1
`
`s
`
`it
`
`It
`
`i ss
`
`n
`
`EXHIBIT
`
`Sensitive Drug Distribution System and Method
`
`5
`
`The present
`
`invention relates to distribution of drugs and in particular to the
`
`distribution of sensitive drugs.
`
`Field of the Invention
`
`Background of the Invention
`
`Sensitive drugs are controlled to minimize risk and ensure that they are not
`
`10
`
`abused or cause adverse reactions.
`
`Such sensitive drugs are approved
`
`for specific uses
`
`by the Food and Drug Administration and must be prescribed by a licensed physician in
`
`order to be purchased by consumers. Some drugs such as cocaine and other common
`
`street drugs are the object of abuse and illegal schemes to distribute for profit. Some
`schemes include Dr. shopping diversion and pharmacy thefts. A locked cabinet or safe
`
`15
`
`is a requirement
`
`for distribution of some drugs.
`
`Certain agents such as gamma hydroxy buterate GJAB are also abused yet also
`
`are effective for therapeutic purposes such as treatment of daytime cataplexy in patients
`
`with narcolepsy. Some patients however will obtain prescriptions from multiple doctors
`
`and have them filled at different pharmacies. Still
`
`further an unscrupulous physician
`
`20
`
`may actually write multiple prescriptions for a patient or multiple patients who use cash
`
`to pay for the drugs. These patients will
`
`then sell
`
`the drug to dealers or others for profit.
`
`There is a need for a distribution system and method that directly addresses these
`
`abuses. There is a further need for such a system and method that provides education and
`
`limits the potential
`
`for such abuse.
`
`25
`
`Summary of the Invention
`A drug distribution system and method utilizes a central pharmacy and database
`
`to track all prescriptions for a sensitive drug.
`
`Information is kept
`
`in a central database
`
`regarding all physicians allowed to prescribe the sensitive drug and all patients receiving
`
`30
`
`the drug. Abuses are identified by monitoring data in the database for prescription
`
`patterns by physicians and prescriptions obtained by patients. Further verification is
`
`Docket
`
`101.031 US 1
`
`l
`
`LMO
`
`ParXyrem 002793
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 1 of 34
`
`

`
`o
`
`x
`
`v
`
`.
`
`H
`
`vx ý
`
`z
`
`4
`
`2
`
`.yi
`
`w
`
`W
`
`z
`
`W
`
`p0c
`
`d
`
`z
`
`U p
`0 a
`
`.
`
`A
`0 ý
`
`4-
`
`z
`
`Z
`
`o
`
`I-
`
`f1
`
`canon
`
`o
`
`W
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 2 of 34
`
`

`
`...
`
`.
`
`a
`
`a
`
`0
`
`W N
`
`az c o
`
`v
`
`ý
`
`AW
`0
`
`uC
`
`MN
`0
`
`.
`
`uý
`
`Uo
`
`UE.
`
`. a
`
`C4
`
`-ti
`
`h_
`
`07U
`R
`
`w
`
`v
`
`Z3
`
`Ne
`
`A
`
`ov
`
`a
`
`41.
`
`0
`
`U
`
`v0
`
`sMa
`
`cm
`
`Va
`
`aE
`
`1-4
`
`all
`
`q
`
`ý
`
`C O
`
`N
`
`U
`
`CA
`
`ti
`
`w
`
`p ý
`
`N
`
`.
`
`d
`
`Its
`
`Q
`
`i
`
`ti
`
`0
`
`aý
`
`r
`
`CL1
`
`ýG
`
`O
`
`a
`
`UswE
`Cp
`
`k
`
`0
`U
`v
`
`cC
`
`Ev
`W p v
`
`4-1
`
`aNpC Cr a C
`
`N
`.
`
`yrp
`
`LL
`
`-
`
`obi
`
`u-
`
`CL
`
`oA
`
`SG
`
`v
`
`ao
`
`G
`
`of
`
`Z
`
`CQ
`
`m
`
`ON
`
`0
`cý3
`
`-a
`
`0
`
`p
`
`y
`
`p v
`
`aU
`
`L.
`
`QQr
`Cpt
`
`C O
`
`i
`
`4ý
`
`C
`
`o
`
`C
`S
`y
`
`C
`
`Uý c
`
`v
`
`cc
`
`ý
`
`c0
`
`pv
`
`v
`
`ca
`
`v
`
`Ea
`
`LuC 0
`
`vy ý
`
`a C
`
`L
`
`vCx
`
`OA
`
`S7
`L
`v
`Vi
`
`ýw
`L
`
`v
`
`LvH
`
`A wE r
`
`UzE3a
`p 0
`00v
`
`- x m
`
`0
`
`w
`
`p
`
`0
`
`A
`
`w
`a
`
`vNo
`
`ro
`
`z 0 40 v
`
`E
`u
`
`S
`
`-4-a u ý
`
`h0dL
`
`b
`3
`
`all
`
`E c
`
`A
`
`y
`
`voýS
`
`-0
`
`mý c
`
`a
`
`0
`
`w
`
`ý
`
`x
`
`Xw
`
`w.
