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US Health Care Professional Perspectives on Adverse Drug Event Reporting in the Hospital Setting and the Opportunity for Information Technology Gustavo Grampp Amgen Inc. ! Stella Stergiopoulos, Tufts CSDD; Carrie A. Brown, Tufts University;

  1. US Health Care Professional Perspectives on Adverse Drug Event Reporting in the Hospital Setting and the Opportunity for Information Technology Gustavo Grampp Amgen Inc. ! Stella Stergiopoulos, Tufts CSDD; Carrie A. Brown, Tufts University; Thomas Felix, Amgen Inc.; Kenneth A. Getz; Tufts CSDD

  2. Disclosure - !"#$%#&#'%("$)#&(%*+#)$*,$-"*&$.%#&#,-'/0,$1'&$&2..0%-#)$+3$'$4%',-$ 5%06$764#,$8,(9$-0$!2:&$;#,-#%$50%$-"#$<-2)3$05$=%24$=#>#?0.6#,-9$$ 8,-#%.%#-'/0,&$.%0>*)#)$%#.%#&#,-$-"#$&"'%#)$.#%&.#(/>#&$05$-"#$ '2-"0%&9$ "!

  3. What is the role of health information technology (HIT) in pharmacovigilance? • ! #$%&'(!)%*!+,!-!+-../,.!*%!.,0%.1)2!-(3,.4,!(.&2!,3,)*4!567849! • ! #$%&'(!'/):!0-1,)*!;-.,<!0$-.=-;>!-)(!/)41*&1%)-'!4-?,*>!4>4*,=4! • ! @(,)1A-+',!0-1,)*<!.,0%.*-+',!,3,)*<!4&40,;*!(.&2!540%)*-),%&4!.,0%.*49! • ! #$%&'(!;%=0'>!B/*$!2%3,.)=,)*!0%'/;/,4!-)(!4*-)(-.(4! • ! C.%(&;*D40,;/A;!-)(!+-*;$D40,;/A;!*.-;:/)2!%?!+/%'%2/;-'!0.%(&;*4! E!

  4. Tufts CSDD 2014 Survey of ADE Reporting Practices in the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

  5. Phase 1 findings related to HIT: Many systems are used in typical hospital practice ?&,+9)*"#+';4-9,<-' 8KPU 8IP! 8KPU!8IP ' 8',;*.%)/;!K,-'*$!P,;%.(4U8',;*.%)/;!I,(/;-'!P,;%.(4! @P! MCV8! MCV8 ' M%=0&*,./Y,(!C$>4/;/-)!V.(,.!8)*.>!4>4*,=! 8',;*.%)/;! ,I6P ' #>4*,=4! 8',;*.%)/;!I,(/;-1%)!6(=/)/4*.-1%)!P,;%.(! WMI6 ' WMIC! ,I6P! W-.;%(,D,)-+',(!I,(/;-1%)!6(=/)/4*.-1%)! WMIC ' W-.DM%(,!I,(/;-1%)!C.,0-.-1%)!L,;$)%'%2/,4! WMI6! @P ' 8',;*.%)/;!/);/(,)*!.,0%.1)2!4>4*,=! X!

  6. Phase 2: Survey findings identified a typical Hospital-based ADE reporting process flow 7.&2!-)(!68! P,*./,3,! P,0%.*! P,*./,3,! 7.&2! 7%;&=,)*,(! 7,*-/'4!-+%&*! 6(3,.4,! 7,*-/'4!-+%&*! #&40,;*,(! /)!C-1,)*! *$,!6(3,.4,! 83,)*! *$,!7.&2! P,;%.(4! 83,)*! 7.&2!-)(!68!7%;&=,)*,(!/)!@)*,.)-'!@);/(,)*!P,0%.*! I%4*!.,40%)(,)*4!$-3,!4&+=/[,(!/)*,.)-'!.,0%.*4!5RS\9<!+&*!=-)>!$-(!-'4%! .,0%.*,(!*%!]76!5XG\9!%.!-!=-)&?-;*&.,.!5EX\9^! ^!_&,41%)!B-4!`L%!B$/;$!%?!*$,!?%''%B/)2!%.2-)/Y-1%)4!$-3,!>%&!.,0%.*,(!-)! 678a!54,',;*!-''!*$-*!-00'>9b!5)c!XR9! Z!

