPON
DETERMINING
THAT
A PATIENT
IS UNINSURED
OR
UNDERINSURED,
THE NORD
A REIMBURSEMENT
SPECIALIST EXPUUNS
AND
PROGRAM
TO THE PATIENT
FAXES AN
APPLICATION
REQUEST FORM TO NORD FOR THE PATIENT
t
IN
515
SPECIALIST DOCUMENTS
HAS BEEN REQUESTED
CHiPS THAT
AN
APPLICATION
THROUGH
NORD
t
NORD
MAILS A PAP APPLICATION
1
520
TO THE
DAY
PATIENT WITHIN
BUSINESS
525
THE PATIENT
530
=
545
LETTER TO THE
NORD
SENDS A DENIAL LETTER TO THE PATIENT
APPROVED?
YES
NORD
PATIENT AND
540
SDS DOCUMENTS
IN
SENDS
AN
ACCEPTANCE
TO
CHiPS
THAT
FAXES A VOUCHER
SDS
INDICATING
THE
THE PATIENT
WAS
DENIED
BY NORD
PATIENTS APPROVAL
FOR THE PROGRAM
t
AN
550
SPECIALIST SUBMITS A
TEAM
APPROVAL
THAT
COVERAGE
FORM
TO THE PHARMACY
AS
NOTIFICATION
THE PATIENT
HAS BEEN APPROVED
FOR COVERAGE
THROUGH
NORD
t
A
+555
U.S. Patent
Jul. 27, 2010
Sheet 9 of 16
US 7,765,106 B2
236
CH WEEK, THE DIRECTOR OF PHARMACY
INVENTORY
TRANSFERS
FOR THE WEEK'S SHIPMENTS TO A

LOCATION
SEGREGATED WAREHOUSE
FOR PRODUCTION
INVENTORY
1I
236
FOR THE
A PURCHASE
INVENTORY
LOCATION
ORDER IS GENERATED
TRANSFERRED
TO THE PRODUCTION
8t IS FAXED TO THE OMI CONTROLLER
236
THE OMI CONTROLLER
INVOICES
SDS FOR
THE PRODUCT
MOVED TO PRODUCTION
END
)- &50
6
- 810
-820 -830
FIG.
PRESCRIBER FIELDS
PATIENT
-710
-720 -730
I-740
QUERY I QUERY 2 QUERY
PRESCRIPTIONS BY PRESCRIPTIONS BY
PHYSICIAN
FIELDS FIELDS
PATIENT
NAME
PRESCRIPTION
5 PRESCRIPTIONS
BY FREQUENCY
INSURANCE
FIELDS
QUERY
PRESCRIPTIONS BY
DOSE
FIG.
FIG.
U.S. Patent
Jul. 27, 2010
Sheet 10 of 16
US 7,765,106 B2
900
PRESCRIPTION
PRESCRIBER'S NAME:
STREET ADDRESS:
CITY:
ANO
ENROLLMENT
FORM
PRESCRIBER INFORMATION
OFFICE CONTACT:
STATE:
FAX:
DEA NUMBER:
2IP:
PHONE:
LICENSE NUMBER:
MD
SPECIALTY:
PRESCRIPTION
PATIENT
FORM
DOB
NAME:
Ssg:
STATE:
SEX
M/F
ADDRESS:
CI1Y:
Ij.'IP:
MONTHS
Rx: XYREM ORAL SOLUTION

SIG: TAKE
GMS
(500 mg/mL)
DILUTED IN
180
Ml. BOTTLE
QUANTITY:
SUPPLY
P.O.
60
mL WATER AT H.S. AND THEN AGAIN
2 1/2
TO
HOURS
lATER
REFILLS (CIRCLE ONE):
(MAXIMUM
OF
MONTH
SUPPLY)
DATE:
/
INITIAL
PRESCRIBER'S SIGNATURE
~ ~ ~
DAY
PIIYSICIAN
DECLARATIDN
HAVE
PLEASE CHECK EACH

IN
BOK
I
TO
BE COMPLETED AT
PRESCRIPTIDN
ONLY
READ THE MATERIALS
THE XYREM PHYSICIAN

WITH
SUCCESS PROGRAM
RESPECT TO XYREM PREPARATION,
IN
VERIFY THAT THE PATIENT

UNDERSTAND
THAT
THAT
HAS BEEN EDUCATED
DOSING AND SCHEDULING.
XYREM IS APPROVED
FOR THE TREATMENT OF CATAPLEXY
PATIENTS WITH
NARCOLEPSY,
AND
I
SAFETY OR EFFICACY HAS NOT BEEN ESTABLISHED FOR ANY OTHER INDICATION.
THAT
UNDERSTAND
THE SAFETY OF DOSES GREATER THAN
9gm/DAY
HAS NOT BEEN ESTABLISHED
PATIENT
BEST TIME TO CONTACT
PATIENT:
DAY
INFORMATION
NIGHT
$:
COMPANY
NAME: NAME:
EVENING
g:
II:
TO PATIENT:
INSURANCE
PHONE
INSURED
RElATIONSHIP
IDENTIFICATION
NUMBER:
CARD:
NO
POLICY/GROUP
NUMBER:
PRESCRIPTION
YES
IF
YES, CARRIER:
POLICY
g:
CARDS
GROUP:
PLEASE ATTACH
COPIES OF PATIENTS INSURANCE
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
(1-866-997-5688)
U.S. Patent
Jul. 27, 2010
Sheet 11 of 16
US 7,765,106 B2
PATIENT
DATE:
ASSISTANCE
APPLICATION
REQUEST FORM
TO:
FROM:
PATIENT ASSISTANCE
ORGANIZATION
SDS
FAX
II:
203-798-2291
APPLICATION
PLEASE SEND A XYREM PATIENT ASSISTANCE PROGRAM
TO:
PATIENT
NAME
ADDRESS
TELEPHONE:
PATIENT
DOSAGE:
(GRAMS) TWICE NIGHTLY
FOR A TOTAL DOSAGE OF
(GRAMS)
BOTTLES (THREE MONTHS

