B Y TTRNG I HC DC H NI NGC TRM KHO ST TNH HNH BO COPHN NG C HI CA THUC (ADR)TI BNH VIN BCH MAI GIAI ON 2011 - 2012 KHA LUN TT NGHIP DC S H NI - 2013 B Y TTRNG I HC DC H NI NGC TRM KHO ST TNH HNH BO CO PHN NG C HI CA THUC (ADR) TI BNH VIN BCH MAI GIAI ON 2011 - 2012 KHA LUN TT NGHIP DC S Ngi hng dn:1. TS. Nguyn Hong Anh 2. DS CK II. Nguyn Th Hng Thy Ni thc hin: Trung tm DI & ADR Quc gia Khoa Dc, Bnh vin Bch Mai H NI - 2013 LI CM N Trc tin, ti xin by t lng cm n su sc ti TS. Nguyn Hong Anh GingvinbmnDclc,PhgimcTrungtmDI&ADRQucgia.Vi kin thc chuyn ngnh su rng cng s tn ty v nhit tnh vi sinh vin, thy lunlngithym tingng mnht. Nhcccbigingcathy,ti thc s cm nhn c tnh yu khoa hc v am m nghin cu. TixinchnthnhcmnDSCKII.NguynThHngThyTrng khoa Dc Bnh vin Bch Mai cho ti nhng ng gp qu bu trong qu trnh thc hin lun vn ny. TicngxinchnthnhcmnDS.TrnNgnH,cnbTrungtm DI&ADR Quc gia v s quan tm, s nhit tnh v c s nghim khc ch dnh cho ti. Ch lun st cnh bn ti t nhng bc u tin, ng vin ti nhng lc ti nnlng.Khalunnyskhngthchonthnhnukhngcsgip ca ch. Ti xin gi li cm n su sc ti tp th cc thy c gio Trng i hc Dc H Ni, nhng ngi tn tm dy d, trang b cho ti cc kin thc v k nngtrong hctp, nghincu.Cmncc cnbTrungtmDI&ADRQuc gia, cc cn b khoa Dc Bnh vin Bch Mai to mi iu kin gip ti thc hin ti ny. Chn thnh cm n nhng ngi bn tuyt vi ca ti v nhng ngy thng stcnhcngtivt quakhkhnkhithchin ti ny.bnccbn, mi khkhntrnnthtnhb.Cuicng,tixinbytlngbitnsuscnht dnh cho gia nh ca ti, nhng ngi thn yu lun quan tm, tin tng, ng vin v chm sc ti trong sut thi gian thc hin ti ny. H Ni, ngy 21 thng 5 nm 2013 Ngc Trm MC LC T VN .........................................................................................................1 CHNG 1. TNG QUAN ...................................................................................3 1.1.CC BIN C C HI LIN QUAN N S DNG THUC TRONG BNH VIN........................................................................................................3 1.1.1.Phn ng c hi ca thuc ...................................................................3 1.1.2.Sai st trong s dng thuc..................................................................4 1.1.3.Vn cht lng thuc ......................................................................5 1.2.GIM ST ADR TRONG BNH VIN...................................................7 1.2.1.Cc i tc tham gia gim st ADR trong bnh vin ............................7 1.2.2.Cc bc gim st ADR trong bnh vin .............................................8 1.3.BO CO ADR TRONG BNH VIN ..................................................12 1.3.1.Tm quan trng ca vic bo co ADR trong bnh vin.....................12 1.3.2.Nhng trng hp cn bo co ADR.................................................12 1.3.3.S tham gia ca cn b y t trong bo co ADR ti bnh vin ...........13 1.3.4.Nhng tn ti ca cng tc bo co ADR trong bnh vin .................13 1.4.MTSBINPHPTHCYBOCOADRTRONGBNH VIN .................................................................................................................15 1.4.1.Mt s bin php thc y bo co ADR trong bnh vin..................15 1.4.2.Tnh hnh bo co ADR bnh vin Bch Mai. .................................18 CHNG 2. I TNG V PHNG PHP NGHIN CU.......................19 2.1. I TNG NGHIN CU.....................................................................19 2.2.PHNG PHP NGHIN CU.............................................................19 2.3.CH TIU NGHIN CU.......................................................................19 2.3.1.Quy trnh bo co ADR .....................................................................19 2.3.2.Thng tin v s lng bo co ADR. .................................................20 2.3.3.Thi gian tr hon gi bo co ADR ..................................................20 2.3.4.C cu bo co ADR .........................................................................20 2.3.5.Cht lng bo co ADR...................................................................21 2.4.X L S LIU.....................................................................................22 CHNG 3. KT QU........................................................................................24 3.1.QUYTRNHBOCOADRCABNHVINBCHMAINM 2011 V 2012....................................................................................................24 3.2.THNG TIN V S LNG BO CO ADR......................................25 3.2.1.S lng bo co ADR......................................................................25 3.2.2.T l bo co c gi ln Trung tm DI&ADR Quc gia ................26 3.3.THI GIAN TR HON GI BO CO ADR......................................27 3.4.C CU BO CO ADR.......................................................................28 3.4.1.Thng tin v bo co..........................................................................28 3.4.2.Thng tin v thuc nghi ng gy ADR...............................................30 3.4.3.Thng tin v ADR .............................................................................33 3.5.NHGICHTLNGBOCOADRTIBNHVINBCH MAI GIAI ON 2011 2012..........................................................................41 3.5.1.Kt qu nh gi cht lng bo co ADR ti bnh vin Bach Mai giai on 2011 - 2012 ............................................................................................41 3.5.2.im cht lng bo co trung bnh ca cc khoa phng...................43 CHNG 4. BN LUN ....................................................................................45 KT LUN V XUT ..................................................................................50 DANH MC NHNG CH VIT TT ADRPhn ng c hi ca thuc (Adverse Drug Reaction) ADEBin c bt li ca thuc (Adverse Drug Event) FDACc Qun l Thc phm v Dc phm Hoa K (U.S Food and Drug Administration) ICD - 10Bng phn loi quc t bnh tt ln th 10 (International Classification of Diseases 10) STTS th t Trung tm DI&ADR Quc gia Trung tm Quc gia v thng tin thuc v theo di phn ng c hi ca thuc WHOT chc Y t Th gii (World Health Organization) DANH MC CC BNG STTTn bngTrang 1 Bng 3.1 So snh mt s nt chnh ca quy trnh bo co ADR ca bnh vin Bch Mai nm 2011 v 2012 24 2 Bng 3.2. S lng bo co nm 2011 v 2012 26 3 Bng 3.3. T l bo co c gi ln trung tm DI&ADR Quc gia 26 4Bng 3.4. Thi gian tr hon gi bo co trung bnh (ngy)27 5Bng 3.5. Thng tin v i tng tham gia bo co ADR28 6Bng 3.6. Cc khoa phng tham gia bo co ADR28 7Bng 3.7. L do s dng thuc theo phn loi ICD-1030 8 Bng 3.8. Cc ng dng thuc nghi ng gy ADR c bo co 31 9Bng 3.9. Cc h dc l c bo co nhiu nht32 10Bng 3.10. Cc thuc ghi ng gy ADR c bo co nhiu nht33 11 Bng 3.11. Tng hp phn loi bo co ADR theo t chc c th b nh hng v cc phn ng c hi 34 12Bng 3.12. Cc biu hin ADR c ghi nhn nhiu nht35 13 Bng 3.13. Cc cp thuc-biu hin ADR c ghi nhn nhiu nht 36 14Bng 3.14. Cc ADR nghim trng c ghi nhn nm 201137 15Bng 3.15. Mt s ADR nghim trng c ghi nhn nm 201237 16 Bng 3.16. Cc biu hin ADR c pht hin qua xt nghim cn lm sng 39 17Bng 3.17. Cc ADR him gp c ghi nhn nm 201140 18 Bng 3.18. Cc ADR him gp c ghi nhn nm 2012 41 19 Bng 3.19. Cc thng s thng k nh gi im cht lng bo co nm 2011 v 2012 42 20 Bng 3.20. im bo co trung bnh ca cc khoa phng nm 2011 v 2012 43 DANH MC CC HNH STTTn hnhTrang 1 Hnh 2.1. Thang im nh gi cht lng bo co ADR theo WHO 21 2Hnh 3.1. im cht lng bo co ADR nm 2011 v 201242 1 T VN Vicsdngthucnichungvsdngthuctrongbnhvinniring bn cnh nhng li ch, hiu qu cng lun thng trc nguy c v phn ng c hi ca thuc-ADR. Vic gim st ADR trong bnh vin khng ch gip cc cn b y t kp thi x tr tng tnh hung c th cho bnh nhn, m thng tin v ADR khi c gi v trung tm DI&ADR Quc gia cn c th ng gp vo d liu ca h thng Cnh gic dc quc gia t c nhng phn hi tch cc, m bo vic s dng thuc an ton, hp l. Ti Vit Nam, mt s bin php c p dng nhm gim st ADR trong bnhvin,trong hnhthc bocoADRt nguynlhnh thc ph bin nht nh tnh n gin v d thc hin. Vic thu thp ADR cng c quy nh trong cc vn bn quy phm php lut do B Y t ban hnh. Nh nhng n lc ca trung tmDI&ADRQucgiacngnhshptccaccbnhvintrncnc,t nm2010nnay,trungtmnhnc7050bocoADR[12],[22],[23]. Trong 3 qu u nm 2012, bo co ADR c gi v t 288 c s iu tr trn c nc [21]. VnnicmnhttrongcngtcbocoADRlhintngboco thiu v bo co km cht lng [58]. Trong h thng bo co ADR t nguyn ti Anh c n 98% bin c lm sng c lin quan n dng thuc l khng c bo co.Mt nghincuticc bnhvintrng imca VitNam (2011-2012)cho thy c n 65,5% bo co ADR thiu thng tin [3]. Do vy, vic thc y bo co ADR c v s lng cng nh cht lng l mt nhim v trng tm trong cng tc Cnh gic dc, i hi nhng bin php thch hp m bo hiu qu. Bnhvin BchMai lmt bnh vin akhoatuyncuic quym1400 ging bnh vi khong 60 000 bnh nhn ni tr mi nm [90]. S lng bo co ADRcghinhntronggiaiongiaion1998-2000l122boco,vgiai on 2006-2008 l 813 bo co [11],[17], [18]. Nm 2012, Bnh vin Bch Mai 2 thay i hnh thc bo co ADR t phng thc s dng s ghi chp ADR ti cc khoa, phng iu tr sang phng thc mi vi biu mu chi tit s dng mu bo co theo Thng t s 23/2011/TT-BYT Hng dn s dng thuc trong cc c s yt c ging bnh. Nhm nh gi tc ng ca vic thay i phng thc bo co ADR ny n hiu qu bo co ADR, chng ti tin hnh ti Kho st tnh hnh bo co phn ng c hi ca thuc (ADR) ti bnh vin Bch Mai giai on 2011-2012 vi mc tiu: So snh bo co ADR ca bnh vin Bch Mai gia hai nm 2011 v 2012 v s lng bo co, thi gian tr hon bo co, c cu bo co v cht lng bo co khi thay i quy trnh bo co ADR. 3 CHNG 1. TNG QUAN 1.1.CCBINCCHILINQUANNSDNGTHUC TRONG BNH VIN Theo Leape (1995):Bin c c hi ca thuc c nh ngha l tt c cc tn thng l h qu ca vic s dng thuc, bt k mi quan h nhn qu ny c c chng minh hay khng [57]. Theo Edwards v Aronson (2000), Bin c c hicathucl mt phn nggyhihocgykhchu ngk,l huquca vic can thip c lin quan n s dng dc phm, m c th d on c tc hi nu lp li vic s dng, t cho php tip tc dng phng, iu tr bnh, hay thay i ch iu tr hoc ngng s dng dc phm [41]. Bin c c hi ca thuc l nhng bin c lin quan n an ton thng gp nht trong bnh vin [44], [56]. Cc nghin cu ti M cho thy bin c c hi ca thuc lm tng thi gian nm vin ln t 1,74 n 2,2 ngy, tng nguy c t vong vchiphnmvintnggngp2ln[32],[40].Nhmmbovicsdng thucantonvhpltrongbnhvin,cnbytcnccungcpnhng thng tin v an ton thuc thch hp t can thip mt cch tch cc vo vic gimstvhnchccbincchicathucclinquannADR,saist trong s dng thuc v cht lng thuc [53]. 