,i #aag? ,,congress #b;d ,session ,h4 ,r4 #fhge ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,febru>y #bh1 #bjbb,mr4 ,swalwell 7= himself & ,mr4 ,emm]7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to update ! ,national ,action ,plan = ,adv]se ,drug ,ev5t ,prev5tion to provide educational in=mation on adv]se drug ev5ts & ph>macog5omic te/+1 to improve electronic heal? records = ph>macog5omic in=mation1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,"r ,drug ,dose ,n[ ,act4 #b4 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4,sec4 #b4 ,table ( cont5ts4,sec4 #c4 ,national ,action ,plan = ,adv]se ,drug ,ev5t ,prev5tion4,sec4 #d4 ,adv]se drug ev5t & ph>macog5omic te/+ aw>5ess4,sec4 #e4 ,improv+ ,,ehr sy/ems to improve ! use ( ph>macog5omic in=mation4,sec4 #f4 ,increas$ au?orization = ph>macog5omics implem5tation rese>*4,sec4 #g4 ,def9ition4 #c4 ,national ,action ,plan = ,adv]se ,drug ,ev5t ,prev5tion ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 9 coord9ation ) ! heads ( o!r relevant ,f$]al dep>tm5ts & ag5cies includ+ ! ,director ( ! ,national ,human ,g5ome ,rese>* ,in/itute1 & 9 consultation ) ! ,director ( ! ,eunice ,k5n$y ,%riv] ,national ,in/itute ( ,*ild ,heal? & ,human ,developm5t1 ! ,director ( ! ,national ,c5t] = ,biote*nology ,in=mation1 & ! ,director ( ! ,national ,libr>y ( ,m$ic9e1 submit a report to ! ,congress on-- 7,a7 ! implem5tation ( ! ,national ,action ,plan = ,adv]se ,drug ,ev5t ,prev5tion ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 & 7,b7 ! progress 9 meet+ ! t>get approv$ by ! ,f$]al ,int]ag5cy ,/e]+ ,committee = ,adv]se ,drug ,ev5ts = a #aj-p]c5t r$uction =-- 7i7 ! rate ( adv]se drug ev5ts f anticoagulants among ,unit$ ,/ates inpati5t /ays2 7ii7 ! rate ( adv]se drug ev5ts f hypoglycemic ag5ts among ,unit$ ,/ates inpati5t /ays2 7iii7 ! rate ( adv]se drug ev5ts f opioid analgesics among ,unit$ ,/ates inpati5t /ays2 7iv7 ! rate ( visits to ,unit$ ,/ates hospital em]g5cy dep>tm5ts = adv]se drug ev5ts associat$ ) injury f oral anticoagulants2 7v7 ! rate ( visits to ,unit$ ,/ates hospital em]g5cy dep>tm5ts = adv]se drug ev5ts associat$ ) injury f insul92 & 7vi7 ! rate ( visits to ,unit$ ,/ates hospital em]g5cy dep>tm5ts = adv]se drug ev5ts associat$ ) !rapeutic use ( opioid analgesics2 7#b7 conv5e ! ,f$]al ,int]ag5cy ,/e]+ ,committee = ,adv]se ,drug ,ev5ts to update ! ,national ,action ,plan = ,adv]se ,drug ,ev5t ,prev5tion2 & 7#c7 require su* ,committee1 9 updat+ ! ,national ,action ,plan = ,adv]se ,drug ,ev5t ,prev5tion-- 7,a7 to consid] advances 9 sci5tific und]/&+ & te*nology p]ta9+ to drug-g5e-drug int]actions1 cl9ical outcomes1 heal? c>e utilization1 & ! decreas+ co/ ( g5etic te/+2 7,b7 to assess ! role ( ph>macog5etics te/+ comb9$ ) cl9ical decision support z an evid5ce-bas$ prev5tion tool2 & 7,c7 to evaluate op]at+ *>act]i/ics = ,f$]al adv]se drug ev5t surveillance sy/ems & exp& capabilities to id5tify g5etic associations 9 adv]se ev5ts4 #d4 ,adv]se drug ev5t & ph>macog5omic te/+ aw>5ess ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+3 #cii,v-#g4 ,adv]se drug ev5t & ph>macog5omic te/+ aw>5ess 7a7 ,public ,education ,campaign 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,human ,g5ome ,rese>* ,in/itute1 9 consultation ) ! ,director ( ! ,eunice ,k5n$y ,%riv] ,national ,in/itute ( ,*ild ,heal? & ,human ,developm5t1 ! ,director ( ! ,national ,c5t] = ,biote*nology ,in=mation1 & ! ,director ( ! ,national ,libr>y ( ,m$ic9e1 %all conduct