sensitive drug distribution system and method (us patent 7765106)

8/13/2019 Sensitive drug distribution system and method (US patent 7765106)

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IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIUS007765106B2

&12~ United States PatentReardan et al.

(Io) Patent No.: US 7,765,106 B2(45) Date of Patent: *Jul. 27, 2010

(54) SENSITIVE DRUG DISTRIBUTION SYSTEMAND METHOD

(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 Alto, CA(US)

( * ) Notice: Subject to any disclaimer, the term of thispatent is extended or adjusted under 35U.S.C. 154(b) by 1645 days.

6,021,392 A

6,045,501 A

6,055,507 A

6,112,182 A

6,315,720 Bl6,347,329 Bl6,564,121 Bl6,687,676 Bl6,755,784 B2

6,952,681 B2

7,058,584 B2

2/2000

4/2000

4/2000

8/2000

11/2001

2/2002

5/2003

2/2004

6/2004

10/2005

6/2006

Lester et al.

Elsayed et al.

Cunningham

Akers et al.

Williams et al.

Evans

Wallace et al.

Denny

Williams et al.

McQuade et al .

Kosinski et al.

This patent is subject to a terminal dis-claimer.

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

(22) Filed: Nov. 2, 2004

(Continued)

OTHER PUBLICATIONS

NASCSA National Conference, iNov. 20001,8 pages.

(65) Prior Publication Data

US 2005/0090425 Al Apr. 28, 2005

Related U.S.Application Data

(51) Int. Cl.G060 10/00 (2006.01)

(52) U.S.Cl................................................05/2; 705/3

(58) Field of ClassiTication Search .....................05/2,705/3

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

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4/1998 Edelson et al.

12/1998 Mayaud ..........7/1999 Evans .............

705/3

705/3

(62) Division of application No. 10/322,348, filed on Dec.17, 2002, now Pat. No. 7,668,730.

(57) ABSTRACT

A drug distribution system and method utilizes a centralpharmacy and database to track all prescriptions for a sensi-tive drug. Information is kept in the database regarding allphysicians 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 thedrug by consulting a separate database, and optionallywhether any actions are taken against the physician. Multiplecontrols beyond those for normal drugs are imposed on thedistribution depending on the sensitivity of the drug.

S Claims, 16 Drawing Sheets

(Continued)

Primary Examiner Gerald J.O'onnorAssistant Examiner Lena Najarian

(74) Attorney, Agent, or Firm Schwegman, Lundberg &Woessner, P.A.

202

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US 7,765,106 B2

U.S. PATENT DOCUMENTS

7,668,730 B22001/0001144 AI2001/0042050 AI2001/0047281 AI

2002/0010661 AI2002/0032581 AI2002/0032582 AI2002/0042725 AI2002/0042762 AI2002/0052762 AI2002/0161607 AI2002/0177232 AI2003/0033168 AI2003/0046110 AI2003/0050802 AI2003/0093295 AI2003/0110060 AI2003/0127508 AI2003/0144876 AI2003/0160698 AI2003/0197366 AI

2003/0229519 AI2003/0233256 AI2004/0008123 AI2004/0019567 AI2004/0019794 AI2004/0078237 AI2004/0107117 AI2004/0117126 AI2004/0122712 AI2004/0122713 AI2004/0162740 AI2004/0176985 AI2005/0216309 AI2005/0222874 AI

2/20105/2001

11/200111/2001

I/20023/20023/20024/20024/20025/2002

10/200211/20022/20033/20033/20035/20036/20037/20037/2003g/2003

10/2003

12/200312/2003I/2004I/2004I/20044/20046/20046/20046/20046/2004g/20049/20049/2005

10/2005

Reardon et al.

KappFletcher et al.Keresman, HI et al.

Waddington et al.ReitbergFeeney, Jr, et al.MayaudMcQuade et al.Kobylevsky et al.SubichMelker et al.Califano et al.GogolakJay et al.Lilly et al.ClementiJonesKosinski et al.Andreasson et al.Kusterbeck

Eidex et al.Cardenas et al.Carrender et al.Herceg et al.Moradi et al.Kaafarani et al.DennyFetterman et al.Hill, Sr, et al.Hill, Sr, et al.Ericsson et al.Lilly et al.Reardan et al.Reardan et al.

OTHER PUBLICATIONS

Diversion Prevention Through Responsible Distribution , NADDI

Regional Training, (May 2001),12pages. Diversion Prevention Through Responsible Distribution , NADDIRegional Training Tennessee, (Jun. 2001),14Pages. Diversion Prevention Through Responsible Distribution , NADDINational Conference, (Nov. 2001),15pages. Peripheral and Central Nervous System Drugs Advisory Commit-tee , Department of Health and Human Service Food and DrugAdmi ni strati on.Center for Drug Evaluat ion and Research, Holiday Inn, Bethesda,Maryland,(Jun. 6, 2001),7 pages. Peripheral and Central Nervous System Drugs Advisory Commit-tee , Department ofHealth and Human Services Food and DrugAdministration Center for Drug Evaluation and Research, HolidayInn, Bethesda, Maryland,(Jun. 6, 2001),7 pages. Preliminary Amendment Pursuant to 37 CFR 1.115filed 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),103pgs.

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, Advisory Action mailed Feb. 5, 2007 ,

3 pgs. U.S.Appl. No. 10/322,348, Amendment and Response to FinalOffice Action mailed Jan. 17, 2007 , 17 pgs. U.S.Appl. No. 10/322,348, Amendment and Response to FinalOffice 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 Responsemailed 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 Responsemailed 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 May29, 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 mailedOct. 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 NonFinal 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 FinalOffice Action mailed Nov. 12, 2009 , 11 pgs. U.S.Appl. No. 11/097,651, Response filed Sep. 17, 2009 to NonFinal 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.Patent Jul. 27, 2010 Sheet 1 of 16 US 7,765,106 B2

100

110 120

cpu MEMORY

130

140 150 160

STORAGE i/O COMM




202

MO IIAILS/FAXES IN IAt/ENROLLMEIO FORII

204

AN INTAKE/REIMBURSEMENT SPECIALIST MAKE A COPY OF

THE Rx/ENROLLMENT FORM (THE COPY IS STAMPED

'OPY') AND THE ORIGINAL FAX IS THEN FORWARDED

TO THE PHARMACY TEAM

I

t 206

MO MAILS/FAXES IN Rx/ENROLLMENT FORM

I 210

THE INTAKE/REIMBURSEMENT SPECIALIST ENTERS THE

PATIENT AND PHYSICIAN INFO INTO CHiPS

212THE INFO

COMPLETE?

YES 220

THE INTAKE/REIMBURSEMENT SPECIALIST CONTACTS MD

TO VERIFY RECEIPT & ACCURACY OF THE PATIENT'S Rx

& THIS CONTACT IS RECORDED IN CHiPS

I 222

THE INTAKE/REIMBURSEMENT SPECIALIST SENDS CONSENT

FORM AND A COVER LETTER TO THE PATIENT

I 224THE INTAKE/REIMBURSEMENT SPECIALIST FAXES A

STATEMENT OF MEDICAL NECESSITY TO THE

MD TO COMPLETE

I 226

THE INTAKE/REIMBURSEMENT SPECIALIST CONTACTS

THE PATIENTS INSURANCE PROVIDER TO VERIFY

COVERAGE & BENEFITS

228IS

OVERAGE FOR XYRE

PROVED?

YES 238

INTAKE/REIMBURSEMENT SUBMITS A COVERAGE

APPROVAL FORM (STAPLED TO THE COPY OF THE Rx

ENROLLMENT FORM) TO THE PHARMACY TEAM AS

NOTIFICATION TO PROCESS THE PATIENTS Rx

214

AN INTAKE REPRESENTATIVE WILL NKE 1 ATTEMPT TO

REACH THE MD TO OBTAIN THE MISSING INFORMATION

216

THE MISSING INFORMATION HAS NOT BEEN OBTAINED

WITHIN 24 HOURS, THE Ih/ENROLLMENT FORM IS FAXED

BACK TO THE MD WITH A REJECTION EXPlNATION LETTER

218

A NOTE IS ENTERED IN CHiPS THAT THE

APPLICATION WAS REJECTED

232

( SEE NORD PROCESS FOR PATIENTS iHO ARE UNINSURED OR UNDERINSUREDJ

NQ 230IS THE

PATIENT WILLING/ABL

TO PAY?