`
`0
`
`-a
`
`-_
`
`U0L
`
`c
`
`s
`
`ýL.CN
`Ct
`
`C
`
`0.
`
`0
`
`w
`
`40v
`
`wCEy
`C 0
`
`L
`
`v0
`
`v0
`
`vý
`
`ýpvp 0
`
`ý
`
`coao
`
`U
`
`C
`
`61
`
`v
`
`w
`
`A
`
`LC
`
`S
`
`4-4
`
`T
`
`y0QOw
`LECL C
`
`OL
`
`CSCR
`
`07Q
`vC.0
`.yy.
`
`ti
`
`-0
`
`S
`
`m
`
`Cw
`
`p
`
`G
`
`C
`
`uC
`
`AS
`
`yýc
`
`ý
`
`S
`
`Ccp
`
`v
`
`tv
`
`-0
`
`CU
`
`av
`oau
`
`OOLCC
`
`OC
`CECO
`EoC
`
`ro
`
`C
`
`33z
`
`h
`
`cý
`
`0ýLa
`wud
`.G
`
`ti
`
`L
`
`.
`
`cC
`
`L.
`
`n0pvý
`
`ýo
`
`V5
`
`ai
`
`E
`
`uyv
`
`cyýC
`
`.CCc
`
`tný
`
`ýxý
`
`30o
`
`roý
`
`sb
`
`ýýov
`
`vý
`
`Fm
`
`ECU
`
`C
`
`CC
`
`wC
`
`a..
`
`vz
`
`p
`
`4-
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 3 of 34
`
`

`
`ý.
`
`I
`
`0
`
`pý
`
`.
`
`uz
`
`ýO u 4
`p 0
`oacisub
`
`ýý
`
`aw
`
`týv
`
`Ov
`
`t3
`
`ao
`
`A
`
`ro
`
`ýa
`
`.0
`
`p
`
`4ý
`
`qj
`
`vý
`
`5
`
`roo
`
`00
`.
`
`ý
`
`42
`
`-
`
`v a
`
`-
`
`p
`0yý
`
`.
`
`cio
`
`tg
`
`1
`
`a
`v
`
`cCý
`
`V.
`
`4-4
`
`u
`
`4-3
`
`cxo
`ub
`
`ro0s.
`
`uwO
`ýg
`
`CL
`
`.
`
`ro
`
`0
`
`c b
`
`I-W
`
`0 0 W
`
`o
`
`ýýa
`0
`
`bD
`
`nv
`
`co
`
`.
`
`0
`
`cc
`
`wA -
`
`rov
`
`0
`
`ý
`
`ro
`
`w
`
`0
`
`w
`
`.
`
`0
`
`ýw
`
`0
`
`aý1
`
`a
`
`v
`
`p
`
`w
`
`o
`
`ro
`
`U4
`
`a
`
`CC
`
`U
`
`I.a V
`
`as
`
`u-uo.saý
`Wý
`
`00 z
`
`W
`0
`
`0
`
`l14
`
`by
`
`p
`
`si
`
`u00
`
`ro
`
`--
`
`ý
`v
`
`o.ý
`
`Ciifl
`
`rop
`
`0
`
`ca
`
`row
`
`00
`
`p v a
`v.
`
`.
`
`.
`
`...pv 0
`roov
`
`v
`
`0
`a
`
`mý...
`
`v
`E
`
`0
`
`0
`
`F.
`
`ti4ýý0
`
`ro
`
`o
`
`0ý.
`
`uýxv
`F w
`
`o
`
`...
`
`v
`0
`
`v
`
`GW
`
`..
`
`ý
`
`b
`
`0
`
`ro
`
`0
`
`C
`.
`
`0 ý
`
`ro
`
`0
`
`0
`0
`c
`
`w
`
`rov
`
`ro
`
`-0
`
`aý
`w
`
`ý
`
`v
`
`wq
`
`Qý
`
`wm6
`roAwý -
`
`0or
`
`..
`
`/ý
`
`ýav
`
`N r
`
`o
`
`.
`d
`
`wQ
`
`V
`
`G
`
`ro
`
`n
`
`4i
`
`bA
`
`ýo . w
`
`b
`
`bo.cCv
`
`-s..
`
`eCýO
`
`uo
`
`nwý
`ro
`
`vGlL4v
`
`aV
`
`V u
`
`ro
`
`0u
`
`uý
`
`.
`v
`
`uFo
`
`a
`
`ý
`
`ro
`
`.
`
`r
`
`y-
`
`o
`
`ro
`
`ro
`
`w
`0ý
`u
`
`v
`
`0Cy
`ýCd
`
`N
`z
`
`o
`
`n
`
`a
`w
`
`4.1
`
`ý.ro
`
`-Q
`
`1v
`
`tiv
`
`..
`
`o
`
`u
`
`u
`
`.