a national evid5ce-bas$ education campaign to increase ! public's aw>5ess reg>d+-- 7,a7 ! preval5ce ( adv]se drug ev5ts & adv]se drug reactions2 7,b7 specific risk factors t increase an individual's likelihood ( exp]i5c+ an adv]se drug ev5t or adv]se drug reaction2 7,c7 basic in=mation ab\t ph>macog5omic te/+ & h[ its use1 includ+ incorporation 9 compreh5sive m$ication managem5t1 may prev5t adv]se drug reactions 9 c]ta9 cl9ical situations2 7,d7 ! role ( heal? c>e provid]s 9 p]=m+ ph>macog5omic te/+1 int]pret+ ! results ( su* te/+1 & adju/+ m$ications bas$ on su* results2 7,e7 ! availability ( ph>macog5omic te/+2 7,f7 compreh5sive m$ication managem5t2 & 7,g7 h[ ! b5efits ( an individual's ph>macog5omic te/ results might *ange or be relevant ov] "t4 7#b7 ,consid]ation ( advice ( /akehold] exp]ts ,! education campaign "u p>agraph 7#a7 %all take into consid]ation ! advice ( /akehold] expects1 su* z ^? specializ+ 9 m$ical g5etics & ph>macog5etics & collaborative communities focus$ on ph>macog5omics4 7#c7 ,m$ia campaign ,9 conduct+ ! education campaign "u p>agraph 7#a71 ! ,secret>y1 aft] consid]+ ! advice ( /akehold] exp]ts pursuant to p>agraph 7#b71 may aw>d grants or contracts to entities to e/abli% national multim$ia campaigns t may include adv]tis+ ?r\gh television1 radio1 pr9t m$ia1 billbo>ds1 po/]s1 all =ms ( exi/+ & especially em]g+ social network+ m$ia1 o!r ,int]net m$ia1 & any o!r m$ium det]m9$ appropriate by ! ,secret>y4 7#d7 ,rural regions1 heal? pr(essional %ortage areas1 & und]s]v$ communities ,! ,secret>y %all ensure t ! education campaign "u p>agraph 7#a7-- 7,a7 rea*es rural & m$ically und]s]v$ communities 7z def9$ 9 section #gii72 & 7,b7 includes ! involvem5t ( community heal? c5t]s1 community ph>macies1 & o!r local heal? cl9ics4 7b7 ,heal? c>e pr(essional education campaign 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,human ,g5ome ,rese>* ,in/itute1 9 consultation ) ! ,director ( ! ,eunice ,k5n$y ,%riv] ,national ,in/itute ( ,*ild ,heal? & ,human ,developm5t1 ! ,director ( ! ,national ,c5t] = ,biote*nology ,in=mation1 ! ,director ( ! ,national ,libr>y ( ,m$ic9e1 & ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all e/abli% a national heal? education program = heal? c>e provid]s & heal? c>e lead]s1 includ+ adm9i/rators1 ph>maci/s1 nurse practition]s1 physicians' assi/ants1 physician m$ical g5etici/s1 laboratory m$ical g5etici/s1 g5etic c\nselors1 m$ical educators1 & ! faculty ( s*ools ( m$ic9e & o!r s*ools ( heal? pr(essions1 on ! foll[+3 7,a7 ,ph>macog5omic te/+ & ! ext5t ( its ability to prev5t adv]se drug reactions4 7,b7 ,ph>macog5omic te/+1 drug int]action al]t+ sy/ems1 :5 to ref] to or consult ) a g5etics provid]1 & ! /&>ds ( c>e = pati5ts :o are suspect$ or kn[n to h a g5etic v>iant t is kn[n to impact drug metabolism4 7,c7 ,evid5ce-bas$ in=mation t w\ld enc\rage individuals & _! heal? c>e pr(essionals to consid] ph>macog5omic te/+ z "p ( _! heal? c>e plan to ! ext5t appropriate4 7,d7 ,! role ( m$ical pr(essionals :o specialize 9 g5etics & g5omics4 7,e7 ,h[ to incorporate ph>macog5omics into compreh5sive m$ication managem5t4 7#b7 ,grants 7,a7 ,aw>d ,9 c>ry+ out ! national heal? education program "u ?is subsection1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,human ,g5ome ,rese>* ,in/itute1 may aw>d grants to nonpr(it organizations to c>ry out educational activities ) respect to ! topics li/$ 9 subp>agraphs 7,a7 ?r\gh 7,d7 ( p>agraph 7#a74 7,b7 ,use ( funds ,a grant "u