YES 234

THE PATIENT IS INFORMED OF THE COST OF THE

PRODUCT AND IS GIVEN PAYMENT OPTIONS

236

ONCE PAYMENT IS RECEIVED, INTAKE/REIMBURSEMENT

SUBMITS A COVERAGE APPROVAL FORM (STAPLED TO

THE COPY OF THE Rx/ENROLLMENT FORM) TO THE

PHARMACY TEAM AS NOTIFICATION TO PROCESS

THE PATIENT'S Rx

FIG. 2A ( A )




208

PHARNCY WORK FLOW

268

THE PATIENT IS SHIPPED

A XYREM SUCCESS

PACKET VIA 2-OAY USPS

YES 272

THE PHARMACIST HOLDS THE

PATIENT'S Rx UNTIL RECEMNG

A COVERAGE APPROVAL FORM

FROM INTAKE/REIMBURSEMENT

276ARE THE

MD. S CREDENTIALS

APPROVED?

YES 280

THE PHYSICIAN IS INDICATED

AS APPROVED IN THE

PHYSICIAN SCREEN IN CHiPS

282

THE PHARMACIST HOLDS THE

PATIENT'S Rx UNTIL RECEMNG

A COVERAGE APPROVAL FORM

FROM INTAKE/REIMBURSEMENT

270 274HAVE THE MD.

CREDENTIALS BEEN VERIFIEDTHE MD.'S CREDENTIALS AND

& APPROVED IN THE KTENTERS ALL FINDINGS IN CHj

5 MONTHS?

IF ANY DISCIPLINARY ACTIONS ARE

IDENTIFIEO, THE DIR. OF PHARM. IS

NOTIFIED AND TAKES ONE OF THE

FOLLOWING ACTIONS:

—Rx IS PROCESSED ANO THE

PHARMACIST MONITORS THE MD. S

PROGRAM ACTMTY

— Rx IS NOT PRXESSED AND

ITHE MD IS NOTED AS UNAPPROVED

I

284

THE PHYSICIAN IS INDICATEO

AS UNAPPROVED IN CHiPS

286

THE MD IS CONTACTED BY A

PHARMACIST & INFORMED THAT

THE PATIENTS Rx CANNOT

BE PROCESSED

288

THE Rx AND ENROLLMENT FORN

IS NILED BACK TO THE MD

ALONG WITH A COVER LETTER

REITEMNG THAT THE Rx

CANNOT BE PROCESSED

290

A LETTER IS SENT TO THE

PATIENT INDICATING THAT THE

Rx CANNOT BE PROCESSED &THE PATIENT IS INSTRUCTED TO

CONTACT HIS/HER PHYSICIAN




( A )t 240

UPON RECEIPT OF THE COVERAGE APPROVAL FORM FROM

INTAKE/REIMBURSEMENT THE PHARMACY TECHNICIAN

CONTACTS THE PATIENT TO COMPLETE THE TECHNICIAN

SPECIFIED SECTIONS OF THE PATIENT

COUNSELING CHECKLIST

242ERE TH NO

PROGRAM MATERIALS

READ?

YES 246

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

THE PHARMACIST INDICATES IN CHiPS THAT THE PATIENT

COUNSELING CHECKLIST WAS SUCCESSFULLY COMPLETED

INCLUDING THE DATE COMPLETED

260

THE PHARMACIST SCHEDULE THE PATIENTS SHIPMENT FOR

THE NEXT BUSINESS DAY OR THE NEXT BUSINESS DAY-THE PATIENT IS AVAILABLE TO SIGN FOR THE PACKAGE

t 254THE PHARMACIST ENTERS THE Rx ORDER

IN CHiPS, CREATING AN ORDER NUMBER

t 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 8( THE

()RDER IS FORWARDED TO THE PHARMACY FOR FULFILLMEN

260

THE SHIPMENT IS CONFIRMED IN CHiPS

t 262

THE ORIGINAL Rx IS FILED WITH THE PHARMACY

Rx S IN NUMERICAL ORDER

t 264

THE ORDER IS SHIPPED BY USPS EXPRESS MAIL

244

THE RECEIPT OF THE MATERIALS IS CONFIRMED AND

ANOTHER CALL IS SCHEDULED TO COUNSEL THE

PATIENT BEFORE THE XYREM IS SHIPPED

252

THE SHIPMENT MUST BE SENT TO THE PATIENTS HOME

ADDRESS UNLESS THE PATIENT IS TRAVELING OR HAS

MOVED, IN WHICH CASE THE PHARMACIST WILL DETERMINE

IF AN EXCEPTION WILL BE MADE. THE PATIENT OR THE

PATIENTS DESIGNEE MUST SIGN FOR THE PACKAGE

UPON DELIVERY

266

ALL XYREM INVENTORY IS CYCLE COUNTED AND

RECONCILED WITH THE CHiPS SYSTEM QUANTITIES

BEFORE THE DAYS SHIPMENTS ARE SENT OUT

FIG. 2C



U.S.Patent Jul. 27, 2010

310

PHYSICIAN SUCCESS

PROGRAM NTERIALS

REQUEST

320

MD CALLS XYREM SUCCESS

PROGRAM AT I-866-XYREM88

TO REQUEST PROGRAM

MATERIALS

330

MD DEMOGRAPHICS, DFAII

AND DATE OF REQUEST ARE

ENTERED INTO CHiPS

340

SDS REQUESTS NTERIALS TO

BE SHIPPED TO THE MD VIA

THE OMI FULFILLMENT WEBSITE

AT WWW.PRAFULFILLMENT.COM

US 7,765,106 B2

II

END +3ro



U.S.Patent Jul. 27, 2010 Sheet 6 of 16 IJS 7,765,106 B2

402

2 POSSIBLE REFILL

iEQUEST PROCESSES

2t 404

EACH WEEK A REFILL REPORT IS GENERATED OF

PATIENTS WITH ID DAYS OF PRODUCT RENINING

I 408

A COPY OF THE REFILL REPORT IS PROVIDED

TO INTAKE/REIMBURSEMENT

I 410

NO SOONER THAN 8 DAYS BEFORE MEDICATION

DEPLETION, A PHARMACY TECHNICIAN CONTACTS THE

PATIENT TO COMPLETE THE PRE-DELIVERY CHECKLIST

412

THE PATIENT

REACHED?

YES 418

THE PHARMACY TECHNICIAN SCHEDULES THE PATIENTS

SHIPMENT FOR THE NEXT BUSINESS DAY OR THE NEXT

BUSINESS DAY THE PATIENT IS AVAILABLE TO

SIGN FOR THE PACKAGE

t 420

THE PHARMACIST ENTERS THE Rx ORDER

IN CHiPS, CREATING AN ORDER NUMBER

t 422

THE PHARMACIST VERIFIES THE Rx AND ATTACHES THE

VERIFICATION N3EL TO THE HARD COPY Rx

t 424

THE SHIPMENT IS CONFIRMED IN CHiPS

t 428A PICK TICKET IS GENERATED FOR THE ORDER & THE

ORDER IS FORWARDED TO THE PHARMACY FOR FULFILLMEN

END )-4X

414

A MESSAGE IS LEFT ONLY MENTIONING

SDS & A RETURN NUMBER

U416

A NOTE IS ENTERED IN THE CHiPS INDICATING THE

DATE THE MESSAGE WAS LEFT FOR THE PATIENT

426

ALL XYREM INVENTORY IS CYCLE COUNTED AND

RECONCILED WITH THE CHiPS SYSTEM QUANTITIES

BEFORE THE DAYS SHIPMENTS ARE SENT OUT

FIG. 4A




406

THE PATIENT CALLS TO REQUEST AN EARLY REFILL

434A XYREM PROBLEM IDENTIFICATION & NNAGEMENT RISK

DIVERSION REPORT IS COMPLETED & DOCUMENTED IN

CHiPS. THE REPORT IS THEN FAXED TO OMI & THE

ORIGINAL IS FILED IN A MONTHLY BATCH FILE

432

A NOTE CODE IS ENTERED IN CHiPS ON THE PATIENT

SCREEN INDICATING THE EARLY REFILL REQUEST

436

THE PHARMACIST EVALUATES THE PATIENTS

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

442

THE PATIENT MUST WAIT UNTIL THE NEXT SCHEDULED

REFILL DATE TO RECEIVE ADDITIONAL PRODUCT

( ENO P 44440DOES

NPTHE PHYSICIAN

APPROVE?