BACKGROUND
INFORMATION:
SUPPLY)
FIG.
10
U.S. Patent
Jul. 27, 2010
Sheet 12 of 16
ASSISTANCE
US 7,765,106 B2
PROGRAM
SENSITIVE DRUG
VOUCHER
PATIENT
INFORMATION
PATIENT
REQUEST FOR MEDICATION

PHYSICIAN
INFORMATION
NAME&
&FIRST NAME&&tAST
&ADDRESS 1& &ADDRESS 2&
NAME&
&PHYSICIAN
&ADDRESS 1& &ADDRESS 2&

&CITY, STATE ZIP CODE&
PHONE:
&123-456-7890
PHONE:
&123-456-7890
DOB:
SSN:
01/01/1900 123-45-6789
100%
ME
CODE-
ffttffff
DRUG ALLOTMENT:
LRD:
03/01/2001
QUANTITY
FIRST SHIPMENT
THIS YEAR
DRUG
XYREEM
180ml btl
VALIDATION
DATE:
DATE:
03/01/2001 05/31/2001 03/15/2001
"'PHARMACY
USE'"
EXPIRATION
ISSUE DATE:
APPROVED
NORD
COPY
(DETACH
PATIENT
INFORMATION
NAME&
HERE)
PHYSICIAN
INFORMATION
&FIRST NAME&&lAST
&ADDRESS I& &ADDRESS 2&
&PHYSICIAN
NAME&
&ADDRESS
I&
&ADDRESS 2&
PHONE:
&123-456-7890
PHONE:
&123-456-7890
DOB:
SSN:
01/01/1900 123-45-6789
100%
ME
COPE- eeeeetee
DRUG ALLOTMENT:
LRD:
03/01/2001
QUANTITY
FIRST SHIPMENT THIS YEAR
DRUG
XYREM
180ml btl
VALIDATION
DATE: DATE:
03/01/2001
'"PHARMACY
USE"'
EXPIRATION
05/31/2001
03/15/2001
ISSUE DATE:
APPROVED
U.S. Patent
Jul. 27, 2010
Sheet 13 of 16
US 7,765,106 B2
SENSITIVE DRUG
PHYSICIAN'S
NEED
CERTIFICATE
OF MEDICAL
PATIENT
INFORMATION
DATE:
NAME:
LAST
DATE
FIRST
OF BIRTH:
DRUG
BEING PRESCRIBED: XYREM
DIAGNOSIS/CONDITION
FOR WHICH
DRUG
IS BEING PRESCRIBED:
ICD-9:
PHYSICIAN
INFORMATION
PHYSICIAN
NAME
(PLEASE PRINT):
PHYSICIAN
SIGNATURE:
DATE:
PLEASE FAX BACK TO SENSITIVE DRUG SUCCESS PROGRAM:
(1-800-TOLL
FREE NUMBER)
FIG.
12
U.S. Patent
Jul. 27, 2010
Sheet 14 of 16
US 7,765,106 B2
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US 7,765,106 B2
1
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. RELATED APPLICATIONS In one embodiment, the drug may be shipped by the central 6 pharmacy to another pharmacy for patient pick-up. The second pharmacy's ability to protect against diversion before This application is a divisional application of U.S. patent shipping the drug must be confirmed. This ability may be application Ser. No. 10/322,348, filed Dec. 17, 2002, now checked through NTIS and State Boards of Pharmacy. U.S. Pat. No. 7,668,730 which application is incorporated Prescription refills are permitted in the number specified in herein by reference. 10 the original prescription. In addition, if a prescription refill is requested by the patient prior to the anticipated due date, such FIELD OF THE INVENTION refills will be questioned. A lost, stolen, destroyed or spilled is documented and replaced to the extent prescription/supply The present invention relates to distribution of drugs, and necessary to honor the prescription, and will also cause a in particular to the distribution of sensitive drugs. 16 review or full investigation. The exclusive central database contains all relevant data BACKGROUND OF THE INVENTION related to distribution of the drug and process of distributing it, including patient, physician and prescription information. Sensitive drugs are controlled to minimize ensure that they Several queries and reports are run against the database to are not abuse and adverse reactions. Such sensitive drugs are 20 provide information which might reveal potential abuse of the Administrafor uses the Food and specific approved Drug by sensitive drug, such as early refills. tion, and must be prescribed by a licensed physician in order to be purchased by consumers. Some drugs, such as cocaine BRIEF DESCRIPTION OF THE DRAWINGS and other common street drugs are the object of abuse and illegal schemes to distribute for profit. Some schemes include FIG. 1 is a block diagram of a computer system for use in Dr. shopping, diversion, and pharmacy thefts. A locked cabi- 26 implementing the system and method of the present invennet or safe is a requirement for distribution of some drugs. tion. Certain agents, such as gamma hydroxy buterate (GHB) FIGS. 2A, 2B and 2C are a flowchart describing a method are also abused, yet also are effective for theraputic purposes for sensitive drug distribution at least partially utilizing a such as treatment of daytime cataplexy in patients with nar30 computer system such as that shown in FIG. 1. colepsy. Some patients however, will obtain prescriptions FIG. 3 is a flowchart of a physician success program at least from multiple doctors, and have them filled at different pharpartially implemented on a computer system such as that macies. Still further, an unscrupulous physician may actually shown in FIG. 1. write multiple prescriptions for a patient, or multiple patients, FIGS. 4A and 4B are a flowchart describing a method for who use cash to pay for the drugs. These patients will then sell 36 handling refill requests at least partially utilizing a computer the drug to dealers or others for profit. system such as that shown in FIG. 1. There is a need for a distribution system and method that FIG. 5 is a flowchart of a process for requesting special directly addresses these abuses. There is a further need for reimbursement when a patient is uninsured or underinsured at such a system and method that provides education and limits least partially utilizing a computer system as that shown in the potential for such abuse. 40 FIG. 1.
SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
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. A drug distribution system and method utilizes a central FIG. 7 is a block diagram of database fields. pharmacy and database to track all prescriptions for a sensi- 46 FIG. 8 is a block diagram showing a list of queries against tive drug. Information is kept in a central database regarding the database fields. all physicians allowed to prescribe the sensitive drug, and all FIG. 9 is a copy of one example prescription and enrollpatients receiving the drug. Abuses are identified by monitorment form. ing data in the database for prescription patterns by physiFIG. 10 is a copy of one example of a NORD application cians and prescriptions obtained by patients. Further verifi- 60 request form for patient financial assistance. cation is made that the physician is eligible to prescribe the FIG. 11 is a copy of one example voucher request for drug by consulting a separate database for a valid DEA medication for use with the NORD application request form license, and optionally state medical boards to determine of FIG. 10. whether any corrective or approved disciplinary actions relatFIG. 12 is a copy of certificate of medical need. ing to controlled substances have been brought against the 66 FIGS. 13A, 13B and 13C are descriptions of sample physician. Multiple controls beyond those for traditional reports obtained by querying a central database having fields drugs are imposed on the distribution depending on the senrepresented in FIG. 7. sitivity of the drug. DETAILED DESCRIPTION OF THE INVENTION Education is provided to both physician and patient. Prior to shipping the drug for the first time, the patient is contacted 60 to ensure that product and abuse related educational materials In the following description, reference is made to the have been received and/or read. The patient may provide the accompanying drawings that form a part hereof, and in which name of a designee to the central pharmacy who is authorized is shown by way of illustration specific embodiments in to accept shipment of the drug. Receipt of the initial drug which the invention may be practiced. These embodiments shipment is confirmed by contacting the patient. Either a 66 are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that phone call or other communication to the patient within a set time after delivery may be made to ensure receipt. Further, a other embodiments may be utilized and that structural, logical
SUMMARY OF THE INVENTION
US 7,765,106 B2