1.1.1.Phn ng c hi ca thuc -nh ngha phn ng c hi ca thuc: T chc Y t th gii (WHO) nm 1972 a ra nh ngha chnh thc v phnngc hicathuc:Phn ngchicathuclmt phnngchi, khng c nh trc v xut hin liu thng dng cho ngi phng bnh, chn on bnh hoc cha bnh, hoc lm thay i mt chc nng sinh l.nh ngha nykhng baogm nhng phn ng do dngsaithuc, dngsailiu, dng liu cao, c ch nh hoc v tnh [15], [66], [84], [86]. -Hu qu ca ADR trong bnh vin 4 Phn ng c hi ca thuc (ADR) l l do c bo co nhiu nht trong s nhng bincchicathuctrongthigian nmvin,vitlgn20%[55], [65].TnsutxuthinADRtrong6thngtiBnhvinHonggiaLiverpool, vng quc Anh l 20%, vi hu qu 73% tn thng nh, 25% tn thng trung bnh, 2%tnthngnng,0,2%tvong.TiMhng nmc2,2triucaADR nngtrong nhng bnh nhn nitrtiM,trong c 106 000catvong.Gn 20% bnh nhn ni tr tri qua t nht mt ADR trong thi gian nm vin, trong s ny c n trn 14% chu hu qu l tn tt nghim trng [31], [55]. MtnghincutiMchothyphnngchicathuctrungbnh lm tng thi gian nm vin ca mi bnh nhn ln gn 2 ngy, tiu tn gn 3,500 -la M (vi thi gi -la nm 1997). Tn tht ny cha tnh n chi ph do sai st trong iu tr cng nh chi ph thit hi ca bn thn bnh nhn [32], [40]. -Gim st ADR XydngvcngcmththnggimstADRngycngtthnl nhim v cn c u tin hng u ngn nga cc ADR v cc bin c c hi cathuctrongbnhvin[72].Theohngdnhotnggimstphnngc hi ca thuc ti cc c s khm cha bnh ca B Y t, vic gim st phn ng c hicathucngvaitrquantrngnhmgimthiunhngnguyclinquan n thuc trong qu trnh s dng thuc ca ngi bnh. Vic gim st phn ng c hi ca thuc bao gm: pht hin, x tr, bo co, nh gi v d phng ADR [4]. 1.1.2.Sai st trong s dng thuc -Khi nim sai st trong s dng thuc Sai st trong s dng thuc c nh ngha l bt c bin c c th phng trnh c no gy ra hoc dn n vic s dng thuc khng hp l hoc gy tc hi cho bnh nhn trong khi vic iu tr ang c kim sot bi cc cn by t hocbnhnhn.Nhngbincnycthlinquannthchnhchuynmn, thuc,quytrnh,hthng,baogmkn,trnhtlinh,ghinhnsnphm, vicnggi,ghidanhmc,vicphach,phnphi,cpphtthuc,sdng 5 thuc, gio dc bnh nhn, gim st bnh nhn v s dng thuc [92]. Sai st trong s dng thuc c th gy ra hoc khng gy ra bin c c hi ca thuc [35]. -Hu qu ca sai st trong s dng thuc Mt nghin cu M cho thy cc sai st trong s dng thuc gy ra t 44 000 n 98 000 ca t vong khng ng c mi nm v trn 1 triu ca tn thng khc [74]. Cng ti nc ny, c quan qun l cng b sai st trong s dng thuc l loi sai st iu tr thng gp nht, ring chi ph iu tr pht sinh cho nhng tn thng c lin quan n thuc xy ra trong qu trnh nm vin ln n 3,5 t -la M mt nm, cha k n thit hi do gim nng sut lao ng v mt thu nhp ca bnh nhn cng nh nhng chi ph chm sc sc khe khc. y ban ny cng cho rng cc con s trn vn cn cha y [67].-Mt s bin php ngn chn sai st trong dng thuc ti bnh vin sau c th c p dng: Xydngnhmlmvicbaogmbcs,dcsviudngla chn quy trnh thc hnh hiu qu nht. S dng ch khng dng bin php trng pht c th thu thp v ghi li nhng thng tin v sai st lin quan n thuc. Xy dng quy trnh s dng bng vn bn, gm hng dn v bng kim cho vic s dng dung dch tim truyn v nhng thuc c nguy c cao. Yu cu phi xc nh ng ngi bnh trc khi cho dng thuc. Yu cu ch vit khi k n phi r rng v ghi y tn thuc. Yu cu s dng cc k hiu c chun ha. Yucuttcccnthucphighirngdngvghiycc hng dn s dng [53]. 1.1.3.Vn cht lng thuc [53], [80] -Khi nim v vn cht lng thuc Thuc km cht lng c chia thnh hai loi: Thuc khng t tiu chun (khng tha mn v mt trong cc ch tiu cht lng v thnh phn, tinh khit hoc cc thng s dc hc khc, khng c mc ch la o) v thuc gi (khng 6 c dccht,c dcchtkhng ng hm lng,dcchtkhcvi dccht ghi trn nhn, mo tn, kiu dng ca thuc ng k bo h, c la o) [6]. -Hu qu ca vn cht lng thuc Thuc km cht lng c th lm gim hiu qu iu tr v gy ra cc phn ngkhngmongmunhaychi,vnhngiunycthgyhichongi bnh (thng qua vic ko di thi gian b bnh hay mc cc bnh do thuc gy ra) cng nh lm lng ph cc ngun lc vn hn hp [53]. -Mtscc binphp cs dngnhm gimstvmbochtlng thuc trong bnh vin bao gm: Cc thnh vin Hi ng Thuc v iu tr cn c chuyn mn su v y dcvcmttrongccvaitrlumilachnnhngsnphmphhp, sontho nhngchnhsch, hng dn lachn, muathuc vs dngthuc hp l v hng dn khoa Dc thc hin. B phn cung ng thuc ca bnh vin phi la chn nhng nh cung cp v sn xut t tiu chun GMP, c giy php hnh ngh, c y h s v quy trnh thc hnh nhm m bo thuc c mua p ng cc tiu chun yu cu v cht lng thng hiu c th tm c qua cc phng tin truyn thng.Hi ngThucviutrcn mchtlngthuc bngcch htr khoa Dc khi xng v gim st h thng bo qun v phn phi thuc. Khothucphiciukinboqunphhpduytrchtlng thuc, trnh cc yu t c th gy hng hay gim cht lng thuc. Hndngcathuccnglmtyutquantrngtrong mbocht lng thuc.Cnlugithuctheo quynh hngn xut trcv phicc ch loi b thuc ht hn. i vi nhng thuc c cng hn s dng, cn tun theo quy nh nhp trc xut trc [53], [80]. 7 1.2.GIM ST ADR TRONG BNH VIN 1.2.1.Cc i tc tham gia gim st ADR trong bnh vin 1.2.1.1.Hi ng Thuc v iu tr Theo WHO, mt trong nhng chc nng ca Hi ng Thuc v iu tr lbomantonthucthngquacngtctheodi,nhgi,trncsngn ngaccADRvsaisttrongiutr.Theo,Hi ngThucviutrc trch nhim xtrccADR,gmgimst, nhgi, boco,xc nhvn v ngn nga [53], [61]. VitNam, B Y t cng quy nh mt trong trong cc nhim v ca Hi ng Thuc v iu tr l t chc theo di cc phn ng c hi v cc vn lin quan n thuc trong bnh vin, c th l theo di st sao vi nhng thuc bit ADR, cnh gic vi thuc cha bit ADR, hi chn v tho lun kt lun v cc ADR, ngthi lm bocovcc vn lin quan nthuctrongBnhvin [9]. NghincucaVThThuHng(2012)ti7bnhvinakhoatuyn Trung ng, 14 bnh vin tuyn tnh v 18 bnh vin huyn/qun trn c nc cho thyc11bnhvincnnhcantoncaccthuctrongvicxydng danh mc thuc bnh vin thng qua thng tin v ADR [14]. Ngy 29/8/2012, Hi ng Thuc v iu tr Bnh vin Bch Mai ch ng gi khuyn co cho cc khoa lm sng trong bnh vin v vic tng nguy c ung th khi s dng calcitonin ko di trong iu tr long xng sau khi cp nht thng tin v an ton ca ch phm ny t c quan qu l Dc phm chu u (EMA) [13]. 1.2.1.2.Khoa Dc B Y t quy nh mt trong cc nhim v ca khoa Dc l tham gia cng tcCnhgic dc;theo di,tp hpcc bo covtc dngkhng mong mun ca thuc trong n v v bo co v Trung tm DI&ADRQuc gia, xut bin php gii quyt v kin ngh v s dng thuc hp l, an ton [7]. TiBnhvinBchMai,khoaDcbnhvintrinkhaitchcchat ngDclmsngvinhng dcslmsng lm victhngtrchoclun 8 phin cng bc s trong qu trnh iu tr cho bnh nhn ti cc khoa lm sng. Nm 2012, khi thay i quy trnh bo co ADR, khoa Dc vit hng dn vit bo co ADR cho cn b y t trang u tin ca s bo co, ghi r nhng trng hp cn bo co, i tng bo co, cch thc ghi bo co v np bo co [1]. 1.2.1.3.Cn b y t Theo WHO, cc cn b y t c iu kin tt nht bo co cc nghi ng v mtADRxy rabnh nhn. Ttccn b thamgiavohthngchmscsc khe u tham gia bo co cc ADR nh mt phn trong trch nhim chuyn mn ca mnh, ngay c khi ADR b nghi ng cha c mi quan h r rng vi vic iu tr [87]. iu 51, Lut Dc quy nh: C s khm bnh, cha bnh, cn b, nhn vin y t c trch nhim theo di v bo co cho ngi ph trch c s, c quan c thm quyn qun l thuc v cc phn ng c hi ca thuc [16]. Thng t 31 ca B Y t ban hnh ngy 20/12/2012 v hng dn hot ng dclmsngtrong bnhvinquynh:Mttrongnhngnhimvcadcs lm sng l theo di, gim st ADR v l u mi bo co cc ADR ti n v theo quy nh hin hnh. Ti khoa lm sng, dc s lm sng ngoi xem xt cc thuc cknchongibnhvchnh,chngch nhcnphixemxtn cc ADR ca thuc [5]. 1.2.2.Cc bc gim st ADR trong bnh vin Vicgimstphnngchicathucgmccbc:phthin,xtr, nh gi, bo co v d phng ADR [4], [53]. 1.2.2.1.Pht hin ADR iu dng vin, h sinh vin, k thut vin trong bnh vin c trch nhim theodivphthinnhngbiuhinlmsngvcnlmsngbtthngtrn ngi bnh,thng bocho bcs iutrv khoaDc,ghiliccthngtinlin quan ti thuc m ngi bnh s dng. BcsthamgiaphthinADRbngcchghinhnnhngbiuhinlm sng v cn lm sng bt thng trn ngi bnh vo bnh n, kim tra li tt c cc 9 thuc thc t ngi bnh s dng, kim tra cht lng cm quan mu thuc c lu li, kim tra vic s dng thuc c ph hp tnh trng bnh l hay khng, c cn nhcnccbnhmckmvchngchnhtrnngibnhhaykhng,liu dng thuc ng nh khuyn co cha, ngi bnh c tin s d ng, c bit l dngthuckhngvcsphhpvthiimdngthucnghingvthi im xut hin ADR khng. Vi dc s, trong qu trnh xem bnh n hoc duyt thuc ti Khoa Dc, dc s pht hin ADR da trn cc thuc c kh nng c s dng x tr phn ngc hicathuc, biu hinlmsngv ktquxtnghimcnlmsng bt thng. u tin xem xt bnh n cc i tng c bit, s dng thuc c nguy c cao xy ra ADR [4].1.2.2.2.X tr ADR Vi iu dng vin, h sinh vin, k thut vin, cn x tr ADR theo ng y lnh, theo di ngi bnh, thng bo kp thi cho bc s iu tr nu c din bin bt thng ca ngi bnh. Trng hp khn cp c th ngng s dng thuc nghi ng gy nh hng ti tnh mng ngi bnh trc khi thng bo cho bc s. Bcsc nhimv nhgi mc nghim trngcaADR quytnh hngxtrlmsngphhp:gimliuhocngngthucnghinggyADR trongiukinlmsngcho php,kp thithchinccbin phpiutrtriu chng, iu tr h tr, m bo chc nng sng cn cho ngi bnh, thc hin theo cchngdnchuynmncaBYtclinquannuvicxtrADRthuc phm vi cc hng dn . Trng hp cn thit, c th trao i hng x tr vi ng nghip,tchc hichnchuynmn,thamkhothmthngtinvADRt Dc s, n v thng tin thuc bnh vin hoc cc Trung tm v Thng tin thuc v Theo di phn ng c hi ca thuc. Gim st cht ch ngi bnh trong trng hp bt buc s dng li thuc nghi ng gy ADR khi khng c thuc thay th hoc khi li ch ca thuc vt tri hn nguy c. Dc s cn phi trao i vi bc s iu tr nu pht hin ADR khi thc hin hot ng dc lm sng ti khoa phng c bin php x tr ph hp, cng nh 10 cungcpthngtinvthuctrongqutrnhxcnhvx trADRtheoyucu ca cn b y t [4]. 1.2.2.3.nh gi ADR Hi ng Thuc v iu tr bnh vin cn phi kim tra cc trng hp nghi ng l ADR, c mt thnh vin chuyn iu tra v phn tch cc bo co, hp nh k tho lun v nh gi cc bo co v thng bo cho cc nhn viny t trong bnh vin. Nhim v nh gi ADR bao gm cc bc c th sau y. -nh gi bn cht ca ADR Cn b y t cn xem xt tin s ngi bnh, kim tra chi tit m t ADR, tra cu ti liu v m t ny v cc thuc nghi ng, tra cu xem ADR c ghi nhn trongt hng dnsdngthuc haycctiliuyvnvthuccha.Phnloi mc nguyhimca phn ng,v nhgimi linh giathuc nghi ng v ADR xut hin trn ngi bnh. -Xc nh nguyn nhn gy ADR Sau khi nhn nh cc triu chng lm sng cu thnh ADR, cn b y t cn quanstthucbnghingvkimtravicmua,boqunthuc,hndngca thuc.TnhtnsutxyraADRtrongcckhoakhcnhauvkimtraxemgia cc khoa c t l mc ADR cao nht v thp nht vi cng mt loi thuc c im khc nhau no khng, thm cc khoa phng c t l ADR cao quan st thuc b nghingckn,cpphtvsdngnhthno.Trongtrnghpcn thit, cthlin hviccc quan, bnhvinkhc hoc c quanqunl tm hiuthngtinvADRtngt,hocgimuthucikimtrachtlng[4], [53]. 