YES 446

THE PHARMACIST ENTERS A NOTE IN CHiPS

IN THE PATIENT SCREEN THAT THE PHYSICIAN

APPROVES THE REQUEST

448

THE PHARMACIST NOTIFIES AN INTAKE/REIMBURSEMENT

SPECIALIST TO CONTACT THE PATIENTS INSURANCE

PROVIDER TO VERIFY COVERAGE FOR THE EARLY REFILL

460

THE PATIENT MUST WAIT UNTIL THE NEXT SCHEDULED

REFILL DATE TO RECEIVE ADDITIONAL PRODUCT

NO

IS THE

PATIENT WILL TO

PAY?

YES 462

THE PATIENT IS INFORMED OF THE COST OF THE

PRODUCT AND IS GIVEN PAYMENT OPTIONS

464

ONCE PAYMENT IS RECEIVED THE ORDER IS RELEASED

466

INTAKE/REIMBURSEMENT SUBMITS A COVERAGE APPROVAL

FORM TO THE PHARMACY TEAM AS NOTIFICATION THAT

THE PATIENTS REFILL REQUEST CAN BE PROCESSED

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

( CONTINUE ) 42O

FIG. 4B

450WILL THE NO

INSURANCE PROVIDER

PAY?

YES 452

INTAKE/REIMBURSEMENT SUBMITS A COVERAGE APPROVAL

FORM TO THE PHARMACY TEAM AS NOTIFICATION THAT

THE PATIENT'S REFILL REQUEST CAN BE PROCESSED

454

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




510

UPON DETERMINING THAT A PATIENT IS UNINSURED OR

UNDERINSURED, A REIMBURSEMENT SPECIALIST EXPUUNS

THE NORD PROGRAM TO THE PATIENT AND FAXES AN

APPLICATION REQUEST FORM TO NORD FOR THE PATIENT

t 515

THE INTAKE/REIMBURSEMENT SPECIALIST DOCUMENTS

IN CHiPS THAT AN APPLICATION HAS BEEN REQUESTED

THROUGH NORD

t 520

NORD MAILS A PAP APPLICATION TO THE

PATIENT WITHIN 1 BUSINESS DAY

525

THE PATIENT

APPROVED?

YES 545

NORD SENDS AN ACCEPTANCE LETTER TO THE

PATIENT AND FAXES A VOUCHER TO SDS INDICATING THE

PATIENTS APPROVAL FOR THE PROGRAM

t 550

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

t

(A +555

530

= NORD SENDS A DENIAL LETTER TO THE PATIENT

540

SDS DOCUMENTS IN CHiPS THAT

THE PATIENT WAS DENIED BY NORD




236

CH WEEK, THE DIRECTOR OF PHARMACY TRANSFERS

INVENTORY FOR THE WEEK'S SHIPMENTS TO A

SEGREGATED WAREHOUSE LOCATION

FOR PRODUCTION INVENTORY

1I236

A PURCHASE ORDER IS GENERATED FOR THE

INVENTORY TRANSFERRED TO THE PRODUCTION

LOCATION 8t IS FAXED TO THE OMI CONTROLLER

236

THE OMI CONTROLLER INVOICES SDS FOR

THE PRODUCT MOVED TO PRODUCTION

END

)-&50

FIG. 6

PRESCRIBER FIELDS

PATIENT FIELDS

PRESCRIPTION FIELDS

INSURANCE FIELDS

FIG. 7

-710

-720

-730

I-740

QUERY I — PRESCRIPTIONS BY PHYSICIAN -810

QUERY 2 — PRESCRIPTIONS BY PATIENT NAME -820

QUERY 5 — PRESCRIPTIONS BY FREQUENCY -830

QUERY N— PRESCRIPTIONS BY DOSE

FIG. 8




PRESCRIBER'S NAME:

STREET ADDRESS:

CITY:

PHONE:

LICENSE NUMBER:

MD SPECIALTY:

STATE:

FAX:

DEA NUMBER:

2IP:

900

PRESCRIPTION ANO ENROLLMENT FORM

PRESCRIBER INFORMATION

OFFICE CONTACT:

DOB

PRESCRIPTION FORM

PATIENT NAME: Ssg: SEX M/FADDRESS:

CI1Y: STATE: Ij.'IP:

Rx: XYREM ORAL SOLUTION (500 mg/mL) 180 Ml. BOTTLE QUANTITY: MONTHS SUPPLY

SIG: TAKE GMS P.O. DILUTED IN 60 mL WATER AT H.S. AND THEN AGAIN 2 1/2 TO 4 HOURS lATER

REFILLS (CIRCLE ONE): 0 I 2 (MAXIMUM OF 3 MONTH SUPPLY)

DATE: / /PRESCRIBER'S SIGNATURE

PIIYSICIAN DECLARATIDN PLEASE CHECK EACH BOKI

TO BE COMPLETED AT INITIAL PRESCRIPTIDN ONLY~ I HAVE READ THE MATERIALS IN THE XYREM PHYSICIAN SUCCESS PROGRAM

I VERIFY THAT THE PATIENT HAS BEEN EDUCATED WITH RESPECT TO XYREM PREPARATION, DOSING AND SCHEDULING.

~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.~ I UNDERSTAND THAT THE SAFETY OF DOSES GREATER THAN 9gm/DAY HAS NOT BEEN ESTABLISHED

PATIENT INFORMATION

BEST TIME TO CONTACT PATIENT: DAY NIGHT

DAY $: EVENING g:

INSURANCE COMPANY NAME: PHONE II:

INSURED S NAME: RElATIONSHIP TO PATIENT:

IDENTIFICATION NUMBER: POLICY/GROUP NUMBER:

PRESCRIPTION CARD: NO YES IF YES, CARRIER: POLICY g:

PLEASE ATTACH COPIES OF PATIENTS INSURANCE CARDS

GROUP:

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)




SENSITIVE DRUG PATIENT ASSISTANCE PROGRAM KÃVOUCHER REQUEST FOR MEDICATION

PATIENT INFORMATION

&FIRST NAME&&tAST NAME&

&ADDRESS 1&

&ADDRESS 2&

&CITY, STATE ZIP CODE&

PHONE: &123-456-7890

DOB: 01/01/1900

SSN: 123-45-6789

DRUG ALLOTMENT: 100%

LRD: 03/01/2001

DRUG

XYREEM 180ml btl

ME CODE- ffttffff

QUANTITY

1

PHYSICIAN INFORMATION

&PHYSICIAN NAME&

&ADDRESS 1&

&ADDRESS 2&


PHONE: &123-456-7890

FIRST SHIPMENT THIS YEAR

VALIDATION DATE:

EXPIRATION DATE:

ISSUE DATE:

APPROVED

PATIENT INFORMATION

&FIRST NAME&&lAST NAME&

&ADDRESS I&

&ADDRESS 2&


PHONE: &123-456-7890

DOB: 01/01/1900

SSN: 123-45-6789

DRUG ALLOTMENT: 100%

LRD: 03/01/2001

DRUG

XYREM 180ml btl

03/01/2001

05/31/2001

03/15/2001

NORD COPY

(DETACH HERE)

ME COPE- eeeeetee

QUANTITY

1

'PHARMACY USE'


&PHYSICIAN NAME&

&ADDRESS I&

&ADDRESS 2&


PHONE: &123-456-7890

FIRST SHIPMENT THIS YEAR

VALIDATION DATE:

EXPIRATION DATE:

ISSUE DATE:

APPROVED

03/01/2001

05/31/2001

03/15/2001

' PHARMACY USE '




SENSITIVE DRUG PHYSICIAN'S CERTIFICATE

OF MEDICAL NEED

PATIENT INFORMATION

DATE:

NAME:

LAST

DATE OF BIRTH:

FIRST

DRUG BEING PRESCRIBED: XYREM

DIAGNOSIS/CONDITION FOR WHICH DRUG IS BEING PRESCRIBED:

ICD-9:


PHYSICIAN S NAME (PLEASE PRINT):

PHYSICIAN S SIGNATURE: DATE:

PLEASE FAX BACK TO SENSITIVE DRUG SUCCESS PROGRAM: (1-800-TOLL FREE NUMBER)

FIG. 12




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US 7,765,106 B21

SENSITIVE DRUG DISTRIBUTION SYSTEMAND METHOD

RELATED APPLICATIONS

This application is a divisional application of U.S. patent

applicationSer. No.