`
`p
`
`ro
`
`to
`
`oQ
`0Sroaar
`
`4-1
`
`uvý.ro.ý
`
`v a c ý
`
`ý-
`p
`
`o ý
`
`rv
`ro
`xq
`
`o
`
`0
`
`haw
`
`v b
`q r
`
`o
`
`Qvv
`
`4
`
`uO
`
`ro
`
`-.
`
`w m
`..vw
`ýu
`
`pv
`
`x
`
`bo
`v
`
`t7v
`
`0 ý m
`
`v
`U
`.
`u
`.
`
`0
`ý
`v
`
`vw
`
`.4
`
`nom0
`0
`C
`
`4i
`
`4W
`
`p
`
`vv
`
`rov
`
`v
`
`o
`
`-44
`
`wooL-
`
`a
`
`w
`
`ý0u
`
`4
`
`ý
`
`of oW
`
`x w
`0 r
`
`o
`
`.ý01.ý
`
`w
`
`-cz
`
`aý
`OF
`p
`0
`
`ro
`
`ro0
`
`VO
`
`oa
`
`b44
`
`1-4
`
`o
`
`o
`
`vN
`
`0
`
`0boGvlý
`
`ýI
`
`ro
`
`4
`
`v
`
`v
`
`G.0
`
`tu
`
`vI
`
`V5
`
`ro
`
`R
`a
`
`r.1
`
`44
`
`4.j
`
`ro
`
`ro
`
`y
`
`CL
`
`O
`
`ý 0
`
`ý
`0
`
`qj
`
`ay
`
`ro
`
`w a
`
`avw
`2
`G
`o
`
`L4
`
`.a
`
`aom
`
`-j
`
`Wb
`
`m
`uý
`
`.
`v
`wp
`ým
`
`L4
`
`ýi
`
`ý
`
`.
`
`0
`0
`
`vTi
`
`a
`
`U
`
`v
`
`ro
`
`0
`H
`
`o
`
`uv
`
`bnoý
`vo
`
`emu
`
`GU
`
`...
`
`roý
`
`oyu
`
`0Z
`COu
`ý
`
`. q
`
`W ý
`
`4-1
`
`v
`
`ovv
`
`v
`
`ýr
`
`ý...
`
`0
`
`.
`
`u..
`
`a w
`
`ro
`
`v o
`
`vwýproupaý0
`roVvaM
`v r
`
`ww0W
`ýoý
`
`o
`00
`
`a.COCý
`
`..1
`
`ý
`
`4A
`
`o
`
`pro
`
`ý--
`
`co
`
`aýuz t
`
`ouqr
`
`Z r
`
`3
`
`Ua
`0ý.w
`ýýo
`vy
`ail
`
`ýcgvr
`
`-
`
`qu
`
`CL
`
`uz
`
`Ov
`
`o
`ý..
`.a
`
`0
`
`U
`
`U4
`
`ýn
`
`v
`
`ý
`
`3-4
`
`uý
`roo
`
`vb
`
`-c
`
`ývwv
`
`to
`
`vvN
`
`w
`
`ro
`
`rooý
`
`WJ
`
`1
`
`Q
`
`0
`
`0
`
`ý a o
`vrov
`aWtiývNý
`
`o
`
`ar
`
`vm
`
`q .
`
`L4
`
`o z
`
`vq c
`v ý
`u w . -
`
`bA
`ro
`
`G
`
`bo
`
`y
`
`v...
`
`C
`0a
`pti
`
`u-
`
`0w-
`
`4yra.1
`rti0U.
`ý4vp0
`
`vx
`
`p0-
`
`U
`
`0
`sq
`Ov
`
`ro
`
`ly
`
`ýI
`
`ry
`
`4.4
`
`ro
`
`robq
`
`Vag
`u
`
`ýro0
`
`roý
`ý.
`ro
`rn
`
`roro
`vwd
`
`V
`
`C1
`
`u
`-0
`
`m
`
`x.
`
`ý.c
`
`q..
`
`ýcCýv1
`0ýýGro
`-OOArobo
`Oýbo-ro
`oNpJ
`
`is
`
`b
`
`oL
`oi
`
`4-6
`
`ru
`o
`
`ýv
`
`v
`ý
`
`o
`
`C
`Oq
`qw
`
`U4
`
`ýI
`
`v
`
`ý
`
`-0
`
`ro
`
`FI
`
`aro
`
`ýý
`
`j 0 d 0
`to..
`Cý
`
`A
`ý
`Z
`ý
`
`U
`
`ro
`
`ýw0
`
`pw
`
`ro
`
`av
`
`a
`
`h
`
`bA
`
`ro
`
`0
`C
`Ebp
`bD
`0 0
`ý
`To
`
`00
`
`a
`
`ý.ýb4a
`
`v
`
`09W
`
`U
`00
`
`h
`
`-A
`
`OO
`O
`
`1 ý
`
`wp-.
`ýw
`py
`
`OWwvýU
`
`N
`
`0
`A
`
`o 0
`
`a
`
`o u v
`
`ro
`
`.ý
`
`uý
`
`ýu
`
`uswv
`
`vv
`
`.
