Exhibit 1016
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1016
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01800
`
`

`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2003/0178031 A1
`Du Pen et al.
`QB)Pub.DaHx
`Sep.25,2003
`
`US 2003017803 1A1
`
`(54) METHOD FOR CANCER PAIN TREATMENT
`
`(75)
`
`Inventors: Stuart L. Du Pen, Bainbridge Island,
`WA (US); Anna R. Du Pen, Bainbridge
`Island, WA (US)
`
`Correspondence Address:
`SEED INTELLECTUAL PROPERTY LAW
`GROUP PLLC
`701 FIFTH AVE
`SUITE 6300
`SEATTLE, WA 98104-7092 (US)
`
`(73)
`
`Assignee: Du Pen, Inc., Bainbridge Island, WA
`
`(21)
`
`Appl. No.:
`
`10/268,179
`
`(22)
`
`Filed:
`
`Oct. 9, 2002
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 09/565,644, filed on
`May 5, 2000, now abandoned.
`
`(60) Provisional application No. 60/133,044, filed on May
`7,1999.
`
`Publication Classification
`
`Int. Cl.7 ................................................... .. A61B 19/00
`(51)
`(52) U.S. Cl.
`............................................................ .. 128/898
`
`(57)
`
`ABSTRACT
`
`Apatient pain management system and method that includes
`assessing patient history; determining a drug treatment in
`response to assessing patient history; and repeatedly reas-
`sessing the pain and assessing side-effects and adjusting the
`drug treatment
`to minimize patient pain. The system
`includes pain assessment tools for assessing patient pain and
`treatment history; treatment choice tools for determining a
`pain treatment protocol; pain reassessment tools for reas-
`sessing patient pain in response to the pain treatment pro-
`tocol; and side-effect assessment tools for assessing side-
`effects experienced by the patient to enable a caregiver to
`continuously reassess patient pain and comfort and adjust
`treatment to minimize patient pain and discomfort.
`
`PAIN ASSESSMENT FLOW CHART
`
`Pain Intensity Assessment
`(99 15)
`
`Nociceptive
`
`Co-Analigesic Drug Choices
`Flow Chm (pg 36)
`
`Co-Analgesic Drug Choices
`Flow Chart
`
`Co-Analgesic Drug Choices
`Flow Chm (pg 36)
`
`(pg 36)
`
`
`
`Opioid Drug Choices for
`Episodic Pain (pg 28)
`
`
`
`
`
`Opioid Drug Choices for
`Constant Pain with or
`without Episodic Pain
`(pg 30)
`
`
`
`Opioid Drug Choices for
`Constant Pain with or
`without Episodic Pain
`(pg 30)
`
`Is the pain controlled?
`UP<4 or wP<6
`
`Yes
`
`Side E”?-‘Ct A55e55me"it
`(pg 21)
`
`No
`
`Assessment
`P°t[i
`Quality
`
`(P9 '5)
`
`Pain Character Assessment
`(pg 18)
`
`Pain Pattern Assessment
`
`Neuropathic
`
`Episodic
`
`Constant with
`Episodic
`
`Constant
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 1 of 43
`
`US 2003/0178031 A1
`
`Body Temploie Chart
`
`FIG. I
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 2 of 43
`
`US 2003/0178031 A1
`
`Patterns of Pain
`
`Sever
`Pom
`
`Continuous Pom
`
`
`
`
`
`Over Time During the Day
`
`'
`
`N
`pgin
`
`.
`.
`Over Time During the -Day
`
`FIG. 2
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 3 of 43
`
`US 2003/0178031 A1
`
`Pain Scale Examples T
`
`|
`1
`
`|
`3
`
`2
`
`‘
`4
`
`l
`5
`Moderaie
`
`‘
`6
`
`Pain
`
`1
`7
`
`1
`8
`
`.