1.2.2.4.Bo co ADR Ngi trc tip vit bo co ADR c th l bc s, dc s, iu dng vin, h sinh vin, k thut vin v cc cn b y t khc, s dng mu bo co do B Y t quy nh. Hi ng Thuc v iu tr bnh vin cn xy dng h thng gim st, theo di, iu tra v bo co ADR ngay trong bnh vin, bt k pht hin nghim trng 11 nocngcnphibocovicquanqunldcphmqucgiav/hocvi nh sn xut. Bococncgitrongthigiansmnhtcthsaukhixyraphn ng, ngay c khi thng tin thu c cha y . C th b sung bo co nu thu thp c thm thng tin [4], [53]. 1.2.2.5.D phng Hi ng Thuc v iu tr c th tng cng vic s dng thuc an ton v d phng cc trng hp ADR bng cch khuyn khch bo co ADR, o to cho cn b v ADR v chng trnh gio dc bnh nhn. Sau trin khai gim st an ton ca mt thuc mi a vo danh mc thuc bnh vin trong trng hp cn thit c th thay i danh mc thuc. Thit lp quy trnh k n mi km theo khuyn ngh v vic khi no dng mt thuc trong danh mc v dng nh th no, xcnhvgimstchtchvicsdngnhngthuccnguyccaotrongdanh mcthuc,xc nhvgimstchtchtrongqutrnh iutr cho nhng nhm bnh nhn c nguy c cao nh ph n c thai, ngi cao tui, tr em v bnh nhn c suy gim chc nng gan thn. Vic nh gi li cc bo co ADR v thng bochocn bytvphmvinh hngvtc ngcaADRtrong bnhvin cng l cn thit. ng thi cn theo di t l xut hin ADR sau khi tin hnh canthiplmgim ADR xcnhchcchnrngcc hot ngcaHi ng Thuc v iu tr c hiu qu hay khng. CccnbytcnhimvtunthtunthquytnhcaHing Thucviutr.Chtngtcthuctrongknvthchinyvic gim st ngi bnh trong qu trnh iu tr m bo k n, s dng thuc hp l.Tunth qui trnhbo qunvs dngthuccho ngi bnh,kimtratng tc thuc v chng ch nh trong n thuc trong qui trnh cp pht thuc ti khoa Dc. TikhoaDc,nvThngtinThucca bnhvincncp nhtthng tinvantonthuc,gincnbytvngibnhtrongcskhmbnh, chabnhdinhiuhnhthc,gimstchtlngtrckhicpphtthucv cc khoa phng, hng dn v h tr cn b y t trong cng tc bo co ADR [4], [53], [75]. 12 1.3.BO CO ADR TRONG BNH VIN 1.3.1.Tm quan trng ca vic bo co ADR trong bnh vin Bo co ADR t nguyn l cng c ch yu trong h thng Cnh gic dc ca bt k quc gia no. Vic thu thp thng tin t cc bo co ADR t nguyn gip quy kt mi quan h nhn qu gia thuc nghi ng v phn ng xy ra, t gip cho c quan qun l a ra cc quyt nh qun l ph hp [30]. V vy, vic bo co ADR trong bnh vin ng vai tr v cng quan trng trong vic pht hin cc ADR ca thuc mi c a vo s dng, cc ADR nghim trng v cc ADR c th c pht hin sm [81]. Hn na, cc d liu v ADR thu thp c trong mi bnh vin s c tnh ph hp cao hn gip cho vic qun l s dng thuc ph hp hn [17]. Rtnhiunghincutrnthgiikhngnhnhcchotngtng cng Cnh gic dc cho cn b y t trong bnh vin nh o to tp hun, cung cp thng tin thuc, phn hi bo co ms lng cng nh cht lng bo co ADR ghi nhn c s ci thin tch cc [39], [43], [62], [83]. 1.3.2.Nhng trng hp cn bo co ADR Cc Qun l Dc Thy in quy nh cc cn b y t cn phi bo co cc ADRnghimtrng,ADRchaccp trongttmttthngtinsnphm, cc ADR lin quan n vic s dng ca thuc mi (lu hnh trn th trng di 2 nm) tr nhng bin c thng gp c in trn t tm tt thng tin sn phm, v nhng ADR m t l xut hin c xu hng tng ln [63]. Vit Nam, cc cn by t c hng dn lm bo co ADR i vi tt c cc phn ng c hi nghi ng ca thuc, vc xin, sinh phmy t, thuc ngy, thuct dcliu, dcliu, vthucyhc ctruyn, c bit vicc phnng nghim trng, cc thuc mi a vo s dng trong iu tr ti bnh vin, cc phn ng khng mong mun hoc cha c bit n, phn ng c hi xy ra lin tc vi mtthuchocmtlthuctrongmtthigian,tngtcthuc,thtbitrong iu tr, cc vn v cht lng thuc hay cc sai st trong s dng thuc [1], [4]. 13 1.3.3.S tham gia ca cn b y t trong bo co ADR ti bnh vin Ti M, 68% bo co ADR nghim trng c gi bi dc s [25]. Ti H Lan, 40% bocoADRntcc dcshiuthuccng ng, ni dungcc bo co nythng tp trung trn cc ADR d pht hin, cht lng bo co thp hn khng ng k so vi cht lng bo co ca bc s [82]. Cn ti Vit Nam, 60-68%sbocoADRcgibibcs,bocotdcschchimkhong 11,3-16,2% [20], [23]. Bnthncn byttibnhvincng c mong mun cthamgiatch cc hn trong vic bo co ADR. Kho st tin hnh ti n cho thy 90,2% s cnbytchitnthnhvicthnhlpmttrungtmCnhgicdcti bnh vin h ang cng tc v 71% bc s cho rng vic bo co ADR nn c coi l bt buc [48]. Mong mun tip xc trc tip vi trung tm Cnh gic dc quc gia, nhn c phn hi chi tit ca bo co cng nh nhng thng tin h tr hot ng bo co ADR cng c ghi nhn t cn b y t [34]. Mt nghin cu khc ti Trung Quc cho thy dc s k vng nhn c s o to, tp hun nhiu hn v Cnh gic dc cng nh s h tr ng vin t khoa Dc bnh vin tham gia bo co ADR tch cc hn [77]. 1.3.4.Nhng tn ti ca cng tc bo co ADR trong bnh vin 1.3.4.1.C s vt cht v nhn lc -Thiu cn b chuyn trch v Cnh gic dc Cc cn by t lm vic ti cc bnh vin m trch nhim v khm, cha bnh vi khi lng cng vic ln. V vy,khng phi bnh vin no cng c th c cn b lm vic chuyn trch v Cnh gic dc, v thiu thi gian bo co ADR do u tin thi gian cho cc nhim v chm sc sc khe khc l mt tn li ln ca vic bo co ADR trong bnh vin [33], [71]. Nhng nghin cu ti H Lan cho thy t l dc s bnh vin tham gia bo co ADR chim cha y 1% v 35% s bc s c hi cho rng vic bo co ADR l rt mt thi gian [70], [82]. -Hn ch v c s vt cht 14 Bcschatipcncvimubocohocviach,sinthoi ca trung tm Cnh gic dc quc gia [33], [71]. 1.3.4.2.Nhn thc ca cn b y t -Cha tch cc tham gia vo h thng bo co ADR t nguyn C nhiu nguyn nhn dn n s km tch cc, thiu hp tc trong bo co ADR ca cn b y t nh: s th , thiu quan tm vi bo co ADR k c khi gp ADR nghim trng, cha c thi quen bo co ADR [48]. Tm l e ngi b lin ly hoc quy kt trch nhim v vic bo co ca mnh [38] v v vi phm tnh bo mt bnh n ca bnh nhn [33]. -Hn ch trong nhn thc v tm quan trng v phm vi ca Cnh gic dc Ti nhiu quc gia, cng tc o to, tp hun v Cnh gic dc vn cha ctrinkhairngkhpdnncchnchtrongnhnthccacnbyt. Nhiu ni cn b y t thiu kin thc v vic bo co ADR nh khng bit vit bo co ADR nh th no v np bo co ADR u [33], [48], [71]. Mt nghin cu tin hnh ti Canada tng kt nhng tr ngi ln nht ca vic bo co ADR bao gm cc cn b y t coi Cnh gic dc l vic l tng, phi hin thc, coi c quan qunl bo colxavi, quan nimcn b yt khngclin quan n nguyc gn vi vic iu tr, h cng khng chc chn v thm quyn ca mnh trong vic bo co cc phn ng c hi [68]. Nhiu cn b y t quan nim ADR ca thuc cnghincu ytrckhithuccavothtrngvchorngch nn bo co ADR nu chc chn rng bin c lin quan n vic s dng thuc [51]. Ro cn ca vic bo co ADR c th l s thiu t tin, lo lng vic bo co c v s v l khi ch l nghi ng mt trng hp ADR hoc khi mi quan h nhn qu gia thuc v bin c c hi l kh xc nh [71]. Cc cn b y t cng c th lo ngi rng nu ch bo co mt ca n l s khng th ng gp g cho kin thc y hc [51], hay mt s ngi c tham vng gi thng tin v ng ti mt chm ca v ADR cho c nhn mnh [33]. 15 -Hn ch v k nng chuyn su cn b lm Cnh gic dc Cn by t cha c trang b nhng hiu bit cn thit v tm quan trng ca h thng bo co ADR t nguyn [71]. 1.3.4.3.H thng bo co t nguyn v phn hi -S lng, cht lng bo co ADR cha cao Nhc imln nhtca bocoADRtnguynnichunglchc mt b phn nh ADR l c bo co. T l bo co ghi nhn c so vi thc t ch chimkhong 6%,cntlnyvibocoADRnghimtrngl10-15%[26], [29], [50], [73]. Mt nghin cu Thy in th cho thy c ti 56% cc trung tm ytcstincnykhngcbocononm2008[49].TiVitNam,cc nghincucngchra rngtlbococha ng mcv slngcc bnh vin cn ang rt cao [17] ,[19]. -C ch phn hi thng tin cha hiu qu. TiTrungtmDI&ADRQucgiaVitNam,dohnchvnhnlcnn hin nay Trung tm u tin phn hi nhng trng hp bo co ADR nghim trng c gi ti. Nhng bo co khng nghim trng c phn hi cn hn ch. Bn cnh , cc thng tin v an ton thuc t C quan qun l cha c truyn ti kp thi n cho cn b y t. 1.4.MTSBINPHPTHCYBOCOADRTRONGBNH VIN 1.4.1.Mt s bin php thc y bo co ADR trong bnh vin1.4.1.1.Tng cng o to nng cao nhn thc v k nng ca cn b y t Nhng nghin cu ti nhiu quc gia trn th gii kt lun rng vic o to v tp hun cho cc cn b y t bng nhiu bin php nh thuyt trnh, t chc kha o to Cnh gic dc ci thin t l bo co ADR cng nh cht lng bo co [78], [43], [62]. Nhiu nghin cu ch ra s cn thit ca cc bin php otovtp hunchocn bytnhmthcyvicbo coADR[38],[46], [54], [79]. Tuy nhin, cng tc ny i hi s quan tm nh k v lin tc, v mt snghincuchrarnghiuqucascanthipthngquaotovtp 16 hun cho cn b y t bt u mt dn i sau 1 nm v khng ko di hn 2 nm nu khng c tin hnh nh k [36], [43], [62], [76].1.4.1.2.Cngchthngbocotnguynvthitlpcchphnhic hiu quNhm cng c h thng bo co ADR t nguyn trong bnh vin, nhiu bin php c xut nh tng cng hot ng ca dc s lm sng ti bnh vin, tin hnh can thip nhiu mt theo tha thun gia ban gim c bnh vin v cc bc s [47], [71]. Gi phn hi chi tit cho bc s bo co ADR cng l mt bin php cho thy hiu qu l tng s lng bo co ADR c gi i v ni dung ca phn hi bo co ADR cho bc s tc ng n t l bo co ADR [83]. Cc bc s khi c phngvncngchorngrocntrongvicbocoADRcth cgiiquyt bng vic rt ngn khong cch gia bc s v Trung tm Cnh gic dc quc gia, cung cp cho cc bc s nhng phn hi t cc hot ng Cnh gic dc [34], [54], [81]. Phn hi c th l mt bn tin v ADR vi mc tng kt nh k nhng ADR bo co trong ton bnh vin, bn lun v nhng ca ng ch , tng hp phn loi nhng ADR thu c theo s quan tm ca tng khoa phng v nhng thng tin cnh bo v ADR ca c quan qun l dc phm quc gia [81].1.4.1.3.y mnh truyn thng v gio dc Vic pht hnh tp ch, bn tin v an ton thuc hng qu v gi cho cc bc s chng minh hiu qu lm gia tng t l bo co ADR [39]. Mt nghincuticc bnhvinNigeria chothy,mcd bcs ghi nhn nhiu ADR, c kin thc tt v ADR, nhng t l bo co ADR li rt thp, v nhn mnh tm quan trng ca vic truyn thng, gio dc cc hot ng Cnh gic dc rng khp trong bnh vin [69].Bin php cng c h thng bo co t nguyn bng cch nh km mu bo co t nguyn theo t n thuc v vo bn tin ADR ri gi n cho bc s iu tr lm tng ng k t l bo co ADR ti Ty Ban Nha [39]. 