`
`01auNvýti
`oaJa
`
`rov.
`tibo
`ýz
`0t
`v o F
`0v
`
`-0
`o0
`
`0
`.5
`0
`bb
`v
`a
`
`ro
`
`u
`0
`bý.
`
`uN
`
`vbo
`
`v
`
`roU
`
`ýv
`
`0ý
`
`v0
`
`q
`
`.
`00
`0
`00
`ý
`r
`ý
`
`0ý
`
`rov
`
`ro
`
`oro
`
`0
`
`up
`a0
`
`oý
`
`q
`
`.
`
`cC
`
`ýarov
`
`u
`
`ro
`
`Oq
`u
`
`y
`
`0
`
`vv
`
`S-1
`
`G
`
`p
`
`r-0
`
`atiroiuwrovF0ýroz0ýv v
`roýao
`
`tOWOaýrýovvav.
`
`Aýýý
`
`0c
`
`o
`
`.ý
`
`aý
`
`r.
`
`Oc6ýýap0vyuGýpNýýi
`vwyý.0
`
`Qvýi
`oz$uo
`Nuwo
`4c.0a
`oýý-0w-
`mvuc
`bDCU
`quwO
`oýjr3
`ýobýýsaroo
`rovýuOgVivO
`ay.robý
`ýmv0ýwr
`vro0
`.-pu
`ýývao
`Oro0p
`tiNvtd
`aý
`
`cý0
`
`vv
`
`o.E
`
`Ua
`
`w
`
`vro
`
`bba
`
`00
`
`ý
`
`b
`
`WN
`
`0
`
`o
`
`ý
`
`-
`
`aC
`
`-
`
`Wý
`
`v
`
`ro0
`
`0boron
`
`oývýl
`
`0-
`
`o
`
`Wvý
`
`v
`.ý
`w0
`
`a0Ob
`
`A
`
`0bz
`
`v
`
`U
`
`ý
`
`ro
`
`cn.ý
`
`0
`
`_a
`
`a
`
`m
`
`L
`
`CL
`
`c
`
`CL
`
`I4-A4
`
`aflflI-
`
`vqau
`
`.-
`0
`ado
`
`ro
`
`oý
`
`uý
`ý
`
`bo
`
`ti
`
`0
`
`bobo
`
`ýcCvw
`ý.-ýNvaý
`ýuv.uAýý
`
`roý
`
`cývns
`
`ý
`
`t0
`
`cC
`
`F.
`
`bo
`ro
`
`uro
`
`000rovýýq boýcu
`o r
`uauCd
`caum
`uvrocd
`vpýy
`rornFv..Qýjý0
`ýao.uý00g
`ýýo
`ýpaý
`ro.oa
`
`CL
`
`LA00C
`
`ar
`
`0q
`00
`
`tj
`
`rni
`
`ý0
`
`aa
`
`ýý
`
`0
`
`w
`
`iý
`
`v
`
`a
`
`ias
`
`40x
`
`v
`
`Vl
`
`iiZ
`q
`
`0p
`
`ý0
`
`vw
`
`.
`
`Lý
`
`ý
`
`roovw
`ýa
`
`Wý.b.
`
`vývroG
`mý3.ýln
`irýC
`Nuppý
`HOgaýQwvýbcejrmu a
`.-00 U
`
`By
`
`4.6
`
`a
`
`CL
`
`L4
`
`ro
`
`1
`
`an
`
`0
`
`A-
`
`w
`
`0v
`
`yew
`
`r.
`
`ro
`
`ýu
`00
`
`0
`
`tt
`
`v
`
`aa
`
`r yao.vr F
`
`ý
`
`Gv-
`
`Au
`
`W
`
`vhvpu
`
`on
`
`oý
`
`co
`
`ti
`
`rov
`
`0ut
`
`i
`
`u
`
`0ýr
`
`o
`
`0oW
`
`4
`
`-0
`
`av
`
`W
`
`-V
`
`ji
`
`it
`
`w
`
`44
`
`v
`
`ro
`
`col
`
`0
`
`CLO
`
`ro
`
`td
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 4 of 34
`
`

`
`CONTENTS
`
`Preface ........................................4a-5
`
`Editorial Staff .................................6a-8
`
`Outside Consultants ..........................
`
`Explanatory Chart ...............................
`Explanatory Notes ...........................
`Divisions in Boldface Entry Words .............
`Spelling ......................................21a-24
`Plurals ......................................25a-26
`
`Capitalization ................................26a-27
`Italicization ......................................27
`
`8a-12a
`
`13a
`
`14a-18a
`
`19a-20a
`
`The Writing of Compounds ...................
`Merriam-Webster Pronunciation Symbols ...........
`
`28a-29a
`
`30a
`
`Guide to Pronunciation .......................
`
`31 a-44a
`
`Divisions in Respelled Pronunciations ..............
`
`45a
`
`Punctuation .................................
`
`46a-49a
`
`Forms of Address .............................49a-52
`
`Abbreviations Used in This Dictionary...........