`
`I
`9
`
`10
`Worsi
`
`Pain Possible
`
`Worst
`Pain Possible
`
`0-10 Scale
`
`0
`No
`
`Pain
`
`No
`Pain
`
`VAS Scale
`
`Descriptive
`
`
`None
`Annoying Uncomforiable Dreadful
`Horrible
`Agonizing
`
`FIG. 3
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 4 of 43
`
`US 2003/0178031 A1
`
`
`
`Training Manual Du Pen, Inc. _
`
`
`CANCER PAIN ALGORITHM PROGRESS NOTE
`
`
`
`Patient Name
`
`PAIN Assessmmrr
`
`Telephone
`Clinic Visit
`Home Visit
`
`Etiology/Location
`
`Cl Non-Cancer Pain
`E] New Site
`Consistent with known tumor sites
`
`El Etiology Unclear
`Treatment Related
`
`
`
`Pain Location:
`
`Character
`
`Nocicepfive
`Aching
`Throbbing
`Cramping
`Tender
`
`Pattern
`
`Constant
`
`Intensitv [0 — 10]
`
`Site #1
`
`Worst
`Usual
`
`Mixed
`
`Episodic
`
`Site #2
`
`Side Effects
`
`Nausea
`
`Drowsiness
`Delirium
`Dry Mouth
`
`Yes No
`
`Yes No
`Yes No
`Yes No
`
`Neuropathic
`Shooting
`Stabbing
`Burning
`Sharp
`
`Constant 8: Episodic
`
`Worst
`Usual
`
`Site #3
`
`Worst
`Usual
`
`GI Distress
`
`Yes No
`
`Constipation
`Myoclonus
`
`Yes No
`Yes N0
`
`Drug Choice Decisions
`Pain Controlled
`Pain Not Controlled
`Sequential Opioid Trial
`
`Reassessment
`Pain 0 - 3 Contact PRN
`
`Pain 4 - 6 Contact at least weekly
`Pain 7 - 10 Contact qd — q72h
`Side Effects Contact per Protocol
`
`No Change in Therapy
`Maximize Co-Analgesics
`
`lnit. S/ E Protocol
`Titrate Opioids
`
`Next Contact Due:
`
`Notes/ Plan
`
`
`
`Signature
`
`Date
`
`
`
`Sections from this manual may be duplicatedfor use in clinical practice provided such reproductions bear
`copyright notice and proper referencing. @1999 Du Pen, Inc. All rights reserved. The mention of or
`reference to any company or product in these pages is not :1 challenge to the owner.
`
`FIG. 4
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 5 of 43
`
`US 2003/0178031 A1
`
`KEY FOR FLOW CHARTS
`
`Start or End of a
`
`flow
`
`Process
`
`
`preformed by a
`
`
`Acfion
`
`
`
`person
`
`ReSu”.S .°f 0
`decision
`
`Modification
`
`Document
`
`to
`
`
`
`reference
`
`‘
`
`’
`
`Reassessment
`
`Represent either a
`simultaneous action or a
`
`"refer to" and "come back
`
`to" mechanism
`
`LAO=Long Acting Opioid
`SAO=Short Acting Opioid
`
`FIG. 5
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 6 of 43
`
`US 2003/0178031 A1
`
`PAIN HISTORY AND PHYSICAL
`FLOW CHART
`
`
`
`TS
`
`the etiology of pain
`known’?
`
`Pain Focused
`Exam
`
`
`location of the pain
`consistent with known
`
`
`
`Diagnostic
`Workup
`
`
`
`Analgesic
`Histow
`
`
`
`Tumor Related
`Pain
`
`
`
`(non—tumor related)
`
`Chronic or Acute Pain
`
`
`
`
`
`
`
`Explore
`"patient goals
`of care
`
`Initiate Rx or obtain
`
`chronic/acute pain consult
`
`
`
`
`
`To Pain Assessment Flow
`
`Chart (pg 6)
`
`Pamcfie
`
`v
`
`Treat Primary Causative
`Generator
`
`FIG. 6
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 7 of 43
`
`US 2003/0178031 A1
`
`
`
`CE2823:§___;
`
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`
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 8 of 43
`
`US 2003/0178031 A1
`
`SIDE EFFECTS ASSESSMENT
`FLOW CHART
`
`Side Effect Assessment
`
`
`
`
`
`
`
`side effect present with
`current medication?
`
`
`Side Effect Protocol
`Over-sedation (pg 81)
`
`Constipation (pg 85)
`Nausea/Vomiting (pg 89)
`Delirium (pg 93)
`
`Myoclonus (pg 97)
`Dry Mouth (pg 100)
`
`CI Distress (pg 103)
`
`
`Opioid Drug Choices
`(pg 26)
`
`
`
`
`
`Manipulate choice and
`close of medication per
`side effect protocol
`
`
`
`NSAID Drug Choices
`(P9 39)
`
`
`
`
`
`
`Neuropothic Co—onu|gesic
`Drug Choices (pg 44, 48)
`
`FIG. 8
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 9 of 43
`
`US 2003/0178031 A1
`
`PAIN RE-ASSESSMENT FLOW CHART
`
`Curreni Pain
`
`Infensiiy
`
`Consider Rapid Opioid
`
`Tiiroiion (pg 32)
`
`Yes
`
`Yes
`
`Yes
`
`
`
`
`is constant pain
`,3
`severe.
`
`No
`
`.
`.
`.
`Is ep|S0d|C pom
`severe?
`
`
`
`No
`
`Is modercuie pain
`persistent?
`
`
`
`FIG.
`
`.9
`
`
`
`within 30 days
`or MD
`
`discretion
`
`No
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 10 of 43
`
`US 2003/0178031 A1
`
`SIDE EFFECTS RE-ASSESSMENT
`FLOW CHART
`
`Current Side Effect
`Profile
`
`
`
`Does side effect
`
`
`
`require urgent
`work-up?
`
`
`
`
`Is side effect severely
`distressing?
`
`
`
`Are there multiple
`moderately distressing
`side effects?