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 implemented in software or a combination of software and human implemented procedures in one embodiment. The software comprises computer executable instructions stored on computer 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 processor, 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 addiction properties or other properties that render the drug sensitive. One example of such a drug is sodium oxybate, also known as gamma hydroxy butyrate (GHB C4H7Na03) which is useful for treatment of cataplexy in patients with narcolepsy. GHB is marketed under the trademark of Xyrem (sodium oxybate oral solution), which trademark can be used with GHB herein. Sensitive drugs also interchangeably 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 and patients about the risks and benefits of Xyrem, including support via ongoing contact with patients and a toll free helpline. Initial prescriptions are filled only after a prescriber and patient have received and read the educational materials. Further, patient and prescribing physician registries are maintained and monitored to ensure proper distribution. In a further embodiment, bulk sodium oxybate is manufactured 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 consignment 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 pharmacy, and is not stocked in retail pharmacy outlets. It is distributed by overnight carriers, or by US mail in one embodiment to potentially invoke mail fraud laws if attempts of abuse occur. FIG. 1 is a simplified block diagram of a computer system 100, such as a personal computer for implementing at least a portion of the methods described herein. A central processing unit (CPU) 110 executes computer programs stored on a memory 120. Memory 120 in one embodiment comprises one or more levels of cache as desired to speed execution of the program and access to data on which the programs operate. The CPU is directly coupled to memory 120 in one embodiment. Both CPU 110 and memory 120 are coupled to a bus 130.A storage 140, I/O 150 and communications 160 are also coupled to the bus 130. Storage 140 is usually a long term storage device, such as a disk drive, tape drive, DVD, CD or other type of storage device. In one embodiment, storage 140 is used to house a database for use with the present invention. I/O 150 comprises keyboards, sound devices, displays and other mechanisms by which a user interacts with the com-
10
16
20
26
30
36
40
46
60
66
60
66
puter system 100. Communications 160 comprises a network, phone connection, local area network, wide area network or other mechanism for communicating with external devices. Such external devices comprise servers, other peer computers and other devices. In one embodiment, such external device comprises a database server that is used in place of the database on storage 140. Other computer system architectures capable o f executing software and interacting with a database and users may also be used. Appropriate security measures such as encryption are used to ensure confidentiality. Further, data integrity and backup measures are also used to prevent data loss. FIGS. 2A, 2B and 2C represent an initial prescription order entry process for a sensitive drug, such as Xyrem. At 202, a medical doctor (MD) sends a Rx/enrollment form via mail, specialfax, email or other means to an intake/reimbursement ist at 204, who makes a copy of the RX/enrollment form that is stamped "copy". The original fax is forwarded to a pharmacy team. The enrollment form contains prescriber information, prescription information, checkboxes for the prescriber indicating they have read materials, educated the patient, understand the use in treatment, and understand certain safety information, and also contains patient information. The prescriber information contains standard contact information as well as license number, DEA number and physician specialty. Patient and prescription information includes name, social security number, date of birth, gender, contact information, drug identification, patient's appropriate dosage, and number of refills allowed, along with a line for the prescriber's signature. Patient insurance information is also provided. There are two workflows involved at the pharmacy team, intake reimbursement 206 and pharmacy workflow 20S, which may proceed in parallel or serially. The intake work flow 206 starts with an intake reimbursement specialist entering the patient and physician information into an application/ database referred to as CHIPS, which is used to maintain a record of a client home infusion program (CHIP) for Xyrem. A check is made to ensure the information is complete at 212. If not, at 214, an intake representative attempts to reach the MD or prescriber to obtain the missing information. If the missing information has not been obtained within a predetermined period of time, such as 24 hours at 216, the Rx/Enrollment form is sent back to the MD with a rejection explanation. A note is entered in CHIPS that the application was rej ected. If the information is complete at 212, the MD is contacted at 220 to verify receipt and accuracy of the patient's Rx. This contact is recorded in CHIPS. The intake and reimbursement specialist then sends a consent form and a cover letter to the patient at 224. The insurance provider is contacted at 226 to verify coverage and benefits. At 22S, a determination is made regarding coverage for the drug. If it is not available, it is determined at 230 whether the patient is willing and able to pay. If not, a process is performed for handling patients who are uninsured or underinsured. In one embodiment, the process is referred to as a NORD process. If the patient is willing and able to pay at 230, the patient is informed of the cost of the product and is given payment options at 234. At 236, once payment is received, the intake reimbursement specialist submits a coverage approval form with the enrollment form to the pharmacy team as notification to process the patient's prescription. If coverage is approved at 22S, the intake reimbursement specialist also submits the coveral approval form with the enrollment form to the pharmacy team as notification to process the patient's prescription. Processing of the prescription is described below.
US 7,765,106 B2
As noted at 266, for the sensitive drug, Xyrem, all invenUpon receipt and initial processing of the prescription enrollment form and sending an original to the pharmacy tory is cycle counted an reconciled with the database system work flow block 20S, the patient is shipped a Xyrem success quantities before shipments for the day are sent. This provides a very precise control of the inventor. packet via mail. In one embodiment, the Xyrem success A physician success program materials request process packet contains educational material for a patient that advises 6 of the proper use, care and handling of the drug and consebegins at 310 in FIG. 3. At 320, the MD calls to the central quences of diversion at 26S. The medical doctor's credentials pharmacy to request program materials. A special phone are checked to determine if the physician has a current DEA number is provided. MD demographics, DEA number, and license to prescribe controlled substances and if he or she has data or request are entered into the database at 330. At 340, a had any actions related to misuse/misprescribing of con- 10 request is made to ship the materials to the MD via a fulfilltrolled drugs against him or her, within a predetermined time, ment website, or other mechanism. The request process ends such as three months at 270. If they have, a pharmacist holds at 350. the prescription until receiving a coverage approval form A refill request process begins at 302 in FIGS. 4A and 4B. from the intake reimbursement specialist at 272. There are two different paths for refills. A first path beginning If the credentials have not been recently checked, the phar- 16 at 404 involves generating a report from the central database of patients with a predetermined number of days or product macist verifies the credentials and enters all findings in the remaining. A second path beginning at 406 is followed when database at 274. If the credentials are approved at 276, the a patient calls to request an early refill. physician is indicated as approved in a physician screen popuIn the first path, a copy o fthe report is provided to an intake lated by information from the database at 2SO. The prescrip20 reimbursement specialist at 40S. No sooner than 8 days tion is then held pending coverage approval at 2S2. before the medication depletion, a pharmacy technician conIf any disciplinary actions are identified, as referenced at tacts the patient at 410 to complete the pre-delivery checklist. block 27S, management of the pharmacy is notified and either At 412, if the patient is not reached, a message is left menapproves processing of the prescription with continued monitioning the depletion, and a return number at 414. A note is toring of the physician, or processing of the prescription is not performed, and the physician is noted in the database as 26 also entered into the database indicating the date the message was left at 416. unapproved at 2S4. The enrollment form is then mailed back If the patient is reached at 412, the next shipment is schedto the physician with a cover letter reiterating that the preuled at 41S, the prescription is entered into the database scription cannot be processed at 2SS. The patient is also sent creating an order at 420, the pharmacist verifies the prescripa letter at 290 indicating that the prescription cannot be processed and the patient is instructed to contact their physician. 