10/322,348,filed

Dec. 17, 2002,now

U.S. Pat. No. 7,668,730 which application is incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to distribution of drugs, andin particular to the distribution of sensitive drugs.

BACKGROUND OF THE INVENTION

Sensitive drugs are controlled to minimize ensure that theyare not abuse and adverse reactions. Such sensitive drugs areapproved for specific uses by the Food and Drug Administra-

tion, and must be prescribed by a licensed physician in orderto be purchased by consumers. Some drugs, such as cocaineand other common street drugs are the object of abuse andillegal schemes to distribute for profit. Some schemes includeDr. 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 purposessuch as treatment of daytime cataplexy in patients with nar-

colepsy. Some patients however, wil l obtain prescriptionsfrom multiple doctors, and have them filled at different phar-macies. Still further, an unscrupulous physician may actuallywrite multiple prescriptions for a patient, or multiple patients,who use cash to pay for the drugs. These patients will then sellthe drug to dealers or others for profit.

There is a need for a distribution system and method thatdirectly addresses these abuses. There is a further need forsuch a system and method that provides education and limitsthe 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 regardingall 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 DEAlicense, and optionally state medical boards to determine

whether any corrective or approved disciplinary actions relat-ing to controlled substances have been brought against thephysician. Multiple controls beyond those for traditionaldrugs are imposed on the distribution depending on the sen-

sitivity of the drug.

Education is provided to both physician and patient. Priorto shipping the drug for the first time, the patient is contactedto ensure that product and abuse related educational materialshave been received and/or read. The patient may provide thename ofa designee to the central pharmacy who is authorizedto accept shipment of the drug. Receipt of the initial drugshipment is confirmed by contacting the patient. Either aphone call or other communication to the patient within a settime after delivery may be made to ensure receipt. Further, a

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courier service's tracking system is used to confirm deliveryin further embodiments. Ifa shipment is lost, an investigationis launched to find it.

In one embodiment, the drug may be shipped by the centralpharmacy to another pharmacy for patient pick-up. The sec-ond pharmacy's ability to protect against diversion beforeshipping the drug must be confirmed. This ability may bechecked through NTIS and State Boards of Pharmacy.

Prescription refills are permitted in the number specified inthe original prescription. In addition, if a prescription refill isrequested by the patient prior to the anticipated due date, suchrefills will be questioned. A lost, stolen, destroyed or spilledprescription/supply is documented and replaced to the extentnecessary to honor the prescription, and will also cause areview or full investigation.

The exclusive central database contains all relevant datarelated 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 toprovide information which might reveal potential abuse ofthesensitive 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 acomputer system such as that shown in FIG. 1.

FIG. 3 is a flowchart ofa physician success program at leastpartially implemented on a computer system such as thatshown in FIG. 1.

FIGS. 4A and 4B are a flowchart describing a method forhandling refill requests at least partially utilizing a computersystem 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 atleast partially utilizing a computer system as that shown inFIG. 1.

FIG. 6 is a flowchart of a process for inventory control atleast partially utilizing a computer system such as that shownin FIG. 1.

FIG. 7 is a block diagram of database fields.FIG. 8 is a block diagram showing a list of queries against

the database fields.FIG. 9 is a copy of one example prescription and enroll-

ment form.FIG. 10 is a copy of one example of a NORD application

request form for patient financial assistance.FIG. 11 is a copy of one example voucher request for

medication for use with the NORD application request formofFIG. 10.

FIG. 12 is a copy of certificate ofmedical need.FIGS. 13A, 13B and 13C are descriptions of sample

reports obtained by querying a central database having fieldsrepresented in FIG. 7.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, reference is made to theaccompanying drawings that form a part hereof, and in whichis shown by way of illustration specific embodiments inwhich the invention may be practiced. These embodimentsare described in sufficient detail to enable those skilled in theart to practice the invention, and it is to be understood thatother embodiments may be utilized and that structural, logical



US 7,765,106 B2

and electrical changes may be made without departing fromthe scope of the present invention. The following descriptionis, therefore, not to be taken in a limited sense, and the scopeof 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 humanimplemented procedures in one embodiment. The softwarecomprises computer executable instructions stored on com-puter readable media such as memory or other type of storagedevices. The term computer readable media is also used torepresent carrier waves on which the software is transmitted.Further, such functions correspond to modules, which aresoftware, hardware, firmware of any combination thereof.Multiple functions are performed in one or more modules asdesired, and the embodiments described are merelyexamples. The software is executed on a digital signal pro-cessor, ASIC, microprocessor, or other type of processoroperating on a computer system, such as a personal computer,server or other computer system.

A sensitive drug is one which can be abused, or has addic-tion properties or other properties that render the drug sensi-

tive. One example of such a drug is sodium oxybate, also

known as gamma hydroxy butyrate (GHB C4H7Na03) whichis useful for treatment of cataplexy in patients with narco-

lepsy. GHB is marketed under the trademark of Xyrem(sodium oxybate oral solution), which trademark can be usedinterchangeably with GHB herein. Sensitive drugs alsoinclude narcotics or other drugs which require controls ontheir distribution and use to monitor behaviors to preventabuse and adverse side effects.

In one embodiment, Xyrem is subject to a restricteddistribution program. One aspect of the program is to educatephysicians and patients about the risks and benefits ofXyrem,including support via ongoing contact with patients and a tollfree helpline. Initial prescriptions are filled only after a pre-scriber and patient have received and read the educationalmaterials. Further, patient and prescribing physician regis-

tries are maintained and monitored to ensure proper distribu-tion.In a further embodiment, bulk sodium oxybate is manufac-

tured at a single site, as is the finished drug product. Followingmanufacture of the drug product, it is stored at a facilitycompliant with FDA Schedule III regulations, where a con-signment inventory is maintained. The inventory is owned bya company, and is managed by a central pharmacy, whichmaintains the consignment inventory. Xyrem is distributedand dispensed through a primary and exclusive central phar-

macy, and is not stocked in retail pharmacy outlets. It isdistributed by overnight carriers, or by US mail in oneembodiment to potentially invoke mail fraud laws if attemptsof abuse occur.

FIG. 1 is a simplified block diagram of a computer system100, such as a personal computer for implementing at least aportion of the methods described herein. A central processingunit (CPU) 110 executes computer programs stored on amemory 120.Memory 120 in one embodiment comprises oneor 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 embodi-ment. Both CPU 110 and memory 120 are coupled to a bus130.A storage 140, I/O 150and communications 160are alsocoupled to the bus 130. Storage 140 is usually a long termstorage device, such as a disk drive, tape drive, DVD, CD orother type of storage device. In one embodiment, storage 140is used to house a database for use with the present invention.I/O 150 comprises keyboards, sound devices, displays andother mechanisms by which a user interacts with the com-

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puter system 100.Communications 160 comprises a network,phone connection, local area network, wide area network orother mechanism for communicating with external devices.Such external devices comprise servers, other peer computersand other devices. In one embodiment, such external devicecomprises a database server that is used in place of the data-base on storage 140. Other computer system architecturescapable ofexecuting software and interacting with a databaseand users may also be used. Appropriate security measuressuch as encryption are used to ensure confidentiality. Further,data integrity and backup measures are also used to preventdata loss.

FIGS. 2A, 2B and 2C represent an initial prescription orderentry process for a sensitive drug, such as Xyrem. At 202, amedical doctor (MD) sends a Rx/enrollment form via mail,fax, email or other means to an intake/reimbursement special-ist at 204, who makes a copy of the RX/enrollment form thatis stamped copy . The original fax is forwarded to a phar-

macy team. The enrollment form contains prescriber infor-mation, prescription information, checkboxes for the pre-scriber indicating they have read materials, educated thepatient, understand the use in treatment, and understand cer-

tain safety information, and also contains patient information.The prescriber information contains standard contact

information as well as license number, DEA number andphysician specialty. Patient and prescription informationincludes name, social security number, date of birth, gender,contact information, drug identification, patient's appropriatedosage, and number of refills allowed, along with a line forthe prescriber's signature. Patient insurance information isalso 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 workflow 206 starts with an intake reimbursement specialist enter-

ing 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) forXyrem. A check is made to ensure the information is com-plete at 212. Ifnot, at 214, an intake representative attempts toreach the MD or prescriber to obtain the missing information.If the missing information has not been obtained within apredetermined period of time, such as 24 hours at 216, theRx/Enrollment form is sent back to the MD with a rejectionexplanation. A note is entered in CHIPS that the applicationwas rej ected.