17 CcthngtinvADRcth cgi ncho bcs quathtn hocth in t. Vic gi email c thng tin v ADR cho cc cn b y t cng cho thy lm tng t l bo co ni chung. Phng php ny c tnh kh thi cao nh r tin, d thc hin v qun l, tuy vn c hn ch v thi quen chung l ch c lt th int[52].Nhngbinphpnynhmmcchcungcpthngtinvnhng ADR c bo co, t vn iu tr da trn bng chng trong nhng trng hp nghi ng ADR c th v nhng kin v quy kt mi quan h nhn qu ca thuc vi ADR [81]. 1.4.1.4.Mt s bin php khc -p dng khen thng, ng vin cho cn b yt cng c th c s dng nh mt bin php b sung lm tng cng t l bo co ADR. H tr ny c th dinhiuhnhthckhcnhau,ikhicthlvss.Ktquchothys lng bo co ADR tng ln sau khi p dng bin php ny [28], [42], [71]. Ngoi bc s, cng cn m rng phm vi i tng c u i t vic bo co n iu dng, bnh nhn [24], [27], [54]. -Vic khuyn khch v mt ti chnh kt hp vi cc bin php tp hun cho cn b y t em li hiu qu v c s lng v cht lng bo co ADR, c th l t l bo co ADR t nguyn ni chung, t l bo co ADR nghim trng, ADR ca thuc mi ni ring [28], [36], [43], [71]. -Ti M, FDA bt u a vic s dng bnh n in t thnh mt phng php nhm thu thp thng tin v an ton thuc. Nhng bo co bin c c hi ca thuc thu c t bnh n in t l mt ngun cung cp thng tin an ton thuc rt trin vng v c gi tr [37].-TiHLan,mtnghincuchorngvicgiaolugiaccngnghip trong cng bnh vin c th l mt cng c hu hiu gip kch thch thi quen bo co ADR. ng thi, vic phn cng trch nhim c th ai bo co nhng ADR no cng gip chia s p lc cng vic v t lm tng t l bo co [70]. -Bin php tng cng gio dc v Cnh gic dc cho sinh vin c bc i hc v sau i hc cng c xut trong mt nghin cu ti Anh [49].18 1.4.2.Tnh hnh bo co ADR Bnh vin Bch Mai. Bnhvin BchMai lmt bnh vin akhoatuyncuic quym1400 ging bnh vi khong 60 000 bnh nhn ni tr mi nm. Bnh vin c 23 Khoa lm sng, 7 Khoa cn lm sng, 5 Trung tm v 2 Vin trc thuc [90]. NmtrongkhoaDcbnhvin,tDclmsngkhngchmnhim vic duyt thuc cho cc Vin/Khoa/Phng m cn kim tra gim st s dng thuc anton,hpl,kimtraquychchuynmncngnhcchotngthngtin thuc. Dc s i lm sng c nhim v theo di bnh nhn, t vn s dng thuc cho bc s [91]. Mt s nghin cu c thc hin v cng tc Cnh gic dc ti Bnh vinBchMai.SlngbocoADRcghinhntronggiaiongiaion 1998-2000l 122 bocovgiaion2006-2008l813boco.Tlboco trn c nhn nhlcnkhthp[11],[17],[18].Tlbocoghichpthiu thng tin cn cao, nh hu qu ADR thiu n 51,7%, tn thuc nghi ng gy ADR thiu4,4%,binphpxtrADRthiu9,7%[17],[18].Nm2012,Bnhvin Bch Mai thay i hnh thc bo co ADR t phng thc c chyu s dng s sch sang phng thc mi vi biu mu chi tit theo Thng t s 23/2011/TT-BYT Hng dn s dng thuc trong cc c s y t c ging bnh v bc u ghi nhn nhng tn hiu tch cc. 19 CHNG 2. I TNG V PHNG PHP NGHIN CU 2.1. I TNG NGHIN CU i tng nghin cu l tt c cc bo co v phn ng c hi ca thuc ca bnh vin Bch Mai trong hai nm 2011 v2012 c lu tr ti cc ngun sau: -SghichpADRticckhoa,phngBnhvinBchMai(phlc1)v ccbocoADRtheomuc(phlc 1)cdcslmsngintrongqu trnh i bung bnh ti cc khoa, phng Bnh vin Bch Mai nm 2011. -Bo co ADR theo mu mi (ph lc 1) lu ti khoa Dc bnh vin Bch Mai trong nm 2012. -CcbocoADRcaBnhvinBchMaicgichoTrungtm DI&ADR Quc gia trong nm 2011 v 2012. Tiuchunloitr:Nhng bocothiuthngtinvthuc nghi nggy ADR v/hoc khng c thng tin v ADR. 2.2.PHNG PHP NGHIN CU Nghin cu c tin hnh ti bnh vin Bch Mai v Trung tm DI&ADR Quc gia. Phng php nghin cu: M t ct ngang khng can thip d liu t s ghi chpvccbocoADRclutrlikhoaDcBnhvinBchMaitrong hai nm 2011 2012. Cu trc d liu: D liu gm 3 phn chnh l thng tin v bo co, thng tin v thuc nghi ng v thng tin v ADR.Do , mi bo co c th lin quan n mt hay nhiu thuc vi mt hay nhiu ADR. 2.3.CH TIU NGHIN CU 2.3.1.Quy trnh bo co ADR So snh quy trnh bo co ADR gia hai nm 2011 v 2012 vi cc ch tiu: -Mc tiu ca quy trnh -Cc i tng tham gia bo co ADR -Hnh thc bo co ADR 20 2.3.2.Thng tin v s lng bo co ADR. -S lng bo co ADR -T l bo co c gi ln Trung tm DI&ADR Quc gia 2.3.3.Thi gian tr hon gi bo co ADR Thi gian tr hon gi bo co ADR l thi gian t khi ADR xy ra n khi boconADRnycgivTrungtmDI&ADRQucgia.Sosnhthi giantrhontrungbnh,thigiantrhontithiuvtiagiahainmvso snhbngphngphpthngkiviccboconichung,boconghim trng v bo co khng nghim trng ni ring.2.3.4.C cu bo co ADR 2.3.4.1.Thng tin v bo co -i tng tham gia bo co ADR. -Cc khoa phng tham gia bo co ADR. 2.3.4.2.Thng tin v thuc nghi ng gy ADR ThucnghinggyADRcmhatheohthngphnloiATC.M ATClmththngphnloimtrongcchotchtcphnvonhng nhm khc nhau tng ng vi c quan hoc h c quan m chng tc ng cng nh nhng c tnh iu tr, c tnh dc l v c tnh ha hc ca chng [64]. -Tng hp bo co ADR theo l do s dng thuc: S dng phn loi ICD 10 ca WHO. -Cc ng dng thuc nghi ng gy ADR c bo co.-Cc h dc l c bo co nhiu nht.-Cc thuc nghi ng c bo co nhiu nht.2.3.4.3.Thng tin v ADR BiuhinADRcmtbngbthutngWHO-ART2012(Adverse ReactionTerminology)[85].MibiuhinADRcchunhamcPT (Preferedterm)vmiPTcmhabngmSOC(SystemOrganClasses) tng ng (SOC l m phn loi t chc c th b nh hng) [85]. -Phn loi t chc c th b nh hng. 21 -Cc biu hin ADR c ghi nhn nhiu nht. -Cc cp thuc - biu hin ADR c bo co nhiu nht -CcbocoADRhimgp:lnhngphnngctnsutxuthinnh hn 1/1000 theo Dc th Quc gia Vit Nam [10]. Cc bo co ADR nghim trng: l nhng phn ng gy t vong, e da tnh mng, buc ngi bnh phi nhp vin iu tr hoc ko di thi gian nm vin ca ngi bnh, li di chng nng n hoc vnh vin cho ngi bnh, gy d tt bm sinh thai nhi hay bt k phn ng c hi no c cn b y t nhn nh l gy ra hu qu nghim trng v mt lm sng [4], [88], [60]. -Cc ADR c pht hin qua xt nghim cn lm sng sinh ha v huyt hc [2]. 2.3.5.Cht lng bo co ADR - ChtlngbocoADRc nhgidatrnthang im nhgicht lng bo co ADR ca T chc Y t th gii [45] . Hnh 2.1. Thang im nh gi cht lng bo co ADR theo WHO 22 Quy tc nh gi: Thang im gm 3 nhm cu hi, tr li theo th t t trn xung. Mi nhm c 1 hoc 2 cu hi vi la chn tr li c/khng. Nu tt c cc cu tr li trong mt nhm u l C th tr li tip n nhm tip theo. Nu c mt trong s cc cu hi ca nhm l Khng, dng li vi s im tng ng vi nhm cu hi . im ti thiu l 0 tng ng vi cc bo co c cht lng thp nht, im ti a l 3 cho cc bo co c cht lng cao nht. + Nhm cu hi th nht: C thng tin v ngy xy ra phn ng khng? v C thng tin v ngy bt u s dng thuc khng?. Nu mt trong hai hoc c hai cu tr li l Khng: 0 im. Nu c hai cu tr li l C: xt tip sang nhm cu hi th hai. + Nhm cu hi th hai: C l do s dng thuc khng? v C kt qu sau x tr ADR khng? Nu mt trong hai hoc c hai cu tr li l Khng: 1 im. Nu c hai cu tr li l C: xt tip sang nhm cu hi th ba. +Nhmcu hith ba:Cthngtinphn nglplisaukhitisdngthuc khng?Nu cu tr li l Khng: 2 im. Nu cu tr li l C: 3 im. Vic nh gi c thc hin c lp gia hai ngi, nu c s khc bit th da vo kt qu ng thun thng qua ngi nh gi th ba. -PhntchchtlngbocoADRtrcvsaukhithayiquitrnhbo co gia hai nm 2011 v 2012 +Sosnhimnhgichtlngbococahainmsdngccthngs thng k: gi tr trung bnh, gi tr ln nht, gi tr nh nht, t phn v 25%, 75%, trung v v so snh bng phng php thng k. +So snh im bo co trung bnh ca cc khoa phng qua hai nm. 2.4.X L S LIU Sliucthuthpvxl bngchngtrnh MicrosoftExcel2007 v chng trnh SPSS 15.0. Trong : 23 Kt qu c x l thng k m t v so snh kt qu thi gian tr hon gi bocoADRvchtlngbocoADRsdngphntchkimchun Kolmogorow Smirnowxc nhxemthigiantr hon hoc im boco phn b theo phn b chun hay khng. Nu khng theo phn b chun, s dng test phi tham s Mann Whitney U, nu theo phn b chun, s dng T-test, nh gi s khcbitvmtthngkcathigiantrhongibocohocimscht lng bo co gia hai nm. 24 CHNG 3. KT QU 3.1.QUYTRNHBOCOADRCABNHVINBCHMAINM 2011 V 2012 T nm 2011 sang nm 2012, Bnh vin Bch Mai thay i hnh thc bo coADRtphngthcsdngsghichpADRticckhoa,phngiutr sang phng thc mi vi biu mu chi tit s dng mu bo co theo Thng t s 23/2011/TT-BYT Hng dn s dng thuc trong cc c s y t c ging bnh (Ph lc 1). S khc nhau c th gia hai quy trnh c tm tt bng 3.1.Bng 3.1 So snh mt s nt chnh ca quy trnh bo co ADR ca bnh vin Bch Mai nm 2011 v 2012 Nm 2011Nm 2012 Mc tiu Ghi nhn y v mt s lng phn ng c hi ca thuc. Ghi nhn nhiu v mt s lng, y v mt cht lng v hp l v mt thi gian (kp thi) pht hin phn ng c hi ca thuc. Cc i tc tham gia Cc khoa lm sng bnh vin Bch Mai Khoa Dc bnh vin Bch Mai Trung tm DI & ADR Quc gia Biu mu bo coHnh thc bo co Mikhoalmsngcs ghichpbocoADRv mt s t biu mu bo co ADRcakhoaDc(ph lc 1). Mi Khoa lm sng c s ghi chp bo coADR.S 3lingiyincarbon,c th x ri tng trang. Mi trang l mt mubocodatheomuboco ADRcquynhtrongphlc5, Thngts23/2011/TT-BYTban hnhngy10thng6nm2011, Hngdnsdngthuctrongcc c s y t c ging bnh (ph lc 1). 25 i tng v phng php bo co Cccnbytghithng tinvosghichpADR hocbiumuboco ADR. Cc cn b y t ghi thng tin vo s ghi chp ADR. Thu thp v gi bo co KhoaDckimtras3 thng/ln,ghiliboco ADRvobiumuca khoa.KhoaDcgibo co v Trung tm DI&ADR Quc gia. Khoa Dc kim tra s 3 thng/ln, x bocoADRkhis,mtbnluli khoalmsng,mtbnlutikhoa Dc,mtbngilnTrungtm DI&ADR Quc gia. KhoaDcgibocovTrungtm DI&ADRQucgiatheohthngbo coADRtrctuyntrntrangweb www.canhgiacduoc.org.vn (ph lc 1). QuytrnhbocoADRnm2012vimctiucthhn,hnhthcbo co tp trung v khoa hc hn, vic gi bo co n gin hn to iu kin thun li cho vic bo co ADR hiu qu, cht lng hn. 3.2.THNG TIN V S LNG BO CO ADR 3.2.1.S lng bo co ADR Tin hnh thu thp bo co ADR, ghi nhn c 180 bo co nm 2011 v 150boconm2012.Ccbococxemxtnhmloibnhngboco thiu thng tin v thuc v/hoc ADR. Kt qu sau khi loi bo co c trnh by trong bng 3.2.26 Bng 3.2. S lng bo co nm 2011 v 2012 Nm 2011Nm 2012 S lngT l (%)S lngT l (%) Tng s bo co180100%150100% S bo co b loi168,89%85,33% S bo co a vo x l s liu 16491,11%14294,67% Slngbocoghinhnnm2012thphnsovinm2011l30bo co, gim 16,67%. Tuy nhin, s lng bo co b loi do thiu thng tin v thuc v/hoc ADR gim ng k t 8,89% cn 5,33%. 3.2.2.T l bo co c gi ln Trung tm DI&ADR Quc gia Kt qu v s lng bo co ADR ghi nhn ti bnh vin v bo co gi ln Trung tm DI&ADR Quc gia c trnh by trong bng 3.3. Bng 3.3. T l bo co c gi ln trung tm DI&ADR Quc gia Nm 2011Nm 2012 S lngT l (%)S lngT l (%) Bo co ADR thu nhn c S lng bo co ADR180100%150100% Bo co c gi ln Trung tm DI&ADR Quc gia 116,11%150100% Bo co khng c gi ln16993,89%00% Bo co ADR nghim trng S lng bo co ADR21100%61100% Bo co c gi ln Trung tm DI&ADR Quc gia 419,05%61100% Bo co khng c gi ln1780,95%00% Bo co ADR him gp S lng bo co ADR18100%13100% Bo co c gi ln Trung tm DI&ADR Quc gia 211,11%13100% Bo co khng c gi ln1688,89%00% 27 Nm 2011,ch 11trongs 180 bo coADRghi nhn cgilnTrung tmDI&ADRQucgia(6,11%).TlbocoADRnghimtrngvhimgp c gi i tng ng ch l 19,05% v 11,11%. Nm 2012, tt c cc bo co ghi nhncucgii,nngtlbocoADRnghimtrngvhimgp c gi i ca nm 2012 ln 100%. 