`
`
`
`
`Is moderate side
`
`effect persistent?
`
`
`
`within 30 days
`or MD
`discretion
`
`FIG. 10
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 11 of 43
`
`US 2003/0178031 A1
`
`
`E4528memzo_m_Ha6.95025E_+Q
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`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 12 of 43
`
`US 2003/0178031 A1
`
`OPIOIDS FLOW CHART
`
`Pain Assessment
`
`(P9 5)
`
`
`
`
`
`Does patient have
`severe persistent
`pain?
`
`Yes
`
`Presence of uncontrolled
`pahn UP>3 9; WP>5
`
`
`N0
`Rapid Opioid Trnufion
`(P9 32)
` Is patient opioid
`tolerant?
`
`Yes
`
`
`
`
`
` Is patient drowsy?
`
`Ispmmm‘
`currently taking
`opioids?
`
`
`
`
`
`
`
`Initiate SAO at
`
`starting dose range
`
`
`
`Optimize
`co-analgesics Tritate according to
`pain pattern
`
`algorithm
`
`Tritate at half pain
`'
`pattern recommended
`
`1-7 days
`
`Reassess
`
`FIG. 12A
`
`
`range
`
`
`
`Reassess
`
`1-7 days
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 13 of 43
`
`US 2003/0178031 A1
`
` Tritate according to
`
`
`
`pain pattern
`algorithm
`
`Reassess
`
`1-7 days
`
`
`
`
`
`
`
`Side effects?
`
`
`
`
`Side Effect Protocol
`Over—sedation (pg 81)
`Constipation (pg 85)
`Nausea/Vomiting (pg 89)
`Delirium (pg 93)
`Myoclonus (pg 97)
`Dry Mouth (pg 100)
`CI Distress (pg 103)
`
`
`
`
`
`
`
`Reassess
`within 30 days
`
` Pain controlled?
`or MD
`
`discretion
`
`
`
`Optimize
`
`
`co-analgesics
`
` Tritate according to
`algorithm
`
`pain pattern
`
`
`
`R
`
`'
`
`egmno
`
`(P9 71)
`
`IT h‘
`
`ec mqu
`
`es
`
`
`
`
`Intractoble pain?
`
`FIG.
`
`1215’
`
`

`
`Patent Application Publication
`
`PI0
`
`US 2003/0178031 A1
`
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`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 15 of 43
`
`US 2003/0178031 A1
`
`OTFC FLOW CHART
`
`
`
`
` Does patient have
`
`
`
`
`
`moderate to severe
`
`Patient requiring ultra
`fast onset opioid for
`severe episodic pain
`
`mucositis?
`
`
`
`Initiate at 200 mcg
`dose unfi
`
`Titrate to dose that
`
`
`
`
`
`
`allows one unit
`
`to
`
`cover episode see
`recommended
`
`process
`
`Reassess
`
`
`
`
`
`
`per
`algorithm
`
`
`
`Pursue other route or
`
`drug options
`
`FIG. 14
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 16 of 43
`
`US 2003/0178031 A1
`
`NSAIDS FLOW CHART
`
`Presence of nociceptive
`pain character
`
`
`
`Does the
`
`
`
`
`
`
`
`patient have a current or
`recent history of peptic
`ulcer disease?
`
`
`Y“
`
`Avoid NSAIDS
`
`
`
`
`
`Reassess
`
`
`
`
`
`within 30 days
`or MD
`
`
`
`
`
`discretion
`
`
`
`Go to NSAID Drug choices
`(P9 40)
`
`
`
` Any evidence of
`
`NSAID related GI
`
`distress?
`
`Go to NSAID Related GI
`
`(pg 103)
`
`Distress protocol
`
`FIG. 15
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 17 of 43
`
`US 2003/0178031 A1
`
`TRICYCLIC AND OTHER ANALGESIC
`
`ANTIDEPRESSANTS FLOW CHART
`
`Presence of neuropaihic
`pain character
`
`
`
`
`
`opioid?
`
`lniiiaie at
`
`low end
`
`
`
`
`of dose range and
`fiiraie up every 3-5
`days
`
`
`
`
`Amiiripiyline 10-150
`mg po qhs or in
`
`divided doses V
`
`
`Noriripiyline 10-150
`mg po qhs or in
`divided doses
`
`
`
`*Desipramine 10-150
`mg po qhs or in
`divided doses
`
`Imipramine 20-200
`mg po qhs or in
`divided doses
`
`
`
`Doxepin 25-100 mg
`po qhs or in divided
`doses
`
`
`
`*Despramine is a good 151
`choice in patients wiih a h/o
`or pre-exisiing drowsiness
`
`FIG.
`
`1614
`
`
`
`
`
`lniiiaie a1 lowest
`
`Is the
`
`paiieni already on
`dose and iiiraie up
`aniiconvulsani or
`every 7 days
`
`
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 18 of 43
`
`Us 2003/0173031 A1
`
`Yes
`
`
`
`Side effecis occur
`wiih iniiiciiion?