30 tion and attaches a verification label at 422 and the shipment is confirmed in the database at 424. Note at 426 that the Actual filling of the approved prescription begins with inventory is cycle counted and reconciled with the database receipt of the coverage approval form as indicated at 240. The quantities before the shipments for a day or other time period patient is contacted by the pharmacy, such as by a technician are sent. A pick ticket is generated for the order and the order to complete a technician section of a patient counseling 36 is forwarded for fulfillment at 42S, with the first path ending checklist. If a pharmacist verifies that the program materials at 430. were not read at 242, the receipt of the material is confirmed The second path, beginning at 406 results in a note code at 244 and another call is scheduled to counsel the patient being entered into the database on a patient screen indicating before the drug is shipped. an early refill request at 432. The pharmacist evaluates the If the program materials, were read at 242, the checklist is 40 patient's compliance with therapy or possible product divercompleted at 246 and the technician transfers the patient to sion, misuse or over-use at 436. In one embodiment, cash the pharmacist who reviews the entire checklist and compayers are also identified. The pharmacist then contacts the pletes remaining pharmacist specified sections. At 24S, the prescribing physician to alert them of the situation and conpharmacists indicates in the database that the patient counfirm if the physician approves of the early refill at 43S. If the seling and checklist was successfully completed, indicating 46 physician does not approve as indicated at 440, the patient the date completed. must wait until the next scheduled refill date to receive addiAt 250, the pharmacist schedules the patient's shipment for tional product as indicated at 442, and the process ends at 444. the next business day or the next business day that the patient If the physician approves at 440, the pharmacist enters a or designee is able to sign for the package. Further, as indinote in the database on a patient screen that the physician cated at 252, the shipment must be sent to the patient' home 60 approves the request at 446. The pharmacist notifies an intake address unless the patient is traveling or has moved. In that reimbursement specialist to contact the patient's insurance event, the pharmacist may determine that an exception may provider to verify coverage for the early refill at 44S. If the be made. The patient or the patient's designee who is at least insurance provider will pay as determined at 450, the special18 years old, must sign for the package upon delivery. ist submits the coverage approval form as notification that the At 254, the pharmacist enters the prescription order in the 66 refill may be processed at 452. At 454, the pharmacy technidatabase, creating an order number. The pharmacist then cian contacts the patient to schedule shipment of the product verifies at 256 the prescription and attaches a verification for the next business day, and the process of filling the order label to the hard copy prescription. At 25S, a pick ticket is is continued at 456 by following the process beginning at 240. generated for the order and the order is forwarded to the If the insurance provider will not pay at 450, it is deterpharmacy for fulfillment. The shipment is confirmed in the 60 mined whether the patient is willing and/or able to pay at 45S. database at 260, and the order is shipped by USPS Express If not, the patient must wait until the next scheduled refill date Mail. Use of the US mail invokes certain criminal penalties to receive additional product at 460. If it was determined at for unauthorized diversion. Optionally, other mail services 45S that the patient was willing and able to pay, the patient is informed of the cost of the product and is given payment may be used. Potential changes in the law may also bring criminal penalties into play. Following shipment, the patient 66 options at 462. Once payment is received as indicated at 464, is called by the central pharmacy to confirm that the prescripthe specialist submits a coverage approval form to the phartion was received. macy team as notification that the refill request can be pro-
US 7,765,106 B2
cessed at 466. At 46S, the pharmacy technician contacts the patient to schedule shipment. The process of filling the order is continued at 470 by following the process beginning at 240. A process, referred to as a NORD process in one embodiment is used to determine whether donated, third party funds are available for paying for prescriptions where neither insurance will, nor the patient can pay. The process begins at 510 upon determining that a patient is uninsured or underinsured. A reimbursement specialist explains the NORD program to the patient and faxes an application request form to NORD for the patient. At 515, the intake reimbursement specialist documents in the database that an application has been received through NORD. At 520, NORD mails an application to the patient within one business day. A determination is made at 525 by NORD whether the patient is approved. If not, at 530, NORD sends a denial letter to the patient, and it is documented in the database at 540 that the patient was denied by NORD. If the patient is approved, NORD sends an acceptance letter to the patient and faxes a voucher to the central pharmacy (SDS in one embodiment) to indicate the approval at 545. At 550, an intake reimbursement specialist submits a coverage approval form to the pharmacy team as notification that the patient has been approved for coverage. The process of filling the order is continued at 555 by following the process beginning at 240.
be distributed among multiple computers provided a query operates over all data relating to such prescriptions, prescribers and patients for the drug. An example of one prescription and enrollment form is 6 shown at 900 in FIG. 9.As previously indicated, several fields are included for prescriber information, prescription information and patient information. FIG. 10 is a copy of one example NORD application request form 1000 used to request that an application be sent 10 to a patient for financial assistance. FIG. 11 is a copy of one example application 1100 for financial assistance as requested by form 1000. The form requires both patient and physician information. Social security number information is also requested. The form provides 16 information for approving the financial assistance and for tracking assistance provided. FIG. 12 is a copy of one example voucher request for medication for use with the NORD application request form of FIG. 10. In addition to patient and physician information, 20 prescription information and diagnosis information is also
provided.
26
An inventory control process is illustrated in FIG. 6 beginning at 610. Each week, a responsible person at the central pharmacy, such as the director of the pharmacy transfers inventory for the week' shipments to a segregated warehouse 30 location for production inventory. At 620, a purchase order is locagenerated for the inventory transferred to the production tion and is sent, such as by fax, to a controller, such as the controller of the company that obtained approval for distribution and use of the sensitive drug. At 630, the controller 36 invoices the central pharmacy for the product moved to production. The process ends at 640.
The central database described above is a relational database running on the system of FIG. 1, or a server based system having a similar architecture coupled to workstations via a 40 network, as represented by communications 160. The database is likely stored in storage 140, and contains multiple fields of information as indicated at 700 in FIG. 7. The organization and groupings of the fields are shown in one format for convenience. It is recognized that many different organi- 46 zations or schemas may be utilized. In one embodiment, the groups of fields comprise prescriber fields 710, patient fields 720, prescription fields 730 and insurance fields 740. For purposes of illustration, all the entries described with respect to the above processes are included in the fields. In further 60 embodiments, no such groupings are made, and the data is organized in a different manner. Several queries are illustrated at S00 in FIG. S. There may be many other queries as required by individual state reporting requirements. A first query at S10 is used to identify 66 prescriptions written by physician. The queries may be written in structured query language, natural query languages or in any other manner compatible with the database. A second query S20 is used to pull information from the database related to prescriptions by patient name. A third query S30 is 60 used to determine prescriptions by frequency, and a n'uery finds prescriptions by dose at S40. Using query languages combined with the depth of data in the central database allows many other methods of investigating for potential abuse of the 66 drugs. The central database ensures that all prescriptions, prescribers and patients are tracked and subject to such investigations. In further embodiments, the central database may