If the information is complete at 212, the MD is contactedat 220 to verify receipt and accuracy of the patient's Rx. Thiscontact is recorded in CHIPS. The intake and reimbursementspecialist then sends a consent form and a cover letter to thepatient at 224. The insurance provider is contacted at 226 to

verify coverage and benefits. At 22S, a determination is maderegarding coverage for the drug. If it is not available, it isdetermined at 230 whether the patient is willing and able topay. Ifnot, a process is performed for handling patients whoare uninsured or underinsured. In one embodiment, the pro-cess is referred to as a NORD process.

Ifthe patient is willing and able to pay at 230, the patient isinformed of the cost of the product and is given paymentoptions at 234. At 236, once payment is received, the intakereimbursement specialist submits a coverage approval formwith the enrollment form to the pharmacy team as notificationto process the patient's prescription. If coverage is approvedat 22S, the intake reimbursement specialist also submits thecoveral approval form with the enrollment form to the phar-

macy team as notification to process the patient's prescrip-tion. Processing of the prescription is described below.



US 7,765,106 B2

Upon receipt and initial processing of the prescriptionenrollment form and sending an original to the pharmacywork flow block 20S, the patient is shipped a Xyrem successpacket via mail. In one embodiment, the Xyrem successpacket contains educational material for a patient that advisesof the proper use, care and handling of the drug and conse-quences of diversion at 26S.The medical doctor's credentialsare checked to determine if the physician has a current DEAlicense to prescribe controlled substances and ifhe or she hashad any actions related to misuse/misprescribing of con-trolled drugs against him or her, within a predetermined time,such as three months at 270. If they have, a pharmacist holdsthe prescription until receiving a coverage approval formfrom the intake reimbursement specialist at 272.

If the credentials have not been recently checked, the phar-macist verifies the credentials and enters all findings in thedatabase at 274. If the credentials are approved at 276, thephysician is indicated as approved in a physician screen popu-lated by information from the database at 2SO. The prescrip-tion is then held pending coverage approval at 2S2.

If any disciplinary actions are identified, as referenced atblock 27S, management of the pharmacy is notified and either

approves processing of the prescription with continued moni-toring of the physician, or processing ofthe prescription is notperformed, and the physician is noted in the database asunapproved at 2S4. The enrollment form is then mailed backto the physician with a cover letter reiterating that the pre-scription cannot be processed at 2SS.The patient is also senta letter at 290 indicating that the prescription cannot be pro-cessed and the patient is instructed to contact their physician.

Actual filling of the approved prescription begins withreceipt of the coverage approval form as indicated at 240.Thepatient is contacted by the pharmacy, such as by a technicianto complete a technician section of a patient counselingchecklist. If a pharmacist verifies that the program materialswere not read at 242, the receipt of the material is confirmedat 244 and another call is scheduled to counsel the patient

before the drug is shipped.If the program materials, were read at 242, the checklist is

completed at 246 and the technician transfers the patient tothe pharmacist who reviews the entire checklist and com-pletes remaining pharmacist specified sections. At 24S, thepharmacists indicates in the database that the patient coun-seling and checklist was successfully completed, indicatingthe date completed.

At 250, the pharmacist schedules the patient's shipment forthe next business day or the next business day that the patientor designee is able to sign for the package. Further, as indi-

cated at 252, the shipment must be sent to the patient' homeaddress unless the patient is traveling or has moved. In thatevent, the pharmacist may determine that an exception maybe made. The patient or the patient's designee who is at least

18 years old, must sign for the package upon delivery.At 254, the pharmacist enters the prescription order in the

database, creating an order number. The pharmacist thenverifies at 256 the prescription and attaches a verificationlabel to the hard copy prescription. At 25S, a pick ticket isgenerated for the order and the order is forwarded to the

pharmacy for fulfillment. The shipment is confirmed in thedatabase at 260, and the order is shipped by USPS ExpressMail. Use of the US mail invokes certain criminal penaltiesfor unauthorized diversion. Optionally, other mail servicesmay be used. Potential changes in the law may also bringcriminal penalt ies into play. Following shipment, the patientis called by the central pharmacy to confirm that the prescrip-tion was received.

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As noted at 266, for the sensitive drug, Xyrem, all inven-

tory is cycle counted an reconciled with the database systemquantities before shipments for the day are sent. This providesa very precise control of the inventor.

A physician success program materials request processbegins at 310 in FIG. 3.At 320, the MD calls to the centralpharmacy to request program materials. A special phonenumber is provided. MD demographics, DEA number, anddata or request are entered into the database at 330.At 340, arequest is made to ship the materials to the MD via a fulfill-

ment website, or other mechanism. The request process endsat 350.

A refill request process begins at 302 in FIGS. 4A and 4B.There are two different paths for refills. A first path beginningat 404 involves generating a report from the central databaseof patients with a predetermined number of days or productremaining. A second path beginning at 406 is followed whena patient calls to request an early refill.

In the first path, a copy ofthe report is provided to an intakereimbursement specialist at 40S. No sooner than 8 daysbefore the medication depletion, a pharmacy technician con-tacts the patient at 410 to complete the pre-delivery checklist.

At 412, if the patient is not reached, a message is left men-tioning the depletion, and a return number at 414.A note isalso entered into the database indicating the date the messagewas left at 416.

Ifthe patient is reached at 412, the next shipment is sched-uled at 41S, the prescription is entered into the databasecreating an order at 420, the pharmacist verifies the prescrip-tion and attaches a verification label at 422 and the shipmentis confirmed in the database at 424. Note at 426 that theinventory is cycle counted and reconciled with the databasequantities before the shipments for a day or other time periodare sent. A pick ticket is generated for the order and the orderis forwarded for fulfillment at 42S, with the first path endingat 430.

The second path, beginning at 406 results in a note code

being entered into the database on a patient screen indicatingan early refill request at 432. The pharmacist evaluates thepatient's compliance with therapy or possible product diver-

sion, misuse or over-use at 436. In one embodiment, cashpayers are also identified. The pharmacist then contacts theprescribing physician to alert them of the situation and con-firm if the physician approves of the early refill at 43S. If thephysician does not approve as indicated at 440, the patientmust wait until the next scheduled refill date to receive addi-tional product as indicated at 442, and the process ends at 444.

If the physician approves at 440, the pharmacist enters anote in the database on a patient screen that the physicianapproves the request at 446. The pharmacist notifies an intakereimbursement specialist to contact the patient's insuranceprovider to verify coverage for the early refil l at 44S. If theinsurance provider will pay as determined at 450, the special-ist submits the coverage approval form as notification that therefill may be processed at 452. At 454, the pharmacy techni-cian contacts the patient to schedule shipment of the productfor the next business day, and the process of filling the orderis continued at 456 by following the process beginning at 240.

If the insurance provider will not pay at 450, it is deter-

mined whether the patient is willing and/or able to pay at 45S.Ifnot, the patient must wait until the next scheduled refill dateto receive additional product at 460. If it was determined at45S that the patient was willing and able to pay, the patient isinformed of the cost of the product and is given paymentoptions at 462. Once payment is received as indicated at 464,the specialist submits a coverage approval form to the phar-

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 thepatient to schedule shipment. The process of filling the orderis continued at 470 by following the process beginning at 240.

A process, referred to as a NORD process in one embodi-ment is used to determine whether donated, third party funds

are available for paying for prescriptions where neither insur-

ance will, nor the patient can pay. The process begins at 510upon determining that a patient is uninsured or underinsured.A reimbursement specialist explains the NORD program tothe patient and faxes an application request form to NORD forthe patient. At 515, the intake reimbursement specialist docu-ments in the database that an application has been receivedthrough NORD. At 520, NORD mails an application to the

patient within one business day.

A determination is made at 525 by NORD whether thepatient is approved. Ifnot, at 530,NORD sends a denial letterto the patient, and it is documented in the database at 540 thatthe patient was denied by NORD. If the patient is approved,NORD sends an acceptance letter to the patient and faxes avoucher to the central pharmacy (SDS in one embodiment) toindicate the approval at 545.At 550, an intake reimbursementspecialist submits a coverage approval form to the pharmacyteam as notification that the patient has been approved forcoverage. The process of filling the order is continued at 555by following the process beginning at 240.