`
`
`N0
`
`0
`
`
`
`Buck down io previous
`dose and double the
`
`
`’time beiween ioper
`ups
`
`
`
`Persisieni side
`effecis?
`
`Yes
`
`Swiich io ctliernoie
`aniidepressonis?
`
`Puroxeiine 20-50
`
`mg po qctm
`
`Trozadone 75-225
`
`mg po qd or in
`divided doses
`
`Venlofoxine 75-225
`
`mg po qd or in
`divided doses
`
`Reassessment
`per
`
`Algoriihm
`
`No
`
`
`
`Persisieni side
`effecis?
`
`Yes
`
`Side Eifeci Proiocol
`
`Over—sedc1iion (pg 81)
`Consiipuiion (pg 85)
`Nausea/Vomiting (pg 89)
`Delirium (pg 93)
`Myocionus (pg 97)
`Dry Mouih (pg 100)
`
`CI Disiress (pg 103)
`
`F10.
`
`1615’
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 19 of 43
`
`US 2003/0178031 A1
`
`DEC|S|0NS FLOW CHART
`CO-ANALGESIC DRUG CHOICE
`
`Nocicepiive Pain
`Characier
`
`Neuropoihic Pain
`Character
`
`I
`
`,,
`
`Inmaie/Ophmuze NSAIDS
`
`,
`
`,
`
`I
`
`Iniiioie/Opiimize TCAs
`
`I &/or Anficonvulsoms
`
`I
`
`Mixed Pain
`
`Character
`
`
`
`
`
`Iniiiaie/Opiimize
`NSAIDS/TCAs &/or
`Aniiconvulsonis in
`combinaiion as ioieraied
`
`
`
`per
`algoriihm
`
`Reassess
`
`FIG. 17
`
`
`
`Yes
`Pain conirolled wiih
`co-analgesic alone?
`
`
`
`
`Combine co-analgesic
`wiih an opioid
`
`Opioid Drug Choices
`
`(pg 25)
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 20 of 43
`
`US 2003/0178031 A1
`
`ANTICONVULSANTS FLOW CHART
`
`Presence of nocicepiive
`pain choracier
`
`
` Is he puiieni
`
`already on TCA or
`opioid?
`
`
`
`Iniiiuie at
`low end of
`dose range and iiirafe
`up every 5-5 days
`
`Gabopeniin 100-600
`mg po qid
`
`
`
`
`
`Valproic Acid
`250-1500 mg/days
`as qhs or bid
`
`Carbcimozepine 100
`mg PO bid - 200
`mg qid
`
`*Lamoirigine 25 mg
`po bid - 150 mg
`po qid
`
`
`
`
`
`
`
`
`
`
`
`
`Phenyioin 300 -
`500 mg po qhs
`
`Clonazepam 0.25 mg
`iid - 0.5 mg iid
`
`*TcIper up 01 50 mg/q wk
`
`FIG. 18A
`
`
`
`
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 21 of 43
`
`US 2003/0178031 A1
`
`
`
`
`and fitrote up every 7
`
`days
`
`
`lowest dose
`
`initiate at
`
`
`
` Side effects occur
`time between taper
`with initiation?
`
`ups
`
`
`
`
`Bock down to previous
`dose and double the
`
`
`
`
`
`Persistent side
`
`effects?
`
`
`
`
`Side Effect Protocol
`
`
`Over—sedc:tion (pg 81)
`Consfipoflon (pg 85)
`Nouseo/Vomiting (pg 89)
`
`FIG. 185’
`
`
`
`Reassessment
`
`per
`Algorithm
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 22 of 43
`
`US 2003/0178031 A1
`
`
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`Patent Application Publication
`
`Sep. 25, 2003 Sheet 23 of 43
`
`Us 2003/0173031 A1
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`Patent Application Publication
`
`Sep. 25, 2003 Sheet 24 of 43
`
`US 2003/0178031 A1
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`Patent Application Publication
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`Sep. 25, 2003 Sheet 25 of 43
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`US 2003/0178031 A1
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`Patent Application Publication
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`Sep. 25, 2003 Sheet 26 of 43
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`US 2003/0178031 A1
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`Patent Application Publication
`
`5
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`2
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`US 2003/0178031 A1
`
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`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 28 of 43
`
`US 2003/0178031 A1
`
`
`
` Do you suspect
`
`
`analgesic etiology?
`
`Patient reports
`distressing dry mouth
`
`
`Suspect TCA—induced?
`
`
`
`Suspect
`opioid_induced?
`
`
`
`Encourage increased
`fluid intake
`
`Offer mouth lubricants
`
`Sugarless gum or candy
`
`
`
`
`
`Dry mouth
`resolved?