`
`52a-54a
`
`Special Symbols .................................
`
`Addenda .............................
`
`54a
`
`55a-102a
`
`A Dictionary of the English Language..
`
`_ ..
`
`2662
`
`Tables
`at or near italicized word
`
`cgs electromagnetic
`
`units ab- .....................
`
`Afro-Asiatic languages ............................
`
`alphabet
`
`table ....................................
`
`anthracite coal sizes ..............................
`
`architecture ......................................
`common area formulas ...........................
`
`Beaufort scale ................................
`
`1
`
`38
`
`61
`
`92
`
`114
`
`115
`
`193-194
`
`200
`
`252
`
`metric system ...................................
`
`money ....................................
`
`1424
`
`1458-1460
`
`months of the principal calendars ..................
`
`Morse code .....................................
`
`multiplication table ..............................
`
`cardinal numbers ................................
`
`ordinal numbers ................................
`denominations above one million
`
`1465
`
`1472
`
`1486
`
`1549
`
`1549
`
`1549
`
`ships bells ......................................
`hook sizes .......................................
`
`number.....................................
`
`Braille alphabet ..................................
`
`266
`
`periodic table period ...........................
`
`constellations
`
`.....................................48
`
`chief crusades .....................................54
`
`principal ocean currents drifts streams ..............55
`executive U.S. departments .........................60
`dye tables I and 11 .............................706-71
`
`Easter dates ......................................71
`
`perpetual calendar ...............................
`
`absolute pitches .................................
`
`terrestrial and major planets ......................
`
`personal pronouns ...............................
`
`................................
`radio frequencies
`ranks of the U.S. Armed Forces ..................
`
`chemical elements .................................73
`
`signs of the zodiac ..............................
`
`1680
`
`1685
`
`1725
`
`1730
`
`1816
`
`1873
`
`1881
`
`2115
`
`848
`
`principal spectral types............................2188
`
`principal
`
`four syllogistic figures .............................
`railroad gages gauge .....................94
`common shotgun gauges ...........................94
`geologic time and formations .......................94
`gestation periods ..................................95
`glacial epochs ....................................96
`
`incubation periods ...............................
`
`Indo-European
`
`languages .........................
`
`measures and weights ............................
`
`1146
`
`1153
`
`1399
`
`standard time throughout
`
`the world.................2224
`
`fifty
`
`important stars..............................2225
`
`structural formulas................................
`
`time chart.......................................2395
`
`truth table.......................................2457
`
`Uralic languages ................................
`volume formulas ................................
`
`2266
`
`2520
`
`2563
`
`years of three of the principal calendars.............2648
`
`Full-Page Illustrations
`
`Color
`
`Two plates in color ............
`Constellations and Stars-Northern Hemisphere ......48
`
`between 448 and 449
`
`Man Muscular System and Skeleton .............
`Sails Fore-and-aft and Square.....................
`
`Ship Principal Ropes Spars Parts of Hull..........
`
`1371
`
`2001
`
`2097
`
`Constellations and Stars-Southern Hemisphere.......488
`
`Representative
`
`Trees ..............................243
`
`3a
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 5 of 34
`
`

`
`information includes name social security number date of birth gender contact
`
`information drug identification patients appropriate dosage and number of refills
`
`allowed along with a line for the prescribers signature. Patient
`
`insurance information is
`
`also provided.
`
`5
`
`There are two workflows involved at the pharmacy team intake reimbursement
`
`206 and pharmacy workflow 208 which may proceed in parallel or serially. The intake
`
`work flow 206 starts with an intake reimbursement specialist entering the patient and
`
`referred to as CHIPS which is used to
`physician information into an application/database
`maintain a record of a client home infusion program CHIP for Xyrem. A check
`If not at 214 an intake representative
`made to ensure the information is complete at 212.
`attempts to reach the MD or prescriber to obtain the missing information.
`
`If the missing
`
`is
`
`hours at 216 the Rx/Enrollment
`
`information has not been obtained within a predetermined period of time such as 24
`form is sent back to the MD with a rejection explanation.
`A note is entered in CHIPS that the application was rejected.
`If the information is complete at 212 the MD is contacted at 220 to verify receipt
`
`and accuracy of the patients 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 228
`
`a determination is made regarding coverage for the drug.
`
`If it
`
`is not available it
`
`is
`
`10
`
`15
`
`20
`
`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.
`the process is referred to as a NORD process.
`
`In one embodiment
`
`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
`
`25
`
`the intake reimbursement specialist submits a coverage approval
`
`form with the
`
`enrollment form to the pharmacy team as notification to process the patients
`
`prescription.
`
`If coverage is approved at 228 the intake reimbursement specialist also
`
`submits the coverage approval
`
`form with the enrollment form to the pharmacy team as
`
`notification to process the patients prescription. Processing of the prescription is
`
`30
`
`described below.