subp>agraph 7,a7 may be us$ to support "o or m ( ! foll[+ activities3 7i7 ,increas+ ! k & aw>5ess ( heal? c>e provid]s & heal? c>e lead]s ab\t ph>macog5omic te/+ & drug int]actions4 7ii7 ,increas+ ! numb] ( heal? pr(essional s*ools t incorporate ph>macog5omic curricula 9 classroom in/ruction4 7iii7 ,increas+ ! ability ( heal? c>e provid]s to note & respond to ! impact ( g5d]1 e?nicity1 age1 & o!r relevant *>act]i/ics on drug metabolism4 7iv7 ,develop+ pr9ciples1 practices1 & curriculum in/ruction t prep>e m$ical1 nurs+1 ph>macy1 & o!r heal? pr(essions /ud5ts to effectively apply k & skills ne$$ to recognize-- 7,i7 :5 a pati5t is eligible = ph>macog5omic te/+1 includ+ z "p ( compreh5sive m$ication managem5t :5 appropriate1 & 9 accordance ) ! pati5t's heal? c>e team1 a drug product's label1 & pr(essional cl9ical guidel9es2 & 7,,ii7 h[ to appropriately use ! te/ results to adju/ a prescription or o!rwise *ange a pati5t's heal? c>e plan4 7v7 ,provid+ opportunities = practic+ heal? c>e pr(essionals to receive ph>macog5omics tra9+ & education ?r\gh a v>iety ( modalities includ+ 9-p]son1 electronic m$ia1 pr(essional meet+s & conf]5ces1 & social m$ia4 7c7 ,report+ ,at lea/ e ?ree ye>s1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,human ,g5ome ,rese>* ,in/itute1 9 consultation ) ! ,director ( ! ,eunice ,k5n$y ,%riv] ,national ,in/itute ( ,*ild ,heal? & ,human ,developm5t1 ! ,director ( ! ,national ,c5t] = ,biote*nology ,in=mation1 ! ,director ( ! ,national ,libr>y ( ,m$ic9e1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 & relevant /akehold]s ) exp]tise 9 develop+ quality measures ( label & pe]-review$ pr(essional guidel9es on drug-g5e int]actions1 %all publi% data on-- 7#a7 ! public's aw>5ess reg>d+ adv]se drug ev5ts & ph>macog5omic te/+2 7#b7 ! numb] or p]c5tage ( individuals utiliz+ in=mation to in=m _! heal? c>e decisions reg>d+ prescription m$ications & ph>macog5omic te/+2 7#c7 ! *ange 9 ! numb] or p]c5tage ( individuals enroll$ 9 a prescription drug plan "u "p ,d ( ! title ,,xviii ( ! ,social ,security ,act receiv+ a ph>macog5etic te/1 z recomm5d$ 9 alignm5t ) a drug product's label or pe]-review$ pr(essional guidel9es2 & 7#d7 ! numb] or p]c5tage ( *anges1 beg9n+ "o ye> aft] ! date ( enactm5t ( ?is section1 9 m$ication managem5t z a result ( incorporat+ in=mation f ph>macog5omic te/+4 7d7 ,def9itions ,9 ?is section3 7#a7 ,adv]se drug ev5t ,! t]m adv]se drug ev5t means an injury result+ f any m$ical int]v5tion ) a drug4 7#b7 ,adv]se drug reaction ,! t]m adv]se drug reaction means a response to a drug t-- 7,a7 is noxi\s & un9t5d$2 & 7,b7 occurs at doses normally us$ 9 humans = prophylaxis1 diagnosis1 or !rapy ( disease or = ! modification ( physiologic function4 7e7 ,au?orization ( ,appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #ej1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbg4 4 #e4 ,improv+ ,,ehr sy/ems to improve ! use ( ph>macog5omic in=mation 7a7 ,c]tification crit]ia ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all adopt pursuant to subtitle ,a ( title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq47 c]tification crit]ia = heal? in=mation te*nology1 includ+ = electronic prescrib+ sy/ems & real-"t ph>macy b5efit *ecks1 su* t be=e a m$ication ord] is complet$ & act$ ^u dur+ comput]iz$ provid] ord] entry1 int]v5tions mu/ automatically indicate to a us]-- 7#a7 :5 ph>macog5omic te/+ is appropriate bas$ on a drug product's label or pe]-review$ pr(essional guidel9es2 & 7#b7 drug-g5e & drug-drug-g5e associations1 e/abli%$ by a drug product's label or pe]-review$ pr(essional guidel9es1 bas$ on a pati5t's m$ication li/1 m$ication all]gy li/1 & results f ph>macog5omic te/+4 7b7 ,report+ & association ( adv]se drug ev5ts ,! ,secret>y1 9 consultation ) ! ,commission] ( ,food & ,drugs1 %all c>ry out a program to improve ! report+ ( adv]se drug ev5ts & ! association1 if any1 ( su* ev5ts to a pati5t's g5etic /atus4 ,z "p ( ! program1 ! ,secret>y %all issue regulations pursuant to ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 & o!r applicable /atutory au?orities to-- 7#a7 ensure t drug-g5e int]action al]t+ sy/ems are cont9u\sly updat$ to incorporate in=mation f new or updat$ drug labels ) ph>macog5omic in=mation & newly e/abli%$ pe]-review$ pr(essional guidel9es on drug-g5e associations2 7#b7 facilitate ! report+ ( adv]se drug ev5ts to ! ,,fda ,adv]se ,ev5t ,report+ ,sy/em directly ?r\gh ! use ( ! heal? c>e provid]'s electronic heal? record sy/em2 & 7#c7 all[ = ! report+ ( :e!r an adv]se drug ev5t is caus$ by ph>macog5etic int]actions to ! ,,fda ,adv]se ,ev5t ,report+ ,sy/em directly ?r\gh ! use ( ! heal? c>e provid]'s electronic heal? record sy/em4 7c7 ,updat+ ,,fa]s2 pati5t-,fri5dly report+ ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7#a7 update ! ,,fda ,adv]se ,ev5t ,report+ ,sy/em1 includ+ to-- 7,a7 accept in=mation directly f heal? c>e provid]s' electronic heal? record sy/ems2 7,b7 improve ! collection ( real _w evid5ce 7z def9$ 9 section #eje;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g772 & 7,c7 create a selection tool t all[s individuals to report :e!r an adv]se drug ev5t is associat$ ) a drug-g5e int]action2 7#b7 "w ) relevant ,f$]al ag5cies & (fices1 & /akehold]s1 to create pati5t-fri5dly electronic options = report+ adv]se drug ev5ts su* z submission ?r\gh a designat$ mobile device application or mobile device messag+ application2 & 7#c7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 report to ! ,congress on ! progress made 9 implem5t+ p>agraphs 7#a7 & 7#b74 7d7 ,assessm5t on additional improvem5ts to electronic heal? record sy/ems 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all-- 7,a7 complete an assessm5t on additional improvem5ts to electronic heal? record sy/ems t are ne$$ to fur!r ! developm5t ( real _w evid5ce 7z def9$ 9 section #eje;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g77 9 ph>macog5omics2 & 7,b7 submit a report to ! ,congress on ! f9d+s on ! assessm5t4 7#b7 ,consid]ation ( ne$$ advancem5ts ,z "p ( ! assessm5t "u p>agraph 7#a71 ! ,secret>y %all consid] :at advancem5ts are ne$$ to capture in=mation ab\t ! laboratory & ! te/ us$ z "p ( ph>macog5omic te/+4 #f4 ,increas$ au?orization = ph>macog5omics implem5tation rese>* ,!re is au?oriz$ to be appropriat$ to ! ,national ,in/itutes ( ,heal? #g1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbe = ! conduct1 support1 & ma9t5ance ( ph>macog5omics implem5tation rese>* ?r\gh ! ,g5omic ,community ,res\rces program4 #g4 ,def9itions ,9 ?is ,act3 7#a7 ,! t]m adv]se drug ev5t means an injury result+ f any m$ical int]v5tion ) a drug4 7#b7 ,! t]m compreh5sive m$ication managem5t means m$ication managem5t pursuant to a /&>d ( c>e t ensures ea* pati5t's m$ications are individually assess$ to det]m9e t ea* m$ication is appropriate = ! pati5t1 effective = ! m$ical condition1 & safe giv5 ! comorbidities & o!r m$ications be+ tak5 & able to be tak5 by ! pati5t z int5d$4