`
`No
`
` Reassess
`within 30 days
`
`or MD
`discretion
`
`
`
`
`Yes
`
`Discontinue TCA
`
`Pilocarpine 5-10
`mg po tid
`
`Consider endodontic
`
`cansuh
`
`FIG. 22
`
`
`
`7 days-
`ISO days
`
`
`
`Reassess
`
`
`
`
`Consider switching to
`Optimize non—TCA
`non—TCA antidepressant
`co-analgesics for
`or anticonvulsant
`opioid-sparing effect
`
`
`
`
`
`

`
`Patent Application Publication
`
`B
`
`92
`
`US 2003/0178031 A1
`
`1wmco_.6E£E
`
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`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 30 of 43
`
`US 2003/0178031 A1
`
`
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`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 31 of 43
`
`US 2003/0178031 A1
`
`Puiieni/caregiver reporis
`disiressing myoclonus
`
`MYOCLONUS FLOW CHART
`
`
`Suspeci opioid
`eiiology?
`
` No
`
`Yes
`
`
`
`pain level allow for
`
`Workup
`Diognosiic
`reducing opioid
`
`dose?
`
`Does
`
`
`
`Decrease curreni dose
`
`*Swi’rch i0 oliernoie
`
`opioid
`
`Maximize
`
`of opioid by 50%
`
`Aciion ioken ioword
`
`cousoiive condition
`
`
`co-analgesic for
`opioid sparing effeci
`
`
`
`T Reossess
`
`Redssess
`
`wiihin 30 days
`or MD
`
`24-72 hrs
`
`
`
`Treui wiih
`
`
`
`
`
`
`
`
`
`
`discreiion
`
`benzodiozepines/
`
`oniisposmodics
`Consider regional
`
`biockode/ spinal
`odminisiruiion
`
`
`
`-
`*Consider fenianyl due
`to lock of active
`
`Myoclonus resolved?
`
`Yes
`
`meioboliiies
`
`FIG. 24
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 32 of 43
`
`US 2003/0178031 A1
`
`GI DISTRESS FLOW CHART
`
`
`Suspect NSAID
`etiology?
`
` No
`
`Yes
`
`Patient reports
`GI distress
`
`b
`
`Add mucosal
`
`protectont
`
`
`
`
`Switch to NSAID
`
`with lesser Gl
`
`toxicity profile
`
`Diagnostic
`Workup
`
`Action taken toward
`causative condition
`
`
`
`Yes
` Gt distress
`resolved?
`
`
`
`7-30 days
`
`Reassess
`
`
`
`
`
`Disclofenac 50/75
`mg with Misoprostal
`200 me
`
`
`
`
`
`within 30 days
`or MD
`discretion
`
`mo P0 bid
`
`
`
`Reassess
`
`
`7-30 days
`
`
`
`Gl distress
`resolved?
`
`
`
`
`Discontinue
`
`NSAID
`
`N0
`
`FIG. 25
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 33 of 43
`
`US 2003/0178031 A1
`
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`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 34 of 43
`
`US 2003/0178031 A1
`
`%mGE
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`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 35 of 43
`
`US 2003/0178031 A1
`
`REGIONAL FLOW CHART
`
`Pursue other
`
`route/drug options
`
`N0
`
` localized to 2 or 3
`dermatomes or single
`sympathetic ganglion
`dismbution?
`
`
`
`Yes
`
`Anesthesia
`
`Consult
`
`Presence of severe
`episodic pain requiring
`ultrafost onset of action
`
`systemic therapy
`
`Severe persistent pain
`uncontrolled by optimized
`
`Pain controlled on less
`
`
`
`invasive therapy but with
`unmanageable side effect
`
`
`
`
`
`Diagnostic
`Block
`
`Yes
`
`Yes
`
`
`Side effect protocols
`
`exhausted?
`Was there
`
`relief?
`
`
`Side Effect Protocol
`
`CI Distress (pg 103)
`
`Over—sedation (pg 81)
`Constipation (pg 85)
`Nausea/Vomiting (pg 89)
`,,
`Delirium (pg 93)
`Myoclonus (pg 97)
`Dry Mouth (pg 100)
`
`Spinal Protocol
`(P9 75)
`
`Consider Neurolytic Block
`if amenable
`
`FIG. 27
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 36 of 43
`
`US 2003/0178031 A1
`
`SPINAL ADMlNlSTRATlON/PROCEDURES FLOW CHART
`
`Pursue trial of OTFC
`
`&/or parental
`
`Yes
`
`
`
`
`
`Would OTFC or
`parental be feasible/
`cost-effective?
`
` Anesthesia/
`
`
`Neurosurgery
`Consuh
`
`
`
`Yes
`
`
`Does the patient
`have a capable
`caregiver?
`
`
`No
`
`Care conference to
`
`discuss options
`
`Presence of severe
`
`episodic pain requiring
`
`ultrafast onset of action
`systemic therapy
`
`Severe persistent pain
`uncontrolled by optimized
`
`Pain controlled on less
`
`unmanageable side effect
`
`invasive therapy but with
`
`
`
`Side effect protocols
`exhausted?