`
`Docket
`
`101.031USI
`
`6
`
`ParXyrem 002798
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 6 of 34
`
`

`
`h
`
`1
`
`i
`
`U
`
`t
`
`Upon receipt and initial processing of the prescription enrollment form and
`
`sending an original
`
`Xyrem success packet via mail.
`
`to the pharmacy work flow block 208 the patient
`is shipped a
`the Xyrem success packet
`
`In one embodiment
`
`contains educational material for a patient
`
`that advises of the proper use care and
`
`5
`
`handling of the drug and consequences of diversion at 268. The medical doctors
`to determine if the physician has a current DEA license to
`
`credentials are checked
`
`prescribe controlled substances and if he or she has had any actions related to
`
`rnisuse/misprescribing
`
`of controlled drugs against him or her within a predetermined
`
`time such as three months at 270.
`
`If they have a pharmacist holds the prescription until
`
`10
`
`receiving a coverage approval
`
`form from the intake reimbursement specialist at 272.
`
`If the credentials have not been recently checked the pharmacist verifies the
`
`credentials and enters all
`
`findings in the database at 274.
`
`If the credentials are approved
`
`at 276 the physician is indicated as approved in a physician screen populated by
`
`information from the database at 280. The prescription is then held pending coverage
`
`15
`
`approval at 282.
`
`If any disciplinary actions are identified as referenced at block 278 management
`
`of the pharmacy is notified and either approves processing of the prescription with
`
`continued monitoring of the physician or processing of the prescription is not performed
`
`and the physician is noted in the database as unapproved at 284. The enrollment form is
`
`20
`
`then mailed back to the physician with a cover
`
`letter reiterating that the prescription
`
`cannot be processed at 288. The patient
`
`is also sent a letter at 290 indicating that the
`
`prescription cannot be processed and the patient
`
`is instructed to contact their physician.
`
`Actual
`
`filling of the approved prescription begins with receipt of the coverage
`
`approval
`
`form as indicated at 240. The patient
`
`is contacted by the pharmacy such as by a
`
`25
`
`technician to complete a technician section of a patient counseling checklist.
`
`If a
`
`pharmacist verifies that the program materials were not read at 242 the receipt of the
`
`material is confirmed at 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
`
`30
`
`the technician transfers the patient
`
`to the pharmacist who reviews the entire checklist and
`
`completes remaining pharmacist specified sections. At 248 the pharmacist
`
`indicates in
`
`Docket
`
`l 01.031 US I
`
`7
`
`ParXyrem 002799
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 7 of 34
`
`

`
`it U it
`
`h
`
`a ii d
`
`the database that the patient counseling and checklist was successfully completed
`
`indicating the date completed.
`
`At 250 the pharmacist schedules the patients shipment for the next business day
`
`or the next business day that the patient or designee is able to sign for the package.
`
`5
`
`Further as indicated at 252 the shipment must be sent to the patients home address
`
`unless the patient
`
`In that event the pharmacist may determine
`that an exception may he made. The patient or the patients designee who is at least 18
`
`is traveling or has moved.
`
`years old must sign for the package upon delivery.
`
`At 254 the pharmacist enters the prescription order in the database creating an
`
`10
`
`order number. The pharmacist
`
`then verifies at 256 the prescription and attaches
`
`a
`
`verification label
`
`to the hard copy prescription. At 258 a pick ticket
`
`is generated for the
`
`order and the order is forwarded to the pharmacy for fulfillment.
`
`The shipment
`
`is
`
`confirmed in the database at 260 and the order is shipped by USPS Express Mail. Use of
`the US mail
`
`invokes certain criminal penalties for unauthorized diversion. Optionally
`
`15
`
`other mail services may be used. Potential changes in the law may also bring criminal
`
`penalties into play. Following shipment the patient
`
`is called by the central pharmacy to
`
`confirm that the prescription was received.
`
`As noted at 266 for the sensitive drug Xyrem all
`
`inventory is cycle counted and
`
`reconciled with the database system quantities before shipments for the day are sent.
`
`This provides a very precise control of the inventor.
`A physician success program materials request process begins at 310 in FIG. 3.
`At 320 the MD calls to the central pharmacy to request program materials. A special
`phone number is provided. MD demographics DEA number and data or request are
`entered into the database at 330. At 340 a request is made to ship the materials to the
`MD via a fulfillment website or other mechanism. The request process ends at 350.
`A refill
`request process begins at 302 in FTG.s 4A and 4B. There are two different
`paths for refills. A first path beginning at 404 involves generating a report from the
`
`central database of patients with a predetermined number of days or product
`remaining.
`A second path beginning at 406 is followed when a patient calls to request an early refill.
`
`In the first path a copy of the report
`specialist at 408. No sooner than 8 days before the medication depletion a pharmacy
`
`is provided to an intake reimbursement
`
`20
`
`25
`
`30
`
`Docket
`
`l 01.031 US 1
`
`8
`
`ParXyrem 002800
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 8 of 34
`
`

`
`technician contacts the patient at 410 to complete the pre-delivery checklist. At 412 if
`
`is not reached a message is left mentioning the depletion and a return number
`the patient
`at 414. A note is also entered into the database indicating the date the message was left at
`
`416.
