Letters,
`
`Third-party Payer RelmJ,ursement for Patient Education
`and Pharmacokinetic Dosing Services
`
`The Ohio Slate University Hospitals was heing reimhul'sed
`by 0Blue Cros.<; of Central Ohio for five· palienl•training pro(cid:173)
`grams. 1 As of Septc{llbe~ I, I 978, thore· are two additional
`reimhurs.ement prngrams: a steroid administration training
`program and a pharmacokinetic dosing s.ervice.
`Pharmacists , upnn a wri tten order 'by a physiciaa,, train pa(cid:173)
`tients with adrenal insufficiency to administer steroids intra(cid:173)
`muscularly. A total uf 18 patients have been inslrucled within
`•the last six months. Blue Cros~ of Cenlrs1l Ohio has approved
`a S2fi charge for this training pro1,'l'am.
`The pharmacoki11elic'dming service provides for the phar(cid:173)
`macist t,, do the following:_
`I. He~iew all relev~nl patient daln.
`.2. Plan initial plaiim11 Mmpllnai ir required.
`•
`:t Interpret nnd mnke reeomme11dntiut1R for drul( dose,; ha,<etl
`upnn lhe plasma concentrati11n.
`4. Asse~s the res11ltonl ,;erum druic concentrati1•n~.
`ii. Prepa re a writlen.repHrl.
`.
`6. PreJ)llre,o ,c111nputer-i:e11ernlerl J)lul ur drug ·cun~cntralinn
`ver.;u.s time.
`Blue Cross of Central Ohi<, will reimhu!'1'~ the l10s1>ital.S2O
`for each do.,ing cons.ult (one pell' pat ient). ' l'hil'I charge is rendered
`by the pharmacy and d1ies nol include any costs m t'eesa1-.~nci (cid:173)
`ated with the laboratory test!'!:
`'!'he ap1>r;,val for both progtams re.~ul ~ed from meeLingfi with ·
`Blue Cross nf Cent ral Ohi(I officers, Myles P. Lash, Adrn inis(cid:173)
`tratur, University liuspit:1ls, and me. Both p~ogr.ims will he
`required lo demonstrate C<>$I, effectivene~c; usintc preyioui;ly
`agrted upon standard!'. of performance.
`1. Nold 1-x; and i>Atl,nk OS: Third•1>nr\y rfimhur:wmc111 for clinieul
`pharmocy .lll!l'\' ice><: phil"""i>hY nncl 1,rorli~t>. i\1>1 J Hi,.:p l'lmrm
`;J./:82:1~213 IA11~• 197i.
`Edward G. Nold, l'.1-S., A<.,.,,cia1 ~ Direct<,r
`/)c-parrmrnt of l'lrnrma,·:,·
`"
`U11iurr.~i1.,· Hriipit nl.<
`.//(/ IV. /IW1 Ar1•11t11•
`CtilLfmbu.,. OH .J:/2/11
`
`.
`.
`·Mannitol Crystallization in Plastic Container~
`
`0
`
`Several months all'" I had an unexpected experience while
`bring this ln l1'1e
`using,mannitol 25% injection.. I would like to
`attenti(fn of hosp it.al pharmacisLS as il poses a potential prob•
`lem.
`•
`,
`An rm:ler was r-cceived for mam1itol 2fi I( to he given over :10
`minutes. This n~sitated placing 100 ml of mannilol 25% into
`an empty Vianex hag. Adminiiltr11tiun wa~ delayed <l[lC hour, ily,
`which time a very heavy, white llocculent precipitate appeared.
`I repeated the events using new material and found the pricip(cid:173)
`ita'tc formed in 12 minutes.·
`Using a fresh vial of mannilol I placed some into bhe Com•.
`tinu0o tuhiri!( and had ihe same results. Placing arn,thersample
`into a plla~tic20-ml syringe t\t{ain ga\'t> t he prccipiu1te.
`I am aware that matmitol commonly crystalliz-es when ex•
`p<>scd Lo low temperal\1re. This could 1J11t he the c.ise in th~
`instances since at no time was Lhe mannitol ei.p()sed to lcrn•
`peratures below 75 F. Furthermore, the llocculenl preci1>ita1.e
`ubse.rved in 110. way re.~emhled the more commrn, larice cry:;(cid:173)
`tals.
`I realize lhat usual I~• mannilol is l(iven over a short J)eri1ld c1f
`time and t his problem mav be.mi11imi1.ed. It is my intention to·
`report.tihisoccurrence in ~se_there i~· some sil(nificance ~o it.
`
`Edward Epperson, Pharm. D.