`
`
`Yes
`
`Side Effect Protocol
`
`Over—sedation (pg 81)
`Constipation (pg 85)
`Nausea/Vomiting (pg 89)
`
`Gl Distress
`
`Myoclonus
`Dry Mouth (
`
`' Proceed with Se|ection/
`Placement of Device
`
`FIG. 28
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 37 of 43
`
`US 2003/0178031 A1
`
`TRICYCLIC AND OTHER ANALGESIC
`
`ANTIDEPRESSANTS FLOW CHART
`
`Paiiem‘ requiring
`non—oral
`roule
`
`Palienl requiring a trial
`
`of fenianyl
`in
`sequeniial
`irials
`Does lhe palienl
`have a conslanl pain
`paliern?
`
`Palienl nonadherenl
`
`
`
`secondary To mulliple dosing
`8c/or mulliple meds
`
`
`
`
`
`Trial
`indicaied for
`
`potential benefil of
`less
`consfipafion
`
`
`
`Tiirale afier 72
`
`dose accounfing for
`ihe amounl of
`
`rescue opioids used
`by palieni.
`
`
`
`hours lo a new
`
`
`
`
`
`
`
`Avoid muliiple paiches
`wilh differing
`replacemenl schedules
`
`FIG. 29/1
`
`Increase dose al 72
`
`hour changes
`
`
`
`per
`algorilhm
`
`
`
`Reossess
`
`

`
`Patent Application Publication
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`Sep. 25, 2003 Sheet 38 of 43
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`US 2003/0178031 A1
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`Pursue other
`
`route/drug options
`
`Proceed with trial and
`
`early reassessment
`
`
`
`
`Does
`
`
`
`the patient
`Is
`opioid tolerant?
`
`
`
`
`the patient have a
`history of sensitivity to
`skin adhesiv
`
`
`
`
`
`Initiate with 25 mcg
`patch
`
`Make rescue opioids
`available
`
`Convert using
`equianalgesic table
`
`Previous analgesics
`must be continued for
`18 hours
`
`
`
`Make reseluiloplol s
`avala e
`
`.
`
`.d
`
`
`
`
`
`
`the patient have
`rapidly escalating
`pain?
`
`
`
`Initial
`
`
`reassessment
`
`72 hrs
`
`
`FIG. 2.95’
`
`

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`Patent Application Publication
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`Sep. 25, 2003 Sheet 39 of 43
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`US 2003/0178031 A1
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`Patient Name .
`
`Phone Triage Note
`
`Painlsymptom Assessment
`
`Location:
`
`Intensity (now) ___/10
`Is this a new pain? Yes No
`Other Pain Descriptors: (circle) continuous pain, intermittent spikes of pain,
`pain changes all the time, dull, sharp, radiating, aching, burning, shooting
`
`What pain medicine is ordered?
`What pain medicine is patient actually taking?
`Side effects (constipation, dry mouth, drowsiness, confusion, nausea, vomit)
`
`Treatment Plan
`
`D Make appointment to come in:
`D Increase/decrease scheduledIPRN opioid dose
`El Change opioid
`[1 Change route
`:1 Reinforce: take meds on schedule, use PRN meds, state unrelieved pain,
`refills
`
`El Add tricyclic antidepressant I anticonvulsant:
`D Add NSAID:
`
`D Add non-drug intervention: (circle) heat, cold, massage, distraction, relaxation,
`TENS
`
`confusion
`
`nausea
`
`[3 Treat side effects: (circle)
`constipation dry mouth
`drowsiness
`D Referrals:
`(circle)
`social work
`psychiatry
`
`physical therapy
`
`anesthesia
`
`radiation
`
`Notes:
`
`Next follow up (phone
`
`visit
`
`)
`
`Signature
`
`Date
`
`FIG. 30
`
`

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`Patent Application Publication
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`Sep. 25, 2003 Sheet 40 of 43
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`US 2003/0178031 A1
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`Pain Algorithm
`Standing Orders
`Patient
`
`Physician
`Date
`
`V Check appropriate boxes below
`
`Pain Assessment
`
`_Assess pain with each patient contact.
`[2 Pain intensity on a 0 — 10 scale with each patient contact.
`l2IAssess pattern of pain:
`Continuous pain only
`Continuous pain with some intermittent pain
`Intermittent pain only
`M Assess pain character with each patient contact:
`(Aching, throbbing, dull, sharp, burning, stabbing)
`Assess common side effects of analgesics with each patient contact.
`(Constipation, nausea, GI distress, sedation, delirium, dry mouth,
`myoclonus)
`
`Co-Analgesics
`__ Nonsteroidal anti—inflammatory for somatic or visceral pain at any level.