`
`5
`
`If the patient
`
`is reached at 412 the next shipment is scheduled at 418 the
`
`prescription is entered into the database creating an order at 420 the pharmacist verifies
`
`the prescription and attaches a verification label at 422 and the shipment
`
`is confirmed in
`
`the database at 424. Note at 426 that the inventory is cycle counted and reconciled with
`the database quantities before the shipments for a day or other time period are sent. A
`
`10
`
`pick ticket
`
`is generated for the order and the order is forwarded for fulfillment at 428
`
`with the first path ending at 430.
`
`The second path beginning at 406 results in a note code being entered into the
`
`database on a patient screen indicating an early refill
`
`request at 432. The pharmacist
`
`evaluates the patients compliance with therapy or possible product diversion misuse or
`
`15
`
`over-use at 436.
`
`In one embodiment cash payers are also identified. The pharmacist
`
`then contacts the prescribing physician to alert them of the situation and confirm if
`
`the
`
`physician approves of the early refill at 438.
`
`If the physician does not approve as
`
`indicated at 440 the patient must wait until the next scheduled refill date to receive
`
`additional product
`
`as indicated at 442 and the process ends at 444.
`
`20
`
`If the physician approves at 440 the pharmacist enters a note in the database on a
`
`patient screen that the physician approves the request at 446. The pharmacist notifies an
`
`intake reimbursement specialist
`
`to contact
`
`the patients insurance provider to verify
`
`coverage for the early refill at 448.
`
`If the insurance provider will pay as determined at
`
`450 the specialist submits the coverage approval
`
`form as notification that the refill may
`
`25
`
`be processed at 452.
`
`At 454 the pharmacy technician contacts the patient
`
`to schedule
`
`shipment of the product
`
`for the next business day and the process of filling the order is
`
`continued at 456 by following the process beginning at 240.
`
`If the insurance provider will not pay at 450 it
`
`is determined whether
`
`the patient
`
`is willing and/or able to pay at 458.
`
`If not the patient must wait until
`
`the next scheduled
`
`30
`
`refill date to receive additional product at 460.
`
`If it was determined at 458 that the patient
`
`was willing and able to pay the patient
`
`is informed of the cost of the product and is given
`
`Docket
`
`101.031 US 1
`
`9
`
`ParXyrem 002801
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 9 of 34
`
`

`
`payment options at 462. Once payment
`
`is received as indicated at 464 the specialist
`
`submits a coverage approval
`
`form to the pharmacy team as notification that the refill
`
`request can be processed at 466. At 468 the pharmacy technician contacts the patient to
`
`schedule shipment. The process of filling the order is continued at 470 by following the
`
`5
`
`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
`is uninsured or underinsured. A reimbursement specialist
`determining that a patient
`explains the NORD program to the patient and faxes an application request
`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
`
`form to
`
`application to the patient within one business day.
`A determination is made at 525 by NORD whether
`at 530 NORD sends a denial
`
`letter to the patient and it
`
`540 that the patient was denied by NORD.
`
`If the patient
`
`the patient
`
`is approved.
`
`If not
`
`is documented in the database at
`is approved NORD sends an
`
`10
`
`15
`
`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
`
`20
`
`has been approved for coverage.
`
`The process of filling the order is continued at 555 by
`
`following the process beginning at 240.
`
`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 weeks shipments to a segregated warehouse location for
`
`25
`
`production inventory. At 620 a purchase order is generated for the inventory transferred
`
`to the production location 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 invoices the central pharmacy for the product moved to
`
`production.
`
`The process ends at 640.
`
`30
`
`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
`
`Docket
`
`l 01.031 US 1
`
`10
`
`ParXyrem 002802
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 10 of 34
`
`

`
`workstations via a 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 organizations or schemas may he
`
`5
`
`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 embodiments no such groupings are made and the data is organized in a different
`
`manner.
`
`10
`
`Several queries are illustrated at 800 in FIG. 8. There may be many other queries
`as required by individual state reporting requirements. A first query at 810 is used to
`
`identify 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 820 is used to pull
`prescriptions by patient name. A third query 830 is used to determine prescriptions by
`
`information from the database related to
`
`15
`
`frequency and a nh query finds prescriptions by dose at 840. Using query languages
`
`combined with the depth of data in the central database allows many other methods of
`
`investigating for potential abuse of the drugs. The central database ensures that all
`
`prescriptions prescribers and patients are tracked and subject
`
`to such investigations.
`
`In
`
`20
`
`further embodiments the central database may 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 shown at 900 in FIG. 9.
`
`As previously indicated several fields are included for prescriber information
`
`25
`
`prescription information and patient
`FIG. 10 is a copy of one example NORD application request
`request that an application be sent to a patient
`
`information.
`
`form 1000 used to
`
`for financial assistance.
`
`FIG. 1 1
`
`is a copy of one example application 1100 for financial assistance as
`
`requested by form 1000. The form requires both patient and physician information.