`Assisten~ Director of Pharma.cy Arfairs
`Woarlland MC'm11rial H,mpital
`132!; C1111,11i1vuud Str<'t'I
`W11ocl/a11d, CA ~95
`
`The observations reported by Dr. Epperson relative tu crys(cid:173)
`tnllizat ion of supersat ura ted solutions nr mannitol when ex(cid:173)
`tempnraneoui1ly packaged in tir allowed lo cont.act plastic par•
`enteral cunt.a.iners, plastic admini~tration lubing and plastic
`syringes are accurate.
`The aque1ms room temperature solubility of manniLol is in
`the neighborhctod or 18% w/v. Supersaturated :;0)11tiuns of20%
`·and ·25,,:. w/v are eummercially availahle. Such pmduc("' fre,
`quently contain the long, needle-like cryi;tals L)'J>iClll ofrnai~niwl
`which ha!I ·undergone sluw, relatively undiNturhcd cr~•stnl
`growth. Jn case~ where such crystal l(rowth has occurred, the
`mam1itol moy lie rel)oluhi lize<I by the aid of heat as described
`in the prt►duct's laheling. Recrysta!tizalion nocrmnlly doe!\ not
`occu r during the lime required for Jldminislralion to the pa-
`'t.ienl..
`·
`Ple!ltk container or plafitic admini~treti1111 device !<Urfoce
`characteristic:!; f're<iuenlly differ from thc>i;C ufthe 11l11sscont3iner
`orii,:inally utilized tu packa~e the pmcluct. These surface.-. may
`act as nucll'i for cryi;talfo.alilln to occur at n rapid role, therehy
`providing alyJ>icallr smell cr)'Sf.Jlls when su1>ersaturated man(cid:173)
`nitCII injccUon!. ore ut ilized. Resi1luhilizalion of these cr)<-Stal,::
`,with. the nid of heat will ncil prove fr'1ilfu l becau!'e the material
`may recrystallize within a short lime period.
`Where ~olution volume intake is not a rnajur 1..·oncem, thi:,
`prnblecn may be overcome hy aque-ou,:: dilution of the super(cid:173)
`.saturnted injection to I 8'1:, w/v or le!'..~ J>rior. lo contarL with the
`pla,i.ic c:ontainer or adminis4rat.ion d~vice. In all ('a.-<e.'I, ht1wever,
`it iis ,our iecomrnendalion lhal a filtra tion devic:1c he u~ed d urin!{
`the administmlion or the lluid.
`R L. Nfdith, Ph.D.,S~niur Mnnn~l'r, JJJutr1n:1ceutiml De\·eh~i ment
`' 7'rmwnul l.ahomtr,ri,•s. Ju ...
`{)J(I / /,1'nwlr1 .-1,·,·nuc·
`Mrirwn {;r11ri•. //, lit11I,:;:1
`
`Salary Survey of Hosplt:al Pharmacy Residency Programs
`
`'rhe Rhude Ii-lRnd Ho!:pital Department of Pharmacy con(cid:173)
`ducted a salary sur\'ey or pharmacy re~idency proj(ram~ in
`hvspitals in Marth 1973. Qucstionnnir~ were mailed lo eoch
`of the 89 tr11ini ng proj!rams accredited hy the American &1ciety
`of Hospital Pharmaci~ts al that t ime. Eighty-two (88%) uf the
`q,1e:f;tiunnairei- were com1,letM and rt>turnecl. Similar surveys
`were cmrduc·ted in I 97fl,I I 976~ and 1977 .:1
`The salary rnni:c, hased on an annunl ~tipcnd, for the 12-
`mt,nlh nunocadcmic, m>r11(m·ernmemt:il 1>m~ram~ (N = 48) was
`• $6.BO0~$I :,,9.:\2. The menn wa« $ I0,796 and the median $10,670.
`'The 1977 .sur\•cy reveale<I a mean and medi1ui of SI0,2:tl and
`$10,:120, rei:peclively.
`The :-alary ranl{e ror mmat'adem iC', ~overnmental pro~ram:1
`(N = 111 wa:i $13,000-$20,6fi2 wiLh a mean 11f $l.5,G40 a1ld a
`median or$i4 .i12. ThC!;e programi. are 12 months in duration.