An inventory control process is illustrated in FIG. 6 begin-

ning at 610. Each week, a responsible person at the centralpharmacy, such as the director of the pharmacy transfersinventory for the week' shipments to a segregated warehouselocation for production inventory. At 620, a purchase order isgenerated for the inventory transferred to the production loca-tion and is sent, such as by fax, to a controller, such as thecontroller of the company that obtained approval for distri-bution and use of the sensitive drug. At 630, the controllerinvoices the central pharmacy for the product moved to pro-duction. The process ends at 640.

The central database described above is a relational data-base running on the system ofFIG. 1,or a server based systemhaving a similar architecture coupled to workstations via anetwork, as represented by communications 160. The data-base is likely stored in storage 140, and contains multiplefields of information as indicated at 700 in FIG. 7.The orga-nization and groupings of the fields are shown in one formatfor convenience. It is recognized that many different organi-zations or schemas may be utilized. In one embodiment, the

groups of fields comprise prescriber fields 710, patient fields720, prescription fields 730 and insurance fields 740. Forpurposes of illustration, all the entries described with respectto the above processes are included in the fields. In furtherembodiments, no such groupings are made, and the data isorganized in a different manner.

Several queries are illustrated at S00 in FIG. S.There may

be many other queries as required by individual state report-ing requirements. A first query at S10 is used to identifyprescriptions written by physician. The queries may be writ-

ten in structured query language, natural query languages orin any other manner compatible with the database. A secondquery S20 is used to pull information from the databaserelated to prescriptions by patient name. A third query S30 isused to determine prescriptions by frequency, and a n'ueryfinds prescriptions by dose at S40. Using query languagescombined with the depth ofdata in the central database allows

many other methods of investigating for potential abuse of thedrugs. The central database ensures that all prescriptions,prescribers and patients are tracked and subject to such inves-

tigations. In further embodiments, the central database may

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be distributed among multiple computers provided a queryoperates over all data relating to such prescriptions, prescrib-ers and patients for the drug.

An example of one prescription and enrollment form isshown at 900 in FIG. 9.As previously indicated, several fieldsare included for prescriber information, prescription informa-tion and patient information.

FIG. 10 is a copy of one example NORD applicationrequest form 1000 used to request that an application be sent

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 formrequires both patient and physician information. Social secu-

rity number information is also requested. The form providesinformation for approving the financial assistance and fortracking assistance provided.

FIG. 12 is a copy of one example voucher request formedication for use with the NORD application request formofFIG. 10. In addition to patient and physician information,prescription information and diagnosis information is alsoprovided.

FIGS. 13A, 13B and 13C are descriptions of sample

reports obtained by querying a central database having fieldsrepresented in FIG. 7. The activities grouped by sales, regu-

latory, quality assurance, call center, pharmacy, inventory,reimbursement, patient care and drug information. Eachreport has an associated frequency or frequencies. The reportsare obtained by running queries against the database, with the

queries written in one ofmany query languages.While the invention has been described with respect to a

Schedule III drug, i t is useful for other sensitive drugs that areDEA or Federally scheduled drugs in Schedule II-V, as wellas still other sensitive drugs where multiple controls aredesired for distribution and use.

The invention claimed is:1.A therapeutic method for treating a patient with a pre-

scription drug that is effective for therapeutic purposes, but is

also a drug that has potential to be abused, misused, ordiverted, comprising:receiving, only into an exclusive central computer system,

all prescriptions for any and all patients being prescribedthe prescription drug and from any and all doctorsallowed to prescribe the prescription drug, the prescrip-tions containing information identifying the patient, theprescription drug, and various credentials of the medicaldoctor who is prescribing the prescription drug;

requiring entering of the information into an exclusivecomputer database associated with the exclusive centralcomputer system for analysis of potential abuse, misuse,or diversion of the prescription drug, such that all pre-scriptions for the prescription drug are processed forauthorization only using the exclusive central computersystem and the exclusive computer database;

controlling the distribution of said prescription drug usingthe exclusive central computer system that tracks allprescriptions of said prescription drug and analyzes forthe potential abuse, misuse, or diversion of the prescrip-tion drug by determining current and anticipated pat-terns of potential prescription abuse, misuse, or diver-

sion of said prescription drug from periodic reportsgenerated by the exclusive central computer system andthe exclusive computer database based on prescriptiondata from a medical doctor, wherein said prescriptiondata contain information identifying the patient, thedrug prescribed, and credentials of the doctor; andselecting multiple controls for distribution using saidexclusive central computer system, the controls selected



US 7,765,106 B210

from the group consisting of communicating prescrip-tions from a physician to the exclusive central computersystem; identifying the physician's name, license, andDEA (Drug Enforcement Agency) registration informa-tion; verifying the prescription; obtaining patient infor-

mation; verifying the physician is eligible to prescribethe prescription drug by consulting the National Tech-nical Information Services to determine whether thephysician has an active DEA number and to check onwhether any actions are pending against the physician;providing comprehensive printed materials to the phy-sician; contacting the patient's insurance company ifany; verifying patient registry information; providingcomprehensive education information to the patient;verifying the patient has received and/or reviewed theeducational 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 18year old designee to receive the drug; confirming receiptofan initial shipment ofthe drug to the patient; returningthe drug to a pharmacy after two attempts to deliver;launching an investigation when a shipment is lost; ship-

ping to another pharmacy for delivery; requiring manu-facture at a single location; authorizing release of inven-

tory in a controlled manner; questioning early refills;flagging repeat instances of lost, stolen, destroyed, orspilled prescriptions; limiting the prescription to a onemonth supply; requiring rewriting of the prescriptionperiodically; and making the database available to theDEA for checking for abuse, misuse, or diversion pat-terns in the data, for cash payments, and for inappropri-ate questions;

authorizing the filling, using the exclusive central com-puter system, of a prescription for the prescription drugthat has been subjected to said multiple controls and hasbeen approved for shipment to the patient;

noting, based on one or more ofthe analysis of the potential

abuse, misuse, or diversion of the prescription drug andthe periodic reports, that there is a potential for abuse,misuse, or diversion by the patient to whom the prescrip-tion drug is prescribed; and

delivering the prescription drug to the patient in order totreat the patient with the prescription drug.

2. The method of claim 1,wherein the controls for distri-bution are communicating prescriptions from a physician tothe exclusive central computer system; identifying the phy-sician' name, license, and DEA (Drug Enforcement Agency)registration information; verifying the prescription; obtainingpatient information; verifying patient registry information;providing comprehensive education information to thepatient; verifying the patient has received and/or reviewed theeducational materials; or requiring rewriting of the prescrip-

tion 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 prescribedsodium oxybate and from any and all medical doctorsallowed to prescribe sodium oxybate, the prescriptionscontaining information relating to the patient, sodiumoxybate, and various credentials of the medical doctorwho is prescribing the sodium oxybate;

requiring entering of the information into an exclusivecomputer database associated with the exclusive centralcomputer system for analysis ofpotential abuse, misuse,or diversion, such that all prescriptions for sodium oxy-

5

10

15

20

25

30

35

40

45

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65

bate are processed for authorization only using theexclusive central computer system and the exclusive

computer database;

controlling the distribution of sodium oxybate using theexclusive central computer system that tracks all pre-scriptions of sodium oxybate and analyzes for the poten-

tial abuse, misuse, or diversion by determining currentand anticipated patterns of potential prescription abuse,misuse, or diversion of sodium oxybate from periodicreports generated by the exclusive central computer sys-tem based on prescription data from a medical doctor,wherein said prescription data contain information iden-

tifying the patient, sodium oxybate as the drug pre-scribed, and credentials of the doctor; and selecting mul-

tiple controls for distribution using said exclusivecentral computer system, the controls selected from the

group consisting ofcommunicating 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 informa-

tion; verifying the physician is eligible to prescribesodium oxybate by consulting the National TechnicalInformation Services to determine whether the physi-cian has an active DEA number and to check on whether

any actions are pending against the physician; providingcomprehensive printed materials to the physician; con-tacting the patient' insurance company ifany; verifyingpatient registry information; providing comprehensiveeducation information to the patient; verifying thepatient has received and/or reviewed the educationalmaterials; verifying the home address of the patient;shipping via US postal service or a commercial shippingservice; receiving the name of an at least 18 year olddesignee to receive the drug; confirming receipt of aninitial shipment of the drug to the patient; returning the

drug to a pharmacy after two attempts to deliver; launch-ing an investigation when a shipment is lost; shipping toanother pharmacy for delivery; requiring manufacture ata single location; authorizing release of inventory in acontrolled manner; questioning early refills; flaggingrepeat instances of lost, stolen, destroyed, or spilledprescriptions; limiting the prescription to a one month

supply; requiring rewriting of the prescription periodi-cally; and making the database available to the DEA forchecking for abuse, misuse, or diversion patterns in thedata, for cash payments, and for inappropriate questions;

authorizing the filling, using the exclusive central com-puter system, of a prescription for sodium oxybate thathas been subjectedto saidmultiple controls and has beenapproved for shipment to the patient;

noting, based on one or more ofthe analysis ofthe potentialabuse, misuse, or diversion of the prescription drug andthe periodic reports, that there is a potential for abuse,misuse, or diversion by the patient to whom the prescrip-tion drug is prescribed; and

delivering the sodium oxybate to the patient in order totreat the patient with the sodium oxybate.