3.3.THI GIAN TR HON GI BO CO ADR Kt qu thi gian tr hon gi bo co ADR c tnh ton v trnh by trong bng 3.4. Bng 3.4. Thi gian tr hon gi bo co trung bnh (ngy) Nm 2011Nm 2012 S lng bo co gi trung tm DI&ADR Quc gia11 bo co150 bo co Thi gian tr hon ti thiu19610 Thi gian tr hon ti a403382 Thi gian tr hon trung bnh262,8137,6 S lng bo co ADR khng nghim trng gi trung tm DI&ADR Quc gia 7 bo co 62 bo co Thi gian tr hon ti thiu20224 Thi gian tr hon ti a403382 Thi gian tr hon trung bnh266,7162,6 S lng bo co ADR nghim trng gi trung tm DI&ADR Quc gia 4 bo co56 bo co Thi gian tr hon ti thiu19610 Thi gian tr hon ti a396344 Thi gian tr hon trung bnh256,0179,8 S dng phn tch kim chun Kolmogorow Smirnow (p=0,002) cho thy dliuphnbkhngtheophnbchun.Dovy,testphithamsMann Whitney U c s dng so snh s khc bit v thi gian tr hon gi bo co gia hai nm. Kt qu cho thy thi gian tr hon gi bo co ca nm 2012 c rt ngn r rt so vi nm 2011 (p=0,007). 28 3.4.C CU BO CO ADR3.4.1.Thng tin v bo co 3.4.1.1.i tng tham gia bo co ADR S lng v t l bo co ADR theo tng i tng bo co ADR c trnh by trong bng 3.5. Bng 3.5. Thng tin v i tng tham gia bo co ADR Nm 2011Nm 2012 i tng S bo coT l (%)S bo coT l (%) Bc s9658,548459,15 Dc s42,4485,63 iu dng63,662014,08 Khng r5835,373021,13 Tlbococabcsnm2012tngnhsovi2011(t58,54%ln 59,15%). T l bo co n t dc s tng t 2,44% ln 5,63% v t l bo co ca iu dng tng mnh t 3,66% ln 14,08%. Chim mt t l ln trong c hai nm lnhng boco btrng mcitngboco(35,37%v 21,13%tng ng trong nm 2011 v 2012). 3.4.1.2.Cc khoa phng tham gia bo co ADR S lng v t l bo co ADR t cc khoa phng trong bnh vin nm 2011 v 2012 c trnh by trong bng 3.6.Bng 3.6. Cc khoa phng tham gia bo co ADR Nm 2011Nm 2012 STTTn n v S lngT l (%)S lngT l (%) 1Trung tm Chng c84,8874,93 2Khoa Chn on hnh nh21,2221,41 3Khoa C Xng Khp84,8864,23 4Khoa Da liu53,0500,00 29 5 Trung tm D ng min dch lm sng 169,761913,38 6Khoa ng Y21,2242,82 7Khoa Gy m hi sc53,0521,41 8Khoa Huyt hc Truyn mu31,8353,52 9Khoa H hp95,4932,11 10Khoa iu tr tch cc95,491611,27 11Khoa Khm bnh theo yu cu00,0064,23 12Khoa Mt21,2200,00 13Khoa Ngoi00,0021,41 14Khoa Nhi63,6632,11 15Khoa Ni tit00,0053,52 16Trung tm Phc hi chc nng00,0042,82 17Khoa Rng-Hm-Mt42,4400,00 18Khoa Sn2917,6853,52 19Khoa Thn kinh159,15107,04 20Vin Tim mch2615,853121,83 21Khoa Tai-Mi-Hng10,6100,00 22Khoa Truyn nhim10,6132,11 23Khoa Thn - Tit niu31,8321,41 24Khoa Tiu ho31,8332,11 25 Khoa Y hc ht nhn v ung bu 63,6621,41 26Khoa Cp cu00,0000,00 27Khoa Khm bnh00,0000,00 28Khoa Thn nhn to00,0000,00 29Vin Sc khe tm thn00,0000,00 30 C 21/29 khoa phng (chim 72,41% s khoa phng) c bo co trong nm 2011 v nm 2012. Trung tm d ng min dch lm sng v Vin Tim mch, khoa Thn kinh l hai n v dn u v s bo co trong hai nm. C 4/19 khoa phng (chim 21,05% s khoa phng) ch c bo co trong mt trong hai nm v cng c 4 nvkhc(chim21,05%skhoaphng)khngcboconotrongchai nm.3.4.2.Thng tin v thuc nghi ng gy ADR 3.4.2.1.Phn loi thuc nghi ng theo l do s dng thuc (ICD - 10) Tin hnh tng hp l do s dng thuc nghi ng gy ADR, mt s kt qu in hnh c trnh by qua bng 3.7. Chi tit tham kho ph lc 2. Bng 3.7. L do s dng thuc theo phn loi ICD-10 Nm 2011Nm 2012 Phn loi ICD Loi bnh ttTn sut T l (%) Tn sut T l (%) A00 - B99Bnh nhim trng v k sinh trng159,152215,49 G00 - G99Bnh h thn kinh53,0553,52 I00 - I99Bnh h tun hon2314,0253,52 J00 - J99Bnh h h hp127,32139,15 L00 - L99Cc bnh da v m di da2012,2032,11 M00- M99 Bnhhc-xng-khpvmlin kt 74,271913,38 O00 - O99Thai nghn, sinh , hu sn2615,8521,41 Z00- Z99 Ccyu t nh hng n tnh trng sc khe v tip xc dch v y t 21,221913,38 Nm 2011, l do thai nghn, sinh , hu sn l l do s dng thuc chim t lln nhtvi 15,85%, th hailldo bnhhtunhonvi 14,02%.Ldo s dngthuccghinhnnhiunhtnm2012lbnhnhimtrngvksinh trngvi15,49%,theosaulbnhhcxngkhpvmlinktchimtl bng cc yu t nh hng n tnh trng sc khe v dch v y t vi 13,38%. 31 3.4.2.2.Phn loi thuc nghi ng gy ADR theo ng dng thuc Kt qu tng hp v phn loi cc thuc nghi ng gyADR theo ng s dng thuc c trnh by trong bng 3.8. Bng 3.8. Phn loi thuc nghi ng gy ADR theo ng dng thuc Nm 2011Nm 2012 ng dng Tn sutT l (%)Tn sutT l (%) Tim, truyn tnh mch12274,3910876,06 Ung3118,903927,46 Tim bp116,7164,23 t hu mn84,8800,00 Th phn ng31,8300,00 Tim di da10,6132,11 t m h10,6100,00 Khng r84,88149,86 SlngbocoADRghinhnphnbtnggingnhauccng dng thuc trong c 2 nm. Cc bo co c ghi nhn chyu khi bnh nhn s dngthuctheongtim,truyntnhmch(nm2011:74,39%,nm2012: 76,06%).Thphnt3n4lnngdngnylccADRghinhnkhis dngngung.Cc ngdngcnlituycboconhngslngtng i t. 3.4.2.3.Cc h dc l c bo co nhiu nht Cc bo co ADR c tng hp phn loi theo h dc l ca thuc nghi ng gy ADR, da vo m ATC ca thuc. 10 h dc l c ghi nhn nhiu nht c trnh by trong bng 3.9. 32 Bng 3.9. Cc h dc l c bo co nhiu nht Nm 2011Nm 2012M phn loi H dc lTn s T l (%) Tn s T l (%) J01DKhng khun beta-lactam khc (*)7948,176847,89 M04ACc thuc iu tr gt74,27128,45 J01MCc khng sinh nhm quinolon53,05128,45 J01XCc khng sinh khc (**)31,83139,15 J01CKhngkhunnhmbeta-lactam,cc penicillin 95,4942,82 N03ACc thuc iu tr ng kinh74,2732,11 J04ACc thuc iu tr lao84,8810,70 J01GKhng khun nhm aminoglycosid63,6621,41 S01BCc tc nhn chng vim74,2700,00 M01ACcthucchngvim,iutrthp khp khng steroid 10,6164,23 (*) Khng khun beta lactam khc bao gm cc cephalosporin, monobactam v carbapenem. (**) Cc khng sinh khc bao gm cc khng sinh glycopeptid, cc polymixin, cc khng sinh steroid, cc dn cht imidazol, cc dn cht nitrofuran v cc khng sinh khc. Ccnhm dclcghinhnvcbn ltngtnhauquahainm 2011v2012.Ktquchothytlvttricaccthuckhngkhun.Nm 2011 v 2012 c tng ng 48,17% v 47,89% cc thuc nghi ng gy ADR thuc nhm khng khun beta lactam khc.3.4.2.4.Cc thuc ghi ng gy ADR c bo co nhiu nht Cc thuc nghi ng gy ADR c ghi nhn nhiu nht c trnh by trong bng 3.10. 33 Bng 3.10. Cc thuc ghi ng gy ADR c bo co nhiu nht Nm 2011Nm 2012 STT Thuc nghi ng gy ADRS bo coT l (%)S bo coT l (%) 1Ceftriaxon3420,732114,79 2Cefoperazon2314,021611,27 3Allopurinol74,2796,34 4Ceftazidim106,1085,63 5Cc acid amin63,6685,63 6Levofloxacin21,2264,32 7Imipenem/cilastatin00,0053,52 8Vancomycin31,8353,52 9Carbamazepin53,0532,11 10Cefoperazon/sulbactam21,2221,41 Ceftriaxonlthuc b nghi nggyADR nhiu nhttrong tngs boco vi t l 20,73% nm 2011 v 14,79% nm 2012. Trong 10 thuc hay gp nht, c n 7 i din thuc nhm khng sinh, m 4 thuc trong s l khng sinh nhm cephalosporin.Thuciutrgoutviutrngkinhcidintngngl allopurinol v carbamazepin cng nm trong cc thuc c bo co nhiu nht ca hai nm. 3.4.3.Thng tin v ADR 3.4.3.1.Tng hp phn loi bo co ADR theo t chc c th b nh hng v cc phn ng c hi Bo co ADR c tng hp phn loi theo t chc c th m ADR gy nh hng, kt qu c trnh by trong bng 3.11. 34 Bng 3.11. Tng hp phn loi bo co ADR theo t chc c th b nh hng v cc phn ng c hi Nm 2011Nm 2012 STT M SOC Biu hin ADR Tn sut T l (%) Tn sut T l (%) 10100Ri lon da v m di da13783,5413292,96 20200Ri lon h c - xng - khp00,0010,70 30410 Ri lon h thn kinh trung ng v ngoi bin 137,9396,34 40431Ri lon th gic10,6110,70 50500Ri lon tm thn00,0042,82 60600Ri lon h tiu ha169,762014,08 70700Ri lon h gan mt00,0042,82 80800 Ri lon chuyn ha v dinh dng 21,2221,41 91010Ri lon h tim mch53,0564,23 101030Ri lon nhp tim53,0510,70 111040Ri lon mch mu00,0010,70 121100Ri lon h h hp148,541611,27 131220Ri lon bch cu00,0042,82 141230 Ri lon tiu cu, h ng mu - chy mu 74,2774,93 151300Ri lon h tit niu00,0021,41 161810Ri lon ton thn3521,343323,24 171820Phn ng ti ch137,93117,75 Cc ri lon v da v m di da, ri lon ton thn, ri lon h tiu ha, h hp l nhng ri lon xut hin vi tn sut ln nht. Nm 2012 ghi nhn 17 h c quan b ri lon, a dng hn nhiu nm 2011 (11 h c quan). Mt s ri lon ca 35 nm 2012 ghi nhn c thm nh c xt nghim cn lm sng nh ri lon bch cu, ri lon h gan mt. 3.4.3.2.Cc biu hin ADR c ghi nhn nhiu nht CcbiuhinADRcghinhnnhiunhtcthngkvtrnhby trong bng 3.12. Bng 3.12. Cc biu hin ADR c ghi nhn nhiu nht Nm 2011Nm 2012 STT Biu hin ADR Tn sut T l (%) Tn sut T l (%) 1Ban nga6439,023625,35 2Ban 3521,344632,39 3Nga116,712719,01 4Kh th116,71139,15 5Sc phn v95,49117,75 6Bun nn74,2774,93 7Hi chng Stevens Johnson74,2774,93 8St63,6674,93 9Nn74,2764,23 10 Phn ng ti v tr a thuc 63,6653,52 Biu hin c boco nhiu nhttrong nm2011v 2012 lBan nga ctll39,02%v25,35%vBanvi21,24%v32,39%.NhngADR mangtnhcptnh,nghimtrngnhScphnvvHichngStevens Johnsoncng nmtrongs nhngADRcboco nhiu nhttrong hai nm, vi tng t l chim trn 10% mi nm. 3.4.3.3.Cc cp thuc - biu hin ADR c ghi nhn nhiu nht Cc cp thuc - biu hin ADR c tng hp v nhng cp ph bin nht c trnh by trong bng 3.13. 36 Bng 3.13. Cc cp thuc-biu hin ADR c ghi nhn nhiu nht Nm 2011Nm 2012 STTCp thuc- ADRTn sut T l (%) Tn sut T l (%) 1Ceftriaxon - Ban nga2112,8042,82 2Ceftriaxon - Ban 95,49128,45 3Cefoperazon - Ban nga116,7196,34 4Ceftriaxon - Nga31,8364,23 5Allopurinol - Ban 31,8353,52 6 Allopurinol - Hi chng Stevens Johnson 31,8342,82 7Cefoperazon - Nga21,2253,52 8Cefoperazon - Ban 10,6153,52 9Ceftriaxon - St53,0510,70 10Vancomycin - Ban 10,6153,52 Cp Ceftriaxon Ban nga t t l cao nht l 12,80% trong tng s bo cotrongnm2011.CeftriaxonBanlcpcboconhiunhtnm 2012 vi 8,45%. Allopurinol vi biu hin ADR nghim trng l hi chng Stevens Johnson cng c ghi nhn vi t l qua hai nm tng ng l 1,83% v 2,82%. 3.4.3.4.Cc ADR nghim trng c ghi nhn Nhng ADR nghim trng trong 2 nm 2011 v 2012 c tng hp v chn lc trnh by qua hai bng 3.14. v 3.15. 