`
`30
`
`Social security number information is also requested. The form provides information for
`
`approving the financial assistance and for tracking assistance provided.
`
`Docket
`
`101.031 US I
`
`11
`
`ParXyrem 002803
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 11 of 34
`
`

`
`FIG. 12 is a copy of one example voucher request
`NORD application request
`
`form of FIG. 10.
`
`In addition to patient and physician
`
`for medication for use with the
`
`information prescription information and diagnosis information is also provided.
`
`FIG.s 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
`
`II-Vas well as still other sensitive drugs where multiple controls are desired for
`
`one of many query languages.
`
`While the invention has been described with respect to a Schedule III drug it
`useful for other sensitive drugs that are DEA or Federally scheduled drugs in Schedule
`
`is
`
`distribution and use.
`
`5
`
`10
`
`15
`
`Docket
`
`101.031US1
`
`12
`
`ParXyrem 002804
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 12 of 34
`
`

`
`Claims
`
`1.
`
`A method of distributing a sensitive drug the method comprising
`
`receiving prescription requests from a medical doctor containing information
`
`identifying the patient
`
`the sensitive drug and various credentials of the doctor
`
`entering the information into a central database for analysis of potential abuse
`
`situations
`
`checking the credentials of the doctor
`
`confirming with the patient
`
`that educational material has been read prior to
`
`shipping the sensitive drug
`
`confirming receipt of the sensitive drug and
`
`generating periodic reports via the central database to evaluate potential abuse
`
`patterns.
`
`2.
`
`The method of claim I wherein receipt of the sensitive drug is confirmed by
`
`telephone call from the central pharmacy to the patient.
`
`3.
`
`The method of claim I and further comprising launching an investigation of lost
`
`shipments.
`
`4.
`
`The method of claim 1 and further comprising recording the confirmation with the
`
`patient
`
`that the educational material has been read in the central database.
`
`5.
`
`The method of claim I and further comprising verifying the patients home
`
`address.
`
`6.
`
`The method of claim I and further comprising recording a designee identified by
`
`the patient
`
`to receive the sensitive drug.
`
`7.
`
`The method of claim I and further comprising establishing a delivery date.
`
`Docket
`
`101.031 US 1
`
`13
`
`ParXyrem 002805
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 13 of 34
`
`

`
`8.
`
`The method of claim I wherein prescription refills
`
`requested prior to an
`
`anticipated date are questioned by the pharmacist.
`
`9.
`
`The method of claim I and further comprising shipping comprehensive printed
`
`materials to the physician if
`
`the physician is a first
`
`time prescriber of the sensitive drug.
`
`10.
`
`The method of claim 1 wherein the credentials of the doctor comprise DEA Drug
`
`Enforcement Agency and state license numbers.
`
`11.
`
`A method of monitoring potential abuse of a sensitive drug by use of an exclusive
`
`central database the method comprising
`
`generating queries of prescription information from a database containing selected
`
`information for all prescriptions of the sensitive drug wherein the queries comprise
`
`prescriptions by physician specialty prescriptions by patient name prescriptions by
`
`frequency and prescriptions by dose.
`
`12.
`
`The method of claim 11 and further comprising running multiple predetermined
`
`reports based on data in the exclusive central database.
`
`13.
`
`The method of claim 12 wherein such reports are selected from groups of reports
`
`consisting of sales regulatory quality assurance pharmacy inventory reimbursement
`
`patient care and drug information.
`
`14.
`
`The method of claim 13 wherein sales reports are selected from the group
`
`consisting of prescriptions by zip code prescriptions by physician by zip code and total
`
`dollars by zip code.
`
`15.
`
`The method of claim 13 wherein regulatory reports are selected from the group
`
`consisting of number of physician registries number of denied physician registries and
`
`reasons number of completed patient registries number of problem identification
`
`number of cycle counts performed.
`
`Docket
`
`101.031 US I
`
`14
`
`ParXyrem 002806
`
`PAR1048
`IPR for U.S. Patent No. 8,457,988
`Page 14 of 34
`
`

`
`16.
`
`The method of claim 13 wherein inventory reports are selected from the group
`consisting of number of returned products and reasons number of outdated bottles of
`inventory counts of consignment and production inventory number of units
`
`product
`
`received and lots received.
`
`17.
`
`The method of claim 13 wherein patient care reports are selected from the group
`consisting of number of adverse events number of dosing problems and type number of
`noncompliance episodes and reason number of patients counseled and reason number of
`and reason number of patients referred to physician and reason number of
`active patients number of new patents number of restart patients and number of
`
`discontinued
`
`discontinued patients and reason.
`
`18.
`
`The method of claim 13 wherein selected reports are run weekly monthly or
`
`quarterly.
`
`19.
`
`A method of obtaining FDA Food and Drug Administration approval
`
`for a
`
`sensitive drug the method comprising
`
`determining current and anticipated patterns of potential abuse of the sensitive
`
`drug
`
`selecting multiple controls for distribution by an exclusive central pharmacy
`
`m