FIGS. 13A, 13B and 13C are descriptions of sample reports obtained by querying a central database having fields represented in FIG. 7. The activities grouped by sales, regulatory, quality assurance, call center, pharmacy, inventory, reimbursement, patient care and drug information. Each report has an associated frequency or frequencies. The reports are obtained by running queries against the database, with the queries written in one of many query languages. While the invention has been described with respect to a Schedule III drug, it is useful for other sensitive drugs that are DEA or Federally scheduled drugs in Schedule II-V, as well as still other sensitive drugs where multiple controls are desired for distribution and use. The invention claimed is: 1. A therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused, misused, or diverted, comprising: receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed the prescription drug and from any and all doctors allowed to prescribe the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical doctor who is prescribing the prescription drug; requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for authorization only using the exclusive central computer system and the exclusive computer database; controlling the distribution of said prescription drug using the exclusive central computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the exclusive central computer system and the exclusive computer database based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and selecting multiple controls for distribution using said exclusive central computer system, the controls selected
US 7,765,106 B2
10
from the group consisting of communicating prescriptions from a physician to the exclusive central computer system; identifying the physician's name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying the physician is eligible to prescribe the prescription drug by consulting the National Technical Information Services to determine whether the physician has an active DEA number and to check on whether any actions are pending against the physician; providing comprehensive printed materials to the physician; contacting the patient's insurance company if any; verifying patient registry information; providing comprehensive education information to the patient; verifying the patient has received and/or reviewed the educational materials; verifying the home address of the patient; shipping via US postal service or a commercial shipping service; receiving the name of an at least 18 year old designee to receive the drug; confirming receipt o f an initial shipment o fthe drug to the patient; returning the drug to a pharmacy after two attempts to deliver; launching an investigation when a shipment is lost; shipping to another pharmacy for delivery; requiring manufacture at a single location; authorizing release of inventory in a controlled manner; questioning early refills; flagging repeat instances of lost, stolen, destroyed, or spilled prescriptions; limiting the prescription to a one month supply; requiring rewriting of the prescription periodically; and making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions; authorizing the filling, using the exclusive central computer system, of a prescription for the prescription drug that has been subjected to said multiple controls and has been approved for shipment to the patient; noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and delivering the prescription drug to the patient in order to treat the patient with the prescription drug. 2. The method of claim wherein the controls for distribution are communicating prescriptions from a physician to the exclusive central computer system; identifying the physician' name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying patient registry information; comprehensive education information to the providing patient; verifying the patient has received and/or reviewed the educational materials; or requiring rewriting of the prescription periodically. 3. A therapeutic method for treating a narcoleptic patient with sodium oxybate for daytime cataplexy comprising: receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed sodium oxybate and from any and all medical doctors allowed to prescribe sodium oxybate, the prescriptions containing information relating to the patient, sodium oxybate, and various credentials of the medical doctor who is prescribing the sodium oxybate; requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion, such that all prescriptions for sodium oxy-
bate are processed for authorization only using the exclusive central computer system and the exclusive computer database;
5
10
15
20
25
30
35
40
1,
45
controlling the distribution of sodium oxybate using the exclusive central computer system that tracks all prescriptions of sodium oxybate and analyzes for the potential abuse, misuse, or diversion by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of sodium oxybate from periodic reports generated by the exclusive central computer system based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, sodium oxybate as the drug prescribed, and credentials of the doctor; and selecting multiple controls for distribution using said exclusive central computer system, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive central computer system; identifying the physician's name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying the physician is eligible to prescribe sodium oxybate by consulting the National Technical Information Services to determine whether the physician has an active DEA number and to check on whether any actions are pending against the physician; providing comprehensive printed materials to the physician; contacting the patient' insurance company i f any; verifying patient registry information; providing comprehensive education information to the patient; verifying the patient has received and/or reviewed the educational materials; verifying the home address of the patient; shipping via US postal service or a commercial shipping service; receiving the name of an at least 18 year old designee to receive the drug; confirming receipt of an initial shipment of the drug to the patient; returning the drug to a pharmacy after two attempts to deliver; launching an investigation when a shipment is lost; shipping to another pharmacy for delivery; requiring manufacture at a single location; authorizing release of inventory in a controlled manner; questioning early refills; flagging repeat instances of lost, stolen, destroyed, or spilled prescriptions; limiting the prescription to a one month supply; requiring rewriting of the prescription periodically; and making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions;
authorizing the filling, using the exclusive central computer system, of a prescription for sodium oxybate that has been subjectedto saidmultiple controls and has been approved for shipment to the patient;
50
55
60
noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and delivering the sodium oxybate to the patient in order to treat the patient with the sodium oxybate.
4. The method of claim 3, wherein the controls for distribution are communicating prescriptions from a physician to the exclusive central computer system; identifying the physician' name, license, and DEA (Drug Enforcement Agency) 65 registration information; verifying the prescription; obtaining patient information; verifying patient registry information; comprehensive education information to the providing
US 7,765,106 B2
12
patient; verifying the patient has received and/or reviewed the educational materials; or requiring rewriting of the prescription periodically.
5. A therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is 6 also a drug that has potential to be abused, misused, or diverted, comprising: receiving, only into an exclusive computer database in a computer system, from any and all medical doctors 10 allowed to prescribe the prescription drug and any and all patients being prescribed the prescription drug, all prescriptions for the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical 16 doctor who is prescribing the prescription drug; requiring entering of the information into the exclusive computer database for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for 20 authorization only via the exclusive computer database;
