[PPT] - US Health Care Professional Perspectives on Adverse Drug Event PowerPoint Presentation

SLIDE 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

SLIDE 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$

"!

SLIDE 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!

SLIDE 4

Tufts CSDD 2014 Survey of ADE Reporting Practices in the US

F! @),.3/,B,(!GG!,H0,.4!/)!=,(/;/),<!0$-.=-;>!-)(!/)(&4.>! F! I-00,(!678!.,0%.1)2!0.%;,44!J%B4!-)(!K@L!4>4,=4!/)! $%40/*-'4<!;'/)/;4!-)(!0$-.=-;/,4!

C$-4,!G!

F! M.,-,(!-)(!(/4./+&,(!4&.3,>!/)4.&=,)!%!N#!0.-;11%),.4!/)! 3-./%&4!4,O)24!5$%40/-'<!0$-.=-;><!;'/)/;9! F! P,;,/3,(!QR!.,40%)4,4!?.%=!$%40/-'!0.-;11%),.4!50$-.=-;/4*4<! I74<!)&.4,49!

C$-4,!"!

S!

!"#$%&'()+,--'.&/'%"0'1%2'3"%&4-#-' 56%"$74#"8'9:,'(%)$,-'%"0';4-9,<-'#"=&=,0'#"'3>?'@,2)$"8'

C.-;1;,!.,'-,(!A)(/)24!-.,!0.,4,),(!/)!(-9,)'(ABC'-!*$/4!;%)?,.,);,T!

SLIDE 5

Phase 1 findings related to HIT: Many systems are used in typical hospital practice

8',;.%)/;! #>4,=4! 8KPU 8IP! MCV8! ,I6P! WMI6! WMIC! @P!

X!

?&,+9)*"#+';4-9,<-'

8KPU!8IP' 8',;.%)/;!K,-'$!P,;%.(4U8',;.%)/;!I,(/;-'!P,;%.(4! MCV8' M%=0&,./Y,(!C$>4/;/-)!V.(,.!8).>!4>4,=! ,I6P' 8',;.%)/;!I,(/;-1%)!6(=/)/4.-1%)!P,;%.(! WMI6' W-.;%(,D,)-+',(!I,(/;-1%)!6(=/)/4.-1%)! WMIC' W-.DM%(,!I,(/;-1%)!C.,0-.-1%)!L,;$)%'%2/,4! @P' 8',;.%)/;!/);/(,)!.,0%.1)2!4>4,=!

SLIDE 6

Phase 2: Survey findings identified a typical Hospital-based ADE reporting process flow

Z!

7.&2! #&40,;*,(! 7.&2!-)(!68! 7%;&=,)*,(! /)!C-1,)*! P,;%.(4! P,*./,3,! 7,*-/'4!-+%&*! *$,!7.&2! P,*./,3,! 7,*-/'4!-+%&*! *$,!6(3,.4,! 83,)*! P,0%.*! 6(3,.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!

SLIDE 7

R!

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!

SLIDE 8

Lack of system integration was cited as a significant reason for not reporting ADEs (52%)* d,>!(,-/'4!-.,!40.,-(!-=%)2! =&'10',!(--!4%&.;,4!

! 7.&2!(,*-/'4!40.,-(!-;.%44!S!%.!

=%.,!4%&.;,4!5SZ\<!)cRS9!

! 678!(,*-/'4!40.,-(!-;.%44!E!%.!

=%.,!4%&.;,4!5XG\<!)cZe9!!

Q!

>)68'0,9%#&-'' 3>?'0,9%#&-'

,I6P!5Ee\9' 8KP!U!8IP!5S"\9' 8KP!U!8IP!5EX\9' @P!#>4*,=!5Ef\9' MCV8!5"X\9'

V$,.!)%)DK@L!4%&.;,4g! !!C$-.=-;>!5ER\9! !!C-1,)!M$-.!5"Q\9! !!C-0,.!+-4,(!@P!5G"\9$ V$,.!)%)DK@L!4%&.;,4g! !!C-1,)!;$-.!5SS\9! !!M-.,!2/3,.!5"Q\9! !!C-0,.!+-4,(!@P!5GG\9$

@,2)9,0'-6)+,-'7)'0,9%#&-'' FG'7'),-2*"0,"9-H'

^_&,41%)!B-4!!`W-4,(!%)!>%&.!,H0,./,);,<!$%B!%h,)!(%!,-;$!%?!$,4,!.,-4%)4!0.,3,)! $,-'$!;-.,!0.%3/(,.4!?.%=!.,0%.1)2!6784!%!$,!]76!%.!$,!=-)&?-;*&.,.a!`!5)cQR9!

SLIDE 9

Limited availability of important drug data elements in HIT systems

e!

i%*,g!i!c!ZET!!_&,41%)!B-4!`j$/;$!%?!*$,!?%''%B/)2!(-*-!-+%&*!*$,!0-.1;&'-.!(.&2!-(=/)/4*,.,(!*%!-! 0-.1;&'-.!0-1,)*!-.,!.%&1),'>!-3-/'-+',!/)!>%&.!,',;*.%)/;!4>4*,=4ab!

! 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('

SLIDE 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="

Gf!

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!bG!!

G!M%&);/'!7/.,;13,!"fGfUQSU8M<!-.*T!Gf"5,9<!"fGf!VTlT!5m!ESQ9!RS<!QS!5-=,)(/)2!M%&);/'!7/.,;13,!"ffGUQSU8M9T!

='-'$(02%-#&3$05$H'%6'*,)2&-%*'$ E*9%&'M,0-K'QRSTUV'

Can the medicines be looked for by brand? Is INN only predefined in a drop down menu so that the doctor can select it?

SLIDE 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!

SLIDE 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"!

SLIDE 13

Thank you!

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

SLIDE 14

About the Tufts CSDD

! M,)*,.!-*!L&h4!N)/3,.4/*>!#;$%%'!%?!I,(/;/),!

5$[0gUU;4((T*&h4T,(&9!

! @)(,0,)(,)*<!-;-(,=/;!2.%&0!?%;&4/)2!%)!(.&2!

(,3,'%0=,)!4;/,)1A;<!.,2&'-%.><!,;%)%=/;!-)(! =-)-2,=,)*!0%'/;>!

! q.-)*!?&)(,(!-)(!5;.%44D/)(&4*.>9!40%)4%.,(!

4*&(/,4!!

! P,4&'*4!$-3,!/)?%.=,(!M%)2.,44<!*$,!i-1%)-'!

6;-(,=/,4!%?!#;/,);,<!]%&)(-1%)4<!@)(&4.><! M-0/-'!I-.:,!-)-'>44!-)(!/)3,4%.4<!P,2&'-%.>! 62,);/,4<!$,!i-1%)-'!@)41&,4!%?!K,-'$!

GS! Tufts CSDD: Furthering the Cause of Pharmaceutical Innovation

!

! ! !

!

! Staff

Presentations Louis Lasagna Library of Drug Development Electronic

Databases &

Bibliographies

!

Sponsorship ! ! ! Surveys & Questionnaires

Information Services

Multi-Company Project Series !

!

Manuscripts, White Papers & Book Chapters

!

Research and Publications

!

Industry Programs