37 Bng 3.14. Cc ADR nghim trng c ghi nhn nm 2011 STT ADR nghim trng Thuc nghi ng gy ADRS ca Tng cng 1T vongCeftazidim11 Ceftriaxon2 Cefoperazon1 Vancomycin1 Pantoprazol1 Cefepim1 Ceftazidim1 Lidocain2 2Sc phn v Cefoperazon/sulbactam1 10 Allopurinol3 Carbamazepin33 Hi chng Stevens Johnson Sulfamethoxazol/trimethoprim1 7 Allopurinol1 Carbamazepin14Hi chng LyellThuc nam1 3 5 Ngng tun hon Amphotericin B11 Nm 2011ghi nhn21 bocoADRnghimtrng,chim12,80%tngs bo co nm 2011. C 1 trng hp ghi nhn l t vong do ADR, chim 0,61% s bo co ADR. 38 Bng 3.15. Mt s ADR nghim trng c ghi nhn nm 2012 STT ADR nghim trng Thuc nghi ng gy ADRS ca Tng cng 1T vongRifampicin/isoniazid11 Ceftazidim3 Alpha chymotrypsin1 Rifampicin/isoniazid1 Lidocain1 Ceftriaxon1 Cc acid amin2 2Sc phn v Cefoperazon2 11 3Hi chng LyellCytarabin11 4Tt huyt p Ioxitalamic acid /natri ioxitalamat 11 5H kali muMetoprolol11 Allopurinol v colchicin1 Allopurinol3 Carbamazepin2 6 Hi chng Stevens Johnson Colchicin v meloxicam1 9 7 au thng v Tng men gan H kali mu Theophylin11 8 Co git ton thn trn mt Imipenem/cilastatin22 9 Tng creatinin V niu Colistin11 10 Mt ng Lon thn Levofloxacin11 39 S bo co ADR nghim trng nm 2012 l 61 bo co, chim 42,96% tng sboconm2012.Nm2012cngghinhn1trnghptvongdoADR, chim t l 0,70%. Tl bo co nghim trng nm 2012 tng ln trn 3 ln so vi nm 2011. Cc nhm thuc gyADR nghim trng l rt a dng, gm c nhm khng sinh, iu tr gout, iu tr ng kinh, iu tr lao, thuc cn quang 3.4.3.5.Cc biu hin ADR c pht hin qua xt nghim cn lm sng CcADRcphthinquaxtnghimcnlmsngctnghpv trnh by trong bng 3.16. Bng 3.16. Cc biu hin ADR c pht hin qua xt nghim cn lm sng Nm 2011Nm 2012 STTBiu hin ADRTn sut T l (%) Tn sut T l (%) 1Tng tiu cu53,0542,82 2Gim bch cu00,0021,41 3Tng bch cu00,0010,70 4Tng t l bch cu i toan00,0010,70 5H kali mu21,2210,70 6H natri mu00,0010,70 7Tng transaminase00,0042,82 8Tng creatinin mu00,0010,70 Tng s74,271510,56 S loi biu hin ADR c pht hin qua xt nghim cn lm sng nm 2011 l 2 loi, cn trong nm 2012 la 8 loi. Nm 2012, t l ADR c pht hin qua bt thng ca cc xt nghim cn lm sng tng t 4,27% ln 10,56%.3.4.3.6.Cc ADR him gp c ghi nhn CcADRhimgptrongtngnmctnghpvtrnhbytrongcc bng 3.17. v 3.18. 40 Bng 3.17. Cc ADR him gp c ghi nhn nm 2011 STTThuc nghi ngBiu hin ADRTn sut 1CeftriaxonSc phn v2 Nn3 2Cefoperazon Bun nn1 Hi chng Stevens Johnson3 3Carbamazepin Hi chng Lyell1 4CefepimSc phn v1 5VancomycinSc phn v1 6PyrazinamidNga1 Co git1 Nhp nhanh17Amphotericin B Ngng tun hon1 Nga1 Ban nga1 Ban 1 8Ethambutol M ay1 9 Sulfamethoxazol/ trimetoprim Hi chng Stevens Johnson1 10CiprofloxacinKh th1 Tng s22 Nm 2011 ghi nhn 22 biu hin ADR him gp trong 18 bo co, chim 10,98% tng s bo co nm 2011. 41 Bng 3.18. Cc ADR him gp c ghi nhn nm 2012 STTThuc nghi ngBiu hin ADRTn sut 1CarbamazepinHi chng Stevens Johnson2 2CefalexinPh Quinck1 Bun nn2 au u13Cefoperazon Nn1 Bun nn1 4Cefoperazon/Sulbactam Nn1 6CeftriaxonSc phn v1 7CiprofloxacinBan 1 Ph Quincke1 8Ibuprofen Ban 1 Ban 2 9Metronidazol Nga2 Tng s17 SlngADRhimgpca nm 2012l 17biu hin,xut hintrong 13 bo co, chim 9,15% tng s bo co nm 2012. SlngbocoADRhimgpghinhntrongnm2011v2012tng ngl18bocov13boco,daongtrongkhong10%tngsboco. Khng c s thay i ng k v t l gia 2 nm. 3.5.NH GI CHT LNG BO CO ADR TI BNH VIN BCH MAI GIAI ON 2011 2012 3.5.1.KtqunhgichtlngbocoADRtibnhvinBch Mai giai on 2011 - 2012 nhgichtlngbocoADRhainm 2011v2012theothangim ca T chc Y t th gii, kt qu cht lng bo co c trnh by trong hnh 3.1. 42 Hnh 3.1. im cht lng bo co ADR nm 2011 v 2012 Nm 2011, cc bo co im 0 chim a s vi 86,59% v khng c bo co no t im ti a. Nm 2012, t l bo co im 0 ch cn 30,99%, s lng bo co im 1 v 2 u cao hn so vi nm trc, v xut hin 3 bo co t im ti a l 3.SkhcbitimchtlngbocoADRcanm2011v2012c nh gi bng cc thng s thng k: gi tr trung bnh, gi tr ln nht, nh nht, t phn v 25%, 75%, trung v. Kt qu thu c trnh by trong bng 3.19. Bng 3.19. Cc thng s thng k nh gi im cht lng bo co nm 2011 v 2012 STTThng s thng kNm 2011Nm 2012 1im cht lng bo co ADR trung bnh0,231,18 2Gi tr nh nht00 3T phn v 25%00 4Trung v01 5T phn v 75%02 6Gi tr ln nht23 imchtlngbococanm2012cgitrtrungbnh,trungv,t phn v 75% v im ti a u cao hn im nm 2011 chng t s tri hn ca cht lng bo co nm 2012. 43 SdngkimchunKolmogorowSmirnow(p=0,000).Chothydliu khngtheophnbchun.VvytestphithamsMannWhitneyUcs dng so snh s khc bit v im s gia hai nm. Kt qu cho thy im nh gi cht lng bo co ca nm 2012 cao hn c ngha thng k so vi nm 2011 (p=0,000). 3.5.2.im cht lng bo co trung bnh ca cc khoa phng Tin hnh so snh im trung bnh bo co ca cc khoa phng trc v sau khi thay i hnh thc bo co. Kt qu ca nhng khoa phng c bo co trong c hai nm c trnh by trong bng 3.20. Bng 3.20. im bo co trung bnh ca cc khoa phng nm 2011 v 2012 im trung bnh cht lng bo co STTTn n v Nm 2011Nm 2012 1Trung tm Chng c0,501,14 2Khoa Chn on hnh nh0,002,00 3Khoa C Xng Khp0,000,67 4Trung tm d ng min dch lm sng0,001,47 5Khoa ng Y0,501,50 6Khoa Gy m hi sc - Phng hu phu0,001,00 7Khoa Huyt hc Truyn mu0,000,80 8Khoa H hp0,331,67 9Khoa iu tr tch cc0,221,31 10Khoa Nhi0,002,00 11Khoa Sn0,070,20 12Khoa Thn kinh0,071,70 13Vin Tim mch0,621,06 14Khoa Truyn nhim0,001,33 15Khoa Thn - Tit niu0,671,50 16Khoa Tiu ho0,001,67 17Trung tm Y hc ht nhn v Ung bu0,002,00 Trmtskhoa phngkhnggibocotrong1trong2nmhocc2 nm,tonbcckhoaphngcnliucimtrungbnhchtlngboco 44 ADR cao hn so vi nm trc. Nm 2011, khng khoa phng no c im trung bnh ln hn 0,67 (im trung bnh bo co ca Khoa Thn Tit niu). Nm 2012, nhiu khoa phng c im trung bnh bo co t 2,00 nh Khoa chn on hnh nh, Khoa nhi, Trung tm Y hc ht nhn v Ung bu. 45 CHNG 4. BN LUN Bo co ADR ng vai tr rt quan trng trong cc hot ng gim st ADR tibnhvin.VicthcybocoADRtrongbnhvinnhmhnhthnhthi quen thc hnh Cnh gic dc cho cn b y t, ng thi to nn mi lin kt gia cc Khoa lm sng vi Khoa Dc, Hi ng Thuc v iu tr bnh vin v trung tm DI&ADR Quc gia, nhm hng ti mc ch cui cng l pht hin kp thi v x tr ph hp cc vn an ton thuc trong bnh vin. Mc tiu c k vng trong cng tc bo co ADR l tng s lng bo co ADR ghi nhn, trong ch trng n bo co ADR him gp, ADR nghim trng v ADR ca cc thuc mi. Thng 6 nm 2011, B Y t ban hnh Thng t s 23 quy nh Hng dn s dng thuc trong cc c s y t c ging bnh, trong c km theo biu mu mi ca bo co phn ng c hi ca thuc [8]. Trong bi cnh , Bnh vin Bch Mai tin hnh thay i quy trnh bo co c s dng trong nhiu nm sang s dng mt biu mu da theo mu quy nh. Nghin cu ny c tin hnh nhm sosnh bocoADRcaBnhvin BchMai giahainm 2011v2012 vs lng bo co, thi gian tr hon bo co, c cu bo co v cht lng bo co khi thay i quy trnh bo co ADR thm d hiu qu ca bin php gim st ADR ny. Kt qu cho thy quy trnh bo co ADR mi ti Bnh vin Bch Mai thu c mt s kt qu ng ch sau: Mtl, tlADR nghim trng,ADRc pht hin quaxtnghimcn lm sng c ghi nhn nhiu hn. S bo co gm nhiu trang c th x ri khng chgipci thintlbocogivTrung tmDI&ADRQucgia mcnlm tng ng k t l bo co ADR nghim trng (12,80% ln 42,96%) v ADR c pht hin qua xt nghim cn lm sng (4,27% ln 10,56%) c gi i. Nm 2012 ghi nhn 17 t chc c th b ri lon bi ADR, nhiu hn so vi nm 2011 vi 11 t chc c th. Nhng t chc ri lon c ghi nhn mi nm 2012 l ri h gan-mt, h to mu, h tit niu ch yu l nhng ri lon khng quan st c bng 46 khmlmsngmcndatrnktqutccxtnghimcnlmsng.Sci thin ny c c cng l nh hot ng tch cc ca n v Dc lm sng bnh vin v nh tnh chi tit trong mu bo co ca nm 2012: c mc nh gi mc nghim trng ca phn ng, ghi chp cc xt nghim cn lm sng ca bnh nhn, nhng mc ny khng c trong mu bo co ca nm 2011. CngtrongbicnhpdngquytrnhCnhgicdcmi,tlboco ADRnghimtrng timt bnhvin i hcMa-rc ghi nhn cl46%[89]. Mtphntchmetat39nghincutincuvtlADRghinhntrnbnh nhn ni tr ti M cho thy t l xut hin ADR nghim trng l 6,7%, thp hn so vitl12,80%nm2011v42,96%nm2012tiBnhvinBchMai[55]. im tng ng gia phng php ca hai nghin cu l t l ADR u c gp catlADRxyrakhibnhnhnangnmvinvitlADRdnnvic bnh nhn nhp vin. Tuy nhin, nghin cu ti bnh vin Bch Mai khng loi tr sai st trong s dng thuc, khng tun th iu tr, qu liu, lm dng thuc v tht bi iu tr. Thm vo , nh ngha v ADR nghim trng trong nghin cu ca chngtirng hn nh nghatrong phntch metanitrn,vn chltvong, buc bnh nhn phi nhp vin hoc li di chng vnh vin. Hai l do ny gp phn gii thch cho vic t l ADR nghim trng ghi nhn ti Bnh vin Bch Mai li cao hn so vi t l ghi nhn ti cc bnh vin ti M. Hai l, t l bo co khng c gi v Trung tm DI&ADR Quc gia gim ingk.HnhthcthitksbocoADRkhoahc hnsovisghichp ADR ti khoa phng iu tr trc y, mi bo co t ng sao thnh 3 lin v c th x ri lu v gi i, gip 100% s bo co ADR ghi nhn c gi v TrungtmDI&ADRQucgiatrong nm2012,cao hnrt nhiusovivi nm 2011(6%).Hintngbocothiusovithct(under-reporting)vnlmt thch thc ln ca h thng bo co ADR t nguyn khp ni trn th gii [49], [59].Tlbocoghinhn csovi thctchchimkhong 6%,cntl ny vi bo co ADR nghim trng l 10-15% [26], [29], [50], [73]. Tuy vy, nm 2011BnhvinBchMai,trongsnhngbococghinhn,chc 47 6,11% bo co c gi v Trung tm DI&ADR Quc gia, to s chnh lch vi s lng bo co Trung tm DI&ADR Quc gia thu c so vi thc t. Hin tng nyccithintrongnm2012,khngcboconocghinhnti bnh vin m khng c gi v cho Trung tm DI&ADR Quc gia. Bal,cithinchtlngbocochungcabnhvinvcacckhoa phng.Viccitinmubocorrng,chitit,nhiucuhinhiulachn, thaycctrngthngtinintdothnhcccuhinggiplmgims lng bo co thiu thng tin v thuc v/hoc biu hin ADR t 8,89% xung cn 5,33%. Thi quen bo co cha chnh xc ca Trung tm D ng v min dch lm sngt nm 2011vtrclghi hu quca ADRvo mcl dos dngthuc nh ckhc phctrittrongnm2012.Slng bocoim 0ca nm 2012 gim, s bo co im 1, 2, 3 tng so vi nm 2011 v im cht lng bocotrung bnhcattccckhoaphngucao hnsovi nmtrc.Mt nghincucatcgiGedde-Dahlpdngcngthangimnhgicht lngchoccbocoADRcabcstiNaUy[45].Vicmunghincu tngng(304bocoADRtrongnghincutiNaUysovi330boco trong nghin cu ti Bch Mai) cho thy 45% bo co t im 0, ch c 1,83% bo cotim3.Ktqunytngngvitl40%bocotim0v 2,11% bo co t im 3 ti Bnh vin Bch Mai nm 2012. Bncnh nhng iu lm c, quy trnh bo coADRnm 2012cng bc l nhng im hn ch cn khc phc: Mtl, chac bin php nokhc cpdngnhmthcyvicbo coADRtrong bnhvin.Slng boco ADRnm2012khng nhng khng tng m gim 16,67% so vi nm 2011. Hot ng trin khai ti bnh vin trng i hc Ma-rc l mt m hnh c th tham kho pht trin hot ng Cnh gic dc. Nh cc bin php tch cc thnh lp hi ng chuyn mn Cnh gic dc, tchc hithokhoa hckt hpviTrung tmCnhgicDc PhpvTrung tm chng c v Cnh gic dc Ma-rc, xut bn bn tin Cnh gic dc cho cc 48 cn b y t bnh vin s lng bo co ADR ghi nhn tng t 100 bo co ban u ln 520 bo co sau ba nm [89]. Thmvo,khngcthayingktrongsbocoADRhimgp ghinhnc.Thigiantrhonnm2012tuyngnhnnm2011cngha