controlling the distribution of said prescription drug with the computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the computer system based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and selecting multiple controls for distribution of the prescription drug, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive computer database; identifying the physician's name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying the physician is eligible to prescribe the prescription drug by consulting the National Technical Information Services to determine whether the physician has an active DEA number and to check on whether any actions are pending against the physician; providing comprehensive printed materials to the physician; contacting the patient's insurance company if any; verifying patient registry information; providing comprehensive education information to the patient; verifying the patient has received and/or reviewed the educational materials; verifying the home address of the patient; shipping via US postal service or a commercial shipping service; receiving the name of an at least 18 year old designee to receive the drug; confirming receipt o f an initial shipment o fthe drug to the patient; returning the drug to a pharmacy after two attempts to deliver; launching an investigation when a shipment is lost; shipping to another pharmacy for delivery; requiring manufacture at a single location; authorizing the release of inventory in a controlled manner; questioning early refills; flagging repeat instances of lost, stolen, destroyed, or spilled prescriptions; limiting the prescription to a one month supply; requiring rewriting of the prescription periodically; and making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions; authorizing the filling, using the exclusive computer database, of a prescription for the prescription drug that has
26
30
36
40
46
60
66
60
66
been subjected to said multiple controls and has been approved for shipment to the patient; noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and delivering the prescription drug to the patient in order to treat the patient with the prescription drug. 6. The method of claim 5, wherein the controls for distribution are communicating prescriptions from a physician to the exclusive computer database; identifying the physician' name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying patient registry information; comprehensive education information to the providing patient; verifying the patient has received and/or reviewed the educational materials; or requiring rewriting of the prescription periodically. 7. A therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused, misused, or diverted, comprising: receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed the prescription drug and any and all medical doctors allowed to prescribed the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical doctor who is writing the prescription; requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for authorization only using the exclusive central computer system and the exclusive computer database; controlling the distribution of said prescription drug using the exclusive central computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the exclusive central computer system and the exclusive computer database based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and selecting multiple controls for distribution using the exclusive central computer system, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive central computer system; identifying the physician's name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying the physician is eligible to prescribe the prescription drug by consulting the National Technical Information Services to determine whether the physician has an active DEA number and to check on whether any actions are pending against the physician; providing comprehensive printed materials to the physician; contacting the patient's insurance company if any; verifying patient registry information; providing comprehensive education information to the patient; verifying the patient has received and/or reviewed the educational materials;
US 7,765,106 B2
13
14
verifying the home address of the patient; shipping via noting, based on one or more of the analysis of the potential US postal service or a commercial shipping service; abuse, misuse, or diversion of the prescription drug and receiving the name of an at least 18 year old designee to the periodic reports, that there is a potential for abuse, receive the drug; confirming receipt of an initial shipmisuse, or diversion by the patient to whom the prescripment of the drug to the patient; returning the drug to a 5 tion drug is prescribed; and pharmacy after two attempts to deliver; launching an delivering the prescription drug to the patient in order to investigation when a shipment is lost; shipping to treat the patient with the prescription drug. another pharmacy for delivery; requiring manufacture at S. The method of claim 7, wherein the controls for distria single location; authorizing release of inventory in a controlled manner; questioning early refills; flagging to bution are communicating prescriptions from a physician to the exclusive central computer system; identifying the phyrepeat instances of lost, stolen, destroyed, or spilled sician' name, license, and DEA (Drug Enforcement Agency) prescriptions; limiting the prescription to a one month registration information; verifying the prescription; obtaining supply; requiring rewriting of the prescription periodipatient information; verifying patient registry information; cally; and making the database available to the DEA for education information to the checking for abuse, misuse, or diversion patterns in the t5 providing comprehensive patient; verifying the patient has received and/or reviewed the data, for cash payments, and for inappropriate questions; educational materials; or requiring rewriting of the prescripauthorizing the filling, using the exclusive central comtion periodically. puter system, of a prescription for the prescription drug that has been subjected to said multiple controls and has been approved for shipment to the patient;
UNITED STATES PATENT AND TRADEMARK OFFICE
CERTIFICATE OF CORRECTION
PATENT APPLICATION DATED
NO.: NO.:
7,765,106 B2
10/979665
Dayton
Page
of
: July27,2010
INVENTOR(S):
It is
T. Reardan et al.
patent and that said Letters Patent is hereby corrected as shown below:
certified that error appears in the above-identified
In column 12, lines 20-67, column 13, lines 1-20, column 14, lines 1-7, in Claim 7, delete "7. A therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused, misused, or diverted, comprising: receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed the prescription drug and any and all medical doctors allowed to prescribed the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical doctor who is writing the prescription; requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for authorization only using the exclusive central computer system and the exclusive computer database; controlling the distribution of said prescription drug using the exclusive central computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the exclusive central computer system and the exclusive computer database based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and selecting multiple controls for distribution using the exclusive central computer system, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive central computer system; identifying the physician's name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying the physician is eligible to prescribe the prescription drug by consulting the National Technical Information Services to determine whether the physician has an active DEA number and to check on whether any actions are pending against the physician; providing comprehensive printed materials to the physician; contacting the patient's insurance company if any; verifying patient registry information; providing comprehensive education information to the patient; verifying the patient has received and/or reviewed the educational materials; verifying the home address of the patient; shipping via US postal service or a commercial shipping service; receiving the name of an at least 18 year old designee to receive the drug;
Signed and Sealed this