  7. " Phase 2 survey identified key factors preventing ADE reporting in Hospitals ! D!E'),&%9,0' @2#&/0,$'&A#)B$CD'&#)$0,$302%$#E.#%*#,(#F$"01$0:#,$)0$#'("$05$-"#&#$%#'&0,&$.%#>#,-$"#'?-"$ ('%#$.%0>*)#%&$5%06$%#.0%/,4$7=G&$-0$-"#$H=7$0%$-"#$6',25'(-2%#%IJ$ 5)!c!QR9! R!

  8. Lack of system integration was cited as a significant reason for not reporting ADEs (52%)* @,2*)9,0'-*6)+,-'7*)'0,9%#&-'' FG'*7'),-2*"0,"9-H' d,>!(,*-/'4!-.,!40.,-(!-=%)2! >)68'0,9%#&-'' 3>?'0,9%#&-' =&'10',!(-*-!4%&.;,4! ,I6P!5Ee\9 ' 8KP!U!8IP!5S"\9 ' • ! 7.&2!(,*-/'4!40.,-(!-;.%44!S!%.! 8KP!U!8IP!5EX\9 ' @P!#>4*,=!5Ef\9 ' =%.,!4%&.;,4!5SZ\<!)cRS9! MCV8!5"X\9 ' • ! 678!(,*-/'4!40.,-(!-;.%44!E!%.! V*$,.!)%)DK@L!4%&.;,4g! V*$,.!)%)DK@L!4%&.;,4g! =%.,!4%&.;,4!5XG\<!)cZe9! ! !!C$-.=-;>!5ER\9! !!C-1,)*!;$-.*!5SS\9! !!C-1,)*!M$-.*!5"Q\9! !!M-.,!2/3,.!5"Q\9! !!C-0,.!+-4,(!@P!5G"\9 $ !!C-0,.!+-4,(!@P!5GG\9 $ ^_&,41%)!B-4!!`W-4,(!%)!>%&.!,H0,./,);,<!$%B!%h,)!(%!,-;$!%?!*$,4,!.,-4%)4!0.,3,)*! $,-'*$!;-.,!0.%3/(,.4!?.%=!.,0%.1)2!6784!*%!*$,!]76!%.!*$,!=-)&?-;*&.,.a!`!5)cQR9! Q!

  9. Limited availability of important drug data elements in HIT systems • ! I-)&?-;*&.,.!5A,'(!%.!i7M!;%(,9!-)(!'%*!/(,)1A,.4!-.,!4;-.;,!/)!=%4*!4>4*,=4! • ! W-.!;%(,!+-4,(!4>4*,=4!=->!/=0.%3,!(-*-!;-0*&.,! IJE?K'I>L'/#&&'M,'6-,0'%-'9:,'N;' 2)*06+9'#0,"$O,)'#"''9:,'!;J'!>P(' i%*,g!i!c!ZET!!_&,41%)!B-4!`j$/;$!%?!*$,!?%''%B/)2!(-*-!-+%&*!*$,!0-.1;&'-.!(.&2!-(=/)/4*,.,(!*%!-! 0-.1;&'-.!0-1,)*!-.,!.%&1),'>!-3-/'-+',!/)!>%&.!,',;*.%)/;!4>4*,=4ab! e!

  10. Could HIT impact drug identification in other countries? #$%&! ' ()*+,!-.!/0123'4!4-'03516'!'4-7+8!5415!'-9+!+:0)+';)3<32=!','5+9'!+2;-()1=+! -)!)+>(3)+!?@@!0)+';)3<32= " Can the medicines be Is INN only predefined in a drop down looked for by brand? menu so that the doctor can select it? E*9%&'M,0-K'QRSTUV' ='-'$(02%-#&3$05$H'%6'*,)2&-%*'$ 6.,!4&;$!4>4*,=4!;%=0-1+',!B/*$!*$,!8M!Ck!(/.,;13,a!` !"#!$#%%$#&&'(&')#!*$+*#,-'*,$#'*$!#.*/$!($)0*/123$ 4%*#'%3$#/3$5)(%(6)4#%$+*0)4)/#%$&'(0-4!$&'*,4')5*07$8)!"$0-*$'*6#'0$!($!"*$/#+*$(2$!"*$+*0)4)/#%$&'(0-4! b G !! G !M%&);/'!7/.,;13,!"fGfUQSU8M<!-.*T!Gf"5,9<!"fGf!VTlT!5m!ESQ9!RS<!QS!5-=,)(/)2!M%&);/'!7/.,;13,!"ffGUQSU8M9T ! Gf!