4. The method of claim 3, wherein the controls for distri-bution are communicating prescriptions from a physician tothe exclusive central computer system; identifying the phy-sician' name, license, and DEA (Drug Enforcement Agency)registration information; verifying the prescription; obtainingpatient information; verifying patient registry information;providing comprehensive education information to the



US 7,765,106 B212

patient; verifying the patient has received and/or reviewed theeducational materials; or requiring rewriting of the prescrip-tion periodically.

5. A therapeutic method for treating a patient with a pre-scription drug that is effective for therapeutic purposes, but isalso 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 doctorsallowed to prescribe the prescription drug and any andall patients being prescribed the prescription drug, all

prescriptions for the prescription drug, the prescriptionscontaining information identifying the patient, the pre-scription drug, and various credentials of the medicaldoctor who is prescribing the prescription drug;

requiring entering of the information into the exclusivecomputer database for analysis of potential abuse, mis-

use, or diversion of the prescription drug, such that all

prescriptions for the prescription drug are processed forauthorization only via the exclusive computer database;

controlling the distribution of said prescription drug with

the computer system that tracks all prescriptions of saidprescription drug and analyzes for the potential abuse,misuse, or diversion of the prescription drug by deter-

mining current and anticipated patterns ofpotential pre-scription abuse, misuse, or diversion of said prescriptiondrug from periodic reports generated by the computersystem based on prescription data from a medical doc-tor, wherein said prescription data contain informationidentifying the patient, the drug prescribed, and creden-tials of the doctor; and selecting multiple controls fordistribution of the prescription drug, the controlsselected from the group consisting of communicatingprescriptions from a physician to the exclusive computerdatabase; identifying the physician's name, license, andDEA (Drug Enforcement Agency) registration informa-

tion; verifying the prescription; obtaining patient infor-mation; verifying the physician is eligible to prescribethe prescription drug by consulting the National Tech-nical Information Services to determine whether thephysician has an active DEA number and to check onwhether any actions are pending against the physician;providing comprehensive printed materials to the phy-sician; contacting the patient's insurance company ifany; verifying patient registry information; providingcomprehensive education information to the patient;verifying the patient has received and/or reviewed theeducational materials; verifying the home address of the

patient; shipping via US postal service or a commercialshipping service; receiving the name of an at least 18year old designee to receive the drug; confirming receiptofan initial shipment ofthe drug to the patient; returning

the drug to a pharmacy after two attempts to deliver;launching an investigation when a shipment is lost; ship-

ping to another pharmacy for delivery; requiring manu-

facture at a single location; authorizing the release ofinventory in a controlled manner; questioning earlyrefills; flagging repeat instances of lost, stolen,destroyed, or spilled prescriptions; limiting the prescrip-tion to a one month supply; requiring rewriting of the

prescription periodically; and making the databaseavailable to the DEA for checking for abuse, misuse, ordiversion patterns in the data, for cash payments, and forinappropriate questions;

authorizing the filling, using the exclusive computer data-

base, of a prescription for the prescription drug that has

6

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30

36

40

46

60

66

60

66

been subjected to said multiple controls and has beenapproved for shipment to the patient;

noting, based on one or more ofthe analysis ofthe potentialabuse, misuse, or diversion of the prescription drug andthe periodic reports, that there is a potential for abuse,misuse, or diversion by the patient to whom the prescrip-tion drug is prescribed; and

delivering the prescription drug to the patient in order totreat the patient with the prescription drug.

6. The method of claim 5, wherein the controls for distri-bution are communicating prescriptions from a physician tothe exclusive computer database; identifying the physician'name, license, and DEA (Drug Enforcement Agency) regis-tration information; verifying the prescription; obtainingpatient information; verifying patient registry information;providing comprehensive education information to thepatient; verifying the patient has received and/or reviewed theeducational materials; or requiring rewriting of the prescrip-tion periodically.

7.A therapeutic method for treating a patient with a pre-scription drug that is effective for therapeutic purposes, but isalso 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 prescribedthe prescription drug and any and all medical doctorsallowed to prescribed the prescription drug, the prescrip-tions containing information identifying the patient, theprescription drug, and various credentials of the medicaldoctor who is writing the prescription;

requiring entering of the information into an exclusivecomputer database associated with the exclusive centralcomputer system for analysis of potential abuse, misuse,or diversion of the prescription drug, such that all pre-scriptions for the prescription drug are processed forauthorization only using the exclusive central computersystem and the exclusive computer database;

controlling the distribution of said prescription drug usingthe exclusive central computer system that tracks all

prescriptions of said prescription drug and analyzes forthe potential abuse, misuse, or diversion of the prescrip-tion drug by determining current and anticipated pat-terns of potential prescription abuse, misuse, or diver-

sion of said prescription drug from periodic reportsgenerated by the exclusive central computer system andthe exclusive computer database based on prescriptiondata from a medical doctor, wherein said prescriptiondata contain information identifying the patient, thedrug prescribed, and credentials of the doctor; andselecting multiple controls for distribution using theexclusive central computer system, the controls selectedfrom the group consisting of communicating prescrip-tions from a physician to the exclusive central computersystem; identifying the physician's name, license, andDEA (Drug Enforcement Agency) registration informa-tion; verifying the prescription; obtaining patient infor-

mation;verifying the physician is eligible to prescribe the prescrip-

tion drug by consulting the National Technical Informa-tion Services to determine whether the physician has anactive DEA number and to check on whether any actionsare pending against the physician; providing compre-hensive printed materials to the physician; contactingthe patient's insurance company ifany; verifying patientregistry information; providing comprehensive educa-tion information to the patient; verifying the patient hasreceived and/or reviewed the educational materials;



13US 7,765,106 B2

14verifying the home address of the patient; shipping viaUS postal service or a commercial shipping service;receiving the name of an at least 18year old designee toreceive the drug; confirming receipt of an initial ship-ment of the drug to the patient; returning the drug to a 5

pharmacy after two attempts to deliver; launching aninvestigation when a shipment is lost; shipping toanother pharmacy for delivery; requiring manufacture ata single location; authorizing release of inventory in acontrolled manner; questioning early refills; flagging to

repeat instances of lost, stolen, destroyed, or spilledprescriptions; limiting the prescription to a one month

supply; requiring rewriting of the prescription periodi-cally; and making the database available to the DEA forchecking for abuse, misuse, or diversion patterns in the t5

data, for cash payments, and for inappropriate questions;authorizing the filling, using the exclusive central com-

puter system, of a prescription for the prescription drugthat has been subjected to said multiple controls and hasbeen approved for shipment to the patient;

noting, based on one or more ofthe analysis ofthe 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 prescrip-tion drug is prescribed; and

delivering the prescription drug to the patient in order to

treat the patient with the prescription drug.S. The method of claim 7, wherein the controls for distri-

bution are communicating prescriptions from a physician tothe exclusive central computer system; identifying the phy-sician' name, license, and DEA (Drug Enforcement Agency)registration information; verifying the prescription; obtainingpatient information; verifying patient registry information;providing comprehensive education information to thepatient; verifying the patient has received and/or reviewed theeducational materials; or requiring rewriting of the prescrip-tion periodically.



UNITED STATES PATENT AND TRADEMARK OFFICE

CERTIFICATE OF CORRECTION

PATENT NO.: 7,765,106 B2APPLICATION NO.: 10/979665DATED : July27,2010INVENTOR(S): Dayton T. Reardan et al.