`1. _lbuprofen 600 — 800 mg PO tid
`. ____Cho|ine magnesium trisalicylate 1000 - 1500 mg PO tid
`Diclofenac 50 - 75 mg P0 tid
`Etodolac 250 — 400 mg PO q6-8 hr
`Ketoprofen 50 — 75 mg PO qid
`Salsalate 750-1500 mg P0 tid
`Sodium Salicylate 1000 — 1500 mg PO tid
`Naproxen 375 — 550 PO bid
`Flurbiprofen 50 — 100 mg PO tid
`lndomethacin 75 mg pr bid
`Oxaprozin 600-1800 mg PO qd
`Sulindac 200 mg PO bid
`Diflunisal 500 mg PO tid
`Piroxicam 20 mg qd
`Nabumetone 500 — 750 mg P0 tid
`_Sequential trials of agents #
`__Nonsteroidal anti—inflammatory drugs contraindicated for patient
`
`.‘°P°.“9°!'-"P.°°'°
`
`10.
`11.
`12.
`13.
`14.
`15.
`
`1
`
`FIG. 31A
`
`

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`Patent Application Publication
`
`Sep. 25, 2003 Sheet 41 of 43
`
`US 2003/0178031 A1
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`__ Tricyclic antidepressant for neuropathic pain at any level.
`1. ___Amitripty|ine 10 mg P0 qhs; increase by 10-25 mg q3-5d up to max 150
`mg/day
`2. ___Nortripty|ine 10 mg PO qhs; increase by 10-25 mg q3-5d up to max 150
`mg/day
`3. ___Desipramine 10 mg PO qd; increase by 10-25 mg q3-5d up to max 150
`mg/day
`4. _Doxepin 10 mg PO q hs; increase by 10-25 mg q 3-5d up to max 150
`mg/day
`____Sequentia| trials of agents #
`_Previous side effects contralndicate use in this patient
`
`Anticonvulsants for neuropathic pain unrelieved by tricylics alone, or when tricyclics
`cause unmanageable side effects (i.e. instead of tricyclics)
`1. ___Carbamazepine 200 mg P0 bid — increase. by 100 mg/day q5-7d up to
`800 mg! day
`2. _Gabapentin 100 mg PO tid — increase by 300 mg/day q5-7d up to 3000
`mg/day
`3. ___Lamotrigine 25 mg PO bid — increase by 50 mg/day q7d up to 600 mg/day
`__Sequential trials of agents #
`__Previous side effects contraindicate use in this patient
`
`l2l For patients on both tricyclic and anticonvulsant drugs be aware of synergy
`between agents - may need to decrease dose of one or the other
`check serum tricyclic levels if patient experiences increasing sedation while on
`k stable doses of tricylic / anticonvulsant combinations
`
`Side Effects
`
`_ For patients that experience side effects — initiate appropriate side effect protocol.
`Nausea
`
`El Constipation
`Oversedation
`
`lZl Dry Mouth
`I21 Delirium
`
`l2l Myoclonus
`l2l GI Distress
`
`Opioid Therapy
`__First time initiation of opioids
`Utilize intermittent pain orders to initiate therapy -— may convert to long acting
`opioids after 72 hrs for control of continuous pain
`M Initiate constipation protocol
`Reinforce to patient to report sedation, nausea, rash, etc
`
`F10. 3115’
`
`

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`Patent Application Publication
`
`Sep. 25, 2003 Sheet 42 of 43
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`US 2003/0178031 A1
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`____lntermittent pain
`___Opioid Nai've Patients
`Do not exceed 4000 mglday of Acetaminophen
`1. ___Codeine 30 mg with APAP 325 mg;
`i-ii tab PO q4h PRN
`2. ____Hydrocodone 5 mg with APAP 325 mg; i-ii tab PO q4h PRN
`3. ___Hydrocodone 7.5 mg with APAP 500 mg; i-ii tab P0 q4h PRN
`4. _Hydrocodone 10 mg with APAP 500 mg; i-ii tab PO q4h PRN
`5. __Oxycodone 5 mg with APAP 325 mg; i-ii tab P0 q4h PRN
`6. __Oxycodone 5 mg; i-ii tab PO q4h PRN
`__Sequential trials of agents #
`
`__0pioid Tolerant Patients
`Do not exceed 4000 mg I day of acetaminophen
`1. __Oxycodone 5 mg with APAP 325 mg; i-ii tab PO q4h PRN
`__Oxycodone 5 mg; i-ii tab PO q4h PRN
`_Hydromorphone 2 mg tab; i-iii tab PO q4h PRN
`. __Hydromorphone 4 mg tab; i-iii tab PO q4h PRN
`. __Hydromorphone 8 mg tab; i-iii tab PO q4h PRN
`. __Hydromorphone 4 mg suppository; i-ii pr q4h PRN
`__Morphine Sulfate 10 mg tab; i-iii tab PO q4h PRN
`__Morphine Sulfate 15 mg tab; i-iii tab PO q4h PRN
`__Morphine Sulfate 30 mg tab; i-iii tab PO q4h PRN
`0.__Morphine Sulfate Solution 1 mg/mL; ‘/2 to 5 mL PO q 2-4 hr.