  11. Summary and Discussion • ! K%40/*-'!@L!4>4*,=4!-.,!-)!,44,)1-'!4%&.;,!?%.!.,;%.(/)2!-)(!.,*./,3/)2! 678!-)(!4&40,;*!(.&2!/)?%.=-1%)! • ! C.,4,);,!%?!=&'10',!4>4*,=4!*$-*!'-;:!/)*,2.-1%)!=->!+,!-)!%+4*-;',!*%! ,n;/,)*!678!.,0%.1)2! • ! I-)>!4>4*,=4!=->!)%*!;-0*&.,!(.&2!/(,)1A,.4!%*$,.!*$-)!+.-)(!-)(U%.! @ii! • ! P,;%==,)(-1%)4g! • ! @=0.%3,!-;;,44!*%!/)?%.=-1%)g!!@)*,.%0,.-+/'/*>U/)*,2.-1%)!%?!(.&2!/(,)1A,.4!-)(! 678!(-*-!?.%=!=&'10',!4>4*,=4! • ! #>4*,=!(,4/2)4!4$%&'(!0,.=/*!&4,!%?!+.-)(!)-=,4!?%.!+/%'%2/;4! • ! @)*,2.-*,!0.%(&;*D40,;/A;!(-*-!?.%=!+-.!;%(,!+-4,(!4>4*,=4!/)*%!%*$,.!K@L!4>4*,=4! *%!/=0.%3,!'%*D',3,'!*.-;,-+/'/*>! GG!

  12. Limitations • ! L$,!=-o%./*>!%?!$%40/*-'!+-4,(!4&.3,>!.,40%)4,4!%./2/)-*,(!?.%=!E!N#! 4*-*,4!5i,B!p%.:<!i,B!l,.4,><!j-4$/)2*%)9! • ! "E\!%?!$%40/*-'!.,40%)(,)*4!5)cX"9!$-(!),3,.!.,0%.*,(!-)!678! 5/)*,.)-''>!%.!,H*,.)-''>9! • ! SQ\!$-(!),3,.!.,0%.*,(!-)!678!*%!]76!%.!-!=-)&?-;*&.,.! G"!

  13. Thank you! q&4*-3%!q.-=00! 6=2,)!@);T!

  14. About the Tufts CSDD Tufts C S DD : Furthering the Cause of Pharmaceutical I nn o v a t i o n • ! M,)*,.!-*!L&h4!N)/3,.4/*>!#;$%%'!%?!I,(/;/),! ! ! ! 5$[0gUU;4((T*&h4T,(&9! ! ! ! L o u i s L a s a g na E l e c t r o n ic ! ! L i b r a r y of D r u g Databases & S t a ff S p o n s o r s h i p D e v e l o p m e n t B i b li og r aph i e s P r e s e n t a t i o n s ! ! ! • ! @)(,0,)(,)*<!-;-(,=/;!2.%&0!?%;&4/)2!%)!(.&2! Surveys & I n f o r ma t i o n M u l t i- C o m pany P r o j e c t S e r i e s Q u e s t i o nna i r e s S e r v i c e s (,3,'%0=,)*!4;/,)1A;<!.,2&'-*%.><!,;%)%=/;!-)(! ! ! ! ! M anu s c r i p t s , S p o n s o r e d Research a n d I n du s t r y =-)-2,=,)*!0%'/;>! White Papers & R e s e a r c h Pub li ca t i o n s P r o g r am s P r o j e c t s Book C hap t e r s ! ! ! T u ft s C SDD C o mm e n t a r i e s E x e c u t i v e & E d i t o r i a l s F o r u m ! • ! q.-)*!?&)(,(!-)(!5;.%44D/)(&4*.>9!40%)4%.,(! ! ! Public H e a r i n g s Q ua r t e r l y 4*&(/,4!! U pda t e s & T e s t i m o ny Tufts Center for the S t u d y of Drug D eve l o p m e n t ! ! ! T U F T S U N I V E R S I T Y A nnua l B i-M o n t h l y P o s t g r adua t e I m pa c t R e p o r t • ! P,4&'*4!$-3,!/)?%.=,(!M%)2.,44<!*$,!i-1%)-'! C o u r s e ! ! 6;-(,=/,4!%?!#;/,);,<!]%&)(-1%)4<!@)(&4*.><! ! ! ! A nnua l Subscription- Training & A nnua l L e ad e r s h i p Outlook R e p o r t Based R e p o r t s W o r k s h o p s C o u r s e M-0/*-'!I-.:,*!-)-'>4*4!-)(!/)3,4*%.4<!P,2&'-*%.>! ! ! ! ! W e b i na r s , 62,);/,4<!*$,!i-1%)-'!@)41*&*,4!%?!K,-'*$! Quarterly R & D ! Wkshps., & R & D Mgmt. R e p o r t R o und t ab l e s GS!

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