`l n analyzinl( tihe data l'rom the programs surveyed which were
`offere,d l;y the various f:oVemmenta~ ~ r,·icci: one mrn,t co111:ider
`other-criteria since in m:any instan c~~ linanciol remuneration
`
`Continued on pa,:e 1340
`
`Vol 35 Nov 1976 Allle{iC81l JOll"nal or Hospital Pharmacy 1337
`
`FRESENIUS EXHIBIT 1009
`Page 1 of 1
`
`
`
`Third-party Payer RelmJ,ursement for Patient Education
`and Pharmacokinetic Dosing Services
`
`The Ohio Slate University Hospitals was heing reimhul'sed
`by 0Blue Cros.<; of Central Ohio for five· palienl•training pro(cid:173)
`grams. 1 As of Septc{llbe~ I, I 978, thore· are two additional
`reimhurs.ement prngrams: a steroid administration training
`program and a pharmacokinetic dosing s.ervice.
`Pharmacists , upnn a wri tten order 'by a physiciaa,, train pa(cid:173)
`tients with adrenal insufficiency to administer steroids intra(cid:173)
`muscularly. A total uf 18 patients have been inslrucled within
`•the last six months. Blue Cros~ of Cenlrs1l Ohio has approved
`a S2fi charge for this training pro1,'l'am.
`The pharmacoki11elic'dming service provides for the phar(cid:173)
`macist t,, do the following:_
`I. He~iew all relev~nl patient daln.
`.2. Plan initial plaiim11 Mmpllnai ir required.
`•
`:t Interpret nnd mnke reeomme11dntiut1R for drul( dose,; ha,<etl
`upnn lhe plasma concentrati11n.
`4. Asse~s the res11ltonl ,;erum druic concentrati1•n~.
`ii. Prepa re a writlen.repHrl.
`.
`6. PreJ)llre,o ,c111nputer-i:e11ernlerl J)lul ur drug ·cun~cntralinn
`ver.;u.s time.
`Blue Cross of Central Ohi<, will reimhu!'1'~ the l10s1>ital.S2O
`for each do.,ing cons.ult (one pell' pat ient). ' l'hil'I charge is rendered
`by the pharmacy and d1ies nol include any costs m t'eesa1-.~nci (cid:173)
`ated with the laboratory test!'!:
`'!'he ap1>r;,val for both progtams re.~ul ~ed from meeLingfi with ·
`Blue Cross nf Cent ral Ohi(I officers, Myles P. Lash, Adrn inis(cid:173)
`tratur, University liuspit:1ls, and me. Both p~ogr.ims will he
`required lo demonstrate C<>$I, effectivene~c; usintc preyioui;ly
`agrted upon standard!'. of performance.
`1. Nold 1-x; and i>Atl,nk OS: Third•1>nr\y rfimhur:wmc111 for clinieul
`pharmocy .lll!l'\' ice><: phil"""i>hY nncl 1,rorli~t>. i\1>1 J Hi,.:p l'lmrm
`;J./:82:1~213 IA11~• 197i.
`Edward G. Nold, l'.1-S., A<.,.,,cia1 ~ Direct<,r
`/)c-parrmrnt of l'lrnrma,·:,·
`"
`U11iurr.~i1.,· Hriipit nl.<
`.//(/ IV. /IW1 Ar1•11t11•
`CtilLfmbu.,. OH .J:/2/11
`
`.
`.
`·Mannitol Crystallization in Plastic Container~
`
`0
`
`Several months all'" I had an unexpected experience while
`bring this ln l1'1e
`using,mannitol 25% injection.. I would like to
`attenti(fn of hosp it.al pharmacisLS as il poses a potential prob•
`lem.
`•
`,
`An rm:ler was r-cceived for mam1itol 2fi I( to he given over :10
`minutes. This n~sitated placing 100 ml of mannilol 25% into
`an empty Vianex hag. Adminiiltr11tiun wa~ delayed <l[lC hour, ily,
`which time a very heavy, white llocculent precipitate appeared.
`I repeated the events using new material and found the pricip(cid:173)
`ita'tc formed in 12 minutes.·
`Using a fresh vial of mannilol I placed some into bhe Com•.
`tinu0o tuhiri!( and had ihe same results. Placing arn,thersample
`into a plla~tic20-ml syringe t\t{ain ga\'t> t he prccipiu1te.
`I am aware that matmitol commonly crystalliz-es when ex•
`p<>scd Lo low temperal\1re. This could 1J11t he the c.ise in th~
`instances since at no time was Lhe mannitol ei.p()sed to lcrn•
`peratures below 75 F. Furthermore, the llocculenl preci1>ita1.e
`ubse.rved in 110. way re.~emhled the more commrn, larice cry:;(cid:173)
`tals.
`I realize lhat usual I~• mannilol is l(iven over a short J)eri1ld c1f
`time and t his problem mav be.mi11imi1.ed. It is my intention to·
`report.tihisoccurrence in ~se_there i~· some sil(nificance ~o it.
`
`Edward Epperson, Pharm. D.