`PRN
`
`-‘.‘°.°°.“°"°"‘S*’!"
`
`11.__Morphine Sulfate Solution 20 mg/mL; ‘/2 to 5 mL PO q 2-4 hr.
`PRN
`
`12.___Morphine Sulfate 5 mg suppository; i-ii pr q4h PRN
`13.__Morphine Sulfate 10 mg suppository; i-ii pr q4h PRN
`14. __Morphine Sulfate 20 mg suppository; i-ii pr q4h PRN
`15.___Morphine Sulfate 30 mg suppository; i-ii pr q4h PRN
`16. _Oxymorphone 5 mg suppository; i-ii pr q4h PRN
`
`_Sequentia| trials of agents #
`
`___Continuous Pain
`_____Opioid Naive Patients
`__After 72 hours on short acting opioids convert opioid naive
`patients with continuous pain to long acting agents — utilize
`equal dose for same opioid — 30% reduction when changing
`opioids
`
`FIG. 31C
`
`

`
`Patent Application Publication
`
`Sep. 25, 2003 Sheet 43 of 43
`
`US 2003/0178031 A1
`
`S°.°°.“.°’.°':".°’.N.-‘
`
`__Opioid Tolerant Patients
`___Oxycodone Controlled Release 10mg tabs; i-iii PO q 8-12 hrs
`__Oxycodone Controlled Release 20mg tabs; i-iii PO q 8-12 hrs
`_0xycodone Controlled Release 40mg tabs; i-iii PO q 8-12 hrs
`___Oxycodone Controlled Release 80mg tabs; i-iii PO q 8-12 hrs
`___Morphine Slow Release 20 mg capsule PO q 12-24 hrs
`_Morphine Slow Release 15 mg tabs; i-iii PO q 8-12 hrs
`Morphine Slow Release 30 mg tabs; i-iii PO q 8-12 hrs
`Morphine Slow Release 50 mg capsule P0 q 12-24 hrs
`__Morphine Slow Release 60 mg tabs; i-iii PO q 8-12 hrs
`Morphine Slow Release 100 mg tabs; i-iii PO q 8-12 hrs
`10.
`Morphine Slow Release 100 mg capsule PO q 12-24 hrs
`11.
`Morphine Slow Release 200 mg tabs; i-iii P0 q 8-12 hrs
`12.
`Transdermal Fentanyl 25 mcg patch; i-ii q 72 hrs
`13.
`Transdermal Fentanyl 50 mcg patch; i-ii q 72 hrs
`14.
`Transdermal Fentanyl 75 mcg patch; i-ii q 72 hrs
`15.
`Transdermal Fentanyl 100 mcg patch: i-iii q 72 hrs
`16.
`Levodromoran 2 mg tabs; 1-3 tabs PO q6hrs
`17.
`Levodromoran 2 mg tabs; 4-6 tabs PO q6hrs
`18.
`19. Methadone 10 mg tabs; 1/4 - 1/2 tab PO q6hrs
`20. Methadone 10 mg tabs; i-iii tab PO q6hrs
`21. Methadone 10 mg tabs; 4 — 6 tab PO q6hrs
`Sequential trials of agents #
`
`l l
`
`llllll
`
`_IntermittentI Continuous Pain
`Utilize intermittent and continuous drug selections above
`__Patients with primarily continuous pain and some intermittent pain
`should have short acting opioids available at a dose that is 10-30%
`of their 24 hour dose of long acting opioids
`__Patients with severe intermittent pain and mild-moderate continuous
`pain should have their short acting opioids titrated to effect
`independently from their long acting opioids.
`
`__Titration Protocols
`_Opioid Nai've Patients
`_Pain level l_e_s_.§ than 6I10 titrate opioid dose (10-30%) on a daily basis
`to a pain level of 4/10 or below.
`___Pain level 2 7 call physician refer to pain crisis intervention.
`
`__Opioid Tolerant Patients
`___Pain level less than 6/10 titrate opioid dose (20-50%) on a daily basis
`to a pain level of 4/10 or below.
`___Pain level 2 7 call physician and refer to pain crisis Intervention.
`
`FIG. 31D
`
`

`
`US 2003/0178031 A1
`
`Sep. 25, 2003
`
`METHOD FOR CANCER PAIN TREATMENT
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`[0001] This application claims the benefit of U.S. Provi-
`sional Patent Application No. 60/133,044 filed May 7, 1999,
`where this provisional application is incorporated herein by
`reference in its entirety.
`
`STATEMENT OF GOVERNMENT INTEREST
`
`[0002] This invention was made with government support
`under 5 R01 CA64877-03 awarded by The National Insti-
`tutes of Health, National Cancer Institute. The government
`has certain rights in the invention.
`
`TECHNICAL FIELD
`
`[0003] The present invention pertains to the treatment of
`pain, and, more particularly to a cancer pain management
`system that implements an algorithmic process for assess-
`ment, treatment decisions, and reassessment that is continu-
`ous o