Twenty-third
Day
of November, 2010
David
J. Kappos
Director of the United States Patent and Trademark Office
CERTIFICATE OF CORRECTION (continued) U.S. Pat. No. 7,765,106 B2
Page 2
of 3
confirming receipt of an initial shipment of the drug to the patient; returning the drug to a pharmacy after two attempts to deliver; launching an investigation when a shipment is lost; shipping to another pharmacy for delivery; requiring manufacture at a single location; authorizing release of inventory in a controlled manner; questioning early refills; flagging repeat instances of lost, stolen, destroyed, or spilled prescriptions; limiting the prescription to a one month supply; requiring rewriting of the prescription periodically; and making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions; authorizing the filling, using the exclusive central computer system, of a prescription for the prescription drug that has been subjected to said multiple controls and has been approved for shipment to the patient; noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and delivering the prescription drug to the patient in order to treat the patient with the prescription drug." and
insert 7. A therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused, misused, or diverted, comprising: receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed the prescription drug and any and all medical doctors allowed to prescribed the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical doctor who is writing the prescription; requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for authorization only using the exclusive central computer system and the exclusive computer database; controlling the distribution of said prescription drug using the exclusive central computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the exclusive central computer system and the exclusive computer database based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and selecting multiple controls for distribution using the exclusive central computer system, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive central computer system; identifying the physician's name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying the physician is eligible to prescribe the prescription drug by consulting the National Technical Information Services to determine whether the physician has an active DEA number and to check on whether any actions are pending against the physician; providing comprehensive printed materials to the physician; contacting the patient's insurance company if any; verifying patient registry information; providing comprehensive education information to the patient; verifying the patient has received and/or reviewed the educational materials; verifying the home address of the patient; shipping via US postal service or a commercial shipping service; receiving the name of an at least 18 year old designee to receive the drug; confirming receipt of
CERTIFICATE OF CORRECTION (continued) U.S. Pat. No. 7,765,106 B2
Page 3
of 3
an initial shipment of the drug to the patient; returning the drug to a pharmacy after two attempts to deliver; launching an investigation when a shipment is lost; shipping to another pharmacy for delivery; requiring manufacture at a single location; authorizing release of inventory in a controlled manner; questioning early refills; flagging repeat instances of lost, stolen, destroyed, or spilled prescriptions; limiting the prescription to a one month supply; requiring rewriting of the prescription periodically; and making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data, for cash payments, and for inappropriate
questions; authorizing the filling, using the exclusive central computer system, of a prescription for the prescription drug that has been subjected to said multiple controls and has been approved for shipment to the patient; noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and delivering the prescription drug to the patient in order to treat the patient with the prescription therefor. drug. ,
UNITED STATES PATENT AND TRADEMARK OFFICE
CERTIFICATE OF CORRECTION
PATENT NO. APPLICATION NO. DATED INVENTOR(sl
It is
: 7,765,106 B2 : 10/979665 : July27,2010 : Dayton T. Reardan et al.
Page I
of 3
certified that error appears in the above-identified
patent and that said Letters Patent is hereby corrected as shown below:
Delete the Title Page showing an illustrative figure, and substitute the attached Title Page therefor. Delete Sheet 2 of 16 showing Fig. 2A, and substitute the attached sheet therefor.
On Sheet 10 of 16, in Figure 9, line 23, after "ESTABLISHED" insert
. .
In column 1, line 27, delete "buterate" and insert
therefor. butyrate , therefor. therapeutic ,
In column 1, line 28, delete "theraputic" and insert In column 4, line 65, delete "coveral" and insert
therefor. coverage ,
Signed and Sealed this Fifteenth Day of February, 2011
David
J. Kappos
Director of the United States Patent and Trademark Office
CERTIFICATE OF CORRECTION (continued)
Page 2
of 3
(t
United States Patent