thngk,tuynhinvnqudivithigianbocotrungbnh137ngy.TheohngdngimstADRticccskhmchabnh,thigiannycquy nh l hng thng i vi bo co thng thng v khng qu 15 vi bo co ADR nghim trng [4]. Hai l,chacccbin phptphunchocnbyttrongbnhvin thch ng vi quy trnh bo co ADR mi dn n nhng thiu st trong vic in boco,inhnhnhVintimmch.Sboconm2012caVinltrn 20%, nhng khi thng k ch thy bnh h tun hon chim hn 3% tng s l do s dng thuc, nguyn nhn do cn b y t thng b trng hoc ghi khng ng l dosdngthuc.DochatcngnthiquenbocoADRcacnbyt nn c cu bo co ADR v ng dng, phn loi thuc nghi ng theo h dc l, ccthucthnggp,ccbiuhinthnggp,cccpthucbiuhinADR thnggpgiahainmlgingnhau.Cthniquytrnhboconm2012 cha c tc ng ng k v mt c cu bo co so vi nm 2011. Trong hai nghin cu nh gi tnh hnh bo co ADR giai on 2006 2008 trc y c tin hnhti bnhvinBchMaicaTrnNhnThngvNguynMinhThnh[17], [18], nhiuimtng ng cghi nhnviktqunghincucachng ti:cckhoaphngthamgiabocoADRtchccnhtbaogmTrungtmD ng v min dch lm sng, Vin tim mch, Khoa Sn, Khoa Thn kinh, Khoa Hi sctchccngdngcghinhnnhiunhtquaccbococngl ngtimtruyntnhmchvngung.Tchccthbnhhngbi ADRghinhnnhiunhtlrilon davmdida(70-74,5%),rilontng qut (10,9-19,2%) v ri lon tiu ha (5,3-7,3%). Cc con s ny tng ng kt qu ti ny l 83,5-93,0%; 21,3-23,2% v 9,8-14,1%, u cao hn so vi kt qu cahai nghincutrc.Tronghainghincutrc,mibocochcquy 49 vo mt loi ri lon c th, cn ti ny, chng ti thu thp tt c cc biu hin ADR c ghi trong bo co v phn loi chng vo cc t chc c th. iu ny c ngha l mi bo co c th lin quan n hai hoc nhiu hn s t chc c th b nh hng bi ADR.V vy, kt qu tl phn trm t chc c th b nh hng bi ADR cao hn so vi kt qu ca hai nghin cu trc. V t l thiu thng tin vng dngthuc,ccnghincuchoktqul 5,5%,cnkt quca ti chng ti l 4,9% nm 2011 v 9,86% nm 2012. T l ny nm 2011 khng c s chnhlchlnvinghincugiaion20062008bilt2011trvtrc bnh vin dng cng mt mu bo co ADR ging nhau. Nm 2012, t l bo co thiu thng tin v ng dng thuc tng ln cao c th c gii thch do vic s dng mu bo co mi cha i km vi cc bin php tp hun, hng dn bo co cho cn b y t. Nh vy, quy trnh bo co ADR mi c p dng t nm 2012 ca Bnh vinBchMaigpphnlmtngslngbocoADRnghimtrng,s lng bo co ADR c pht hin qua xt nghim cn lm sng v cht lng bo co ADR tt c cc khoa phng. iu ny chng t hiu qu sau nm u tin cpdngquitrnhmi.BngccbinphpthcyvicbocoADRv khcphc nhnghnchcntnti,cngtcbocoADRtiBnhvinBch Mai chc chn s thu c nhng kt qu tch cc hn trong tng lai. 50 KT LUN V XUT KT LUN SaukhitinhnhkhosttnhhnhbocoADRBnhvinBchMai giaion20112012,chngticmtsktlunsau:Victhayiquytrnh bocoADRBnhvinBchMaiemlinhngthayivmtslng bo co, thi gian tr hon gi bo co, c cu bo co cng nh cht lng bo co ADR ca bnh vin. -VslngbocoADR,quytrnhkhnglmtngtnglngboco chungvbocoADRhimgpnhnglmtnggp3lnsbocoADR nghimtrngvlmgimngktlbocokhngcgivTrungtm DI&ADR Quc gia. -VthigiantrhongiboconTrungtmDI&ADRQucgia,thi gian tr hon gi bo co nm 2012 ngn hn c ngha so vi nm 2011. -V c cu bo co ADR: Bo co phn b ng u hn gia cc i tng thamgiabocoADR,nhngskhoa phngthamgiabocoADRkhngthay i. ng dng thuc, phn loi thuc theo cc h dc l v cc thuc nghi ng gy ADR thng gp, cc t chc c th b nh hng, cc biu hin ADR hay gp v cc cp thuc biu hin ADR thng gp gia hai nm khng c s khc bit.-V chtlngboco, boco nm 2012cchtlngthng tincao hn bo co nm 2011 th theo im trung bnh cht lng bo co cao hn nm 2011. 51 XUT -p dng cc bin php thc y vic bo co ADR nh o to v tp hun v Cnh gic dc cho cn b y t, tng cng hot ng dc lm sng trong bnh vin,giphnhichititvbocoADRchongiboco,githngtinv ADR n cc bc s, a ra mt s khuyn khch v mt ti chnh nhm thu c bocovislngnhiuhn, nhngthngtintbocoyvchnhxc hn. -Thc hin vic gi bo co hng thng hoc trong thi gian quy nh i vi bo co ADR nghim trng theo hng dn ca B Y t nhm lm gim thi gian tr hon gi bo co. -Thc y vic gim st nhng bnh nhn c nguy c cao (tin s d ng, s dng nhng thuc c t l gp ADR cao) nhm ngn nga v kp thi x tr khi ADR xy ra. -Tng cng r sot nhng bt thng trong kt qu xt nghim cn lm sng c th lin quan n ADR ca thuc. -Khuynkhchvicbocotrctuyntrntrangweb www.canhgiacduoc.org.vn nhm gim thiu thi gian tr hon gi bo co cng nh tngtnhchnhxccathngtinthunhnc,trnhtnhtrngchvitxu thng xuyn khng dch c. TI LIU THAM KHO Ti liu tham kho ting Vit 1.Bnh vin Bch Mai (2012), "Hng dn lm bo co ADR". 2.B mn Ni, khoa Y trng i Hc Y - Dc TP. HCh Minh (2000), Cc ch s cn lm sng, Tp H Ch Minh, pp. 24-47. 3.B mn Qun l v Kinh t Dc, trng i hc Dc H Ni, D n H tr h thng Y t do Qu Ton Cu phng chng Lao, St rt v HIV/AIDS ti tr (2013), Nghin cu t l phn trm cc bin c bt lilin quan n thuc bo co c x tr ph hp ti cc bnh vin trng im. 4.B Y T (2013), Hng dn hot ng gim st phn ng c hi ca thuc (ADR)ticccskhmbnh,chabnh.Ban hnhkmtheoQuytnh1088 ca B trng B Y t. p. 3-13. 5.B Y T (2012), Thng t s 31/2012/TT-BYT v vic hng dn hot ng dc lm sng trong bnh vin. 6.B Y T (2011), Php ch Dc, NXB Gio dc Vit Nam, pp. 177. 7.BYT(2011),Thngts22/2011/TT-BYTQuynhtchcvhot ng ca khoa Dc bnh vin. 8.BYT(2011),Thngts23/2011/TT-BYTvvichngdnsdng thuc trong cc c s y t c ging bnh. 9.B Y T (1997), Thng t s 08/BYT-TT v hng dn t chc, chc nng, nhim v ca Hi ng Thuc v iu tr bnh vin. 10.BYT(2009),TrungtmDcin-DcThQucgiaVitNam, Dc th Quc gia Vit Nam (National Drug Formulary), NXB Y hc. 11.Hy Thanh H (2001), Kho st tnh hnh s dng khng sinh v phn ng c hicakhngsinhtimtskhoabnhvinBchmaitnm1998-2000,Kha lun tt nghip Dc s i hc, Trng i hc Dc H Ni. 12.Trn Ngn H (2012), "Tng kt cng tc bo co ADR nm 2011", Bn tin Cnh gic dc, 1, pp. 12-14. 13.HingThucviutrbnhvinBchMai(2012),"Khuyncov vic s dng calcitonin ko di trong iu tr long xng". 14.V Th Thu Hng (2012), nh gi hot ng ca Hi ng Thuc v iu tr trong xy dng v thc hin danh mc thuc ti mt s bnh vin a khoa, Lun n Tin s Dc hc, Trng i hc Dc H Ni15.Hong Kim Huyn (ch bin) (2011), Dc lm sng, NXB Y hc, pp. 87-102. 16.Quc Hi nc Cng Ha X Hi Ch Ngha Vit Nam (2010), Lut Dc, NXB T Php. p. 41. 17.TrnNhnThng(2012),"TnghpvphntchccbocoADRca Bnh vin Bch Mai giai on 2006-2008", Tp ch Dc hc, 434, pp. 10-16. 18.NguynMinhThnh(2010),Tng hpv nhgitnh hnh boco phn ngchicathucti bnhvinBchMaigiaion2006-2008,Khaluntt nghip Dc s i hc, Trng i hc Dc H Ni. 19.L Th Phng Tho (2010), "nh gi thc trng bo co phn ng c hi cathuc(ADR)ticccsiutrVitNamtthng6/2006nthng 12/2008", Kha lun tt nghip Dc s, trng i hc Dc H Ni, pp. 20.L Th Phng Tho, Hong Thanh Mai, Trn Thu Thy, V Th Thu Thy, NguynHongAnh(2011),"Phntchthctrngbocophnngchica thuc (ADR) ti Vit Nam giai on 2006-2008", Tp ch Y hc thc hnh, 787, pp. 12-34. 21.Trung tm DI&ADR Quc gia (2012), "Tng kt cng tc bo co ADR n ht qu III nm 2012", Bn tin Cnh gic dc, 4, pp. 10-12. 22.Trung tm DI&ADR Quc gia (2012), "Tng kt cng tc bo co ADR nm 2012". 23.Trung tm DI&ADR Quc gia (2010), Tng kt cng tc bo co ADR nm 2010. p. 10-24. Ti liu tham kho ting Anh 24.AagaardL.,NielsenL.H.,HansenE.H.(2009),"Consumerreportingof adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006", Drug Saf, 32(11), pp. 1067-74. 25.Ahmad S. R., Freiman J. P., Graham D. J., Nelson R. C. (1996), "Quality of adversedrugexperiencereportssubmittedbypharmacistsandphysicianstothe FDA", Pharmacoepidemiol Drug Saf, 5(1), pp. 1-7. 26.Alvarez-RequejoA.,CarvajalA.,BegaudB.,MorideY.,VegaT.,AriasL. H.(1998),"Under-reportingofadversedrugreactions.Estimatebasedona spontaneous reporting scheme and a sentinel system", Eur J Clin Pharmacol, 54(6), pp. 483-8. 27.BackstromM.,EkmanE.,MjorndalT.(2007),"Adversedrugreaction reporting by nurses in Sweden", Eur J Clin Pharmacol, 63(6), pp. 613-8. 28.BackstromM.,MjorndalT.(2006),"Asmalleconomicinducementto stimulateincreasedreportingofadversedrugreactions--awayofdealingwithan old problem?", Eur J Clin Pharmacol, 62(5), pp. 381-5. 29.BackstromM.,MjorndalT.,DahlqvistR.(2004),"Under-reportingof seriousadversedrugreactionsinSweden",PharmacoepidemiolDrugSaf,13(7), pp. 483-7. 30.BandekarM.S.Bandekar,S.R.Anwikar,N.A.Kshirsagar(2010),"Quality check of spontaneous adverse drug reaction reporting forms of different countries", Pharmacoepidemiology and Drug Safety, 19, pp. 1181-1185. 31.BatesD.W.,Cullen,D.andLaird,N.(1995),"Incidenceofadversedrug events and potential adverse drug events: implications for prevention", J. Am. Med. Assoc, 274, pp. 29-34. 32.BatesD.W.,Spell,N.,Cullen,D.J.,Burdick,E.,Laird,N.,Peterson,L.A., Small,S.D.,Sweitzer,B.J.andLeape,L.L.(1997),"Thecostsofadversedrug eventsinhospitalizedpatients.AdverseDrugEventsPreventionStudyGroup", ibid., 277, pp. 307-311. 33.BeltonK.J.(1997),"Attitudesurveyofadversedrug-reactionreportingby healthcareprofessionalsacrosstheEuropeanUnion.TheEuropean Pharmacovigilance Research Group", Eur J Clin Pharmacol, 52(6), pp. 423-7. 34.Biriell C Edwards IR. (1997), "Reasons for reporting ADR - some thoughts based on international review", Pharmacoepidemiol Drug Saf, 6, pp. 21-6. 35.BlegenRondaG.Hughes;MaryA.(2008),PatientSafetyandQuality:An Evidence-BasedHandbookforNurses.,AgencyforHealthcareResearchand Quality (US), pp. 398. 36.Bracchi R. C., Houghton J., Woods F. J., Thomas S., Smail S. A., Routledge P.A.(2005),"Adistance-learningprogrammeinpharmacovigilancelinkedto educational credits is associated with improved reporting of suspected adverse drug reactions via the UK yellow card scheme", Br J Clin Pharmacol, 60(2), pp. 221-3. 37.BrajovicS.,Piazza-HeppT.,SwartzL.,DalPanG.(2012),"Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration", Pharmacoepidemiol Drug Saf, 21(6), pp. 565-70; discussion 571-2. 38.Bukirwa H., Nayiga S., Lubanga R., Mwebaza N., Chandler C., Hopkins H., Talisuna A. O., Staedke S. G. (2008), "Pharmacovigilance of antimalarial treatment inUganda:communityperceptionsandsuggestionsforreportingadverseevents", Trop Med Int Health, 13(9), pp. 1143-52. 39.CastelJ.M.,FiguerasA.,PedrosC.,LaporteJ.R.,CapellaD.(2003), "Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads", Drug Saf, 26(14), pp. 1049-55. 40.ClassenD.C.,Pestotnik,S.L.,Evans,R.S.,Lloyd,J.F.andBurke,J.P. (1997),"Adversedrugeventsinhospitalizedpatients.Excesslengthofstay,extra costs, and attributable mortality", J. Am. Med. Assoc, 277, pp. 301-306. 