`Assisten~ Director of Pharma.cy Arfairs
`Woarlland MC'm11rial H,mpital
`132!; C1111,11i1vuud Str<'t'I
`W11ocl/a11d, CA ~95
`
`The observations reported by Dr. Epperson relative tu crys(cid:173)
`tnllizat ion of supersat ura ted solutions nr mannitol when ex(cid:173)
`tempnraneoui1ly packaged in tir allowed lo cont.act plastic par•
`enteral cunt.a.iners, plastic admini~tration lubing and plastic
`syringes are accurate.
`The aque1ms room temperature solubility of manniLol is in
`the neighborhctod or 18% w/v. Supersaturated :;0)11tiuns of20%
`·and ·25,,:. w/v are eummercially availahle. Such pmduc("' fre,
`quently contain the long, needle-like cryi;tals L)'J>iClll ofrnai~niwl
`which ha!I ·undergone sluw, relatively undiNturhcd cr~•stnl
`growth. Jn case~ where such crystal l(rowth has occurred, the
`mam1itol moy lie rel)oluhi lize<I by the aid of heat as described
`in the prt►duct's laheling. Recrysta!tizalion nocrmnlly doe!\ not
`occu r during the lime required for Jldminislralion to the pa-
`'t.ienl..
`·
`Ple!ltk container or plafitic admini~treti1111 device !<Urfoce
`characteristic:!; f're<iuenlly differ from thc>i;C ufthe 11l11sscont3iner
`orii,:inally utilized tu packa~e the pmcluct. These surface.-. may
`act as nucll'i for cryi;talfo.alilln to occur at n rapid role, therehy
`providing alyJ>icallr smell cr)'Sf.Jlls when su1>ersaturated man(cid:173)
`nitCII injccUon!. ore ut ilized. Resi1luhilizalion of these cr)<-Stal,::
`,with. the nid of heat will ncil prove fr'1ilfu l becau!'e the material
`may recrystallize within a short lime period.
`Where ~olution volume intake is not a rnajur 1..·oncem, thi:,
`prnblecn may be overcome hy aque-ou,:: dilution of the super(cid:173)
`.saturnted injection to I 8'1:, w/v or le!'..~ J>rior. lo contarL with the
`pla,i.ic c:ontainer or adminis4rat.ion d~vice. In all ('a.-<e.'I, ht1wever,
`it iis ,our iecomrnendalion lhal a filtra tion devic:1c he u~ed d urin!{
`the administmlion or the lluid.
`R L. Nfdith, Ph.D.,S~niur Mnnn~l'r, JJJutr1n:1ceutiml De\·eh~i ment
`' 7'rmwnul l.ahomtr,ri,•s. Ju ...
`{)J(I / /,1'nwlr1 .-1,·,·nuc·
`Mrirwn {;r11ri•. //, lit11I,:;:1
`
`Salary Survey of Hosplt:al Pharmacy Residency Programs
`
`'rhe Rhude Ii-lRnd Ho!:pital Department of Pharmacy con(cid:173)
`ducted a salary sur\'ey or pharmacy re~idency proj(ram~ in
`hvspitals in Marth 1973. Qucstionnnir~ were mailed lo eoch
`of the 89 tr11ini ng proj!rams accredited hy the American &1ciety
`of Hospital Pharmaci~ts al that t ime. Eighty-two (88%) uf the
`q,1e:f;tiunnairei- were com1,letM and rt>turnecl. Similar surveys
`were cmrduc·ted in I 97fl,I I 976~ and 1977 .:1
`The salary rnni:c, hased on an annunl ~tipcnd, for the 12-
`mt,nlh nunocadcmic, m>r11(m·ernmemt:il 1>m~ram~ (N = 48) was
`• $6.BO0~$I :,,9.:\2. The menn wa« $ I0,796 and the median $10,670.
`'The 1977 .sur\•cy reveale<I a mean and medi1ui of SI0,2:tl and
`$10,:120, rei:peclively.
`The :-alary ranl{e ror mmat'adem iC', ~overnmental pro~ram:1
`(N = 111 wa:i $13,000-$20,6fi2 wiLh a mean 11f $l.5,G40 a1ld a
`median or$i4 .i12. ThC!;e programi. are 12 months in duration.
`l n analyzinl( tihe data l'rom the programs surveyed which were
`offere,d l;y the various f:oVemmenta~ ~ r,·icci: one mrn,t co111:ider
`other-criteria since in m:any instan c~~ linanciol remuneration
`
`Continued on pa,:e 1340
`
`Vol 35 Nov 1976 Allle{iC81l JOll"nal or Hospital Pharmacy 1337
`
`FRESENIUS EXHIBIT 1009
`Page 1 of 1
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