ReardaII et aj.
(l03
(453
Patetlt No.: Bate Of Patent

2. 2000
US 7,765. I06 82 *JIIl. 27, 2010

l ester et al
l
l
(54) SENSITIYE DRUG DIsTRDIIJTIO(rt sYSTKM A;iD MEFI HOD

(75)
lnvenrors:
Dayton T. Reardanr Excelsior, MI4 (US); Petti A. Fngel, Eagan, MN (US3; Sr)h Gagnc, St. Paul, h)IN (US)
6.02t,392 A 6.045.50l A 6,055,507 A 6,1 l2.l82 6 1l5,720 Ill 6347,329 Rl

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(US3
Palo Alto, CA
()2Q03 Waltare er af
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Williams ei al tp 2005 Mi&Jurrde er al 6 2I)06 Kr r.inski et al
Notice:
Subject io any disclaimer, the term of this patent is extended or adjusted under 35 V.S.C. l 54(bl by l 645 days.
This patent is subject to a (errninal disclir I Incr.
6,'2004
6.952.68t B2
7.058)58-1 R2
(Cont inued)
CXfHER PUIJLLCATlONS
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Appi No.: 10/979,665

Filed'.
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(22)
2, 2004
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US 2005/0090425 A I
Apr, 28, 2005
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liled on Dec.
Woessner. P.A.
Pal. No. 7,668,730.
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(513 Int. Cl.

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(56)
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References Cited

l/197 t Guarr 7/1989 Hal verso)i
)2r l 990 Mangiai st al. 4/l998 Frtetson es al.
t ~~
4,976,15 l A
&.737.5 30 A
drug dirtribuiion system and nicthod rrtilircs a cerrtrd pharmacy and database to tmck a'll prescriptions for 0 sensitive dnig. h)formation is kept in tile database regirrding all physicians allo~ed to prescribe the seniiine drtr)t, and all patients receiving the drug. Abuses are iilentified by ntonitorrng data in th database tor prescripiiorl pattents by pltysicians and prescriptions i)btained by patienLs. Further vert(ication )s made that the physician is eligible to prescribe thc arne drug hy consulting a separate database and opiiinially whether any actions are taken against the phystcran. iv) tilt)p)e controls beyond those for normal drtrgs an. imposed on the distribution depending otr thc si:sitivity r if'hi dnig
5,845,255 A 5,924,074 A
)99)t Mayaud 7r l 999 Fvans
....,
........
705/3 705/3
8 Clahns. I6 Drawing Sheeti
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CERTIFICATE OF CORRECTION (continued)
Page 3
of 3
U.S. Patent
Jul. 27, 2010
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Sensitive Drug Distribution System and Method (US Patent 7765106)

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United States Patent

No.: Date of Patent:

US 7,765,106 B2 *Jul. 27, 2010

JPI Commercial, LLC, Palo

Akers et al. Williams et al.

11/2001 2/2002 5/2003 2/2004 6/2004 10/2005 6/2006

(21) Appl. No.: 10/979,665

Prior Publication Data

Primary Examiner Assistant Examiner

Related U.S. Application Data

of application No. 10/322,348,

(74) Attorney, Woessner, P.A.

Gerald J. O'onnor Lena Najarian Schwegman, Agent, or Firm

17, 2002, now Pat. No. 7,668,730.

See application file for complete search history.

U.S. PATENT DOCUMENTS

1/1971 7/1989 12/1990 4/1998 12/1998 7/1999

Guarr Halvorson Mangini et al. Edelson et al. Mayaud Evans

S Claims, 16 Drawing Sheets

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Atlf IS fMIAtD IH (II IS IHtl AMMU% Nt AUIUW

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PIXf(l ftlt MfN!

6 IIIINMI HI MI X(l tf Ilf Nt I! RQB MINN UQIHB 236 t

Ib~tNI It BNUKtlKH It IUXfll tf MWX R

U.S. PATENT DOCUMENTS

"U.S.Appl. No. 10/322,348,

Advisory Action mailed Feb. 5, 2007",

"U.S. Appl. No. 10/322,348,

Jul. 27, 2010

Jul. 27, 2010

SPECIALIST MAKE A COPY OF

BACK TO THE MD WITH A REJECTION

CHiPS THAT THE

SPECIALIST SENDS CONSENT

FORM AND A COVER

OF MEDICAL NECESSITY TO THE

SEE NORD PROCESS FOR PATIENTS

WHO ARE UNINSURED

IS INFORMED OF THE COST OF THE

PRODUCT AND IS GIVEN

SUBMITS A COVERAGE APPROVAL

FORM) TO THE PHARMACY

TO PROCESS THE PATIENTS

Jul. 27, 2010

IF ANY DISCIPLINARY ACTIONS ARE

PACKET VIA 2-OAY USPS

TAKES ONE OF THE

ENTERS ALL FINDINGS

THE MD IS NOTED AS UNAPPROVED

IS NILED BACK TO THE

Jul. 27, 2010

SPECIFIED SECTIONS OF THE PATIENT

BEFORE THE XYREM IS SHIPPED

THE SPECIFIED SECTIONS OF THE

CHECKLIST WITH THE PATIENT THE PHARMACY

TRANSFERS THE CALLER TO THE PHARMACIST

CHiPS THAT THE PATIENT

CHECKLIST WAS SUCCESSFULLY COMPLETED

THE DATE COMPLETED

MUST BE SENT TO THE PATIENTS