41.EdwardsI.R.,AronsonJ.K.(2000),"Adversedrugreactions:definitions, diagnosis, and management", Lancet, 356(9237), pp. 1255-9. 42.FeelyJ.,MoriartyS.,andPO'Connor(1990),"Stimulatingreportingof adverse drug reactions by using a fee.", BMJ, 300(6716), pp. 2223. 43.FigueirasA.,HerdeiroM.T.,PoloniaJ.,Gestal-OteroJ.J.(2006),"An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial", JAMA, 296(9), pp. 1086-93. 44.Forster A. J., Halil R. B., Tierney M. G. (2004), "Pharmacist surveillance of adverse drug events", Am J Health Syst Pharm, 61(14), pp. 1466-72. 45.Gedde-DahlAHargP,Stenberg-NilsenH,BuajordetM,GranasAG,Horn AM.(2007),"Characteristicsandqualityofadversedrugreactionreportsby pharmacists in Norway.", Pharmacoepidemiol Drug Saf. , 16(9), pp. 999-1005. 46.GranasA.G.,BuajordetM.,Stenberg-NilsenH.,HargP.,HornA.M. (2007),"Pharmacists'attitudestowardsthereportingofsuspectedadversedrug reactions in Norway", Pharmacoepidemiol Drug Saf, 16(4), pp. 429-34. 47.GreenCFMottramDR,RowePH,elal.(1999),"Adversedrugreaction monitoringbyUnitedKingdomhospitalpharmacydepartments:impactofthe introductionof'yellowcard'reportingfor pharmacists",IntJPharmPract,7,pp. 238-46. 48.Hardeep,JagminderKaurBajaj,Rakeshkuma(2013),"ASurveyonthe Knowledge,AttitudeandthePracticeofPharmacovigilanceAmongtheHealth CareProfessionalsinaTeachingHospitalinNorthernIndia",JournalofClinical and Diagnostic Research, 7(1), pp. 97-99. 49.HazellL.ShakiS.A. (2006),"Under-reporting ofadverse drugreactions:a systematic review", Drug Safety, 29, pp. 385-386. 50.Hazell L., Shakir S. A. (2006), "Under-reporting of adverse drug reactions : a systematic review", Drug Saf, 29(5), pp. 385-96. 51.HerdeiroM.T.,FigueirasA.,PoloniaJ.,Gestal-OteroJ.J.(2005), "Physicians'attitudesandadversedrugreactionreporting:acase-controlstudyin Portugal", Drug Saf, 28(9), pp. 825-33. 52.Johansson M. L., Brunlof G., Edward C., Wallerstedt S. M. (2009), "Effects of e-mails containing ADR information and a current case report on ADR reporting rate and quality of reports", Eur J Clin Pharmacol, 65(5), pp. 511-4. 53.KathleenHollowayTerryGreen(2003),DrugandTherapeutics Committees: A practical guide, World Health Organization, pp. 2-61. 54.Kazeem A Oshikoya Jacob O Awobusuyi (2009), "Perceptions of doctors to adversedrugreactionreportinginateachinghospitalinLagos,Nigeria",BMC Clinical Pharmacology, 9(14), pp. 6. 55.LazarouLazarouJ.(1998),"Incidenceofadversedrugreactionsin hospitalised:ameta-anylasisofprospectivestudies",JournalofAmerianMedical Association, 279, pp. 1200-1205. 56.Leape L. L., Brennan T. A., Laird N., Lawthers A. G., Localio A. R., Barnes B.A.,HebertL.,NewhouseJ.P.,WeilerP.C.,HiattH.(1991),"Thenatureof adverseeventsinhospitalizedpatients.ResultsoftheHarvardMedicalPractice Study II", N Engl J Med, 324(6), pp. 377-84. 57.LeapeLL.(1995),"Preventingadversedrugevents",AmJHealthSyst Pharm, 52, pp. 379-82. 58.Lexchin J. (2006), "Is there a role for spontaneous reporting of adverse drug reactions? ", CMAJ., 174, pp. 191192. 59.Lopez-GonzalezE.,HerdeiroM.T.,FigueirasA.(2009),"Determinantsof under-reportingofadversedrugreactions:asystematicreview",DrugSaf,32(1), pp. 19-31. 60.Macfarlane Nicholas , Lovells Paul Brown (2007), Pharmacovigilance, John Wiley and Sons, pp. 7-15. 61.Management Sciences for Health (2007), Drug and Therapeutics Committee Training Course, World Health Organization. 62.McGettiganP.,GoldenJ.,ConroyR.M.,ArthurN.,FeelyJ.(1997), "Reportingofadversedrugreactionsbyhospitaldoctorsandtheresponseto intervention", Br J Clin Pharmacol, 44(1), pp. 98-100. 63.Medical Products Agency Sweden (2006), Code of statutes.64.MethodologyWHOCollaboratingCentreforDrugStatistics(2013), Guidelines for ATC classification and DDD assignment 2013, pp. 15. 65.MillerR.R.(1974),"Hospitaladmissionsduetoadversedrugreactions:A reportfromtheBostonCollaborativeDrugSurveillanceprogram",Arch.Intern. Med., 134, pp. 219-223. 66.Montanastatehospital,Adversedrugreactionreporting.2012:Montana state hospital policy and procedure. p. 1. 67.NationalNationalResearchCouncil(2007),PreventingMedicationErrors, The National Academies Press, Washington, DC. 68.Nichols V., Theriault-Dube I., Touzin J., Delisle J. F., Lebel D., Bussieres J. F.,BaileyB.,CollinJ.(2009),"Riskperceptionand reasonsfor noncompliancein pharmacovigilance: a qualitative study conducted in Canada", Drug Saf, 32(7), pp. 579-90. 69.Okezie E. O., Olufunmilayo F. (2008), "Adverse drug reactions reporting by physicians in Ibadan, Nigeria", Pharmacoepidemiol Drug Saf, 17(5), pp. 517-22. 70.PassierA.,tenNapelM.,vanGrootheestK.,vanPuijenbroekE.(2009), "Reporting of adverse drug reactions by general practitioners: a questionnaire-based study in the Netherlands", Drug Saf, 32(10), pp. 851-8. 71.Pedros C., Vallano A., Cereza G., Mendoza-Aran G., Agusti A., Aguilera C., DanesI.,VidalX.,ArnauJ.M.(2009),"Aninterventiontoimprovespontaneous adversedrugreactionreportingbyhospitalphysicians:atimeseriesanalysisin Spain", Drug Saf, 32(1), pp. 77-83. 72.Ramesh M., Pandit J., Parthasarathi G. (2003), "Adverse drug reactions in a southIndianhospital--theirseverityandcost involved",PharmacoepidemiolDrug Saf, 12(8), pp. 687-92. 73.RawlinsMD(1988),"Spontaneousreportingofadversedrugreactions.I: the data.", Br J Clin Pharmacol., 26(1), pp. 15. 74.SaulWeingartN.,RossMcLWilson,RobertWGibberd,Bernadette Harrison (2000), "Epidemiology of medical error", BMJ 320, pp. 774. 75.SchumockGTThorntonJP(1992),"Focusingonthepreventabilityof adverse drug reactions", Hosp Pharm, 27, pp. 538. 76.Scott H. D., Thacher-Renshaw A., Rosenbaum S. E., Waters W. J., Jr., Green M.,AndrewsL.G.,FaichG.A.(1990),"Physicianreportingofadversedrug reactions.ResultsoftheRhodeIslandAdverseDrugReactionReportingProject", JAMA, 263(13), pp. 1785-8. 77.SuC.,JiH.,SuY.(2010),"Hospitalpharmacists'knowledgeandopinions regardingadversedrugreactionreportingin NorthernChina",Pharmacoepidemiol Drug Saf, 19(3), pp. 217-22. 78.TabaliM.etal.(2009),"Educationalinterventiontoimprovephysician reportingofadversedrugreactions(ADRs)inaprimarycaresettingin complementary and alternative medicine", BMC Public Health, 9, pp. 274. 79.TokluHZUysalMK(2008),"TheknowledgeandattitudeoftheTurkish communitypharmaciststowardpharmacovigilanceintheKadikoydistrictof Istanbul", Pharm World Sci., 30(5), pp. 556-562. 80.United States Pharmacopeia, Drug Quality and Information Program (2007), EnsuringtheQuality ofMedicinesinResource-LimitedCountries:Anoperational guide, pp. 52-63. 81.Vallano A., Cereza G., Pedros C., Agusti A., Danes I., Aguilera C., Arnau J. M.(2005),"Obstaclesandsolutionsforspontaneousreportingofadversedrug reactions in the hospital", Br J Clin Pharmacol, 60(6), pp. 653-8. 82.VanGrootheestMDA.C.,vanPuijenbroekE.P.,MD, PhDandL.T.W.de Jong-vandenBergPharmD,PhD.(2002),"Contributionofpharmaciststothe reporting of adverse drug reactions", Pharmacoepidemiol Drug Saf, 11(3), pp. 205-10. 83.Wallerstedt S. M., Brunlof G., Johansson M. L., Tukukino C., Ny L. (2007), "Reportingofadversedrugreactionsmaybeinfluencedbyfeedbacktothe reporting doctor", Eur J Clin Pharmacol, 63(5), pp. 505-8. 84.WHO (2013), Glossary of terms used in Pharmacovigilance, pp. 4. 85.WHO (2012), WHO Adverse Reaction Terminology. 86.WHO(2004),WHO guidelines on safetymonitoringof herbalmedicinesin pharmacovigilance systems, Geneva, pp. 7. 87.WHOWHOCollaboratingCenterforInternationalDrugMornitoring (2002),SafetyofMedicinesAguidetodetectingandreportingAdverseDrug Reactions, Geneva Switzerland, pp. 5-18. 88.WorkingGroupIV.CIOMS,BenefitRiskBalanceforMarket-ingDrugs: Safety Signals. 1998, CIOMS: Geneve. Ti liu tham kho ting Php 89.Khabbal,Y.,Alami,L.,Nejjari,C.(2012),Introductionof pharmacovigilanceinanewuniversityhospitalinMorocco:howandwhy,East Mediterr Health J, 18(6), pp. 648-52. Trang web tham kho 90.BnhvinBchMai(2013),"LchshnhthnhbnhvinBchMai", Retrieved, from http://bachmai.gov.vn. 91.KhoaKhoaDcBnhvinBchMai,GiithiukhoaDcBnhvin BchMai,CngthngtinintkhoaDcbnhvinBchMai, www.duocbachmai.org. 92.National National Coordinating Council for Medication Error Reporting and Prevention,Whatisamedicationerror?.2013: http://www.nccmerp.org/aboutMedErrors.html. PH LC Ph lc 1: Mt s hnh nh ca cc hnh thc bo co ADR ti bnh vin Bch Mai nm 2011-2012 Hnh1.1SbocoADRlutikhoa lm sng nm 2011 Hnh1.2.BiumubocoADRc lu ti khoa lm sng nm 2011 Hnh 1.3. Ni dung ca mt s bo co ADR nm 2011 Hnh 1.4. Ba s bo co ADR c lu ti khoa lm sng nm 2012 Hnh 1.5. Cc mu bo co ADR trong s bo co nm 2012 Hnh 1.6. Giao din mc bo co ADR trc tuyn ti trang web www.canhgiacduoc.org.vn Ph lc 2: L do s dng thuc theo phn lai ICD-10 Nm 2011Nm 2012 Phn loi ICD Loi bnh ttTn sut T l (%) Tn sut T l (%) A00 - B99Bnh nhim trng v k sinh trng159,152215,49 C00 - D48Bu tn sinh84,8800,00 D50 - D98 Bnhca mu,c quanto muvcc ri lon lin quan n c ch min dch 10,6121,41 E00 - E90 Bnhnitit,dinhdngvchuyn ha 10,6174,93 F00 - F99Ri lon tm thn v hnh vi00,0010,70 G00 - G99Bnh h thn kinh53,0553,52 H00 - H59Bnh mt v phn ph21,2200,00 H60 - H95Bnh tai v xng chm00,0000,00 I00 - I99Bnh h tun hon2314,0253,52 J00 - J99Bnh h h hp127,32139,15 K00 - K93Bnh h tiu ha95,4953,52 L00 - L99Cc bnh da v m di da2012,2032,11 M00- M99 Bnhhc-xng-khpvmlin kt 74,271913,38 N00 - N99Bnh h sinh dc - Tit niu31,8310,70 O00 - O99Thai nghn, sinh , hu sn2615,8521,41 P00- P96 Mtsbnhlxutphttrongthik chu sinh 00,0000,00 Q00- Q99 Dttbmsinh,bindngvbt thng v nhim sc th 53,0500,00 R00 - R99 Cctriuchng,duhiuvnhng biu hin lm sng v cn lm sng bt 21,2221,41 thng khng phn loi phn khc S00- T98 Chnthng,ngcvmtshu qu khc do nguyn nhn bn ngoi 63,6653,52 V01 - Y98 Nguyn nhn ngoi sinh ca bnh tt v t vong 63,6600,00 Z00- Z99 Ccyutnhhngntnhtrng sc khe v tip xc dch v y t 21,221913,38 Khng r116,713121,83