Page 1 of 3

It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:

In column 12, lines 20-67, column 13, lines 1-20, column 14, lines 1-7, in Claim 7, delete 7.Atherapeutic 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 forauthorization only using the exclusive central computer system and the exclusive computerdatabase;

controlling the distribution of said prescription drug using the exclusive central computer systemthat 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 ofpotential prescription abuse, misuse, or diversion of said prescription drug from periodic reportsgenerated by the exclusive central computer system and the exclusive computer database basedon 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 multiplecontrols for distribution using the exclusive central computer system, the controls selected fromthe group consisting of communicating prescriptions from a physician to the exclusive central

computer system; identifying the physician's name, license, and DEA (Drug EnforcementAgency) registration information; verifying the prescription; obtaining patient information;

verifying the physician is eligible to prescribe the prescription drug by consulting the NationalTechnical Information Services to determine whether the physician has an active DEA number

and to check on whether any actions are pending against the physician; providingcomprehensive printed materials to the physician; contacting the patient's insurance companyif any; verifying patient registry information; providing comprehensive education information tothe 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 ofNovember, 2010

David J. KapposDirector ofthe 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 apharmacy 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 repeatinstances of lost, stolen, destroyed, or spilled prescriptions; limiting the prescription to a one

month supply; requiring rewriting of the prescription periodically; and making the databaseavailable 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 forshipment 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 fortherapeutic 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 forauthorization only using the exclusive central computer system and the exclusive computerdatabase;

controlling the distribution of said prescription drug using the exclusive central computer systemthat 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 ofpotential prescription abuse, misuse, or diversion of said prescription drug from periodic reportsgenerated by the exclusive central computer system and the exclusive computer database basedon 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 multiplecontrols for distribution using the exclusive central computer system, the controls selected fromthe group consisting of communicating prescriptions from a physician to the exclusive centralcomputer 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 numberand to check on whether any actions are pending against the physician; providing comprehensiveprinted materials to the physician; contacting the patient's insurance company if any; verifyingpatient registry information; providing comprehensive education information to the patient;verifying the patient has received and/or reviewed the educational materials; verifying the homeaddress 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 attemptsto deliver; launching an investigation when a shipment is lost; shipping to another pharmacy fordelivery; requiring manufacture at a single location; authorizing release of inventory in acontrolled 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 forabuse, 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 forshipment 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 prescriptiondrug. —,herefor.



UNITED STATES PATENT AND TRADEMARK OFFICE

CERTIFICATE OF CORRECTION

PATENT NO.

APPLICATION NO.

DATED

INVENTOR(sl

: 7,765,106 B2

: 10/979665

: July27,2010: Dayton T. Reardan et al.

Page I of 3

It is 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 —butyrate —,herefor.

In column 1, line 28, delete theraputic and insert —herapeutic —,herefor.

In column 4, line 65, delete coveral and insert —coverage —,herefor.

Signed and Sealed this

Fifteenth Day of February, 2011

David J. Kappos

Director ofthe United States Patent and Trademark Office



CERTIFICATE OF CORRECTION (continued) Page 2 of 3

(t» United States PatentReardaII et aj.

(l03 Patetlt No.:(453 Bate Of Patent

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

(54) SENSITIYE DRUG DIsTRDIIJTIO(rt sYSTKMA;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)

(733 Assignee: JPI Cnsnrnerclal, LLC, Palo Alto, CA(US3

(a

3 Notice: Subject io any disclaimer, the term of thispatent is extended or adjusted under 35V.S.C. l 54(bl by l 645 days.

6.02t,392A

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6,055,507 A

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2.2000 l ester et al4 00t) l l sayed ct al

This patent is subject to a (errninal dis-clir IIncr.

(2 t) Appi No.: 10/979,665

(22) Filed'. istnv. 2, 2004

(65) Prlnr PubiicatIon Dahe

US 2005/0090425 A I Apr, 28, 2005

(513 Int. Cl.r,Ork(7 IOZOO (2006.0I 3

(52)(58)

U.S.CL ...................,...„....,,....05/2; 705/3FleM nf CIasal6cattan Search...........05/2,

705/3See application hie lor rornpletc search history.

(56) References CitedU.S. PATENT DOCUMENTS

1,556.3r)24,847,7644,976,15 l

&.737.5 305,845,2555,924,074

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A

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l/197 t7/1989

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GuarrHal verso)i

Mangiai st al.Frtetson es al.

Mayaud ........Fvans ....,

705/3705/3

Related U S.Appacatinn Data

(62) Division of application No, 30/322,348, liled on Dec.l 7. 200 , now Pal. No. 7,668,730.

(Cont inued)

CXfHER PUIJLLCATlONS

(573 ASSTRAt. I'

drug dirtribuiion system and nicthod rrtilircs a cerrtrd

pharmacy and database to tmck a'll prescriptions for 0 sensi-tive 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 ntonitor-

rng data in th» database tor prescripiiorlpattents

bypltysi-

cians and prescriptions i)btained by patienLs. Further vert(i-cation )s made that the physician is eligible to prescribe thcdrug hy consulting a separate database and opiiiniallywhether any actions are taken against the phystcran. iv) tilt)p)econtrols beyond those for normal drtrgs an. imposed on thedistribution depending otr thc si:»sitivity r if'hi dnig

8 Clahns. I6 Drawing Sheeti

Ã4SCSA /Varionaf Corke rerrre, (btov. 2000),8 pages.

(Contiiniicd)

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in~i~~.



CERTIFICATE OF CORRECTION (continued) Page 3 of 3

U.S. Patent Jul. 27, 2010 Sheet 2 of 16 7,765,106 B2

202

1MD MAILS/FAXES IN Rx/91NklMENT FMl

j

204AN INTIE/RDMBURSOlENT SPECIAUST MAKE A COPY OF~ h/DNOLLMENT FORM (m COPY IS SrAMPEO

COPY') AND 7'RIGINAL FAX IS THEN FORlSHED

TO THE P~ TEAM

206

Mo eaS/FAxES e h/ENROUMENr FORM

210THE INTAKE/REIll8URSEMENT SPEOAUST ENTERS 1HE

PATIENT ANO RlrslCIAN INFo INro CHIPs

Is 2121K INFO

CSIPIETV.

lES 220

THE INTAKE/REIMBURSEIKNr SPECIAUST CONTAC1S MO

TO VERIFY RECEPT 4 ACCURACY OF THE PAlIENI'S Rx

4 TH6 CONTACT IS REID I CHIPS

222

THE INrAKE/REIMBURSEMENT SPECIAUST SENDS cONSENT

FORM AI A CNtER LOITER TO THE PAlXNT

J224

THE INTAKE/IHLSLIRSEMENT SPECIAUST FNES A

srATEMENT 0F i8Kk NEKi91Y To THE

MD TO COMPLEIE

226

lHE INTAKE/REIMIISEMENT SPECALIST CGIQC5THE PATIENT s INsIlliNKE PRNDER To YERIFY

CVKPAEE Jt %NEFHS

228

96NK MR

YES 238ITAKE/REIMDUIISEMENT SUMrs A CoVERm

APPRovAL FoRM (srAPLED To THE coPY of THE lbOemoelr FORM) TO THE PHARMAI~ lEAM AS

NIIFICATIN TO PROCESS W PATIENT'S h

214AN INTAKE REPRES9rrATIvE wILL MAKE I ATIEMPT TO

REACH THE MD TO ONAI THE MIXING INFORMATIOIII

216

THE MISSING NFORMAIIII HAS NOT SEEN OBTAIED

wITHIN 24 HQURs, THE Ih/ENRoLLMENT roRM Is FAxED

BACK TO THE MD WII A REJECTIN EXPLANATIoN LErrER

J 218

A NOTE IS ENTERED IN CHIPS THAT fHE

APPUCATN WAS REJEClED

232SEE NORD PROCESS FOR PATIENTS 5

WHO ARE UNINSURED OR UNDERINSURE/)

NO

IS Tl-I

PATIENT WILUNG/AEI

TO PAY?

YES 234

THE PATIENT IS INFORMED oF THE COST oF THE

PRODUCT AND IS OVEN PAYLIENT OPIIONS

236

ONCE PAIMENT IS RECElvED, INTAKE/RDMBURSEMST

Smrs A COVERAGE APPROvAL FDRM (sTAPLED ro

THE COPY OF lHE Rx/ENROLLLIENT FORM) TO TIIE

PHA84ACY 19kl AS NOTIFICATION TG PROCESS

THE PATIM'S Rx

( A FlG. 2AJA )

sensitive drug distribution system and method (us patent 7765106)

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